Olaparib (Lynparza®) for the maintenance treatment of adult patients with carcinoma of the ovaries, tubes or peritoneum
The National Health Care Institute has completed its assessment whether olaparib (Lynparza®) as a monotherapy for the maintenance treatment of adult patients with advanced (FIGO III or IV) BRCA1/2 mutated (germ line and/or somatic), high-grade epithelial carcinoma of the ovaries, tubes or peritoneum that exhibit a full or partial response to primary treatment with platinum-containing therapeutic agents can be included in the insured package. Due to its expected high costs the Minister of Medical Care and Sports has placed olaparib in the so-called ‘package lock’ or ‘sluice’ for expensive drugs. These products can only be accepted into the insured package after the National Health Care Institute 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 National Health Care Institute advises the Minister to include olaparib in the package for the mentioned indication. However, admitting olaparib to the package should be seen as provisional, due to uncertainty about olaparib for the stated indication and to considerations on appropriate use.
Criteria for including treatments in the insured package
The National Health Care Institute 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 National Health Care Institute 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 National Health Care Institute 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.
The National Health Care Institute's advice
The National Health Care Institute advises the Minster to include olaparib in the package for the mentioned indication. Given the considerable gain in progression-free survival, the limited financial risk if it is included in the package and the high likelihood of its being cost-effective, rapid market access for olaparib for the above-mentioned indication is desirable. However, admitting olaparib to the package should be seen as provisional, due to uncertainty about olaparib for the stated indication and to considerations on appropriate use.
This report is a summary of recommendations by the National Health Care Institute. The original text of this excerpt is in Dutch.