Prior Auth Protocol

FDA Approved Indications:

For treatment of uncomplicated Plasmodium falciparum malaria.

Health Net Approved Indications and Usage Guidelines:

Diagnosis of P. falciparum

OR

Diagnosis of babesiosis

Coverage is Not Authorized For:

Prevention or treatment of nocturnal leg cramps
Non-FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature.

General Information:

According to the Black Box warning in the package insert, Qualaquin use for the treatment or prevention of nocturnal leg cramps may result in serious and life-threatening hematologic reactions, including thrombocytopenia and hemolytic uremic syndrome/thrombotic thrombocytopenic purpura (HUS/TTP). Chronic renal impairment associated with the development of TTP has been reported. The risk associated with Qualaquin use in the absence of evidence of its effectiveness in the treatment or prevention of nocturnal leg cramps outweighs any potential benefit.
The FDA approved additional product information concerning the use of quinine sulfate for the treatment or prevention of nocturnal leg cramps warns quinine sulfate may cause unpredictable serious and life-threatening hypersensitivity reactions, QT prolongation, serious cardiac arrhythmias, including torsades de pointes, and other serious adverse events requiring medical intervention and hospitalization. Fatalities have also been reported. The risk associated with the use of quinine sulfate in the absence of evidence of its effectiveness for the treatment or prevention of nocturnal leg cramps, outweighs any potential benefit in treating and or preventing this benign, self-limiting condition.
Health Net, Inc. has a position paper on the use of quinine sulfate for the treatment and prevention of nocturnal leg cramps that concludes the drug should not be used for this condition.
Qualaquin is contraindicated in patients with prolongation of QT interval, Glucose-6-phosphate dehydrogenase (G6PD) deficiency, myasthenia gravis, and optic neuritis.
Qualaquin is class IIa for babesiosis in Micromedex.

Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
atovaquone (Mepron^R)	Babesiosis 750 mg PO every 12 hours with azithromycin 500-1000 mg PO x1 followed by 250 mg PO QD for 7 to 10 days	10 days
chloroquine sulfate (Aralen^R)	P. falciparum 1 gram of the salt (600 mg base) PO, then 0.5 gram PO after 6-8 hours, then 0.5 gram PO QD for 2 days	3 days
atovaquone-proguanil (Malarone^R)	Uncomplicated malaria: 1 gram atovaquone/400 mg proguanil hydrochloride PO QD for 3 days	3 days
Coartem^R(artemether/lumefantrine)	P. falciparum: 80 mg artemether/480 mg lumefantrine PO initially and 8 hours later, then BID for a total of 6 doses in 3 days	Total of 6 doses over 3 days

* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
Qualaquin^R (quinine sulfate)	Malaria: 648 mg PO every 8 hours for 7 days Babesiosis: 650 mg PO every 6 to 8 hrs with clindamycin 600 mg PO every 8 hours for 7-10 days	Malaria: 7 days Babesiosis: 7-10 days

Product Availability:

Capsule: 324 mg

References:

Qualaquin [Prescribing Information] Philadelphia, PA: Mutual Pharmaceutical Company, Inc.; July 2014.
Quinine Sulfate. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed June 25, 2015.
Micromedex^R Healthcare Series [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed June 24, 2015.
Clinical Pharmacology Web site. Available at: http://clinicalpharmacology-ip.com. Accessed June 25, 2015.