co.value® | Support Throughout the AMNOG Process

AMNOG Consulting in Germany

Support Throughout the AMNOG Process

co.value supports pharmaceutical and biotechnology companies throughout the AMNOG process in Germany. Our Market Access Consultants provide support from early strategic planning and G-BA advice through AMNOG strategy and the development of Modules 1–5 of the AMNOG dossier to the written statement, oral hearing and reimbursement price negotiations with the GKV-Spitzenverband.

G-BA Advice and AMNOG Strategy

co.value supports the strategic preparation of G-BA advice and the development of the subsequent AMNOG strategy. We assess the starting position, develop and substantiate the relevant questions for G-BA advice, and translate the outcome into the evidence strategy, AMNOG dossier and subsequent stages of the AMNOG process.

Development of Complete AMNOG Dossiers

co.value develops complete AMNOG dossiers covering Modules 1–5 as well as individual dossier modules. Together with your team, we assess the available evidence and potential evidence gaps, develop the dossier and added-benefit strategy, and translate these into the required dossier content.

Market Access, Medical Writing and AMNOG Statistics work together as an integrated team. This allows statistical analyses, indirect treatment comparisons and meta-analyses as well as epidemiological models to be aligned directly with the evidence strategy and AMNOG dossier development.

Written Statement and Oral Hearing in the AMNOG Process

Following publication of the benefit assessment, co.value supports pharmaceutical and biotechnology companies with the written statement and oral hearing. We analyse the assessment, develop the response strategy, prepare the written statement and support your team in preparing for the oral hearing. This includes Q&A documents and hearing simulations.

If required, we also accompany your team during the oral hearing and subsequently support the preparation and conduct of reimbursement price negotiations with the GKV-Spitzenverband through to the final agreement.

Experience Across the AMNOG Process

co.value has more than ten years of experience supporting companies throughout the AMNOG process in Germany. Our team has contributed to 50 AMNOG dossiers, 40 G-BA consultations, 40 written statements, 45 oral hearings and 10 reimbursement price negotiations.

Services Throughout the AMNOG Process

G-BA advice and strategic preparation
AMNOG strategy and evidence planning
Development of complete AMNOG dossiers and individual modules
AMNOG-specific statistical analyses and evidence preparation
Written statements and preparation for oral hearings
Support during oral hearings and reimbursement price negotiations with the GKV-Spitzenverband

contact co.value^®

Frequently Asked Questions About AMNOG Process Support

Does co.value support the entire AMNOG process?

Yes. co.value supports pharmaceutical and biotechnology companies throughout the AMNOG process in Germany, from early strategic planning and G-BA advice through AMNOG dossier development to the written statement, oral hearing and reimbursement price negotiation with the GKV-Spitzenverband. Support can cover the entire AMNOG process or individual stages.

Does co.value develop complete AMNOG dossiers?

Yes. co.value develops complete AMNOG dossiers covering Modules 1–5 as well as individual dossier modules. Market Access Consultants, Medical Writers and Statisticians work as an integrated team across dossier strategy, evidence preparation, statistical analyses and dossier development.

Can co.value support individual stages of the AMNOG process?

Yes. Support can be provided for individual stages of the AMNOG process. This may include G-BA advice, AMNOG strategy, individual dossier modules, statistical analyses, written statements, oral hearing preparation or reimbursement price negotiations.

Does co.value provide support after AMNOG dossier submission?

Yes. Following publication of the benefit assessment, co.value supports the analysis of the assessment, preparation of the written statement and preparation for the oral hearing. If required, we also provide support during the hearing and subsequent reimbursement price negotiations with the GKV-Spitzenverband.