After years of budget woes and disagreements about its place in the National Health Service (NHS), the Cancer Drugs Fund (CDF) will no longer be conducting reviews of oncology products. The National Institute for Health and Care Excellence (NICE) will now be reviewing all new cancer drugs and significant changes in indications for existing drugs. NICE is amending its technology appraisal (TA) process to provide for some drugs to be temporarily funded through the CDF while companies seek further data to strengthen the evidence in favor of routine use. NICE is also placing greater emphasis on providing rapid access to cancer drugs and intends to publish guidance on cancer drugs within 90 days of marketing authorization.
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?
G-BA and NICE are two influential health technology assessment (HTA) agencies: both have large markets for pharmaceuticals, many countries look to Germany for reference pricing, and NICE decisions are referenced in other agencies’ assessments.
The product team at Context Matters is always working on ways to improve our customers’ subscriptions. This year alone we’ve published new data from over 2,000 HTA reviews and regulatory labels and deployed over 130 updates to our application and data model. Today, I’d like to highlight some of the capabilities our customers can now use and provide a preview of what we’re working on this spring.