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[How do generic quotas work? An analysis using HIV infection as an example].

Robin Rüsenberg1, Axel Baumgarten1,2, Stefan Mauss1,3

  • 1Deutsche Arbeitsgemeinschaft niedergelassener Ärzte in der Versorgung HIV-Infizierter e. V. (dagnä), Berlin, Deutschland.

Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz
|April 14, 2021
PubMed
Summary

Generic quotas for human immunodeficiency virus (HIV) medications are largely ineffective, as prescribers already support generic use. Current regulations and guidelines optimize generic utilization in HIV care.

Keywords:
Ambulatory healthcareManaged primary careMedical supplySecondary dataStatutory health insurance

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Area of Science:

  • Health policy
  • Pharmacoeconomics
  • Infectious disease management

Background:

  • Statutory healthcare instruments for medical supply control are debated in health policy.
  • Many tools aim to control drug expenditure, focusing on physician prescribing behavior.
  • Indication-directed quotas for generics/biosimilars are increasingly used, including for human immunodeficiency virus (HIV) medications.

Purpose of the Study:

  • Analyze benefits and limitations of generic quotas in HIV care.
  • Utilize statutory health insurance drug prescription data.
  • Provide recommendations for action.

Main Methods:

  • Analysis of statutory health insurance drug prescription data.
  • Evaluation of generic quota implementation in HIV care.
  • Assessment of prescriber behavior regarding generic substitution.

Main Results:

  • The potential for generic drug quotas in patent-free HIV medications is nearly exhausted.
  • HIV prescribers actively support product exchange for generics.
  • Current regulatory instruments are nearly optimized.

Conclusions:

  • Optimal regulation achieved through a combination of instruments like framework agreements and guideline-based prescribing.
  • Pharmaceuticals Market Reorganisation Act (AMNOG) and reference pricing contribute to cost control.
  • Adherence to guidelines and use of single-tablet regimens are crucial for maintaining high-quality HIV care.