Advice on the clustering of combination products and ghost clusters in GVS (part 4)
The Minister for Health, Welfare and Sport (VWS) has asked the National Health Care Institute for advice on the clustering of certain (groups of) interchangeable medicinal products in the Medicine Reimbursement System (GVS). These are combination products (medicinal products containing more than 1 active substance in a fixed combination) and the so-called ghost clusters (clusters in the GVS containing only 1 product). Because the Minister's question is about a large number of medicinal products, it has not been possible to discuss all medicinal products in 1 report. That is why the National Health Care Institute will advise the Minister in parts.
Advice by the National Health Care Institute (part 4)
In this advisory report (part 4), the National Health Care Institute assesses 2 insulin preparations (Insuman® Infusat and Insulatard®) and 3 parenteral administration forms (ceftazidime powder for solution for injection, erythrocin powder for intravenous infusion and Haldol® solution for injection). In addition, the National Health Care Institute provides an advisory report on Sustanon® solution for injection. This medicinal product has been a ghost drug since October 2022, after the National Health Care Institute advised that Nebido® (reassessment) – which was included in cluster 0G03BAAP V with Sustanon® – could be placed on List 1B.
Based on the assessments, the National Health Care Institute has completed the following advice: Insuman® Infusat (cartridge), Insuman® Infusat (vial), ceftazidime powder for solution for injection, Insulatard®, Erythrocin® powder for intravenous infusion, Haldol® solution for injection (5 mg/ml) and Sustanon® are not interchangeable with any other medicinal product in the GVS and are therefore eligible for inclusion in List 1B.
Medicine Reimbursement System (GVS)
An extramural drug (medicinal products prescribed by a physician and available at the pharmacy) is only reimbursed if it is included in the GVS. The amount of the reimbursement depends on the list the product is listed on. Interchangeable medicinal products are placed in 1 cluster on List 1A. These may be subject to a reimbursement limit. Each cluster contains at least 1 payment-free medicinal product. Unique medicinal products are listed in List 1B. The medicinal products on this list do not have a reimbursement limit.
The Minister's request for an advisory report on combination products and ghost clusters is based on the intended decision to modernise the GVS. This request is in preparation of this decision.
Combination products (medicinal products containing more than 1 active substance in a fixed combination) have so far been frequently placed in a Y cluster or in List 1B of the GVS. The reimbursement limits for the combination products have so far been calculated differently from the reimbursement limits for the monopreparations.
With the modernisation of the GVS, the Ministry of Health, Welfare and Sport wants to also apply the traditional calculation system for medicinal products in the GVS to combination products. The guiding principle here is that, after the recalculation of the reimbursement limits, at least 1 product without additional payment becomes available.
To enable the use of the regular calculation system for combination preparations, these products must first actually be placed in one cluster. The Minister for Medical Care therefore asked the National Health Care Institute to advise which combination preparations in the GVS can be clustered together and which cannot. In the advisory report, attention should to be paid to the medicinal products for HIV and hepatitis C, which have an exemption status in the GVS.
Ghost clusters are clusters on List 1A that contain only 1 product, sometimes with an additional payment. VWS is considering eliminating the ghost clusters in the GVS by clustering the products wherever possible. This is possible if they are interchangeable with other products. The Minister has asked the National Health Care Institute to advise on the interchangeability of products currently in a ghost cluster.