CurrentCentenePolicy CP.PMN.262

Quinine sulfate (Qualaquin) coverage and medical necessity criteria

Defines medical necessity, approval criteria, limitations, dosing, contraindications, and prior-authorization requirements for quinine sulfate (Qualaquin) for Commercial, HIM/ICHRA, and Medicaid lines of business under Centene policies.

Policy Summary

PayerCentene

PolicyQuinine sulfate (Qualaquin) coverage and medical necessity criteria

Policy CodePolicy CP.PMN.262

Change TypeRevisions & additions (coverage criteria, off-label indications, step therapy bypass, LOB added)

Effective DateJun 1, 2021

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results or other clinical information) supporting that member meets all approval criteria.

POLICY UPDATE CHANGES

For babesiosis, requirement added to use in combination with clindamycin per IDSA and CDC.

Revised policy to include generic quinine and added additional off-label malaria species (P. ovale, P. malariae, P. knowlesi) as coverable per CDC.

Added step therapy bypass for Illinois HIM per IL HB 5395 (effective 2026-01-01).

Added ICHRA line of business.

2Covered Indications (including off-label babesiosis)

3Off-label Plasmodium species added

1,944 mg/dayMaximum daily dose

7 days / up to 10 days

Typical approval durations (malaria / babesiosis)

Coverage Summary & Scope

Coverage stance: covered_with_criteria. This policy defines medical necessity and prior-authorization criteria for quinine sulfate (Qualaquin) and generic quinine for specified indications. Scope: applies to Commercial, HIM/ICHRA, and Medicaid lines of business and defines approval criteria, limitations, dosing, contraindications, and prior-authorization requirements. Subject: Quinine sulfate (Qualaquin) coverage and medical necessity criteria. Status: CURRENT. Effective date: 2021-06-01. Last review: 2026-05-26.

The policy covers Qualaquin (quinine sulfate) and generic quinine for treatment of uncomplicated Plasmodium falciparum malaria and, per CDC guidance adopted in the policy, also covers select off-label Plasmodium species (P. vivax, P. ovale, P. malariae, P. knowlesi) when criteria are met. The policy also provides coverage for babesiosis (off-label) when quinine is prescribed in combination with clindamycin per IDSA/CDC guidance. The policy notes boxed warnings and contraindications at a high level (see boxed warnings for use in nocturnal leg cramps and hematologic risks) and lists exclusions such as prevention of malaria and treatment/prevention of nocturnal leg cramps. Additional programmatic details include step therapy requirements (with Illinois HIM bypass per IL HB 5395 effective 2026-01-01) and a maximum daily dose threshold of <= 1,944 mg/day.

Covered Indications (count)2

Off-label Plasmodium species coveredP. vivax, P. ovale, P. malariae, P. knowlesi (3 off-label species added in brief stats)

Maximum daily dose<= 1,944 mg/day (6 capsules of 324 mg)

Typical approval durationsMalaria: 7 days; Babesiosis: duration of request or up to 10 days

I. Initial Therapy Criteria

I. Initial Approval Criteria

Covered when ALL of the following are met:

ALL of the following

Diagnosis (one of)
- Uncomplicated Plasmodium falciparum malaria
- Uncomplicated Plasmodium vivax malaria (off-label)
- Uncomplicated Plasmodium ovale malaria (off-label)
- Uncomplicated Plasmodium malariae malaria (off-label)

II. Continued Therapy / Re-authorization

II. Continued Therapy

Conditions for re-authorization / continuation

ALL of the following

Re-authorization is not permitted for Malaria or Babesiosis (member must meet initial approval criteria).
For other diagnoses/indications, refer to label-change or off-label policies as described in I.C

Denial Risk

Re-authorization not permitted

Re-authorization is not permitted for malaria or babesiosis. Continuing therapy beyond the initial approval requires a new authorization and the member must meet the initial approval criteria; requests for continuation that do not meet this requirement risk denial.

III. Diagnoses/Indications Not Covered

III. Diagnoses/Indications for which coverage is NOT authorized

ANY of the following

Non-FDA approved indications not addressed in this policy unless sufficient documentation of efficacy and safety per off-label use policy or evidence of coverage
Prevention of malaria
Treatment or prevention of nocturnal leg cramps

The product carries a boxed warning that use of Qualaquin for the treatment or prevention of nocturnal leg cramps may result in serious and life‑threatening hematologic reactions (including thrombocytopenia and HUS/TTP) and that the risks outweigh any potential benefit because effectiveness for leg cramps is not established. Because of these risks and the lack of demonstrated benefit, the policy explicitly excludes treatment or prevention of nocturnal leg cramps from coverage.

The policy further excludes non‑FDA approved indications not addressed in the policy unless there is sufficient documentation of efficacy and safety per the off‑label use policies; nocturnal leg cramps are specifically listed among diagnoses/indications for which coverage is not authorized.

Applicable Codes

NDC / product codesNDC

No codes listed

Provider Actions & Billing Guidance

Documentation Required

Submit clinical documentation

Submit clinical documentation (office chart notes, laboratory results, or other clinical information) that demonstrates the member meets all initial approval criteria for quinine/Qualaquin.

Office chart notes
Laboratory results
Other relevant clinical information

Prior Authorization

Prior authorization required for quinine/Qualaquin

Prior authorization is required for quinine/Qualaquin and requests must meet the policy criteria. Approval durations: malaria — 7 days; babesiosis — duration of request or 10 days (whichever is less).

