Part I: An overview of the new review process in the UK by Claudia Graeve, PhD, and Anastasios Pappas (Health Advances GmbH)
• The Accelerated Access Review aims to speed up access to innovative drugs, devices and diagnostics for NHS patients
• Transformative medical products will enjoy an improved and transparent development pathway by aligning and coordinating regulatory, reimbursement and distribution processes
Patients expect the NHS (UK’s National Health System) to provide life-changing innovations as soon as they become available. However, governmental evidence has shown that the UK often lags behind other European countries and that accessing innovation in the NHS has become increasingly challenging. This creates frustration for patients who frequently have to wait for life-saving treatments, as well as for innovative manufacturers which need to navigate multiple processes before their products can be used.
The New Review Process Proposal
The Accelerated Access Review (AAR) Report of the NHS was presented in October 2016 and sets out 18 recommendations which are expected to help the NHS to provide the best care to patients, use funds more effectively, and create the conditions to help the life sciences industry continue to thrive. At its core is a managed access pathway, reserved for those drugs, devices and digital technologies which could truly make a significant difference to patients. This new process should align and coordinate regulatory, reimbursement, and distribution processes to bring these products to patients more quickly.
For the accelerated approval process, potentially transformative candidates will be identified through initiatives such as EAMS (Early Access to Medicines Scheme, reserved for access to breakthrough therapies) and/or an enhanced horizon scanning process, which now includes also medical technologies, diagnostic and digital products. Products will be selected based on
• high unmet need
• magnitude of health gain
• potential for significant measurable improvement of patient-related outcomes
• high strategic importance to the NHS (eg conditions with high prevalence and/or high costs)
• increased affordability to the NHS
• innovative nature of the technology, and
• an otherwise much slower development pathway.
Selected products will be subjected to a streamlined process, which could speed up patient access drastically – in the case of drugs by two to four years. Streamlining of the clinical development process will be achieved via concurrent regulatory and HTA processes, managed patient access and reimbursement with flexible pricing. If full access is not possible immediately after review, conditional entry periods can be used to generate further clinical and real-world evidence needed for final approval (see figure 1).
Figure 1: Timelines of the Standard and Accelerated Access Pathway
Gov.uk, Association of the British Pharmaceutical Industry (ABPI), PharmaPhorum, House of Commons Library
Coming Soon: Part Two
Our next FactBites e-newsletter will review the structural elements and implications for manufacturers of the proposed review process.
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