SKYCLARYS Copay Program

Eligible commercially insured patients may lower their out-of-pocket costs to as low as $0.

During participation in the program, assistance provided by Biogen will not exceed an individual annual cap, which is based on certain factors, including but not limited to, insurance coverage, claim details, and/or participation in other insurance plan-sponsored programs. Once this cap is reached, you will be responsible for paying 100% of your total copay amount. By completing this form, you will be screened for eligibility in the SKYCLARYS Copay Program.

Federal and state laws and other factors may prevent or otherwise restrict eligibility. People covered by Medicare, Medicaid, Veterans Affairs (VA), the Department of Defense (DoD), or any other federal plans are not eligible to enroll. You are eligible to enroll in the SKYCLARYS Copay Program for as long as it is offered and you are treated with this Biogen medication, provided that you meet the eligibility criteria.

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Patient Eligibility

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*TRICARE® is a registered trademark of the Department of Defense; Defense Health Agency. All rights reserved.

Patient Information

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In order to allow Biogen to provide you with support services,
please complete the patient authorization below.

I. Authorization to Share Health Information

I understand that I have certain rights related to the collection, use, and disclosure of [my/my child’s] medical and health information. This information is called “protected health information” (PHI) and includes demographic information (such as sex, race, date of birth, etc.), the results of physical examinations, clinical tests, blood tests, X-rays, and other diagnostic medical procedures that may be included in [my/my child’s] medical records. Biogen will not use [my/my child’s] PHI without my consent.

By signing this Authorization, I authorize [my/my child’s] healthcare provider, [my/my child’s] health insurance company and [my/my child’s] pharmacy providers (“Healthcare Entities”) to disclose to Biogen, and companies working with Biogen (collectively, “Biogen”), health information relating to [my/my child’s] medical condition, treatment, and insurance coverage for Biogen to (i) provide [me/my child] with support services (and related information and materials) related to any of Biogen’s products, including but not limited to, online support, financial assistance services, compliance and persistency and other therapy support services, and (ii) conduct data analysis, market research and other necessary internal business activities, and (iii) provide me with information about Biogen’s products, services, and programs for educational or other purposes. I understand that once I sign this Authorization, and [my/my child’s] medical and health information is disclosed to Biogen by the Healthcare Entities, the Health Insurance Portability and Accountability Act (HIPAA) will no longer protect my information because Biogen is not covered by HIPAA. However, Biogen agrees to protect [my/my child’s] health information by using and disclosing it only for purposes authorized in this Authorization or as required by law or regulations. I understand that [my/my child’s] pharmacy provider may receive remuneration from Biogen in exchange for the health information and/or for any therapy support services provided to [me/my child].

I understand that I may refuse to sign this Authorization. I further understand that [my/my child’s] treatment (including with a Biogen product), payment for treatment, insurance enrollment or eligibility for insurance benefits are not conditioned upon my agreement to sign this Authorization; but if I do not sign it or later cancel it, [I/my child] will not be able to receive Biogen’s therapy support services.

I may cancel this Authorization at any time by mailing a letter to: Biogen, ATTN: Patient Services, 5000 Davis Drive, Morrisville, NC, 27560 or emailing privacy@biogen.com. Canceling this Authorization will end consent to further disclosure of [my/my child’s] health information to Biogen by [my/my child’s] Healthcare Entities after they are notified of my cancellation but will not affect previous disclosures by them pursuant to this Authorization. Canceling this authorization will not affect [my/my child’s] ability to receive treatment, payment for treatment, or [my/my child’s] eligibility for health insurance.

This Authorization expires ten (10) years, or such shorter timeframe required by applicable law, from the day I sign it as indicated by the date next to my signature unless otherwise canceled earlier as set forth above.

I have read and understand the Authorization to Share Health Information and agree to the terms.

Please type your name below to provide your signature to authorize the consent:
(If the patient is a minor and you are the patient's Parent/Legal Guardian, please type in your name.)

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II. Patient Services Authorization

By signing this Authorization, I authorize Biogen, and companies working with Biogen, to provide [me/my child] with support services related to any of Biogen’s products, including but not limited to: online support, financial assistance services, compliance and persistency and other therapy support services, as well as any information or materials related to such services. I understand and agree that personnel, including but not limited to nurses, providing such support services on behalf of Biogen are not employed by [my/my child’s] healthcare professional. I authorize Biogen, and companies working with Biogen, to contact me to provide such services and information by mail, email, fax, telephone call, text message (including calls and text messages made with an automatic telephone dialing system or a prerecorded voice), chat, push notifications and other forms of electronic messaging.

