Pharmacy Prior Authorization Criteria

Contraceptives - Step Therapy

Indications for Prior Authorization

Slynd (drospirenone)

• For diagnosis of Contraception
  Indicated for use by females of reproductive potential to prevent pregnancy.

Twirla (levonorgestrel/ethinyl estradiol)

• For diagnosis of Contraception
  Indicated as a method of contraception for use in women of reproductive potential with a BMI less than 30 kg/m2 for whom a combined hormonal contraceptive is appropriate.

  Limitation of Use: Consider TWIRLA’s reduced effectiveness in women with a BMI ≥ 25 to < 30 kg/m2 before prescribing TWIRLA. TWIRLA is contraindicated in women with a BMI ≥ 30 kg/m2.

Criteria

Slynd

*Examples of non-contraception uses: (1) Abnormal or excessive bleeding disorders (eg, amenorrhea, oligomenorrhea, menorrhagia, dysfunctional uterine bleeding); (2) Acne; (3) Decrease in bone mineral density; (4) Dysmennorrhea; (5) Endometriosis; (6) Hirsutism; (7) Irregular menses / cycles; (8) Ovarian cysts; (9) Perimenopausal symptoms; (10) History of Pelvic Inflammatory Disease (PID); (11) Polycystic Ovarian Syndrome (PCO or PCOS); (12) Premenstrual Syndrome (PMS); (13) Premenstrual Dysphoric Disorder (PMDD); (14) Prevention of endometrial and/or ovarian cancer; (15) Prevention of menstrual migraines; (16) Turner’s syndrome; (17) Uterine fibroids or adenomyosis. **Any justification of medical necessity/appropriateness provided by the prescriber is adequate to approve access.

Step Therapy

Length of Approval: 12 Month(s)

• One of the following:
• Both of the following:
• Patient is using the requested product for contraception or other FDA-approved condition*
• The requested product is medically necessary**
OR
• Both of the following:
• Patient is using the requested product for contraception or other FDA-approved condition*
AND
• Trial and failure (of a minimum 28-day supply), contraindication, or intolerance to one of the following:
• Incassia
• Norlyroc
• Norlyda
• Norethindrone
• Deblitane
• Sharobel
• Lyza
• Emzahh
• Errin
• Camila
• Nora-Be
• Heather
• Jencycla
• Lyleq
OR
• If requested for an off-label indication, the off-label guideline approval criteria have been met

Twirla

*Examples of non-contraception uses: (1) Abnormal or excessive bleeding disorders (eg, amenorrhea, oligomenorrhea, menorrhagia, dysfunctional uterine bleeding); (2) Acne; (3) Decrease in bone mineral density; (4) Dysmennorrhea; (5) Endometriosis; (6) Hirsutism; (7) Irregular menses / cycles; (8) Ovarian cysts; (9) Perimenopausal symptoms; (10) History of Pelvic Inflammatory Disease (PID); (11) Polycystic Ovarian Syndrome (PCO or PCOS); (12) Premenstrual Syndrome (PMS); (13) Premenstrual Dysphoric Disorder (PMDD); (14) Prevention of endometrial and/or ovarian cancer; (15) Prevention of menstrual migraines; (16) Turner’s syndrome; (17) Uterine fibroids or adenomyosis. **Any justification of medical necessity/appropriateness provided by the prescriber is adequate to approve access.

Step Therapy

Length of Approval: 12 Month(s)

• One of the following:
• Both of the following:
• Patient is using the requested product for contraception or other FDA-approved condition*
• The requested product is medically necessary**
OR
• Both of the following:
• Patient is using the requested product for contraception or other FDA-approved condition*
AND
• Trial and failure (of a minimum 3-month supply) or intolerance to one of the following:
• An oral generic form of levonorgestrel/ethinyl estradiol (e.g., Aviane, Levora, Jolessa, Amethia, Fayosim, Amethyst)
• A transdermal patch generic form of norelgestromin/ethinyl estradiol (e.g., Xulane, Zafemy)
OR
• If requested for an off-label indication, the off-label guideline approval criteria have been met

P & T Revisions

2025-01-15, 2024-01-20, 2023-01-19, 2022-07-22, 2022-06-08, 2021-12-22, 2020-12-14, 2020-02-10, 2019-12-16

References

1. Slynd Prescribing Information. Exeltis USA, Inc. Florham Park, NJ. July 2024.
2. Twirla Prescribing Information. Agile Therapeutics, Inc., Princeton, NJ. April 2022.

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Revision History

• 2025-01-15: 2025 annual review: updated trial/failure options for Slynd and Twirla. Background updates.
• 2024-01-20: 2024 annual review - Consolidated Slynd, Twirla, and Taytulla into one guideline and renamed to "Contraceptives - Step Therapy". For all three drugs, updated trial and failure options.
• 2023-01-19: Updated trial and failure criterion to include trial duration.
• 2022-07-22: Revise criteria to allow for approval upon medical necessity. Reduce trial requirement from a double to a single step.
• 2022-06-08: Updated guideline
• 2021-12-22: 2022 Annual Review
• 2020-12-14: Annual review, no updates to clinical criteria
• 2020-02-10: updated guideline
• 2019-12-16: added new guideline

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