Pharmacy Prior Authorization Criteria

Signifor, Signifor LAR (pasireotide) - PA, NF

Indications for Prior Authorization

Signifor LAR (pasireotide)

• For diagnosis of Acromegaly
  Indicated for the treatment of patients with acromegaly who have had an inadequate response to surgery and/or for whom surgery is not an option.

• For diagnosis of Cushing’s disease
  Indicated for the treatment of patients with Cushing's disease for whom pituitary surgery is not an option or has not been curative.

Signifor (pasireotide)

• For diagnosis of Cushing's disease
  Indicated for the treatment of adult patients with Cushing's disease for whom pituitary surgery is not an option or has not been curative.

Criteria

Signifor LAR

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Acromegaly

• Diagnosis of acromegaly
AND
• One of the following:
• Inadequate response to surgery
• Patient is not a candidate for surgery

Signifor LAR

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Acromegaly

• Patient demonstrates positive clinical response to therapy (e.g., patient’s growth hormone level or insulin-like growth factor 1 level for age and gender has normalized/improved)

Signifor, Signifor LAR

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Cushing's disease

• Diagnosis of endogenous Cushing's disease
AND
• One of the following:
• Pituitary surgery has not been curative for the patient
OR
• Patient is not a candidate for pituitary surgery
AND
• Prescribed by or in consultation with an endocrinologist

Signifor, Signifor LAR

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Cushing's disease

• Patient demonstrates positive clinical response to therapy (e.g., a clinically meaningful reduction in 24-hour urinary free cortisol levels, improvement in signs or symptoms of the disease)

Signifor

Non Formulary

Length of Approval: 12 Month(s)
For diagnosis of Cushing's disease

• Submission of medical records (e.g., chart notes) confirming a diagnosis of endogenous Cushing's disease
AND
• One of the following:
• Pituitary surgery has not been curative for the patient
OR
• Patient is not a candidate for pituitary surgery
AND
• Prescribed by or in consultation with an endocrinologist

P & T Revisions

2024-11-04, 2023-11-20, 2022-11-22, 2021-12-30, 2021-11-03, 2021-09-27, 2021-05-26, 2021-05-25, 2020-10-27, 2019-10-09

References

1. Signifor LAR Prescribing Information. Recordati Rare Diseases Inc. Bridgewater, NJ. July 2024.
2. Signifor Prescribing Information. Recordati Rare Diseases Inc. Bridgewater, NJ. July 2024.

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Revision History

• 2024-11-04: 2024 annual review: updated NF criteria to require submission of medical records confirming diagnosis. Background updates.
• 2023-11-20: 2023 annual review: Updated standard reauth criteria from "documentation of..." to "Patient demonstrates positive clinical response to therapy" with no change to clinical intent. Background updates.
• 2022-11-22: Annual review: update initial authorization duration for acromegaly from 6 months to 12 months
• 2021-12-30: Updated to add NF criteria section for Signifor.
• 2021-11-03: 2021 Annual Review, no changes to criteria.
• 2021-09-27: Addition of EHB formulary to guideline, no changes to criteria
• 2021-05-26: Addition of EHB formulary to guideline, no changes to criteria
• 2021-05-25: Addition of EHB formulary to guideline, no changes to criteria
• 2020-10-27: 2020 Annual Review. Updated LAR product GPI and removed reference to drug name from reauth criteria.
• 2019-10-09: 2019 Annual Review, no changes to criteria.

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