NICE and NHS England pilot a shorter first appraisal to halve waits for new medicines

NICE and NHS England have started a pilot that gives selected new medicines a shorter first appraisal, with the aim of cutting the wait for NHS patients from around a year to six months¹. The scheme, called SMART (Streamlined Managed Access Route for Therapies), was reported on 6 November 2026¹.

How the pilot works

Under the current managed access route, NICE appraises a medicine twice: once before patients can be treated and again once more evidence exists¹. SMART tests a lighter initial assessment, followed by a managed access period in which NICE watches how the medicine performs in clinical practice, and then a full evaluation that decides whether it stays in routine NHS use¹.

A medicine has to clear four tests to be considered¹:

• highly promising early data;
• the ability to be introduced into the NHS quickly;
• clear plans to generate real-world evidence afterwards;
• good value for money for the health service.

Steve Williamson, associate director of NICE's managed access team, set out the pilot in a NICE blog. He said "Speeding up access does not mean lowering standards," and that the pilot "also includes financial safeguards to protect both the NHS and companies while additional evidence is being collected."¹

SMART is one of the schemes first announced by the Department of Health and Social Care on 2 July 2026². A joint taskforce of government, industry and NHS representatives drew them up in a 10-week sprint with input from patient organisations, as part of delivering the UK-US pharmaceutical arrangement². The other pilots cover a way to count the productivity benefits of new medicines, such as patients returning to work, a mechanism for industry to co-invest in screening, testing and the full patient pathway, and dedicated regional funding for priority medicines².

What it means for the market

For companies planning UK launches, SMART creates a route in which reimbursement decisions lean more heavily on evidence gathered after launch. Eligibility depends on a credible real-world evidence plan¹, so the quality of a sponsor's post-launch data collection becomes part of the access case rather than an afterthought.

The pilots sit on top of the change to NICE's cost-effectiveness threshold made in April 2026, which DHSC says has already led to 9 additional medicines being approved for patients in England and Wales². NICE expects that up to 5 extra medicines a year could be approved as the new mechanisms bed in, set against a record of approving more than 90% of the medicines it assesses². The government has tied the programme to a commitment to double spending on innovative medicines from 0.3% to 0.6% of GDP over the next decade².

Genetic Alliance UK, which represents people with rare conditions, said managed access without waiting for a full NICE assessment "could mean people get treated months earlier"². That makes rare disease sponsors, whose products often reach market with small evidence packages, an obvious group to watch.

Caveats

SMART is a pilot, and the sources do not say how many medicines it will take, which products are first in line, or how the financial safeguards are structured¹. The estimate of 5 extra approvals a year covers the package of changes, not SMART alone¹². Every medicine accepted onto the pilot will still face a full NICE evaluation before any decision on its long-term NHS use¹.