Market access the challenges for medical devices

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2 likes•5,046 views

With increased incidences of reimbursement rejections by payers and a growing usage of pricing and reimbursement tools market access is becoming increasingly restricted…

PARIOFORMA

 Market Access for Medical Devices and Diagnostics is hampered by national differences in coding
as well as globally diverse coverage and payment mechanisms.
 Furthermore, great variations exist in the DRG systems in the countries that have implemented
these classification methods - depending on each country’s health system structure, payment
methods and availability of information.
 Such factors can have a resultant impact on sales.

The role of medical devices in healthcare is essential – but the $300 billion medical device industry is
highly regulated and market access is becoming increasingly restricted…
 The process for gaining reimbursement is now characterized by a health technology assessment (HTA) approach
whereby payer organizations evaluate new technologies on the basis of their clinical value, cost-effectiveness and
other health economic factors.
 Manufacturers now face unique
informational and evidentiary
demands to demonstrate
comparative value.
 Payer access is most critical –
therefore, the sooner Market
Access is at the table, the more
likely successful reimbursement
and coverage strategies are to be
realized.

Parioforma Ltd – 55 Princes Gate – London SW7 2PN – United Kingdom
www.parioforma.com

Case Study:
A global medical device manufacturer contacted us to undertake a pre-launch PARIOFORMA
environment mapping exercise in Hungary and other selected emerging markets.

Key findings:
 Changing decision-makers – physician power
is eroding.
 Multiple buyers – all with different priorities
and differing views about your device, adding
complexity to the purchasing process.
 Rise of new influencers – payer organisations
and health technology assessment agencies
are becoming gatekeepers.
 Pricing pressure – intense pressure to
contain costs and work within pre-defined
budgets.
 Stakeholder fragmentation – a broadened
range of market access stakeholders.
 Emerging markets are complex and evolving
environments – political and economic
transition has resulted in many changes in
the healthcare environment of these
countries.

Parioforma Ltd – 55 Princes Gate – London SW7 2PN – United Kingdom
www.parioforma.com

Plan ahead and start early in the product lifecycle:
 Every market is different – environment mapping is key to helping manufacturers understand the
complex reimbursement, coverage and decision making landscape. PARIOFORMA
 Studies need not be in-depth, early directional work can guide strategy development, help build
early value messages and save time and money by ensuring that any future large global study
asks the right questions and is not overly complicated.

We can help you:

We specialise in environment mapping - quickly and affordably - in particular, payer research. With a
network of over 500 payer specialists worldwide - our scope is global and we have the resources and
experience to tailor our services to meet your needs…
For further information, or to discuss your Market Access requirements,
contact us now on +44 (0) 207 225 3538 or email Charles Rowlands at:
charles.rowlands@parioforma.com

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The document provides an overview of health technology assessment (HTA) processes and requirements in selected countries. It describes the status of HTA agencies, guidelines, selection criteria for drugs to review, preferred assessment approaches, weighting of clinical versus economic evidence, outcome measures, comparators, decision thresholds, cost perspectives, budget impact analysis requirements, and modeling and data requirements for each country. Countries discussed include Argentina, Colombia, Czech Republic, Hungary, Israel, Mexico, and Poland.

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This paper examines key success factors for effective collaboration in the pharmaceutical industry. In an industry where speed to market is critical and where informed and timely decisions can have large financial implications, collaboration is a key factor to ensure value is delivered. Consequently, considerable investment is being made by pharmaceutical companies to enable project teams to work more effectively together across departmental, functional, company and geographic boundaries.

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The document provides an overview of health technology assessment (HTA) in selected emerging market countries. It notes that many emerging markets have adopted social health insurance models and increased healthcare spending driven by economic growth, aging populations, and expanding access to medical technologies. However, this has also brought challenges around cost containment and improving access. As a result, many countries are now establishing HTA agencies and processes to help guide healthcare spending and policy decisions based on costs and effectiveness. The document includes brief summaries of the current state of HTA in Argentina and an unnamed country.

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Market access the challenges for medical devices

1. PARIOFORMA  Market Access for Medical Devices and Diagnostics is hampered by national differences in coding as well as globally diverse coverage and payment mechanisms.  Furthermore, great variations exist in the DRG systems in the countries that have implemented these classification methods - depending on each country’s health system structure, payment methods and availability of information.  Such factors can have a resultant impact on sales. The role of medical devices in healthcare is essential – but the $300 billion medical device industry is highly regulated and market access is becoming increasingly restricted…  The process for gaining reimbursement is now characterized by a health technology assessment (HTA) approach whereby payer organizations evaluate new technologies on the basis of their clinical value, cost-effectiveness and other health economic factors.  Manufacturers now face unique informational and evidentiary demands to demonstrate comparative value.  Payer access is most critical – therefore, the sooner Market Access is at the table, the more likely successful reimbursement and coverage strategies are to be realized. Parioforma Ltd – 55 Princes Gate – London SW7 2PN – United Kingdom www.parioforma.com

2. Case Study: A global medical device manufacturer contacted us to undertake a pre-launch PARIOFORMA environment mapping exercise in Hungary and other selected emerging markets. Key findings:  Changing decision-makers – physician power is eroding.  Multiple buyers – all with different priorities and differing views about your device, adding complexity to the purchasing process.  Rise of new influencers – payer organisations and health technology assessment agencies are becoming gatekeepers.  Pricing pressure – intense pressure to contain costs and work within pre-defined budgets.  Stakeholder fragmentation – a broadened range of market access stakeholders.  Emerging markets are complex and evolving environments – political and economic transition has resulted in many changes in the healthcare environment of these countries. Parioforma Ltd – 55 Princes Gate – London SW7 2PN – United Kingdom www.parioforma.com

3. Plan ahead and start early in the product lifecycle:  Every market is different – environment mapping is key to helping manufacturers understand the complex reimbursement, coverage and decision making landscape. PARIOFORMA  Studies need not be in-depth, early directional work can guide strategy development, help build early value messages and save time and money by ensuring that any future large global study asks the right questions and is not overly complicated. We can help you: We specialise in environment mapping - quickly and affordably - in particular, payer research. With a network of over 500 payer specialists worldwide - our scope is global and we have the resources and experience to tailor our services to meet your needs… For further information, or to discuss your Market Access requirements, contact us now on +44 (0) 207 225 3538 or email Charles Rowlands at: charles.rowlands@parioforma.com

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