I also authorize Biogen, and companies working with Biogen, to use and disclose [my/my child’s] medical and health information in connection with providing the services, including but not limited to, disclosing [my/my child’s] information to vendors, processors, and service providers for business purposes associated with providing the services, sharing such information with [my/my child’s] healthcare provider, insurance provider, or pharmacy, or disclosing [my/my child’s] information where required by applicable laws or regulations. I also authorize the disclosure of [my/my child’s] health information to specific individuals that I have designated.

I have read and understand the Patient Services Authorization and agree to the terms

Please type your name below to provide your signature to authorize the consent:
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III. Marketing Authorization

By checking the “Agree to terms” box, I authorize Biogen, and companies working with Biogen, to contact me by mobile or online digital media, mail, email, fax, telephone call, and text message (including autodialed and prerecorded calls and messages) for marketing purposes or otherwise provide me with information about Biogen’s products, services, and programs or other topics of interest, conduct market research or otherwise ask me about [my/my child’s] experience with or thoughts about such topics. I understand and agree that any information that I provide may be used by Biogen for marketing, including targeted online marketing, as well as to develop new products, services, and programs. I understand that Biogen will not sell or transfer [my/my child’s] personal data to any unrelated third party for marketing purposes without my express permission. I understand that my consent is not required as a condition of purchasing or receiving any goods or services from Biogen. I understand that I may revoke this authorization and choose not to receive information from Biogen by sending an email with the subject “Unsubscribe” to privacy@biogen.com, or mailing a letter to Biogen, 5000 Davis Drive, Morrisville, NC 27560. For more information visit biogen.com/privacy.

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Residents of certain US States (including but not limited to California) may have additional rights regarding the collection, use, maintenance, disclosure, and deletion of your personal information. To understand or exercise those rights California residents please visit https://www.biogen.com/privacy-center.html.

I understand that I have the right to receive a copy of the terms and conditions of my agreement with Biogen, and that I may request that copy at the time of signing or at a later date by contacting Biogen at: Biogen, ATTN: Patient Services, 5000 Davis Drive, Morrisville, NC, 27560 or emailing privacy@biogen.com.



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Terms and Conditions — SKYCLARYS® (omaveloxolone)

By using the SKYCLARYS® (omaveloxolone) Copay Program, the patient acknowledges and confirms that, at the time of usage, they are currently eligible and meet the criteria set forth in the terms and conditions described below.

The SKYCLARYS Program is valid ONLY for patients with commercial insurance who have a valid prescription in accordance with FDA-approved Prescribing Information. The patient must have a US prescriber and a US shipping address. The patient must be a US resident or US citizen. If the patient has federally funded insurance, such as Medicare, Medicaid, VA, TRICARE®*, or DoD insurance coverage, the patient is not eligible for assistance through the Biogen Copay Program for SKYCLARYS. If the patient obtains a federally funded plan, such as Medicare, Medicaid, VA, TRICARE, or DoD, at any time during the enrollment period, the patient must notify Biogen immediately, and Biogen may be required to stop copay payments and immediately remove patient from the program.

The SKYCLARYS Copay Program covers only the cost of the drug and does not cover copays related to administration, office visits, or any network penalties levied by patient’s insurance. The assistance provided through the Copay Program will be subject to an annual cap. Once the maximum amount of assistance has been provided, the patient will be responsible for paying 100% of total copay amounts for the remainder of the year after funds are exhausted.

The SKYCLARYS Copay Program is not valid if the costs are eligible to be reimbursed in their entirety by private insurance or other programs.

The SKYCLARYS Copay Program cap will reset every January 1st. These programs are not health insurance or benefit plans. The programs do not obligate the use of a specific product or provider.

The Copay Program is intended to help patients afford SKYCLARYS® (omaveloxolone). Patients may have insurance plans that attempt to increase the amount of patient’s out-of-pocket costs to reflect the availability of support offered by a manufacturer assistance program. In those situations, the program may change its terms including but not limited to removing these patients from the program.

Biogen will not provide copay assistance directly to the patient. All program claims will be paid directly to the patient’s pharmacy upon receipt of appropriate claim submission. The patient’s pharmacy will be responsible for submitting claims directly to the SKYCLARYS Copay Program.

