ARE VACCINATIONS REALLY DIFFERENT TO PHARMACEUTICALS WITH RESPECT TO MARKET ACCESS IN GERMANY?
Author(s)
Droeschel D1, Vollmer L1, Krone FA2, Walzer S1
1MArS Market Access & Pricing Strategy GmbH, Weil am Rhein, Germany, 2State University Baden-Wuerttemberg, Loerrach, Germany
OBJECTIVES: Although AMNOG was introduced to reorganize the medicine products market, it is not applicable for vaccines. Immunization in Germany is organized de-centrally under the responsibility of the social health insurance. The aim of this study was to analyze the market access route and compare that to the AMNOG process. METHODS: The market access route was analyzed systematically and mapped the pathway by identifying key processes, stakeholders, applicable regulations and laws, pricing and negotiation setting and supply chain conditions. RESULTS: Based on the results of the systematic analysis we could ascertain specifics for the vaccination market. The Standing Committee on Immunisation (STIKO) by the Robert Koch Institute decides regularly on vaccination recommendations. Vaccinations are obligatory provisions of the SHIs and based on a regulation within with the G-BA defines details and requirements, type and scope. Further, SHIs can provide optional benefits according to their statutes for those vaccinations not defined as mandatory. Vaccines are generally to be prescribed by a physician and pharmacies have the obligation to provide permanent supply of specific vaccines. The vaccination is conducted by physicians and public health offices. The MoH defines, if the costs of specific vaccinations have to be beard by the SHIs other can be provided at no cost by the public health offices. The general pricing regulations for pharmaceuticals are applicable as well for vaccines however exemptions e.g. of surcharges etc. exist for those defined as mandatory vaccinations. Additionally tenders are regular instruments for vaccination buying processes. Key differences to the AMNOG are varying stakeholders at different levels and responsibilities of those. Pricing might be more flexible with vaccinations even though that tenders might apply. CONCLUSIONS: The systematic analysis revealed a clear market access road map, stakeholder compass and important strategic implications for the processes along with key differences to the AMNOG.
Conference/Value in Health Info
2015-11, ISPOR Europe 2015, Milan, Italy
Value in Health, Vol. 18, No. 7 (November 2015)
Code
PHP199
Topic
Health Policy & Regulatory
Topic Subcategory
Reimbursement & Access Policy
Disease
Multiple Diseases