Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Quinine Sulfate. The Plan did not grant this request. We received this case to conduct an independent review.   We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Quinine Sulfate. The drug is requested to treat leg cramps and spasms with chronic pain in the hips and lower back, which are off-label (non-FDA approved) uses. The Medicare-approved compendia do not support the use of this drug for treatment of the noted conditions due to serious safety concerns. The following citation in DrugDex, a Medicare approved compendium states:  Summary:  Qualaquin(R) (quinine sulfate oral capsule) is not approved for and should not be used for the prophylaxis or treatment of nocturnal leg cramps [25][27]. Qualaquin(R) (quinine sulfate oral capsule) is not approved for prophylaxis or treatment of nocturnal leg cramps. Use has been associated with serious and life-threatening hematological adverse events (eg, thrombocytopenia, hemolytic-uremic syndrome/thrombotic thrombocytopenia purpura), with some cases resulting in chronic renal impairment, hospitalization, and death.  The risk associated with the use of quinine outweighs the benefits for the treatment or prevention of leg cramps [25]. Therefore, it should not be used for the prophylaxis or treatment of nocturnal leg cramps [27].   25. Product Information: QUALAQUIN(R) oral capsules, quinine sulfate oral capsules. AR Scientific, Inc. (per FDA), Philadelphia, PA, 2013.   27. US Food and Drug Administration: FDA Drug Safety Communication: New risk management plan and patient Medication Guide for Qualaquin (quinine sulfate). US Food and Drug Administration. Rockville, MD. 2010. Available from URL: http://www.fda.go. As accessed 2010-07-08.   Therefore, this drug is not being prescribed for a medically accepted indication as defined by Medicare law. As such, an exceptions request based on medical necessity cannot be considered because the requested drug, as prescribed, does not meet the definition of a Medicare Part D drug. Therefore, the requested drug is not eligible for coverage under Medicare Part D for the noted conditions . For coverage under Part D, Medicare requires that the drug must be prescribed for a medically accepted indication. A medically accepted indication means a use that is approved by the FDA or a use that is supported by one or more citations in Medicare approved compendia.   Our Physician Reviewer reviewed this file and determined that there are no citations in the Medicare approved compendia that support the use of Quinine Sulfate for the diagnosed conditions. As a result, the drug is not being prescribed for a medically accepted indication as defined by Medicare law. As such, it cannot be covered under the Medicare Part D benefit for these conditions. An exceptions request based on medical necessity cannot be considered because this drug, as prescribed, does not meet the definition of a Medicare Part D drug. Therefore, our decision is that the Plan is not required to provide coverage for Quinine Sulfate.  This decision does not concern the medical necessity of the requested drug. It only establishes if payment can be made under the Medicare Part D benefit.