How are you taking part in this consultation?

You will not be able to change how you comment later.

You must be signed in to answer questions

  • Question on Consultation

    • Has all of the relevant evidence been taken into account?

  • Question on Consultation

    • Are the summaries of clinical and and cost effectiveness reasonable interpretations of the evidence?

  • Question on Consultation

    • Are the recommendations sound and a suitable basis for guidance to the NHS?

  • Question on Consultation

    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?
The content on this page is not current guidance and is only for the purposes of the consultation process.

Berotralstat for preventing recurrent attacks of hereditary angioedema

Closed for comments This consultation ended on at   Request commenting lead permission

2 Information about berotralstat

Marketing authorisation indication

2.1 Berotralstat (Orladeyo, BioCryst) is indicated for 'routine prevention of recurrent attacks of hereditary angioedema (HAE) in adult and adolescent patients aged 12 years and older'.

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 berotralstat is £10,205 for a 28-pack of 150 mg capsules (company submission), which equates to an annual cost of £133,120.60. The company has a commercial arrangement, which would have applied if the technology had been recommended.