One licence, four decisions about paying for it, and a year between them
The Medicines and Healthcare products Regulatory Agency licenses a cancer drug for the whole United Kingdom. That says the drug may be sold, not that the NHS will buy it. Four bodies then decide that separately, and the gap between a licence and a funded prescription is measured in months: of the medicines licensed in Europe between 2020 and 2023, 65 percent had become available in England and 57 percent in Scotland, with a median wait after licensing of 310 and 303 days.
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The MHRA has been the sole United Kingdom regulator since 1 January 2021. Its European reliance routes ended on 31 December 2023 and were replaced on 1 January 2024 by the International Recognition Procedure, a 60-day or 110-day route that relies on a prior approval by the regulators of Australia, Canada, the European Union, Japan, Switzerland, Singapore or the United States; the national route runs to 150 or 210 days. In 2025/26 the agency approved 921 medicinal products including 39 new medicines. Then the payers: NICE for England, whose recommendation carries a statutory funding requirement under regulation 7 of the 2013 NICE Constitution and Functions Regulations, which gives commissioners three months, or 30 days for products in the Early Access to Medicines Scheme or a fast-track appraisal. Scotland decides for itself through the Scottish Medicines Consortium, which sits inside Healthcare Improvement Scotland and has advised on more than 2,000 medicines since 2002; in 2024/25 it published 96 pieces of advice, accepting 66 percent. Wales adopts NICE and its All Wales Medicines Strategy Group appraises only what NICE has not, with the New Treatment Fund requiring health boards to fund a recommended medicine within 60 days. Northern Ireland's Department of Health reviews each NICE appraisal for legal, policy and financial consequences within four weeks of final publication, issues a service notification within fifteen weeks of endorsement and expects implementation within three months; where NICE has not looked at a treatment, Northern Ireland considers adopting the Scottish and then the Welsh decision, in that order. From 1 April 2026 the MHRA and NICE run an aligned pathway intended to bring some English decisions three to six months forward.
The three different things a "no" means, and why the difference matters
A cancer drug can be unavailable on the NHS for three quite different reasons, and they are routinely reported as one. A committee can look at the evidence and judge the price too high. A committee can never look at it, because the company submitted nothing. Or the drug can never have been put in front of a committee. Only the first is a judgement about the medicine. Of NICE's 666 recommendations on cancer drugs since 2000, 96 are refusals and 100 are appraisals that never happened.
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NICE's own figures, read from its cancer appraisal data page: "Since 2000, we have published: 596 technology appraisals on cancer drugs. These have resulted in: 666 individual recommendations", of which "83% of our recommendations on cancer drugs have been positive". Then, under a heading reading "Not included in the data": "Recommendations could not be made for 100 technology appraisals in the absence of a submission from the company (known as a non-submission)." A hundred cancer appraisals that never happened are counted separately from the 666 that did, which is the distinction in a single sentence. A refusal is a decision: NICE TA580 refused enzalutamide for high-risk hormone-relapsed non-metastatic prostate cancer on 15 May 2019 because "the estimates are not within the range that NICE usually considers a cost-effective use of NHS resources". A termination is the absence of one: NICE's wording is "NICE is unable to make a recommendation ... This is because the company did not provide an evidence submission", and terminated appraisals sit at a different address, nice.org.uk/guidance/terminated/, which is how a machine can tell them apart. Process manual PMG36 adds a nuance worth knowing: at 5.6.9 NICE will consider terminating if no submission arrives, but at 5.6.12 it "may also use the termination process to manage a company submission with a significantly high ICER", and at 5.6.13 a termination can be restarted, so the individual guidance page is the only reliable evidence of which happened. Scotland does the opposite with the same facts: rather than terminate, the Scottish Medicines Consortium issues substantive negative advice anyway, printing "Advice in the absence of a submission from the holder of the marketing authorisation: [medicine] is not recommended for use within NHSScotland", and its April 2025 process document confirms this does not prevent a later submission, which would supersede the advice. The third case has no page at all, but for cancer in England the gap is largely closed: since the 2016 Cancer Drugs Fund reforms "all new cancer drugs and significant new licensed indications for cancer drugs are now referred automatically to NICE for appraisal". Where a medicine falls outside that, as sonidegib does for locally advanced basal cell carcinoma, there is no decision to find, and the NHS Constitution's answer is a different right: a right to expect a local decision made rationally on the evidence, rather than a right to the drug.
