Package advice dabrafenib/trametinib (Tafinlar®/Mekinist®)
Zorginstituut Nederland has completed its reassessment of the pharmaco-economic analysis of dabrafenib in combination with trametinib (Tafinlar®/Mekinist®) in the adjuvant treatment of adult patients with stage III melanoma. The Minister of Medical Care placed dabrafenib in combination with trametinib in the package lock for expensive medicinal products for the indication ‘adjuvant treatment after full surgical treatment of stage III melanoma with a BRAF V600E/\/600K mutation in adult patients with ECOG status 0-1 and lymph node metastasis >1 mm’. On 28 August 2019, we sent the Minister an initial advisory report on this combination therapy. At that time, the Zorginstituut recommended not to include dabrafenib/trametinib in the package, because we could not provide a realistic estimate of the cost-effectiveness. Based on this reassessment, we now recommend the Minister to include this combination treatment in the basic package after a price negotiation. After successful price negotiations, the minister has temporarily admitted the treatment to the basic package from 1 November 2020.
Reassessment dabrafenib in combination with trametinib
The marketing authorisation holder has provided a new pharmaco-economic analysis. On this basis, the Zorginstituut concludes, after consulting the Scientific Advisory Board, that the analysis is now sufficient and suitable to make a realistic assessment of the cost-effectiveness.
Package advice
The Zorginstituut considers it important that the combination of dabrafenib/trametinib for the assessed indication is rapidly made available on the basis of this reassessment. It is an effective therapy that could provide a solution for some of the patients with a contraindication for immunotherapy (5-10 percent). The Zorginstituut advises the Minister to negotiate the price of this combination therapy because in this case, the reference value used for cost-effectiveness is too high for a number of reasons.
Firstly, it is still unclear whether the treatment will lead to survival gains, compared to a wait-and-see approach. Secondly, the occupational group has access to other substances recently made available (immunotherapy with nivolumab or pembrolizumab) to treat the majority of this patient group (90-95 percent). It is still unclear whether this combination therapy is more effective than these two adjuvant treatments.
Appropriateness
The occupational group has a melanoma register (DMTR) that collects all data, ensuring that the treatment results can also be monitored in the longer term and reported to the Zorginstituut. We will actively ask for this from the management of the melanoma register. We will discuss these treatment outcomes further with the occupational group, in light of the use of the medicinal products within the treatment landscape of melanoma treatment applicable at the time. If the combination therapy dabrafenib/trametinib is included in the insured package, the Zorginstituut will actively monitor the use.
Criteria for including treatments in the insured package
The Zorginstituut assessed the above-mentioned combination treatment based on the four package criteria effectiveness, cost-effectiveness, necessity and feasibility. Assessing from the perspective of the basic package which is paid from collective premiums, the Zorginstituut looks at whether new care is better than what is currently available. In doing this we look not only at the degree of certainty that has been achieved, from a scientific perspective and from the perspective of societal support, but also at efficiency aspects. The Zorginstituut was advised by two independent committees: the Scientific Advisory Board (WAR) which examines data on established medical science and medical practice and determines the cost-effectiveness, and the Insured Package Advisory Committee (ACP) which considers the societal assessment. Stakeholders are also consulted during the process.
This report is a summary of recommendations by Zorginstituut Nederland. The original text is in Dutch.