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Medicaid Rebate Suit Focuses On FDA Approval Status Of Acthar's New Indication

 
• By Brenda Sandburg

US government says Mallinckrodt avoided millions in Medicaid rebates by claiming Acthar’s added indication was approved as a new NDA rather than a supplemental application.

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Mallinckrodt price hikes for Acthar mandated higher Medicaid rebates, government claims

The fight over how much Mallinckrodt PLC must pay in Medicaid drug rebates for Acthar Gel (repository corticotropin injection) intensified as the US government intervened in a False Claims Act suit alleging the company underpaid hundreds of millions of dollars that were owed as a result of large price hikes for the drug.

Mallinckrodt has been battling with the government for several years over Medicaid rebate calculations for Acthar. The company filed suit against the Centers for Medicare & Medicaid Services last year challenging CMS's decision to require Mallinckrodt to change the base date average manufacturer price (AMP) that had been used to calculate Medicaid drug rebates for Acthar since 2013

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Raising Drug Prices In The EU Could Take Years, Even If Pharma Effort Succeeds

 
• By Cathy Kelly

Manufacturers are engaging the European Commission and individual countries to allocate more health care spending to innovative medicines and align prices more closely to those in the US.

Why Successful Companies Are ‘Tough On Themselves’ When It Comes To HTA

 
• By Eliza Slawther

Pharmaceutical companies need to “pressure test” their clinical development strategies early for health technology assessment purposes, particularly in light of the new EU HTA Regulation, a life sciences consultant says.

If CMS Takes Over 340B, Will Government Allow Rebate Model Changes?

 
• By Cathy Kelly

Manufacturers have supported the proposed shift in oversight authority, which could create a more pharma-friendly environment in the drug discount program, but uncertainty remains.