Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Orenitram ER 2.5 mg tablet. 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 Orenitram ER 2.5 mg tablet.Orenitram ER 2.5 mg tablet is requested for ongoing treatment of severe pulmonary hypertension, which is in part related to primary pulmonary arterial hypertension (WHO Group 1). The enrollee has a complicated medical history; his clinical course, extensive evaluation, and prior treatment are well documented in the medical records. The documentation provided supports the prescriber's contention that the enrollee has primary pulmonary arterial pulmonary hypertension contributing to his severe pulmonary hypertension. On August 13, 2014, evidence of WHO group 2 pulmonary hypertension related to heart disease was documented on cardiac catheterization demonstrating a mean pulmonary artery pressure mean (PA mean) of 50 - 55, and pulmonary capillary wedge (PCW) pressure of 32 (at best); the prescriber has indicated that the noted cardiac catheterization was done prior to the initiation of hemodialysis (likely volume overloaded). The enrollee's symptoms worsened associated with acute worsening in echocardiogram in July 2018 prompting another cardiac catheterization in October 2018 which revealed markedly elevated pulmonary artery pressure (mean 53), normal PCW of 10, and elevated pulmonary vascular resistance (PVR) of 11.6. The patient was started on Sildenafil at that time; Abrisentan was later added with improvement. It is noted that the enrollee had worsening dyspnea in the last year. A repeat cardiac catheterization in October 2019 revealed a PA mean of 59, PCW of 12, and PVR of 11.8. Orenitram was added and uptitrated to 2.5 mg twice daily; the patient has noted a marked improvement on triple therapy. The prescriber states that the enrollee is stable on the current therapy, with a high risk of significant adverse clinical outcome with a medication change. 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 metA 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 Orenitram ER.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.