Bloomberg BNA's Pharmaceutical Law & Industry Report helps you stay informed of regulatory and litigation developments affecting the pharmaceutical and biotech industries....
Oct. 9 — Sens. Pat Roberts (R-Kan.) and Thomas Carper (D-Del.), as well as 18 other senators, Oct. 8 sent a letter to the CMS expressing concerns about biosimilar reimbursement in the 2016 proposed physician fee schedule rule.
The proposed rule (CMS-1631-P) was released by the Centers for Medicare & Medicaid Services July 8. The proposal would assign all biosimilars of a single reference (brand) product one Healthcare Common Procedure Coding System (HCPCS) code and would reimburse biosimilars with the same HCPCS code based on the weighted average of their average sales price under Medicare Part B.
“We have heard concerns from patient and physician groups, pharmacy organizations, biosimilar manufacturers, and other stakeholder organizations that reimbursement for biosimilar drugs may be important for tracking usage of these drugs for purposes of patient safety and research, medical innovation, and increasing patient access to biosimilar treatments,” the senators said.
Therefore, the CMS should “withhold the proposed Medicare reimbursement policy for biosimilars until the Food and Drug Administration has completed regulations for these drugs and the biosimilar drugs pipeline and market are safe and stable,” the senators said.
The Affordable Care Act, through its Biologics Price Competition and Innovation Act (BPCIA), created a pathway for the FDA to approve follow-on biologic drugs, or biosimilars. On March 6, the FDA approved Novartis AG's version of Amgen Inc.'s cancer drug Neupogen (filgrastim), marking the first time a biosimilar will go on sale in the U.S. The market launch of Zarxio was delayed after FDA approval due to litigation between Sandoz and Amgen.
House members also have expressed concern with the biosimilars reimbursement proposal. On Aug. 4, Reps. Joe Barton (R-Texas) and Anna G. Eshoo (D-Calif.), as well as 31 other House members, sent a letter to the CMS saying they are concerned that the proposed rule treats biosimilars like traditional generic drugs.
The Biosimilars Forum Oct. 8 released a statement expressing support of the senators for their leadership in sending the letter.
“The House, Senate and countless stakeholders have now made their concerns clear that multiple biosimilars being grouped and issued the same J-code for Medicare reimbursement purposes could result in fewer biosimilars being introduced in the United States, and ultimately in fewer treatment options for health care professionals and patients,” Michael Werner, Biosimilars Forum policy adviser, said. “The Biosimilars Forum shares this concern. Under this proposed rule, thousands of patients facing serious diseases and disorders who are expected to benefit from biosimilars may have limited access to treatments and therapies offered by their health care professionals.”
Werner said “we are pleased that this issue is being addressed now by both the House and the Senate, and applaud those who are working to correct the proposed regulation to reflect the intent of Congress and the BPCIA’s biosimilar payment and coding requirements.”
“We urge CMS to revise its proposed rule for Part B to better reflect the law and to support this new industry by giving each biosimilar of the same reference product its own, unique Medicare claims code and payment amount,” Werner said.
The Biosimilars Forum is a nonprofit organization whose mission is to advance biosimilars in the U.S. Its founding members include Actavis, Amgen, Boehringer Ingelheim, Coherus BioSciences, EMD Serono, Hospira, Merck, Pfizer, Samsung, Sandoz and Teva.
To contact the reporter on this story: Bronwyn Mixter in Washington at email@example.com
To contact the editor responsible for this story: Janey Cohen at firstname.lastname@example.org
The letter is at http://src.bna.com/xt.
The proposed rule is at http://www.gpo.gov/fdsys/pkg/FR-2015-07-15/pdf/2015-16875.pdf.
All Bloomberg BNA treatises are available on standing order, which ensures you will always receive the most current edition of the book or supplement of the title you have ordered from Bloomberg BNA’s book division. As soon as a new supplement or edition is published (usually annually) for a title you’ve previously purchased and requested to be placed on standing order, we’ll ship it to you to review for 30 days without any obligation. During this period, you can either (a) honor the invoice and receive a 5% discount (in addition to any other discounts you may qualify for) off the then-current price of the update, plus shipping and handling or (b) return the book(s), in which case, your invoice will be cancelled upon receipt of the book(s). Call us for a prepaid UPS label for your return. It’s as simple and easy as that. Most importantly, standing orders mean you will never have to worry about the timeliness of the information you’re relying on. And, you may discontinue standing orders at any time by contacting us at 1.800.960.1220 or by sending an email to email@example.com.
Put me on standing order at a 5% discount off list price of all future updates, in addition to any other discounts I may quality for. (Returnable within 30 days.)
Notify me when updates are available (No standing order will be created).
This Bloomberg BNA report is available on standing order, which ensures you will all receive the latest edition. This report is updated annually and we will send you the latest edition once it has been published. By signing up for standing order you will never have to worry about the timeliness of the information you need. And, you may discontinue standing orders at any time by contacting us at 1.800.372.1033, option 5, or by sending us an email to firstname.lastname@example.org.
Put me on standing order
Notify me when new releases are available (no standing order will be created)