Study suggests follow-on biologics legislation may wait a year

WASHINGTON Follow-on biologics might have to wait another year for legislation to be introduced after there was hope it would be introduced this year after it was unable to slip into legislation before the end of last year, according to The Regulation Policy Market Access Report.

Some of the reasons for the delay are: Sen. Ted Kennedy’s, D-Mass. health, the presidential election, and the Medicare bill. Even before Kennedy became sick with a malignant brain tumor, the chairman of the Senate Health, Education, Labor & Pensions Committee had said that it would be difficult to get legislation to move because of the high number of other high-profile legislative priorities ahead. The Medicare compromise looks to be the only major health legislation that will make it through Congress in 2008 and if that is the case, follow-on biologics would have to add itself to that bill. Finally with the election, Congressional leaders will be out supporting their respective candidates for the rest of 2008 and then the first half of 2009 will be spent on setting up the new administration.

One factor that seems positive for follow-on biologics is, a report from the Pharmaceutical Care Management Association estimated that cost-savings from follow-on biologics for the top 200 Medicare Part B- reimbursed therapies would be about $14 billion over 10 years. As a result of this, the Congressional Budget Office is conducting a study of its own to see the 10-year savings with follow-on biologics. If the numbers match, it would be difficult for Congress to pass up looking up at relatively soon.