- The document analyzes misperceptions about migraine and its treatment. It finds that while migraine affects more women, over half of diagnosed migraine patients are over age 40, contradicting the idea that it only impacts young women.
- It also finds that the majority (76%) of diagnosed adult migraine patients have cardiovascular risk factors that caution against the use of triptan medications, much higher than generally believed. Having a migraine diagnosis increases the risk of future cardiovascular events.
- Current treatment patterns show triptan use is lower in high-risk patients than others, and off-label opioid use is higher, suggesting this population is underserved by existing options.
Medical errors are one of the top 10 causes of death according to the WHO. A review of statistical evidence found that one in 10 hospital admissions results in an adverse event and one in 300 admissions results in death due to medical errors. The estimated number of people harmed or killed each year by unnecessary medical care and procedures in the US is in the millions, including over 2 million adverse drug reactions, 20 million unnecessary antibiotic prescriptions, and 8.9 million unnecessary hospitalizations. Only a small fraction of medical errors are ever reported due to various systemic issues.
Growth, Innovation And Leadership Insights In Apac Healthcare Market June 2009Jasminder_Kaur
This document contains information about growth, innovation, and leadership insights in the APAC healthcare industry. It discusses 10 key trends driving changes in the healthcare market across Asia, including rising costs, an aging population, new business models, and increasing mergers and acquisitions. It also examines emerging medical technologies, such as infection control devices, home therapy solutions, and robotic surgical systems. Finally, the document provides strategies for healthcare market leaders to adapt, including becoming a brand builder, market maker, or standard setter through strategic alliances, customized solutions, and achieving scale.
The document provides an overview of the Hunter Syndrome market insights, epidemiology, and market forecast from 2020 to 2030. It discusses key insights on the disease including prevalence, symptoms, types, and current treatment practices. It also includes graphs on epidemiology segmentation and prevalence trends in the 7 major markets from 2017-2030. The market outlook discusses the current ERT treatment and potential opportunities for new emerging therapies to treat the disease. It forecasts that the market size will increase significantly due to expected launches of new therapies and increasing R&D activities.
various measures for the measurement of outcome such as incidence prevalence and other drug us measures are briefly discussed here with suitable examples and equations
Austin Ophthalmology is an open access, peer reviewed, scholarly journal dedicated to publish articles covering all areas of Ophthalmology.
The journal aims to promote latest information and provide a forum for doctors, researchers, physicians, and healthcare professionals to find most recent advances in the areas of Ophthalmology. Austin Ophthalmology accepts research articles, reviews, mini reviews, case reports and rapid communication covering all aspects of Ophthalmology.
Austin Ophthalmology strongly supports the scientific up gradation and fortification in related scientific research community by enhancing access to peer reviewed scientific literary works. Austin Publishing Group also brings universally peer reviewed journals under one roof thereby promoting knowledge sharing.
1) The study evaluated a smartphone app aimed at improving medication adherence and lifestyle changes in myocardial infarction patients. 174 patients were randomized to either an interactive app (active group) or a simplified app (control group) in addition to usual post-MI care.
2) The primary outcome was a composite score of ticagrelor adherence based on missed doses and treatment gaps, measured via patient-registered data in the app. Secondary outcomes included changes in cardiovascular risk factors, quality of life, and patient satisfaction.
3) At 6 months, greater ticagrelor adherence was achieved in the active group compared to the control group based on the adherence score. The active group also showed trends toward improved smoking cessation, physical
This document discusses medication errors, including their scope and causes. It notes that medication errors are a major problem, causing many preventable deaths each year and billions in costs. Common causes of errors include look-alike drug names and packaging, multiple drug concentrations, labeling issues, and time constraints on nurses. High-risk drugs and IV medications are particularly prone to errors. Errors can involve wrong drugs, doses, preparations or contamination. The document outlines various technologies and practices that can help reduce errors, such as electronic prescribing, bar coding, and computerized physician order entry.
This document discusses the justification and roles of an Emergency Medicine Pharmacist (EMP). It begins by outlining the objectives which include explaining the justification for an EMP, describing their core roles and strategies for implementation, and ways EMPs can improve patient care. It then discusses how the emergency department is inherently a patient safety risk due to factors like high volume and distractions. Having an EMP can help fill gaps in medication safety. The document outlines the roles of an EMP which include clinical consultation, order screening, high-risk medication preparation, and education. It concludes by providing strategies for implementing an EMP position, overcoming challenges, and demonstrating return on investment through cost savings from reducing adverse drug events.
The document discusses several developments for treating inherited neuropathies:
1) The first gene therapy clinical trial to treat an inherited neuropathy, Giant Axonal Neuropathy, is approved. It will deliver a healthy copy of the GAN gene to spinal cord nerves using an AAV9 viral vector.
2) The Hereditary Neuropathy Foundation is creating a directory of expert healthcare providers for Charcot-Marie-Tooth and providing them resources to improve diagnosis and care.
3) An advisory board meeting was held to discuss the Foundation's research funding to date and future goals, including several projects aimed at developing treatments for CMT and related diseases.
The document discusses quality improvement initiatives in several countries aimed at reducing patient harm and mortality in healthcare. It outlines specific interventions and goals for the UK, Scotland, Denmark, Canada, Wales, and the US including reducing surgical complications, preventing central line infections, reducing harm from high-risk medicines, and preventing MRSA infections. Evidence is presented on the impact of certain interventions like proper use of antibiotics, beta blockers, and venous thromboembolism prophylaxis in surgery.
Evaluation of Clinical Decision Support Alerts for Medications Contraindicate...Allison McCoy
Computerized provider order entry-based alert systems were created to advise health care providers when prescribing medications to patients. This tool is helpful when ordering medications for cancer patients, due to their intensified risk of experiencing drug interactions with cancer therapies. The purpose of the study was to describe alerts for contraindicated medications of cancer patients to understand reasons for alert overrides and to provide additional information for further study in improving clinical support systems.
Eisai developed the drug BANZEL to treat Lennox-Gastaut Syndrome, a rare and severe form of epilepsy. To effectively communicate information about appropriate use of BANZEL, Eisai used physician-level data to identify the small population of neurologists who treat LGS patients. In New Hampshire, where a data restriction law was passed, Eisai struggled to identify these neurologists and faced delays in disseminating important safety information about BANZEL. The experience demonstrated how such laws can negatively impact patient care by reducing the effectiveness and efficiency of information sharing regarding new treatment options.
Precision Medicine: Opportunities and Challenges for Clinical TrialsMedpace
The momentum and muscle behind "finding the right drug for the right patient at the right dose" has further escalated with President Barack Obama’s announcement of a $215 million dollar Precision Medicine Initiative earlier this year. In this webinar, Dr. Frank Smith will explore advances in precision medicine and how it is affecting clinical research. As a pediatric hematologist/oncologist, he will use his extensive clinical and research background as a backdrop for the discussion.
Topics will include:
The evolution of "personalized medicine" to "precision medicine"
How state-of-the-art molecular biology is creating new diagnostic and prognostic strategies
How these new strategies are helping inform the design of clinical trials
Case study: How precision medicine is improving clinical trials in hematology and oncology
This document provides information about the Emergency Medicine Reports Summit 2015 taking place August 28-29 in Las Vegas. It is celebrating AHC Media's 40th anniversary of providing continuing education. The summit will feature talks from leading emergency physicians on the top 10 issues in emergency medicine today. Attendees can earn up to 14.5 credits for continuing medical education and nursing by attending presentations, completing a post-test and evaluation. The summit is intended for emergency physicians, nurses and staff and aims to discuss approaches to common emergencies, ways to increase efficiency in emergency departments, new challenges in emergency medicine, treatments for unusual disorders, and improving workplace satisfaction.
This presentation features a compilation of national medical malpractice claim data from 2006 to 2015. It highlights the three most prevalent chief medical factors and patient outcomes by specialty.
NGS-based diagnostic testing compared to single-marker genetic testing (SMGT), has the potential to improve testing efficiency and to identify more cancer patients who could benefit from targeted therapies, but the impact on outcomes and total costs of care is uncertain. Recent studies using simulation modeling informed with data from the Flatiron Health database, representing curated electronic health record-derived clinical information from 191 oncology practices, has shown only moderate cost effectiveness of NGS vs. SGMT for patients with advanced non-small cell lung cancer (aNSCLC). The data suggests, however, that efforts to increase the proportion of patients who receive targeted therapies would improve the cost-effectiveness of NGS. To effectively inform access and reimbursement policy decisions there is a need to examine the NGS value proposition from the perspective of all stakeholders.
