Pharmacy Prior Authorization Criteria

Crinone Gel 8% Quantity Limit

Indications for Prior Authorization

Crinone Gel 8%

• For diagnosis of Assisted Reproductive Technology
  Indicated for progesterone supplementation or replacement as part of an Assisted Reproductive Technology (“ART”) treatment for infertile women with progesterone deficiency.

• For diagnosis of Secondary Amenorrhea
  Indicated for the treatment of secondary amenorrhea. Crinone 8% is indicated for use in women who have failed to respond to treatment with Crinone 4%.

Criteria

Crinone 8%

Quantity Limit

Length of Approval: 12 Week(s)
For diagnosis of Assisted Reproductive Technology (ART)

• Quantity requested is intended for use as part of an Assisted Reproductive Technology (ART) treatment for infertile women
AND
• One of the following:
• Dose or quantity requested is supported in the dosage and administration section of the manufacturer's prescribing information
OR
• Dose or quantity is supported by one of the following compendia:
• American Hospital Formulary Service Drug Information
• Micromedex DRUGDEX System
AND
• Trial and failure, contraindication, or intolerance to Endometrin
AND
• Prescribed by or in consultation with a reproductive endocrinologist

P & T Revisions

2024-08-28, 2022-08-22, 2021-07-26, 2021-05-20, 2020-07-14, 2019-11-08

References

1. Crinone Prescribing Information. Allergan USA, Inc. Irvine, CA. June 2017.
2. Endometrin Prescribing Information. Ferring Pharmaceuticals, Inc. Parsippany, NJ. January 2018.

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Revision History

• 2024-08-28: QL program reimplemented to support formulary strategy.
• 2022-08-22: Annual review: no criteria changes.
• 2021-07-26: 2021 annual review: no criteria changes.
• 2021-05-20: Addition of EHB formulary to guideline, no changes to criteria
• 2020-07-14: 2020 Annual Review: no clinical changes
• 2019-11-08: Annual Review: no changes; updated background & references

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