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.
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:
It’s easy to think of health technology assessment (HTA) reimbursement decisions as boiling down to a simple a “Yes” (Recommend) or “No” (Do Not Recommend). In fact, there are often multiple dimensions to the outcomes of HTA agency reviews. Failure to take the nuances of these decisions into account when developing a market access strategy can have significant impact on everything from clinical trial design, building an economic model, to projecting revenue and beyond. Working with an accurate and precise classification of a decision, and taking into account the context of that decision, enables manufacturers to use decision qualifications, such as restrictions, to develop a well-informed strategic blueprint for market access.
In November 2013, the National Institute for Health and Care Excellence (NICE) in the UK began its assessment of Sovaldi® (sofosbuvir) for Hepatitis C. Fifteen months later, in February 2015, NICE published its final recommendation, recommending Sovaldi for use and reimbursement for Hepatitis C genotypes 1-6, with various conditions set to ensure the drug reaches those populations for whom the drug was found to be the most cost effective.
Health Technology Assessment (HTA) agencies have been widely promoting their interest in taking relevant patient data into account during the drug review process. The effort to make a place for the patient voice in reviews is promising in an economic climate where the cost of innovation is under constant scrutiny. However, it raises two critical questions:
- How much weight does the patient data have in the HTA decision process?
- Are submissions by patient and professional groups associated with positive decisions?
The recent and frequent outcry over expensive drugs has made evident the gap in the United States’ healthcare system. While no perfect system exists, other countries have health technology assessment (HTA) agencies to evaluate efficacy and/or cost-effectiveness and inform reimbursement decisions.
What might the U.S. learn from countries like England, Germany, and France in structuring a methodology for evaluating drugs?
The ongoing debate around the high cost of drugs in the United States, especially in oncology, has produced interesting responses from special interest groups. The American Society for Clinical Oncology (ASCO) is the latest to enter the fray, believing they may have found a solution for drug valuation in the United States. Does ASCO’s new framework solve a problem in the drug evaluation process in the United States, or does it expose a serious and still unmet need?