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  • Question on Consultation

    Has all of the relevant evidence been taken into account?

  • Question on Consultation

    Are the summaries of the criteria considered by the committee, and the clinical and economic considerations reasonable interpretations of the evidence?

  • Question on Consultation

    Are the provisional recommendations sound and a suitable basis for guidance on the use of setmelanotide in the context of national commissioning by NHS England?

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    Are there any aspects of the recommendations that need particular consideration to ensure we avoid unlawful discrimination against any group of people on the grounds of race, gender, disability, religion or belief, sexual orientation, age, gender reassignment, pregnancy and maternity?
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Introduction

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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.

Price

2.3 The list price of setmelanotide is £2,376.00 per 10 mg/ml vial for injection (excluding VAT; company's evidence submission). The company has a commercial arrangement, which would have applied if the technology had been recommended.