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

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
• All of the following:
• Trial and failure of at least 4 weeks, or intolerance to generic dimethyl fumarate
AND
• Trial and failure of at least 4 weeks, or intolerance to at least one of the following disease-modifying therapies for MS: [A, 5]
• Bafiertam (monomethyl fumarate)
• Vumerity (diroximel fumarate)
AND
• One of the following:
• Trial and failure (of a minimum 4-week supply), contraindication, or intolerance to generic fingolimod
OR
• For continuation of therapy
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)

• Patient demonstrates positive clinical response to therapy (e.g., stability in radiologic disease activity, clinical relapses, disease progression)
AND
• All of the following: (applies to Brand Tecfidera only)
• Trial and failure of at least 4 weeks, or intolerance to generic dimethyl fumarate
AND
• Trial and failure of at least 4 weeks, or intolerance to at least one of the following disease-modifying therapies for MS: [A, 5]
• Bafiertam (monomethyl fumarate)
• Vumerity (diroximel fumarate)
AND
• One of the following:
• Trial and failure (of a minimum 4-week supply), contraindication, or intolerance to generic fingolimod
OR
• For continuation of therapy
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

Non Formulary

Length of Approval: 12 Month(s)

• Submission of medical records (e.g., chart notes) confirming a 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
• Both of the following:
• Submission of medical records (e.g., chart notes) confirming objective information indicating a lack of adequate clinical response after at least a 4-week trial with generic dimethyl fumarate
AND
• Valid clinical justification provided explaining how Brand Tecfidera is expected to provide benefit when generic dimethyl fumarate has not been shown to be effective despite having the same active ingredient
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 both of the following:
• Bafiertam
• Vumerity
AND
• One of the following:
• Submission of medical records (e.g., chart notes) or paid claims confirming failure after a trial of at least 4 weeks, contraindication or intolerance to one formulary alternatives from the following:
• Avonex (interferon beta-1a)
• Betaseron (interferon beta-1b)
• Copaxone/Glatopa (glatiramer acetate)
• Fingolimod
• Kesimpta (ofatumumab)
• Mayzent (siponimod)
• Zeposia (ozanimod)
OR
• Both of the following:
• Submission of medical records (e.g., chart notes) or paid claims confirming continuation of prior therapy, defined as no more than a 45-day gap in therapy for continuation of therapy
AND
• Patient demonstrates positive clinical response to therapy
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

2024-11-25, 2024-10-14, 2024-10-09, 2024-09-19, 2024-04-30, 2023-11-02, 2023-10-04, 2023-04-26, 2022-11-10, 2022-08-31, 2022-08-05, 2022-05-11, 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. March 2024.
4. Dimethyl Fumarate Prescribing Information. Mylan Pharmaceuticals Inc. Morgantown, WV. February 2022.
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 and Vumerity were based off of Tecfidera, the consultant thinks that the two drugs should have the same efficacy and safety profile as Tecfidera since they were 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

• 2024-11-25: Updated NF criteria.
• 2024-10-14: Reverted NF criteria. To be updated at Nov P&T.
• 2024-10-09: Updated NF criteria to ensure clinical intent is clear; removed criterion 3 referring to trial through fingolimod as this is covered by criterion 4. P&T approved at September P&T.
• 2024-09-19: Updated PA criteria to include a trial through generic fingolimod & a trial through generic fingolimod, with allowance for COT for fingolimod trial. Updated NF criteria: 1) Added submission of medical records requirement for diagnosis 2) Added criteria to trial through generic & provide reasoning as to why a response is expected when the generic was not successful & a trial through generic fingolimod, with allowance for COT for this trial 3) Trial through at least two other DMTs 4) for COT, requirement of a positive clinical response to therapy.
• 2024-04-30: 2024 UM Annual Review. Updated NF criteria to require t/f of all of the following: generic dimethyl fumarate, Bafiertam and Vumerity. Background updates
• 2023-11-02: Updated brand Tecfidera starter pack, generic dimethyl fumarate starter pack gpi.
• 2023-10-04: Program update to standard reauthorization language. No changes to clinical intent
• 2023-04-26: 2023 UM Annual Review. No criteria changes. Updated references
• 2022-11-10: Update to include "paid claims" to NF criteria
• 2022-08-31: Formulary strategy update for Brand Tecfidera
• 2022-08-05: Removed submissions verbiage from PA criteria
• 2022-05-11: 2022 Annual Review - updated criteria
• 2021-05-03: Formulary strategy update for Brand Tecfidera.

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