Abemaciclib (Verzenios®) for the treatment of metastatic breast cancer

Zorginstituut Nederland has completed its assessment of abemaciclib (Verzenios®) for the treatment of metastatic breast cancer. Due to its expected high costs the Minister of Health, Welfare and Sport (VWS) has placed tisagenlecleucel in the so-called ‘waiting room’ or ‘sluice’ for expensive drugs.
These products can only be accepted into the insured package after the Zorginstituut has advised on their inclusion in the insured package and, where applicable, subject to Ministry negotiations to arrive at a financial arrangement with the supplier.
The Zorginstituut was advised by two independent committees: the Scientific Advisory Board (WAR), which examines the 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.

Registration

Abemaciclib, a selective inhibitor of cycline-dependent kinases 4 and 6 (CDK4/6) is indicated for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor 2 (HER2)-negative locally advanced or metastatic breast cancer:
- in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have previously received endocrine therapy.

Integral consideration of the package criteria and package advice

Abemaciclib, in combination with endocrine therapy, complies with the statutory criterion ‘established medical science and medical practice’ for patients with hormone-receptor positive, HER2-negative, advanced or metastatic breast cancer who were not previously treated with endocrine treatment (first line), or for patients who did receive prior endocrine therapy (second line). Based on indirect comparisons, we conclude that there are probably no clinically relevant differences in favourable and unfavourable effects between abemaciclib and the other CDK4/6 inhibitors, ribociclib (Kisqali®) and palbociclib (Ibrance®), which were already accepted into the insured health care package in earlier 'waiting-room' procedures on 1 August 2017 and 1 May 2018 respectively. In daily clinical practice, this will enable medical professionals to select one of the three products for individual patients or subpopulations.

Zorginstituut's advice

In view of the high budget impact of abemaciclib, and in the light of the availability of ribociclib and palbociclib – for which a financial arrangement exists – the Zorginstituut states that the current price of abemaciclib is unacceptable. In consultation with the Insured Package Advisory Committee (ACP), we advise the Minister to include abemaciclib in the same financial arrangement as ribociclib and palbociclib. When this arrangement ends (i.e. by 31 December 20204), the products should be able to compete with one another.

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