Advocacy & Practice Updates — Clinical Updates

Repackaged Avastin Market Disruption: Key Updates for Retina Specialists and Patients

Update on Avastin Shortage for Retina Patients

Retina Specialists are having difficulty obtaining Avastin because one of the largest providers of the drug, Pine Pharmaceuticals, shut down production.

While retina specialists are doing all they can to provide the treatment, there may be delays. In the meantime, ASRS is calling on health plans to allow retina specialists to use alternate medications.

If you are not able to receive care because your insurance plan tells you that you need to use Avastin first, you should let the plan know that it is not available and email us at members@asrs.org.

On October 11, 2024, Pine Pharmaceuticals informed ASRS that it would cease production of repackaged Avastin. A 503B outsourcing facility, Pine was the largest supplier of repackaged Avastin to retina specialists’ practices, who in turn use it to treat millions of patients for potentially-blinding chronic diseases, such as age-related macular degeneration (AMD) and diabetic retinopathy. 

What is Repackaged Avastin? Avastin (bevacizumab) is a biologic that is FDA-approved to treat certain cancers. Through a compounding process known as repackaging, it can be made into smaller doses for ocular use. Its use for retinal disease is off-label.

Why is this disruption a problem? While there are several FDA-approved drugs that are manufactured specifically for ocular use, they are more expensive than repackaged Avastin. Thus, most Medicare Advantage (MA) and commercial insurance plans require patients to begin treatment with Avastin before covering the branded drugs. This type of “fail first” policy is known as step therapy and can prevent patients from accessing the treatment their retina specialists determine would be most appropriate in a timely fashion. ASRS strongly opposes step therapy.

Since smaller outsourcing facilities are not able to fill the demand and supply repackaged Avastin in the quantities needed nationwide, patients who have insurance plans with Avastin-first step therapy policies are in a bind and may have difficulty accessing sight-saving care. ASRS has stepped up to advocate that payers suspend these policies while supplies are limited.

How has ASRS advocated and what are the results? Upon learning of the looming shortage, ASRS immediately began informing payers and asking that they suspend their Avastin-first policies. While most insurers have been slow to respond, there are a few who have provided relief and suspended their policies:

  • Aetna
  • Unitedhealthcare
  • BCBS of Minnesota
  • Sentara

We thank these insurers for their cooperation.

ASRS has also teamed with the Academy of Ophthalmology (AAO) on a letter to the Centers for Medicare and Medicaid Services (CMS) asking the agency to direct all MA plans to suspend Avastin-first policies. In a meeting with key CMS staff, they acknowledged the situation but were non-committal on a response at that time.

We are also engaging with advocacy groups for patients who suffer from these diseases to help amplify our message.

We will keep this page updated with key developments.

(Published 11.17.24)

Related links:

ASRS, AAO Meet With CMS to Seek Suspension of Avastin-First Step Therapy (Published 11.12.24)