Pharmacy Prior Authorization Criteria

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)

• 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
• Submission of medical records (e.g., chart notes, laboratory values) documenting failure after a trial of at least 4 weeks, or intolerance to both of the following:
• generic dimethyl fumarate
• 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

Brand Tecfidera

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

• 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
• Submission of medical records (e.g., chart notes, laboratory values) documenting failure after a trial of at least 4 weeks, or intolerance to both of the following:
• generic dimethyl fumarate
• Bafiertam (monomethyl fumarate)
AND
• Not used in combination with another disease-modifying therapy for MS [B, 6, 7]
AND
• Prescribed by or in consultation with a neurologist

Brand Tecfidera, 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

P & T Revisions

2023-11-02, 2022-05-11, 2021-09-27, 2021-05-27, 2021-05-03

References

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. Mylan Pharmaceuticals Inc. Morgantown, WV. May 2020.
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.

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End Notes

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]

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Revision History

• 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.

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