Clinical Evidence & References

Primary source cited in the policy: Qualaquin Prescribing Information, Mutual Pharmaceutical, June 2019 (accessed January 23, 2026).

Guideline and reference support used to inform coverage decisions include the CDC malaria treatment tables and CDC clinical care guidance for babesiosis, as well as the IDSA 2020 guideline on diagnosis and management of babesiosis (Krause et al.).

These sources are referenced in the policy rationale for coverable malaria species, dosing recommendations, and the requirement that babesiosis treatment include concurrent clindamycin.

Background & Definitions

Qualaquin (quinine sulfate) is an antimalarial indicated for treatment of uncomplicated Plasmodium falciparum malaria and is effective in areas with documented chloroquine resistance. The label notes Qualaquin is not approved for treatment of severe or complicated P. falciparum malaria, not approved for prevention of malaria, and not approved for treatment or prevention of nocturnal leg cramps.

The prescribing information includes boxed warnings that use of Qualaquin for nocturnal leg cramps may cause serious, life‑threatening hematologic reactions (including thrombocytopenia and HUS/TTP) and reports of chronic renal impairment associated with TTP; because effectiveness for leg cramps is lacking, the risks outweigh potential benefit.

Dosing: capsules are 324 mg each with a maximum daily dose of 1,944 mg/day; malaria dosing recommendations reference combination therapy (e.g., doxycycline, tetracycline, or clindamycin) and babesiosis dosing is 648 mg PO TID with clindamycin for 7–10 days (off‑label).

Term	Definition
{"text":"G6PD","status":""},{"text":"glucose-6-phosphate dehydrogenase","status":""}
{"text":"HUS/TTP","status":""},{"text":"hemolytic uremic syndrome / thrombotic thrombocytopenic purpura","status":""}

Revision History

2022-01-25policy_change

For babesiosis, requirement added to use in combination with clindamycin per IDSA and CDC. (P&T Approval 2022-05-22).

2024-02-07policy_change

Revised policy to include generic quinine and added additional off-label malaria species (P. ovale, P. malariae, P. knowlesi) as coverable per CDC. (P&T Approval 2024-05-24).

2025-04-07policy_change

Added step therapy bypass for Illinois HIM per IL HB 5395 (recorded 2025-04-07; revised 2025-06-25 to apply bypass to brand Qualaquin).

Policy Summary

PayerCentene

PolicyQuinine sulfate (Qualaquin) coverage and medical necessity criteria

Policy CodePolicy CP.PMN.262

Change TypeRevisions & additions (coverage criteria, off-label indications, step therapy bypass, LOB added)

Effective DateJun 1, 2021

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results or other clinical information) supporting that member meets all approval criteria.

On This Page

Uncomplicated Plasmodium knowlesi malaria (off-label)

Failure of a formulary antimalarial agent (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 Illinois HIM requests, the step therapy requirements above do not apply as of 2026-01-01 per IL HB 5395; see Step therapy requirement for malaria callout for details.

If request is for brand Qualaquin, member must use generic quinine, unless contraindicated or clinically significant adverse effects are experienced

Dose does not exceed 1,944 mg (6 capsules) per day<= 1,944 mg/day

I.B Initial Approval Criteria — Babesiosis (off-label)

Covered when ALL of the following are met:

ALL of the following

Diagnosis of babesiosis
Prescribed in combination with clindamycin
If request is for brand Qualaquin, member must use generic quinine, unless contraindicated or clinically significant adverse effects are experienced
Dose does not exceed 1,944 mg (6 capsules) per day<= 1,944 mg/day

Step Therapy

Step therapy requirement for malaria

Failure of a formulary antimalarial agent is required prior to coverage of quinine for malaria, unless there is a documented contraindication, clinically significant adverse effects, or documented species resistance. Illinois HIM (IL HB 5395) step therapy bypass effective 2026-01-01: step therapy requirements do not apply to Illinois HIM requests. Note: the step therapy bypass was revised to apply to brand Qualaquin effective 2025-06-25.

Effective date: 2026-01-01 (IL HIM step therapy bypass)
Impacted line(s) of business: Illinois HIM

Prior Authorization

Prior authorization required for quinine/Qualaquin

Prior authorization is required for quinine (generic) and Qualaquin (brand). Typical approval durations: malaria — 7 days; babesiosis (off-label) — duration of request or 10 days, whichever is less. Providers must obtain prior authorization before initiating therapy when required by the plan.

Documentation Required

Submit clinical documentation

Submit office chart notes, laboratory results, and any other clinical documentation supporting that the member meets all approval criteria (diagnosis, prior therapy or contraindication to formulary agents, concomitant clindamycin for babesiosis, dosing).

Step Therapy

Step therapy requirement for malaria

Failure of a formulary antimalarial agent is required prior to quinine unless there are clinically significant adverse effects, all formulary agents are contraindicated, or the causative species is resistant. Illinois HIM step therapy bypass applies as of 2026-01-01 per IL HB 5395 and was revised 2025-06-25 to apply to brand Qualaquin as well. For brand Qualaquin requests, members must use generic quinine first unless contraindicated or clinically significant adverse effects occur.

Denial Risk

Re-authorization not permitted

Re-authorization is not permitted for malaria or babesiosis. A new authorization meeting the initial approval criteria is required for any continuing therapy; failure to provide evidence meeting initial criteria may result in denial.

2026-03-30policy_changeLatest

Added ICHRA line of business. (P&T Approval 2026-05-26).