Approved Treatment

Some insurance companies may require a patient’s health care provider to seek approval for coverage of SKYCLARYS prior to the prescription being written. This is called a prior authorization. The process of submitting a prior authorization request is different for each insurance company. Some insurance companies may have prior authorization criteria, or a list of standards, that the patient must meet for the prior authorization to be approved. Many insurance companies use the SKYCLARYS Food and Drug Administration (FDA) label, which states that patients must be over the age of 16 and have a genetic diagnosis of FA. Other insurance companies create strict criteria that many FA patients are unable to meet, often leading to a denial. These denials can and should be appealed because they do not align with the FDA’s label.

There are several reasons why your insurance may have denied coverage for SKYCLARYS. Some of these reasons include:

• Patient’s healthcare provider did not submit a prior authorization
• Patient does not meet the prior authorization criteria
• SKYCLARYS is not on the insurer’s formulary (list of drugs that the insurance company provides coverage for)

Your insurance company should have sent you a letter or other type of communication notifying you of the denial and explaining why you were denied. The specific reason(s) for denial should be referenced when appealing the denial.

The appeal process is different for each insurance company, and you should work with your doctor and insurance company to figure out how to proceed. Often, the first step is submitting an appeal letter arguing that SKYCLARYS is a medically necessary treatment for FA. Sometimes, multiple rounds of appeals are necessary to gain approval. Higher levels of appeal could include a peer-to-peer conversation between the patient’s health care provider and a clinician who works with the insurance company. Use the resources below to help with your appeals.

The Biogen REACH program is a resource available to people with FA taking or trying to access SKYCLARYS. REACH Family Access Managers may be able to contact the insurance company to determine the proper steps for appealing a denial and answer questions about the process. They may also be able to investigate options for accessing SKYCLARYS without insurance approval through different free or reduced-price drug programs you may be eligible for.

Biogen REACH

Most insurance companies accept appeal letters from both doctors and patients or caregivers, and you can find a template below for each scenario. The letters explain results from the SKYCLARYS clinical trials, why SKYCLARYS is a medical necessity for people with FA, and that any insurance criteria excluding people with specific symptoms or disease states does not align with the Food and Drug Administration label for SKYCLARYS. You or your doctor must fill out [bracketed areas] of the letter templates with information specific to your FA symptoms, care, and reason for insurance denial.

Clinician appeal letter

Patient/caregiver appeal letter

Options may be available to help people in the U.S. afford their prescribed medication.*

Biogen Family Access Managers with Biogen REACH can help explore affordability options.

*Subject to eligibility and program terms and conditions. REACH affordability options are not healthcare insurance.