NICE recommends Amgen’s melanoma treatment after price cut

Patients in England will be able to receive Amgen’s treatment for advanced melanoma Imlygic (talimogene laherparepvec) after NICE recommended the treatment.

The cost and clinical effectiveness watchdog issued final draft guidance on the drug yesterday, reversing an earlier decision to reject its use on the NHS.

The drug has been recommended for advanced melanoma that has spread and can’t be surgically removed.

NICE says it changed its mind after Amgen provided further information on the drug, and also offered a price discount via a Patient Access Scheme.

Derived from a herpes virus, talimogene laherparepvec is a new immunotherapy treatment injected directly into tumours that has fewer side-effects than some other immunotherapies for treating melanoma.

NICE recommends talimogene laherparepvec in adults, as an option for treating unresectable, regionally or distantly metastatic (Stage IIIB, IIIC or IVM1a) melanoma that has not spread to bone, brain, lung or other internal organs.

The drug can only be used if treatment with systemic immunotherapies is not suitable and if the Amgen provides the (confidentially) agreed discount.

Experts say the treatment would be suitable for about 10-15% of those with advanced melanoma that has spread and can’t be surgically removed.

Talimogene laherparepvec 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; based on the company’s submission).

The approval comes at a time of significant progress in melanoma treatment, with BMS’s Yervoy and Opdivo and Merck’s Keytruda becoming the standards of care in advanced melanoma.

Amgen is also pursuing trials of Imlygic in combination with Merck’s immunotherapy Keytruda (pembrolizumab) in unresected stage IIIB-IV melanoma.