Reimbursable Innovation

A new white paper authored by Alberto Grignolo Ph.D. and Chuck Stevens J.D. , M.B.A.

PAREXEL Consulting assists companies of all sizes and in all stages of development to address the changing market place dynamics with real-world tailored solutions including: Consulting, Early Phase Product Development, Phase II-III Clinical Research, Late Phase Clinical Research, Medical and Payer Communications, and an industry-leading eClinical technology suite.

Powered by trusted experts, operational excellence and technology, we help our clients manage risk, and successfully innovate and complete in the global marketplace. Download our white paper today, and contact us for an executive briefing. We will arrange a meeting with experts tailored to your specific product and geographic needs.

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Executive Summary of Reimbursable Innovation:

Authored by Alberto Grignolo Ph.D., Corporate Vice President, Global Strategy, PAREXEL Consulting  and Charles A. (Chuck) Stevens J.D., M.B.A., Vice President and General Manager, Reimbursement and Market Access, PAREXEL Consulting.

Background

• The “train” has left the station and regulatory approval is not the end game anymore.
• Payers have become crucial gatekeepers to success and want proof of compelling healthcare value. 
• Investors also want to know the potential value of a drug before they open their wallets. 
• Examples from the US and Europe are presented, and relevance to emerging markets also noted.

Specific Challenges        

• FDA CMS Collaboration has been occurring for years on an informal basis and cannot be ignored.
• An added challenge for drug companies in the EU is that each country sets its own pricing and reimbursement policies—a matter the EU Commission is barred by law from interfering in.
• Companies that neglect to bring payers into the development process may win regulatory approval of a product, but face an inefficient and uphill battle when seeking reimbursement. 
• The good news is that there is increasing evidence that payers are willing to sit down with sponsors and regulators to review and discuss how a particular product is being, or should be developed; however, the challenge for manufacturers is how to put a plan into action.

Possible Solutions                                                                                  

• To succeed, companies need to synchronize Regulatory, Clinical and Commercial strategies to address the needs of their stakeholders:  Regulators, Patients, Providers and Payers.
• This white paper outlines specific ways companies can incorporate the payer perspective in their development strategies, how to engage private and public payers, and the benefits of doing so.