gms | German Medical Science

Introduction: In 2011, the Act on the Reform of the Market for Medical Products (AMNOG) came into effect. From that point, pharmaceutical companies are legally obligated to submit a dossier to the Federal Joint Committee (G-BA) in order to prove a patient-relevant (additional) medical benefit regarding mortality, morbidity and health-related quality of life when the approved pharmaceutical product has entered the market. Due to the lack of sufficient data regarding the potential influence of decisions by the G-BA on the prescription behavior we analyzed prescription characteristics of various drugs (assessed by the G-BA) in the selected medical fields of diabetes and multiple sclerosis during the years 2009-2018 in Schleswig-Holstein.

Methods: Based on data comprising numbers of prescriptions reimbursed by statutory health insurance in the period from January 2009 until October 2017 we analyzed prescriptions of pharmaceuticals applied in the selected medical fields of diabetes, multiple sclerosis and chronic infections with the hepatitis c virus (HCV) that recently were assessed by the G-BA.

Results: Prescriptions of newly approved drugs immediately started when drugs had gained market access. Thus, in almost all of the cases there were already significant numbers of prescriptions of the relevant drug at the time of announcement of an appraisal by the G-BA. For example in the medical field of diabetes numbers of prescriptions of the SGLT2 inhibitor dapagliflozin added up to 14 in the last quarter 2012 (market entry) and reached 351 prescriptions in the second quarter 2013 when the G-BA stated no additional benefit of this new compound compared to appropriate comparative therapy (ACT). Nevertheless, number of prescriptions increased to 412 during the following quarter and peaked out 2,589 prescriptions in the second quarter of 2017. Similarly, the number of prescriptions of the DPP-IV inhibitor sitagliptin in combination with metformin that initially has been appraised having a minor additional benefit in one subgroup amounted to 6,900 prescriptions in the fourth quarter of 2013 and reached 11,922 prescriptions in the fourth quarter of 2016 when a second appraisal by the G-BA revoked an additional benefit compared to ACT. After this, the number of prescriptions stabilized at a high level (11,801 prescriptions in the second quarter of 2017). Prescriptions of empagliflozin increased from 10 in quarter three 2014 (market entrance) to 238 in the second quarter of 2015 (first appraisal by the G-BA, no additional benefit compared to ATC) and to 1,920 in quarter three 2016 (second appraisal by the G-BA stating a considerable medical benefit in the subgroup of patients with cardiovascular diseases compared to ATC). After the latter decision, the number of prescriptions almost doubled to 3,861 in the second quarter of 2017.

Discussion: This analysis regarding three selected chronic diseases revealed no obvious influence of medical benefit assessments by the G-BA on prescription behavior in Schleswig-Holstein. This may be explained in part by stable therapeutic approaches with newly available drugs achieved in individual patients, by elaborated and complex appraisals, and by the availability of negotiated (or arbitrated) discounts.

The authors declare that they have no competing interests.

The authors declare that an ethics committee vote is not required.