Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Testosterone 1.62% Gel PKT 75/30. 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 1.62% Gel.Testosterone 1.62% Gel is requested for treatment of testicular hypofunction in this 71 year old man. The diagnosis requiring testosterone was initially stated to be late onset hypogonadism, the prescriber later stated that the enrollee has secondary hypogonadism based on a low total testosterone level (137, 67) with a low LH (luteinizing hormone) level of 0.8 (normal 1.6 - 15.2), and normal FSH (follicle stimulating hormone) level. The cause of the secondary hypogonadism was not stated, and additional endocrine testing was not submitted. There is a discrepancy in the information provided regarding the symptoms experienced by the enrollee. The prescriber's letter of appeal states that the enrollee complains of erectile dysfunction, decreased libido, hot flashes, and some fatigue; however the medical record submitted from a patient encounter on that date indicated that the enrollee had no complaints; It was specifically stated in the review of systems that the enrollee denied fatigue, muscle weakness, depression, and sweats, and there were no complaints of decreased libido or hot flashes noted. It was stated that the enrollee has ongoing erectile dysfunction at baseline which has worsened.In aging men, the predominant form of testosterone deficiency (TD) is mixed with primary and secondary hypogonadism components, Low serum testosterone with normal gonadotropin levels (consistent with secondary hypogonadism) is the most common hormonal pattern found during the work-up of hypogonadism in the aging male. It is noted that the enrollee is obese with a BMI (body mass index) of 35.1; obesity can impact sex hormone-binding globulin (SHBG). Free testosterone level was not submitted. Additionally, obesity can contribute to hypogonadotropic hypogonadism which can be reversible with weight reduction. The enrollee does not satisfy the Plan's coverage criteria. Although secondary hypogonadism is not inconsistent with age related hypogonadism, the markedly low total testosterone level is noted. However the prescriber has not indicated a specific condition causing the secondary hypogonadism, although as noted, obesity may contribute. The prescriber has not sufficiently addressed the Plan's coverage criteria and/or has not indicated why all alternatives required by the Plan would likely not be as effective for the enrollee as the requested drug, and/or would likely cause adverse reaction(s) or other harm to the enrollee. Our Physician's opinion is that neither prior authorization nor 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 not met. Therefore, the Plan is not required to cover Testosterone 1.62% Gel PKT 75/30.