Package advice lenvatinib (Kisplix®) in combination with pembrolizumab for the treatment of renal cell carcinoma
The National Health Care Institute has assessed whether the medicinal product lenvatinib (Kisplix®) in combination with pembrolizumab can be reimbursed from the basic health care package. This medicinal product can be used to treat certain patients with advanced renal cell carcinoma (RCC). Due to the high costs that can be expected, the Minister of Health, Welfare and Sport has placed this medicinal product in ‘lock procedure for expensive medicinal products’. The National Health Care Institute advises the Minister to reimburse lenvatinib in combination with pembrolizumab from the basic health care package after price negotiations.
Indication for which reimbursement is requested
The reimbursement was requested for the first-line treatment of advanced renal cell carcinoma (RCC) in adults. In RCC, there is a malignant tumour in the kidney. There are different types of renal cell carcinoma. The most common type is clear cell renal cell carcinoma. The different types are important for determining the treatment and affect the prognoses.
If renal carcinoma is not discovered or treated, the tumour continues to grow. The cancer cells can eventually spread through the lymph nodes or the blood to other parts of the body. We call the cancer advanced when it has grown through the kidney wall or has metastasized to other parts of the body. The combination of lenvatinib and pembrolizumab can be used to treat patients with advanced renal cell carcinoma.
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, but only if the net price after successful price negotiations with the marketing authorisation holder does not exceed the lowest net price of any of the following combinations:
- cabozantinib in combination with nivolumab; or
- axitinib in combination with pembrolizumab; or
- nivolumab in combination with ipilimumab,
since the National Health Care Institute concludes that the effectiveness of the lenvatinib and pembrolizumab combination is similar to the other combinations already reimbursed from the basic health care package. A cost-effectiveness analysis is not relevant in this case. The Insured Package Advisory Committee has advised the National Health Care Institute in general terms that the price for a treatment should be reduced when several medicinal products are available for the same indication. In addition, no comparative study of the effects of the individual components compared to the combination treatment has been conducted. As a result, it is unclear how effective the individual medicinal products are for the combination treatment.
Lock procedure for expensive medicinal products
The Minister has placed lenvatinib in combination with pembrolizumab in the ‘lock procedure for expensive medicinal products'. Medicinal products that are used in the hospital are called inpatient medicines. New inpatient medicines are mostly admitted to the health insurance's basic insured package without any special (price) agreements.
If new medicinal products are costly, the Minister of Health, Welfare and Sport may decide to temporarily remove them from the basic health care package and place them in the 'lock procedure for expensive medicinal products'. This means that the medicinal product will only be eligible for reimbursement from the basic health care package if:
- a positive package advice has been issued by the National Health Care Institute;
- arrangements have been made for the appropriate use of the product;
- price reductions have been successfully negotiated with the manufacturer.
The Minister makes the final decision as to whether the drug should or should not be reimbursed through the basic health insurance package.