Among the casualties were Roche’s breast cancer drug Kadcyla (trastuzumab emtansine), and Avastin (bevacizumab) for cervical, breast and bowel cancers, plus Celgene’s pancreatic cancer treatment Abraxane (paclitaxel) and melanoma drugs Revlimid (lenalidomide) and Imnovid (pomalidomide).
The Rarer Cancers Foundation described the cuts as a ‘hammer blow’ to patients with rare cancers including melanoma, estimating the decision to remove funding for the cancer treatments would result in more than 5,500 patients missing out on life-extending cancer treatment.
There are also fears that the decision – the latest in a long line of NHS cuts – will lessen the appeal of the UK as a welcoming market, and could lead pharma companies to relocate research and clinical trials to other European countries. This is a distinct possibility, as companies active in oncology told Pharmafocus of their struggle to justify investment in England in an increasingly unattractive business environment.
For background, the cuts were made in an attempt to bring the Fund’s spiralling costs – up from £200 million at its inception in 2010 to £340m in 2015/16 – under control. Despite the budget increase, the CDF is set to overspend by some £70 million for this period, and the NHS has been forced to tighten its belt.
The affected drugs’ removal from the scheme will come into effect on November 4, and while patients who began receiving the removed treatments before this date will continue to do so, much of the negative response comes from the fact that new patients will not be given access to these medications on the NHS.
Reform needed
While it was broadly accepted around the time of the announcement that cuts were inevitable, the consensus appears to be that the CDF was never fit for purpose in the first place, and that reform could and should have been made earlier to avoid a situation where some patients will be deprived of potentially life-saving or extending medications.
Alison Clough, acting chief executive of the ABPI, comments: “The CDF was specifically set up to allow patients to benefit from timely access to the innovative cancer medicines that are routinely available to patients in other European countries.
“This announcement flies in the face of that intent.“We have long voiced the view that the Cancer Drugs Fund is a sticking plaster, albeit one that has enabled thousands of patients to access new and innovative medicines. We believe that the de-listing process, which we recognise will be distressing for cancer patients, could have been avoided if NICE and NHS England had transitioned earlier to a more appropriate, sustainable solution for evaluating and approving cancer medicines for routine use. We are pleased that treatments for existing patients will be protected, but remain of the view that this re-evaluation process was fundamentally flawed.”
Professor Paul Workman, chief executive at The Institute of Cancer Research, London, also called for reform to the Fund’s operation, saying: “(The decision) is an example of the confusion at the heart of our drug assessment system – with some treatments first being refused by NICE, then accepted onto the Cancer Drugs Fund and now to be removed from the list and denied to new patients. What we urgently need is a new unified system for evaluating treatments that can attract widespread support and ensure that the most innovative and effective cancer drugs reach the patients who need them as fast as possible.”
Pharma companies joined in the widespread calls for changes to the system, including key figures at Roche, which was hit by the removal of its breast cancer treatment, Kadcyla, from the Fund.
NICE chief executive Sir Andrew Dillon has previously spoken of Kadcyla’s ‘unacceptable price tag’ of £90,000 per patient, although Roche says it has offered NHS England £15 million of savings on its products. Kadcyla’s removal from the fund is evidence that in an era of budget pressures, drugs must offer value as well as efficacy to make the grade. But where does this leave patients?
Deborah Lancaster, director of Roche Products, says that while the CDF had been successful in achieving patient access to medicines, the new de-listings ‘speak to the need to reform,’ and that despite financial pressures, “patients should not be denied access to innovative and clinically effective medicines.”
Roche’s medical director, Dr Daniel Thurley, adds that access to these medicines would only be achieved with ‘long-term reform’ that is ‘pragmatic, flexible and sustainable,’ while company chief executive Severin Schwan called for urgent reform to the UK access system to ensure patients continue to get treated with innovative medicines. Schwan claimed that the current system’s failure to measure the wider value medicines add to society, and sole focus on cost, must be addressed.
Charities dismayed
Cancer charities also reacted with great disappointment. Samia al Qadhi, chief executive at Breast Cancer Care, called the cuts – particularly the loss of Kadcyla – a ‘devastating decision’ which will “shatter hopes for thousands of women who could have been helped by these drugs.” She adds: “We desperately hope these failings will be tackled by the new system. However, we are extremely concerned that until this new system is up and running, patients will continue to face huge uncertainty over access to drugs.”
While Mark Flannagan, chief executive of Beating Bowel Cancer, added to the voices that fear the changes will see England lose further ground to the rest of Europe on cancer survival rates, saying: “Yet again we will see more and more (bowel cancer) patients being denied proven, clinically effective, internationally recognised standards of treatment.
“By taking away from tomorrow’s cancer patients what is available today, we are effectively taking a step backwards for cancer treatment in this country compared to other countries in Europe and the world. We urge all parties to think again and not give up on bowel cancer patients.”
