SKYCLARYS (omaveloxolone) is a once daily oral medication that was shown in clinical trials to slow progression of FA symptoms. It was approved by the Food and Drug Administration (FDA) in the United States in 2023 and the European Commission in the European Union in 2024 for the treatment of people with FA over the age of 16.

Watch the video on the right to learn how SKYCLARYS impacts mitochondrial function. Additional information about the research that led to SKYCLARYS’s approval can be found on the SKYCLARYS Drug Development Program page.

SKYCLARYS overview
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Recent News on SKYCLARYS

| Mar 4, 2024

FA Community Update from Biogen

Industry News
| Feb 12, 2024

Biogen Received European Commission Approval for SKYCLARYS® (omaveloxolone), the First Therapy to Treat Friedreich’s Ataxia

Industry News
| Dec 15, 2023

CHMP Issues Positive Opinion for Biogen’s SKYCLARYS® (omaveloxolone), the First Therapy to Treat Friedreich’s Ataxia, a Rare Neurodegenerative Disease

Industry News
| Sep 26, 2023

Biogen Completes Acquisition of Reata Pharmaceuticals

Industry News

Prescriptions for SKYCLARYS in the United States

Like many rare disease drugs, SKYCLARYS cannot be picked up at a local pharmacy.

When prescribing SKYCLARYS, doctors first must enroll their patient in Biogen REACH, a program that assists people with FA and their doctors during the prescription process. Representatives from REACH will work with the patient’s insurance company to obtain coverage for SKYCLARYS. The prescription process is different from person to person depending on an insurance company’s policies and coverage. Once approved for SKYCLARYS, the patient will receive the prescription through the mail.

Prescriptions for SKYCLARYS outside the United States

As of May 2024, SKYCLARYS is only approved for people living with FA in the U.S. and E.U. who are over 16. The European Commission granted Marketing Authorization for SKYCLARYS in February 2024. Individual European Union countries are submitting reimbursement files to their local authorities. Biogen, the company that owns and manufactures the drug, is currently undertaking efforts to expand approval in additional countries and in children.

Access and Insurance Coverage for SKYCLARYS

It is not uncommon for people affected by rare diseases to face difficulties when seeking insurance coverage for medications, medical equipment, or other types of care. It’s important to know that in most cases, there are steps patients and healthcare providers can take to appeal a denial. FARA provides resources about the insurance approval process, as well as template documents to support insurance appeals.

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.