Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Xolair 150 mg. 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 Xolair 150 mg. The drug is requested to treat IgE mediated moderate persistent allergic asthma. 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. The following citation in DrugDex, a Medicare approved compendium, supports the use of the requested drug for the enrollee's condition: Omalizumab is indicated in patients 6 years or older with symptoms of moderate to severe persistent asthma not controlled by inhaled corticosteroids (ICS) and who have a positive skin test or in vitro reactivity to a perennial aeroallergen. Therefore, the requested drug is being prescribed for a medically accepted indication.Additional medical information was requested by the Part D QIC. The prescribing physician was asked to address the Plan's prior authorization criteria. The prescriber has clarified the enrollee's diagnosis as noted. The enrollee was inadequately controlled on Advair, Incruse Ellipta, Prednisone, and Montelukast. The prescriber states that the enrollee has been on Xolair since 2016 and that enrollee's asthma has improved on treatment with Xolair, with less to no exacerbation of her asthma. The prescribing physician has submitted reports of RAST testing and IgE level documenting positive blood test to at least one perennial aeroallergen and baseline IgE level of 149. The enrollee satisfies the Plan's coverage criteria. Our Physician Reviewer's opinion is that prior authorization criteria are met.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 citations in the Medicare approved compendia that support the use of Xolair 150 mg for the diagnosed condition. As a result, Xolair 150 mg is being prescribed for a medically accepted indication as defined by Medicare law.Medicare rules allow a Part D Plan to manage its formulary by requiring prior approval for certain drugs. Based on the available documentation, our Physician Reviewer's opinion is that prior approval criteria are met. Therefore, our decision is the Plan is required to cover Xolair 150 mg.Please note that if the Plan does not agree with our decision, they can ask us to open a case again. We only open a case again if we believe there was a mistake or if there is new information to review. The health plan has to show us the mistake and/or send us the new information. This does not happen often. If we decide to open the case again, we will notify you in writing that the case is being reviewed again and the outcome of the reopening.