The recently announced collaboration suggests a new era of bespoke commercial arrangements with NHS England, driven by the targets of the Long Term Plan and the NHS Commercial Framework.
Last week, NHS England and Novartis entered an innovative ‘in principle’ agreement to research a new atherosclerotic cardiovascular disease (ACD) treatment, inclisiran. If approved, the drug is expected to be available through a world-first population-level agreement by early 2021. The Department of Health and Social Care (DHSC) has described this commercial arrangement as a “new cost-effective process” i. Although this new form of collaboration potentially brings a welcome new dimension to commercial arrangements, it also adds to the unpredictability and uncertainty attached to the UK access landscape.
This collaboration represents “an innovative approach to tackling major public health issues“, according to the Government, and opens the door for more bespoke agreements between pharmaceutical companies and the NHS ii. It may also lead to novel agreements in other therapeutic areas, particularly high-impact public health interventions, and priority areas mentioned in the NHS Long Term Plan (LTP), such as respiratory disease, diabetes or cancer. In fact, the LTP’s commitment to preventing 150,000 cardiovascular deaths over 10 years is the raison d’etre for the NHSE & Novartis agreement. Indeed, this collaboration is a clear attempt to incentivise investment in major public health issues. With many companies having scaled back research into these areas due to poor profitability, this collaboration now suggests NHSE will recognise companies’ efforts to focus on major health issues. Nonetheless, this raises questions over NHSE’s appetite to negotiate innovative deals for therapeutic areas not included in the LTP, that is, areas NHSE is not being scrutinised to deliver on.
This deal is significant for several reasons: firstly, it indicates a willingness by both parties to trial new commercial arrangements. Secondly, it will allegedly expedite patient access and minimise costs by improving efficiency and fast-tracking clinical trials and the NICE appraisal process. Thirdly, it is being used to promote the UK as “destination of choice for innovation” amongst fears that the life sciences ecosystem will worsen due to post-Brexit regulatory uncertainty. Fourthly and perhaps most importantly, it represents a commitment to move towards smarter, more efficient and cost-effective healthcare to respond to the unprecedented demands on the system.
This agreement is undoubtedly positive; it reflects well on the company involved as well as on its architects at NHSE, and reaffirms the Government’s commitment to the LTP. However, increased collaboration and flexibility between industry and the NHS will be most beneficial if it also features strongly in the ongoing NICE methods review and MedTech funding consultation. It is unclear whether this type of negotiation will be formally codified in the NICE methods review, or whether it lends itself to a more ad hoc and informal option.
Although welcomed by the ABPI for enabling “earlier conversations between companies, regulators, NICE and the NHS”, this collaboration has introduced some additional confusion to the already complex market access landscape. A robust access system must offer clarity on how products are going to be processed through that system. It is unclear to what extent this new development will increase uncertainty within the system. Is this considered a better alternative to existing commercial arrangements, particularly given that the message for years now has been that simple patient access schemes are preferable?
The draft NHS Commercial Framework for medicines, which outlines commercial arrangements with industry, offers insight into the direction of travel: “Although the types of commercial schemes that may be available to companies are described in this Framework, the different challenges facing different treatments (value, uncertainty, affordability) demands consideration on a case-by-case basis. No previous deals are an indicator of future deals and discretion on whether an acceptable offer has been made and to agree a commercial arrangement ultimately rests with NHS England.” The relationship between NHS England and industry is evolving and pharma may pursue similar deals to Novartis’, but the draft Commercial Framework cautions that NHSE does not guarantee replicating a deal just because it has agreed one previously. Hopefully, the final draft of the Commercial Framework will shed some light into the process and criteria for this new type of arrangement, restoring some certainty and predictability to industry.
Pharmaceutical companies will be watching with interest. Although welcomed warmly by industry representatives iii iv, little is known as yet of this intriguing deal. It is too early to tell whether this collaboration will be a success, but one thing is clear: it could have far reaching consequences for the life sciences ecosystem. Government-funded incentives into major health areas and the introduction of new commercial arrangements, not to mention a government with a spring in its step set on making a success of Brexit, could herald some important developments for industry in 2020. Indeed, it is exciting to see these radical ideas emerging, with NHSE and industry jointly exploring innovative answers to our biggest health problems.
Cristina Ruiz de Villa