UK Cancer Drugs Fund Revamped to Speed Access

Liam Davenport

August 02, 2016

The Cancer Drugs Fund (CDF) in England, which provides access to as-yet-unapproved cancer drugs, has been revamped to speed up the appraisal process and provide interim funding to allow patients faster access to novel medications.

The revamped CDF was developed by a partnership between National Health Service (NHS) England, the National Institute for Health and Care Excellence (NICE), Public Health England, and the Department of Health.

It has added four new cancer drugs to the list, which could benefit up to 4500 patients, and the new administration hopes to reduce the time to access by up to 4 months.

The CDF was originally set up by the government in April 2011 as a temporary solution to allow patients access to cancer drugs not routinely available on the NHS.

It was originally due to end in 2014 because it had been envisaged to act as a bridge to a new system of value-based pricing. That was abandoned, however, and so the CDF was continued.

Although the CDF has helped almost 100,000 patients with cancer to gain access to treatments not routinely available on the NHS, it has courted controversy since its inception. As previously reported by Medscape Medical News, the CDF has routinely overrun its budget, despite the repeated removal of drugs and indications from its list.

The CDF was closed to new drugs in October 2015 and, after a 12-week public consultation that was launched in December and brought input from patient groups and industry, was closed altogether on March 31, 2016.

During the consultation period, several bodies, including the National Audit Office and the Cancer Taskforce, heavily criticized the previous way in which the CDF was run. As reported by Medscape Medical News, the parliamentary spending watchdog, the House of Commons Public Accounts Committee, also made a series of damning observations about the CDF in February 2016. It said that the Fund had not been managed effectively and needed urgent reform to stop costs from spiraling out of control and to ensure that it was improving patient outcomes.

CDF Now Reopened

The CDF has now reopened, as of July 29, and will now be administered by the NHS/NICE partnership as a new managed access scheme with clear entry and exit criteria.

The new system means that NICE will assess all cancer drugs and indications for which marketing authorization will be sought, with early funding available for drugs that receive a draft recommendation for routine use or use within the CDF. Off-label drugs that are thought to have clinical promise in treating cancer may also receive funding.

NICE says it will conduct appraisals of newly referred drugs earlier than previously, with final guidance to be issued within 90 days of a drug receiving its license. Moreover, interim funding will be provided to pay for access to until final approval is published and comes into force.

The CDF will have a fixed budget of £340 million ($448 million), which will be overseen by NHS England and NICE and be subject to an expenditure control mechanism to reduce the risk of overspending.

This will achieved by the CDF working with the pharmaceutical industry "to encourage the responsible pricing of drugs" to achieve greater value for money, NHS England says. In return, the industry will have access to a new fast-track system and earlier funding via interim funding payments.

Rather than using a one-size-fits-all approach, NICE will also use "bespoke" data collection and individualized arrangements for commercial access for each drug to more rapidly resolve any uncertainties.

One of the results of negotiation with the pharmaceutical industry to make treatments more affordable is that four new drugs have become available before final NICE guidance has been issued, as follows:

  • Ceritinib (Zykadia, Novartis) for the treatment of lung cancer;

  • Dabrafenib (Tafinlar, Novartis) combined with trametinib (Mekinist, Novartis) for the treatment of melanoma;

  • Ipilimumab (Yervoy, Bristol-Myers Squibb) plus nivolumab (Opdivo, Bristol-Myers Squibb) for the treatment of melanoma; and

  • Trifluridine (Viroptic, Pfizer) and tipiracil (Lonsurf, Taiho Oncology) for the treatment of bowel cancer.

In addition, bosutinib (Bosulif, Pfizer), which is used in chronic myeloid leukemia, and pemetrexed (Alimta, Lilly), a maintenance therapy given after pemetrexed-containing chemotherapy to patients with lung cancer, have been recommended under draft guidance and will be funded until final guidance is published.