Author(s) and affiliation(s): Lotte Steuten (Office of Health Economics, London, UK); Bernardo Goulart (Fred Hutchinson Cancer Research Center, Seattle, WA, US & Seattle Cancer Care Alliance, Seattle, WA, US); Neal J. Meropol (Flatiron Health, New York, NY, US & Case Western Reserve University, Cleveland, OH, US); Daryl Pritchard (Personalized Medicine Coalition, Washington, DC, US); and Scott D. Ramsey (Fred Hutchinson Cancer Research Center, Seattle, WA, US)
Event: ISPOR 2019
Location: New Orleans, LA, United States
Date: 20/05/2019
This study examined whether a psychological opioid-risk evaluation influenced physicians' opioid prescribing decisions for 151 chronic pain patients being considered for chronic opioid therapy. Patients underwent an evaluation that assigned them an opioid-risk level of low, moderate, or high. The evaluation report was made available to physicians before their follow-up appointment where prescribing decisions were made. Results found that risk level significantly predicted opioid prescribing, with lower risk patients more likely to be prescribed opioids. A history of substance abuse also predicted less likely opioid prescribing. Demographic factors did not significantly influence prescribing contrary to some previous research. This suggests providing additional information about patients' abuse risk aids prescribing decisions and may reduce bias.
The document discusses post-marketing surveillance (PMS) of pharmaceutical drugs. PMS involves monitoring drug safety after market release using approaches like spontaneous reporting databases, patient registries, and record linkage between health databases. Data from PMS is important for discovering undesirable effects that were not found in pre-market clinical trials due to limited sample sizes and durations. PMS plays a key role in improving understanding of a drug's risks and benefits in real-world use.
The safe use of medicines is perhaps the single most important criteria that any regulatory authority within a given country has to ensure in order both to protect the public health and the integrity of its health care system. For the same purpose pharmacovigilance was established. According to WHO, Pharmacovigilance is the science and activities related to the collection, detection, and assessment of ADR’s. It promotes the systematic, rational use and assures the confidence for the safety of drugs. It improves patient care and safety. Significance of pharmacovigilance is growing as the patients or consumers have become more responsive about the advantage and hazard of medicines. Pharmacovigilance is a complex process and a robust system is essential to undertake the activity. A good pharmacovigilance system will identify the hazard aspects in the short period of time. This review article tries to explain the some basic principles, history and developments, methods and some scope of this developing field i.e. Pharmacovigilance in India.
Epilepsy Drugs Market PPT: Growth, Outlook, Demand, Keyplayer Analysis and Op...IMARC Group
The global epilepsy drugs market size reached US$ 2.3 Billion in 2023. Looking forward, IMARC Group expects the market to reach US$ 4.4 Billion by 2032, exhibiting a growth rate (CAGR) of 7.16% during 2024-2032.
More Info:- https://www.imarcgroup.com/epilepsy-drugs-market
Pharmaceutical Industry's Role in Advancing Precision MedicineClinosolIndia
The pharmaceutical industry plays a pivotal role in driving advancements in precision medicine, a revolutionary approach that tailors medical treatment to individual patient characteristics. By leveraging cutting-edge technologies, conducting innovative research, and collaborating with diverse stakeholders, the pharmaceutical sector contributes significantly to the development and implementation of precision medicine, ushering in a new era of personalized healthcare.
This study evaluated whether continuing dual antiplatelet therapy (DAPT) beyond one year after drug-eluting stent placement reduces adverse events. It was a large randomized controlled trial comparing aspirin + thienopyridine to aspirin + placebo in patients who had completed one year of standard DAPT. Continuing thienopyridine therapy until 30 months reduced stent thrombosis and major adverse cardiovascular events, but increased moderate or severe bleeding risks compared to placebo. The study provides evidence that prolonging DAPT to 30 months may benefit patients who complete one year of standard therapy without adverse events.
[Inf 295] week 6 parul seth patient-reported outcomes as a source of evidence...parulseth
Patient-reported outcomes from online communities can provide new evidence for off-label drug use. A study of two drugs on PatientsLikeMe found that less than 1% of users took modafinil and 9% took amitriptyline for their approved uses, while most reported the drugs helped for off-label conditions. Effectiveness was often comparable or better for off-label uses. Online data collection could identify new treatment targets at low cost compared to traditional trials, but has limitations like potential for bias and incomplete information.
Over 350 million people worldwide are suffering from rare diseases. Which is why it is necessary to understand the rare disease landscape to date.
Drug development is challenging at the best of times, and made even harder within the realm of rare diseases. Overall, the largest number of drugs has targeted indications within the therapeutic areas of oncology and infectious disease (ID), with malaria being an area of high interest with both therapeutic and preventive interventions.
View this slideshare to get the most accurate and timely intelligence about rare diseases drug development.
In this detailed 20-page report, containing numerous comparative graphs, you will discover:
- The top 25 Rare Diseases by total drugs in development to date
- Current Rare Disease drug development landscape
- Top 15 originators of drugs in development for Rare Diseases (includes non-rare disease drug counts and % of portfolio dedicated to Rare Diseases)
- Therapeutic area distribution of rare diseases and drugs in development
- The top 5 Rare Diseases by drug count per therapeutic area (TA)
- Rare Infectious Diseases with 10 or more drugs in development
- The top 15 originators developing drugs for Rare Infectious Diseases
- Rare cancers with 10 or more drugs in development
- The top 15 originators developing drugs for rare cancers
- Non-ID, non-cancer Rare Diseases with 20 or more drugs in development
- The top 15 originators developing drugs for non-ID, non-cancer Rare Diseases
The document discusses the importance of consumer reporting of adverse drug reactions (ADRs) in Malaysia. It notes that while Malaysia has a national pharmacovigilance program, it suffers from weaknesses like under-reporting and a lack of consumer involvement. Consumer reporting can help address under-reporting by capturing ADRs not reported by healthcare professionals. It also promotes consumer rights and participation. The document argues for establishing a consumer reporting program in Malaysia and enhancing the existing national pharmacovigilance program through improved awareness, a national drug prescription database, and strategies to improve reporting.
Prescription Pharmaceuticals Market, Global Revenue, Trends, Growth, Share, S...Scalar Market Research
Prescription Pharmaceuticals Market to grow from USD 761.85 billion in 2016 and reach USD 918.74 billion by 2020, growing at a CAGR of 4.8% during the forecast period.
Browse report : https://www.scalarmarketresearch.com/market-reports/prescription-pharmaceuticals-market
The global acquired orphan blood diseases therapeutics market size reached US$ 8.12 Billion in 2022. Looking forward, IMARC Group expects the market to reach US$ 13.34 Billion by 2028, exhibiting a growth rate (CAGR) of 8.30% during 2023-2028.
More Info:- https://www.imarcgroup.com/acquired-orphan-blood-diseases-therapeutics-market
Preventing Medication Errors: A $21 Billion OpportunityHealth Catalyst
With a potential industry-wide savings of almost $21 billion and an impact on more than seven million patient lives, preventing harmful medication error is a significant improvement opportunity for health systems. Also known as adverse drugs events (ADEs), harmful medication errors comprise about 37 percent of all medical harm. Approximately 50 percent of ADEs are preventable, making their reduction a highly impactable area of patient safety.
Current data and analytics workflow tools are making ADE surveillance, monitoring, and prevention increasingly more effective with four key capabilities:
Perspective surveillance for ADEs and identification of previously undescribed ADEs.
Identification of the root cause of many ADEs by drug class.
Prescription at appropriate doses for patients with compromised kidney or liver functions.
Identification of different types of harm to find causes.
The document discusses medicines authentication and outlines several myths to be challenged regarding the Falsified Medicines Directive (FMD), healthcare industry, authentication systems, and a UK pilot project. It proposes conducting a UK pilot to evaluate an authentication system, support FMD compliance, and stimulate stakeholder engagement. Key lessons from the pilot so far include the need for multi-organizational support and representative tests, as well as the importance of clinical engagement and governance structures.
The global acquired orphan blood diseases therapeutics market size reached US$ 8.8 Billion in 2023. Looking forward, IMARC Group expects the market to reach US$ 17.2 Billion by 2032, exhibiting a growth rate (CAGR) of 7.5% during 2024-2032.
More Info:- https://www.imarcgroup.com/acquired-orphan-blood-diseases-therapeutics-market
Pharmacoepidemiology is the study of the use and effects of drugs in large populations. The document discusses the definition, origins, need and applications of pharmacoepidemiology. Specifically, it notes that pharmacoepidemiology applies epidemiological techniques to study drug use and effects in populations. It also discusses limitations of pre-marketing drug trials that pharmacoepidemiology aims to address through post-marketing surveillance and other techniques.
This document discusses the importance and benefits of pharmacogenomics in clinical practice. Pharmacogenomics is the study of how genes affect a person's response to medications. It combines pharmacology and genomics to develop safe and effective medication doses tailored to a person's genetic makeup. Integrating pharmacogenomic testing into practice can help reduce adverse drug reactions, enhance patient outcomes, and lower healthcare costs by avoiding trial-and-error prescribing. Certain populations, such as older adults taking multiple chronic medications, are most likely to benefit from this personalized approach to medication treatment and management. Successful integration requires a partnership approach to help navigate workflow requirements and provide expertise, education and support to providers.
The document discusses perspectives on risk from various healthcare stakeholders. It finds that while stakeholders generally expect longer lifespans, opinions diverge on expectations for curing diseases like cancer. U.S. payers and biopharma executives are less optimistic than others about cost-effective healthcare. Patients want information on medication benefits but are less confident in understanding risks. Both U.S. and U.K. patients want new drugs faster but many also think approval processes don't adequately balance safety. Stakeholders must work together to better understand differing views of risk.
