CurrentmhnPolicy CP.PMN.251

Lactic Acid/Citric Acid/Potassium Bitartrate (Phexxi) vaginal gel

Medical necessity and coverage criteria for on-demand contraceptive vaginal gel (Phexxi) for members covered under Centene-affiliated health plans (Commercial and Medicaid). Applies to providers requesting coverage/authorization.

Policy Summary

Payermhn

PolicyLactic Acid/Citric Acid/Potassium Bitartrate (Phexxi) vaginal gel

Policy CodePolicy CP.PMN.251

Change TypeNo material changes

Effective Date12.01.20

Next Review Date

Key ActionSubmit prior authorization with documentation that all approval criteria are met, including medical justification for inability to use nonoxynol-9 spermicide and dose ≤5 g per act.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

5 gmaximum single-use dose

12 monthsapproval duration

Box of 12packaging

Commercial, Medicaidlines of business

NotedMedicaid precedence

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Initial approval — Contraception

Covered when ALL of the following are met:

Contraception (initial): 1. Prescribed for prevention of pregnancy; 2. Medical justification supports inability to use vaginal spermicide (active ingredient nonoxynol-9) (e.g., member is contraindicated or has experienced clinically significant adverse effects) (see Appendix B); 3. Phexxi is not prescribed concurrently with vaginal ring products; 4. Dose does not exceed 5 grams (one pre-filled applicator) before each act of vaginal intercourse.

Continuation therapy — Contraception

Continued therapy — Covered when ALL of the following are met:

Contraception (continued): 1. 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); 2. Member is responding positively to therapy; 3. If request is for a dose increase, new dose does not exceed 5 grams (one pre-filled applicator) before each act of vaginal intercourse.

Requests for use of Phexxi for non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider submits sufficient documentation demonstrating efficacy and safety in accordance with the applicable off‑label use policies: CP.CPA.09 for Commercial members and CP.PMN.53 for Medicaid members (or other applicable evidence of coverage documents).

For Medicaid members, when there is a conflict between a state Medicaid coverage provision and the coverage provisions in this clinical policy, the state Medicaid coverage provisions take precedence. Providers should refer to the applicable state Medicaid manual for specific coverage requirements and details.

Provider Requirements, Authorization, and Administration

Prior Authorization

Prior Authorization Required

Prior authorization is required. Provider must obtain prior authorization before Phexxi (lactic acid/citric acid/potassium bitartrate) will be considered for coverage and submit supporting clinical documentation with the request (office chart notes, relevant lab results, prior treatments and responses, and other pertinent clinical information).

PA required for initial and renewal requests
Submit office notes, labs, treatment history, and any relevant clinical records

Denial Risk

Non‑FDA Indications — Documentation Required

Requests for non–FDA‑approved (off‑label) indications will be denied unless sufficient documentation is provided demonstrating efficacy and safety consistent with applicable off‑label use policies (CP.CPA.09 for commercial and CP.PMN.53 for Medicaid) or other evidence of coverage documents.

Off‑label requests require detailed clinical rationale and supporting literature or guideline evidence
If off‑label use is contested, refer to payer off‑label policies CP.CPA.09 and CP.PMN.53

Step Therapy

Therapeutic Alternatives / Step

Therapeutic alternatives (step therapy) should be considered and documented. Phexxi will be approved only when medical justification supports inability to use preferred vaginal spermicide products containing nonoxynol‑9 (e.g., contraindication or clinically significant adverse effect). Providers should document prior use or intolerance of alternatives when applicable.

Preferred alternatives include nonoxynol‑9 vaginal gel, film, or foam (e.g., Conceptrol, Gynol II, VCF) — follow product directions for dosing
If a preferred alternative is not appropriate, include clinical justification (allergies, adverse reactions, contraindications, or treatment failure)

Note

Provider Expectations and Administrative Caveats

Providers are expected to exercise professional medical judgment. This policy is a guide to coverage determination and does not replace clinical decision‑making. Coverage remains subject to the terms, exclusions, and limitations of the member's plan and applicable state and federal requirements.

Coverage decisions governed by member's evidence of coverage, contract terms, and state/federal rules
Policy does not constitute medical advice; providers retain responsibility for clinical care

Documentation Required

Required Documentation

Provider must include supporting documentation with the prior authorization request to demonstrate that all approval criteria are met (e.g., indication for contraception; documentation of inability to use nonoxynol‑9 products; dosing not to exceed one 5 g applicator per act; absence of concurrent vaginal ring use).

Include diagnosis, prior therapies, adverse events, and any relevant diagnostic test results
Requests lacking documentation are subject to denial

OpenPayer

Lactic Acid/Citric Acid/Potassium Bitartrate (Phexxi) vaginal gel

Coverage and Medical Necessity Criteria

Provider Requirements, Authorization, and Administration

Product Background and Clinical Context

Product Definition