CurrentCentenePolicy CP.PMN.262

Quinine Sulfate (Qualaquin) Coverage Criteria

Defines medical necessity, prior authorization, dosing limits, and coverage criteria for quinine sulfate (Qualaquin) for treatment of uncomplicated malaria and certain off-label uses (e.g., babesiosis) for members of Centene-affiliated health plans.

Policy Summary

PayerCentene

PolicyQuinine Sulfate (Qualaquin) Coverage Criteria

Policy CodePolicy CP.PMN.262

Change TypeNo material change

Effective DateJun 1, 2021

Next Review Date

Key ActionSubmit prior authorization with clinical documentation showing diagnosis, prior formulary antimalarial failure or contraindication, and dosing within limits.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1,944 mg/dayMaximum daily dose

7 daysApproval duration (malaria)

7-10 daysBabesiosis duration

324 mgProduct availability

ICHRA/Medicaid/CommercialLines of business

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Initial Therapy — Malaria

Covered when ALL of the following are met:

Malaria initial approval: 1) Diagnosis of one of the following: a) Uncomplicated Plasmodium falciparum malaria; OR b) Uncomplicated Plasmodium vivax, Plasmodium ovale, Plasmodium malariae, or Plasmodium knowlesi (off-label).

Therapeutic trial requirement: 2) Failure of a formulary antimalarial agent (e.g., atovaquone-proguanil, Coartem®, chloroquine, hydroxychloroquine, mefloquine), unless clinically significant adverse effects are experienced, all formulary agents are contraindicated, or the causative species is resistant to all formulary antimalarial agents.*

*For Illinois HIM requests, step therapy requirements do not apply as of 1/1/2026 per IL HB 5395.

Formulary substitution: 3) If the request is for brand Qualaquin, the member must use generic quinine unless the generic is contraindicated or causes clinically significant adverse effects.

Dose limit: 4) Dose does not exceed 1,944 mg (6 capsules) per day.Maximum dose = <= 1,944 mg/day

Approval duration: 7 days.approval duration = 7 days

Initial Therapy — Babesiosis (off-label)

Covered when ALL of the following are met:

Babesiosis initial approval: 1) Diagnosis of babesiosis.

Combination therapy requirement: 2) Quinine is prescribed in combination with clindamycin.

Requirement to use with clindamycin added per IDSA/CDC guidance (2Q 2022).

Formulary substitution: 3) If the request is for brand Qualaquin, the member must use generic quinine unless the generic is contraindicated or causes clinically significant adverse effects.

Dose limit: 4) Dose does not exceed 1,944 mg (6 capsules) per day.Maximum dose = <= 1,944 mg/day

Other Diagnoses/Indications

For other diagnoses/uses not listed:

Other diagnoses: 1) If the drug has recently (within the last 6 months) undergone a label change not yet reflected in this policy, follow the referenced formulary or non-formulary/no coverage policy for the relevant line of business (see policy for specific policy numbers).

Refer to the listed commercial, HIM/ICHRA, or Medicaid policies for applicability.

Off-label pathway: 2) If the requested use (diagnosis, age, dosing) is not specifically listed under section III and criterion 1 does not apply, refer to the off-label use policy for the relevant line of business (CP.CPA.09 for commercial, HIM.PA.154 for HIM/ICHRA, CP.PMN.53 for Medicaid).

Extracted coverage highlights

Summary of explicit coverage-related policy elements present in this fragment:

Babesiosis: Treatment of babesiosis requires quinine in combination with clindamycin per IDSA and CDC (added 2Q 2022).

See policy for full dosing and duration.

Malaria species: Policy expanded to include off-label coverable infections: Plasmodium ovale, Plasmodium malariae, and Plasmodium knowlesi per CDC; malaria dosing recommendations updated per Clinical Pharmacology (2Q 2024).

See policy Section V for dosing details.

Formulary scope: Policy revised to include generic quinine in addition to brand Qualaquin (2Q 2024).

Applies to coverage and step therapy considerations.

State-specific bypass:

This policy explicitly excludes certain uses of quinine/Qualaquin. Treatment of severe or complicated P. falciparum malaria is not an approved indication, and prevention of malaria is not covered. Use for treatment or prevention of nocturnal leg cramps is not authorized and is specifically disallowed given safety concerns described in the labeling (see boxed warning for serious hematologic reactions). Non‑FDA approved indications not addressed in this policy are also excluded unless supported by sufficient documentation per the applicable off‑label use policy.

When there is a conflict between this clinical policy and state Medicaid coverage provisions, the state Medicaid provisions take precedence. Providers should consult the applicable state Medicaid manual and the member’s evidence of coverage/certificate of coverage for state‑specific requirements, and follow those documents where they differ from this policy.

