Support for a Biotech Company entering the french market with an orphan drug.
As one of the leading agencies for the preparation of price negotiations with the National Association of Statutory Health Insurance Funds (GKV-SV) in Germany and preparation of dossiers, we support you in the entire Early Benefit Assessment as required by § 35a SGB V.
- Beginning with a detailed market analysis, from which we derive strategic insights for the specials needs of each drug.
- We support you in the content-related and active preparation of dossiers including the request for early advice as well as the strategic preparation of the client for the G-BA advice meeting. Subsequently we support with the oral hearing procedures.
- We also take care of study design and statistical data analysis as well as the processing of scientific data and literature.
- Based on possible SHI perspectives and strategies we develop, in close work with the pharmaceutical company, the line of argument for the negotiation strategy. In addition, we also perform executive activities such as the completion of Annexes I-III or be a part of the negotiation team in the price negotiation or arbitration board.
- In order to provide you with a comprehensive service, we also offer expertise in regulatory instruments, such as the reference price system, advisory assistance on laws concerning medicinal products and formalities, as well as specific knowledge of the reimbursement systems in inpatient and outpatient care.
To complement our services, we play an active role in European market access projects. We support our customers during national submission by developing core value dossiers, stakeholder interviews and defining European launch strategy and pricing and reimbursement advice.
‘MAP BioPharma’s team of experts has supported over 200 pricing and reimbursement procedures in the UK and Ireland since being founded in 2012. One example, for a very small population in an ultra-rare orphan indication was being scoped by NICE for inclusion in their single technology appraisal programme.
We are pioneers in the utilisation of Multi-Criteria Decision Analysis (MCDA) at international and national level, helping evaluation committees to assess the relative additional value contribution of new health technology and helping companies to better position their product with respect to existing alternatives.
RPN has experience with a wide range of therapeutic areas and particularly with orphan and advanced-therapy medicinal products. RPN support includes early access and P&MA strategic assessments, advisory boards, stakeholder management and full support with national and regional P&R negotiations.