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The content on this page is not current guidance and is only for the purposes of the consultation process.

Pemigatinib for treating relapsed or refractory advanced cholangiocarcinoma with FGFR2 fusion or rearrangement

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

2 Information about pemigatinib

Anticipated marketing authorisation indication

2.1 On 28 January 2021 the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional marketing authorisation for pemigatinib (Pemaryze, Incyte Corporation) for treating 'adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy'.

Dosage in the marketing authorisation

2.2 The dosage schedule will be available in the summary of product characteristics.

Price

2.3 The list price of pemigatinib is £7,159.04 for a 14-pack of 13.5 mg tablets (company submission), which equates to an annual cost of £124,430. The company has a commercial arrangement, which would have applied if the technology had been recommended.