This document discusses the potential for a mental health app system to help the millions of Americans suffering from mental illness. It notes that nearly 25 million Americans experience serious psychological distress each year, but only a portion receive treatment. It then outlines features of a proposed mental health app system that could increase self-monitoring, reduce emergency room visits and costs, and enable more effective early treatment through data collection. The app system would provide a support network and reporting tools to help and connect patients, caregivers, and clinicians. It argues that such a system could improve health outcomes and lower healthcare costs if designed based on evidence-based practices and efficacy metrics.
These are some frequently asked questions in Pharmacovigilance Interview & its Preparation.
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Similar to Facts Addressing Migraine Market Misperceptions (20)
How patient subpopulations are changing the commercialization of oncology pro...IMSHealthRWES
An excerpt from the latest issue of AccessPoint, looking at how genomic profiling data is transforming our understanding of patient subpopulations - a key to targeting treatments with greater precision
IMS Health RWES: The Future of Real-World Insights in CancerIMSHealthRWES
The document discusses IMS Health's real-world evidence solutions for cancer, including their cancer data ecosystem. The ecosystem combines various real-world data sources like medical claims, EMR data, and genomic data from over 15 million anonymous cancer patients. It provides comprehensive insights through innovative analytics to help address challenges across the cancer care continuum for clinicians, payers, pharmaceutical companies, patients, and advocacy groups.
IMS Health at ISPOR - Washington DC - May 2016IMSHealthRWES
This document provides information about IMS Health's activities and participation at the ISPOR 21st Annual International Meeting from May 21-25, 2016 in Washington, DC. The document outlines IMS Health's educational symposium titled "How real-world evidence (RWE) can enable pharma to partner in healthcare delivery" as well as several research posters, presentations, and workshops led by IMS Health experts on topics related to real-world evidence and its use in healthcare. Members of IMS Health's global RWE Solutions team will be available at the company's booth throughout the event.
IMS Health Real-World Evidence BrochureIMSHealthRWES
IMS Health is a global healthcare company that provides real-world evidence solutions to solve healthcare challenges. They use large datasets, advanced technologies and methodologies, and strategic expertise. Their Real-World Evidence Solutions team has opportunities for scientists, researchers, data analysts, product developers, consultants, and marketers to help clients improve patient outcomes. Employees can gain global experience, see the impact of their work, and be rewarded in a meritocratic environment. In one example, they created an algorithm to help diagnose a rare disease faster by identifying high-risk patients.
AccessPoint - 9th Issue - November 2014IMSHealthRWES
This document summarizes an article from IMS Health Real-World Evidence Solutions & HEOR. It discusses three main topics:
1) How new research using real-world evidence is revealing insights into diabetes treatment outcomes and understanding patient subgroups. This is helping to improve care provision.
2) Trends in real-world evidence, including new data strategies, greater involvement of commercial teams, and increased collaboration with external stakeholders.
3) Advancements in real-world evidence, such as improved data sourcing, predictive modeling techniques, and leveraging data from Scandinavia to enable disease-level insights. This is helping to demonstrate treatment value and support care management.
IMS Health Workshop World Orphan Drug CongressIMSHealthRWES
This document provides an agenda for a workshop titled "Using real-world data to find undiagnosed patients with rare diseases" hosted by IMS Health at the World Orphan Drug Congress from April 20-22 in Washington D.C. The workshop will explore how real-world data can help address underdiagnosis of rare diseases. Speakers will discuss using large-scale real-world data to transform understanding of rare diseases, and present case studies of companies leveraging real-world data. The workshop will also cover using predictive modeling of real-world data to identify undiagnosed rare disease patients and new engagement models with healthcare providers and payers to increase rare disease treatments.
How predictive analytics can help find the rare disease patientIMSHealthRWES
This document discusses how predictive analytics using real-world data can help identify undiagnosed rare disease patients. It describes two case studies: 1) A screening algorithm identified potentially undiagnosed patients for a rare multi-system disease with a high risk prevalence of 20.5% compared to 0.7% of the population. 2) An analysis of a rare cardiac disease identified health system barriers like variability between diagnostic centers that could cause under diagnosis. While initial results are promising, challenges remain around data privacy, sample size, and clinician adoption of screening algorithms.
Prospective identification of drug safety signalsIMSHealthRWES
At a time of growing demand for more accurate and timely
drug safety evidence, a landmark study supports the value of
electronic medical records (EmR) for detecting new adverse
reactions.
This document describes how real-world data was used to help expand a clinical trial for a rare disease. Specifically:
1. Claims data was analyzed to identify patients diagnosed with the rare disease and their physicians, applying inclusion criteria like diagnostic tests and drug treatments. This sized the national patient population and located diagnosing/treating doctors.
2. Physicians were mapped to local hospitals to identify areas with high concentrations of relevant patients and doctors.
3. A density analysis identified the top 20 hospitals that could serve as potential new clinical trial sites based on clusters of physicians and their patient counts. This innovative use of real-world data provided new insights to strengthen the company's rare disease research program.
EMR as a highly powerful European RWD sourceIMSHealthRWES
This document discusses leveraging electronic medical record (EMR) data from multiple countries in Europe to improve clinical trial design and patient recruitment for a cardiovascular drug trial. Specifically:
EMR data from France, UK, Italy, Germany and Spain was used to 1) characterize and quantify the number of potential patients meeting the inclusion criteria, and 2) identify and pre-select high-potential clinical trial sites. This approach helped clarify the definition of "statin-intolerant patients" and ensured the number of required trial sites would be sufficient. Using real-world data in this way enhanced the clinical trial strategy and avoided potential delays or additional costs associated with insufficient patient recruitment.
As pharmaceutical manufacturers look for ways to build
stronger relationships with their Integrated Delivery Network
(IDN) clients, RWE is emerging as a desired infrastructure
capability, presenting a window of opportunity to support and
collaborate on IDN efforts. If done well, these RWE-related
partnerships should provide value for both parties involved
but require pharma to expand its mindset beyond
product-specific approaches.
Building innovative, effective RWE platformsIMSHealthRWES
As more pharmaceutical companies pursue RWE as a core
capability in their organization, they have been increasing their
investment in integrated evidence platforms.
Integrate RWE into clinical developmentIMSHealthRWES
With greater application of RWE throughout the pharmaceutical
lifecycle, learnings are emerging that offer guidance for
approaches to derive the maximum value. This article captures
the author’s experience at a leading international biotech, with
insights for smoothing RWE assimilation into clinical
development and realizing the benefits it brings.
IMS Health Real-World Evidence Solutions at ISPOR November 2015IMSHealthRWES
Welcome to the IMS Health Real-World Evidence (RWE) Solutions program of activities at the forthcoming ISPOR 18th Annual European Congress in Milan. We invite you to join us at more than 70 presentations that spotlight exciting innovations and applications of outcomes research and RWE. And please visit us at our booth to learn more about our pioneering efforts including the e360TM technology suite, RWD Catalogue with 1,800+ data sources identified, and the newly launched RWE Dictionary. Full details of our ISPOR schedule can be found in the brochure.
IMS Health Enriched Real-World Data StudyIMSHealthRWES
1) Researchers developed the DIAREG registry in Germany using a mixed methods approach to overcome limitations of electronic medical record databases which often lack critical variables.
2) The registry links retrospective data from electronic medical records with prospective clinical data collected through electronic case report forms and patient-reported outcomes to create a rich data resource.
3) As of September 2014, the DIAREG registry contained data on 1,071 diabetes patients in Germany, enabling granular observational research on relationships and outcomes that were previously difficult to study.
30 – Hours Yogic Sukshma Vyayama Teacher Training Course
What is Sukshma Yoga?
Dhirendra Brahmachari formulated this system and wrote books to clearly formulate the ancient yogic science. This practice simple yet powerful series of specific exercises that improve health and enhance the strength of different organs and systems in the body, from top of head to toes.
Suksma means subtle prana, mind, and intellect: Vyayama means exercise. Suksma Vyayama is meant for the Subtle Body (Suksma Sarira), it is not meant for the Sthula Sarira (Gross Physical Body).
Need of Suksma Vyayama
In yoga, it is said that most pranic blockages start in our joints. Ayurveda says that ‘ama’ or the toxic and undigested waste material tends to settle in the empty spaces of our body, the joints. To remove these impurities we practice Suksma Vyayama, to release any such impurities in our subtle pranic body.
Three dimension of suksma Vyayama:
1.Breathing (slow or fast: Bhastrika/Bellows)
2.Point of concentration (mental concentration on Chakras)
3.Exercise (using Bandhas and Mudras)
Sukshma yoga purifies and recharges the body, mind, energy, and emotion. It prepares the well foundation for further means of Yoga practice. It includes Sukshma Vyayama (Subtle Exercise), and Vishram (Rest & Relaxation). It is itself complete package that fulfills the basic need of human being.
