March 16, 2011—The manufacturer of Avonex, a leading treatment for relapsing-remitting multiple sclerosis (MS), has informed the Office of Pharmacy Affairs (OPA) that it will be repaying 340B covered entities for overcharges on the biotech drug during the fourth quarter of 2000 through the first quarter of 2008.
The company, Biogen Idec, also told OPA that it was sending checks to 340B providers for overcharges during the same period on Amevive, which was the first biologic agent approved for the treatment of moderate to severe chronic plaque psoriasis. Biogen sold the drug’s worldwide rights to Astellas Pharma US in 2006.
Biogen notified OPA of the repayments in a Feb. 4 letter, which OPA made public on March 11. The company did not say how much it owed 340B providers for the overcharges. Biogen reported $2.5 billion in Avonex sales worldwide in 2010 and $48.5 million in comparable Amevive sales in 2005, the latter shortly before it sold the drug’s rights to Astellas.
The average wholesale price per four-dose pack is just under $3,500 for Avonex and just over $5,100 for Amevive.
Pricing Methodology Revised
Biogen told OPA it was revising its 340B ceiling prices in accordance with corrected average manufacturer prices (AMPs) and best prices (BPs) that it submitted to the Centers for Medicare and Medicaid services following a “comprehensive review” of its price calculation methodology.
“Biogen intends to provide payment to those 340B covered entities that would have paid less over the applicable periods had they purchased the listed products at the recalculated ceiling prices for those products,” the company wrote. Providers will get checks along with letters explaining the reason for the repayment and notification that acceptance will absolve Biogen of all liability of claims related to prices it charged during the relevant period.
The company asked that all questions about the repayments be directed to its Associate Director of Government Pricing and Compliance Lisa Kiniklis at lisa.kinliklis@biogenidec.comor (617) 914-4629.
The products and their NDC codes are:
- Avonex Lyo PK/4 (NDC 59627-0001-02)
- Avonex Liquid 30 Mcg, PK/4 (NDC 59627-0002-03)
- Amevive IM 15 Mg, PK/4 (NDC 59627-0021-03)
- Amevive IM 15 Mg, PK/1 (NDC 59627-0021-04)
Refunds for Zegerid
In a related development, OPA has also announced that Santarus Inc. is providing 340B entities a total of $9,377.89 in refunds for overcharges on its proton-pump inhibitor Zegerid during the second quarter of 2007 through the third quarter of 2009.
Providers should direct their questions to Santarus Senior Director of Pricing and Contracting Joan Mimnaugh at jmimnaugh@santarus.com or (858) 314-5778.
The products and their NDC codes are:
- Zegerid 20 mg powder for oral suspension (NDC 68012-0052-30)
- Zegerid 40 mg powder for oral suspension (NDC 68012-0054-30)
- Zegerid 20 mg capsule (NDC 68012-0102-30)
- Zegerid 40 mg capsule (NDC 68012-0104-30)