INTERVIEW: AstraZeneca on the Cancer Drugs Fund reforms
pharmafile | February 26, 2016 | Feature | Medical Communications, Research and Development, Sales and Marketing | Cancer Drugs Fund
Greg Rossi, head of the Oncology Business Unit, AstraZeneca UK and Ireland, and the company’s market access team, spoke to Pharmafile.com about the now-approved changes to the Cancer Drugs Fund, with the consultation period having ended in mid-February.
NHS England this week approved the proposals, confirming that the new ‘managed access fund’ controlled by NICE would begin from July 2016, with a fixed annual budget of £340 million.
Rossi revealed he and AZ colleagues believe some of the changes will be positive for UK patients, but that they had doubts over certain aspects of plans for the revised Fund.
He expressed concern that the UK lags so far behind many other European nations in spending on cancer treatment and resultantly patient outcomes, and that the CDF had failed to address this problem. It is his opinion that this is not an issue that can be fixed by reform alone, and that further investment, alongside changes to the NICE methodology for assessing cancer drugs, are necessary if the UK is to regain lost ground.
He comments: “I think there is a big issue about underfunding. If we look at the context around the Cancer Drugs Fund being set up in the first place, it was related to very few cancer products coming through in England compared to European counterparts. When you look at cancer outcomes in just some of those countries, for example, on ovarian cancer, based on the most recent data that we have, 31% of patients diagnosed with ovarian cancer will be alive within five years, compared to about 40% in France, Germany or Italy.
“We really are at the bottom of the outcomes list for western healthcare systems for cancer outcomes, and a key part of that is the money that we spend. Analysis based on World Bank data that we have available for 2012 reveals that for every pound we spend in the UK on cancer drugs, France spends £1.68, Germany £1.62 and Italy £1.49. So it is very difficult to make up those differences in cancer drugs spending just with a different assessment or approach.
“Funding is a key part that we need to look at, and I think it was right and proper to have a cancer drugs fund to address that. I think the issue with it has been how to manage the sustainability. It was always put in place for an interim period, but nothing has been done in this period to actually look at the underlying issue, of whether the methodology used by NICE is right for cancer. The outcomes when we look at drug approvals and other systems clearly say NICE is very much out of kilter with many other assessment frameworks.
Rossi bemoaned the fact that this means the CDF is failing to reflect the innovation seen in the cancer space, pointing out that no new therapies have come into the Fund in the last 18 months despite the last two years being some of the strongest in terms of new drug approvals from regulators. “We had one of the best years ever for EMA approvals in 2015, but that is not coming through to English patients,” he comments.
NICE’s methodology wrong?
So far as the problems with NICE’s assessment methodology are concerned, Rossi points out the fact that QALY thresholds have remained more or less unchanged since the Institute’s inception at the turn of the century, and have not been adjusted for inflation, which would amount to around £50,000 at today’s prices. He comments: “In real terms, we have had about a 40% reduction in willingness to pay, just because of inflation over that 15-year period.”
Another issue he notes is the complexity of data in oncology drug development, and the fact that efficacy profiles can rapidly alter with new evidence coming to light throughout the process. This uncertainty, he says does not align well with nature of the criteria that can be required to satisfy a health technology assessment.
He comments: “The type of data we have for cancer is much more complex when we think about how to model a complicated set of biology and treatment sequences. We have regulators who are being very progressive in how they think about the type of evidence to prove cancer drugs, and a clash is occurring between accelerated access through regulators: Breakthrough status, PRIME status, using surrogate markers and looking at biomarkers and subgroups that may not have been identified at the beginning of the development programme but have now emerged.
“That really creates a lot of issues for an HTA assessment, where the uncertainty is almost too great for them to model, so there is a reasonable likelihood that this is not cost-effective. AZ has faced these issues with Lynparza, where they said they needed us to think about five-year survival.”
The CDF proposals
The events of last year concerning the CDF highlighted the need for reform, as in early 2015, NHS England revealed it was to remove 25 treatments from the Fund in the search for financial efficiencies. This sparked a long process of negotiation with pharma companies, who agreed certain price cuts and access schemes for their treatments to remain on the list, before a further round of cuts were announced in September and the process began again. At was at this point that the verdict that the Fund was ‘unsustainable in its current form’ became near-universal.
In November, NICE and NHS England revealed their proposals for the CDF as a managed access, transitional fund, where drugs which display promise but cannot yet be conclusively recommended for routine use on the NHS stay on the list for a limited period of time. Additional real-world evidence is gathered over about a two-year period in cases where there is not enough for NICE to approve a drug, but detractors, including Rossi, argue this would only bring access to the limited number of patients needed to prove the drug’s efficacy.
Rossi comments: “One thing I think is very positive is the understanding of the evidence uncertainty and the fact the CDF is being modified into this transitional funding framework for these products with high uncertainty but very high value where there is unmet need. That is a sensible, reasonable move forward.
“It gets right that there is a need to fund exciting new cancer therapies when there remains uncertainty of the evidence and that uncertainty is going to reduce over time, but we shouldn’t stop patients from getting access to very promising therapies. The limitations on patients; numbers that we would have based off this need to resolve evidence issues is, I think, very problematic, and if you need 50 patients-worth of data to resolve a question that NICE and NHS England have, it doesn’t feel very equitable if you are the 51st or 52nd.”
“There are clearly challenges about patient equity and what the industry should need to fund in terms of evidence generation, versus the responsibilities of the health system to provide access for their patients. I think on this one, the majority of the evidence that is outstanding for decision-making, we are already funding anyway, because it is our large-scale randomised trials, where we are just waiting for overall survival input. We only have a fairly limited amount of questions we can be asked by real-world evidence, but the majority of the investment is already being made by the industry to generate the evidence.
The issue of patient equity with the real-world evidence generation is one raised as a concern by several commentators, but what has been largely welcomed is the recognition that the CDF could operate more effectively as part of NICE, and the fact that the reforms recognise the need for greater sustainability in the Fund in financial terms
Rossi continues: “I think working out how you take products and move them into routine commissioning is a critical part and what the CDF got wrong last time. It was a bucket that was getting filled in from the top, but had no outlet at the bottom, and it didn’t take a rocket scientist to realise that if you have a limited capitate fund, and keep putting things in, at some point you will fill the capacity and create difficulties: and that’s the delisting process we had last year. It got it right to say ‘how do we integrate into the system?’
Response to the CDF changes have been a mixed bag, to say the least; but a common theme has been the suspicion that whatever is altered in the structure of the Fund itself, a genuinely effective solution will not be found without NICE reforming its cancer assessment methodology.
Rossi concludes: “We need to push for fundamental reform to how we assess cancer therapies, because, in 2011, the CDF was put there for a reason – because NICE was failing cancer patients. And nothing has been resolved. If all we do is push this back to NICE, we will see the same issues and not address this concept of trying to actually meet a reasonable standard of outcomes for UK cancer patients, versus our European counterparts.”
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