Craig Bradley, Commercial Lead Rare GI at Takeda, PM Society Chair & PM Society Market Access Interest Group Lead, looks at key publications to 2020 impact the UK access environment in 2020.
It really doesn’t seem like it’s been 12 months since I wrote my 2019 forward look, focusing on patient engagement and the empowered patient, however time does seem to fly in this ever-evolving industry. In looking forward to 2020 the major discussion points from my perspective are likely to be access focused – with several potentially pivotal publications due during the year.
Two of the new publications follow on from the Voluntary Scheme for Branded Medicines Pricing and Access document and voluntary access pricing scheme (VPAS)1 scheme which commenced in January 2019, a collaborative piece from the Department of Health and Social Care (DHSC) and the Association of the British Pharmaceutical Industry (ABPI). That agreement is seen as a commitment by the Government, the NHS and the industry to work together to support innovation for the benefit of patients.
“The real question for 2020 is whether anything in practice will actually change”
The first one for 2020 is the final publication of the NHS England Commercial Framework2 in the early part of the year, following a consultation period. The Framework is anticipated to clarify the increasingly important role NHS England (NHSE) plays within the UK access environment for the foreseeable future, so really this is important news for anyone in pharma working on new product launches and innovative treatments for patients.
The Framework itself sets out how NHSE will implement additional commercial flexibility than has previously been available, while reiterating that a simple Patient Access Scheme (PAS) (straight discount) remains the preferred option between companies and NHSE for new treatments attempting to enter the market. One major element not considered in the Framework is the assessment methodology for new products undergoing health technology assessment (HTA), as this is the responsibility of National Institute for Health and Care Excellence’s (NICE) assessment process, which will be covered in the second key publication of 2020; the NICE Methods Review3.
The purpose of this Review is to optimise NICE’s evaluation methods to support the ambition of the NHS to provide high quality care that offers good value to patients and to the NHS. The scope of the Review includes current hot topics such as cell and gene therapies, as well as what is included in the highly specialised technology (HST) programme. It will be interesting to see whether this is evolution or revolution in 2020. This piece of work is due for consultation in the summer of 2020, before its final publication at a later date.
One further update for 2020 that could impact on the landscape of UK pharma is the Conservative Party proposal4 on a £500 million fund to give patients quicker access to the most cutting-edge medicines for both cancer and other diseases. This ‘Innovative Medicines Fund’ will be a ring-fenced fund within the medicines budget set aside to support access to more innovative medicines.
The real question for 2020 is whether anything in practice will actually change with the aforementioned developments – will the speed of market access for novel treatments be positively impacted upon for UK patients? VPAS highlighted the need for engagement in the access process, so it will be fascinating to see whether this comes to fruition in 2020. Will we see strategic engagement between NHSE, NICE and industry in order for innovative new treatments to be appraised and made available for the benefit of patients?
Once the Framework and Review are both in action the other interesting piece will be to see whether new treatments that fall somewhere between not being quite specialist enough for the HST criteria but also not really being appropriate for single technology appraisal route will benefit. Will the flexibility lead to all stakeholders working together to find the most appropriate route for technology evaluation and commercial discussions for the treatment in order to benefit patients?
In addition to the anticipated access landscape changes the other trends that should come to the fore in 2020 are Brexit and how this might impact upon the UK pharma/healthcare landscape; further advancement with innovative treatments such as cell and gene therapies, and a new wave of technology driven innovations through increased collaboration between the industry, the NHS and technology companies. It should be an interesting year ahead.
In order to keep up with the environmental updates at the PM Society we have a range of Interest Groups, run by experts in their field, related to the current key issues in pharma/healthcare communications aiming to advance knowledge, share best practice, and recognise excellence in the industry – including Digital, Market Access, Patient Engagement and the newest one focused on Industry/Agency Relations. PM Society PriMe Training also offers a variety of flexible workshops to support learning on the key issues in the pharmaceutical industry, check out the PM Society website and social media feeds to get involved and join the conversation yourself.
Top 5 takeaways
- The final publication of the NHS England Commercial Framework is due in early 2020.
- The Framework will clarify the role NHSE plays within the UK access environment.
- The NICE Methods Review is due for consultation in summer 2020.
- The scope of the Review includes cell and gene therapies and details of the HST programme.
- Technology driven innovations are possible through collaboration in 2020.
Craig Bradley is Commercial Lead Rare GI at Takeda, PM Society Chair & PM Society Market Access Interest Group Lead. Go to www.pmsociety.org.uk