Topic: Market access and reimbursement
Client: Internationally operating research-based medical technology company from Austria
Field of application: Active implants
- The devices were ought to become part of an integrated supply solution: operated in a specialized clinic, subsequently serviced in specific centers and with processors regularly updated by the manufacturers, the reimbursement options within the existing G-DRG-system at the treating hospital had to be taken into account as well as the remuneration mechanism of the post-treating service centers.
- Together with an international team, SKC was assigned to identify the product specifications and to evaluate and concretize the appropriate reimbursement paths.
Solutions and overall approach
- Analysis and evaluation of price, cost and reimbursement mechanism for active implants in the German market
- Identification of the specific demands/requirements of the German market including legal frameworks
- Compilation and evaluation of the significant stakeholder groups
- Development of a pricing model
- Analysis of the key value levers
- Systemization and quantification of the new product’s differentiating features
- Illustration of implications for market entry and portfolio strategy: including the adjustment of the R&D strategy
- Key success factors of the implementation and reimbursement were identified and addressed. Based on the project results the reimbursement eligibility of the products was relativized, the product features were adapted in the further course, and the measurability of the benefits for the different participants in the reimbursement procedure (InEK, DIMDI, hospital, specialized associations) was increased.
- The research and development strategy was adjusted and was extended by adding the needs for the subsequent benefit assessment. This was achieved by anticipating the requirements of an evidence-based evaluation.
CASE 2: Strategic support with the inclusion of a medical-technical procedure into the trail regulations (according to § 137e SGB V)
Topic: Reimbursement strategy for the German SHI market
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 overall 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.