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.

Taytulla (norethindrone acetate/ethinyl estradiol/ferrous fumarate)

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

  The efficacy of TAYTULLA in women with a body mass index (BMI) of more than 35 kg/m2 has not been evaluated.

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
• Tulana
• 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, etc.)
• Xulane
• Zafemy
OR
• If requested for an off-label indication, the off-label guideline approval criteria have been met

Taytulla

*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 generics:
• Gemmily
• Merzee
• Norethindrone acetate-ethinyl estradiol-ferrous fumarate capsules
• Taysofy
OR
• If requested for an off-label indication, the off-label guideline approval criteria have been met

P & T Revisions

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. May 2019.
2. Twirla Prescribing Information. Agile Therapeutics, Inc., Princeton, NJ. April 2022.
3. Taytulla Prescribing Information. AbbVie Inc. North Chicago, IL. June 2023.

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Revision History

• 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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