$10bn savings from follow-on biologics; CBO report

Implementation of an abbreviated approval pathway for follow-on biologics could result in savings of almost $10bn over a decade, according to a report from the Congressional Budget Office (CBO).

The report predicts that between 2010 and 2019 having an abbreviated approval pathway in place would have a net effect on deficit of $9.2bn.

Additional savings of $2.8bn could be achieved by placing follow-on biologics and their brand name counterparts in the same billing code under Medicare Part B.

The CBO claims this would encourage more widespread use of follow-on biologics as payment rates to physicians are calculated as a weighted average of all products in a billing code.

Consequently those prescribing brand name products would not be fully reimbursed for the brand name products they prescribed when a generic alternative was available.

In turn physicians who prescribe follow-on biologics will benefit financially as they will retain the difference between the products cost and the Medicare payment.

By adopting this carrot and stick approach it is hoped that follow-on biologics will enter into widespread use shortly after they enter the market. As a follow-on biologic becomes more widely used its payment rate under Medicare Part B would decline, offering further savings to the state.

A new market opens

By streamlining the approval process the CBO believes a competitive follow-on biologics market can be created, with multiple manufacturers and a resulting downwards pressure on pricing.

The CBO claims that US spending on biologics exceeded $40bn in 2007 and that products accounting for three quarters of this spending are due to come off patent over the next decade.

This represents a sizeable opportunity for companies entering the follow-on biologics market, such as Merck & Co which is launching a new division for biogenerics, and could confer significant savings to the US.