NICE and NHS England test SMART as a shorter route into managed access for promising medicines

NICE and NHS England have outlined how the Streamlined Managed Access Route for Therapies pilot could reduce the time it takes for selected medicines to enter managed access from around a year to as little as six months. The approach retains a full evaluation before NICE decides whether to recommend routine NHS use.

The Baseline

• A shorter initial assessment would determine whether patients could receive a medicine while further evidence is collected.
• Candidate medicines must offer good value for money, be suitable for rapid introduction into NHS care and have a clear evidence collection plan.
• Financial safeguards would apply during managed access, with NICE’s independent committees assessing the evidence for routine funding.

The National Institute for Health and Care Excellence (NICE) has outlined in a blog post how the Streamlined Managed Access Route for Therapies (SMART) pilot will work, following the announcement of four UK pilot schemes to speed patient access to new medicines. SMART focuses on the point at which a promising medicine can enter managed access, allowing NHS patients to receive treatment while further evidence is gathered on how well it works in practice.

“People should be able to access promising new treatments as quickly as possible, while still being confident that decisions are based on strong evidence and make the best use of NHS resources,” wrote Steve Williamson, Associate Director for the Managed Access Team at NICE.

NICE currently assesses medicines twice under managed access, first before patients can receive treatment and again once additional evidence is available. SMART will test “a shorter assessment at the start, followed by a full NICE evaluation later when more evidence is available.” NICE and NHS England estimate that suitable medicines could enter managed access in as little as six months, although NICE cautioned that “this is the aim of the pilot and is not guaranteed.”

At the initial assessment, NICE would consider whether the medicine can be introduced promptly and whether there is a clear plan to collect the evidence needed for the later appraisal. Drawing on experience with the Cancer Drugs Fund and the Innovative Medicines Fund, Williamson has previously highlighted the importance of establishing early whether further evidence can resolve the uncertainty facing the committee. “The best evidence is still from an ongoing clinical trial, supplemented by RWE,” he said, describing the role of real-world evidence alongside trial follow-up.

Williamson also highlighted existing registries as a practical source of data. “The burden has to be minimal for the system, for clinicians, for pharmacists, for nurses to collect,” he said. A similar consideration applies to real-world data collection in early access programs, where the challenge is to gather evidence that can inform later access decisions while keeping the focus on providing treatment.

Once sufficient evidence has been gathered, NICE’s independent committees will assess whether the medicine offers value for money for routine NHS use. In evaluating SMART, NICE and NHS England will examine both how soon patients can start treatment and whether the shorter initial assessment simplifies the process while preserving the quality of that eventual funding decision.