Refining UK market access
pharmafile | April 7, 2015 | Feature | Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing | NICE, UK, health, market access
“Some people have said NICE needs to change, it needs to create a new vision, but we say we need to evolve and transform rather than change,” says Meindert Boysen, who is the programme director of technology appraisals at NICE.
Late last year the Department of Health (DoH) announced that it would begin its three-yearly review of the function, form and governance of the UK body. However, the wider discussion around reform of the National Institute of Health and Care Excellence was put on hold.
The watchdog suggested more changes needed to be made to deal with concerns around market access. A three-month long consultation initiated by the DoH ended with the conclusion that ‘further work’ is needed before making amends to the way NICE evaluates new medicines.
Speaking at the 9th annual Pharma Pricing & Market Access Congress in March, Boysen said: “Eight out of 10 recommendations we make are positive and provide access for some patients in the NHS. But some in the industry might argue that that’s not all access for all patients. Generally speaking NICE tries to ensure access to most medicines.”
Pharmafile was at the London congress which brought together more than 200 attendees and 40 industry speakers from 15 countries, and where the NICE programme director spoke to delegates about supporting access to new medicines in England.
Boysen said: “One of the big policy developments underway is around early access to medicines. It’s very much in its first steps. The scheme’s real aim is to cover the period between submitting to the regulator and getting marketing authorisation, that’s the window of opportunity.”
An Early Access to Medicines Scheme (EAMS) was launched last year with the aim of giving patients with life threatening conditions access to medicines which are currently not approved by any marketing authorisation. It is overseen by the MHRA.
“I think it’s fair to say that those that are involved with this [EAMS] scheme – NICE, payers and the regulators – are all still trying to find their feet. It all really depends on the technology we see and in what state it comes to us,” Boysen added.
In March Merck’s skin cancer drug Keytruda (pembrolizumab) became the first treatment to be approved via the new scheme. The US firm says that this move is expected to benefit a substantial number of people across the UK who will now get accelerated access to the drug. Keytruda – which makes cancer cells ‘visible’ to the immune system so they can be destroyed by the body’s natural defence mechanisms – is now available to the NHS free of charge under EAMS.
Early access to cancer drugs
Early access to expensive drugs, for example in oncology, has been an issue for some time. Since March 2011, the Cancer Drugs Fund (CDF) has injected an extra £200 million a year into the NHS to pay for new oncology products not recommended by NICE. In January the government announced the budget for the CDF – set up in 2010 – would increase to an expected £340 million when the scheme ends in April 2016.
“A development for NICE has been the CDF – which allows access to cancer medicines when we’ve said no – and we understand why political systems would want to do this. But it’s been a policy that’s been difficult to manage, which has resulted in changes to the direction this policy might travel,” continued Boysen.
He explained to delegates that: “We’re trying to figure out how we can manage the introduction of cancer drugs better. It might be that a system like a fund could be used to explore that very uncertainty, it could be used to help us explore their value.”
Also speaking at the congress was Malcolm Qualie, who is the pharmacy lead for specialised services at NHS England. He discussed the strategy for drug market access and commissioning through evaluation.
Qualie noted that more and more drugs come through the system every year, and as such many patients do benefit from the CDF, adding: “NICE do say yes quite a lot but in cancer, actually not very often lately. This is a huge problem for us because ultimately we are taking those no’s to the CDF and over time, particularly in the last 18 months, we’ve started to actually put drugs onto the CDF prior to them going to NICE.”
In January NHS England published its new CDF list after concluding which cancer treatments it can afford. A total of 16 drugs in 25 indications were removed from the list, although several companies have subsequently had appeals upheld by NHS England.
Removing the drugs will generate savings of around £80 million according to the NHS, and the extra funding will create possibilities for more treatments to be included on the list – one of those being Johnson & Johnson’s leukaemia drug Imbruvica (ibrutinab), which this year received FDA approval to treat waldenström’s macroglobulinemia, a rare indolent type of B-cell lymphoma.
Qualie told delegates: “The CDF is an interesting concept because it gets the medicines to patients much sooner. What we really need to do now though is to work with NICE around the evaluation of the medicines going through their system.
“I actually think the CDF to a certain extent is a success story – but it needs to be re-badged. In a system where we are funding drugs early and allowing access to medicines quicker, and then pushing them through an evaluation process with the support of NICE, it’s actually something we could look at. It could bring out the value in a real world setting. We have to work with NICE in order to adopt their guidance, but we have to do it in a way that’s controlled.
“We’re starting to look at that for things like hepatitis C for instance. We have to think of ways of working with NICE and the legal directions that we have to consider when introducing new medicines.”
Where pharma is concerned
Pharma and the CDF have experienced a rocky working relationship to date. Earlier this year, for example, AstraZeneca withdrew its application for its ovarian cancer drug Lynparza (olaparib) citing concerns over cost and reviews to the list. Roche’s Avastin (bevacizumab) on the other hand kept its place on the recent CDF list, but was removed as a treatment for first-line metastatic bowel cancer and second-line platinum-sensitive advanced ovarian cancer.
