The Biogen REACH Provider Center is an educational resource for healthcare professionals who have prescribed SKYCLARYS. Get started by downloading the Start Form.

The Biogen REACH Provider Center

Education, Access & Care Helpline

The Biogen REACH Provider Center is an informational resource for healthcare professionals who have prescribed SKYCLARYS. Your patient is not required to enroll in Biogen REACH before you prescribe SKYCLARYS. However, their signed consent is required to access all program support services.

Within the Biogen REACH Provider Center you can find information about:

care
Care Navigators

Once your patient is enrolled in Biogen REACH, Care Navigators can help them explore options to help stay on track with their SKYCLARYS prescription. Care Navigators can provide answers to your patient’s questions about their:

  • Insurance coverage
  • Eligibility for affordability options
  • At-home prescription delivery
  • Options to speak with a pharmacy representative or nurse

You or your patient can speak with a Care Navigator by calling 1-844-98-REACH. Care Navigators are available 8 AM-8 PM EST, Monday through Friday (except holidays).

specialty
Specialty pharmacy

Your patient’s SKYCLARYS prescription will be delivered by a specialty pharmacy. The Biogen REACH exclusive specialty pharmacy, Biologics, will contact your patient to confirm the delivery address and collect any copayments or coinsurance that may be required for each monthly supply of their SKYCLARYS prescription. SKYCLARYS is not available at retail pharmacies such as Walgreens, CVS, etc. Biogen REACH can provide information to you and your office staff to understand insurance requirements for obtaining approval for your patient’s SKYCLARYS prescription. The specialty pharmacy may also contact your patient to discuss their:

  • SKYCLARYS prescription
  • Side effect management
  • Insurance benefits and copays
  • Ability to get copay assistance
affordability
Affordability options

Find out if your patient is eligible. Options may be available to help your patient save on their SKYCLARYS prescription whether they are insured, underinsured, or uninsured.* Once they are enrolled in Biogen REACH, your patient may speak with a Care Navigator who can help explore their eligibility for affordability options by calling 1-844-98-REACH.


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

Biogen REACH enrollment


Getting started

You must complete and submit a Start Form for your patient before they can speak with a Care Navigator and access Biogen REACH support offerings. The Start Form should be faxed to Biogen REACH at 1-844-806-1718.

You may need to ask your patient to provide information to complete the patient sections of the form. Your patient or their authorized caregiver will need to sign the form to access support offerings.* If any part of the form that is received by the specialty pharmacy is incomplete or missing, Biogen REACH will contact you or your patient for clarification and completion. Biogen REACH may contact the patient to send a digital consent form. A patient signature is not required to submit and process a prescription.

Your patient is not required to enroll in Biogen REACH support offerings before you prescribe SKYCLARYS or for them to access their prescription.

To get started prescribing SKYCLARYS, fill out a Start Form
Explore SKYCLARYS resources and community support
INDICATION AND IMPORTANT SAFETY INFORMATION
INDICATION
  • SKYCLARYS is indicated for the treatment of Friedreich ataxia in adults and adolescents aged 16 years and older
IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Elevation of Aminotransferases

  • Treatment with SKYCLARYS can cause an elevation in hepatic transaminases (alanine aminotransferase [ALT] and aspartate aminotransferase [AST]). The incidence of elevations of ALT or AST above 5 times and 3 times the upper limit of normal (ULN) was 16% and 31%, respectively, in patients treated with SKYCLARYS. There were no cases of concomitant elevation of transaminases and total bilirubin observed. Maximum increases in ALT and AST occurred within 12 weeks after starting SKYCLARYS. Increases in serum aminotransferases were generally asymptomatic and reversible following discontinuation of SKYCLARYS
  • Monitor ALT, AST, and total bilirubin prior to initiation of SKYCLARYS, every month for the first 3 months of treatment, and periodically thereafter. If transaminases increase to levels greater than 5 times the ULN, or greater than 3 times the ULN with evidence of liver dysfunction (e.g., elevated bilirubin), immediately discontinue SKYCLARYS and repeat liver function tests as soon as possible. If transaminase levels stabilize or resolve, SKYCLARYS may be reinitiated with an appropriate increased frequency of monitoring of liver function

