A two-year extension to the U.K.’s cancer drugs fund has been welcomed by the pharmaceutical industry, but it does little to solve the longer-term problems that oncology drug manufacturers are facing on the reimbursement there front.

British Prime Minister David Cameron’s announcement on Sept. 28 that the Cancer Drugs Fund would be kept afloat until March 2016 – two years beyond its cut-off point of March 2014 – means oncology drug manufacturers will be given a lifeline for those oncology drugs that are excluded from routine funding through the public National Health Service. The extra two years of funding from the CDF will amount to £400 million ($648 million), bringing the total available through the fund since it was launched in October 2010 to more than £1 billion ($1.62 billion) Also see "UK's New Cancer Drug Fund Might Not Alleviate Regional Access Disparities" - Pink Sheet, 1 November, 2010..

Reasons For Extending The CDF

The Cancer Drugs Fund has been viewed by oncology drug manufacturers as something of a godsend since its introduction.

In essence, it has been a haven for major cancer drugs that have fallen shy of the U.K. reimbursement watchdog NICE’s cost-effectiveness assessments. These include Genentech Inc./Roche’s Avastin (bevacizumab), Pfizer Inc.’s Bosulif (bosutinib), Sanofi’s Jevtana (cabazitaxel), Merck KGAA’s Erbitux (cetuximab), Eisai Inc.’s Halaven (eribulin), Eli Lilly & Co.’s Alimta (pemetrexed), Bristol-Myers Squibb Co.’s Sprycel (dasatinib) and Bayer AG’s Nexavar (sorafenib).

“Continuation of the CDF is crucial given that so far NICE has not approved any of the 11 new cancer medicines that have been appraised this year,” Pfizer said in a written statement. Six of the 11 already have been knocked back by the National Institute for Health and Care Excellence – although one is due to be re-appraised following an appeal – and five have provisional negative decisions.

Britain’s prime minister said the drugs fund was being extended because many patients continue to be denied life-saving treatments for rare cancers.

For Pfizer, the reason behind the CDF’s extension is more obvious.

“Patients are being denied innovative medicines that are being turned down by NICE. NICE is blocking medicines when it should be a beacon for innovation,” said Pfizer U.K. Managing Director Jonathan Emms, adding that that is at odds with the British government’s ambitions for innovation in the NHS and better patient outcomes.

Pfizer said extending the CDF is a short-term solution that sends a clear signal that NICE is not working. As long as the health technology assessment system remains broken, the CDF must continue as the only route for English patients to benefit from much needed cancer medicines, the company said.

This view is rife amongst oncology drug manufacturers.

“There is evidence that the problems with the system which led to the creation of the CDF have worsened, with NICE now rejecting over 60% of the cancer drugs it appraises,” a spokesperson for Roche said.

Steve Bates, CEO of the U.K. Bioindustry Association, noted that the CDF actually was supposed to be a stepping stone towards the firm establishment of a value-based pricing (VBP) system in the U.K. through which drugs would be reimbursed according to the value they provide to society. While the CDF is now ongoing, the transition to VBP has made little headway. “I don’t think it is being pursued with the vigor that the previous secretary of state had behind it,” Bates said.

VBP no longer appears to be a top priority for the present health secretary, Jeremy Hunt. Even if the pace of moving towards VBP were to pick up, Roche points out that the final version of such a new reimbursement model might already be prejudiced against the industry because NICE would play a central role in its implementation.

The CDF did not have the shiniest of starts itself. Bates noted that in its first year, funds in the CDF were not fully spent and that there was unwillingness in the NHS to exploit the new mechanism.

“Technically, did they spend all the money in the CDF on cancer drugs? No, they did not. Is it the best policy initiative in the world ever? No, it isn’t,” Bates said.

A few months after it was launched, the Association of the British Pharmaceutical Industry (ABPI) suggested that the CDF actually was in danger of exacerbating existing regional discrepancies in access to, and choice of, innovative cancer treatments, rather than providing the level playing field for all cancer patients that the government had intended Also see "Regional Disparities Threaten Effectiveness Of U.K. Cancer Drugs Fund" - Pink Sheet, 19 January, 2011..

The Way Forward

Going forward, Roche suggested that the CDF be kept going until any new pricing system could be proven effective for accessing cancer drugs. For there to be confidence that the CDF can be withdrawn in the future without an adverse impact on patients, any new access mechanism should meet a number of tests, the Swiss drug maker’s spokesperson said.

Roche believes that any proposed new mechanism must: support clinical practice for cancer which is equivalent to that in comparable countries; provide an effective framework for handling the complexity associated with evaluating modern cancer treatment; enable a swift assessment, leading to the rapid and consistent uptake of treatments among appropriate patients; ensure affordability and financial certainty for the publicly funded NHS; and attract patient, clinical and public confidence.

Bates said that the BIA was pushing for the establishment of a “breakthrough therapy” designation similar to that awarded to some drugs in the U.S. In Europe, this idea is being pushed as “adaptive licensing”, although only Italy really seems to have picked it up effectively Also see "Europe Transparency Initiatives May Aid Progress Toward Adaptive Licensing Systems" - Pink Sheet, 18 March, 2013..

Pfizer’s view is that there is a disconnect between decisions made by NICE and the government’s ambitions for the NHS, and for tackling some of the most-feared diseases. “The government must secure a new mandate for NICE so it’s key goal is for the U.K. to be a global leader in the adoption of new medicines,” Pfizer U.K. Managing Director Emms said.

Pfizer is echoing the view of a pharmaceutical industry that long has called for a fundamental revamp of how NICE approaches HTA, with more emphasis on clinical-, rather than cost-effectiveness. Retraining one of the heavyweights of European HTA may prove to be too tough, however.

Additional Seeds For The Future

The U.K. may be sluggish on revising reimbursement, but it does have some innovative ideas for improving drug targeting.

Alongside plans to extend the CDF, the PM announced plans for a project to map 100,000 genomes through a pioneering partnership between Cancer Research UK and the government-owned Genomics England.

The DNA codes of 3,000 cancer patients will be sequenced as well as a further 3,000 whole DNA sequences for their cancer tumors, with a view to better understanding which treatments and drugs might be most therapeutically effective.

Cancer Research UK and Genomics England’s partnership is part of the government’s commitment to make Britain the first country in the world to sequence 100,000 genomes within five years. This could be something about which the pharmaceutical industry can get excited.

A prospective public-private initiative also might start to materialize in this area of the type advocated recently by Professor Peter Boyle of France’s International Prevention Research Institute, a lead author on the “State of Oncology 2013” report.

But this could happen only if the U.K. government’s commitment to building such an alliance is considerably more than that currently being given to value-based pricing.

Cancer Drugs Fund Extended As Pharma Calls For U.K. HTA Rethink

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