Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Buprenorphine HCL 2 mg SL tablet. 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 Buprenorphine HCL 2 mg SL tablet. Buprenorphine HCL 2 mg SL tablet is requested for treatment ofsevere neuropathic pain associated with disabling depression in this 90 year old enrollee. The prescriberstates that the enrollee experiences severe constant neuropathic pain affecting her right upper arm and handwhich have significantly impacted her mobility and functional status. Additionally, the prescriber states thatthe enrollee has suffered from episodes of disabling depression since the early 1970's which was treatedeffectively up until 2 years ago. The prescriber states that the pain has severely affected the enrollee'smental and physical state and that all other options have been exhausted.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 other uses for the requested drug: Buprenorphine has caused substantial clinicalimprovement in a limited number of patients with refractory endogenous depression when administered asa sublingual tablet for several days. The following reference was cited: Emrich HM, Vogt P, Herz A.Possible anti-depressive effects of opioids: action of buprenorphine. Ann NY Acad Sci. 1982; 398:108-12.[PubMed 6760767]. This small double blind study included patients who met the criteria for majordepressive disorder and were largely non-responders to conventional therapy. The study was notable for50% of study participants demonstrating a significant response (as measured by an improvement inHamilton score) during the active treatment period with Buprenorphine which worsened after treatment.The study supports the use of the requested drug in this enrollee with marked worsening of her documentedlong history of endogenous depression. Therefore, the requested drug is being prescribed for a medicallyaccepted indication. The enrollee does not satisfy the Plan's coverage criteria. However, the prescriber hasindicated why all alternatives required by the Plan would likely not be as effective as the requested drug forthe enrollee, and/or would likely cause adverse reaction(s) or other harm to the enrollee. Therefore, anexception to the Plan's coverage criteria is medically necessary. Our Physician Reviewer's opinion is thatprior authorization exception 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 Buprenorphine HCL.