Avastin Update: CMS, Medicare Payers Urged to Halt Step Therapy

As concern grows about Avastin shortages, the Academy and the American Society of Retina Specialists this week are pushing health plans to halt step therapy and prior authorization requirements imposed on alternative therapies to avoid further patient care disruption.

The American Society of Retina Specialists in partnership with the Academy notified Medicare payers of the supply issue with off-label, repackaged Avastin. In our letter (PDF) this week, we informed payers that this shortage has a far-reaching effect on the supply chain given that Optum’s outsourcing facility, which is a major supplier of Avastin, “has initiated an indefinite halt on the distribution of all bevacizumab syringes.”

Although we anticipate that other outsourcing facilities will increase their production of repackaged Avastin and bring on new customers, there will be delays in the availability of the drug. To support our members and their patients who rely on this treatment, we strongly urge the payers to:

• Ensure patients receiving Avastin who require doses of any branded drug alternatives approved by the U.S. Food & Drug Administration due to the supply issue will not be required to return to Avastin if the FDA-approved branded drug proves to be more effective
• Permanently reverse its step therapy requirement for anti-VEGF drugs

As we told you last week, we alerted the Centers for Medicare & Medicaid Services that the step therapy requirement, which relies on obtaining repackaged Avastin through a fragile supply chain from few suppliers, “interferes with the patient-physician relationship, often resulting in delayed treatment, increased disease activity, disability and, in some cases, irreversible disease progression.”

Given that Optum’s halt in distribution will extend until at least the fourth quarter of 2021, the Academy encourages ophthalmology practices that need Avastin to immediately contact alternative suppliers. Leiters and Fagron Sterile Services have informed us that they are accepting new customers and are able to supply practices with Avastin.

If you are experiencing challenges accessing Avastin, we encourage you to contact the Academy’s health policy staff in our Washington, D.C., office at healthpolicy@aao.org.

It is also especially helpful to know how this shortage is affecting your patients. Tell us if there is increased cost, patient loss of vision or a new need for surgery. These stories help strengthen our advocacy efforts.