NICE rejects Amgen's Imlygic in first draft guidance

NICE has rejected Amgen's Imlygic (talimogene laherparepvec) advanced melanoma drug in first draft guidance for routine NHS funding, saying evidence on clinical effectiveness compared with rivals was inconclusive.

Earlier this week the cost-effectiveness body said that Amgen will have the opportunity to request that the drug is considered under new arrangements for the Cancer Drugs Fund (CDF) that will come into effect from next month.

NICE said Imlygic is not recommended within its marketing authorisation, for regionally or distantly metastatic, unresectable melanoma (Stage IIIB, IIIC and IVM1a) that has not spread to the bone, brain, lung or other internal organs.

Professor Carole Longson, director of the Centre for Health Technology Evaluation at NICE, said: "The committee heard from the patient and clinical experts that, because the drug has fewer side effects than other drugs for advanced melanoma, it would be particularly valuable to some people with this condition.

"However, the committee concluded that there was not enough evidence to be able to say whether talimogene laherparepvec is as clinically effective as other drugs used to treat advanced melanoma."

Imlygic is a modified form of the herpes simplex virus type-1 (HSV-1) that normally causes cold sores. In its altered state it is designed to kill cancer cells both by directly attacking them and also by helping the immune system recognise and destroy them. Imlygic is injected directly into the skin tumour.

Patients treated with Imlygic before the guidance was published can continue treatment until they and their NHS clinician consider it appropriate to stop.

NICE will consult on the draft guidance, which applies to England and Wales, until 13 April.

Its independent committee will review responses and then issue second draft guidance. Until binding final draft guidance is published, NHS bodies should make decisions on funding locally.

Last month NICE recommended Bristol-Myers Squibb's (BMS) Opdivo (nivolumab) for advanced melanoma. It has also recommended BMS's Yervoy (ipilimumab) in adults with advanced melanoma that has either not been treated before, or has previously been treated.

NICE also recommends Merck, Sharp & Dohme's Keytruda (pembrolizumab) for advanced melanoma before and after treatment with Yervoy.

From July, new cancer drugs rejected by NICE can be put on the CDF, which pays for them for up to two years while manufacturers gather more cost-effectiveness data. After two years, NICE will make decisions on these drugs following a shortened review.

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