Pharmacy Prior Authorization Criteria

Antimalarial Agents

Indications for Prior Authorization

Qualaquin (quinine sulfate)

• For diagnosis of Malaria
  Indicated only for treatment of uncomplicated Plasmodium falciparum malaria. Quinine sulfate has been shown to be effective in geographical regions where resistance to chloroquine has been documented.

  Limitations of Use:

  1) Not approved for patients with severe or complicated P. falciparum malaria.

  2) Not approved for prevention of malaria.

  3) Not indicated for the prevention or treatment of nocturnal leg cramps.

Criteria

Brand Qualaquin, Generic quinine sulfate

*Nocturnal leg cramp is an off-label use.

Prior Authorization

For diagnosis of Nocturnal Leg Cramps*

• Requests for coverage when used solely for the treatment or prevention of nocturnal leg cramps are not authorized and will not be approved [1, C]

Brand Qualaquin, Generic quinine sulfate

*Call the Malaria Hotline (770-488-7788) for additional information if needed.

Prior Authorization

Length of Approval: 7 days [1]
For diagnosis of Malaria

• Diagnosis of uncomplicated malaria
AND
• One of the following:
• Both of the following:
• Treatment in areas of chloroquine-sensitive malaria [2-4, A]*
AND
• Trial and failure, contraindication or intolerance to one of the following:
• chloroquine
• hydroxychloroquine
OR
• Treatment in areas of chloroquine-resistant malaria [2-4, B]*

P & T Revisions

2024-05-20, 2023-05-03, 2022-05-04, 2021-06-28, 2021-05-21, 2020-06-18, 2020-01-29

References

1. Qualaquin Prescribing Information. Sun Pharmaceutical Industries, Inc. Cranbury, NJ. August 2019.
2. Center for Disease Control Traveler's Health - Yellow Book 2020 edition. Chapter 4: Infectious diseases related to travel - malaria. Available at: https://wwwnc.cdc.gov/travel/yellowbook/2020/travel-related-infectious-diseases/malaria. Accessed May 1, 2024.
3. Center for Disease Control. Guideline for treatment of malaria in the United States. Available at: http://www.cdc.gov/malaria/diagnosis_treatment/treatment.html. Accessed May 1, 2024.
4. Griffith KS, Lewis LS, Mali S, Parise ME. Treatment of malaria in the United States. A systematic review. JAMA. 2007;297(20):2264-77.

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End Notes

1. Areas of chloroquine-sensitive malaria include: Central America west of the Panama Canal, Haiti and the Dominican Republic. [2-4]
2. Areas of chloroquine-resistant malaria include: Southeast Asia, and all malarious regions except those specified as chloroquine-sensitive listed in Endnote A. [2-4]
3. Quinine is not approved for and should not be used for the prophylaxis or treatment of nocturnal leg cramps. Quinine may cause unpredictable serious and life-threatening hematologic reactions including thrombocytopenia and hemolytic-uremic syndrome/thrombotic thrombocytopenic purpura (HUS/TTP) in addition to hypersensitivity reactions, QT prolongation, serious cardiac arrhythmias including torsades de pointes, and other serious adverse events requiring medical intervention and hospitalization. Chronic renal impairment associated with the development of TTP, and fatalities have also been reported. The risk associated with the use of quinine in the absence of evidence of its effectiveness for treatment or prevention of nocturnal leg cramps, outweighs any potential benefit in treating and/or preventing this benign, self-limiting condition. [1]

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Revision History

• 2024-05-20: 2024 annual review. Background changes.
• 2023-05-03: Annual review - updated references.
• 2022-05-04: Annual review - updated references.
• 2021-06-28: Annual review, updated background and references.
• 2021-05-21: Addition of EHB formulary to guideline, no changes to criteria
• 2020-06-18: Annual review - no changes to clinical criteria, updated references.
• 2020-01-29: Clarified in a new excluded uses section that PA will not be approved if being used solely for the treatment or prevention of nocturnal leg cramps

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