Non-Formulary and Formulary Contraceptives Form


Contraceptive Therapy - Initial Approval

Notes: Approval duration: Duration of request or 12 months, whichever is less

Indications

(439378) Is the requested quantity for contraceptive therapy not exceeding 1 active pill per day, or within compendium-supported maximum dose, or health plan-approved quantity limit? 
(439379) For HIM Washington requests only: Is there medical justification that supports the necessity of the requested quantity exceeding the health plan-approved quantity limit? 

Contraceptive Therapy - Continued Therapy

Notes: Approval duration: 12 months

Indications

(439380) Is the member currently receiving medication via Centene benefit or has previously met initial approval criteria for contraceptive therapy? 
(439381) Is the member currently receiving medication and enrolled in a state and product with continuity of care regulations? 

Other Diagnoses/Indications

Indications

(439382) If this drug recently underwent a label change (e.g., newly approved indication, age expansion, new dosing regimen) within the last 6 months, which is not yet reflected in the policy, does it pertain to off-label use or non-formulary line of business? 

YesNoN/A
YesNoN/A

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Effective Date

05/01/2015

Last Reviewed

NA

Original Document

  Reference



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

  1. 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):
  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
  3. 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):

  4. 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):
  5. 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
  6. 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 5

    CLINICAL POLICY Non-Formulary and Formulary Contraceptives VI. Product Availability
    Refer to individual prescribing information. VII.