Of the 41 drugs that were left on the CDF when it was closed in March, 39 have been transferred to the new system while they are being reconsidered or appraised by NICE. Two-month notice for removal has been given to the remaining two drugs: lenalidomide (Revlimid, Celgene) will subsequently be offered free of charge by the manufacturer on a case-by-case basis, while temsirolimus (Torisel, Pfizer) is no longer used routinely.

Jonathan Fielden, MD, director of specialised commissioning and deputy national medical director at NHS England, said in a release: "The new Cancer Drugs Fund is open for business, with four new treatments to be made immediately available to patients."

The new approach developed by NHS England and NICE is faster and less rigid than before Dr Jonathan Fielden

"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," he said.

Reactions to the New System

Reacting to the news about the revamped CDF, Emlyn Samuel, a senior policy manager at the charity Cancer Research UK, recognized the need for a change to the previous framework. "We do need a system that manages the budget effectively," he told Bloomberg. "I think we all realize the financial constraints that the NHS is under and we do have to work within the confines of that."

However, concerns were voiced by the pharmaceutical industry.

Paul Catchpole, director of value and access at the Association of the British Pharmaceutical Industry, told Pharmaphorum that the new system will require "further evolution."

"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 prioritised," he said.

For David Montgomery, medical director for oncology at Pfizer UK, the new system seems "extremely high risk and not particularly effective" because it could lead to an "uncontrolled price cut on top of what will already be good value for money," he told Bloomberg. He said that there is not only a "great degree of concern that the new CDF isn't actually going to make things better" but also that it may "make things worse." Describing the continuous push to drive down prices as "too simplistic," he said, "We're not in the market of giving away medicines for free."

Bayer UK said in a release that while it has agreed to terms of the updated CDF, it does not believe that they will lead to "sustainable, equitable" access to the latest cancer drugs and that patients in England will lose out compared with patients in Scotland, Wales, and the rest of Europe.

Amanda Cunnington, head of patient access at Bayer, commented: "Rather than addressing the issues with the way NICE appraises cancer medicines, this new process has been designed so that the financial risk is imposed entirely on the pharmaceutical industry and therefore raises questions regarding the potential for future innovation in the long term for companies like Bayer, who invest and risk billions of pounds in researching these medicines."

"There is an urgent need for there to be a longer-term sustainable solution to the access to cancer medicines, which has been the subject of much discussion during the development of the yet-to-be-published Accelerated Access Review," she added.

One case highlighted by a pharmaceutical company is that of lenvatinib (Lenvima, Eisai), which is approved for certain cases of thyroid cancer but is not listed on the relaunched CDF. NICE has indicated it will not be able to issue final guidance on the treatment until around June 2018.

Eisai said that it has met with NHS England and NICE, but, despite extensive dialogue, no agreement has yet been made. In a press release, the company said: "On behalf of patients with advanced thyroid cancer, we have no option but to fight this inequitable situation. For once this is not about cost as we have not been asked to be evaluated for clinical or cost effectiveness but we would welcome the opportunity to do so."

Eisai also criticized the revamped CDF, pointing out that the new system "is underwritten by the pharmaceutical industry, where we take 100% of the financial risk associated with the Fund. This situation would indicate that England is turning the clock back and fast becoming the sick child of Europe in terms of access to innovative cancer drugs. Eisai will therefore fight aggressively for the rights of patients, which may include taking legal action."

In addition, a breast cancer charity poured scorn on the new system. Baroness Delyth Morgan, chief executive of Breast Cancer Now, was quoted by the National Health Executive as saying: "The new CDF will do next-to-nothing to solve the wider problems that are preventing NHS patients from accessing the best cancer drugs."

This new process offers little change. Delyth Morgan

She added: "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."

Nevertheless, Baroness Morgan noted that the pharmaceutical industry should "take responsibility and begin offering more sensible prices." She said, "We believe that enabling the Government to negotiate on price, as happens elsewhere in Europe, could significantly improve access for cancer patients."

No relevant financial relationships have been disclosed.

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