Sukshma Vyayama is one of the major parts for physical activity and the regulation of entire physiologies. Sukshma Vyayama is also known as a kind of warm up exercise or basic exercise or clinically anti-rheumatic group of exercise and also called body scan. The system of the physical and breathing exercise which help to sequentially work out all joints of a body, to warm it up. This system has a strong purifying effect on energy body of a human.
1.1. History of Sukshma Vyayama
We will observe visible Parampara of Sukshma Vyayama. Literal meaning of Parampara is the continuous chain of succession by Master to followers. In Parampara system, the knowledge is passed on without changes from generation to generation). Unfortunately because of the absence of enough information we are not able to find sources of this tradition.
System of Sukshma Vyayama knowledge which was unknown in the west before that was extended by one of outstanding yoga masters, Dhirendra Brahmachari (1925-1994). He received Initiation into Sukshma Vyayama techniques from Maharshi Kartikeya, the prophet and sacred great yogi who was his Master. In the preface to the book “Yogic Sukshma Vyayama” Dhirendra Brahmachari wrote about his precious Guru. Deep knowledge made him the unique expert of human characters, of their abilities and possibilities. From Maharshi Kartikeya, Dhirendra Brahmachari received a precept to spread knowledge about Sukshma Vyayama. The invaluable merit of Dhirendra Brahmachari is that he managed to accumulate knowledge in the convenient form, to make it open and understandable for the audience everywhere. The b
CHAPTER THREE: MUDRA AND BANDHA
Chapter 3 Verse 1 Kundalini is the support of yoga practices
As the serpent (Sheshnaga) upholds the earth and its mountains and woods, so kundalini is the support of all the yoga practices.
Chapter 3 Verse 2 Guru’s grace and opening of the chakras
Indeed, by guru's grace this sleeping kundalini is awakened, then all the lotuses (chakras) and knots (granthis) are opened.
Chapter 3 Verse 3 Sushumna becomes the path of prana and deceives death
Then indeed, sushumna becomes the pathway of prana, mind is free of all connections and death is averted.
Chapter 3 Verse 4 Names of sushumna
Sushumna, shoonya padavi, brahmarandhra, maha patha, shmashan, shambhavi, madhya marga, are all said to be one and the same.
Chapter 3 Verse 5 Sleeping goddess is awakened by mudra
Therefore, the goddess sleeping at the entrance of Brahma’s door should be constantly aroused with all effort by performing mudra thoroughly.
BLOOD DONATION ppt For medical students..pptxdarshitam0310
Mention safety measures and potential side effects. Provide tips on how to prepare for donations such as staying hydrated and eating well.This concise format covers the essential aspects of blood donation.
"NeuroActiv6: Revitalize Your Mind with Youthful Energy and Clarity"Ajay Agnihotri
In today's fast-paced world, maintaining mental clarity and energy can be challenging. The constant demands of work, family, and social commitments often leave us feeling drained and foggy. Enter NeuroActiv6, a revolutionary supplement designed to rejuvenate your mind and restore youthful energy and clarity.
NeuroActiv6 is a brain-boosting supplement that combines a unique blend of natural ingredients known for their cognitive-enhancing properties. This powerful formula is designed to support brain health, improve mental performance, and boost energy levels. Whether you're a busy professional, a student, or someone looking to enhance your cognitive function, NeuroActiv6 offers a range of benefits to help you achieve your goals.
NeuroActiv6 works by providing your brain with the essential nutrients it needs to function at its best. The combination of these powerful ingredients helps reduce brain fog, improve focus and concentration, and increase energy levels. By supporting brain health and enhancing cognitive function, NeuroActiv6 allows you to tackle your day with renewed vigor and mental clarity.
Attitude and Readiness towards Artificial Intelligence and its Utilisation: A...ShravBanerjee
AI is a hot topic in recent days... We students of IPGME&R, Kolkata, India have done a study on Attitude, Readiness and Utilization of AI by medical students.
Artificial Intelligence (AI): The theory and development of computer systems able to perform tasks normally requiring human intelligence, such as visual perception, speech recognition, decision-making, and translation between languages.
Our study showed that:
1. Nearly half of the study participants showed a favorable attitude towards role of AI in healthcare
2. Around three-fifth of the participants could define basic concepts of data sciences and AI and were ready to choose AI based applications for healthcare; they were willing to accept AI usage despite feeling a lack of cognitive skills
3. Most of them used AI-based applications for studying (ChatGPT), however, some of them faced difficulties in using them
Thank you!
Holistic nursing Primacy of nature in the healing process.pptxraima10
HOLISTIC NURSING
Holistic nursing is a way of treating and taking care the patient as a whole body which involves physical, social environment, psychological, cultural and religious beliefs.
This presentation tells about health education for hand wash to children. Every child should know that how to keep hand clean. And maintain the good hand washing practices. Nowadays disease are easily spread through uncleaned hands.germs are habitat in their hands and then it causes different types of diseases.so, we must give the health education for hand washing to every children. And make them practice.
21. Alignment for Advanced Yoga Asana
The advance asanas that are taught during various asana classes throughout the duration of the teacher training are brought up for analytical discussions and practical sessions of methods to adjust advance postures with both verbal cues and hands-on adjustments. Learning revolves around demonstrations, observation and practicums by assisting the lead instructors during some advanced yoga classes. Students will demonstrate observe and assist lead instructors in adjusting in a basic yoga class.
Learning Objective
Be able to identify misalignments of advance postures. Be able to observe student’s capacity during adjustments. Be able to safely and gently adjust advance postures with verbal cues and with hands-on adjustments. To provide adjusting and assisting techniques of yoga asana class.
2. Contents
1. Executive Summary................................................................................................................ 3
1.1. Disclosures.....................................................................................................................5
2. Common Misperceptions about Migraine.............................................................................. 6
2.1. Misperception: Migraine is a Disease of Young Women.............................................. 6
2.2. Misperception: The Migraine Population with CAD Risk Factors is Small ................. 8
2.3. Misperception: Healthcare Professionals have No Concerns Regarding Triptan Use in
Patients at Risk for CAD (CV Risk); View Patients as Well-Served by Triptans...................14
3. Opportunity for New Therapies for Migraine Patients with CV Conditions or Risk Factors19
4. Methodology......................................................................................................................... 20
4.1. Overview ..................................................................................................................... 20
4.2. Patient Cohorts ........................................................................................................... 23
4.2.1. CAD Event Definition...................................................................................... 23
4.2.2. Risk Factor Aggregation ................................................................................. 24
4.3. Modeling Approach .................................................................................................... 24
4.3.1. Scoring of the Patients for CAD Risk ...............................................................25
4.4. Methodology Appendix................................................................................................25
4.4.1. Logistic Regression ..........................................................................................25
5. Authors..................................................................................................................................27
3. Facts Addressing Migraine Market Misperceptions by IMS Health
3
1. Executive Summary
IMS Health, the leading global provider of health-care information and real-world
evidence driven analyses in the pharmaceutical industry, has conducted a retrospective
analysis of migraine patients in a proprietary closed-payer dataset. The analysis
examines the overall migraine market size along with cardiovascular risk in the migraine
patient population in the U.S. using health care claims data. The Framingham Heart
Study, a longitudinal patient study that is the widely-accepted industry standard for
defining and assessing cardiovascular (CV) risk factors in a United States population,
has been used to determine risk factors for Coronary Artery Disease (CAD). Patients in
the headache population as well as the more specific migraine population with
diagnoses, procedures, or associated drug usage for CAD risk factors have been
identified within this analysis.
Informal, qualitative discussions with physicians who treat migraine in the U.S. may
provide incomplete information regarding cardiovascular risk characteristics,
cardiovascular comorbidities, and treatment patterns. In some cases assumptions exist
that most treated migraine patients are young women who have very low risk for
cardiovascular events. Some healthcare professionals are therefore comfortable
prescribing existing vasoconstrictive therapies to a portion of their patients with
cardiovascular risk factors, despite the known contraindications, precautions and
warnings against such prescribing activity.
This analysis conducted by IMS Health specifically focuses on commonly held
misperceptions regarding: 1) the market size and patient demographics for the acute
treatment of migraine in the U.S.; 2) the proportion of migraine patients who have risk
factors for cardiovascular disease or known cardiovascular conditions; and 3) current
acute treatment patterns of migraine, specifically in migraine patients with
cardiovascular risk factors or conditions. Results from this analysis can inform the
potential market opportunity for new therapies in the migraine space.
The data source for this research is the IMS PharMetrics Plus database, which is
comprised of adjudicated claims for health plan enrollees across the United States.
PharMetrics Plus includes enrollees with both medical and pharmacy coverage,
representing more than 42 million unique lives. The data include a range of geographies
and plan types in the U.S. Attributes of the data include medications prescribed (date,
product form, strength), diagnoses and procedures, patient demographics, payer type
and provider information. The PharMetrics Plus sample is sufficiently robust so that it
can be projected to the U.S. insured population of 274 million.
4. Facts Addressing Migraine Market Misperceptions by IMS Health
4
Three common misperceptions are addressed by this research:
Misperception 1: Migraine is a Disease of Young Women
Fact: 3.7 million adult patients in the insured health care system are diagnosed with migraine.
