MARKET ACCESS Beyond the technical strategy

The technical strategy considers factors that directly influence the reimbursement submission dossier (e.g. presentation of the relevant clinical, economic and financial evidence). While this is important, it is necessarily restrictive and typically excludes other factors that influence the value of the new health care intervention for the client, access to the new health care intervention by patients in need and time to market.

A market access strategy developed by SYNEVi therefore includes consideration of the new intervention’s approved marketing authorisation indication, a thorough understanding of the relevant reimbursement authority’s previous decision making, advising on and managing the external environment, legislative and policy context, the client’s internal requirements, the technical reimbursement strategy and a high-quality reimbursement submission document. (incl. economic & financial models). This comprehensive approach to achieving market access is demonstrated to be effective.

HEALTH ECONOMICS & OUTCOMES RESEARCH Innovative solutions based on first principles

The health economics and outcomes research service is aimed at assessing the effect of new health care interventions on patient, clinical, and economic outcomes using a variety of data sources and methodologies. Economic and budget impact models are a key tool to aid healthcare decision making. SYNEVi therefore develops these models within a modelling framework that is clinically appropriate and technically robust, with the results of the analysis presented in a clear and insightful manner.

Systematic reviews, meta-analyses and biostatistical analyses are an essential component of the reimbursement process, with the Authorities requiring that all relevant data are presented to be able to address critical questions with respect to comparative efficacy, safety, quality of life and resource utilisation. The outputs of these reviews and analyses are typically used to inform some or all of the economic model input variables.

PRICING The quantification of value in monetary terms

A recommendation for reimbursement is often associated with additional conditions, which may be imposed by the relevant Authority or are necessary to meet the client’s internal expectations and requirements. When the new health care intervention is reimbursed, there are a wide variety of measures that may affect the price of the health care intervention over time. These measures are typically described in policy documents, regulations or legislations.

SYNEVi has an excellent understanding of the pricing of health care interventions in Australia. We use our knowledge and experience to make clients aware of, understand, plan for and where required, provides support with managing/negotiation prices and price changes.

Experts in rare diseases

Our expertise in rare diseases has provided SYNEVi with the unique ability to work with small and multiple datasets to demonstrate comparative efficacy and safety of the health care intervention, develop clinically appropriate and technically robust economic models as well as design and implement pricing strategies, risk-sharing arrangements and managed access programs.