Advice on the clustering of combination products and ghost clusters in GVS (part 3)
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 3)
In this advisory report (part 3), the National Health Care Institute addresses combination preparations that were not discussed previously. This is about the assessment of their interchangeability within the Medicine Reimbursement System. The following drugs are being considered: Augmentin®, Cofact® and combination preparations where 1 of the substances in the combination preparation is not included in the Medicine Reimbursement System as a monopreparation (see Appendix 15 to part 1). In our advisory process, it is assumed that clustering of combination products is possible after the amendments to articles 2.40 and 2.47 of the Health Insurance Regulation.
The substantive discussion of these combination preparations can be found in Appendix 1. The responses of the various parties can be found in Appendix 2. Based on our assessments, the National Health Care Institute has decided on the following advice:
- Amoxicillin/clavulanic acid powder for suspension 125/31.5 mg/5 ml and 250/62.5 mg/5 ml that were included in paediatric cluster 0J01CRAO K can be moved to cluster 0J01CRAO V. Additionally, the amoxicillin/clavulanic acid injection powder vial 1000/100 mg that is included in paediatric cluster 0J01CRAP K can be moved to the 0J01CRAP V cluster. The positioning of other amoxicillin/clavulanic acid combination preparations in the Medicine Reimbursement System can be retained.
- The prothrombin complex (Cofact®) can be removed from the Medicine Reimbursement System. This medicinal product is already being funded via an add-on as part of medical care.
- Insulin lispro/insulin lispro protamine (Humalog Mix®) is interchangeable with insulin aspart/insulin aspart protamine (Novomix®). Both combination preparations are available as suspensions for injection in a prefilled pen and as suspensions for injection in a cartridge. Given the current structure of the Medicine Reimbursement System, these administration forms are not considered interchangeable. That is why the Humalog Mix® and Novomix® suspensions for injection can be placed in a cluster to be created in List 1A of the Health Insurance Regulation. The Humalog Mix® and Novomix® suspensions in prefilled pens can be placed in a different cluster (also to be created) in List 1A of the Health Insurance Regulation.
- Sulfamethoxazole/trimethoprim (Bactrimel®) concentrate for infusion fluid and sulfametrole/trimethoprim (Rokiprim®) solution for infusion can be grouped in a cluster to be created in List 1A of the Health Insurance Regulation.
- Artemether/lumefantrine (Riamet®) tablets of 20/120 mg can be retained on List 1B. Atovaquone/proguanil tablets of 250/100 mg are offered by various manufacturers and can be grouped in a cluster (to be created). Atovaquone/proguanil hydrochloride film-coated tablets of 62.5/25 mg are specifically licensed for treating children and are offered by various manufacturers. This dosage of atovaquone/proguanil can be grouped in a paediatric cluster (to be created).
- Flumethasone/clioquinol (Lococorten-Vioform®), dexamethasone/framycetin/gramicidin (Sofradex®), hydrocortisone/oxytetracycline/polymyxin B (Terra Cortil + Polymyxine B®), colistin/bacitracin/hydrocortisone (Bacicoline-B®) and fludrocortisone/neomycin/polymyxin B/lidocaine (Panotile®): the positioning of these medicinal products for ear conditions in the Medicine Reimbursement System does not need to be changed; the List 1B status can be retained.
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.