{"id":7042,"date":"2025-07-30T14:04:16","date_gmt":"2025-07-30T12:04:16","guid":{"rendered":"https:\/\/value-dossier.com\/strategic-market-access-consulting\/"},"modified":"2026-04-01T13:00:37","modified_gmt":"2026-04-01T11:00:37","slug":"strategic-market-access-consulting","status":"publish","type":"page","link":"https:\/\/value-dossier.com\/en\/strategic-market-access-consulting\/","title":{"rendered":"Strategic Market Access Consulting"},"content":{"rendered":"\n
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Strategic Market Access Consulting<\/h1>\n <\/div>\n <\/div>\n\n <\/div>\n
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With a population of over 82 million, Germany is the largest and most strategically important pharmaceutical market in the European Union. Free pricing enables early market access, particularly when launching innovative medicines. The reimbursement amount is determined after the early benefit assessment under the AMNOG procedures and the subsequent price negotiations. Furthermore, the German reimbursement price serves as a reference price in numerous European countries as well as in the USA. Therefore, decisions in the German market have wide-reaching international implications.<\/p>\n

Available medicines in European countries as of January 2025<\/div>
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Figure 1: Available medicines in European countries as of January 2025<\/p>\n

We support pharmaceutical companies and medical device manufacturers by providing expert strategic advice throughout the entire market access and reimbursement process. We develop customized market and pricing strategies with our clients that take into account regulatory requirements, as well as national and international benchmarking effects. We advise you on the specific features of German and European health technology assessment, compile the benefit dossier, and prepare you for discussions and negotiations with payers and the Federal Joint Committee (G-BA). Our goal is to optimize your products’ market positioning and achieve sustainable negotiation outcomes.<\/p>\n <\/div>\n\n <\/div>\n<\/section>\n\n\n

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\n General strategic advice on HTA matters<\/summary>\n

We provide comprehensive advice on strategic issues related to health technology assessment (HTA) processes in Germany and Europe. Based on your product\u2019s characteristics, the clinical evidence and the competitive landscape, we develop robust decision-making frameworks at early on. Our goal is to align regulatory requirements, benefit assessment and reimbursement eligibility to minimize risks to market access while making targeted use of opportunities for successful positioning and sustainable reimbursement.<\/p>\n

Furthermore, we are happy to advise you on all matters related to benefit assessments and the reimbursement of medicinal products and medical devices.<\/p>\n<\/div>\n <\/details>\n

\n Study design and gap analysis<\/summary>\n

An appropriate study design is crucial for success in HTAs and subsequent reimbursement. We can develop an optimal study design for you that takes the requirements of HTA authorities into account at an early stage.<\/p>\n

We analyze existing studies as part of a gap analysis to assess their suitability for benefit assessment. Based on a structured analysis of your study\u2019s strengths, weaknesses, opportunities and threats (SWOT), we develop strategies for the optimal use of the available evidence. This includes, \u00a0the rationale for the appropriate comparative therapy, the selection and operationalization of endpoints, as well as supplementary statistical analyses.<\/p>\n<\/div>\n <\/details>\n

\n Statistical Planning<\/summary>\n

We can support you in the statistical planning of your studies to ensure they meet the optimal requirements for benefit-risk assessment. You can find details about our extensive statistical expertise here<\/a>.<\/p>\n<\/div>\n <\/details>\n

\n Reimbursement Issues<\/summary>\n

We can advise you on all relevant matters concerning the reimbursement of medicinal products and medical devices in Germany. We take into account the legal framework and procedures of the G-BA when doing so, and support you in positioning your product for success.<\/p>\n<\/div>\n <\/details>\n

\n Market and pricing analyses<\/summary>\n

Market and pricing analyses are essential for assessing market potential and identifying comparable medicines within a given indication. With our tailored analyses, we will support you in positioning your product, assessing the competition and a potential fixed-amount group allocation, as well as in preparing for AMNOG price negotiations. Details of our services in price analysis can be found here<\/a>.<\/p>\n<\/div>\n <\/details>\n

\n Price negotiations<\/summary>\n

We can prepare you for price negotiations with payers by providing in-depth price analyses and personalized negotiation training. Upon request, we can accompany you to discussions with statutory health insurance funds and represent your position effectively. Further information can be found here<\/a>.<\/p>\n<\/div>\n <\/details>\n <\/div>\n\n <\/div>\n<\/section>\n\n\n

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