Pharmamarkt

Einleitung / Introduction

Gemäß AMNOG sind pharmazeutische Unternehmer(pU) dazu verpflichtet, ihre neu zugelassenen Arzneimittel mit neuen Wirkstoffen nach Markteintritt einer frühzeitigen Nutzenbewertung gemäß §35a SGB V zu unterziehen. Diese Bewertung quantifiziert die Wahrscheinlichkeit und das Ausmaß des Zusatznutzens und dient als Basis für die darauffolgende Preisverhandlung zwischen dem GKV-Spitzenverband und dem pU. Kommt innerhalb einer vorgegebenen Frist kein Konsens zustande, greift die Schiedsstelle zur Festlegung strittiger Vertragsinhalte, einschließlich des zu bestimmenden Erstattungsbetrags ein. In diesem Zuge steht die Schiedsstelle vor der Aufgabe, einen Erstattungsbetrag zu ermitteln, der den monetarisierten Wert des Arzneimittels festlegt. Die Schiedssprüche zu Erstattungsbeträgen wurden deskriptiv analysiert.

Methode / Method

Alle bis Juni 2023 ergangenen Schiedssprüche wurden insbesondere im Hinblick auf die Höhe des festgelegten Erstattungsbetrags, das therapeutische Gebiet, den Orphan Drug Status, den Patientenzahlen und den Zusatznutzen analysiert. Zusätzlich wurde die Preisänderung zwischen dem festgelegten Rabatt und dem Preis zum Zeitpunkt des Beschlusses berechnet. Die Datenbasis umfasste Informationen aus den Schiedssprüchen, den zugehörigen G-BA Beschlüssen sowie der Lauer-Taxe. Wirkstoffe, die mehrfach ein Schiedsverfahren durchlaufen haben, wurden nur 1-mal in der Analyse berücksichtigt, da in diesen Verfahren jeweils der gleiche Erstattungsbetrag verhandelt wurde. Zudem wurden Verfahren ausgeschlossen, bei denen bereits ohne Schiedsstelle eine Einigung und 1 Verfahren, bei dem eine Klage nach dem Schiedsspruch erfolgte.

Ergebnisse / Results

Von den 66 Schiedsverfahren, in denen über den Erstattungsbetrag verhandelt wurde, wurden 55 in die Analyse eingeschlossen. Jedes der vom G-BA kategorisierten therapeutischen Gebiete war von mindestens 1 Schiedsverfahren umfasst, wobei Verfahren zu onkologischen Erkrankungen, Stoffwechselkrankheiten sowie Krankheiten des Nervensystems am stärksten vertreten waren. Insgesamt lag bei 20% der analysierten Schiedssprüche ein Orphan Drug Status vor. Ferner verzeichneten über 50% der eingeschlossenen Schiedsverfahren einen Zusatznutzen in mindestens einer Fragestellung. In nahezu 95% der Fälle wurden alle neuen Erstattungsbeträge mit einem prozentualen Rabatt im Vergleich zum ursprünglichen Herstellerabgabepreis festgelegt. Insgesamt 20 Verfahren ergaben einen prozentualen Rabatt von mehr als 50%, wobei der höchste Abschlag 99,77% betrug.

Zusammenfassung / Conclusion

Das Instrument der Schiedsstelle scheint ein relevantes Mittel, insbesondere bei der Entscheidungsfindung des festzulegenden Erstattungsbetrags zu sein Nach erfolgtem Schiedsverfahren resultiert häufig eine Reduzierung des Erstattungsbetrags im Vergleich zum Herstellerabgabepreis, was einen hohen Rabatt zur Folge hat.

Authors

Nadia Abu Rajab, IQWiG

Julia Blankartz, IQWiG

Sarah Mostardt, IQWiG

Anja Schwalm, IQWiG

Einleitung / Introduction

Medicine shortages can compromise optimal healthcare and cost-effectiveness, impacting patients, providers, and payers. Despite, the comprehensive impacts of such shortages remain insufficiently quantified. We aim to fill this gap by proposing a framework to evaluate how shortages affect a patient's health and healthcare utilization, and determine excess costs faced by statutory health insurances. We apply this framework to the shortage of Valsartan in 2018.

Methode / Method

We integrate a Bayesian Structural Time Series model, allowing for the continuous rather than binary assessment of shortages, with an Instrumental Variable framework to causally identify its effects. Focusing on patients affected by the 2018 valsartan recall, we analyze German health insurance claims data from 2013 to 2021. Leveraging changes in prescriptions among patients who maintained a continuous medication regimen before the shortage, we are able to isolate the effects attributable to the shortage itself.

Ergebnisse / Results

This study provides key insights into the impacts of medicine shortages and informs strategies for future healthcare policy and management. Alongside a refined, continuous measure of shortages based on market volume data, we establish an analytical framework to assess the implications of medicine shortage events. More specifically, we provide detailed insights into the health, healthcare utilization, and cost implications of the Valsartan shortage in 2018, offering a detailed case study that can inform strategies to mitigate the effects of similar events in the future.

Zusammenfassung / Conclusion

We offer a comprehensive approach and quantification of the multifaceted impacts of medicine shortages.

