Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Pentamidine Isethionate (Nebupent). 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 Pentamidine Isethionate (Nebupent) 300 mg. Pentamidine Isethionate (Nebupent) 300 mg is requested for prophylaxis of Pneumocystis Jirovecii (P. Carnii) pneumonia (PCP/PJP) in this enrollee felt to be at high risk for developing PCP/PJP because of ongoing use of immunosuppressive medications following kidney transplant on November 1, 2020. You have explained why other treatment options are not medically appropriate for this enrollee. It is noted that the enrollee is receiving the requested medication via nebulizer at home. The Plan indicated in their denial letters that the requested drug may be eligible for coverage under Medicare Part B, and that the enrollee's condition is not a medically accepted indication for the use of the requested drug per Medicare Part D regulations.  The Medicare Part B regulations do not indicate that the requested drug is eligible for coverage under Medicare Part B for the stated diagnosis; therefore the requested drug is eligible for coverage under Medicare Part D. For coverage under the prescription drug benefit, Medicare requires that the drug prescribed be used for a medically accepted indication. Our Physician Reviewer found that the Medicare-approved resources do contain citations to support the use of the requested drug for treatment of the noted condition. Drugdex states the following in their Adult Dosing section for the requested drug (Quick Answers view only): Orphan drug designation: Prevention of Pneumocystis carinii pneumonia in patients at high risk of developing the disease. The orphan drug designation is not limited to any particular medical condition rendering the patient high risk for developing PCP/PJP. As such, the requested drug is being prescribed for a medically accepted indication. The enrollee satisfies the Plan's coverage criteria which only requires determination of Medicare Part B vs Medicare Part D coverage. As noted, the requested drug is not eligible for coverage under Medicare Part B for this enrollee's diagnosis. Our Physician Reviewer's opinion is that prior authorization criteria are met.  Medicare law specifically excludes coverage for any drug for which payment would be available under Part A or Part B of Medicare for that individual. Medicare Part B may pay for supplies necessary for the effective use of durable medical equipment, including drugs and biologicals which must be put directly into the equipment in order to achieve the therapeutic benefit of the durable medical equipment. Medicare Part B local policy states that a small volume nebulizer and related compressor are covered when medically necessary to administer Pentamidine Isethionate (Nebupent) for the management of Pneumocystis Jirovecii (P. Carnii) pneumonia (PCP/PJP).  In this case, the record shows that Pentamidine Isethionate (Nebupent) is administered for a diagnosis of prophylaxis of Pneumocystis Jirovecii (P. Carnii) pneumonia (PCP/PJP). Medicare Part B does not provide coverage for Pentamidine Isethionate (Nebupent) for this diagnosis. Thus, Pentamidine Isethionate (Nebupent) would not be eligible for Part B coverage in this case. We therefore asked our Physician Reviewer to determine if Part D coverage criteria have been met.