The Academy and the American Society of Retina Specialists are urging the Centers for Medicare & Medicaid Services (CMS) to take the necessary steps to resolve the Avastin drug shortage issue to avoid any further disruption of this important sight saving therapy.
We are asking that CMS notify all Medicare contractors of this supply chain disruption and urging the agency to halt Medicare Advantage step therapy and prior authorization requirements imposed on any alternative therapies to repackaged Avastin.
As we reported last week, Optum, one of the largest supplier of Avastin, is currently unable to ship the drug due to “out-of-specification test results for sub-visible particles on select batches.” Ophthalmology practices, as a result, are experiencing challenges with acquiring repackaged Avastin for their patients.
In a letter that will be sent to CMS, we are urging the agency to acknowledge that disruption to Avastin’s availability will have a major effect on patients.
We are pushing CMS to take the following actions:
- Notify all Medicare administrative contractors (MACs) of this supply chain disruption
- Press the contractors to make the needed adjustments to Avastin reimbursement for the current supply. The use of Avastin, the lowest-cost drug, has been declining over recent years while use of higher-cost drugs has been increasing largely due to low reimbursement and a fragile supply chain
- Facilitate access to alternative therapies, which is critical for patient care and will be a significant help to ophthalmology practices
Avastin is a critically important treatment option for patients facing vision-threatening diseases, such as AMD, macular edema, neovascular glaucoma and others.
Since Avastin is the most commonly administered intravitreal drug worldwide, the Academy and the American Society of Retina Specialists are concerned that the supply chain shortage will result in negative patient outcomes or place unsustainable financial burdens on providers.
Alternative Suppliers
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 the Academy that they are accepting new customers and are able to supply practices with Avastin.
Alternative Therapies
There are only three Food and Drug Administration-approved anti-VEGF medications for ophthalmic indications as an alternative to repackaged Avastin, each of which costs substantially more.
The Academy will tell CMS that patients who must switch therapies should “be allowed to continue whichever clinically appropriate therapy is effectively treating their disease after the shortage has concluded.”
Treatment Barriers
The Academy believes the policy requiring step therapy when there is a fragile supply of lower-cost alternatives, such as Avastin, is highly problematic.
In our letter, we will inform CMS that step therapy policies and requirements:
- Interfere with the patient-physician relationship, often resulting in delayed treatment, increased disease activity, disability and, in some cases, irreversible disease progression
- Create administrative burdens for physicians and staff as they help patients navigate complicated and often unclear and hard-to-understand coverage determination processes
We will urge the agency to take the following actions:
- Halt Medicare Advantage step therapy and prior authorization requirements imposed on any alternative therapies to repackaged Avastin.
- Revisit the allowance of step therapy in Medicare Advantage plans for Part B drugs. Many Medicare Advantage plans require patients try lower cost alternatives like Avastin before the use of other products, such as Lucentis or Eylea.
Additional Steps
In addition to reaching out to CMS, the Academy is taking the following actions to help address practice needs and limit any effects on patient access:
- We are working with manufacturers Regeneron and Genentech to facilitate the availability of Avastin alternatives Eylea and Lucentis for practices unable to acquire Avastin.
- We will be reaching out to payers to ask for the relaxation of step therapy and prior authorizations for branded alternatives.
Send Us Your Patient Stories
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.