The Drug Works on the Heart. The Door Is Still the BMI.

Sieben waagerechte Balken mit quadratischen Markern, dazu eine senkrechte Bezugslinie rechts. Zwei Balken enden deutlich links der Linie, vier reichen ueber sie hinaus, einer ist pink hervorgehoben.

On 7 May 2026 the National Institute for Health and Care Excellence published technology appraisal TA1152. It recommends semaglutide, up to a maintenance dose of 2.4 mg once weekly, for reducing the risk of major adverse cardiovascular events in adults who have established cardiovascular disease and a body mass index of at least 27 kg/m².

The NHS in England had to fund it within 90 days of publication. Counted from 7 May, that deadline fell on 5 August 2026.

This is the first appraisal in our archive that recommends the injection without arguing from weight loss. The endpoint is cardiovascular death, non-fatal heart attack and non-fatal stroke. Weight is not the outcome being bought.

And yet the door into the recommendation is still a BMI number. NICE says so itself, in the same document, and then explains why it is leaving it there.

What the appraisal actually says

The evidence is SELECT, a multinational randomised double-blind placebo-controlled phase 3 trial with 17,604 participants, all with a BMI of at least 27 kg/m² and established cardiovascular disease. Established disease meant a previous heart attack, a previous ischaemic or haemorrhagic stroke, or symptomatic peripheral arterial disease. Semaglutide plus standard care (n=8,803) was compared with placebo plus standard care (n=8,801).

The primary endpoint was time to a first major adverse cardiovascular event. The hazard ratio was 0.80, with a 95% confidence interval of 0.72 to 0.90.

The direction of effect was consistent across the individual components, but not all of them held up on their own. Non-fatal myocardial infarction (HR 0.72, 95% CI 0.61 to 0.85) and coronary revascularisation (0.77, 0.68 to 0.87) did. Non-fatal stroke (0.93, 0.74 to 1.15), cardiovascular death (0.85, 0.71 to 1.01), hospitalisation for unstable angina (0.87, 0.67 to 1.13) and heart-failure hospitalisation (0.79, 0.60 to 1.03) all had confidence intervals that cross 1. That is unremarkable for a composite endpoint, whose components are not individually powered. It is still worth saying plainly, because “cuts heart attacks and strokes” gets repeated as though both had been shown separately. Heart attacks were. Strokes were not.

The company that submitted the evidence is Novo Nordisk. Semaglutide can only be used under a commercial arrangement, and the agreed price is confidential. The published cost-effectiveness range therefore rests on a figure the public cannot see. NICE’s preferred incremental cost-effectiveness ratios ran from £6,878 to £14,594 per quality-adjusted life year, against a threshold of £20,000.

One thing this article does not do: tell anyone whether to take semaglutide. SELECT is a secondary-prevention trial. Everyone in it had already had a cardiovascular event. Nothing in it says anything about people who have not. This piece is about how the rule was built, not about the drug.

Section 3.5: the effect arrives before the weight loss does

In section 3.5, the external assessment group records something that undercuts the usual story:

The EAG noted that the clinical effectiveness of semaglutide in reducing the risk of MACE was seen shortly after starting treatment, before any substantial effect on weight loss was reported. This shows that there is a mechanism of action independent of weight loss.

Read plainly: the cardiovascular benefit showed up too early to be explained by getting smaller. Whatever is protecting these hearts, it is not the number on the scale.

The lead team used this to widen the recommendation, not narrow it. Because risk is highest shortly after a cardiovascular event, and because the benefit does not have to wait for weight loss, it concluded the recommendation should not be restricted by time since the event.

Section 3.9: and the lifestyle programme does not do much either

Section 3.9 is an argument about money, which is why it is more revealing than the clinical sections.

The company’s economic model included no cost at all for healthy lifestyle counselling, in either arm. The lead team had to decide whether that was acceptable, given that SELECT delivered counselling nine times in the first year and four times a year thereafter. It concluded:

It recalled that the effect of semaglutide was seen soon after starting treatment (see section 3.5), which suggested that the benefit of semaglutide was independent of weight loss. So, it was likely that the additional benefit of semaglutide was mostly independent of the lifestyle interventions offered.

So the lifestyle programme was judged unimportant enough to leave out of the costings.

Now read recommendation 1.1, from the same document:

Semaglutide (up to a maintenance dose of 2.4 mg once weekly) can be used, within its marketing authorisation, alongside a reduced-calorie diet and increased physical activity, as an option for reducing the risk of a major adverse cardiovascular event.

The diet is in the recommendation. It is not in the budget. In the economics it is worth nothing; in the prescription it is a condition. That is not a rounding error, it is two different jobs being done by the same sentence. One of them is accounting. The other one is telling patients what they owe.

Section 3.11: NICE names the problem and then declines it

The equality section is the sharpest part of the document, because NICE states the objection against its own criterion and then explains why it will not act on it.

