Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Testosterone 1.62% gel packet. The Plan did not grant this request. Wereceived this case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Testosterone 1.62% gel. Testosterone 1.62% gel is requested for treatment of symptomatic acquiredsecondary hypogonadism (hypogonadotropic hypogonadism) in this 66-year-old man which the prescriberhas indicated is related to long standing Crohn's disease, malabsorption, and chronic steroid use. It is notedthat free testosterone from 10/25/2019 was 4.8 (normal 6.6-18.1). LH and FSH were in the high normalrange. The prescriber has indicated that the enrollee is symptomatic with decreased wellbeing, low energy,low libido, and osteoporosis (bone mineral density -3.9 in the lumbar spine) with multiple vertebralfractures. The prescriber has indicated that osteoporosis is related to corticosteroids and hypogonadism, andthat testosterone replacement can improve bone mineral density, as well as improve other symptoms relatedto hypogonadism. The bloodwork supports the diagnosis of secondary hypogonadism, and it is welldocumented that chronic systemic disease and malnutrition are causes of acquired secondaryhypogonadism.For coverage under the prescription drug benefit, Medicare requires that the drug prescribed be used for amedically accepted indication. Our Physician Reviewer found that the Medicare-approved resources docontain citations to support the use of the requested drug for treatment of the noted condition. AmericanHospital Formulary Service Drug Information (AHFS DI) makes the following statement in theirdiscussion about the use of testosterone to treat hypogonadism: In males, testosterone is used for themanagement of congenital or acquired primary hypogonadism such as that resulting from orchiectomy orfrom testicular failure caused by cryptorchidism, bilateral torsion, orchitis, or vanishing testis syndrome.Testosterone also is used in males for the management of congenital or acquired hypogonadotropichypogonadism such as that resulting from idiopathic gonadotropin or gonadotropin-releasing hormone(luteinizing hormone releasing hormone) deficiency or from pituitary-hypothalamic injury caused bytumors, trauma, or radiation. The wording utilized, management of congenital or acquiredhypogonadotropic hypogonadism SUCH AS that resulting from... 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; however, the prescriber has indicated why allalternatives 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 thePlan's coverage criteria is medically necessary. Our Physician Reviewer's opinion is that prior authorizationexception criteria are met.Medicare rules allow a Part D Plan to manage its formulary by requiring prior approval for certain drugs. APlan must grant an exception to prior approval rules if it determines that the requested drug is medicallynecessary, consistent with the prescriber's statement. Based on the available documentation, our PhysicianReviewer's opinion is that an exception to prior approval criteria is met. Therefore, our decision is the Planis required to cover Testosterone 1.62% gel packet.