Still, plenty of vital oncology treatments have been put through the scheme and have made their way to patients who would not have had access to them otherwise. Patrick Hopkinson, the executive director of health economics and outcomes research markets at Bristol-Myers Squibb (BMS), spoke positively of the CDF when he addressed delegates at the event.
“I see the CDF as having massive benefits for patients in the UK – thousands of patients are benefitting from the scheme and hopefully improved outcomes are being conveyed,” said Hopkinson. “One of the reasons that fundamentally brought the birth of the CDF was a report that showed the UK had some of the poorest outcomes for cancer patients. I don’t think that’s acceptable in terms of us as a well-developed economy and that’s one of the reasons why the CDF came in.”
Some pharma firms have had to rely on the CDF since its inception fi ve years ago, after witnessing their oncology drugs vetoed by NICE on cost grounds. Seattle-based biopharma firm Dendreon this year saw its prostate cancer drug Provenge (sipuleucel-T) rejected by the UK body for the second time in less than a year.
The drug, which is the first and only FDA-approved immunotherapy treatment for people whose disease has spread and are not yet suitable for chemotherapy, was deemed too expensive at around £50,000 per patient. The healthcare guidance body decided not to recommend the cell-based therapy – which stimulates the immune cells to identify and attack cancerous cells – because it could not demonstrate superiority over other treatments.
However, Roche’s Kadcyla (trastuzumab emtansine), a treatment for HER2-positive metastatic breast cancer, was also rejected by NICE, as it said the price the NHS was being asked to pay could not be justified. But unlike some NICE overruled treatments, Roche’s cancer drug – which can cost more than £90,000 per patient – is available on the CDF.
Kadcyla is the first antibody-drug conjugate (ADC) and was approved in the US back in 2013. At the time of its rejection in April last year it was the eighth consecutive treatment for the condition to be overruled by NICE since 2011. UK charity Breakthrough Breast Cancer criticised the decision saying that the body’s judgement processes need to be overruled.
Figures from CRUK show that despite cancer survival rates continuing to improve, the ageing population means that the number of cancer cases may rise – and this has made the CDF and access to oncology medicines even more vital.
Hopkinson concluded: “In terms of NICE and where it is going, I think something has got to be done about cancer medicines. I think that you need to look at the NICE methodology for assessment of cancer medicines.”
Also in attendance at the event was Ed Schoonveld, who is the managing principal at ZS Associates and author of ‘The price of global health – drug pricing strategies to balance patient access and the funding of innovation’.
Commenting on NICE and its drug pricing measures, he told us: “I think NICE is a good system; and the fundamental process of assessing cost-effectiveness makes a lot of sense. We need to make resource decisions, and it provides as good a mechanism as any to make those calls.”
But he added: “A company cannot decide a price for the UK in isolation. Companies would have no choice other than to forego the UK or fi nd some other deal because it would ruin their business in other parts of the world. This is the root of many pricing problems in Europe.
“I wish there was more opportunity for outcomes-based schemes to address some of these problems, and make sure that drugs that can’t demonstrate value at launch are still able to make it to patients. I think there needs to be more conversations between pharma and payers.”
Market access in Scotland
Unlike NICE, which often faces accusations of being stuck in the mud, the Scottish Medicines Consortium (SMC) has made a variety of changes recently.
It has overhauled its medicines access system following complaints from charities and interest groups alleging that patients were losing out. The reforms included the conception of Patient and Clinician Engagement (PACE) meetings held by the Scottish drugs pricing watchdog.
The changes gave pharma companies more chances to drop their prices should they initially charge more than the SMC will accept, and the body has also applied more flexible approaches to the evaluation of ultra-orphan medicines.
The SMC’s chief pharma advisor Anne Lee spoke at the congress about changes to its processes and how they have contributed to improved decision-making and patient understanding.
Lee told delegates: “We’ve made a huge change in a short period of time, so now we need to evolve them as the process goes on.” So far seven PACE meetings have taken place and eight new medicines have been accepted through the new process, including BMS’s Yervoy (ipilimumab) for first-line treatment of advanced melanoma.
As with NICE in England, the SMC makes its decisions based on evidence about how well the drug works and its costeffectiveness. The final verdict is supported by advice from patient organisations, health professionals, experts, and other interested parties.
Lee said: “Our view is that most of these would not have been accepted through the old process. We’ve had full capacity at all our meetings and there has been a big attendance from pharma, and the feedback has been very positive. “We’ve also made a commitment to hold as much of the meeting in public as we possibly can.”
According to Lee, 70% of SMC meeting attendees said they had improved their understanding of SMC decision-making since the gatherings went public. “We have committed to listening to what patients value – I think the challenge is that we’re in exactly the same financial crisis as everyone else so the task is achieving value for the payers.”
Lee concluded that there is a much bigger opportunity now for patients and clinical experts to have their say regarding what’s important about the new medicines coming through.
Indeed speakers at this year’s Pharma Pricing & Market Access Congress revealed that although things have changed there is still a lot to do regarding access to medicines for patients. NICE, the NHS and pharma all need to fi nd a way in which they can work in unison to offer patients the right drug, at the right cost.
Tom Robinson
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