Because Qualaquin is not approved for malaria prevention and because of significant safety risks, use for prevention of malaria is not covered. Additionally, use for nocturnal leg cramps (either treatment or prevention) is considered not covered due to lack of FDA approval and the risk of serious hematologic and renal adverse events described in the product labeling.

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for quinine/Qualaquin. Initial approvals are time-limited: malaria — 7 days; babesiosis — duration of request or 10 days (whichever is less). Requests for continued therapy are not permitted; members must meet initial approval criteria for any new request.

Approval durations: Malaria = 7 days; Babesiosis = duration of request or 10 days (whichever is less); Continued therapy = not applicable (re-authorization not permitted).
Prior authorization required for both generic quinine and brand Qualaquin.

Step Therapy

Step Therapy Requirement

Step therapy is required for malaria: the member must have failure of a formulary antimalarial (e.g., atovaquone-proguanil, Coartem®, chloroquine, hydroxychloroquine, mefloquine) unless clinically significant adverse effects are experienced, all are contraindicated, or the causative species is resistant to all formulary antimalarial agents. For brand Qualaquin requests, use of generic quinine is required unless contraindicated or clinically significant adverse effects are experienced.

Step therapy applies to malaria initial approval (failure of a formulary antimalarial agent).
Generic-first requirement: brand Qualaquin requests require trial of generic quinine unless contraindicated.

Step Therapy

Step Therapy Bypass — Illinois HIM

Per Illinois HB 5395 (effective 01/01/2026 and subsequent updates), the step therapy requirement is bypassed for Illinois Health Insurance Marketplace (HIM) members. The bypass applies to both generic quinine and brand Qualaquin (step therapy bypass updated to include brand as of 06/25/2025).

IL HIM step therapy bypass applies to both generic quinine and brand Qualaquin.
References: IL HB 5395; policy revisions dated 04.07.25 and 06.25.25.

Documentation Required

Clinical Documentation Required

Provider must submit supporting clinical documentation (such as office chart notes, laboratory results, or other clinical information) demonstrating that the member meets all applicable approval criteria. Requests lacking required documentation or objective evidence that criteria are met will be denied or returned for additional information.

Acceptable documentation examples: office notes, labs, diagnostic test results, prior therapy history, and documentation of contraindications or adverse reactions when used to justify bypassing step therapy.
Incomplete requests or those without necessary clinical support will be denied or returned for more information.

Note

Provider Obligations and Coverage Terms

Providers must follow the member's evidence of coverage/certificate of coverage and any applicable state Medicaid manual provisions. When state Medicaid coverage provisions conflict with this clinical policy, the state Medicaid provisions take precedence.

Coverage decisions are subject to all terms, conditions, exclusions, and limitations of the member's coverage documents and applicable state and federal requirements.
For Medicaid members, refer to the state Medicaid manual for coverage provisions that may supersede this policy.

Definitions and Clinical Notes

inv-18: Uncomplicated malaria — definition and relation to Qualaquin indication

DefinitionUncomplicated malaria: infection by Plasmodium species without signs of severe or complicated disease; Qualaquin (quinine sulfate) indicated for uncomplicated P. falciparum.

Covered indicationsPolicy covers uncomplicated Plasmodium falciparum (FDA indication) and may cover other uncomplicated Plasmodium species off-label per criteria.

Relation to Qualaquin useQuinine (Qualaquin) is recommended for use in choroquine-resistant infections or when resistance status is unknown; dosing guidance includes combination therapy (e.g., doxycycline, tetracycline, or clindamycin).

inv-19: Babesiosis therapy requirement — use in combination with clindamycin per IDSA/CDC

Therapy requirementFor babesiosis, quinine must be prescribed in combination with clindamycin per IDSA and CDC guidance (policy update 2Q 2022).

Dosing and durationAdults: 648 mg PO TID with concurrent clindamycin PO or IV for 7–10 days (maximum 1,944 mg/day).

Policy noteRequirement added during 2Q 2022 annual review; references reviewed and updated in policy history.

inv-20: Malaria species coverage — policy expanded to include off-label Plasmodium species per CDC

Expanded species coveragePolicy was revised (2Q 2024) to include off-label coverage for Plasmodium ovale, Plasmodium malariae, and Plasmodium knowlesi per CDC guidelines.

Application to criteriaThese additional species are treated as off-label coverable infections within the malaria initial approval criteria (requirement for formulary agent failure or contraindication still applies).

DocumentationSee policy Section V dosing recommendations and criteria for combination therapy and species-specific considerations.

OpenPayer

Quinine Sulfate (Qualaquin) Coverage Criteria

Coverage Criteria

Coding and Dose Limits

Provider Actions and Requirements

Background and Pharmacology

Definitions and Clinical Notes