Trial regulations: strategic support (according to §137e SGB V)
Client: Swedish medical-technology company, operating throughout Europe
Field of application: Asthma diagnostics
The company has been marketing its products in Germany for more than 10 years. Although the medical specialist market share was exploited to 80% through individual health services and private health insurances, the reimbursement through statutory health insurance in the outpatient sector especially with general practitioners did not exist.
SKC was assigned to examine suitable reimbursement pathways and to develop a promising approach. In the further course of the project the main focus lied on the application for the probatory regulation according to § 137eSGB V which was implemented in the first attempt, to strategically support the process and to implement a flanking stakeholder management.
Solution and approach
First the initial screening of the medical care situation and an analysis of the product's value proposition (the value story) took place, then the main access routes were evaluated and the trail regulation was identified as a potential pathway.
The strategic decision to pursue in this direction was prepared and made at the Swedish headquarters.
What really counts during the probation period is the preparation of the audit request in the anticipation of the key decision parameters as well as the preparation of the study.
- For this purpose, the first step was to define the value story with key messages for all stakeholders.
- Then, the next step was to define the basic strategic logic for the dossier, to support the dossier creation and to prepare and implement the stakeholder management.
The proposal for the trial took a positive decision, which means that the product was granted a benefit potential. The procedure was selected for two areas of application. The G-BA only decided positively on four out of 50 proposals.
The prices for the SHI-reimbursement were negotiated within the scope of a two-year study period and the product was incorporated into clinical care in accordance to the conditions of § 137e SGB V and the associated rules of procedure.