Pharmacy Prior Authorization Criteria

Riluzole Products - PA, NF

Indications for Prior Authorization

Exservan (riluzole film), Rilutek (riluzole tablets), Tiglutik (riluzole suspension), Teglutik (riluzole suspension)

• For diagnosis of Amyotrophic Lateral Sclerosis (ALS)
  Indicated for the treatment of patients with amyotrophic lateral sclerosis (ALS).

Criteria

Brand Rilutek, Teglutik, Tiglutik

Prior Authorization

Length of Approval: 12 Month(s)

• Diagnosis of amyotrophic lateral sclerosis (ALS)
AND
• Trial and failure or intolerance to generic riluzole tablets

Exservan

Prior Authorization

Length of Approval: 12 Month(s)

• Diagnosis of amyotrophic lateral sclerosis (ALS)
AND
• Trial and failure or intolerance to both of the following:
• generic riluzole tablets
• Tiglutik suspension or Teglutik suspension

Exservan

Non Formulary

Length of Approval: 12 Month(s)

• Submission of medical records (e.g., chart notes) confirming diagnosis of amyotrophic lateral sclerosis (ALS)
AND
• Submission of medical records (e.g., chart notes) confirming the patient has experienced intolerance (e.g., allergy to excipient) with both of the following formulary alternatives that have the same active ingredients:
• generic riluzole tablets
• Tiglutik suspension or Teglutik suspension
AND
• Submission of medical records confirming the formulary alternatives have not been effective and valid clinical rationale provided explaining how the Non-Formulary or Excluded Medication is expected to provide benefit when the formulary alternatives have not been shown to be effective despite having the same active ingredient

P & T Revisions

2024-07-02, 2024-03-06, 2024-01-04, 2023-06-07, 2022-07-08, 2021-10-05, 2021-07-22, 2021-05-21, 2020-07-08, 2019-10-29

References

1. Rilutek Prescribing Information. Covis Pharma. Zug, Switzerland. March 2020.
2. Tiglutik Prescribing Information. ITF Pharma, Inc. Berwyn, PA. April 2021.
3. Exservan Prescribing Information. Aquestive Therapeutics. Warren, NJ. April 2021.
4. Teglutik Prescribing Information. ITF Pharma, Inc. Berwyn, PA. February 2024.

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Revision History

• 2024-07-02: 2024 Annual Review - updated NF criteria and references
• 2024-03-06: Addition of Teglutik as a target and as a preferred option to Exservan criteria
• 2024-01-04: Removed generic riluzole as a target
• 2023-06-07: 2023 Annual Review - no changes
• 2022-07-08: 2022 Annual Review- no criteria changes
• 2021-10-05: Updated guideline. Added NF section and addition of Tiglutik as t/f product to Exservan
• 2021-07-22: Renamed guideline "Riluzole Products". Added Exservan film to guideline mirroring criteria for brand Rilutek and Tigultik. 2021 Annual Review.
• 2021-05-21: Addition of EHB formulary to guideline, no changes to criteria
• 2020-07-08: 2020 Annual Review, no changes to criteria, background updates only.
• 2019-10-29: Updated guideline. Switching to Specialty product. SL 10.07.19

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