What has SMC said?

The Scottish Medicines Consortium (SMC) has accepted enfortumab vedotin used together with pembrolizumab for the first-line treatment of adults with advanced urothelial cancer (bladder cancer). It is used in patients who are eligible for platinum-containing chemotherapy.

SMC has accepted enfortumab vedotin used together with pembrolizumab for restricted use in the patients described above. The restriction means that the pembrolizumab part of the treatment can be continued for up to two years.

This document summarises the SMC decision and what it means for patients.

You can find more detailed information about the SMC assessment of enfortumab vedotin by looking at the SMC Detailed Advice Document (SMC2842).

What does SMC’s decision mean for patients?

Enfortumab vedotin for use as described above is available for prescribing on the NHS in Scotland. Your healthcare professional can discuss with you if it is the right treatment for you.

You can find more information about making decisions about your treatment here: Medicines in Scotland: What’s the right treatment for me?

More about SMC’s decision

SMC’s decision takes into account a confidential discount offered by the pharmaceutical company. SMC was also able to be more flexible* in its decision-making because the medicine is for:

  • A rare condition, and
  • A condition where patients taking current treatments are likely to live less than 3 years.

How does SMC make its decision?

SMC carefully considers every new medicine to make sure it benefits patients and is likely to be a good use of NHS resources.

To do this SMC studies the following:

  • Evidence from the company about how well the medicine works compared with current treatments available in Scotland, in relation to how much they will cost to buy and use to treat patients.
  • Information from patient groups about the potential impact of the medicine on patients and carers.
  • Advice from healthcare professionals about any benefits of the new medicine compared to current treatment, along with how the new medicine is likely to be used.

When SMC assesses a medicine it takes account of the needs of all patients in NHSScotland, not only those who may be treated with the medicine.

You can find out more about how SMC decides here: https://www.scottishmedicines.org.uk/how-we-decide/

More information and support

The organisations below can provide more information and support for people living with bladder cancer and their families. SMC is not responsible for the content of any information provided by external organisations.

Action Bladder Cancer
https://actionbladdercanceruk.org 0300 302 0085

Fight Bladder Cancer
https://www.fbc.uk.com


You can find out more about enfortumab vedotin (brand name: Padcev®) in the Patient Information Leaflet (PIL) by searching for the medicine name on the Medicines and Healthcare products Regulatory Agency (MHRA) website.
https://products.mhra.gov.uk/

Date advice published: 11 May 2026
SMC ID: SMC2842