The National Health Care Institute has advised the Minister of Health, Welfare and Sport (VWS) to reimburse enfortumab vedotin (Padcev®) combined with pembrolizumab (Keytruda®) from the basic healthcare package after price negotiations. This medicinal product can be used in certain patients with bladder cancer. The reason for this advice was the medicine being placed in what is known as the ‘lock procedure’ for expensive medicinal products.
Current state of affairs: advisory report sent to the minister
The National Health Care Institute has sent this advice to the Minister of VWS. The minister makes the final decision on whether to reimburse the medicinal product from the basic healthcare package.
Enfortumab vedotin combined with pembrolizumab is intended for certain people with bladder cancer
Enfortumab vedotin is the active substance; the brand name is Padcev®. The other active substance is pembrolizumab, which has the brand name Keytruda®. These medicinal products are used in combination. Both of them are administered by infusion.
This combination of medicinal products can be used for certain patients with bladder cancer. This tumour develops because too many cells are produced in the mucous membrane lining the inside of the urinary tract. These are the bladder, renal pelvises, ureters, and urethra.. Another word for this type of cancer is urothelial cell carcinoma.
This is for the primary treatment of people with unresectable or metastatic urothelial cell carcinoma (la/mUC). Primary or ‘first-line’ means that treatment is aimed at curing or controlling the tumour. Unresectable means that the tumour has grown into the surrounding muscular or adipose tissue and cannot be surgically removed. Metastatic means that tumours have also occurred outside the bladder.
The complete indication for reimbursement can be found in the drop-down menu.
Enfortumab vedotin in combination with pembrolizumab is indicated for the primary care treatment of adult patients with unresectable or metastatic urothelial carcinoma who can be considered for chemotherapy using compounds that contain platinum.
Advice from the National Health Care Institute on the reimbursement of enfortumab vedotin
The National Health Care Institute advises the Minister of VWS to reimburse enfortumab vedotin (Padcev®) through the basic healthcare package.
More information or questions?
If you have any questions about this advice, please send your question to the National Health Care Institute via warcg@zinl.nl. If you have questions about the reimbursement of a medicinal product, the personal expenses or whether you should pay a contribution, please ask your health insurance provider.
How did the advice come about?
The Scientific Advisory Board (WAR) and the Insured Package Advisory Committee (ACP) advise the National Health Care Institute when issuing package advice. The final decision on whether reimbursement from the basic healthcare package will be made lies with the minister.
Explanation of the package lock procedure for expensive medicinal products
The minister has placed enfortumab vedotin in the ‘lock procedure for expensive medicinal products’ for this indication. A medicinal product in this lock procedure will not be eligible for reimbursement from the basic healthcare package until:
- there is a positive package advice from the National Health Care Institute;
- there are arrangements and safeguards for appropriateness in place;
- price reductions have been successfully negotiated with the marketing authorisation holder.
For more information, see the page ‘Lock procedure for expensive medicinal products’.