Pharmacy Prior Authorization Criteria

Thalomid (thalidomide)

Indications for Prior Authorization

Thalomid (thalidomide)

• For diagnosis of Erythema Nodosum Leprosum (ENL)
  Indicated for the acute treatment of the cutaneous manifestations of moderate to severe ENL.

  Not indicated as monotherapy for such ENL treatment in the presence of moderate to severe neuritis.

  Also indicated as a maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrence.

• For diagnosis of Newly Diagnosed Multiple Myeloma
  Indicated in combination with dexamethasone for the treatment of patients with newly diagnosed multiple myeloma.

Criteria

Thalomid

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Erythema Nodosum Leprosum (ENL)

• Diagnosis of moderate to severe erythema nodosum leprosum (ENL) with cutaneous manifestations
AND
• Thalomid is not used as monotherapy if moderate to severe neuritis is present

Thalomid

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Erythema Nodosum Leprosum (ENL)

• Patient demonstrates positive clinical response to therapy

Thalomid

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Multiple Myeloma

• Diagnosis of multiple myeloma
AND
• Used in combination with dexamethasone, unless the patient has an intolerance to steroids

Thalomid

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Multiple Myeloma

• Patient does not show evidence of progressive disease while on therapy

P & T Revisions

2024-04-17, 2023-11-30, 2023-07-05, 2023-05-03, 2022-05-04, 2021-09-27, 2021-05-26, 2020-05-01

References

1. Thalomid Prescribing Information. Celgene Corporation. Summit, NJ. December 2022.

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Revision History

• 2024-04-17: Annual Review - no criteria changes
• 2023-11-30: Program update to standard reauthorization language. No changes to clinical intent.
• 2023-07-05: Removed specialist requirement
• 2023-05-03: Annual review - updated references.
• 2022-05-04: Annual review - no changes.
• 2021-09-27: Annual review - updated references. Added EHB formulary.
• 2021-05-26: Annual review - updated references. Added EHB formulary.
• 2020-05-01: Annual review - removed reference to drug name in reauth criteria; updated references.

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