The lead team noted that people from South Asian, Chinese, other Asian, Middle Eastern, Black African or African-Caribbean ethnic backgrounds are at a higher risk for CVD at lower BMI thresholds. This means that BMI-based criteria for treatment eligibility may not account for ethnic variations in risk.

The lead team acknowledged this. It then noted that recommending semaglutide below a BMI of 27 would fall outside the marketing authorisation, and that there was no safety or efficacy evidence below that threshold to justify it. It concluded that recommending in line with the marketing authorisation across all groups would protect patient safety and was a legitimate aim.

That reasoning is internally sound. NICE cannot recommend outside a licence, and it cannot invent evidence it does not have. The consequence still stands: a threshold that NICE has recorded as a poor proxy for cardiovascular risk in several populations remains the entry condition, and the reason it remains is regulatory, not medical.

There is a second group in the same section. The lead team noted that people with language difficulties or cognitive impairments may find it harder to adhere to a treatment plan or to self-administer an injection. Access does not stop at eligibility.

What this makes the BMI

Put the three sections together.

The benefit does not come from weight loss (3.5). The lifestyle programme attached to it is not doing the work either (3.9). The threshold is known not to track risk equally across populations (3.11). And it is still the threshold.

At that point the BMI is no longer functioning as a medical criterion for this indication. It is functioning as a distribution key: a cheap, universally recorded number that decides who is inside the funded population and who is outside it. That is a defensible thing for a rationing system to need. It is not the same thing as a clinical reason, and the two get spoken as though they were.

That matters beyond the paperwork, because a rule that hands out treatment by body size teaches something about bodies. We have written before about what happens in the consulting room when weight becomes the explanation for everything. TA1152 shows the same move one level up, written into national funding policy: the number gets the last word even where the document itself says the number is not what is doing the healing.

Germany: the same logic, the opposite result

Here the comparison gets genuinely strange, and it turns on a single word in a licence.

In the European Union, semaglutide under the brand Wegovy is authorised for weight management. The EMA’s public information describes it as used together with diet and physical activity to help people lose weight and keep their weight under control, in adults with a BMI of 30 or more, or a BMI of at least 27 who have weight-related health problems. The examples of those problems include “a history of heart attack, stroke or blood vessel problems.”

Look at what that does. The exact population NICE treats as cardiac patients appears in the European licence as people whose heart attack is a reason to treat their weight. Same drug, same people, and the stated purpose is reversed.

Germany then attaches its funding rule to that stated purpose. Under section 34(1) sentence 7 of the German Social Code Book V, medicines used for weight reduction have been excluded from statutory health insurance since 2004 as so-called lifestyle drugs. On 21 March 2024 the Federal Joint Committee formally listed Wegovy in Annex II of the pharmaceuticals directive. Its own statement is explicit about the mechanism:

Because of the therapeutic indication “weight regulation,” the statutory prescribing exclusion applies.

The committee also recorded that it had considered demands for an exception at higher body weights, given the raised risk of accompanying and secondary conditions, and found it had no discretion to grant one. The same statement notes that Wegovy cannot be included in Germany’s disease management programme for obesity either, for the same reason.

Meanwhile Ozempic and Rybelsus, the same active substance under different names and licensed for type 2 diabetes, are reimbursed normally.

So the chain runs like this. The cardiovascular benefit is real enough for NICE to fund the drug in England. In the EU it sits inside a weight-management licence rather than a cardiovascular one. In Germany a weight-management licence is precisely what triggers the exclusion. The better the drug looks at protecting hearts, the more firmly it stays outside German reimbursement, because the label under which that protection is documented is the label the law refuses to pay for.

One thing we could not establish: whether the Federal Joint Committee would revisit its decision if the licence itself were ever rewritten. We could not read the full reasoning document behind the 2024 decision, so we are flagging that as an open question rather than asserting an answer.

We described the cross-border version of this problem when France paid and Germany did not. TA1152 adds the part that is easier to miss: the deciding factor is not how well the drug works, and not who needs it. It is which sentence a regulator wrote on the box.

Why we are reading appraisal documents at all

Because this is where the sentences that follow people into consulting rooms get written, and because the contradictions are usually visible in the text itself if anyone reads past the summary.

It is the same reason we read the ACP position paper that asked for coverage and stigma reduction in one breath, and the AIHTA report from Vienna whose structural recommendations nobody quotes. Institutions rarely hide the tension. They print it in section 3 and trust that the press release is what gets read.

TA1152 printed it three times. The effect is not from the weight. The lifestyle programme is not doing the work. The threshold does not track the risk. And the threshold is still the door.


Sources: NICE, Semaglutide for reducing the risk of major adverse cardiovascular events in people with cardiovascular disease and overweight or obesity (TA1152), published 7 May 2026, sections 1.1, 3.3, 3.5, 3.9 and 3.11. European Medicines Agency, Wegovy. Gemeinsamer Bundesausschuss, G-BA vollzieht den gesetzlichen Verordnungsausschluss für das Abmagerungsmittel Wegovy nach, 21 March 2024.

This article reports on how funding rules are built. It is not medical advice and contains no recommendation for or against any treatment.