gms | German Medical Science

Background: 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. Price negotiations start after the final G-BA decision based on the manufacturers’ dossier, the evaluation by the Institute for Quality and Efficiency in Health Care (IQWiG) and the results of a public hearing as part of the commenting procedure is announced.

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 2009-2017 in Schleswig-Holstein.

Materials and Methods: Based on data comprising numbers of prescriptions reimbursed by statutory health insurance in the period from January 2009 until June 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. These data included the number of prescribing physicians and the number of patients receiving corresponding prescriptions. Hence, the field of diabetes included sodium-glucose transport proteins subtype 2 (SGLT2) inhibitors +/-metformin, dipeptidyl peptidase-4 (DPP-IV) inhibitors +/- metformin, derivatives of human incretin glucagon-like peptide-1 (GLP-1) +/- metformin and the insulin analogue insulin degludec +/- liraglutide. Regarding the field of multiple sclerosis, prescription data of the immunomodulatory drugs dimethylfumarate, fingolimod, teriflunomide and of the inhibitor of Kv1 family of voltage-activated K+ channels fampridine were analyzed.

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 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, number of prescriptions stabilized at a high level (11.801 prescriptions in the second quarter 2017). Regarding vildagliptin in combination with metformin, this pharmaceutical was prescribed 3.871 times during the fourth quarter of 2013 when the G-BA decided that an additional benefit was not evident. The number of prescriptions declined not till the manufacturer announced retraction of vildagliptin + / - metformin from the market in the second quarter 2014. This was also true for insulin degludec + / - liraglutid. Prescriptions of empagliflozin increased from 10 in quarter three 2014 (market entrance) to 238 in the second quarter 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, number of prescriptions almost doubled to 3.861 in the second quarter of 2017. To date, four pharmaceuticals applied in the treatment of multiple sclerosis were assessed by the G-BA. Regarding the immunomodulatory drugs dimethylfumarate and teriflunomide as well as the K+ channel inhibitor fampridine, an additional benefit compared to ACT was not proven. Numbers of prescriptions of dimethylfumarate constantly increased from the first quarter 2014 (market entrance) up to 1.120 during the second quarter of 2017, that of teriflunomide from 182 during quarter three 2013 up to 454 in the second quarter of 2017. Likewise, fampridine was prescribed 51 times in quarter three 2011 and reached 1.651 prescriptions in the second quarter 2017. Notably, a rapid increase of prescriptions of the recently approved daclizumab that will not undergo assessment by the G-BA due to its former authorization as a prophylactic agent for preventing acute rejection in people with kidney transplants was observed (12 in quarter four 2016 to 206 in quarter four 2017).

Conclusion: This analysis regarding two 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.