UK: Commercial Framework Sheds Light On Working With NHS And NICE
Executive Summary
The final text brings some changes, including the introduction of an escalation process when companies and NHS England cannot agree.
England’s National Health Service has published a new NHS Commercial Framework for New Medicines, which the Association of the British Pharmaceutical Industry says brings clarity on how to work with NHS England and the health technology assessment (HTA) institute, NICE, when seeking reimbursement for branded medicines.
The commercial framework was put out for consultation in November 2019. (Also see "Fair Pricing A Key Feature Of NHS England Drug Funding Proposals" - Pink Sheet, 11 Nov, 2019.) It sets out how commercial arrangements regarding publicly funded branded medicines should operate. The framework comes following commitments made in the 2019 Voluntary Scheme for Branded Medicines Pricing and Access (VPAS), which provides a framework to manage branded medicines spend. It was agreed by the government, NHS England and the ABPI.
"The NHS commercial framework for new medicines provides welcome clarity on how companies can partner with the NHS and NICE to get new medicines to the patients who need them,” said Richard Torbett, chief executive of the ABPI.
He added that a system that provides suitable flexibilities and which supports faster uptake and adoption of new medicines is required as more new medicines are discovered. "The Framework provides important recognition of this, and the ABPI will work closely with NHS England as the Framework is reviewed and developed over time," said Torbett.
The framework:
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Outlines the purpose and the principles on which NHS commercial medicines activity will be based.
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Defines the roles and responsibilities of parties involved in commercial medicines activity and details how companies can engage with the NHS.
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Clarifies routes to commissioning in the NHS and where commercial activity is possible within those routes.
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Outlines the possible types of commercial options as well as commercial flexibilities and the circumstances under which they can be considered.
Escalation
The final version of the framework takes into account some concerns and points raised in feedback to the consultation.
For example, some feedback on the consultation suggested that the framework should include an escalation and case review process, according to NHS England’s engagement response document. The framework’s section on commercial options now sets out the process for how either NHS England or the company can escalate a disagreement if there has been a failure to reach an agreement.
The process would start with an initial “level 1” discussion between the head of the commercial development team or deputy at NHS England and the company’s most senior national manager or deputy with knowledge about the issue.
If no agreement is reached, “level 2” discussions can take place between the NHS’ commercial medicines director and a senior independent representative for the company who has not been previously involved in the commercial discussion.
If there is still no agreement following level 2 discussions, the “the relevant commercial discussion will be treated as having come to an end,” says the framework.
In addition, some respondents pointed out that complex commercial arrangements put a large administrative burden on the NHS and called for the framework to encourage simple schemes. The new text now explicitly states that the “fastest (and preferred) route to market in England is for companies to propose simple discounts via a PAS [patient access scheme].”
Off-label medicines
Responders had also sought “reassurance that the framework was not actively promoting the off-label use of medicines,” says the engagement response document. The document put out for consultation says that the relevant commissioning body, such as NHS England or individual clinical commissioning groups will have to make a policy decision on whether a small number of off-label indications are accepted for routine commissioning. The final version includes an additional paragraph stating that the “framework does not advocate the use of off-label indications or suggest companies promote off-label usage of their medicines.”
Commercial Options
The framework sets out the options available for companies, which are: PASs, commercial access agreements, managed access agreements, and budget impact schemes.
According to the framework, simple and complex PASs are the starting point for companies developing a value proposition for NICE. They allow companies to improve a product’s cost-effectiveness beyond the cost effectiveness allowed by the list price. A PAS should always be included in a company’s initial submission unless it wants NICE to consider the list price. There are two types of PAS, simple and complex. Simple PASs offers a fixed discount on the list price. They are confidential and are “always the preferred option.”
Complex PASs are transparent because they involve a more complex reimbursement proposal, which will be more difficult to administer. Transparency helps ensure that administrative and cost burdens are minimized, while ensuring the value of the treatment is achieved.
Commercial access agreements are similar to complex PASs, but are confidential. These can be considered if “there are unusual or unique circumstances that mean launching a product is considered particularly challenging or commercially unviable,” or if the company wants to put forward “an enhanced value offer.” Examples of confidential commercial arrangements include: budget caps, price/volume agreements, cost sharing, stop/start criteria, outcomes based agreements or payment by results.
Managed access agreements can be used when “uncertainty exacerbates the challenge for NICE,” says the framework. Areas of uncertainty include clinical and financial uncertainty. They allow for interim commissioning until a product is reappraised at a set date, based on new data that is to be collected in line with a data collection agreement. As the framework document points out, these agreements have most frequently been used in the context of the Cancer Drugs Fund and NICE Highly Specialized Technologies guidance.
When considering the possibility of a managed access agreement, data collection must be considered to have the potential to collect data on relevant outcomes and overcome uncertainty.
With regard to budget impact schemes, companies and NHS England will enter into commercial discussions if the net budget impact of a product is expected to be more than £20m ($28.3mn) a year in the first three years of the technology’s use.