ModifiedmhnPolicy CP.PMN.262

Quinine Sulfate (Qualaquin)

Defines medical necessity, prior authorization, and coverage criteria for quinine sulfate (Qualaquin) for treatment of uncomplicated malaria and select off-label uses (e.g., babesiosis) for members across commercial, HIM, and Medicaid lines of business.

Policy Summary

Payermhn

PolicyQuinine Sulfate (Qualaquin)

Policy CodePolicy CP.PMN.262

Change TypeCoverage revisionsstep therapy bypass added/revised

Effective Date06.01.21

Next Review Date

Key ActionSubmit prior authorization with documentation showing diagnosis, prior formulary failure or contraindication, appropriate dosing (≤1,944 mg/day), and for babesiosis include clindamycin co-prescription.

SourceLink

POLICY UPDATE CHANGES

Added step therapy bypass for IL HIM per IL HB 5395 and later revised to apply to brand Qualaquin as well.

Revised policy/criteria to include generic quinine and expand coverable Plasmodium species (ovale, malariae, knowlesi) per CDC guidelines; updated babesiosis recommendation to require combination with clindamycin.

Removed Appendix D with supplemental links on malaria and babesiosis.

1,944 mg/dayMaximum daily dose

7 daysApproval duration for malaria

7-10 daysTypical babesiosis duration

Capsule 324 mg

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Product availability

06.25.25Most recent bypass revision

Coverage and Medical Necessity Criteria

Inv-01: Initial Approval — 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).

Malaria initial approval: 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 does not apply as of 1/1/2026 per IL HB 5395.)

Malaria initial approval: 3. If request is for brand Qualaquin, member must use generic quinine unless contraindicated or clinically significant adverse effects are experienced.

Malaria initial approval: 4. Dose does not exceed 1,944 mg (6 capsules) per day.Dose <= 1,944 mg/day

Approval duration: 7 days

Inv-02: Initial Approval — Babesiosis

Covered when ALL of the following are met

Babesiosis initial approval: 1. Diagnosis of babesiosis.

Babesiosis initial approval: 2. Prescribed in combination with clindamycin.

Babesiosis initial approval: 3. If request is for brand Qualaquin, member must use generic quinine unless contraindicated or clinically significant adverse effects are experienced.

Babesiosis initial approval: 4. Dose does not exceed 1,944 mg (6 capsules) per day.Dose <= 1,944 mg/day

Approval duration: Duration of request or 10 days (whichever is less); typical regimen 7-10 days

Inv-03: Other Indications / Off-label routing

Other uses: 1. If the drug has had a label change within the last 6 months not reflected in this policy, refer to the no coverage criteria or non-formulary policies for the relevant line of business as specified (see policy references).

Refer to CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16 as applicable

Other uses: 2. If the requested use (diagnosis, age, dosing) is not 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, HIM.PA.154, CP.PMN.53).

Inv-04: Covered Indications and Required Concomitant Therapy

Policy covers quinine sulfate (generic and brand Qualaquin) for malaria species and babesiosis with conditions per guidelines.

Malaria coverage expansion: Covers Plasmodium falciparum and Plasmodium vivax, and additionally Plasmodium ovale, Plasmodium malariae, and Plasmodium knowlesi as off-label coverable infections per CDC guidance.

Added in 2Q 2024

Babesiosis coverage: For babesiosis, quinine must be used in combination with clindamycin per IDSA and CDC guidance.

Requirement added per 2Q 2022 review

Formulation recognition: Policy explicitly recognizes both generic quinine sulfate and brand Qualaquin; requests should specify formulation and brand redirection to generic applies unless contraindicated or adverse effects are present.

This policy does not authorize coverage for prevention of malaria or for the treatment or prevention of nocturnal leg cramps. Non‑FDA approved indications not specifically addressed in this policy require supporting documentation of efficacy and safety and should be evaluated under the applicable off‑label use policy (see CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid).

Appendix D, which previously contained supplemental links on malaria and babesiosis, was removed from the policy materials and is no longer included with this document.

Qualaquin (quinine sulfate) is not authorized for the treatment or prevention of nocturnal leg cramps. The boxed warning indicates use for this indication may result in serious and life‑threatening hematologic reactions, including thrombocytopenia and hemolytic uremic syndrome/thrombotic thrombocytopenic purpura (HUS/TTP), and reports of chronic renal impairment associated with TTP have been described; the risk outweighs any potential benefit.

Within the coverage criteria portion of this document there is no separate, explicit section labeled “not medically necessary.” Coverage determinations and exclusions are described under the Diagnoses/Indications and Exclusions headings and through referenced contraindications and boxed warnings.

Dosing, Limits, and Coding

inv-09: Maximum daily dose — 1,944 mg/day

Maximum daily dose1,944 mg/day (does not exceed 1,944 mg / 6 capsules per day)

Malaria approval duration7 days

Babesiosis typical duration7-10 days (maximum 10 days)

Prior Authorization, Documentation, and Step Therapy

Prior Authorization

Prior Authorization Required

Prior authorization is required. For malaria initial approvals, the request must meet the listed diagnosis and clinical criteria (e.g., uncomplicated P. falciparum or specified off‑label Plasmodium species) and other policy conditions. For Illinois Health Insurance Marketplace (HIM) members, the step therapy requirement does not apply per IL HB 5395 (effective 01/01/2026) — a step therapy bypass is available for IL HIM requests.

