Regulatory

The Real-World Consequences of Classification

Simply enter the question "are eggs dairy?" in your favorite search engine to experience how classification can shape our view of the world. The search results will include all kinds of articles, discussions, and even videos from people asking and trying to answer this question—generally because eggs are placed in the dairy section of most US grocery stores.

This implicit classification leads many people in the US to believe that eggs are dairy. This may be a surprising assumption to those in other countries such as the UK where eggs are kept in the dry goods section. We often are not aware of the way classification shapes our perceptions and decisions. Classification of eggs in the grocery store is, for most of us, a low-stakes problem. Classification of pharmaceutical products, on the other hand, can have massive clinical and economic effects, but for most individuals, the classification is just as invisible.

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:

Regulatory Restrictions on Biologic Rheumatoid Arthritis Drugs

A drug’s market share is dependent on several external factors, one of which is the drug’s health technology assessment (HTA). We analyzed HTA decisions from NICE, HAS, IQWiG, HIS, and SMC for rheumatoid arthritis (RA) drugs, specifically examining the subpopulations established by the HTA agencies through restrictions against the European label, and noting whether these restrictions changed over time.