Pharmacy Prior Authorization Criteria

Lambert-Eaton Myasthenic Syndrome (LEMS) Agents - PA, NF

Indications for Prior Authorization

Firdapse (amifampridine phosphate)

• For diagnosis of Lambert-Eaton Myasthenic Syndrome (LEMS)
  Indicated for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults and pediatric patients 6 years of age and older.

Criteria

Firdapse

Prior Authorization (Initial Authorization)

Length of Approval: 3 Month(s) [A]

• Diagnosis of Lambert-Eaton myasthenic syndrome (LEMS)
AND
• Documentation of symptomatic LEMS that interfere with daily functions (e.g., difficulty climbing stairs, walking up steep hills)
AND
• Patient is 6 years of age or older
AND
• Prescribed by or in consultation with a neurologist

Firdapse

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

• Patient demonstrates positive clinical response to therapy (e.g., improvement in dynamometry, Timed 25-Foot Walk Test, Timed Up and Go Test)

Firdapse

Non Formulary

Length of Approval: 3 Month(s) [A]

• Submission of medical records (e.g., chart notes) confirming diagnosis of Lambert-Eaton myasthenic syndrome (LEMS)
AND
• Submission of medical records (e.g., chart notes) documenting symptomatic LEMS that interfere with daily functions (e.g., difficulty climbing stairs, walking up steep hills)
AND
• Patient is 6 years of age or older
AND
• Prescribed by or in consultation with a neurologist

P & T Revisions

2024-09-13, 2024-07-31, 2023-10-10, 2023-08-02, 2022-10-11, 2022-08-03, 2022-02-16, 2021-12-17, 2021-08-05, 2020-07-29, 2020-01-27, 2019-11-11, 2019-07-27

References

1. Firdapse Prescribing Information. Catalyst Pharmaceuticals, Inc. Coral Gables, FL. May 2024.
2. Per clinical consult with neurologist. January 18, 2019.

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End Notes

1. Per clinical consultation and P&T committee recommendation, it is appropriate to check for positive clinical response earlier due to the drug's rapid onset of action. [2]

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Revision History

• 2024-09-13: Added requirement for submission of medical records in non-formulary criteria.
• 2024-07-31: 2024 Annual Review. No criteria changes. Updated references.
• 2023-10-10: Patient demonstrates positive clinical response to therapy
• 2023-08-02: Annual review, no changes.
• 2022-10-11: Update Um Guideline
• 2022-08-03: Annual Review, no criteria changes.
• 2022-02-16: Program update to remove Ruzurgi criteria and its associated information due to FDA rescission of approval. Ruzurgi was also removed as a trial and failure requirement for Firdapse.
• 2021-12-17: Updated to add NF criteria section for Firdapse.
• 2021-08-05: Annual review: Background updates.
• 2020-07-29: Annual review: background updates.
• 2020-01-27: Added embedded step through Ruzurgi for Firdapse.
• 2019-11-11: Modified criteria due to 2019 CMS concerns - SL - 11.11.19
• 2019-07-27: Added Ruzurgi to previously approved criteria for Firdapse. Per team discussion on 7/10/19, will not call out approval in different age ranges due to our standard age policy. There is also legitimate off-label support for use in adults for Ruzurgi, and calling out age in pediatric population only per the FDA label would not change its approval in any way. JM 7/10/2019

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