Lactic Acid/Citric Acid/Potassium Bitartrate (Phexxi) Form

Lactic acid/citric acid/potassium bitartrate vaginal gel (Phexxi®) is an on-demand method of contraception. FDA Approved Indication(s) Phexxi is indicated for the prevention of pregnancy in females of reproductive potential for use as an on-demand method of contraception. Limitation(s) of use: Phexxi is not effective for the prevention of pregnancy when administered after intercourse. 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 Phexxi is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Contraception (must meet all):

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);
2. 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. Approval duration:
      Medicaid – 12 months
      Commercial – 12 months or duration of request, whichever is less B. Other diagnoses/indications (must meet 1 or 2):

3. 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): Page 1 of 5

   CLINICAL POLICY Lactic Acid/Citric Acid/Potassium Bitartrate a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial and CP.PMN.255 for Medicaid; 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: CP.CPA.190 for commercial and CP.PMN.16 for Medicaid; or

4. 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: CP.CPA.09 for commercial and CP.PMN.53 for Medicaid.
   II. Continued Therapy A. Contraception (must meet all):
5. 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. Approval duration:
      Medicaid – 12 months
      Commercial – 12 months or duration of request, whichever is less
      B. Other diagnoses/indications (must meet 1 or 2):
6. 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: CP.CPA.190 for commercial and CP.PMN.255 for Medicaid; 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: CP.CPA.190 for commercial and CP.PMN.16 for Medicaid; or

7. 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: CP.CPA.09 for commercial and CP.PMN.53 for Medicaid.
   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 policies – CP.CPA.09 for commercial and CP.PMN.53 for Medicaid or evidence of coverage documents.
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   CLINICAL POLICY Lactic Acid/Citric Acid/Potassium Bitartrate IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key FDA: Food and Drug Administration Appendix B: Therapeutic Alternatives
   This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent for all relevant lines of business and may require prior authorization.
   Drug Name Dosing Regimen Dose Limit/ Maximum Dose Examples of vaginal spermicide products (active ingredient nonoxynol-9 - gel, film, foam) • nonoxynol-9 vaginal gel (Options Conceptrol 4%, Options Gynol II Contraceptive 3%, VCF Vaginal Contraceptive 4%) See product directions See product directions • nonoxynol-9 vaginal film 28% and foam 12.5% (VCF) Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic. OTC Appendix C: Contraindications/Boxed Warnings None reported
   V. Dosage and Administration
   Indication Pregnancy prevention Dosing Regimen Administer one pre-filled applicator (5 grams) vaginally immediately before or up to one hour before each act of vaginal intercourse. If more than one act of vaginal intercourse occurs within one hour, an additional dose must be applied. Maximum Dose See dosing regimen VI. Product Availability
   Pre-filled single-dose vaginal applicators with vaginal gel, supplied as a box of 12 individually wrapped applicators in sealed foil pouches along with a plunger: 5 g containing lactic acid (1.8%), citric acid (1%), and potassium bitartrate (0.4%) VII.