Client Challenge
The company’s German organisation, inexperienced with AMNOG and understaffed for the process, had great difficulty explaining the importance of the AMNOG procedure for the launch and pricing process to its English parent company. Preparations were fragmented and asynchronous.
The creation of the Value Dossier had only just begun, even though the internationally scheduled launch date was already approaching.
Kintiga Germany was tasked with supporting the process through rigorous project management and strategic sparring, and with compensating for the lack of market access resources.
Kintiga Approach
Overall, project management for market access of the most important pipeline product was set up – accompanied by an internal and external communication plan.
Together with the various specialist departments (Regulatory, Medical, Commercial, Legal), the overarching strategy was developed in the AMNOG procedure and coordinated within the group. Correspondingly, strategic support was provided for the creation of the Value Dossier, including all accompanying AMNOG processes:
- Preparation of the G-BA consultation documents,
- Analysis of the G-BA consultation meeting,
- Final editing of the Value Dossier,
- Preparation of the written statement,
- Preparation for the hearing,
- Scenario calculations for price setting,
- Preparing for price negotiations with negotiation training,
- Team building and
- Stress test
Mandated by the management, we also took over the negotiation with the GKV-Spitzenverband (National Association of Statutory Health Insurance Funds).
In parallel, Kintiga Germany supported the AMNOG process by preparing for market penetration: aligning marketing & sales and PR activities with the AMNOG process, developing a comprehensive stakeholder management concept, training and supervision of the market access managers, and supporting the establishment of contacts with statutory health insurance funds.
Solution
The product was launched within the planned timeframe with marginal and anticipated price reductions, evaluated by IQWiG and G-BA, and negotiated with the GKV-SV. As a result, the German organisation received special recognition within the group for its outstanding management results (Excellence Award).
