Pharmacy Times
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Congressional action to create a clearregulatory pathway for generic biotechdrugs would conservatively result in $14billion in prescription drug cost savings forthe Medicare Part B program over the next10 years, according to a new researchstudy. The analysis, conducted by researchers at Engel & Novitt,concludes that "Medicare must continue to pay higher costs—even on older, off-patent biologics—because the FDA lacks aclear regulatory pathway for approving ‘biogenerics.'"

In addition to the $14 billion in savings estimated for Part B,the researchers predicted that billions more in drug savingsfrom the new Medicare Part D would also result from FDA guidancefor approving "follow-on biologics." In calling for fast actionfrom Congress, the researchers noted that expenditures for biologicsare rising faster than most other Medicare costs, andthat, last year alone, Part B spending for these products exceeded$5 billion.

"Lifesaving and enhancing biologics can cost tens or evenhundreds of thousands of dollars per patient per year, so introducingas much competition as possible is vital to making thesetreatments more accessible to consumers," said thePharmaceutical Care Management Association, which sponsoredthe study.

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