Client Challenge
The devices were intended to become part of an integrated care solution : operated on in a specialised clinic, followed up in specific centers and regularly updated by the manufacturer with processor updates, both the billing capability by the treating clinics in the existing G-DRG system and the remuneration mechanism of the follow-up service centers had to be taken into account.
Kintiga Germany was tasked with working with an international team to develop the product specification and to evaluate and specify the appropriate reimbursement pathways .
Kintiga Approach
Solution and approach
The comprehensive solution included the following aspects:
- Analysis and evaluation of the pricing, cost, and reimbursement mechanisms in the German market for active implants
- Highlighting the specific requirements of the German market, including the legal framework.
- Identification and assessment of key stakeholder groups
- Development of a pricing model
- Analysis of the key value creation levers
- Systematization and quantification of the differentiating features of the new product
- Highlighting implications for market entry and portfolio strategy: including adjustments to the R&D strategy
| Units / Departments | Personnel Costs | Material Costs | Infrastructure | |||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Medical Service | Nursing Service | Medical/Technical Service | Medications (General) | Medications (Direct Costs) | Implants | Other Medical Supplies (General) | Other Medical Supplies (Direct Costs) | Third‑Party Medical Services | Medical Infrastructure | |
| General Ward | • | • | • | • | • | • | • | • | • | • |
| Intensive Care Unit | • | • | • | • | • | • | • | • | • | • |
| Dialysis Unit | • | • | • | • | • | • | • | • | • | • |
| Operating Room Area | • | • | • | • | • | • | • | • | • | • |
| Anesthesia | • | • | • | • | • | • | • | • | • | • |
| Delivery Room | • | • | • | • | • | • | • | • | • | • |
| Cardiology Diagnostics / Therapy | • | • | • | • | • | • | • | • | • | • |
| Endoscopy / Therapy | • | • | • | • | • | • | • | • | • | • |
| Radiology | • | • | • | • | • | • | • | • | • | • |
| Laboratories | • | • | • | • | • | • | • | • | • | • |
| Other Units | • | • | • | • | • | • | • | • | • | • |
| Patient Admissions | • | • | • | • | • | • | • | • | • | • |
Solutions
Key success factors for the introduction and reimbursement process were identified and addressed . Based on the project results, the eligibility for reimbursement of the products was reassessed, and product characteristics were subsequently adapted to improve the assessability of the benefits for the various stakeholders involved in reimbursement (InEK, DIMDI, hospitals, professional associations, etc.).
The research and development strategy was adapted and expanded to include the needs for subsequent benefit assessment by anticipating the requirements for an evidence-based evaluation.
Glossary of terms:
- AI – Artificial Intelligence
- AMNOG – Arzneimittelmarktneuordnungsgesetz (German Pharmaceutical Market Restructuring Act)
- HTA – Health Technology Assessment
- EPRI – Endpoint Result Interpreter
- G-BA – Gemeinsamer Bundesausschuss (Federal Joint Committee)
