Evaluating International Marketing Access

Across international pharmaceutical markets, the criteria used to assess the value of new therapies in relation to standards of care vary markedly and are changing rapidly, reflecting the evolving priorities and growing influence of national and regional payers.

In the United Kingdom, a value-based pricing scheme will be introduced in 2014 to augment NICE’s cost-effectiveness assessment approach. In Germany, pharmaceutical manufacturers face newly stringent criteria for evaluating a new therapy’s benefits and for achieving market access and price premiums as a result of “AMNOG” health care policy reform.

Manufacturers must be able to determine a payer’s response to the introduction of a new therapy to a new market by studying responses in mature and emerging markets. This includes identifying specific drivers of value and quantifying the trade-offs payers make between access to sub-populations and patients with specific indications or conditions, and the prices allowable to gain marketing authorization. The impact of pricing on access varies significantly by country and under different patient coverage assumptions. Modeling the expected access of a specific product as a function of net price per day, for example, reveals significant disparities between established markets and emerging ones such as China and Brazil.

Innovative market access schemes, including risk-sharing and outcomes-based arrangements, are increasingly common as new therapies seek market access. For example, in Italy such arrangements have been necessary for many therapies to gain market authorization. The process for evaluating options for access arrangements assesses risk exposure and the potential financial benefit to payers; primary research is also useful for testing the impact of different approaches.

In addition, pricing and launch sequencing decisions can benefit from the use of modeling to address the complexities of international reference pricing, to understand the sometimes disproportionate or unintended impact a pricing change in one country can have on prices in other markets.