Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Testosterone 25 mg/2.5 gm packet as prescribed. 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 Testosterone 25 mg/2.5 gm.Testosterone 25 mg/2.5 gm packet is requested for ongoing treatment of primary idiopathic hypogonadism. The enrollee's endocrinologist states that the enrollee was diagnosed with the stated condition at the age of 60 with multiple low testosterone levels and an elevated LH (leutinizing hormone) level consistent with primary hypogonadism without obvious cause. The prescriber states that the enrollee had multiple symptoms related to the low testosterone level which have been effectively treated with testosterone replacement. The prescriber has specifically stated that this enrollee does not have late onset/age related hypogonadism.Acquired causes of primary hypogonadism include idiopathic (reference UpToDate). 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. American Hospital Formulary Service Drug Information (AHFS DI) makes the following statement in their discussion about the use of testosterone to treat hypogonadism: In males, testosterone is used for the management of congenital or acquired primary hypogonadism such as that resulting from orchiectomy or from testicular failure caused by cryptorchidism, bilateral torsion, orchitis, or vanishing testis syndrome. The citation specifically states management of congenital or acquired conditions such as that resulting from...The wording utilized, such as, indicates that the list is not exhaustive. Therefore, the requested drug is being prescribed for a medically accepted indication.The enrollee does not satisfy the Plan's coverage criteria. 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 prior authorization exception criteria are met.Medicare rules allow a Part D Plan to manage its formulary by requiring prior approval for certain drugs. A Plan must grant an exception to prior approval rules if it determines that the requested drug is medically necessary, consistent with the prescriber's statement. Based on the available documentation, our Physician Reviewer's opinion is that an exception to prior approval criteria is met. Therefore, our decision is the Plan is required to cover Testosterone 25 mg/2.5 gm packet as prescribed.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.