NHS England has released a consultation draft of its new Commercial Framework, agreed as part of the UK’s 2019 Voluntary Scheme. The aim of the document is to clarify commercial options available to companies, streamline the engagement process, and reduce delays in patient access.
The consultation on the draft will run until the 10th January 2020, with final publication of a finalised Commercial Framework in early 2020. Those wishing to provide feedback should note that NHS England is only accepting feedback on specific questions, which are outlined in Annex A of the draft.
NHS England will be running stakeholder events in London and Manchester (open to all who are interested). Due to limited space, a maximum of two people per organisation will be admitted.
As expected, the Framework sets out how NHS England will implement additional commercial flexibility, while reiterating that a Simple PAS (straight discount) remain the preferred option. It does not consider assessment methodology as this is the responsibility of NICE’s assessment process, elements of which are currently being considered in the NICE Methods Review.
The origin of the Framework in the Voluntary Scheme means the focus is on branded medicines, but generics and biosimilars are expected to be considered in future revisions (although there is currently no agreed timeline for this).
Cautionary MAP Insights
Notably the Framework cites ‘affordability’ as a key principle, showing that budget-impact and not just cost-effectiveness represents a formal factor in commercial negotiation.
At present, confidential complex Commercial Access Arrangements (CAAs) are available within the context of the Cancer Drugs Fund (CDF), Highly Specialised Technology (HST) programme, and products where spending exceeds NICE’s Budget Impact Test (BIT). A key part of the Framework is a commitment to make these agreements available more widely where such flexibility is useful (although there is limited detail on what circumstances would warrant it).
The draft highlights that:
“such arrangements would normally correspond to medicines that would be expected to have value propositions at or below the lower end of the standard NICE cost effectiveness threshold range [£20,000/QALY]”,
or where there are:
“unusual or unique circumstances that mean launching a product is considered particularly challenging or commercially unviable.”
This latter point appears to focus particularly on medicines with multiple indications where launching in a new indication would be commercially unsound unless commercial flexibility were offered (i.e. where to gain a NICE recommendation in a new indication a company would need to commit to a discount that would actually reduce its overall revenue).
Positive MAP Insights
A central plank of the new framework is a central point/route of contact for commercial enquiries via firstname.lastname@example.org. This system is already running in interim form, and will be formalised following the publication of the finalised Framework.
The Framework also contains commitments to continue to work with the Association of the British Pharmaceutical Industry (ABPI) to develop commercial negotiation processes for companies marketing combination therapies that allow two companies to offer the NHS discounts without breaching competition law.
The draft also sets out additional clarity on the types of innovative schemes which NHS England is prepared to consider within the scope of additional commercial flexibility, listing the following examples:
- Cap on total budget
- Price/volume agreement
- Cost-sharing (company funds in some circumstances)
- Starting/stopping criteria
- Outcomes-based agreement
However, it notes that case-by-case flexibility will be considered where necessary. NHS England is keen to stress that any case-by-case deals should not be seen as precedents, or commitment to agreeing similar deals at any future point.
The draft also notably appears to confirm that NHS England’s Commissioning Policy pathway will continue in its current form for any relevant specialised services products which fall outside of NICE’s expanded remit for assessing medicines.
This consultation and others can be found on the MAP Online Consultation Tracker.