NICE consults on ‘no’ recommendation for skin cancer drug talimogene laherparepvec

16 March 2016 - NICE has today issued draft guidance not recommending talimogene laherparepvec (Imlygic, Amgen) as an option for people with melanoma that has spread and can't be surgically removed.

Talimogene laherparepvec 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. Talimogene laherparepvec is injected directly into the skin tumour.

Professor Carole Longson MBE, Director of the Centre for Health Technology Evaluation at NICE, said: "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.

"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 NICE recommended nivolumab (Opdivo, Bristol Myers Squibb) for advanced melanoma. NICE has also recommended ipilimumab (YERVOY, Bristol-Myers Squibb) as a possible treatment for adults with advanced melanoma that has either not been treated before or that has previously been treated. In addition, NICE recommends pembrolizumab (Keytruda, Merck Sharp & Dohme) for advanced melanoma used before and after prior treatment with ipilimumab.

Consultees, including the company, healthcare professionals and members of the public have until 13 April to comment on the preliminary guidance. Comments received during this consultation will be fully considered by the Committee at its meeting on 19 April and following this meeting the next draft guidance will be issued. 

Until final guidance is issued, NHS bodies should make decisions locally on the funding of specific treatments. Once NICE issues its final guidance on a technology, it replaces local recommendations across the country.

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. 

Ends

For more information call the NICE press office on 0300 323 0142 or out of hours on 07775 583 813.

The draft guidance on talimogene laherparepvec will be available on the NICE website from 16 March.

  1. The draft guidance states:

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

            1.2       People whose treatment with talimogene laherparepvec was started within the NHS before this guidance was published should be able to continue treatment until they and their NHS clinician consider it                                                   appropriate to stop.

  1. Talimogene laherparepvec has a marketing authorisation in the UK for the treatment of adults with 'unresectable melanoma that is regionally or distantly metastatic (Stage IIIB, IIIC and IVM1a) with no bone, brain, lung or other visceral disease'.
  2. The acquisition cost of talimogene laherparepvec is £1,670 per 1 ml vial of either 106 plaque forming units (PFU) per ml or 108 PFU per ml (excluding VAT; company's submission).
  3. 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.
  4. The committee concluded that it was not possible to establish whether talimogene laherparepvec was a cost-effective use of NHS resources given the uncertainty about its effect on overall survival compared with ipilimumab and other immunotherapies.

About melanoma

  1. Melanoma is a cancer of the skin. In its early stages, melanoma is normally asymptomatic and can often be cured by surgery (resection). However, at presentation, around 10% of melanomas have spread to nearby lymph nodes (stage III) or to other parts of the body (stage IV).
  2. It occurs more commonly in fair-skinned people and there is strong evidence that ultra violet exposure is causal. People with an above-average mole count, sun-sensitive skin, or a strong family history of melanoma are at increased risk.
  3. There were 11,281 new diagnoses of melanoma and 1781 deaths registered in England in 2012. In the UK, more than one-third of people diagnosed with melanoma are aged less than 55 years. Approximately 20-73% of people with stage III melanoma (including 20-34% of people with stage IIIc) and 5-22% of those with stage IV will live longer than 5 years, with survival rates being slightly higher in women than in men.
  4. Approximately 50% of melanomas harbour activating BRAF mutations, and over 90% of these are BRAF V600 mutations. Diagnostic tests can be used to detect the BRAF mutation, including the cobas test, generic PCR sequencing tests and other validated BRAF mutation tests.

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