While Baroness Delyth Morgan, chief executive at Breast Cancer Now, said at the time of the announcement that it was “a dreadful day for breast cancer patients,” referring to Kadcyla’s removal. She added that “because government, the NHS and the pharmaceutical industry have failed to agree realistic prices for new drugs, some women will die sooner.”
The loss of the pancreatic drug Abraxane was of particular concern, in light of the condition’s poor survival rate: the worst of all 22 common cancers, and Abraxane’s status as the only life-prolonging treatment for the condition. Ali Stunt, founder and chief executive of Pancreatic Cancer Action, called the cuts a “travesty forsufferers of pancreatic cancer and their loved ones in England.”
Impact on clinical trials
It became clear shortly after the announcement that the ramifications of the CDF amendments could extend beyond patient well-being. Large pharma companies who lost drugs to the cuts are also concerned that the move will lead to diminishing returns on their investments into clinical trials in England, with some confirming that they are debating recruiting participants from more competitively-priced nations, such as France or Germany, instead.
In addition to Roche’s concerns, oncology leader Celgene saw two of its products removed from the CDF, and was vocal in its response. Wim Souverijns, general manager of the company in the UK and Ireland, told Pharmafocus his peers in other nations would achieve higher revenues from trials, leading to pressure on the UK branch from the global company.
He added that colleagues and competitors shared his concerns, going so far as to predict a “bloodbath,” with companies unwilling to give up further ground. “Celgene sponsors trials for 15,000 multiple myeloma patients and around 50% of patients on multiple myeloma currently access their drugs through a clinical trial,” he says.
“This is never taken into account when considering the value proposition of a drug. I would like for this to be taken into account and for us to work in conjunction with the reimbursement bodies along with the regulators. Unfortunately in this process it’s not been collaborative. It’s fundamental that we have a collaborative approach to solutions.”
Adrian Kilcoyne, Celgene’s UK medical director, focused on the delisting of Abraxane as a key concern, and stated it would prevent the company from recruiting patients from the UK for clinical trials of the drug. He says: “Abraxane is becoming the backbone for treatment, and increasingly the standard care that other treatments are added on to. Delisting it will mean that we cannot recruit patients for clinical trials in the UK because patients can’t access this treatment. It’s a double blow for UK research.
“It’s becoming a vicious circle,” he adds. “All the other countries in Europe will have Abraxane as standard care. We’ll be able to collect data from trials in those patients, but when we bring data to England for appraisal, NICE will argue we don’t have the right comparators. We have to ask the ethical question. Can we keep investing in patients that will never have access to the treatment? Are we going to be using UK patients as guinea pigs, not for their benefit but for the benefit of other people in the world? I really worry about how we value human life, quite frankly.”
Souverijns says: “I put a hold on any clinical trials because I want to see if there’s room to discussthese challenges with NICE, with the Department of Health and with the Government. If there’s no improvement, we’re going to make that decision. It’s going to be quick.”
Roche CEO Severin Schwan also raised concerns that research and development, as well as clinical trials, could become more difficult in the UK if patients are routinely denied access to new medicines. In a media briefing Schwan told journalists: “Its stupid, from a cost point of view, not to look at the overall cost of healthcare. This is really sad for patients and I have no understanding for this decision whatsoever… there is a fundamental flaw in how the UK operates when it comes to pricing for medicine.”
And he joined Celgene in warning of the knock-on effects on clinical trials in the UK, adding: “Eventually, this will hurt us on the research side in the UK. This is just a bad decision, not only for patients but also for society as a whole.”
Such fears were reinforced by Eric Low, chief executive of Myeloma UK, who claimed pharma companies have told the charity that England is seen as “quite a hostile place to do business.” It is troubling to consider that the logical progression from this viewpoint is for such companies to scale back their operations in the country: a move which would have a hugely negative impact on patients, and the UK pharmaceutical sector more broadly – according to the ABPI’s Alison Clough.
“For some time we have warned the Government and the NHS that if we don’t see the innovation that comes from pharma investment that that will have an impact on how England is viewed. It’s not just cancer. England is a country where we are quite slow in how we use innovative medicines. There’s a large potential impact on how the UK is viewed and companies decisions but there’s a potential impact as well on clinical trials.
“Because we don’t use innovative medicines – which in other countries have been taken up and are becoming the gold standard treatments – then clinical trials won’t recruit here. That’s been a growing issue over the last few years, and potentially an ethical issue as well. These are positions and arguments that we have been making for some time.”
Whatever the future holds for the CDF, it is clear that its current structure and the latest cuts are deeply unpopular with the industry. The potential vicious circle of patients losing access to vital medications and companies abandoning clinical trials England for more profitable shores is a worrying development, and only time will tell to what extent English cancer patients will suffer as a result.
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