The recent unveiling of the new Cancer Drugs Fund (CDF) in the UK marked a major shift in the market access landscape, but it’s one that has caused consternation among pharma and patient groups, and raised some tricky questions about HTA processes.
The new CDF structure was delayed, partly due to the political vacuum that followed the UK’s Brexit vote in June to leave the European Union but also partly, the Department of Health told PME, due to its standard operating procedures being unfinished.
Now, with a Prime Minister in place and CDF processes finalised, the Fund – as expected – has put decisions about access to cancer drugs firmly into the hands of the National Institute of Health and Care Excellence (NICE).
This means the cost-effectiveness watchdog will appraise all drugs and interim funding will be available for up to two years to give patients access to medicines that have either a draft recommendation for routine use on the NHS or a draft recommendation for use within the CDF.
The appraisal process will start earlier with the aim of delivering a verdict before new drugs are licensed, and NHS England is predicting that access to treatments could be accelerated by ‘up to four months’, taking the UK ahead of other countries in Europe.
The new CDF started operating at the end of July, with four new cancer drugs made available under the scheme. Gaining the greenlight were Novartis’ Zykadia (ceritinib) for lung cancer and melanoma combination Tafinlar (dabrafenib) and Mekinist (trametinib), and Servier’s Lonsurf (trifluridine/tipiracil HCl) for bowel cancer.
Since then NICE’s deliberations over how to apply the new rules have caused considerable uncertainty for Novartis’ breast cancer therapy Afinitor (everolimus) and Janssen’s Imbruvica (ibrutinib) for mantle cell lymphoma.
Choosing its words very carefully, NICE said its recently published guidance on the two does not recommend they should be removed from the new version of the CDF. However, it “is advising the two drugs are not cost-effective, which means they may be removed from the CDF list”. The verdict on both treatments is, so far, just a preliminary one and still open for consultation, with the Institute likely hoping to stimulate negotiations on further pricing reductions. Novartis and Janssen had already offered a discount in patient access schemes for the two medicines.
Meanwhile, three other manufacturers reported to be facing the possible expulsion of their drugs from the CDF have cut prices during the reappraisal process in order to win NICE backing for routine NHS use, according to The Guardian. The UK newspaper names the three drugs as Pfizer’s Bosulif (bosutinib) for chronic myeloid leukaemia, Eli Lilly’s Alimta (pemetrexed) for NSCLC and Sanofi’s Jevtana (cabazitaxel) for advanced prostate cancer.
This is a high risk industry and it is not as simple as, or sustainable, to continuously ask companies to drop the price of these specialist medicines
– Pfizer’s David Montgomery
Raising pharma’s ire
Unsurprisingly, critics are unimpressed with the changes, saying the new CDF will be hamstrung by underlying issues with NICE’s core appraisals process, which according to Richard Erwin, the general manager of Roche UK, “necessitated the creation of the original CDF”.
“We have made five cancer medicines available to UK patients in the last three years and have 70 new molecular entities in our pipeline but, under the current system, they may never reach the patients they are designed for.
“We – NICE, patient organisations, the pharmaceutical industry and NHS England – must all work together to ensure patients in the UK have access to the latest medicines. This means finding ways to ensure patients have access to effective and potentially game-changing treatments. It is heartbreaking to think we may have years of R&D sitting on a shelf with patients unable to benefit.”
That view was echoed by medical charity Breast Cancer Now, which said: “With the fund’s drug assessment now being handed back to NICE, we worry that patients in England will miss out on effective drugs that are available in other countries.”
Baroness Delyth Morgan, the charity’s chief executive, said: “The new CDF will do next-to-nothing to solve the wider problems that are preventing NHS patients from accessing the best cancer drugs.
“The CDF was set up because NICE’s methodology was not working for cancer drugs and this new process offers little change.”
But, sounding a warning for the industry, Baroness Morgan also called on pharma to “take responsibility and begin offering more sensible prices”.
“Absolutely nobody benefits if effective new drugs are not made available on the NHS, and we believe that enabling the Government to negotiate on price – as happens elsewhere in Europe – could significantly improve access for cancer patients.”
High risks
The requirement to absorb 100% of the risk of overpayment has also incensed some pharma companies.
David Montgomery – oncology medical director at Pfizer UK – said that developing new cancer drugs “takes an enormous investment of time, money and knowledge with thousands of scientists dedicating years to invent the latest treatments and cures”.
“This is a high risk industry and it is 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,” he added.