Negative NICE draft guidance on Amgen's Imlygic

Drugs cost-effectiveness watchdog for England and Wales, the National Institute for Health and Care Excellence (NICE) has today issued draft guidancenot recommending talimogene laherparepvec as an option for people with melanoma that has spread and can’t be surgically removed. The drug is marketed by US biotech major Amgen’s (Nasdaq: AMGN) under the Imlygic trade name.

“Up until very recently the treatments available for advanced melanoma were very limited and in some cases restricted to palliative care. Talimogene laherparepvec represents an innovative approach to the treatment of the disease,” said Carole Longson, director of the NICE Centre for Health Technology Evaluation.

Prof Longson continued: “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. Given the uncertainty about its effect on overall survival compared with these drugs it was not possible to recommend talimogene laherparepvec as a cost-effective use of NHS resources.”

Last month, the NICE recommended Bristol-Myers’ Opdivo (nivolumab) for advanced melanoma and the firm’s Yervoy (ipilimumab) as possible treatment for adults with advanced melanoma that has either not been treated before or that has previously been treated. In addition, the NICE recommends Merck & Co’s Keytruda (pembrolizumab) for advanced melanoma used before and after prior treatment with ipilimumab.

Consultees, including Amgen, healthcare professionals and members of the public have until April 13 to comment on the preliminary guidance. The company will have the opportunity to request the drug is considered under the new arrangements for the Cancer Drugs Fund which were approved by NICE’s Board at its meeting in Swansea today and will come into effect next month.

The acquisition cost of talimogene laherparepvec is £1,670 ($2,366) per 1 ml vial of either 106 plaque forming units (PFU) per ml or 108 PFU per ml (excluding VAT; company’s submission). The company has agreed a patient access scheme with the Department of Health. If talimogene laherparepvec had been recommended, this scheme would provide a simple discount to the list price of talimogene laherparepvec at the point of purchase or invoice. The level of the discount is commercial in confidence.