by Joe Cormack 21st November, 2019
3 min read

Reviewing the draft NHS commercial medicines framework – clarification made possible through collaboration and dialogue

The draft NHS Commercial Framework for Medicines is published and out for consultation. The Framework was a commitment set out in the recent Voluntary Scheme for Branded Medicines  in order to ensure it establishes the way in which NHS England, NICE and industry will work together to ensure that treatments are made available on the NHS cost-effectively with minimal delays.

Nothing new?

Blake Dark, Commercial Medicines Director of NHS England and architect of the Framework has described the content as containing “no new proposals”, but its publication is significant in demonstrating the expanded leadership and decision-making function of NHS England regarding access to medicines.

You can trace this growing influence from the establishment of the Commercial Medicines Unit, taking responsibility from the Department of Health and Social Care (DHSC) for negotiating Patient Access Schemes (the discount negotiated with the manufacturer to ensure the treatment meets affordability criteria), and reforming the process of specialised commissioning through National Programmes of Care.

Although more of a summary document, the draft framework still provides much needed clarification and relative transparency about the process. It is welcome for those in the industry, and those looking in, to understand:

  • The purpose and principles on which NHS commercial medicines activity will be based;
  • Routes to commissioning and where commercial activity sits within this;
  • The roles of those involved in commercial medicines activity; and
  • What commercial flexibilities are available, and the circumstances where they could be considered.

What the Framework begins to codify is the earlier engagement and planning that NHS England, NICE and the pharmaceutical industry want in order to deliver more efficient discussions on new therapies to support their uptake and adoption in a “fair and responsible” manner.

The pathway that is outlined in section 3 of the document demonstrates the opportunities for industry engagement with NICE and NHS England and it is important that every company with a pipeline of branded technologies are reviewing their processes and engagement relating to the ‘two-step’ process of engagement (outlined in diagram below).

This is especially important with regard to Pharmascan – where the NHS and NICE require the latest data on a medicine in development and will use this forum to seek clarity.  The same goes for the Office for Market Access – the organisation within NICE, established to help industry understand the most effective market entry into the NHS. It will be interesting to learn industry’s reflections on the user ability and ease of engagement with these organisations. Step 2 of the process is more familiar for industry – and will not be required for all medicines.

Section 5 of the Framework gives a broad outline of the types of commercial options available to companies in their negotiations with NHS England and NICE. These range from patient access schemes to confidential commercial agreements and managed access agreements.

Importantly, for those not familiar with the complexity of these issues, the Framework does attempt to explain why different agreements and flexibility is required depending on the medicine. Whilst specific examples are not available, an example of where flexibility is required is if NHS England deem that the company is aspiring to deliver “greater levels of health gain relative to cost”. In this situation, more flexible ‘enhanced value’ offers can be agreed which may include agreements on payment by results, strict rules on how long a patient should be given treatment for and a maximum budget impact for a treatment.

Improved dialogue and collaboration shouldn’t be taken for granted

In recent years, dialogue between the DHSC, NHS England and industry has been much improved as demonstrated by the Life Sciences Industrial Strategy, subsequent Sector Deals, Brexit medicines contingency planning and the Voluntary Scheme. The Commercial Framework is another example of this collaborative approach.

Compromise is an important part of this relationship. Government and NHS England have accepted the need for, and worked towards, providing clear early engagement points to aid market access and have built capabilities to allow for greater flexibility in commercial arrangements. For industry, these developments are overdue and only a step in the right direction but nonetheless welcomed by the Association of the British Pharmaceutical Industry (ABPI).

Those that are quick to make knee jerk and radical suggestions to how the assessment of value and price of medicines should be overhauled should review progress that has been made in recent years, progress which has been made possible through constructive dialogue. A more muscular NHS England are now far more coordinated in their commercial negotiations and work effectively to ensure that medicines are affordable, industries are properly reimbursed – within clear parameters – for their IP and expertise, and NHS patients are getting faster access to the latest treatments, although this can be inconsistent across different types of conditions.

NHS England are encouraging feedback from a range of organisations – not just the pharmaceutical industry – by 10th January and will be hosting workshops to outline the framework in more detail. Those responding should consider whether horizon scanning, and earlier engagement has progressed enough and where commercial arrangements are working effectively and there is further need for flexibility.

See more articles by Joe Cormack