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Important Updates About Vigabatrin and Patient Assistance

Patient Assistance Programs for Sabril® and Currently Available Generic Vigabatrin

Due to recent challenges reported by patients and healthcare providers, the following table was developed to help you and your healthcare provider understand currently available patient assistance programs and their requirements for Lundbeck Sabril® and generic vigabatrin products offered by PAR Pharmaceutical, Amneal and Upsher-Smith as well as a private foundation offering help with co-pays.

Lundbeck Sabril®
SHAREPlus Program Support Center
888-457-4273 (Monday to Friday, 8 a.m. to 8 p.m. ET)		 Amneal Pharmaceuticals Generic Vigabatrin for Oral Solution
Patient Support Program
877-369-5872 (Monday to Friday, 8 a.m. to 6 p.m. ET)		 PAR Pharmaceutical Generic Vigabatrin
Patient Assistance Resource
833-PAR-HELP (833-727-4357)		 Upsher-Smith Vigadrone® for Oral Solutions, Access Pathways® Program Support
866-923-1954 (Monday-Friday 8 a.m. to 9 p.m. ET; Weekends, Friday 9 p.m. to Sunday 9 p.m. ET)		 The Assistance Fund
Private Foundation Patient Support
844-762-9237
  • Only new commercially insured patients one month to 2 years old with a confirmed diagnosis of infantile spasms and registered in the REMS system are eligible for a one-time 30-day supply while receiving insurance approval.
  • No bridge supply offered for ongoing prescription.
  • Co-pay assistance may be available for commercially insured patients. Download this PDF for eligibility information.
  • Other patient assistance may also be available. For more information, contact the Lundbeck Patient Assistance Program at 1-833-800-0119.
  • Help with benefits verification and prior authorizations (PAs) and appeals.
  • “Quick Start Shipments” provide a 5-day supply of product where a PA or appeal will take more than 24 hours to resolve.
  • A second 5-day supply will be available for patients experiencing longer delays for coverage.
  • Patient Assistant Program offers no-cost product for those who do not qualify for coverage, co-pay or alternate funding.
  • Co-Pay Assistance where alternate funding assistance is not available for commercially insured patients (those without Medicare Part D or Medicaid).
  • Only for commercially insured patients one month to 2 years old with a confirmed diagnosis of infantile spasms.
  • “Quick Start” pack will provide a 5-day supply for those requiring prior authorization.
  • A second 5-day supply will be dispensed on an as-needed basis during insurance approval.
  • For eligible patients, PAR provides co-pay assistance and patient assistance programs.  For eligibility requirements, contact the Patient Assistance Resource numbers above.
  • Available for new and existing patients.
  • Starter Prescription / Bridge Prescription will provide a 7-day supply if there is any delay in getting a prescription filled (prior authorization, weekend, insurance change).
  • Additional 7-day supply will be dispensed as needed if there are further delays due to insurance approval (up to 28 days per starter prescription).
  • Access Pathways® provides co-pay and patient assistance for eligible patients. To learn more about these programs, contact Access Pathways® at the number above.
  • For more information, visit vigadrone.com
  • Offers co-pay assistance program for infantile spasms only.
  • Provides eligible underinsured individuals with financial assistance to cover all or part of the individuals’ out-of-pocket cost for the supported medications. These programs give individuals the ability to afford their medications.
  • For more information, visit tafcares.org/patients/
    covered-diseases/.

Sample Vigabatrin Appeal Letter

In response to many of our TSC families receiving insurance denials for vigabatrin — brand (Sabril®) and generic, the TSC Alliance has prepared an appeal letter you can use with your insurance provider.  You can download it here.

January 15, 2018: Vigabatrin Assistance and Access – Call for Stories

The TSC Alliance is asking for your help to better understand the barriers or challenges faced in obtaining Sabril or vigabatrin prescriptions. We are asking our constituents to send us your stories about access, affordability, and reliable delivery with Sabril (brand name) and/or generic vigabatrin. If you have an experience you’d like to share with us, please email us at grc@tscalliance.org.  We truly appreciate each individual story as they help us understand what challenges most affect our constituents, assist us in discussions with specialty pharmacies, and inform Congress of the difficulties impacting your family.  Our goal is to advocate for access to treatment, timely delivery, and continuity of care with whichever treatment you and your physician have found works best for you.

We’re also reaching out to again share some updates on patient assistance programs and tips for navigating this changing environment.

Changes to Sabril Patient-Assisted Programs:

  1. For any questions regarding changes to the Sabril Patient-Assistance or Co-Pay programs, please contact SHARE PLUS. They may also be able to provide a list of additional resources of independent charity patient assistance programs to assist you with covering out-of-pocket costs. Please be aware SHARE PLUS hours will be 8 am to 8 pm ET, Monday – Friday only. There will be no weekend hours moving forward. The support center can be reached at (888) 457-4273.
  2. There are hospitals stocked with Sabril in case of a weekend emergency requiring an inpatient stay.  Those can be found at: https://www.vigabatrinrems.com/#Pharmacy/Lookup.
  3. If you encounter any challenges in seeking information, please let us know immediately by contacting TSC Alliance Director of Medical Affairs, Ashley Pounders, MSN, FNP-BC at apounders@tscalliance.org or (240) 472-4302.