Fact: Females comprise 82% of the adult migraine diagnosed population in this study and 85%
of the treated population.
Fact: Fifty-four percent (2.2 million) of diagnosed migraine patients are 40 years and older; 57%
(1.1 million) of treated migraine patients are 40 years and older.
Fact: Women between the ages of 40 and 49 constitute the largest age cohort for patients
diagnosed and treated for migraine (21%, 403k of all diagnosed and treated migraine patients).
Fact: Men comprise roughly one out of five diagnosed migraine patients (20%) but are less likely
to receive a prescription treatment compared to women (41% treated compared to 51%).
Misperception 2: The Migraine Population with CAD Risk Factors is Small
Fact: 2.8 million adult migraine patients (76%) carry cardiovascular conditions or risk factors
that contraindicate or warn against triptan use during the study period.
Fact: 1.3 million (35%) adult diagnosed migraine patients have a contraindication that limits the
use of triptans.
Fact: Migraine patients have a substantially increased rate of CAD events compared to the
general population (9.9% compared to 6.4%).
Fact: Having a migraine diagnosis, even among younger patients, increases the likelihood of a
future CAD event as compared to patients without a migraine diagnosis (4.5 times for female
patients 18-29 years of age; 5.1 times for males in same age range).
Misperception 3: Healthcare Professionals have No Concerns Regarding Triptan
Use in Patients at Risk for CAD (CV Risk); View Patients as Well-Served by
Triptans
Fact: Triptan use is lower in patients with a history of CAD event or at CV risk compared to use
in the general adult migraine treated population--56% compared to 75%.
Fact: Off-label use of opioids is more likely in CV risk patients than in the general adult treated
migraine population. The proportion of patients having high CV risk or a known CAD event who
are prescribed opioids for treating migraine is higher than the proportion having high CV risk or
a known CAD event who are prescribed triptans (74% compared to 56%).
Fact: Of the 2.3 million adult migraine patients with a CAD event or high CV risk, 1.2 million
(53%) are untreated.
Fact: The relatively large size of the diagnosed migraine population with a history of CAD event
or at CV risk not treated with prescription medication or choosing alternative therapies such as
opioids suggests that this population is under-served.
6. Facts Addressing Migraine Market Misperceptions by IMS Health
6
2. Common Misperceptions about Migraine
Large scale epidemiologic studies demonstrate that migraine afflicts 36 million Americans and
accounts for more than 112 million days of lost work annually. Individuals differ widely in the
frequency, severity and associated symptom profiles of their attacks as well as their
comorbidities. As a consequence, individualized treatment is of crucial importance for this
heterogeneous disorder making it prone to misunderstanding, under diagnosis and under
treatment. The launch of triptans (5-HT1B/1D agonists) in the early 1990s dramatically
improved the acute treatment of migraine. Use of triptans is limited by the known coronary
vasoconstrictor effects of these drugs as well as the adverse event profile which includes non-
cardiac chest pain and angina as well as myocardial infarction. As a consequence, the
development of an acute migraine therapy with triptan-like efficacy, free of cardiovascular risk,
has long been a goal of the field.
This analysis highlights facts surrounding several pervasive misconceptions which have an
adverse impact on the delivery of optimal treatment. The analysis and data are a tool to facilitate
a real-world evidence discussion of the treatment of migraine and illuminate the potential role of
new therapies, such as lasmiditan, in treatment of the migraine population.
2.1. Misperception: Migraine is a Disease of Young Women
Healthcare professionals and lay-people commonly believe that migraine is a disease
predominantly affecting young women, and that the population of patients with migraine
decreases after age 40. IMS Health’s analysis confirms that although there are a number of
younger female patients with a migraine diagnosis, the majority of the diagnosed population
(55%) is 40+ (Exhibit 1). The total adult (over 18) migraine diagnosed population is 3.7 million,
of which 82% (3 million) are female and 18% (668k) are male.
Exhibit 1: Diagnosed U.S. Migraine Patient Population by Age and Gender, 2013
Both Sexes Male Female
Age Group Number Percent Number Percent Number Percent
0-17 377,963 9% 153,861 19% 224,102 7%
18-29 721,448 18% 138,000 17% 583,448 18%
30-39 749,856 18% 121,048 15% 628,809 19%
40-49 842,390 21% 133,591 16% 708,800 22%
50-59 710,513 18% 129,164 16% 581,349 18%
60+ 651,771 16% 146,966 18% 504,804 16%
Total 4,053,940 100% 822,629 100% 3,231,311 100%
Source: IMS Health, PharMetrics Plus, January - December 2013 Cohort Projected to U.S. Insured Patient
Population, 2015
However, considering the adult treated migraine patient population, more than half (57%) are
over the age of 40 (Exhibit 2). Within the adult diagnosed migraine population, 49%, or 1.8
million, are treated and 85% of the treated population is female.
7. Facts Addressing Migraine Market Misperceptions by IMS Health
7
Exhibit 2: Diagnosed and Treated U.S. Migraine Patient Population by Age, 2013
Source: IMS Health, PharMetrics Plus, January – December 2013 Cohort Projected to U.S. Insured Patient
Population, 2015
Although men are 19% of the diagnosed, adult migraine patients, they are only 15% of the
treated population. The number of men with migraine and the relatively smaller (in comparison
to women) population should not detract from the fact that the male patient population is
substantial, and potentially interesting to investigate for ways to better serve this population.
The perception of migraine as exclusively a women’s disease has the result of making treatment
more difficult for men and results in a substantial gap in providing them meaningful relief and
care for migraine.
Thus, the IMS closed source database identifies patients over age 40, particularly female
patients, as the largest addressable migraine population in the U.S.
18-29 years old
324k
30-39 years old
386k
40-49 years old
463k
50-59 years old
373k
60+ years old
258k
Under 40 Years Old 40 Years and Older
43%
829k
57%
1.1 million
Nearly two-thirds of diagnosed, treated migraine patients are 40 years and older
0-17 years old 120k
8. Facts Addressing Migraine Market Misperceptions by IMS Health
8
2.2. Misperception: The Migraine Population with CAD Risk
Factors is Small
Triptan product labels explicitly state that triptans are contraindicated in patients with ischemic
coronary artery disease, coronary artery vasospasm, angina, arrhythmias, history of stroke or
transient ischemic attack (TIA), history of hemiplegic or basilar migraine, uncontrolled
hypertension, myocardial ischemia, and myocardial infarction. These contraindications have
been provided due to potential adverse cardiac reactions occurring following the administration
of a triptan product. As a result, it is recommended that all healthcare professionals perform a
full cardiovascular evaluation prior to prescribing triptans to any migraine patients.
Discussion of misperception 1 establishes that migraine is a disease that disproportionately
affects women. As the discussion moves to CAD and CV risk, it is important to note that heart
disease is the leading cause of mortality among women in the U.S. There is a documented lack of
research examining the symptoms and risks of cardiovascular disease for women. The shortage
of research often means women’s risks are not assessed, they do not receive diagnostic and
screening procedures and they are not aware of signs and symptoms1. Given that the majority of
diagnosed and treated migraine patients are women, it is important to note CV risk for migraine
patients, especially women.
Data cited in this section are based on two analyses. First, patients’ observed CAD events and
clinically appropriate ICD-9 codes as related to triptan labeling (contraindications and
precautions and warnings) recorded in the health care claims database are flagged for analysis.
Second, IMS utilizes patient cardiovascular risk factors based upon a number of attributes
available in the data including ICD-9 coded comorbidities and demographic data to build a CV
risk factor profile for modeling risk.
This model, using diagnoses and prescription data, predicts the likelihood of a future CAD event
based upon the data available in the PharMetrics Plus database. The model for assessing risk is
based upon the Framingham Heart Study, a landmark, long-term longitudinal study established
to identify the common risk factors and characteristics associated with CAD events. The IMS
data assess the patient risk for patients with migraine, as well as the general patient population
for comparison.
IMS Health’s analyses show that 3.7 million adult patients are diagnosed with migraine during
the one year study period. By leveraging medical codes and applying the risk model derived from
the Framingham Heart Study, 2.8 million diagnosed patients (76%) carry cardiovascular
conditions or risk factors that contraindicate or warn against triptan use (Exhibit 3).
1 Wenger, Nannete MD; Women and Coronary Heart Disease: A Century After Herrick: Understudied, Underdiagnosed, and
Undertreated; Summaries of the AHA Council Lectures 2011
9. Facts Addressing Migraine Market Misperceptions by IMS Health
9
Exhibit 3: Triptan Label Restrictions and CV Risk in the Adult Diagnosed U.S.
Migraine Patient Population, 2013
Source: IMS Health, PharMetrics Plus, January – December 2013 Cohort Projected to U.S. Insured Patient
Population, 2015
In the general insured adult patient population in the IMS PharMetrics Plus database (a
population of insured patients predominantly under the age of 65), the rate of Coronary Artery
Disease (CAD) events is 6.4%. As expected, the cardiovascular event rate increases with age. For
example, the one year CAD event rate in the population over age 50 is 11.6% annually. The
comparator for risk that will be used in this discussion will therefore be 6.4%.
