UK Cancer Drugs Fund Debuts To Muted Applause From Pharma, Charities

The re-launch of the controversial Cancer Drugs Fund in the UK has offered another point for debate about cancer drug pricing, budgetary pressures and the cost of innovation.

Pharma and charities in the UK gave a lukewarm welcome to the formal launch of the revamped Cancer Drugs Fund, saying the new entity – controlled by the National Institute For Health and Clinical Excellence (NICE) – will not solve underlying problems of drug reimbursement which, in turn, restrict access to novel oncology therapies.

NHS England earlier in July issued new guidelines on how cancer drugs will be appraised and funded in the UK, including the operation of the controversial Cancer Drugs Fund (CDF), which had been established in 2011 as a separate silo fund for cancer drugs that NICE assessed as being too costly for the publicly funded National Health Service (NHS). It was closed in March after heavily overspending. (Also see "UK Cancer Drugs Fund Reforms Get Cautious Welcome, But More Needed" - Scrip, 11 Jul, 2016.)

Announcing the revamped fund is "open for business," Jonathan Fielden, deputy national medical director at NHS England, on July 29 said: "Today marks the culmination of extensive work to ensure the new CDF will benefit the cancer patients, taxpayers and industry. The new approach developed by NHS England and NICE is faster and less rigid than before, meaning patients will be able to access promising new and innovative treatments much earlier."

"The new approach developed by NHS England and NICE is faster and less rigid than before, meaning patients will be able to access promising new and innovative treatments much earlier." – NHS England's Jonathan Fielden

The new CDF is a "managed access" fund, with a fixed annual budget of £340m. Publishing of the reforms, unveiled late on July 8, followed a 12-week consultation that ended in February.

Under the new process, all new cancer drugs will be referred to NICE, which is independent of government, for appraisal, a process which will start much earlier than previously with the aim of publishing draft guidance prior to a drug receiving its marketing authorization and then final guidance within 90 days of marketing authorization wherever possible.

Any drugs receiving either a draft recommendation for routine commissioning or, where uncertainty exists, a recommendation for use within the CDF will receive interim funding from the CDF from the point of marketing authorization.

The new Cancer Drugs Fund will now have clear entry and exit criteria allowing medicines to move in and out over time, whereas the old fund only had entry points. There is also a much needed system for getting some promising new cancer medicines to National Health Service patients more rapidly, while gathering evidence about their effectiveness.

All new drugs will enter the NICE appraisal process before licensure, and products referred to NICE by government ministers will get draft recommendations at the time of a positive opinion from the European Medicines Agency and final guidance will be published within 90 days of marketing authorization. "This is faster than any other European country and will benefit NHS patients and companies alike," a spokesperson said. NICE has already started looking at the drugs in the old CDF to see whether they can be recommended for routine funding, he added.

CDF Overspend Worries Pharma

A major sore point for the pharma sector will be how overspending by the fund is financed.

To avoid the CDF overspending – and thus being closed to potential new entrants – a proportional rebate will be applied to all pharmaceutical companies receiving any funding from the new CDF budget in the event of an overspend. Agreement to this mechanism will be a condition for all pharmaceutical companies receiving funding from the CDF budget, according to NHS England.

That arrangement worries the pharma industry operating in the UK.

"Given the fact that the old fund consistently overspent significantly on its allocated budget, and that industry already underwrites the majority of expenditure on branded medicines over and above agreed levels, a fairer and more equitable system of financial risk must be prioritized," said Paul Catchpole, value and access director at the Association of the British Pharmaceutical Industry (ABPI), referring to the negotiated voluntary five-year Pharmaceutical Price Regulation Scheme (PPRS) currently in effect in Britain.

David Montgomery, Pfizer UK's oncology medical director, said that "while we've indicated our agreement to proceed with the new arrangements for the fund, we remain concerned that many cancer medicines still won't get to patients through either NICE or the new CDF."

"The new CDF won't work for many modern cancer medicines. NHS England has not listened to concerns expressed by industry around the expenditure control mechanisms, in which companies are expected to underwrite 100% of all risk in managing the CDF budget," Montgomery said, adding "we believe that this creates uncertainty for industry and does not accurately reflect the significant contribution that industry makes already in improving patient access to the medicines they need."

Lisa Anson, country president for AstraZeneca UK and Ireland, said the fundamental issues with how NICE assesses cancer medicines remain. "Unless these are addressed, patients will continue to face the same access challenges that led to the CDF being set up in the first place. Also, the new operating procedure for the CDF introduces a complex commercial process for companies to navigate, on top of discussions that have already taken place with NICE."

Some patient groups are alarmed by the changes.

“The new CDF will do next-to-nothing to solve the wider problems that are preventing NHS patients from accessing the best cancer drugs," said Baroness Morgan, the chief executive of the charity Breast Cancer Now.

“The CDF was set up because NICE’s methodology was not working for cancer drugs, and this new process offers little change. With the Fund’s drug assessment now being handed back to NICE, we worry that patients in England will miss out on effective drugs being made available in other countries," she said.

But the NICE spokesperson threw the issue back at the drug makers, saying "it’s now up to those companies to show that they recognize the challenges as well as the opportunities their new drugs present to patients and the NHS by showing the same flexibility on cost as they have in their recent negotiations with NHS England for drugs already in the CDF.”

Anticipating that stance, AstraZeneca's Anson said "we recognize NHS budget challenges, however it is also important to recognize the value of novel breakthrough cancer medicines that extend and improve the quality of patients’ lives.”

Pfizer's Montgomery noted that pharma "is a high-risk industry and it's not as simple as, or sustainable to, continuously ask companies to drop the price of these specialist medicines. It will impact our ability to make further medical progress if we do so."

"We are calling on UK government today to review NICE’s assessment methodology to stop patients facing ongoing anxiety around the availability of existing and new cancer medicines." – Roche UK General Manager Richard Erwin

Roche UK's general manager Richard Erwin echoed that frustration, adding: “now that the assessment of new cancer medicines for reimbursement has been returned to NICE, we must, as a matter of urgency, address the challenge they have in assessing the real clinical value of cancer treatments – which necessitated the creation of the original CDF. We are calling on government today to review NICE’s assessment methodology to stop patients facing ongoing anxiety around the availability of existing and new cancer medicines."

Breast Cancer Now's Morgan said the pharmaceutical industry should also take responsibility and begin offering "more sensible prices." She said the UK government should also get more actively involved to find a workable balance.

"Absolutely nobody benefits if effective new drugs are not made available on the NHS. We believe that enabling the British government to negotiate on price – as happens elsewhere in Europe – could significantly improve access for cancer patients,” she said.