Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Stimate 150 mcg spray. 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 Stimate 150 mcg spray. Stimate is requested for ongoing use as needed for excessive bleeding in this enrollee with VonWillibrand's disease, type II. The prescriber states that the enrollee has used Stimate 150 mcg spray since 2005, and that it has been effective to stop bleeding. Although the prescriber initially stated that the Plan's generic nasal Desmopressin alternative would be an appropriate alternative, the prescriber has subsequently indicated that the formulary alternative is not at an appropriate dosage for this enrollee - the prescribed drug provides 15 times the amount of active drug per actuation compared to the generic formulation. The Plan subsequently denied coverage because they determined that the requested drug is not being prescribed for a medically accepted indication.For coverage under the prescription drug benefit, Medicare requires that the drug prescribed be used for a medically accepted indication. The medical records indicate that the enrollee has been diagnosed with Type II VonWillibrand's; the requested drug is only FDA approved for use in patients with type I. However, 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. AHFSDI (American Hospital Formulary Services Drug Information) states the following in its USES section in its discussion about the treatment of VonWillibrand's disease: Desmopressin Acetate may be effective for the management of bleeding in some, but not all, individuals with type 2A, 2M, or 2N von Willebrand disease. Although Desmopressin Acetate reportedly has been used effectively in some patients with type 2B VonWillebrand disease, the drug usually is not used in these individuals because of an increased risk of thromboembolic events. Although the prescriber has not indicated which subclass of type II disease this enrollee has, there are only 4 types which are all addressed in the noted citation. As noted, the drug has been effective and well tolerated in this patient for 15 years. Therefore, the requested drug is being prescribed for a medically accepted indication.The prescriber has indicated why all alternatives required by the Plan would likely not be as effective as the requested drug for the enrollee, and/or would likely cause adverse reaction(s) or other harm to the enrollee. Therefore, an exception to the Plan's coverage criteria is medically necessary. Our Physician Reviewer's opinion is that formulary exception criteria are met.A Plan must grant an exception for a drug that is not on its formulary if it determines that the requested drug is medically necessary, consistent with the prescriber's statement. Based on a review of the available documentation, our Physician Reviewer's opinion is that formulary exception criteria are met. Therefore, the Plan is required to cover Stimate 150 mcg spray.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.