Contraindications, Precautions
and Warnings or High Risk
NoLabel Restrictions, Low
or Moderate Risk
76% of Migraine Patients
2.8 million
24% of Migraine Patients
869k
=100,000 adult migraine patients
35% Contraindications
16% Precautions and
Warnings
25% High Risk for
Future CAD Event
Three-quarters of adult,migraine patients carry CV risk, precautions, or
contraindications that warn against triptan use
10. Facts Addressing Migraine Market Misperceptions by IMS Health
10
Compared to the general population, diagnosed migraine patients have higher rates of CAD
events-- 1.5 times the rate of the general population, 9.9% compared to 6.4% (Exhibit 4). In
every age and gender cohort comparison, CAD event rates of migraine patients are higher; in
patients under 40 the rates are 3 times as high as the general population rate (4.6% compared to
1.4%), and in patients 40+, CAD event rates are 1.8 times higher among migraine diagnosed
patients (18.0% compared to 10.2%). This is true for both men and women across all age
cohorts.
Exhibit 4. CAD Event Rate in the Adult Diagnosed U.S. Migraine U.S. Patient
Population, 2013
Source: IMS Health, PharMetrics Plus, January – December 2013 Cohort Projected to U.S. Insured Patient
Population, 2015
This study also compares the rate of CAD events for diagnosed and treated migraine patients as
well as those treated with triptans or other acute therapies. Triptan treated patients have an
event rate of 5.9% compared to the event rate for the overall migraine population of 9.9% during
the study time period. This suggests that, as shown by prescription data, physicians avoid use of
triptans in high risk populations, either not treating patients with drug therapy or choosing
alternatives such as bultalbitals and opioids. In other words, physicians are selective in
prescribing triptans.
3%
4%
5%
7%
8%
11%
13%
23%
3%
4%
6%
8%
11%
13%
17%
29%
18-29 30-34 35-39 40-44 45-49 50-54 55-59 60+
Female Male
Overall Population
Baseline CAD Event rate
6.4%
Migraine Population
Baseline CAD Event rate
9.9%
There is a much higher CAD event rate in migraine patients
11. Facts Addressing Migraine Market Misperceptions by IMS Health
11
In addition to examining the rate of experiencing a coronary artery event, the study analyzes risk
factors to determine the likelihood of predicting a future CAD event in the twelve months of the
study. IMS modeled CAD risk factors based upon the Framingham Heart Study and developed a
logistic regression model to provide a specific odds ratio (OR) for each patient included in the
study during a 3-year period. ORs are commonly used to quantify the association of risk in a
population; an OR of 1 indicates there is no association; an OR >1 indicates that the predictor
favors the likelihood of the outcome. An OR does not indicate causation, but a predictive
relationship. Due to the specific differences within age groups, and the varying risk factors
associated with gender, the modeled risk factor ORs are unique to each age and gender cohort of
interest. Exhibit 5 summarizes the OR predictor, regardless of age or gender.
12. Facts Addressing Migraine Market Misperceptions by IMS Health
12
Exhibit 5: Risk Factors for Predicting a CAD Event (Odds Ratios) Among a General
Adult Patient Sample (CAD Event Cohort), 2013
Source: IMS Health, PharMetrics Plus, October 2012 – September 2013 Cohort, 2015. Note: Any predictor that falls to
the right side of the dashed line (OR ≥ 1.0) favors the likelihood of an outcome (i.e. future CAD event); the further away from 1.0,
the stronger the relationship between the predictor and the outcome (i.e., CAD event). For example, Family History of CAD
indicaates that patients are 3.3 times more likely to have a CAD event when compared to patients without a Family History of
CAD coded during the study time period, all else held equal. Not all predictors are statistically significant. The table in the
Methodology Section (page 21) shows ORs by age and gender as applied in the model.
Exhibit 5 shows the ORs in aggregate, while Exhibit 10 in the Methodology Section shows all
ORs by age and gender in detail. Risk factors of family history of CAD, hypertension and
smoking increase the likelihood of a future CAD event in both females and males for all age
cohorts. For example, men and women (18-29) with a family history of CAD are about four
times more likely to have an event (odds ratio of 4.1 and 3.8 respectively) than patients without a
family history of CAD. Dyslipidemia, diabetes, and obesity also increase the chances of a future
event; however, the increases are more variable by patient age and gender.
3.3
2.7
2.7
2.7
1.8
1.7
1.6
1.5
1.4
1.2
1.1
1.0
0.8
-1.0 0.0 1.0 2.0 3.0 4.0
Family History CAD
Hypertension Dx or Rx
Smoking
Migraine Dx Only
Dyslipidemia Dx or Rx
Migraine Dx & Triptan Rx
Under Weight/Normal Weight
Diabetes Dx or Rx
Obesity
Triptan Rx Only
Menopause
Oral Contraceptives
Bariatric Surgery
Predictors
Likelihood of CAD EVENT
Family history of CAD, hypertension, smoker, or migraine diagnosis are
much more likely to have a CAD event
13. Facts Addressing Migraine Market Misperceptions by IMS Health
13
A migraine diagnosis is a predictor of a future CAD event. The analysis shows that among
female patients ages 18-29, a migraine diagnosis carries a risk of four times more likely (OR 4.5)
to have a future CAD event. Note that this is higher than the risk for women with a hypertension
diagnosis or treatment. In fact, a migraine diagnosis in this age cohort of 18-29 is the highest
predictor of a future CAD for women. Likewise, a migraine diagnosis in younger male patients
also resulted in the highest risk (OR, 5.1 and 5.7), for those 18-29 and 30-34 respectively.
14. Facts Addressing Migraine Market Misperceptions by IMS Health
14
2.3. Misperception: Healthcare Professionals have No Concerns
Regarding Triptan Use in Patients at Risk for CAD (CV
Risk); View Patients as Well-Served by Triptans
The definition of a patient who is “well served” is somewhat subjective. IMS collects data on
prescription drugs; however, IMS does not include over the counter (OTC) or alternative
(chiropractic, acupuncture) therapy. For this analysis, IMS did not capture medication “in
hand”, i.e. medication filled prior to the study period, and IMS may not capture “off-label” use of
certain drugs to treat migraine.
The exact nature of the untreated population cannot be easily assessed. Those patients may be
categorized as untreated because they have medication ‘in hand’ from prior to the study period;
or, they may be untreated because they have not had success with any of the available products
or are concerned about the risks associated with existing products after consultation with their
health care provider.
In addition, the definition for a migraine patient treated with an opioid or butalbital is
conservative in this IMS analysis. Only opioid use in migraine patients that met the following
criteria were included in this analysis: a diagnosis of interest within 14 days prior to the
prescription, a refill of the same product class in 30 days, and no record of any surgery within 30
days prior. This is considered a conservative estimation of opioid use.
Within just the diagnosed, adult migraine population, the overall treated migraine market size
is 1.8 million (49% of diagnosed) patients, with 1.6 million (42% of diagnosed) patients receiving
acute treatments for migraine and 653k (18% of diagnosed) patients receiving migraine
prophylaxis. There is overlap among these patients, whereby, 410k patients receive both an
acute and prophylaxis therapy.
Among the treated, adult migraine patients, 75% (1.4 million) receive a triptan treatment during
that year. Of the 1.4 million triptan patients, nearly a third (32%) is filling multiple classes of
acute and prophylaxis prescription medications during a 12-month period (Exhibit 6).
15. Facts Addressing Migraine Market Misperceptions by IMS Health
15
Exhibit 6: Acute Treated Adult U.S. Migraine Patient Population, 2013
Source: IMS Health, PharMetrics Plus, January – December 2013 Cohort Projected to U.S. Insured Patient
Population, 2015
There are a number of patients treated with other classes of currently available therapies,
specifically the butalbital and opioids (17%). The quantification of treatment patterns with
opioids in this analysis is conservative, and it is likely that the use of opioids in the acute
treatment of migraine is underreported. If medication in hand and all therapies are considered,
the overall percentage of patients filling prescriptions would likely be higher. Therefore a
substantial majority of diagnosed migraine patients are treated, and are treated with multiple
therapy classes.
Seventy one percent (962k) of all adult patients prescribed a triptan have CV conditions or risk
factors for CAD (Exhibit 7), suggesting that triptans are being used ‘inappropriately’, or contrary
to triptan product labeling for contraindications, precautions and warnings. Thirty percent
(405k) of adult, migraine patients receiving triptan treatment have had a recent CAD event or
are taking a triptan with a defined contraindication, 25% (338k) are in a high-CV risk category,
while an additional 16% (218k) are receiving a triptan with defined precautions and warnings.
