NICE’s New Recommendation for Adults Unconfirmed; Stock Closes at $86.44
Key Facts
It could not be verified that the National Institute for Health and Care Excellence issued a new recommendation on 4 November 2026 allowing adults with Bardet-Biedl syndrome to begin treatment with setmelanotide, marketed as IMCIVREE. In its recommendation published on 22 May 2024, the institute recommended the treatment for patients who start it between ages 6 and 17, while allowing them to continue after reaching adulthood. Shares of Rhythm Pharmaceuticals, the drug’s developer, closed at $86.44 in the 3 November session, according to EL7 data. This places the stock’s performance in the previous session in the context of the circulating news, but does not establish that the price movement was linked to a new recommendation. The officially available recommendation remained tied to the age at which treatment begins, rather than to a confirmed expansion to adults starting treatment in adulthood.
In its previous assessment, NICE specified that setmelanotide was an option for treating obesity and hyperphagia in people with genetically confirmed Bardet-Biedl syndrome, provided the patient had started treatment between ages 6 and 17. The institute said that those who start treatment in this age group can continue after reaching adulthood until their condition warrants stopping it. The recommendation thus distinguished between continuing treatment after reaching adulthood and starting treatment as an adult, a group not covered by the previous recommendation. NICE’s later review specifically addressed the adult group that the previous HST31 recommendation did not recommend for treatment. However, identifying the review’s subject does not by itself confirm that a new decision was issued or that the conditions for access to the drug changed.
In its explanation of the evidence published in 2024, NICE said trial results suggest that setmelanotide may reduce weight and body mass index in people with Bardet-Biedl syndrome aged 6 years and older. The institute added that the benefit appeared greater among those who started treatment between ages 6 and 17 than among those who started as adults. This observation supports the context of the previous recommendation, which tied eligibility to start treatment to the younger age group, but does not in itself amount to a new recommendation for adults. In its previous assessment, the NICE committee described the new evidence submitted by the company as supporting the treatment’s short-term clinical effectiveness. At the same time, the committee retained restrictions on the recommendation because of uncertainty about cost effectiveness.
NICE defined Bardet-Biedl syndrome as a rare genetic condition that causes hyperphagia and severely affects the quality of life of people with the condition, their families and caregivers. The adult review focused on people with obesity and hyperphagia, and NICE identified weight, body mass index, hunger and quality of life among the outcomes it would examine. The scope of the review reflects the institute’s consideration of the treatment’s use for this group, but does not confirm the assessment’s outcome or any coverage conditions it may decide. In its previous assessment, NICE said the recommended treatment should be made available through England’s National Health Service within 3 months of publication of the assessment. In Wales, the usual deadline for providing funding and resources is 2 months from the first publication of the final draft.