NICE and NHS England have started a pilot called SMART, the Streamlined Managed Access Route for Therapies, which replaces the first full appraisal of a promising medicine with a shorter initial assessment. The aim is to cut the time to patients from about a year to about six months. For market access teams, the change moves weight from the first decision to the evidence plan behind it.

Where SMART comes from

SMART is one of four pilots the Department of Health and Social Care announced on 2 July 2026. The others test ways of counting productivity benefits such as returning to work, industry co-investment in screening and testing, and regional funding for priority medicines. A 10-week taskforce sprint produced them, and testing begins as early as September 2026.

They follow a pricing reset. In April 2026 the UK raised the NICE threshold from £20,000–£30,000 to £25,000–£35,000 per QALY, the first revision in over two decades, and cut the VPAG rebate rate to 15% for 2026. DHSC says 9 additional medicines have been approved since the threshold changed, and expects up to 5 more a year once the new mechanisms are in place. NICE already approves more than 90% of the medicines it assesses, so the pilots target speed, not approval rates.

How the SMART route works

Today, a medicine in managed access is assessed twice by NICE: once before patients can receive it, and again after more evidence is collected. SMART shortens the first assessment. A managed access period follows, and NICE then runs a full evaluation to decide routine funding.

Entry is selective. According to pharmaphorum, a medicine needs:

  • Highly promising early data. What counts as "highly promising" has not been defined publicly.
  • Fast NHS introduction. The service must be able to deliver the medicine quickly.
  • Clear, robust plans for real-world evidence. These are judged up front, not agreed afterwards.
  • Value for money. The case must still be good for the NHS, with financial safeguards for both sides while evidence accumulates.

Steve Williamson of NICE's managed access team says that speeding up access does not mean lowering standards, and that piloted medicines will still face a full NICE evaluation before any long-term NHS decision.

What is still open

The government page leaves eligibility for the faster-access pilot undefined. Genetic Alliance UK notes that the medicines to be selected and the assessment methods were still to be confirmed, and that the pilots run from September 2026 to September 2027. The MHRA and NICE also run a separate aligned pathway that brings NICE decisions forward to coincide with licensing and claims to save 3–6 months. A company will need to decide which route fits its product.

What it means for market access teams

  • The real-world evidence plan is now an entry test. Endpoints, data sources, follow-up length and the analysis that will answer NICE's uncertainties need to be specified before the first submission.
  • Price and safeguards need to be ready earlier. Financial safeguards are part of the pilot, so commercial terms and a managed access price should be modelled before the shorter assessment, not after.
  • The second evaluation carries the decision. The managed access period ends in a full evaluation, so the data collection should be designed against the committee's likely objections.
  • Launch sequencing changes. A route that may reach patients in about six months affects UK timing relative to other European markets and any international reference pricing exposure.

We expect the first selected medicines to shape how strictly "highly promising" and "robust" are read. Until then, prepare the dossier as though the full evaluation will follow.

To discuss how SMART or the aligned pathway fits your UK evidence and launch plan, get in touch.