Evidence-based recommendations on pembrolizumab (Keytruda) for untreated locally advanced or metastatic urothelial carcinoma in adults.

  NICE is aware that European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended restricting the use of pembrolizumab as a first line-treatment for patients with urothelial cancer ineligible for cisplatin-based chemotherapy. It has said that pembrolizumab should now only be used for first-line treatment of urothelial cancer in adults ineligible for cisplatin-based chemotherapy with high levels of PD-L1. The CHMP opinion will be forwarded to the European Commission, which will issue a final legally binding licensing decision applicable in all EU Member States.

Once this decision has been released, NICE will update its guidance to reflect the new marketing authorisation and NHS England will modify its treatment criteria for use in the Cancer Drugs Fund. For more information, see the European Medicine Agency’s website. One of the consequences for NHS England is that PD-L1 testing will have to be done for all patients considered for first-line pembrolizumab in adults with urothelial cancer ineligible for cisplatin-based chemotherapy.

Guidance development process

How we develop NICE technology appraisal guidance

Next review: More evidence on pembrolizumab is being collected, until November 2019. After this, NICE will decide whether or not to recommend it for use on the NHS and update the guidance. It will be available through the Cancer Drugs Fund until then, as part of the managed access agreement.

Commercial arrangement

There is a commercial access agreement for pembrolizumab. Contact keiron.hughes@merck.com for details.

Your responsibility

The recommendations in this guidance represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, health professionals are expected to take this guidance fully into account, alongside the individual needs, preferences and values of their patients. The application of the recommendations in this guidance is at the discretion of health professionals and their individual patients and do not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or their carer or guardian.

Commissioners and/or providers have a responsibility to provide the funding required to enable the guidance to be applied when individual health professionals and their patients wish to use it, in accordance with the NHS Constitution. They should do so in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities.

Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.

  • National Institute for Health and Care Excellence (NICE)