As a new attendee to this conference, I wasn’t sure what to expect. The sessions certainly didn’t disappoint – the focus was clearly on the future of the industry and some of the challenges facing us all, here in the UK (a looming Brexit) and further afield (drug affordability, data access and so on).
Patient Access to Medicines
A big theme through many of the sessions was the issue of patient access to medicines. We heard some startling metrics from Lisa Anson, the current ABPI President and the AstraZeneca UK Country President. For example, a patient in the UK is 5 times less likely to get innovative new medicines than in Germany or France. Something which could become even worse with our impending exit from the EU.
We heard first from Ian Hudson, the Chief Executive of the MHRA. There are a number of schemes to try and improve patient access to medicines; accelerated access review, the life sciences industrial strategy and the early access to medicines scheme. The MHRA are working closely with NICE and will accelerate review of protocols where the need is urgent (for example, the Ebola protocols were reviewed in 3 days). There were some questions and comments about harmonisation of regulations and the impact of Brexit; can 1 dossier still be submitted – unfortunately this is still to be negotiated. Will submissions go to EMA or have to go to EMA and MHRA?
We then heard from Leslie Galloway from NICE. The relationship between NICE and the MHRA was mentioned but in essence, drugs can be approved by the MHRA however NICE decide whether they will fund the drug via the NHS. NICE actually deliver 80% positive recommendations on new drugs but this includes optimised recommendations. Their relationship with NHS England is crucial; enhancing access and giving priority to drugs. NICE argue that much has been done to enhance patient access to medicines but that there is still some way to go including changing their view of risk and even better collaboration with industry.
The session on Pricing, Affordability and Transparency was hosted by Gabrielle Silver from Brunswick Group.
A number of good points were raised by this panel; governments ration medicine; we have a pricing framework which is a start; people only really discuss a part of the pricing ecosystem. There was a feeling that NHS England is moving towards trying to get the lowest price and we mustn’t lose the value assessment alongside the price.
Brexit was never far from the discussions and the acknowledgement that the UK has a large R&D legacy (we punch above our weight) which may well be adversely impacted by a no deal hard Brexit.
There has been a payment by results scheme running over the past few years. If a patient does not respond to a treatment, the sponsor company is expected to refund the cost – this is a true outcomes based scheme. However, pressure is now being applied to stop the scheme due to its administration burden on the NHS. As an outsider, that seems insane. Would the cost of administering the scheme really out-price the cost of the drug?
There were discussions about how drug price is defined. If it is the cost of R&D and getting the drug to market where is the transparency? It was acknowledged that due to the competitive nature of the industry, there is a reticence to share information. And above all, drug price is also covering the cost for the failures that came before.
And what is cost effectiveness anyway? We need to balance quality of life with measurable results. The oncology measure of progression free survival or overall survival was mentioned.
An argument that is often provided for the high price of some treatments (the recent approval of the first CAR-T treatment has the price of cure in the hundreds of thousand dollar mark) is that it will save money for the NHS. However, all that happens is that the resources are used elsewhere.
Without a doubt this is a complex and emotive issue. While I sat listening to these sessions I saw news that Pfizer had reduced the price of one of its oncology drugs. No doubt this had something to do with pressure from patients. There is still a view that Pharma charge as much as they can to maximise profits without taking everything else into consideration. Having heard from some highly regarded industry experts, it really is not that straightforward. Our country has pricing strategies and guidance in place and as many agreed, will pay for innovative life changing medicines (cost vs value) but there is no answer to the financial struggles we face every day in the NHS. And even with life changing or even curative drugs, these do not save the NHS money; the resources that are saved are just re-deployed to another area. There is much that can be done to make the development of new medicines more efficient and that seems to be where pharma and biotech are starting to focus their attention.