ModifiedHealth NetPolicy CP.PMN.262

Quinine sulfate (Qualaquin) coverage

Defines medical necessity and prior authorization criteria for quinine sulfate (Qualaquin) for treatment of uncomplicated malaria and certain off-label uses (e.g., babesiosis) for Health Net members. Applies to commercial, HIM and Medicaid lines of business governed by this payer policy.

Policy Summary

PayerHealth Net

PolicyQuinine sulfate (Qualaquin) coverage

Policy CodePolicy CP.PMN.262

Change TypeMaterial: step therapy bypass revisednon‑material: appendix removed, references updated

Effective DateJun 1, 2021

Next Review DateN/A

Key ActionSubmit prior authorization with supporting clinical documentation showing diagnosis, prior formulary therapy failure or contraindication, and dosing within 1,944 mg/day.

SourceLink

POLICY UPDATE CHANGES

Revised step therapy bypass for IL HIM to remove specification for generic quinine so it now applies to brand Qualaquin.

Removed Appendix D with supplemental links on malaria and babesiosis.

References reviewed and updated.

7 daysApproval duration

1,944 mg/dayMax daily dose

324 mgCapsule strength

Commercial,HIM,MedicaidLines of business

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Coverage and Medical Necessity Criteria

Initial Approval — Malaria (Uncomplicated)

Covered when ALL of the following are met for Initial Approval — Malaria:

Initial Approval for Malaria: 1) Diagnosis: Uncomplicated Plasmodium falciparum malaria (policy also recognizes use for P. vivax, P. ovale, P. malariae, or P. knowlesi as off-label per policy updates); 2) Failure of a formulary antimalarial agent (e.g., atovaquone-proguanil, artemether‑lumefantrine [Coartem], chloroquine, hydroxychloroquine, mefloquine) unless clinically significant adverse effects are experienced, all are contraindicated, or the causative species is documented resistant to all formulary antimalarial agents; 3) If the request is for brand Qualaquin, the member must use generic quinine unless contraindicated or clinically significant adverse effects are experienced; 4) Dose does not exceed 1,944 mg (6 capsules) per day.N/A

Approval duration: 7 days

Initial Approval — Babesiosis (off-label)

Covered when ALL of the following are met for Initial Approval — Babesiosis (off-label):

Initial Approval for Babesiosis: 1) Diagnosis of babesiosis; 2) Prescribed in combination with clindamycin (concurrent administration); 3) If the request is for brand Qualaquin, the member must use generic quinine unless contraindicated or clinically significant adverse effects are experienced; 4) Dose does not exceed 1,944 mg (6 capsules) per day.N/A

Approval duration: duration of request or 10 days (whichever is less)

Other Diagnoses/Indications

Other uses or requests not meeting the above:

Other diagnoses/indications: 1) If the drug has had a recent label change (within the last 6 months) that is not yet reflected in this policy, refer to the applicable policy for guidance; OR 2) For requested uses not covered above, follow the applicable formulary/no-coverage, non‑formulary, or off‑label use policy for the member's line of business (commercial: CP.CPA.190 or CP.CPA.09; health insurance marketplace/HIM: HIM.PA.33 or HIM.PA.103 or HIM.PA.154; Medicaid: CP.PMN.255 or CP.PMN.16 or CP.PMN.53).N/A

Refer to the listed companion policies for coverage determination

Coverage is not authorized for the prevention of malaria. Qualaquin is indicated only for treatment of uncomplicated Plasmodium falciparum malaria and is not approved for malaria prevention (see FDA-approved indications). Requests for uses that are not FDA-approved and are not specifically addressed in this policy must follow the payer's off-label use policies (e.g., CP.CPA.09, HIM.PA.154, CP.PMN.53) and include sufficient documentation of efficacy and safety.

Use of Qualaquin for the treatment or prevention of nocturnal leg cramps is specifically excluded from coverage and will not be authorized under this policy.

For Medicaid members, state Medicaid coverage provisions take precedence when they conflict with the coverage provisions in this clinical policy. Providers should consult the applicable state Medicaid manual for any state-specific coverage rules that supersede this policy.

Coverage determinations remain subject to the terms, conditions, exclusions, and limitations of the member's evidence of coverage, certificate/policy, and applicable law or regulation; when discrepancies exist, legal and regulatory requirements govern.

Use of Qualaquin for the treatment or prevention of nocturnal leg cramps is not authorized under this policy. The product carries boxed warnings that such use may result in serious and life‑threatening hematologic reactions, including thrombocytopenia and hemolytic uremic syndrome/thrombotic thrombocytopenic purpura (HUS/TTP); chronic renal impairment with TTP has also been reported. The documented risks outweigh any potential benefit for this indication.

Requests for Qualaquin for nocturnal leg cramps will be denied unless compelling, documented evidence consistent with the payer's off‑label use criteria is provided; however, the boxed‑warning safety concerns remain a contraindication to routine coverage for this indication.

Coding and Dose Information

No specific CPT/HCPCS/NDC codes listed in this part of the documentmixed

No codes listed

inv-08: Maximum daily dose

Maximum daily dose1,944 mg per day (maximum of 6 capsules/day)

Typical adult dosing for malaria648 mg (two capsules) PO every 8 hours for 3–7 days

Capsule strength324 mg per capsule

Prior Authorization, Documentation, and Step Therapy

Prior Authorization

Prior Authorization Required

Prior authorization is required. Provider must submit supporting clinical documentation (e.g., office chart notes, laboratory results, diagnostic testing, or other clinical information) demonstrating the medical necessity criteria are met. Requests without adequate documentation or that are for excluded indications (for example, prevention of malaria or treatment/prevention of nocturnal leg cramps) will be denied.

Prior authorization required — include clinical notes and labs
Requests lacking documentation or for excluded uses will be denied

Documentation Required

Evidence of Clinical Need

Providers must supply evidence of clinical need with the prior authorization request. Documentation should demonstrate diagnosis and treatment history (including trials and failures of formulary antimalarial agents when applicable), rationale for using quinine or brand Qualaquin over formulary agents, dosing information, and any contraindications or documented adverse reactions to alternative agents.

Drug Background and Clinical Context

Quinine sulfate (Qualaquin) is an antimalarial drug indicated for treatment of uncomplicated Plasmodium falciparum malaria and is effective in geographic regions with documented chloroquine resistance. It is not approved for prevention of malaria, for treatment of severe or complicated P. falciparum malaria, or for treatment/prevention of nocturnal leg cramps.

Relevant contraindications include G6PD deficiency and known hypersensitivity to quinine or related agents; clinicians should also note warnings for QT prolongation and other serious adverse events when considering therapy.

Definitions and Contraindications

inv-18: Uncomplicated malaria

FDA‑approved indicationTreatment of uncomplicated Plasmodium falciparum malaria

Effective where chloroquine resistance existsQuinine sulfate has been shown to be effective in geographical regions with documented chloroquine resistance

Not approved for prevention or severe diseaseNot approved for prevention of malaria or treatment of severe/complicated P. falciparum malaria

inv-19: G6PD deficiency

Contraindication: G6PD deficiencyGlucose-6-phosphate dehydrogenase (G6PD) deficiency is a contraindication to quinine

Other listed contraindicationsKnown hypersensitivity to quinine, mefloquine, or quinidine; myasthenia gravis; optic neuritis