204k
14%
244k
11%
917k
68%
149k
11%
290k
21%
1.4 m
75%
Two-thirds of adult, migraine patients are treated with triptans; 32% of
them also receive multiple medication classes
1.8 million treated
adult migraine patients
1.4 million triptan-treated
adult migraine patients
Non-triptan
Treated
Triptan Treated
Prophylaxis
Only
Triptan Only
Triptan & Other
Acute Classes
Triptan &
Prophylaxis
16. Facts Addressing Migraine Market Misperceptions by IMS Health
16
Exhibit 7: Risk Assessment of Triptan Treated Adult U.S. Migraine Patient
Population, 2013
Source: IMS Health, PharMetrics Plus, January – December 2013 Cohort Projected to U.S. Insured Patient
Population, 2015
However, the data suggest that healthcare professionals, as a whole, alter their treatment
patterns for migraine patients with CV conditions or risk factors for CAD, frequently choosing to
forego treatment or choosing a non-triptan, non-vasoconstrictive therapy.
Treatment rates are also lower among migraine patients with a CAD event or high CV risk (47%
compared to 53%). Only 69% of patients at high-risk or with a CAD event are triptan-treated
compared to triptan-treated rates of 75% among all migraine patients.
The IMS data show that adult, migraine patients with CAD events and high CV risk have a
higher treatment rate with butalbital and opioids. Opioids are not indicated for the treatment of
migraine and have been associated with abuse and medication overuse headache. Off-label use
of opioids is more likely in CV risk patients than in the general adult treated migraine
population. The proportion of patients having high CV risk or a known CAD event who are
prescribed opioids for treating migraine is higher than the proportion having high CV risk or a
known CAD event who are prescribed triptans (74% compared to 56%) (Exhibit 8). Thus, these
patients are likely not currently well served by available therapies.
30%
16%
25%
29%
1.4 million triptan-treated
adult migraine patients
CAD Event and Contraindications
Precautions and Warnings
High Risk for Future CAD Event
No Label Restrictions or Low to
Moderate Risk
71% of current adult triptan patients carry CV risk and contraindications that
warn against triptan use
17. Facts Addressing Migraine Market Misperceptions by IMS Health
17
Exhibit 8: CAD Event Rate and High CV Risk among Diagnosed Adult U.S. Migraine
Patient Population by Type of Treatment, 2013
Source: IMS Health, PharMetrics Plus, January – December 2013 Cohort Projected to U.S. Insured Patient
Population, 2015
The fact that there is such a substantial diagnosed population that is not treated indicates that at
least some portion of this nearly 1.9 million untreated patients are not well served by current
therapies. In addition, these data indicate that currently diagnosed migraine patients may not be
well served by triptans, since in a third-party covered population these widely available
medications are used by less than half of all adult, diagnosed migraine patients (37%).
Although the focus of this analysis is on the migraine population, IMS has also examined the
treatment patterns in the overall primary headache population for two reasons: 1) many patients
diagnosed with primary, non-traumatic headaches are thought to actually suffer from migraines
and receive treatment; and 2) to understand the overall incidence of CV conditions or high risk
of CAD in primary headache patients who could also benefit from a non-vasoconstrictive drug
therapy.
Results of our study indicate that primary headache patients and migraine patients share many
similarities and needs. Of particular interest:
• The diagnosed adult, primary headache patient population (10.8 million) is substantially
larger than the migraine population (3.7 million).
12%
6%
14%
50%
50%
60%
Untreated adult migraine
patients
Triptan-treated adult
migraine patients
Non-Triptan treated
(including Opioids) adult
migraine patients
CAD Event High Risk
1.9 million
62% 1.4 million
56%
448k
74%
Healthcare professionals are selective in prescribing triptans to high risk
patients
18. Facts Addressing Migraine Market Misperceptions by IMS Health
18
• The overall CAD event rate is higher among adult diagnosed primary headache patients
(12.2% vs. 6.4%) than the general population.
• Triptans are frequently prescribed for adult diagnosed and treated primary headache—
27% of all triptan use is for patients with a diagnosis of primary headache.
• Frequency of triptan use decreases in patients with CAD events and CV risk factors—66%
for adult diagnosed and treated primary headache patients compared to 60% for adult
diagnosed and treated headache patients with a CAD event or who are at high CV risk.
19. Facts Addressing Migraine Market Misperceptions by IMS Health
19
3. Opportunity for New Therapies for Migraine Patients
with CV Conditions or Risk Factors
As shown by IMS data, physicians tend to alter their use of triptans in high risk patients, either
by not treating patients with drug therapy or choosing alternatives such as bultalbitals and
opioids. In other words, physicians are selective in prescribing triptans. Thus there is a
significant market opportunity for new therapies that can be prescribed to the 2.8 million U.S.
adult migraine patients who have had either a CAD event, are at high CV risk, or are otherwise
contraindicated for triptan use. These data infer that new therapies for the acute treatment of
migraine, specifically those absent the contraindications, precautions and warnings associated
with vasoconstrictive properties of triptans, may expand the number of treated migraine
patients who receive therapy.
The IMS study identifies that half of the diagnosed adult migraine population are not treated
(1.9 million). This study does not answer the ‘why’s’ behind this finding; however, in a diagnosed
population, this finding can be safely identified as an opportunity in half the diagnose migraine
population. If some of these patients are not being treated because of concern about
contraindications, or warnings and precautions per triptan product labeling, there is a
substantial unmet need that can be immediately addressed with a new therapy without
vasoconstrictive properties.
There is also use of opioids and butalbital within the migraine population, which may be
reduced with the introduction of a new therapeutic option. These products are
disproportionately prescribed for patients who have had a CAD event or are at high CV risk;
indicating that they are prescribed due to lower cardiovascular risk. Introduction of a product
specifically indicated for the treatment of migraine without the triptan-associated CV issues is
likely to 1) appeal to patients, providers, and payers or 2) provide an attractive therapeutic
option to patients, providers, and payers.
20. Facts Addressing Migraine Market Misperceptions by IMS Health
20
4. Methodology
4.1. Overview
IMS Health’s PharMetrics Plus database is comprised of adjudicated claims for health plan enrollees
across the United States. PharMetrics Plus includes enrollees with both medical and pharmacy coverage,
representing more than 50 million unique lives. The data includes a range of geographies and plan types
in the U.S. Attributes of the data include medications prescribed (date, product form, strength),
diagnoses and procedures, patient demographics, payer type and provider information.
In order to understand the overall headache and migraine diagnosed and treated patient population,
patients with a headache diagnosis of interest during January 1, 2013 through December 31, 2013 are
included in the study from their first claim of interest. Patients must have continuous healthcare
enrollment during the entire period (3 years), which ensures a more complete view of the patient’s
relevant healthcare claims. From that first diagnosis claim in 2013, patients are followed forward for 12-
months (1-year) to track relevant treatment patterns. Patient history and events (up to a 12-month look
back and 12-month look forward) are examined to determine presence of contraindications, precautions
and warnings as indicated by triptan labels and as coded in the healthcare billing system. In addition,
patients’ historic information is used to determine cardiovascular risk and CAD event rates among the
diagnosed headache and migraine patients (Exhibit 9). The sample data is projected to the U.S. insured
population in 2013 of 274 million.
Exhibit 9: PMTX Plus Sample Selection for Market Sizing Cohort
Migraine
Hemiplegic Migraine
Migraine w/aura
Migraine w/o auro
Migraine w/
Infarction
Migraine Other
Other
Headache
Pain
Cluster Headache
Headache Pain Other
Acute
Migraine
Treatment
Opioids/Bultabitals
Ergotamine Derivatives
Migraine Combos
NSAIDs
Triptan/NSAID
Combos
Triptans
Migraine
Prophylaxis
Anticonvulsants
Beta Blockers
Neurotoxins
Diagnosed-centricDiagnosis Treatment
12 Months 12 Months 12 Months
Max – 01/01/2012 01/01/2013 – 12/31/2013 Max – 12/31/2014
Look-Back Period
Look-Back: A period relative to and
immediately preceding each index event;
this period is used to flag ‘Newly
Diagnosed’ patients, as well as those with
a contraindication
A period used to select diagnosed patients
for the analysis; patient will be selected if
they are diagnosed with migraine
AND/OR other headache pain
Selection Period Look-Forward Period
Look-Forward: A period relative to and
immediately following each index even
this period is used to flag treatments(s), if
any, for the diagnosed population, and
count migraine medication fills on
Diagnosis Treatment
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This study recreates elements of the model from the Framingham Study using the IMS PharMetrics Plus
data. The PharMetrics Plus data does not capture all the Framingham variables, but enough that it is
sufficient for modeling purposes. The identified cardiovascular risk factors (see dependent variables
below) are used to determine the likelihood (expressed as an odds ratio) of having a CAD event.
The data used for modeling consist of one row of variables per patient. The response variable is the naïve
CAD event during the study period (between October 1, 2013 and September 30, 2014). Patients with a
naive CAD event are included in the model data set. IMS has selected a control set of patients without a
CAD event during the entire study period from a random sample of 10% of the PharMetrics Plus patient
population. Any patient with a CAD event in the index or look back period has been dropped.
