Package advice on the lock procedure medicinal product lenvatinib (Lenvima®) for the treatment of endometrial carcinoma
The National Health Care Institute has assessed whether the medicinal product lenvatinib (Lenvima®) in combination with pembrolizumab can be reimbursed from the basic health care package. This medicinal product is used to treat certain patients with endometrial carcinoma. The reason for this advice was the placing of the product in the so-called ‘lock procedure’ for expensive medications’. The National Health Care Institute advises the Minister of Health, Welfare and Sport (VWS) to reimburse lenvatinib for the aforementioned condition from the basic health care package after price negotiations, but believes that the price should be reduced by at least 65%.
Indication for which reimbursement is requested
Lenvatinib in combination with pembrolizumab can be used in the treatment of adult patients with advanced or recurrent endometrial carcinoma (EC) who have disease progression on or following prior treatment with platinum-containing therapy in any setting. These are patients who are not eligible for curative surgery or radiation.
Endometrial carcinoma is the most common form of uterine cancer. The tumour originates from cells in the mucous uterine membrane: the endometrium. This type of cancer often grows slowly and is usually easy to cure. There are different types of endometrial carcinoma. The different types are important for determining the treatment and affect the prognoses.
Recommendations from the National Health Care Institute
The National Health Care Institute advises the Minister of Health, Welfare and Sport to include lenvatinib in combination with pembrolizumab in the basic health care package for the above indication. In this respect, the National Health Care Institute considers a discount of at least 65% appropriate.
Lock procedure for expensive medicinal products
The Minister has placed lenvatinib for this indication in the lock procedure for expensive medicinal products. A medicinal product in this lock procedure will not be eligible for reimbursement from the basic health care package until:
- there is a positive package advice from the National Health Care Institute;
- there are arrangements and safeguards for appropriate use in place;
- price reductions have been successfully negotiated with the manufacturer.
The Scientific Advisory Board (WAR) and the Insured Package Advisory Committee (ACP) advise the National Health Care Institute when issuing a package advice. The final decision as to whether or not reimbursement from the basic health care package will take place lies with the Minister.