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Considering Commercial Success During Clinical Development: Maintaining a Global Perspective

Although commercial success is the ultimate goal of pharmaceutical research and development (R&D), many new treatments do not meet expectations and fail to achieve broad global reimbursement after initial regulatory approval., This causes therapies to underperform across international markets and, more importantly, limits access for patients in need. For example, only 56% of all new drugs approved by the European Medicines Agency (EMA) between March 2000 and March 2018 went on to receive a positive reimbursement recommendation by the National Institute for Health and Care Excellence (NICE) in the United Kingdom (UK)—the country’s central health technology assessment (HTA) body.

Several factors contribute to suboptimal global reimbursement, including a bias toward United States (U.S.) market characteristics and the compartmentalization of expertise within specific stages of the R&D process. As the single largest pharmaceutical market, U.S. market considerations heavily influence the focus of global pharmaceutical R&D programs despite differing market access requirements in other regions. Indeed, the differences between regional markets means a “one size fits all” approach is not feasible for achieving global commercial success. In particular, regulatory approval is generally sufficient to achieve U.S. market access, and most phase II and III clinical trials focus predominantly on obtaining the clinical safety and efficacy evidence needed to achieve regulatory approval. However, in many non-U.S. markets, new drug candidates must overcome several additional mandatory steps to gain market access, including demonstrating cost effectiveness and affordability. Nevertheless, demonstrating economic benefit is becoming ever more important to supporting optimal product revenue even in the U.S.

An important step to gaining market access in Europe and many other regions is assessment by Health Technology Assessment (HTA) agencies

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Author
Melissa Thompson, B.Sc., MBA
Senior Vice President, Value and Evidence

Melissa Thompson is a global thought leader in health economic and outcomes research with over 20 years of experience. Prior to joining EVERSANA, Melissa spent 13 years as a Managing Partner at Cornerstone Research…

Mike Ryan
Executive Vice President, Europe

With more than 25 years of experience in the life science industry, Mike has held global leadership positions in both clinical development and life-sciences software companies. Given this experience, he is highly experienced in…

Adam Hardy
Vice President, Commercial Operations

Adam Hardy is a leader in the pharmaceutical industry, having worked in the industry for over 15 years in both European and US-based organizations. This experience includes working in all phases of pharmaceutical R&D,…

Ari Mendell, MSc, PhD
Associate Director, Value Communications

In his role as Associate Director, Ari supports all aspects of value communications at EVERSANA, including GVDs, AMCP dossiers, structured/targeted literature reviews and summary slide decks, manuscripts, value propositions, and payer objection handlers. Ari…

Joshua Gauci
Associate Director

Josh has medical writing experience in chronic myeloid leukemia, psoriatic arthritis, B-cell lymphomas, systemic light chain (AL) amyloidosis, and chronic kidney disease. ​He specializes in developing global value dossiers, clinical summaries, and other value…

Nicole Hengst
Head of Health Strategies Insights by EVERSANA™

Nicole Hengst leads Health Strategies Insights by EVERSANA™ with the goal of ensuring that all services and interactions exceed client expectations. Since joining the team, Nicole has led the following services: specialty pharmacies/specialty distributors;…