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NICE swayed by extra data on Amgen's Imlygic

Cost effectiveness watchdog backs immunotherapy in final draft guidance

Amgen Imlygic talimongene laherparepvec 

NICE has recommended Amgen's advanced melanoma treatment Imlygic (talimongene laherparepvec) in final draft guidance, reversing an earlier negative decision.

The cost effectiveness watchdog for the NHS in England and Wales said it was swayed by 'further information' provided by the drug's manufacturer.

Consequently Imlygic is now set to be backed for the treatment of advanced melanoma that has spread and can't be surgically removed - around 10-15% of advanced melanoma patients.

The guidance does come with some restrictions, namely Imlygic can only be used if treatment with systemic immunotherapies is not suitable and if Amgen provides it to the NHS with the discount agreed in its patient access scheme.

The size of the discount - as is usually the case - remains confidential, but at its list price the drug costs £1,670 per 1 ml vial of either 1,000,000 plaque forming units (PFU) per ml or 100,000,000 PFU per ml (excluding VAT).

Imlygic is a genetically modified live Herpes simplex virus that is designed to infect and destroy melanoma lesions in the skin and lymph nodes that cannot be fully removed with surgery.

The virus is administered directly into the lesions via a series of injections and has fewer side-effects than some other immunotherapies for melanoma.

Imlygic was approved in the US in October and in Europe in December last year, after becoming the first oncolytic immunotherapy to demonstrate therapeutic benefit for patients with metastatic melanoma in a phase III clinical trial.

Amgen future plans for the the oncolytic virus therapy include looking at combining it with Merck & Co's checkpoint inhibitor Keytruda (pembrolizumab) in head and neck cancer, and last year started phase I trials of the duo.

Article by
Dominic Tyer

9th August 2016

From: Regulatory

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