Generic Drug Firms Want CMS To Change Proposed Definition Of “Original NDA”
How CMS defines an “original NDA” for the purpose of rebate payments in its proposed Medicaid rule could mean some drugs currently charged at the generic drug rebate rate will soon be charged the higher brand drug rate.
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Pharmaceutical industry stakeholders could have to wait another year before Medicaid details how to calculate average manufacturer prices for drugs and drug rebates and how to handle other complex issues from the Affordable Care Act.
Calculating AMP: Medicaid Proposed Rule Provides Answers, Some Detailed, Some Vague, To Manufacturers’ Questions
Manufacturers seeking answers on how to comply with the law on calculating average manufacturer price for drugs in Medicaid can turn to CMS’ proposed rule on the topic, published in the Feb. 2 Federal Register. The rule addresses a wide range of issues, including how closely manufacturers must track sales to retail community pharmacies for reporting, how to define a “retail community pharmacy,” how to define “bona fide service fees” and fair market value for them, since they can be excluded from AMP, and how to identify “5i” specialty drugs not generally dispensed at a retail community pharmacy, since they have their own special rules for calculating AMP.
New biologic for severe asthma doesn't stack up well to standard of care on generally accepted levels of cost per quality-adjusted life year.