Update on Recent Cancer Drugs Fund Changes

On March 16, 2016, the National Institute for Health and Care Excellence (NICE) approved some major changes to the UK’s Cancer Drugs Fund (CDF). The most significant of these changes is that NICE will now be evaluating all oncology drugs approved by the European Medicines Agency (EMA), including those previously funded through the CDF. Prior to this change, the CDF had independently conducted its own reviews. Now, the CDF will only serve as a funding source to be used at NICE’s discretion. This reorganization was precipitated by years of budget difficulties and numerous disagreements about the respective roles of NICE and the CDF.

NICE has started to release oncology reviews under its revised technology appraisal process, with many additional reviews in development and expected to be released in the next few months. In this post, we will discuss those reviews and what they may indicate about the future of oncology drug funding in the UK. 

Big Changes to Cancer Drugs Fund as NICE Takes Over All UK Oncology Evaluations

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.

Science vs. Marketing

A Wall Street Journal article on March 13 reported that Bristol-Myers Squibb’s cancer drug Opdivo® has outperformed Merck’s similar drug, Keytrudo®, by falling back on an “old, mass-marketing approach.” Merck’s product is paired with a diagnostic test used to identify patients expressing the PD-L1 protein, in whom the drug would be the most effective. Merck’s trials only included patients expressing this protein, and the FDA approved the drug only in those who test positive for it.

ASCO Conceptual Value Framework Demonstrates Gap in US Healthcare Valuation Process

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?

For UK Cancer Drug Fund, Does Cost Really Outweigh Clinical Efficacy in Their Decision-making Process?

The addition of cost as an evaluation criterion and the re-evaluation of drugs already on the CDF priority list has been a contentious topic within the oncology market access world. The pharmaceutical industry and cancer advocacy groups are fearful that cost will be the major factor in CDF decisions and will further restrict the number of treatment options that are available to patients. Others applaud the change, viewing it as preventing the use of overpriced drugs in the UK.  

Are the manufacturers’ and cancer advocacy groups’ fears warranted? Does cost really outweigh the clinical efficacy of the drug in the CDF decision-making process? 

Which Outcomes Matter in Solid-state Oncology?

When evaluating surrogate outcomes in Solid-state Oncology, the gold standard for measuring clinical trial success is the use of overall survival (OS). However, given the expense and time delay for patients in getting access to important treatments, both the FDA and the EMA (European Medicines Agency) accept progression-free survival (PFS) and disease-free survival (DFS) as appropriate surrogate outcomes. These trials are cheaper to run and take less time, but we wondered if using either PFS or DFS has an impact on getting a positive recommendation from Health Technology Assessment (HTA) agencies. To have a better understanding, we analyzed 245 reviews for six solid-state oncology conditions that were published between 2005 and 2013 by 10 different Health Technology Assessments (HTA) agencies to determine if using PFS or DFS decreased their likelihood of a positive recommendation.