NICE approves Keytruda combination therapy for NSCLC through CDF

The UK’s healthcare regulator the National Institute of Health and Care Excellence (NICE) has recommended Merck’s Keytruda (pembrolizumab) combined with two chemotherapy drugs, carboplatin and paclitaxel or nabpaclitaxel, be made immediately available to National Health Service (NHS) non-small cell lung cancer (NSCLC) patients through the Cancer Drugs Fund (CDF).

The Keytruda combination therapy will be only be available through the CDF, rather than for routine use, because NICE’s recommendation is based upon the ongoing KEYNOTE-407 trial, meaning the data is immature and the cost-effectiveness of the drug is uncertain.

Based on NICE’S modelling assumptions the cost of the drug was more than the regulator’s maximum guideline of £50,000 per quality-adjusted life year gained.

Merck’s KEYNOTE-407 clinical development programme suggests that the Keytruda combination therapy could allow people to live longer and without their cancer progressing than chemotherapy alone. In June last year, the company announced that Keytruda plus chemotherapy reduced the risk of death by 365 compared to chemotherapy along.

However, NICE noted there remains uncertainty about whether the Keytruda combination could replace chemotherapy and be a life-extending treatment at the end of life.

The combination failed to meet the end-of-life criteria in the trial, compared to the Keytruda monotherapy approved to treat people whose tumours express programmed cell death-ligand 1 (PD-L1) with a tumour proportion score of at least 50.

Within its recommendations NICE placed some parameters around access to the combination treatment through the CDF; Keytruda will only be available to patients with metastatic squamous NSCLC who haven’t had any previous treatment and whose cancer has not spread to other parts of the body. It will also only be available for two years, and may be stopped earlier if there are signs of disease progression.

NICE stated that the list price of the Keytruda combination is £5,260 per 200g infusion needed every three weeks, however, Merck and the regulator have agreed a lower, undisclosed price.

NICE Centre for Health Technology Evaluation director Meindert Boysen said: "The committee heard from the patient experts that people with squamous non-small-cell lung cancer often have a poor quality of life, and that treatments that have the potential to extend life would be of great importance.

"Pembrolizumab combination therapy is a promising treatment option for these patients who currently have very few.

"We are therefore pleased to be able to use the flexibility provided by the Cancer Drugs Fund to recommend it while further data on its clinical effectiveness is collected."

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