MSD’s Keytruda is the first and only immunotherapy to be recommended for NHS use to treat urothelial carcinoma patients, when prior platinum-containing chemotherapy fails.

The National Institute for Care and Health Excellence (NICE) has issued final guidance recommending NHS funding in England and Wales for Keytruda (pembrolizumab) via the Cancer Drugs Fund (CDF) as an option for treating locally advanced or metastatic forms of the disease.

The guidelines state the drug should be stopped at two years of uninterrupted treatment or earlier in the event of disease progression, and that conditions in the managed access agreement are followed.

"Outcomes of patients with chemotherapy refractory metastatic bladder cancer remain stubbornly poor,” said Professor Thomas Powles, director of Barts Cancer Centre, London.

“Pembrolizumab is the first immune check point inhibitor in this setting to show extended survival in this group of patients. This opens a new chapter in the treatment of bladder cancer. NICE's recommendation for pembrolizumab is a bright ray of light for patients with this difficult disease."

“It is encouraging to see more treatment options being available to people with urothelial carcinomas and as an organisation we are thoroughly excited as to what this means for the future,” added Allen Knight, Chairman from Action Bladder Cancer UK.

Data from the KEYNOTE-045 trial showed that the drug extended overall survival by nearly three months more than chemotherapy (median overall survival of 10.3 months versus 7.4 months).

The Institute said in August last year that it was leaning towards a ‘no’ for the drug in this setting, after concluding that all plausible cost effectiveness estimates overshoot what it normally considers acceptable for end-of-life treatments - £50,000 per quality-adjusted life year (QALY).

However, “after consultation on the Appraisal Consultation Document (ACD) and input from medical experts, patient advocates and other stakeholders, the NICE committee has concluded that there was sufficient evidence that pembrolizumab had an important extension-to-life benefit compared with standard of care. Therefore, it has made changes to its draft recommendations and pembrolizumab will now become available to patients through the CDF,” a company spokesperson told PharmaTimes.

Over 10,000 people a year are diagnosed with bladder cancer in the UK and over 9,000 with urothelial cancer; around 540 of whom could now benefit from treatment with Keytruda.