Dabrafenib/trametinib (Tafinlar®/Mekinist®) for the adjuvant treatment of adult patients with stage III melanoma

Zorginstituut Nederland has completed its assessment of dabrafenib (Tafinlar®) in combination with trametinib (Mekinist®) for the adjuvant treatment of adults with stage III melanoma. The Minister of VWS placed dabrafenib in combination with trametinib for the said indication in the waiting room ('sluis’) for expensive drugs.
The Zorginstituut was advised by two independent committees: the Scientific Advisory Board (WAR) which examines data against the criterion of established medical science and medical practice and determines the cost-effectiveness, and the Insured Package Advisory Committee (ACP) which considers societal aspects. We also consulted relevant parties during the assessment process.
Based on our assessment, we advise the Minister of Health, Welfare and Sport (VWS) not to include this combination treatment in the basic package.

Zorginstituut's advice

Based on initial results, we can state that dabrafenib in combination with trametinib complies with the legal criterion ‘established medical science and medical practice’ for the proposed indication, as adjuvant treatment after full surgical treatment of stage III melanoma with a BRAF V600E/V600K mutation in adult patients with ECOG 0-1 status and a lymphatic node metastasis >1 mm. About half of the patients with a melanoma have a BRAF-V-600 mutation.

The cost-effectiveness analysis supplied by the manufacturer is of insufficient quality, despite the fact that the manufacturer was given – and took advantage of – the opportunity to address this shortcoming. As a result, the Zorginstituut is unable to realistically estimate the cost-effectiveness, and unable to inform the Minister of VWS what price reduction is needed to reach an acceptable cost-effectiveness.

The Zorginstituut therefore advises the Minister of VWS, in light of the advice of the WAR and the ACP, not to include the combination dabrafenib/trametinib in the standard package. The Zorginstituut is well aware that the outcome of our assessment will be disappointing for patients and their specialists. We therefore invite the manufacturer to provide better evidence of the (cost-) effectiveness. Then, assessing from the perspective of the standard package, which is funded from collective premiums, the Zorginstituut will be able to realistically assess the costs and benefits of treating patients with stage III melanoma.

This report is a summary of recommendations by Zorginstituut Nederland. The original text is in Dutch.