All patients are responsible for appropriately reporting enrollment into the SKYCLARYS Copay Program as required by their insurer. It is the patient’s responsibility to ensure compliance with all terms of their insurance as outlined by their insurance plan.

Eighteen (18) months of inactivity may result in removal from the SKYCLARYS Copay Program.

Biogen reserves the right to modify or discontinue this program with respect to any patient, or in its entirety, at any time. Patient participation does not mean that the patient is entitled to receive assistance indefinitely.

*TRICARE is a registered trademark of the Department of Defense; Defense Health Agency. All rights reserved.

WHAT IS SKYCLARYS?

  • SKYCLARYS® (omaveloxolone) is used for the treatment of Friedreich ataxia in adults and children aged 16 years and older. It is not known if SKYCLARYS is safe and effective for use in children younger than 16 years of age.

IMPORTANT SAFETY INFORMATION

What are the possible side effects of SKYCLARYS?

SKYCLARYS may cause serious side effects, including:

  • Increase in blood liver enzymes: Some people taking SKYCLARYS have had an increase in the level of liver enzymes in their blood. Your healthcare provider will do liver function tests
    • before you start taking SKYCLARYS
    • every month for the first 3 months after starting your treatment with SKYCLARYS
    • during certain times as needed while taking SKYCLARYS
  • If your liver enzymes increase, your healthcare provider may change your dose, stop treatment for some time, or completely stop treatment with SKYCLARYS.
  • Increase in a blood protein called B-Type Natriuretic Peptide (BNP). BNP tells how well your heart is working. Your healthcare provider will check your BNP levels before your treatment with SKYCLARYS. Tell your healthcare provider if you have signs and symptoms of your heart not working well such as too much fluid in your body (fluid overload). Signs and symptoms may include:
    • sudden weight gain (3 pounds or more of weight gain in 1 day, or 5 pounds or more of weight gain in 1 week)
    • swelling in your arms, hands, legs, or feet (peripheral edema)
    • fast heartbeat (palpitations)
    • shortness of breath
  • If you have symptoms of fluid overload that is considered a side effect of SKYCLARYS, your healthcare provider may stop treatment with SKYCLARYS.
  • Changes in cholesterol levels. Increases in low density lipoprotein cholesterol (LDL-C) or bad cholesterol and decreases in high density lipoprotein cholesterol (HDL-C) or good cholesterol have happened during treatment with SKYCLARYS. Your healthcare provider will check your cholesterol levels before and during your treatment with SKYCLARYS
  • The most common side effects of SKYCLARYS include: increased liver enzymes (ALT/AST), headache, nausea, stomach pain, tiredness, diarrhea, and muscle pain.

Before taking SKYCLARYS, tell your healthcare provider about all of your medical conditions, including if you:

  • have liver problems
  • have a history of heart problems, including heart failure
  • have a high level of fat in your blood (high blood cholesterol)
  • are pregnant or plan to become pregnant. It is not known if SKYCLARYS will harm your unborn baby. Women who use hormonal birth control should use another form of birth control such as a non-hormonal intrauterine system or an extra non-hormonal birth control such as condoms while using SKYCLARYS and for 28 days after stopping SKYCLARYS
  • Pregnancy exposure registry: There is a pregnancy registry for women who are pregnant and are taking SKYCLARYS. The purpose of this registry is to collect information about the health of you and your baby. Your healthcare provider can enroll you or you may enroll yourself by calling 1-866-609-1785 or by sending an email toSkyclarysPregnancySurveillance@ppd.com
  • are breastfeeding or plan to breastfeed. It is not known if SKYCLARYS passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take SKYCLARYS
  • Tell your healthcare provider about all the medicines you take, including prescription and over-the- counter medicines, vitamins, and herbal supplements such as St. John’s Wort.
  • Taking SKYCLARYS with other medicines can cause serious side effects
  • SKYCLARYS may affect the way other medicines work, and other medicines may affect how SKYCLARYS works
  • Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine

What should I avoid while taking SKYCLARYS?

  • Do not drink grapefruit juice or eat grapefruit. These may change the amount of SKYCLARYS in your blood

These are not all the possible side effects of SKYCLARYS. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA- 1088.

Please see full Prescribing Information, including Patient Information.

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©2026 Biogen. All rights reserved. 04/25 FPS-US-0273 v6

This site is intended for residents 18 years or older of the United States, Puerto Rico, and US territories.

All trademarks are the property of their respective owners.

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