The Cancer Drugs Fund: England's way of saying "not yet" instead of "no"
England's distinctive invention is a fund that pays for a cancer drug while the evidence is still being collected. NICE recommends it for managed access, the NHS pays from the draft guidance onward, data come back from the national chemotherapy dataset and the continuing trial, and the drug is appraised again at the end. It exists because the first version of the fund, which simply paid for drugs NICE had refused, overspent by a third and could not show that it had helped anyone.
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The original Cancer Drugs Fund ran from October 2010 with a lifetime budget of 1.27 billion pounds and supported over 74,000 patients to March 2015. The National Audit Office's investigation of 17 September 2015 found that 51 percent of the patients supported between April 2013 and March 2015 received drugs NICE had appraised and not recommended, that the fund overspent its allocated budget by 35 percent across those two years, and, most damningly, that "due to a lack of data, it is not possible to evaluate the impact that the Fund has had on patient outcomes, such as survival". NHS England's own account records a 2015/16 outturn of 466 million pounds against 340 million, a 37 percent overspend, and the board's decision on 26 February 2016 to rebuild it. The new fund began on 29 July 2016 with a fixed 340 million pound annual budget, an expenditure control mechanism that claws back overspend, and a third NICE outcome, "recommended for use within the Cancer Drugs Fund", available where NICE sees "plausible potential" but "significant remaining clinical uncertainty". A managed access agreement runs for at most five years, after which a full reappraisal decides whether the drug moves to routine commissioning. NICE has made 61 Cancer Drugs Fund recommendations since 2016; 14 cancer medicines are in managed access now. The sister Innovative Medicines Fund, launched in June 2022 with an identical 340 million pound budget, is for non-cancer medicines only, and is barely used by comparison: NICE has made three Innovative Medicines Fund recommendations in its history against 61 for cancer.
How often the nations actually disagree, and what a patient can do when the answer is no
The four nations agree far more than they differ. A study of every oncology appraisal published by NICE and the Scottish Medicines Consortium between 2017 and 2022 found 111 medicines appraised by both and disagreement on 14 of them, 12.6 percent: six that NICE refused and Scotland funded, eight that Scotland refused and NICE funded. Where the answer is no, each nation has a route for one patient at a time, and the tests are not the same.
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Across the full study, 148 SMC and 161 NICE oncology appraisals published between 1 January 2017 and 31 December 2022, the two bodies recommended almost identically, 90.5 percent of SMC decisions positive against 89.4 percent of NICE's. The real difference was speed, and only for solid tumours: a median 291 days from marketing authorisation to guidance for the SMC against 257 for NICE overall, which did not reach significance, but 273 against 231.5 days for solid organ cancers, which did. The author attributes the gap in part to the Cancer Drugs Fund. On the individual route, England's individual funding request still turns on "clinical exceptionality", meaning a clinician must show the patient is in a different clinical condition from the typical patient with the same disease. Wales abolished that test after a 2017 review and its individual patient funding request panels now ask instead whether significant clinical benefit is expected for that patient and whether the cost is in balance with it. Scotland replaced individual patient treatment requests in February 2018 with the Peer Approved Clinical System, whose tier two guidance was announced with the striking instruction that "a decision for non-routine access must not include cost-effectiveness as part of the consideration", alongside a separate ultra-orphan pathway introduced in October 2018 for conditions affecting one person in 50,000 or fewer, which funds for up to three years while data are gathered. Northern Ireland runs individual funding requests through a regional scrutiny committee, and its endorsement circular is explicit that a patient already on a drug NICE later refuses "should have the option of continuing their therapy until they and their clinicians consider it appropriate to stop".
What this corpus holds on UK approvals and funding
240 products carry a sourced United Kingdom approval row in the approvals by region matrix, and 5 are recorded as under review (DCVax-L, Galleri, Lifileucel, Nadofaragene firadenovec, Sugemalimab). The NICE, Cancer Drugs Fund and SMC position for each approved product is on NHS coverage, where a status of “not yet researched” means exactly that and links to a NICE search. An absent row means not yet researched, never “not approved”.