Please login to the form below

Not currently logged in

NICE rejects Keytruda for advanced bladder cancer in final guidance

Treatment had been authorised for use in this indication via the Cancer Drugs Fund in 2018

The UK’s National Institute for Health and Care Excellence (NICE) has issued a second final appraisal document rejecting MSD’s Keytruda for the treatment of advanced bladder cancer.

MSD – known as Merck & Co in the US and Canada – had initially been granted authorisation for Keytruda (pembrolizumab) in advanced or metastatic urothelial carcinoma patients who had previously received platinum-based chemotherapy via NICE’s Cancer Drugs Fund in 2018.

As part of the managed access agreement, further evidence could be collected for Keytruda in this indication, which was then reviewed by NICE as part of its final decision.

NICE decided not to issue a permanent recommendation for Keytruda in this patient population in March 2020, after results from the KEYNOTE-045 demonstrated a benefit for overall survival but not for progression-free survival in the second-line setting.

Following this rejection, MSD appealed the decision, although NICE has upheld its previous guidance not to recommend Keytruda as a second-line treatment for advanced bladder cancer patients.

In a statement issued today, NICE said that although evidence shows Keytruda meets its ‘life-extending treatment’ criteria, the cost-effectiveness estimate for the immunotherapy is uncertain.

‘This [uncertainty] is because it is not clear which adjustment for treatment switching or model of overall survival is most appropriate. It is also unclear how long the treatment benefit of pembrolizumab should continue,’ the cost-effectiveness watchdog added.

“Following the initial decision by the NICE committee not to recommend the use of pembrolizumab in this setting, we have done what we can to ensure continued access for patients,” said David Peacock, managing director, MSD.

“Following our successful appeal of the original decision, MSD was able to bring fresh data analyses and make a further offer on the patient access scheme to address the committee’s concerns.

“We feel strongly that the appeal was the right decision and that patient access to this medicine should have been maintained. MSD remains committed to research in bladder cancer, where unmet need endures, and we hope we can make meaningful positive impact through our science in the years ahead,” he added.

NICE said in its own statement that it now recommends Roche’s anti-PD-L1 drug Tecentriq (atezolizumab) for bladder cancer patients at this stage of the treatment pathway.

Article by
Lucy Parsons

18th March 2021

From: Regulatory



Subscribe to our email news alerts

Featured jobs


Add my company

Viseven is a Global MarTech Services Provider for Pharma and Life Sciences Industries...

Latest intelligence

Value is in the eye of the customer. Co-creation is a bridge to value.
We conducted 16 hours of qualitative interviews with HCPs and Senior Pharma industry leaders in the UK, supported with in-depth industry scanning. Our interviews reveal important insights about the tensions...
Partnering with Patients and Caregivers in Clinical Research
Practical advice for Early Scientific Advice (ESA) in HTA submissions
A step-by step guide on the benefits, processes, and key considerations involved in the Healthcare Technology Assessment (HTA) Early Scientific Advice (ESA) consultation as part of planning the holistic evidence...