IL HIM step therapy bypass effective 01/01/2026 per IL HB 5395
Step therapy generally requires failure of a formulary antimalarial unless contraindicated

Step Therapy

Step Therapy and IL HIM Bypass

Step therapy is required for malaria: members must have failed a formulary antimalarial (e.g., atovaquone‑proguanil, Coartem®, chloroquine, hydroxychloroquine, mefloquine) unless clinically significant adverse effects are documented, all are contraindicated, or the causative species is resistant. However, the Illinois HIM step therapy bypass applies as noted — the bypass was added per IL HB 5395 and was later revised to include brand Qualaquin as well as generic quinine.

Clinical Background and Drug Information

Quinine sulfate is an antimalarial agent indicated for treatment of uncomplicated Plasmodium falciparum infection and demonstrates activity in regions with chloroquine resistance. The policy also recognizes off‑label use for other uncomplicated Plasmodium species (including P. vivax, P. ovale, P. malariae, and P. knowlesi) per CDC guidance and for babesiosis when prescribed in combination with clindamycin. The document notes that both generic quinine and the brand formulation Qualaquin are addressed by the policy.

Terms and Formulation Definitions

inv-19: Qualaquin / quinine sulfate — brand name formulation identification

Brand identificationQualaquin is the brand name formulation of quinine sulfate

Drug classAntimalarial

FDA indication (brand)Qualaquin indicated for treatment of uncomplicated Plasmodium falciparum malaria

inv-20: G6PD — G6PD deficiency noted as contraindication due to hemolysis risk

ContraindicationGlucose-6-phosphate dehydrogenase (G6PD) deficiency

RationaleG6PD deficiency listed as contraindication due to risk of hemolysis

Other listed contraindications

Policy Changes and Revision Timeline

2021-02-15policy_created

Policy created (adapted from CP.PCH.10); Medicaid line of business added and requests specified as for generic formulation; references reviewed and updated.

2022-01-25clinical_update

Babesiosis criteria updated to require quinine be prescribed in combination with clindamycin per IDSA and CDC guidance.

2024-02-07coverage_expansion

Policy Summary

Payermhn

PolicyQuinine Sulfate (Qualaquin)

Policy CodePolicy CP.PMN.262

Change TypeCoverage revisionsstep therapy bypass added/revised

Effective Date06.01.21

Next Review Date

SourceLink

On This Page

Formulary failure required for initial malaria approval unless contraindicated
IL HIM bypass was revised to apply to brand Qualaquin in addition to generic quinine

Documentation Required

Documentation Required — Failure to Provide May Lead to Denial

Provider must submit documentation (such as office chart notes, laboratory results, or other clinical information) demonstrating that the member meets all approval criteria. Lack of adequate documentation (diagnosis, prior formulary failure or contraindication, dosing, or combination therapy where required) may result in denial of the request.

Include office notes, labs, and any prior therapy documentation showing failure or intolerance
Specify whether request is for generic quinine or brand Qualaquin and document reasons if brand requested

Prior Authorization

Babesiosis Combination Therapy Requirement

For babesiosis (off‑label) requests, therapy with quinine must be prescribed in combination with clindamycin per IDSA and CDC guidance; requests that do not document combination therapy may be noncompliant with policy and subject to denial.

Babesiosis approval requires documented diagnosis and concomitant clindamycin
Approval duration: duration of request or 10 days (whichever is less)

Prolongation of QT interval; myasthenia gravis; known hypersensitivity to quinine, mefloquine, or quinidine; optic neuritis

inv-21: Formulation — policy recognizes generic quinine and brand Qualaquin formulations

Formulations recognizedPolicy explicitly recognizes both generic quinine and brand Qualaquin formulations

Request specificationRequests should specify generic or brand formulation per policy; brand requests are redirected to generic unless contraindicated

Policy revisionsPolicy revised to include generic quinine and to apply step therapy bypass to both generic and brand formulations (per updates)

inv-22: Babesiosis combination therapy — definition that babesiosis treatment should be in combination with clindamycin per IDSA/CDC

Babesiosis therapy requirementBabesiosis must be treated with quinine in combination with clindamycin (per IDSA and CDC guidance)

Dosing regimen for babesiosisAdults: 648 mg PO TID with concurrent clindamycin PO or IV for 7-10 days; maximum dose 1,944 mg/day

Policy historyRequirement for combination therapy with clindamycin was added in 2Q 2022 and retained in subsequent reviews

Policy revised to include generic quinine and expand coverable off-label malaria species to include P. ovale, P. malariae, and P. knowlesi; malaria dosing recommendations in Section V updated.

2025-04-07policy_review_and_step_therapy_addition

2Q 2025 annual review removed Appendix D and added a step therapy bypass for Illinois HIM per IL HB 5395.

2025-06-25step_therapy_revisionLatest

Step therapy bypass for Illinois HIM revised to apply to both generic quinine and brand Qualaquin (removed prior specification limiting bypass to generic quinine).