Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover and provide a tiering exception for Mesalamine DR 800 mg, Lialda DR 1.2gm, Apriso ER 0.375 gm, Asacol DR (Brand) 1.2 gm. and Mesalamine DR 1.2 gm. The Plan did not grantthis request. We received this case to conduct an independent review.Mesalamine DR 800, Lialda DR 1.2 gm, Apriso ER 0.375 gm, Asacol DR (Brand) 1.2 gm:We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Mesalamine DR 800 mg. The drug is requested to treat ulcerative colitis. You have not indicated whyall alternatives required by the Plan (Balsalazide capsule and Mesalamine DR 1.2 gram tablet) would likelynot be as effective for the enrollee as the requested drug; and/or would likely cause adverse reaction(s) orother harm to the enrollee. Therefore, an exception to the Plan's coverage criteria is not supported. OurPhysician Reviewer's opinion is that formulary exception criteria are not met.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Lialda DR 1.2 gm. The drug is requested to treat ulcerative colitis. You have not indicated why allalternatives required by the Plan (Balsalazide capsule and Mesalamine DR 1.2 gram tablet) would likelynot be as effective for the enrollee as the requested drug; and/or would likely cause adverse reaction(s) orother harm to the enrollee. Therefore, an exception to the Plan's coverage criteria is not supported. OurPhysician Reviewer's opinion is that formulary exception criteria are not met.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Apriso ER 0.375 gm capsule. The drug is requested to treat ulcerative colitis. You have not indicatedwhy all alternatives required by the Plan (Balsalazide capsule and Mesalamine DR 1.2 gram tablet) wouldlikely not be as effective for the enrollee as the requested drug; and/or would likely cause adversereaction(s) or other harm to the enrollee. Therefore, an exception to the Plan's coverage criteria is notsupported. Our Physician Reviewer's opinion is that formulary exception criteria are not met.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor Asacol DR (Brand) 1.2 gm tablet. The drug is requested to treat ulcerative colitis. You have notindicated why all alternatives required by the Plan (Balsalazide capsule and Mesalamine DR 1.2 gramtablet) would likely not be as effective for the enrollee as the requested drug; and/or would likely causeadverse reaction(s) or other harm to the enrollee. Therefore, an exception to the Plan's coverage criteria isnot supported. Our Physician Reviewer's opinion is that formulary exception criteria are not met.A Plan must grant an exception for a drug that is not on its formulary if it determines that the requesteddrug is medically necessary, consistent with the prescriber's statement. Based on a review of the availabledocumentation, our Physician Reviewer's opinion is that formulary exception criteria are not met.Therefore, the Plan is not required to cover Mesalamine DR 800 mg, Lialda DR 1.2 gm, Apriso ER 0.375gm, Asacol DR (Brand) 1.2 gm.Please note: the request for a tiering exception (lower copayment) for Mesalamine DR 800 mg, Lialda DR1.2 gm, Apriso ER 0.375 gm, Asacol DR (Brand) 1.2 g. was not reviewed. We cannot consider a tieringexception for a drug for which the Part D Plan is unable to provide coverage.Mesalamine DR 1.2 gm:We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the requestfor a tiering exception for Mesalamine DR 1.2 gm. The drug is requested to treat the enrollee's condition.The drug is a generic drug on Tier 4 of the Plan's formulary. There are no available lower tier drugs on thePlan's formulary to treat the enrollee's condition. Therefore, the drug is not eligible for a tiering exception.Our Physician Reviewer's opinion is that tiering exception criteria are not met.Medicare rules permit a Plan to grant an exception to its tiering structure so long as there is a drug of thesame type (such as brand or biologic drugs when considering an exception for a brand or biologic drug) in alower cost-sharing tier approved for treating the same condition that the higher cost-sharing tiered drug isbeing used to treat. Our Physician Reviewer's opinion is that tiering exception criteria are not met becausethere are no lower cost-sharing tiered drugs of the same type for treating the enrollee's condition.Therefore, our decision is the Plan is not required to provide a tiering exception for Mesalamine DR 1.2gm.