FDAnews
www.fdanews.com/articles/167755-england-to-reimburse-fewer-cancer-drugs-under-proposed-changes

England to Reimburse Fewer Cancer Drugs Under Proposed Changes

October 10, 2014

The English government is considering halting reimbursement on costly cancer drugs, which officials concede could restrict patients from receiving certain treatments.

The National Health Service of England unveiled proposed changes Friday to the Cancer Drug Fund (CDF), which reimburses patients for drugs not covered under the UK financial watchdog the National Institute for Health and Care Excellence (NICE). The move comes as patient demand has increased.

The most drastic change appears to be a re-evaluation of all the drugs currently on the list. The NHS will assess the cost of a drug per patient in relation to the clinical benefit delivered, and products with a low clinical benefit will be removed.

The NHS will also apply this evaluation to new drugs applying for reimbursement by the fund. A drugmaker would have the option to confidentially adjust a product’s price to ensure it remains on the list of reimbursed drugs.

The evaluation on clinical benefit and cost effectiveness represents a sharp shift from the current practice. The fund normally lists cancer drugs that were rejected by NICE as not cost effective or weren’t reviewed by NICE because they treated rare cancers.

Under the proposed scheme, the government will assess a drug’s impact on progression-free survival, overall survival, quality of life, toxicity and a robust definition of unmet need, Peter Clark, MD, an oncologist that chairs the fund, said.

Clark conceded that patient access to some drugs will be restricted. “The aim is to make this restriction as fair as possible to cancer patients when considered as a whole,” he said.

Need for the CDF has risen since its inception in 2011, with approximately 2,000 new patients gaining access to treatments every month, according to a summary of the changes. Clark said that the CDF has only a fixed pot of funding, and the changes will ensure that funding is only spent on “drugs which offer the better levels of clinical impact but at a level of drug pricing which delivers value for money.”

In August, the English government pledged an additional $202 million over the next two years to strengthen the fund. The CDF is not available in other parts of the UK. — Robert King

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.