Package advice on the lock procedure medicinal product brexucabtagene autoleucel (Tecartus®) for the treatment of mantle cell lymphoma (MCL)
The National Health Care Institute has assessed whether the medicinal product brexucabtagene autoleucel (Tecartus®) can be reimbursed from the basic insured health care package. This medicinal product can be used to treat certain patients with recurrent or refractory mantle cell lymphoma (MCL). Because of the expected high costs, the Minister of Health, Welfare and Sport (VWS) has placed this drug in the ‘lock procedure for expensive medicinal products’. The National Health Care Institute advises the Minister to include brexucabtagene autoleucel in the basic health insurance package but believes that the price should be reduced by at least 80%.
Indication for which reimbursement is requested
Brexucabtagene autoleucel can be used to treat adult patients with recurrent or refractory MCL. This refers to treatment after 2 or more lines of systemic therapy, including a Bruton’s tyrosine kinase inhibitor (BTK inhibitor).
Mantle cell lymphoma is a form of lymph node cancer. It belongs to the group known as non-Hodgkin's lymphomas. Recurrent means that the cancer has reappeared after initially disappearing, wholly or in part. Refractory means that the tumour has not responded to previous treatment. This refers to treatment for patients who have received 2 or more lines of systemic therapy. Systemic means that the treatment affects the whole body, tackling the tumour and any metastases at the same time.
Recommendations from the National Health Care Institute
In earlier package advice issued in September 2022, the National Health Care Institute advised the Ministry of Health, Welfare and Sport not to reimburse brexucabtagene autoleucel. The manufacturer had not provided sufficient substantiation for the cost-effectiveness of the drug. As a result, the National Health Care Institute was unable to give the Minister proper advice about what price reduction would be needed if the drug was to be made reimbursable. The manufacturer has now submitted a modified analysis of the cost-effectiveness. The National Health Care Institute concludes that the medicine does have added value for the patients mentioned in that it extends the overall survival. The exact size of the effect remains uncertain, however. The National Health Care Institute therefore recommends that the Minister should include brexucabtagene autoleucel in the basic health insurance package and should require a price reduction of at least 80%.
Lock procedure for expensive medicinal products
The Minister has placed brexucabtagene autoleucel 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 basic insured health care package without any special agreements e.g. about pricing.
If new medicines are expensive, the Ministry of Health, Welfare and Sport can decide to keep them out of the basic health insurance package and place them in what is known as the ‘lock procedure for expensive medicinal products’. This means that the drug can only be considered for remuneration through the basic health insurance package when:
- the National Health Care Institute has issued a positive package advice recommendation;
- agreements have been made about appropriateness of the use of the medicine;
- negotiations have been successfully concluded with the manufacturer about a price reduction.
The Scientific Advisory Council (Dutch: WAR) and the Package Advisory Committee (Dutch: ACP) advise the National Health Care Institute about issuing package advice. The Minister makes the final decision as to whether the drug should or should not be reimbursed through the basic health insurance package.