WHA
 

Tecfidera (dimethyl fumarate) - PA, NF

Indications for Prior Authorization

Tecfidera (dimethyl fumarate)
  • For diagnosis of Relapsing forms of MS
    Indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

Criteria

Brand Tecfidera

Non Formulary

Length of Approval: 12 Month(s)

  • Submission of medical records (e.g., chart notes) confirming diagnosis of a relapsing form of MS (e.g., clinically isolated syndrome, relapsing-remitting disease, secondary progressive disease, including active disease with new brain lesions) [3]
    • AND
  • One of the following:
    • Both of the following:
      • Paid claims or submission of medical records (e.g., chart notes) confirming a minimum duration of 4-week trial of generic dimethyl fumarate
        • AND
      • Submission of medical records (e.g., chart notes) documenting objective information indicating a lack of adequate clinical response to generic dimethyl fumarate
      OR
    • Submission of medical records (e.g., chart notes) documenting ONE of the following:
      • An adverse event (e.g., cellulitis) due to treatment with generic dimethyl fumarate
      • Potential for an allergic reaction due to a non-active ingredient that is contained in generic dimethyl fumarate but not included in the requested product
    AND
  • Submission of medical records (e.g., chart notes) or paid claims confirming failure after a trial of at least 4 weeks, or intolerance to Bafiertam (monomethyl fumarate) [A, 5]
    • AND
  • Not used in combination with another disease-modifying therapy for MS [B, 6, 7]
    • AND
  • Prescribed by or in consultation with a neurologist
Generic dimethyl fumarate

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

  • Diagnosis of a relapsing form of multiple sclerosis (MS) (e.g., clinically isolated syndrome, relapsing-remitting disease, secondary progressive disease, including active disease with new brain lesions) [4]
    • AND
  • Not used in combination with another disease-modifying therapy for MS [B, 6, 7]
    • AND
  • Prescribed by or in consultation with a neurologist
Generic dimethyl fumarate

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

  • Documentation of positive clinical response to therapy (e.g., stability in radiologic disease activity, clinical relapses, disease progression)
    • AND
  • Not used in combination with another disease-modifying therapy for MS [B, 6, 7]
    • AND
  • Prescribed by or in consultation with a neurologist

  • Guideline ID
    GL-641260

  • Formulary
    ehb

  • Effective date
    Sep 1, 2026

  • P&T approval date
    Jun 16, 2021

P & T Revisions

2026-06-22, 2025-12-18, 2023-11-02, 2022-05-11, 2021-09-27, 2021-05-27, 2021-05-03

  1. Rae-Grant A, Day GS, Marrie RA, et al. Practice guideline: Disease-modifying therapies for adults with multiple sclerosis. Neurology 2018;90:777-788.
  2. National Multiple Sclerosis Society. Types of MS. Available at: https://www.nationalmssociety.org/What-is-MS/Types-of-MS. Accessed March 29, 2019.
  3. Tecfidera Prescribing Information. Biogen Idec Inc. Cambridge, MA. February 2022.
  4. Dimethyl Fumarate Prescribing Information. Aurobindo Pharma Limited. East Windsor, NJ. April 2024.
  5. Per clinical consultation with MS specialist, July 22, 2020.
  6. Wingerchuk, D., & Carter, J. (2014). Multiple Sclerosis: Current and Emerging Disease-Modifying Therapies and Treatment Strategies. Mayo Clinic Proceedings, 89(2), 225-240.
  7. Sorensen, P., Lycke, J., Erälinna, J., Edland, A., Wu, X., & Frederiksen, J. et al. (2011). Simvastatin as add-on therapy to interferon beta-1a for relapsing-remitting multiple sclerosis (SIMCOMBIN study): a placebo-controlled randomised phase 4 trial. The Lancet Neurology, 10(8), 691-701.
  1. Although the trial results of Bafiertam was based off of Tecfidera, the consultant thinks that the two drugs should have the same efficacy and safety profile since Bafiertam was approved via the FDA 505(b)(2) pathway. [5]
  2. The advantage of using combination disease-modifying therapy (DMT) compared to monotherapy DMT use has not been demonstrated, but there are safety concerns, such as reduced efficacy or disease aggravation, with combination use. [6, 7]
  • 2026-06-22: 2026 Annual Review. Updated Brand Tecfidera NF criteria to align with standard terminology. Removed Brand Tecfidera PA criteria as product is not on the EHB comp grid. Updated reference.
  • 2025-12-18: no criteria changes, added IL statute operational note
  • 2023-11-02: Updated brand Tecfidera starter pack, generic dimethyl fumarate starter pack gpi.
  • 2022-05-11: 2022 Annual Review. Updated criteria
  • 2021-09-27: New guideline for Optum EHB.
  • 2021-05-27: New guideline for Optum EHB.
  • 2021-05-03: Formulary strategy update for Brand Tecfidera.