Since December 2012, NHS England has periodically issued Clinical Commissioning Policies (CCPs), which are coverage determinations for specialised services, including pharmaceuticals, that do not have regulatory approval in England. The stated protocol around CCPs is that when a critical mass of providers (e.g. physicians, nurses, or carers) request funding for a product that is not commissioned (i.e. funded) by NHS England, a formal review process is triggered and a CCP is issued, determining whether the service will or will not be covered by the NHS. Although likely implemented as a means of granting access to cutting edge medical technology and practices, this process can in fact expose pharmaceutical manufacturers to significant risk.
Rather than issuing final policy decisions as top-down decrees, NHS England has instituted a 12-week consultation process following the issuance of each CCP, inviting the public to review and provide feedback on the CCP before it is enacted into law. In recent years, several CCPs and ensuing consultations have concerned discretionary uses of products funded by the NHS for other indications, including RITUXAN™ (rituximab) for anti-neutrophic cytoplasmic antibody-associated vasculitis and VELCADE™ (bortezomib) for refractory antibody mediated rejection post-kidney transplant. As regulatory approval, NHS funding, and potential NICE assessment can frequently lag behind the needs of clinical practitioners, this process also serves as a mechanism for early access that benefits patients (by offering additional valuable treatment options), providers (by commissioning the use of novel therapies / procedures) and manufacturers (by offering an additional means of accessing funding).
However, the mechanics of this process present considerable risks for manufacturers. In determining whether to commission use of a product when drafting a CCP, NHS England reviews available clinical evidence in the manner of an HTA assessment. But because the services in question are not yet approved, and are not necessarily studied through controlled manufacturer-sponsored clinical trials, NHS England often relies on available real-world data from clinical practices across the country – including anecdotal evidence. Problematically, the data generated by these practices are not necessarily to the standard of RCTs and may not be administered according to standard dosages or as part of standardised therapy regimens that the manufacturer has deemed appropriate. Moreover, in addition to considering these data privately in their CCP rulings, NHS England, in its commitment to public transparency, makes these data available to their Clinical Reference Groups and to the general public. This can result in the publication of data that are not representative of a drug’s value in a particular indication, and could affect future pricing and / or reimbursement potential for a product – both in England and throughout the region, and possibly the world.
As the process is relatively new and has significant positive potential for patients, the potentially problematic side of CCPs and their accompanying consultations have not yet received widespread attention. But if the NHS intends to continue undertaking CCPs to evaluate and control utilisation, they must evolve their approach to include consultation with manufacturers to offer an opportunity to provide evidence for use and funding and avoid publication of incomplete evidence and premature decisions. Although intended to benefit all parties, in their haste to evaluate a product’s value, CCPs can rely on premature or non-representative data that affect the perceived value of a product in the short and long term.
Theodore Schroeder is a Senior Analyst in CBPartners’ Pricing and Market Access practice.