NHS Commercial Framework for new medicines

NHS England and NHS Improvement has a significant role to play in supporting patient access to clinically and cost-effective medicines by offering enhanced commercial arrangements where appropriate and practical.

The 2019 Voluntary Scheme for Branded Medicines Pricing and Access committed NHS England and NHS Improvement to publishing a commercial framework, setting out more operational detail on the commercial arrangements with industry.

The commercial framework:

  • outlines the purpose and principles on which NHS commercial medicines activity will be based.
  • defines the roles and responsibilities of those involved in commercial medicines activity and detailing how pharmaceutical companies can engage with the NHS.
  • clarifies the routes to routine commissioning in the NHS, and where commercial activity can occur in those routes.
  • outlines commercial flexibilities, and circumstances where they could be considered.

This framework was developed by NHS England and NHS Improvement with the help and input of partners including the National Institute for Health and Care Excellence (NICE), the Department of Health and Social Care and the Office for Life Sciences. It sets out our existing arrangements and provides further operational detail to complement the Voluntary Scheme.

Frequently asked questions about the Framework

The Commercial Framework is a first edition – what is the timeline for updating the document?

The updating of the Framework will be at the discretion of NHS England and NHS Improvement and will require dialogue with stakeholders such as NICE and the Department of Health and Social Care.

NHS England and NHS Improvement believe that it is essential that the Framework has the balance and stability of a long-term strategy and remains up-to-date to reflect key developments which have an impact on its implementation. As the Framework is fully aligned to the Voluntary Scheme, NHS England and NHS Improvement will review it following any relevant updates to the Voluntary Scheme or any other applicable policy changes.

What is the process once I have submitted a commercial query to the NHS England and NHS Improvement Triage system and when can I expect a response?

NHS England and NHS Improvement will send an acknowledgement to confirm that the query has been safely received and is being considered.

The time for a formal response will depend on the nature of the enquiry and the current caseload. As the commercial capacity at NHS England and NHS Improvement evolves, the aim in future is to have a service-level agreement (SLA) with timelines for response.

How has the COVID-19 pandemic affected the commercial framework?

Publication of the Commercial Framework was expected in early 2020. Due to the NHS England and NHS Improvement response to COVID-19, resource was diverted away from this activity so publication is later than planned.

Operationally this has not been impactful as the commercial arrangements detailed throughout the framework are already being followed by the relevant functions at NHS England and NHS Improvement.

The Commercial Framework focuses on branded new medicines – will future editions extend to include generic medicines and biosimilars?

The Commercial Framework was a commitment set out in the Voluntary Scheme. It is therefore appropriate that the first edition of the Framework focuses primarily on pricing and access issues associated with branded medicines.

Whilst the focus of the Framework is on new medicines, it is expected that a separate framework may be developed in the future to include, for example, information on the commercial approach for best value biologics (biosimilars) and generic medicines.

Can you provide further information on early engagement? For example, is it possible to engage with the Office for Market Access (OMA), NICE Scientific Advice (NSA) and NHS England and NHS Improvement?

NHS England and NHS Improvement and NICE have established processes for providing advice to companies across the product lifecycle. In the Framework, we have clarified these opportunities and encourage industry to engage throughout the product development process.

How will horizon scanning evolve under the Commercial Framework?

Horizon scanning is a vital tool to understand the future healthcare environment and is a cornerstone of the emerging commercial strategy at NHS England and NHS Improvement. The Voluntary Scheme reaffirms the commitment to enhance the NHS’ horizon scanning capability. A cross-function Horizon Scanning Steering Group (HSSG) is coordinating activity to meet this commitment.

Companies are encouraged to engage with UK PharmaScan and provide timely, accurate and relevant data to ensure the NHS can optimise the delivery of new medicines to patients.

Further details on horizon scanning are outlined in the Framework.

How is the NHS going to manage combination therapies moving forward?

As set out in the Voluntary Scheme, realising the full potential health benefits from combination drug therapies can be challenging, given the need for commercial confidentiality and the requirement to maintain competition. NHS England and NHS Improvement and NICE will work with the Department of Health and Social Care to continue to support and comment on any solutions proposed by the Association of the British Pharmaceutical Industry (ABPI).

What should a company take into account before making a commercial offer to NHS England and NHS Improvement as part of the NICE technology appraisal process?

Among the commercial proposals available to companies, a simple confidential discount (a simple patient access scheme [PAS]) remains the preferred offer. More complex arrangements are available in certain circumstances, and companies should note that as complexity increases, so does the requirement to demonstrate increased value.

Will the Commercial Framework allow complex arrangements such as harnessing Real-World Evidence (RWE) to support reimbursement?

NICE’s methods review will be considering how RWE is utilised in the appraisal setting.

NHS England and NHS Improvement acknowledge that it is possible that NICE may recommend that managed access agreements (MAAs) are explored in a broader set of circumstances than topics recommended for the Cancer Drugs Fund and highly specialised technology appraisals. The Framework also acknowledges the practical data collection considerations and their link to health outcomes which will be critical to resolving any clinical and financial uncertainties. NHS England and NHS Improvement feel it is out of scope for the Framework to comment on the application of RWE and any possible data infrastructure requirements at this time.

Can you further clarify the difference between a managed access agreement (MAA) and a commercial access agreement (CAA)?

MAAs consist of two key components – a Data Collection Agreement to mitigate clinical uncertainty (as defined by NICE’s technology appraisal committee) and either (a) a simple PAS and /or (b) CAA (see below).

CAAs are a commercial-financial arrangement to enhance the value proposition for a medicine. They are agreed directly through engagement with NHS England and NHS Improvement and can be in addition to a simple PAS discount.

A CAA can therefore be part of a MAA or a standalone commercial-financial arrangement.