pharmaphorumNovember 26, 2018
In first draft guidance, NICE said Keytruda (pembrolizumab) will be reimbursed by the Cancer Drugs Fund, with pemetrexed and platinum chemotherapy, for adults with untreated non-squamous non-small cell lung cancer.
Their tumours must have no epidermal growth factor receptor (EGFR) or anaplastic lymphoma mutations.
NICE estimates that more than 3,000 patients in England will be eligible for the treatment, made by Merck Sharp and Dohme, known as Merck & Co in the US.
The cost-effectiveness body said that it could not recommend regular NHS funding because of uncertainties over the overall survival benefit from Keytruda.
But this question could be answered soon by data from the combination arm of the KEYNOTE-189 trial.
As a result NICE’s independent committee said that Keytruda could be reimbursed in this use by the Cancer Drugs Fund on an interim basis until June 2019, when there will be a further review of the guidance.
Patients will be able to receive Keytruda for a maximum of two years.
The decision applies to England, but Wales is likely to follow suit and reimburse Keytruda in this use as it usually follows NICE’s guidance.
Meindert Boysen, director of the NICE Centre for Health Technology Evaluation, said: "Over the past two decades there have been few improvements for people with this type of lung cancer so we are pleased to support access to this new option via the Cancer Drugs Fund, and keen to see further data on its effectiveness as it becomes available.
"NICE recommends that this treatment is given for a maximum of two years, because it is thought that patients do not need to continue treatment beyond this point to achieve the benefits. NICE will consider this point when we review the additional evidence."
John Stewart, NHS England’s director of specialised commissioning, said: "NHS England has worked closely with MSD to reach a commercial deal to make this innovative drug available to a new group of lung cancer patients. This is another example of how a more flexible approach to price negotiation has clear benefits – not only for patients, but also for industry and taxpayers."
This combination therapy will be available to NHS patients in England immediately. Subject to appeal, NICE’s final guidance will be published in January – just 8 months after the appraisal began.
Keytruda is administered every 3 weeks by intravenous infusion. The 200 mg infusion has a list price of £5,260, but the company has offered the NHS a confidential discount.
Another option for first line lung cancer is Keytruda alone; this option was approved by NICE for routine NHS use in June.
NICE is due to publish its appraisal of a separate Pembrolizumab combination therapyfor patients with untreated squamous non-small cell lung cancer next year.
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