Strategic Market Access Planning
A Market Access strategy connects clinical development and evidence planning with the requirements of subsequent HTA and reimbursement processes. co.value analyses relevant evidence requirements and potential evidence gaps and translates them into a Market Access plan for further development and market entry.
For Germany, we consider the requirements of G-BA and AMNOG at an early stage. For international development programmes, we additionally incorporate the requirements of relevant national HTA, Pricing and Reimbursement processes.
Assessing Evidence Requirements and Evidence Gaps Early
co.value assesses whether the available and planned evidence meets the expected requirements of the relevant HTA processes. We analyse comparators, patient populations, endpoints, study designs and available analyses and identify potential evidence gaps.
Based on these findings, we develop a product-specific Market Access and Evidence Strategy. Depending on the individual situation, this may include additional statistical analyses, indirect treatment comparisons and meta-analyses, Real-World Evidence or further evidence generation.
Combining Global Market Access Strategy with Local Expertise
As part of Cytel, co.value combines global evidence and Market Access strategies with local HTA expertise. In Germany, co.value provides local expertise in G-BA, AMNOG and reimbursement strategy. In France, stève consultants provides expertise in Market Access, Pricing & Reimbursement and submissions to the Haute Autorité de Santé (HAS). Through Cytel, HTA submissions and Market Access activities can also be planned and implemented for markets including the United Kingdom and Canada.
This approach allows global evidence strategies to be aligned early with the requirements of relevant target markets and subsequently translated into national HTA and reimbursement processes with local expertise.
EU HTA and National Market Access Strategies
co.value supports pharmaceutical and biotechnology companies at the interface between European evidence planning and national market access. In Germany, a particular focus is the transition from the Joint Clinical Assessment (JCA) to the AMNOG process and the identification of national evidence requirements for the Delta Dossier.
Strategic Market Access Services
- Development of Market Access and Evidence Strategies
- Analysis of national HTA and evidence requirements
- Identification of evidence gaps
- Strategic preparation for G-BA advice
- Planning of additional evidence generation, RWE and statistical analyses
- Integration of EU HTA and JCA into national Market Access planning
- Alignment of global strategies with national HTA submissions
Frequently Asked Questions About Strategic Market Access
When should the Market Access strategy for a pharmaceutical product begin?
Market Access strategy should be considered during clinical development. Comparators, patient populations, endpoints and evidence requirements can determine which data will later be relevant for HTA, benefit assessment and reimbursement. Early planning helps identify potential evidence gaps before national HTA submissions are prepared.
Does co.value support international Market Access strategies?
Yes. As part of Cytel, co.value combines German Market Access expertise with international HTA and evidence expertise. In addition to Market Access and AMNOG strategy for Germany, strategies and HTA submissions for markets including France, the United Kingdom and Canada can be integrated into an overarching evidence and access strategy.
How does co.value connect global and national Market Access strategies?
co.value and Cytel consider the evidence and HTA requirements of relevant target markets as part of overarching Market Access planning. Global evidence strategies can therefore be developed with national requirements in mind and subsequently translated into local HTA, Pricing and Reimbursement processes with in-market expertise.
How are Market Access strategy and AMNOG strategy connected?
AMNOG strategy is a central component of Market Access planning for Germany. co.value considers German requirements regarding comparators, evidence, target populations and benefit assessment at an early stage and translates these into a specific AMNOG strategy and process preparation as German market entry approaches.
How does co.value incorporate EU HTA into Market Access strategy?
co.value considers EU HTA and national Market Access requirements together. In Germany, the focus is on the interface between the Joint Clinical Assessment and the AMNOG process, including which European evidence can be used for the German benefit assessment and which national additions are required.