Out-Law News 2 min. read

Changes to the funding of cancer drugs may pave the way for a level playing field


The recent changes to the way drugs are assessed for funding under the Cancer Drugs Fund (CDF) may align assessment of treatments in all disease areas, possibly paving the way for the phasing out of the CDF in 2016, an expert has said. 

"The CDF was an interim measure and was founded on the premise that society values the health benefits of drugs for patients with cancer more highly, all else being equal, then other medical conditions," life sciences specialist Helen Cline of Pinsent Masons, the law firm behind Out-Law.com, said. "The CDF has many critics who do not see the equity in having different assessment processes for cancer drugs over those for other disease such as Alzheimers."

Cline was commenting ahead of an expected announcement by NHS England of its recent review of drugs funded under the CDF.

The CDF was set up in 2011 as an interim measure to provide a means of improving patient access to cancer drugs prior to the anticipated reform of arrangements for branded drug pricing on expiry of the previous Pharmaceutical Price Regulation Scheme (PPRS) at the end of 2013.  The current CDF is in place until March 2016.

The main objectives behind the fund is for it to support NHS cancer patients, give specialist clinicians more control over decision-making on treatments and act as an effective bridge to the Government’s original plan of introducing a value-based pricing system for branded drugs in 2014.

However, NHS England has raised concerns about the costs of the CDF to the taxpayer. It is expected that NHS England will announce the results of its review of drugs funded under the CDF aimed at keeping the fund within budget. However, a number of pharmaceutical companies have spoken out ahead of the announcement to confirm that their products will be affected by the changes and to criticise the way NHS England review which drugs should feature on the list of those that can be paid for using the CDF. Some in the industry have threatened to take legal action against NHS England.

The tensions that exist on drugs pricing stem from the high costs involved for pharmaceutical companies in developing new drugs, said Paul Ranson, life sciences expert at Pinsent Masons, the law firm behind Out-Law.com. "Although those companies should not be expected to subsidise health care in England they are already engaging earlier in the drug delivery and development process with regulators and payers to ensure that the right data is in place," Ranson said. "This could make the process more predictable and help companies get their drugs to market quicker, save on development costs and ultimately reduce the price of those products to the taxpayer."

Ranson pointed to the UK's Early Access to Medicines Scheme (EAMS) and the adaptive licensing pilot announced by the European Medicines Agency (EMA) as two initiatives aimed at fast-tracking new drugs onto the market.

Pricing and reimbursement consultancy MAP Biopharma warned of the potential negative effect of changes to how the UK approaches cancer treatment.

"The UK’s change in approach toward cancer comes at a time when the UK still trails behind our EU neighbours in terms of outcomes, and this latest news suggests that the recent ‘catch up’ with access to more cancer medicines may fall back," Mark Harries of MAP BioPharma said.

Christian Hill, also of MAP BioPharma, said: "The predictability of process under the CDF echoes the experience of the PPRS. Companies are thinking very carefully about entering the UK at the moment due to shifting sands."

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