Strategic support and negotiation lead: AMNOG

The German organization, which had no previos AMNOG experience and was understaffed for the procedure, had great difficulties to explain the importance of the AMNOG process for the launch and price-setting process to the English headquarter. The preparations proceeded in a fragmented and asynchronous manner.

Although the internationally scheduled launch date was already approaching, the value dossier preparation had only just begun.

SKC was assigned to support the process with a stringent project management and strategic sparring in order to compensate the lack of market access resources.

The market access project management of the most important pipeline product was comprehensively drafted and backed up by an internal and external communication schedule.

The overall strategy in the AMNOG procedure was developed together with the various specialist departments (regulatory, medical, commercial, legal) and coordinated within the organization.

The strategic support of the value dossier development including all associated AMNOG processes took place correspondingly:

• preparation of the G-BA consultation materials,
• analysis of the G-BA advice meeting,
• preparation of the written statement,
• preparation of the oral hearing,
• scenario calculations for price determination,
• preparation of the price negotiation with negotiation training,
• team building and
• stress test.

Mandated by the management, SKC conducted the negotiation with the SHI umbrella organization as the team leader.

Simultaneously, SKC supported the AMNOG procedure by preparing the market penetration: alignment of marketing, sales and PR activities with the AMNOG process, development of a comprehensive stakeholder management concept, training and supervision of the market access manager and support in establishing relations with the SHI.

It was possible to launch the product, to have it evaluated by the IQWiG and G-BA and to negotiate a marginal and anticipated markdown with the SHI umbrella organization all within the scheduled timeframe.

The German organization was specially honored for its outstanding management results by the corporate headquarter with the CEO's Excellence Award.