Par Pharmaceutical’s Patient Assistance Resource (PAR):

  1. Par Pharmaceutical makes available their PAR program for its generic vigabatrin including insurance authorization, REMS enrollment, patient and co-pay assistance, quick start and questions on product.
  2. For information, you can call (833) PAR-HELP or (833) 727-4357.

Tips for Navigating this Changing Environment:

  1. Call your specialty pharmacy ahead of time and confirm if your prescription will be filled with brand or generic.
    —Please call your insurer to learn about any changes to their formularies that might be in effect with the new year.
  2. If you wish to remain on brand, you may need to contact your physician to request a new prescription.  This also may depend on your insurance carrier.  You will want your physician to be sure to write “dispense as written” or “do not substitute” if you wish to remain on brand and qualify for coverage, although this is no guarantee.
  3. If you choose or if your insurance only allows for generic, you may also ask the specialty pharmacy if you will remain on the same generic each month (eg. Par’s generic vigabatrin).
  4. Be sure to confirm your prescription is being shipped timely.  We suggest you call seven days before you run out of your current prescription to ensure the next fill is being shipped and arrives in time.  In addition, it’s best to call back the day before your prescription is supposed to ship to confirm it’s still scheduled to go out.
  5. If you have any issues with timely delivery of drug after speaking with your specialty pharmacy, please contact TSC Alliance Director of Medical Affairs, Ashley Pounders, MSN, FNP-BC at apounders@tscalliance.org or (240) 472-4302.

Reporting Adverse Events (AEs) to the FDA:

If you experience breakthrough seizures or other adverse events during formulary changes, please be sure to report them to the FDA through their secure reporting system, MedWatch.

Thank you for helping us respond to these challenges.  We look forward from hearing back from you!

December 20, 2017: Important Message About Patient Assistance and Patient Co-Pay Assistance for Users of Sabril

Changes Already In Effect

The TSC Alliance has been contacted by several constituents experiencing challenges with changes in patient assistance programs for Sabril.  We also know there have been additional challenges in filling prescriptions now that new generic vigabatrin products are coming to market.  Therefore, we want to provide information and some tips in dealing with these challenges.

Changes to Sabril Patient Assistance Programs:

  1. For any questions regarding changes to the Sabril Patient Assistance or Co-Pay programs, please contact SHARE PLUS.  They may also be able to provide a list of additional resources of independent charity patient assistance programs to assist you with covering out-of-pocket costs.  Please be aware SHARE PLUS hours will be 8 a.m. to 8 p.m. ET Monday to Friday only.  There will be no weekend hours moving forward.  The support center can be reached at 888-457-4273.
  2. There are hospitals stocked with Sabril in case of a weekend emergency.  Those can be found at https://www.vigabatrinrems.com/#Pharmacy/Lookup.
  3. If you encounter any challenges in seeking information, please let us know immediately by contacting TSC Alliance Director of Medical Affairs, Ashley Pounders, MSN, FNP-BC at apounders@tscalliance.org or (240) 472-4302.

Tips for Navigating this Changing Environment:

  1. When you receive a call from your specialty pharmacy for refill, be sure to ask if it will be filled with brand or generic.
  2. If you wish to remain on brand, you may need to contact your physician to request a new prescription.  This also may depend on your insurance carrier.  You will want your physician to be sure to write “dispense as written” if you wish to remain on brand and qualify for coverage, although this is no guarantee.
  3. Be sure to confirm your prescription is being shipped timely.  This may require you to place an additional call to the specialty pharmacy (even if you have been told it’s shipping on a particular day) with enough time so you do not miss a dose.
  4. If you have any issues with timely delivery of drug after speaking with your specialty pharmacy, please contact TSC Alliance Director of Medical Affairs, Ashley Pounders, MSN, FNP-BC at apounders@tscalliance.org or (240) 472-4302.

You may wonder why all of these changes are taking place.  There are stricter enforcements within the definitions of charitable patient assistance programs under the anti-kickback statute.  The regulatory and legal environment is shifting, and many companies are taking a more conservative approach.  With the introduction of multiple new generics for vigabatrin over the next year, patient assistance programs are changing and will be different from company to company.  And wherever government funding is involved, such as Medicaid, regulations have an impact on what manufacturers are able to do.  The TSC Alliance is most concerned with ensuring access to critical medications, and we will continue to work to compile additional resources we can share with you in the future.

For California Residents — New Law Goes Into Effect January 1, 2018

The TSC Alliance has recently become aware of a new California law (AB-265) that will go into effect on January 1.  The law will impact co-pay assistance programs and will likely require families on such assistance to pay greater out-of-pocket expenses.  We wanted to share this information with you immediately.

The new law prohibits drug manufacturers from offering discounts on patients’ out-of-pocket expenses for prescription drugs when a lower cost generic drug is available that the Food and Drug Administration approves as having the same treatment response as the brand name drug and that drug is covered under the individual’s health insurance on a lower cost-sharing tier.

Under this law, no discounts, repayment, product vouchers or any reductions in out-of-pocket costs may be given by the manufacturers.  The exception is “independent charity patience assistance programs” provided by outside foundations to help with patient costs and/or free product provided by manufacturer.   For more information, we are providing a link to a very helpful article provided by Hogan and Lovells: https://www.lexology.com/library/detail.aspx?g=5bad7782-3316-4a19-8b56-c94b5d0ede99.