Dependent variables are based on the two year look-back from the naïve CAD event date for CAD patients
or a randomly assigned index date during the index period for the non-CAD event patients. The
dependent variables for modeling the CAD event are:
1) Hypertension diagnosis or treatment
2) Diabetes diagnosis or treatment
3) Dyslipidemia diagnosis or treatment
4) Menopause diagnosis
5) Obesity (direct ICD-9 code or BMI coding of 30 or more)
6) Underweight/Normal weight diagnosis
7) Smoking diagnosis or cessation treatment
8) Family history of CAD
9) Oral Contraceptives
10) Bariatric Surgery
11) Migraine diagnosis
12) Triptan Treatment
13) Age group
14) Gender
IMS uses the empiric baseline rates of CAD events by age and gender and then uses a logistic regression
model to compute the relative risks as odds ratios. Results are displayed in Table 1.
Once odds ratios of the cardiovascular risk factors are determined from the sample data (Exhibit 10),
headache patients are assigned to one of four CAD risk groups, based on individual CV history: CAD
Event (Observed during study period), High (Top 25%), Moderate (Middle 50%) and Low (Bottom 25%).
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4.2. Patient Cohorts
1. The analysis uses two patient cohorts within the IMS LifeLink PharMetrics Plus Claims Database:
a. Market Sizing Cohort
i. Purpose: Headache and Migraine Diagnosed Sample
ii. Data Time Frame: January 1, 2012 – December 31, 2014
iii. Selection Period: January 1, 2014 – December 31, 2014
iv. Look-Back Period: 24 months prior to first event of interest date during the index
period.
b. Modeling Cohorts
i. 10% PharMetrics Plus random sample
1. Purpose: Baseline CAD Event Rates
2. Data Time Frame: October 1, 2011-September 30, 2014
ii. CAD Event Cohort
1. Purpose: Cardiovascular Risk Factor Odds Ratios
2. Data Time Frame: October 1, 2011 – September 30, 2014
3. Selection Period: October 1, 2013 – September 30, 2014
4. Look-Back Period: 2 years from the CAD event
4.2.1. CAD Event Definition
A CAD event corresponds to the ICD-9, CPT and ICD-9 procedure codes of interest. For the event to be
defined as naïve there cannot be another CAD event in the look back period. IMS Health clinical team has
provided the codes for a CAD event.
Coronary Artery Disease Events are used as end-point predictors in modeling. They include:
• Myocardial Infarction (Myocardial infarction acute/old, Acute coronary insufficiency, Impending
MI)
• TIA (Transient ischemic attack)
• Stroke (Cerebral infarction / occlusion / thrombosis / embolism - acute and old)
• Claudication
• Angina
• Coronary Bypass Surgery
• Coronary Angioplasty/Stenting
• Carotid Artery Surgery/Stenting
• Peripheral Vascular Bypass Surgery
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4.2.2. Risk Factor Aggregation
The diagnosis codes, NDC and procedure codes are mapped to their corresponding predictive variable. All
predictor variables are “yes” and “no” variables except age and gender. If a patient has any condition
during the 2 year look back, that patient is coded with the condition. IMS Health clinical team has
provided the codes for the risk factors.
Risk Factors include diagnoses, procedures, and prescription products associated with:
• Diabetes
• Dyslipidemia
• Hypertension
• Weight/Obesity Concerns (includes codes for Bariatric Surgery, Normal/Under Weight)
• Smoking
• Migraine
• Triptan Use
• Menopause
• Oral Contraceptive Use
• Family History of CAD
4.3. Modeling Approach
IMS has analyzed two cohorts of patients separately:
1. The CAD risk data. Data sets 1 and 2.
2. The Migraine cohort.
This produced two models:
1. Average CAD risk
The first step of the average CAD risk model is to calculate the base rate of CAD events in males and
females for the following age groups:
1) 18 – 29
2) 30 – 34
3) 35 – 39
4) 40 – 44
5) 45 – 49
6) 50 – 54
7) 55 – 59
8) 60 – 64
9) 65+
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From the 10% sample (Data set 1) IMS has computed the number of patients in each group that had a
CAD event during the data time frame and has divided the number of patients that had a CAD event by the
number of patients in each group. This forms the base rate of a CAD event.
The patients in data set 2, the CAD event data set, are used to enrich the 10% sample for the calculation of
relative risk. Data sets 1 and 2 are combined and a logistic model has been fit to each of the 20 age and
gender segments.
Coding the Variables for Relative Risk
The outcome variable for the model is the presence of a CAD event from October 2013 to September 2014.
The event is naïve because IMS removed patients who had a CAD event in the two year look back period
from the first CAD event in the index period. The predictive variables used in the model are identical to
those used in the CAD event model.
2. Migraine cohort
The same two models have been applied to migraine cohort, data set 3. The average risks for the age and
gender segments are estimated. The data set is not enriched and a logistic regression has been fit to each
age and gender cohort. These logistic regressions have been used to compute the odds ratios.
4.3.1. Scoring of the Patients for CAD Risk
Finally the average rates and the odds ratios of the risk factors from the logistic model have been applied
to the diagnosed headache and migraine patient cohort.
First, diagnosed patients, who had a CAD event in the pre-or post-index period are assigned to the CAD
Event group. Next, the remaining patients are assigned to 1 of 3 groups, based on scoring of
cardiovascular risk factors in their history:
1) CAD Event
2) High: meaning the patient has a score in the top 25%. This is usually called the top quartile.
3) Medium: meaning the patient has a score between the 25% and 75% percentile.
4) Low: meaning the patient has a score in the bottom 25%. This is usually called the bottom quartile.
4.4. Methodology Appendix
4.4.1. Logistic Regression
In traditional regression, one has a dependent variable Y that they wish to model on a set of independent
variables X1, . . ., Xn. The dependent variable is continuous, taking any value. There is an extension called
logistic regression where the dependent variable takes one of two values. The values are canonically
labeled success or failure, but they can refer to anything, such as “CAD event” and “No CAD event.” One
uses logistic regression to analyze the case when the dependent variable has two values.
One models the dependent variable as Y = β0 + β1X1 + ⋯ + βnXn + ε in traditional regression. ε stands for
the error that is usually Normal with mean 0 and unknown variance. One needs a function that returns a
value between 0 and 1 for logistic regression. The logistic function is typically used and it has the form:
L(x) =
ex
1 + ex
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For logistic regression, the model is Y = L(β0 + β1X1 + ⋯ + βnXn). The error term ε has been eliminated
because the probability model is: Y is a success with probability L(β0 + β1X1 + ⋯ + βnXn) and a failure
with probability1 − L(β0 + β1X1 + ⋯ + βnXn). A computer maximization program is used to find
coefficients that maximize the probabilities of seeing the success and failures.
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5. Authors
Jenn Millard
Principal, IMS Health Real World Evidence Services
Jenn Millard is a Principal in the Real World Evidence Solutions group and has served as a
consultant, performing both quantitative and qualitative analyses to understand market
dynamics. Jenn is highly experienced at delivering and implementing recommendations
covering a variety of strategic sales and marketing issues, with significant focus on product
launch, performance management and market insight development. Jenn is an accomplished
researcher with over 15 years of research experience, which encompasses many therapeutic
areas, including multiple sclerosis, diabetes, vaccines, mental health, pain, respiratory, rare
diseases, and migraine. Before joining IMS Health, Jenn worked for Fox Chase Cancer Center
and the University of Pittsburgh Cancer Institute, where she designed primary market
research studies; moderated qualitative research sessions; prepared research protocols; and
coordinated grant submissions. Jenn has earned her B.S. degree from Pennsylvania State
University with a dual major in Marketing and Psychology and earned her M.B.A. in
Marketing from Temple University’s Fox School of Business.
Kelly Peters
Vice President, IMS Health Commercial Services
Kelly leads the Commercial Services team that focuses on providing pre-launch and in-
market operational guidance to specialized pharmaceutical companies, the creative agencies
that support the healthcare industry, and advocacy organizations that seek to incorporate
Real World Evidence into their healthcare initiatives. Kelly is highly experienced in providing
evidence-based operational guidance to marketing, sales, and business development client
teams. She has hands-on experience in the assessment of product potential, development of
multi-channel operational plans tied to reaching that potential, and creation of diagnostic
solutions across several therapeutic markets (spanning orphan drug categories through
mainstream conditions that impact a broad base of patients). Kelly holds a B.S. degree in
Marketing from the Pennsylvania State University.
Donna DiStefano
Engagement Manager, IMS Health Commercial Services
Donna is an Engagement Manager with the Commercial Services group within IMS Health.
Donna is focused on developing customized opportunities for market access, product
development, market sizing, and product strategy. Donna has extensive experience in
several therapeutic areas including ophthalmology, diabetes, chronic kidney disease,
cardiovascular disease. She has held several positions in both Commercial Analysis and
Product marketing. She is particularly skilled at building collaboration with sales, marketing
and commercial analysis teams by integrating market research, competitive intelligence,
secondary data and market analytics to address key business objectives. Before joining IMS,
Donna was with Reata Pharmaceuticals in Irving Texas; prior to that she spent nearly five
years at Alcon Laboratories in various positions in Marketing and commercial analysis in the
pharmaceutical and surgical franchises. Donna holds a BS in Biology from Loyola University
in Maryland, and an MPH from Rutgers University.