2 Information about setmelanotide

Marketing authorisation indication

2.1 Setmelanotide (Imcivree, Rhythm Pharmaceuticals) has a marketing authorisation for the 'treatment of obesity and the control of hunger associated with genetically confirmed loss-of-function biallelic pro-opiomelanocortin (POMC), including PCSK1, deficiency or biallelic leptin receptor (LEPR) deficiency in adults and children 6 years of age and above'.

Dosage in the marketing authorisation

2.2 The dosage schedule is available in the summary of product characteristics for setmelanotide.

Price

2.3 The list price of setmelanotide is £2,376.00 per 10 mg per ml vial for injection (excluding VAT; company's evidence submission). The company has a commercial arrangement. This makes setmelanotide available to the NHS with a discount. The size of the discount is commercial in confidence. It is the company's responsibility to let relevant NHS organisations know details of the discount.

  • National Institute for Health and Care Excellence (NICE)