Authors

Jan Panhuysen, Hertie School

Eva Goetjes, University of Duisburg-Essen

Katharina Blankart, University of Duisburg-Essen

Mujaheed Shaikh, Hertie School

Einleitung / Introduction

Over the past 20 years, biologics have amplified the treatment options for many diseases. However, their high costs are raising concerns about long-term affordability for patients and health care systems. One possible cost-containment strategy is non-medical switching between originator biologic products and biosimilars. Our objective was to assess the effect of physician-led switching between biologics and biosimilars on therapy outcomes and cost for patients with an Inflammatory Bowel Disease (IBD).

Methode / Method

We analysed German claims data spanning from 2014 to 2021 on IBD patients who received a biologic therapy subject to biosimilar competition. Our statistical analysis was based on IBD patients (ICD K50, K51 and K52.3) who received Infliximab (ATC L04AB02) or Adalimumab (ATC L04AB04) during the observation period. Patients without a biosimilar switch were reweighted to resemble patients with a biosimilar switch using entropy balancing based on the time since an insured person was observed in the data and received Infliximab/Adalimumab, sociodemographic variables (age and sex), comorbidities (Elixhauser score), disease activity (steroids received) and the calendar year. We investigated the effect on pharmaceutical costs, in-patient and out-patient costs, adherence measured as proportion of days covered (PDC) and disease activity using a difference-in-difference approach. Moreover, we analysed persistence with a hazard model.

Ergebnisse / Results

We identified 4721 IBD patients who received Infliximab or Adalimumab during the observation period. Among these, 886 patients switched from an originator biologic to a biosimilar (Infliximab: 428, Adalimumab: 458). Preliminary results of the difference-in-difference analyses show a temporary relative reduction in pharmaceutical costs by 600€ per quarter over the first year (p < 0.000), 440€ per quarter over the first two years (p < 0.000) and 250€ per quarter over the first three years after switching (p < 0.010). We observe two opposing developments: Costs per defined daily dose (DDD) decreased as expected by 10€ per quarter (p < 0.000) over the first 3 years after the switch while the effect on the number of DDD per quarter was positive (Infliximab: 26, p < 0.000; Adalimumab: 11, p < 0.000). Accordingly, the effect on the PDC was positive (p < 0.000). While out-patient costs remained unaffected, we observed a relative decline of in-patient costs by 190€ per quarter over the first three years (p < 0.004). Disease activity remained unaffected by switching from biologics to biosimilars.

Zusammenfassung / Conclusion

Our first results suggest that physician-led switching between originator biologic drugs and biosimilars leads to lower cost without showing worse health outcomes. Thus, it appears to be an effective cost-containment tool.

Authors

Isa Maria Steiner, Hamburg Center for Health Economics, Universität Hamburg

Benjamin Birkner, GWQ ServicePlus AG

Tom Stargardt, Hamburg Center for Health Economics, Universität Hamburg

Einleitung / Introduction

Automated drug dispensing (ADD) describes the dispensing of patient-specific, automatically packaged units of medication that are sorted in the chronological order of the time of intake. In contrast, for conventional drug dispensing (CDD) the therapy duration is not necessarily matched to the package size and once opened packages must be thrown away. ADD, however, allows drugs to be portioned according to individual needs, thus reducing medication waste and costs. Another cost advantage relates to the unit price of a drug: The price for ADD can be charged based on the largest package, whereas with CDD, mainly smaller packages with higher unit prices are dispensed. Furthermore, some of the operating costs of pharmacies (e.g., infrastructure and personnel costs) can be saved. In nursing homes, where ADD has been used most frequently to date, it is possible to replace the manual handling of medication and consequently save resources. In addition to these direct effects of ADD, there are further indirect savings. Thanks to the safer dispensing of medication, there are fewer medication errors, which reduce follow-up costs (e.g., in the form of hospitalizations). ADD also leads to higher adherence to treatment. The necessary use of a management system for prescribed medication leads, in addition to operational benefits, to a more efficient and reliable medication review.

Methode / Method

With the complete data of all drugs sold in Switzerland that are billed via the mandatory health insurance, we estimate the savings potential due to the differing unit prices per drug by package size. Based on the daily medication intake profiles of one of the largest producers of ADD in Switzerland, we can estimate the therapy duration per drug and its deviation from the optimal package according to CDD. This difference corresponds to a lower bound of medication wastage. Using high-quality time data for individual tasks obtained from a complete survey of nursing homes of a medium-sized Swiss canton, we estimate the time saved by eliminating the need for a complete manual preparation of medication intake.

Ergebnisse / Results

Preliminary results show a direct savings potential through the full implementation of ADD in the order of CHF 720 million, which is about 9.3% of the total cost of drugs covered by mandatory health insurance.

Zusammenfassung / Conclusion

Today, ADD systems are mainly used in nursing homes. However, the potential of ADD could also be extended to long-term outpatient care and to people with multi-medication but without need for nursing care. Regulatory consideration of ADD (e.g., through the approval of bulk packaging) would allow economies of scale to be exploited to an even greater extent and production costs to be further reduced..

Authors

Christoph A. Thommen, Zurich University of Applied Sciences