A consultant in a rare disease clinic knows the arithmetic by heart. The drug has received regulatory approval, and the manufacturer has now set its price. The patient's condition advances month by month, while the route to NHS funding still holds a year of assessment, then a period of managed access, then a second full appraisal at the end. Clinicians in many specialties have lived with this sequence for years. The pilot announced by NICE and NHS England, the Streamlined Managed Access Route for Therapies, or SMART, is an attempt to shorten its first stage.
The mechanics are simple. At present a medicine entering managed access is assessed twice by NICE, once before patients can receive it and again after more evidence has accumulated. SMART would replace the first assessment with a shorter test of whether the medicine suits managed access, and keep the full evaluation for the point at which routine availability is decided. The aim is to cut the wait from around twelve months to as little as six. NICE has described that as an objective and has not promised it. No medicines have been named and no timetable has been published. Candidates must look promising, be capable of quick introduction, carry a credible plan for collecting further evidence and offer good value for money. Financial safeguards are meant to protect the health service and the manufacturer while data builds up.
The headline is speed. The more consequential matter is what that speed requires of everyone afterwards. A shorter first assessment does not remove uncertainty about a medicine. It defers the uncertainty into the managed access period, where it has to be resolved by data gathered in ordinary NHS practice. That places weight on parts of the system that have not always carried it well.
The record so far is mixed. Analysis published two years after the Innovative Medicines Fund opened found managed access slow to take hold outside cancer, with one suggested explanation being manufacturers' wariness of supplying a drug free of charge if no price is agreed at the end. A faster door does little for a medicine whose developer declines to walk through it. Whether SMART's financial safeguards address that wariness will become clear only when companies start putting products forward.
Then there is the data itself. Real-world evidence sounds tidy in a policy document. In a trust managing long waiting lists, tight budgets and a stretched workforce, it means clinicians and analysts recording outcomes consistently, often across fragmented systems and for small numbers of patients. Rare disease therapies, which stand to gain most from earlier access, are also the ones where evidence is hardest to produce. If registries are thin and coding is inconsistent, the second NICE evaluation will face the same uncertainty as the first, with the added complication that patients are already receiving the treatment.
The political setting explains why the pilot has arrived now. NICE's cost-effectiveness thresholds were revised alongside the US-UK trade arrangements on pharmaceuticals, and the Department of Health and Social Care has said these changes and related pilots could lead to roughly five additional medicines being approved each year. Several large manufacturers scaled back or paused UK investment plans in 2025, citing pricing and slow access. Ministers want to show that Britain can be a credible early launch market, and SMART is one of four pilots running between September 2026 and September 2027. Read in that light, it is as much a message to industry as a procedural adjustment.
That message carries a risk that officials will understand better than anyone. Entry into managed access is a pleasant announcement. Exit is the difficult part. Suppose the full evaluation concludes that the evidence is insufficient, or that the price cannot be justified. The NHS would then be withdrawing, or declining to continue funding, a medicine that patients have been taking for two or three years. Patient groups would object, clinicians would speak publicly and the government that championed earlier access would own the outcome. Few decisions in health policy are more exposed to public anger than taking something away. A pilot designed to move quickly at the front needs exit rules that are specific, agreed in advance and understood by patients before they begin treatment.
The practical implications fall unevenly. NHS leaders and commissioners need clarity on who pays during managed access and for how long, because regional variation in uptake would undermine the equity argument that sits behind the whole programme. The pilot packages include regional funding work, which suggests the problem is recognised. Policymakers should treat data collection as a funded task with named responsibility, and should resist assuming that existing clinical teams can absorb it. Companies stand to gain speed but will accept closer scrutiny of their evidence plans, and the health-tech and analytics firms that support registries and outcome tracking may find a new market in that obligation. Patients should be told plainly that access under managed access is conditional.
NICE's insistence that speeding up access does not mean lowering standards is reasonable, and the full evaluation does remain in place. Standards, however, are only as good as the information they are applied to. A route that gets a medicine to patients in six months and then cannot say, three years later, whether it works will have saved time only on paper. SMART should be judged by what the NHS knows at the end of the managed access period, and by whether it has the data and the nerve to act on it.