Elevation of B-Type Natriuretic Peptide

  • Treatment with SKYCLARYS can cause an increase in B-type natriuretic peptide (BNP), a marker of cardiac function. A total of 14% of patients treated with SKYCLARYS had an increase from baseline in BNP value above the ULN (100 pg/mL), compared to 4% of patients who received placebo. The incidence of elevation of BNP above 200 pg/mL was 4% in patients treated with SKYCLARYS. Cardiomyopathy and cardiac failure are common in patients with Friedreich ataxia. Whether the elevations in BNP are related to SKYCLARYS or cardiac disease associated with Friedreich ataxia is unclear
  • Elevations in BNP may indicate cardiac failure and should prompt an evaluation of cardiac function. Check BNP prior to initiation of SKYCLARYS. Monitor patients for the signs and symptoms of fluid overload, such as sudden weight gain (3 pounds or more of weight gain in one day, or 5 pounds or more of weight gain in a week), peripheral edema, palpitations, and shortness of breath. If signs and symptoms of fluid overload develop, worsen, or require hospitalization, evaluate BNP and cardiac function, and manage appropriately. Management of fluid overload and heart failure may require discontinuation of SKYCLARYS

Lipid Abnormalities

  • Treatment with SKYCLARYS can cause changes in cholesterol. In Study 1, 29% of patients treated with SKYCLARYS reported elevated cholesterol above ULN at one or more time points. Mean increases were observed within 2 weeks of initiation of SKYCLARYS and returned to baseline within 4 weeks of discontinuing treatment. A total of 16% of patients treated with SKYCLARYS had an increase in low-density lipoprotein cholesterol (LDL-C) from baseline, compared to 8% of patients who received placebo. The mean increase in LDL-C for all SKYCLARYS-treated patients was 23.5 mg/dL at 48 weeks. A total of 6% of patients treated with SKYCLARYS had decreases in high-density lipoprotein cholesterol (HDL-C) from baseline compared to 4% of patients who received placebo. The mean decrease in HDL-C for all SKYCLARYS-treated patients was 5.3 mg/dL at 48 weeks
  • Assess lipid parameters prior to initiation of SKYCLARYS and monitor periodically during treatment. Manage lipid abnormalities according to clinical guidelines

ADVERSE REACTIONS

  • Adverse reactions reported in 10% or more of patients and greater than placebo were elevated liver enzymes (AST/ALT), headache, nausea, abdominal pain, fatigue, diarrhea, musculoskeletal pain, oropharyngeal pain, influenza, vomiting, muscle spasms, back pain, decreased appetite, rash

DRUG INTERACTIONS

  • Avoid concomitant use of SKYCLARYS with moderate or strong CYP3A4 inhibitors. If use cannot be avoided, dosage modifications are recommended
  • Avoid concomitant use of SKYCLARYS with moderate or strong CYP3A inducers
  • Refer to the prescribing information for dosing instructions for concomitant use of CYP3A4 and CYP2C8 substrates and monitor for lack of efficacy of the concomitant treatment
  • Advise patients to avoid concomitant use with combined hormonal contraceptives, implants, and progestin only pills

SPECIFIC POPULATIONS

Pregnancy

  • There are no adequate data on the development risks associated with the use of SKYCLARYS in pregnant women

Lactation

  • There are no data on the presence of omaveloxolone or its metabolites in human milk. The effects on milk production and the breastfed infant are unknown. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for SKYCLARYS and any potential adverse effects on the breastfed infant from SKYCLARYS or from the underlying maternal condition

Hepatic Impairment

  • Avoid treatment with SKYCLARYS in patients with severe hepatic impairment, including those who develop severe hepatic impairment
  • Reduced dosage in patients with moderate hepatic impairment with close monitoring for adverse reactions is recommended

Please see full Prescribing Information.

Skyclarys (omaveloxolone) 50mg capsules