Preparations made from biologicals – G-BA regulates interchangeability in pharmacies
20.06.2023 13:37
Biotechnologically produced drugs (biologics) are playing an increasingly important role in the treatment of autoimmune diseases such as rheumatoid arthritis or in cancer therapy - not only medically, but also in terms of the cost shares of drug expenditure. Because of the financial relevance, the Federal Joint Committee (G-BA) has now regulated the interchangeability of medically prescribed preparations of finished medicinal products with biotechnologically produced active ingredients in pharmacies on behalf of the legislature.
Such preparations are usually infusion or injection solutions prepared individually for each patient by pharmacies, which are administered to the patient directly in the medical practice. The G-BA's instructions for economical medical prescribing of biologics have been in effect since November 2020.
Interchangeability in pharmacies
For the production of parenteral preparations with biotechnologically produced drugs, pharmacies should select an inexpensive product based on the active ingredient. If a medicine is available with a discount agreement from the insured person's health insurance company, cost-effectiveness is ensured and a further cost comparison is then not necessary.
The essential prerequisite for exchanging for an inexpensive product is that the medically prescribed medicinal product matches the finished medicinal product processed by the pharmacy, at least in the same application methods. In addition, agreement is necessary at least for the areas of application of the prescribed finished medicinal product. In principle, a substitution can take place in the relationship between a reference medicinal product and its biosimilars and between biosimilars, provided that these are approved with reference to the same reference medicinal product.
The Appendix VIIa The Medicines Directive - an overview of the relationships between the biologics approved in Germany and their biosimilars - serves as a basis for pharmacies to make replacement decisions. This has existed since March 2022 and is continually updated by the G-BA.
If the doctor has ruled out exchanging the prescribed biologic for medical and therapeutic reasons, the pharmacy is no longer obliged to exchange it. In addition, the pharmacy can refrain from replacing it, taking into account patient-specific aspects. This would be conceivable, for example, if the pharmacy was aware of any side effects, intolerances or allergies that the insured person had in the past.
The regulations will come into force in October 2023 at the earliest
The decision to add a new Section 40b to Section M of the Medicines Directive will now be submitted to the Federal Ministry of Health for review. Provided there are no objections and publication in the Federal Gazette, the regulations will then come into force in October 2023 at the earliest.
Background: Therapeutic comparability of biosimilars and their reference drugs
When the intellectual property rights for a biological drug expire, copycat preparations (biosimilars) can be approved, which are usually marketed at a cheaper price. When these biosimilars are approved, additional clinical studies are usually required to ensure that any differences that may exist do not affect their effectiveness and safety. These deviations are due, among other things, to the use of living organisms in the production of active ingredients. Since biosimilars are not always identical to the original or reference drug, they are also referred to as essentially the same drugs.
In connection with the increasing availability of generally cheaper biosimilars, the legislature commissioned the G-BA to provide information on the possible interchangeability of biological reference medicinal products with essentially the same biosimilars.