An interview with Jennifer Lee, Director of Health Economics, Market Access, Reimbursement & Advocacy, Janssen UK conducted by April Cashin-Garbutt, MA (Cantab)
Why is there an unmet need in prostate cancer in the UK?
A major reason for the unmet need in prostate cancer in the UK is the length of time it takes to get new treatments through the reimbursement system with NICE (National Institute for Health and Care Excellence). This has a long-term impact on the UK, making the UK far behind the rest of Europe and even globally in terms of standard of care.
Consequently, when you carry out global clinical trials because the standard of care in the UK is lagging, it is difficult for the trial to be generalizable and to have the right comparators in the UK.
What are the main reasons why the UK is lagging?
Traditionally the clinical community here in the UK is quite conservative and slow to use new treatments. You can see this just by looking at the life science competitive indicators, which show you just how long it takes for new medicines to get used in this country compared to everywhere else.
As well as being a cultural issue, the impact of the way NICE assesses the evidence associated with medicines causes this lag-behind in the UK.
The UK’s method of assessment is different to many other countries. In the UK, NICE spend a lot of time reviewing the lack of evidence and discussing the uncertainty and different possibilities that could occur.
Other countries that have a similar GDP to the UK have a different reimbursement system to this and they look at the evidence that is available and spend their time assessing that evidence. It's a fundamentally different way of looking at things.
Another aspect to consider is health economics, which the UK is the world leader for, and heavily relies on the cost per QALY (quality-adjusted life year) methodology. However, this does not work well for everything and is particularly unsuited to oncology when, for example, a phase 2 single-arm, immature trial, or phase three trial with cross-over, is carried out.
Because of the way NICE looks at evidence, these sorts of trials, that are common in cancer, are not ideal. For NICE, the ideal evidence is a phase 3, large, randomized controlled trial with long follow-up. In oncology, this is not realistic. It’s shocking that the framework and the methodology has not evolved and hasn’t changed since 1999.
How important are real-world studies?
The conditional approval piece is about the new CDF (Cancer Drugs Fund), which is a managed access fund, which means you're managing the introduction of a new medicine into the healthcare system based on the promise of evidence later.
Even though the evidence at launch might be fine for the EMA (European Medicines Agency) and the FDA, NICE don’t think it’s enough. They allow access now on a conditional basis, but more evidence must be collected. That evidence could be as simple as allowing a trial to mature.
However, in many instances it will be real world evidence, for example how well a drug works in UK clinical practice. This, of course, can differ dramatically to randomized controlled trials, because it’s not in an idealized condition. A clinical trial is good for estimating the treatment effect of a new drug, but it doesn't estimate the effectiveness in the real world, and that's what real world evidence is about.
How important is collaboration?
It is the most important aspect to create change and a better market access system to benefit patients. It is not about attacking NICE or attacking the health system - that is not productive.
We need to work together in the best interest of patients to find a better way forward and manufacturers want this too. There may be some controversy on this outlook, but it is what I believe and it is what Janssen believes.
You have to collaborate with the system, with every stakeholder, patients, clinicians etc. in order for there to be a positive change in the system.
What changes do NICE need to make?
NICE are making some of those changes already, it is part of the controversial consultations that came out recently.
NICE have introduced the fast track approval for medicines under £10,000 per QALY. This won't benefit oncology because those medicines are never under £10,000 per QALY, but NICE are recognizing that for situations where there is known evidence, for example it might be very similar to something that's already on the market, in these cases, let the treatment go through the process quickly, as opposed to spending a lot of time on evaluating evidence. That will also free up NICE’s resources to spend more time on situations where they need to critique the evidence more thoroughly.
NICE ran a consultation that ended on the 28th February. Patients were involved in this consultation, where NICE elicited responses from the patient community, companies, relevant stakeholders and asked how do we better take the patient’s voice into our decision making?
How important do you think innovation is going to be?
The term innovation can often just refer to something new, but this doesn't necessarily mean it is better. Here at Janssen, as well as meaning new, we think of innovation as being better than what's already out there and something that makes an impact on patients' lives.
Better patient outcomes are a key component of the market access system, and that's what makes it difficult for new treatments to compete with current ones under the cost per QALY methodology.
If your comparator is a generic treatment, or nothing, or best supportive care, it is very difficult to be very cost-effective against something that costs nothing, whereas it's easy to be cost effective against something that costs a lot and is new.
This is where the perversity of the cost per QALY framework becomes obvious. NICE now recognizes this, and that's one of the fundamental things that need to be changed and there needs to be a broader decision making framework.
It should be recognized and taken into consideration when there is an area of high unmet need for example and that patients have no alternative options other than this new treatment.
The process can take a long time, for example, over five years to get a treatment to market. Meanwhile, the same treatment has been approved in over eighty countries including all major comparable countries in the world!
If we can work with the system in the UK and achieve system reform, then the UK has the potential to be one of the best places for prostate cancer patients because there's good research here. Some of the world's top clinicians and scientists are based in the UK.
Where can readers find more information?
The NICE’s website is a great source for information, there is lots on there and it is very transparent: https://www.nice.org.uk/
About Jennifer Lee, Director of Health Economics, Market Access and Reimbursement (HEMAR) and Advocacy, Janssen UK
Jennifer is a trained health economist and biochemist. She completed her BSc in Biology/Biochemistry at the University of British Columbia, her MBA at the University of Calgary in Canada and her Postgraduate in Pharmacoeconomics in Melbourne, Australia.
She began her career as a health economist consultant in Sydney, Australia, before moving onto a senior health economist role at Sanofi in Australia. She then moved to a regional health economist role with Sanofi based in Singapore, prior to moving to the UK and joining Janssen in 2012.