Non-Formulary and Formulary Contraceptives Form
These are general prior authorization criteria for approval of non-formulary and formulary
contraceptives.
FDA Approved Indication(s)
Contraceptives are indicated for the prevention of pregnancy.
Policy/Criteria
Provider must submit documentation (such as office chart notes, lab results or other clinical
information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that non-formulary and
formulary contraceptives are medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Contraceptive Therapy
- One of the following (a or b): a. Requested quantity does not exceed 1 active pill per day, compendium-supported maximum dose, or health plan-approved quantity limit; b. For HIM Washington (i.e., Coordinated Care) requests only: Medical justification supports necessity of the requested quantity that exceeds the health plan-approved quantity limit. Approval duration: Duration of request or 12 months, whichever is less B. Other diagnoses/indications (must meet 1 or 2):
- If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: HIM.PA.33 for health insurance marketplace; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: HIM.PA.103 for health insurance marketplace; or
If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND Page 1 of 5
CLINICAL POLICY Non-Formulary and Formulary Contraceptives criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: HIM.PA.154 for health insurance marketplace. II. Continued Therapy A. Contraceptive Therapy (must meet all):
- Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B). Approval duration: 12 months B. Other diagnoses/indications (must meet 1 or 2):
- If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: HIM.PA.33 for health insurance marketplace; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: HIM.PA.103 for health insurance marketplace; or
If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: HIM.PA.154 for health insurance marketplace. III. Diagnoses/Indications for which coverage is NOT authorized:
A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off-label use policy – HIM.PA.154 for health insurance marketplace or evidence of coverage documents. IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key FDA: Food and Drug Administration Appendix B: Therapeutic Alternatives
Not applicable Appendix C: Contraindications/Boxed Warnings Refer to individual prescribing information. V. Dosage and Administration
Refer to individual prescribing information. Page 2 of 5CLINICAL POLICY Non-Formulary and Formulary Contraceptives VI. Product Availability
Refer to individual prescribing information. VII.