Regulatory

Part II: 4 Market Access Assumptions Misleading Biotechs

The health technology assessment (HTA) process takes time, but how much delay in market access should you expect? The time it takes for an HTA agency to issue a reimbursement decision can be a major factor in the overall market access timeline. While HTA agencies publish timelines to set an expectation, those timelines are not always adhered to and decisions that take longer slow down speed to market. This can result in significant business repercussions for the manufacturer including decreased ability to gain market share and increase in time to revenue generation. So, when formulating a market access strategy, an understanding of the observed time for decision versus the published timelines can help to plan and set appropriate expectations. We also want to identify other important factors of market access that take place after a decision is issued and have the potential to affect market access.

4 Market Access Assumptions Misleading Biotechs

Biotechnology companies often do not have the market access resources comparable to large pharma. While this can pose a challenge, there is a considerable opportunity for biotechs to reduce this disadvantage by using health technology assessment (HTA) data in innovative ways to inform and drive their market access decision-making.

With our innovative technology platform and focus on data quality, we have been helping biotech companies understand the market access space for bellwether HTA agencies for the past seven years. Throughout our experience with biotechnology companies, we continually see four assumptions about the HTA process and market access:

Discussion on Drug Value Heats Up in US Election

Healthcare costs, specifically those related to prescription drugs, are a major election issue for many Americans. According to the August 2016 Kaiser Health Tracking Poll, two-thirds of Americans say Medicare access and healthcare affordability are top election issues, and 53 percent of voters say that prescription drug costs in particular are top priorities. Many of the efforts to address these issues concern the use of comparative efficacy and cost-effectiveness research. These forms of research, widely used integrated in the healthcare systems of many countries in Europe and elsewhere, are only recently gaining traction in the United States. Policy efforts and election outcomes could have a major impact on how these forms of research are used in the future.

OPDIVO: The High Stakes of Comparative Efficacy

The Wall Street Journal recently reported that Bristol-Myers Squibb stock dropped dramatically on August 5th, 2016. This occurred after clinical trial results indicated that BMS’s immunotherapy drug OPDIVO® (nivolumab) failed to demonstrate a clinical improvement compared to chemotherapy in patients with newly-diagnosed lung cancer.

The financial market reaction to the clinical trial results highlights the growing importance of comparative efficacy research, both for obtaining approval and market access and, increasingly, for remaining competitive and driving profits. The impact of this announcement shows that the stakes are higher than just obtaining regulatory approval. Clinical trial results can have immediate and significant consequences before any regulatory decisions are even made. Here we discuss the importance of comparative efficacy research on market access, pricing, profitability, and competition.

Diagnosing Brexit for Pharma

Brexit has stunned the world and shaken the foundation of many industries, including the pharmaceutical industry. The decision for the United Kingdom (UK) to leave the European Union (EU) is creating more questions than answers. There are many details that will be ironed out in the coming days, months and possibly even years, but pharma should be paying particular attention to how the Brexit will affect drug development, regulatory and health technology assessment (HTA) process and drug pricing.