Appeal type: Prescription Drug
Decision: Partially Favorable

You asked the Plan to cover and provide a tiering exception for Lyrica 100 mg. The Plan did not grant this request. We received this case to conduct an independent review.In this case, the Plan's case file indicates coverage was approved for Lyrica for this enrollee as a formulary exception and the tiering exception request was denied due to off formulary drugs not being eligible for a tiering exception. However, the Plan's 2020 Formulary and the HPMS (Health Plan Management System)indicates the drug is on Tier 4 of the Plan's 2020 formulary with prior authorization criteria. We asked the Plan to verify the current formulary status of Lyrica 100 mg capsule and to provide supporting documentation. After several requests, the Plan failed to provide sufficient documentation showing the drug is not on the 2020 Formulary. Therefore, we reviewed the request based on available Plan documentation.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Lyrica 100 mg. The drug is requested to treat diabetic neuropathy. For coverage under the prescription drug benefit, Medicare requires that the drug prescribed be used for a medically accepted indication. Our Physician Reviewer found that the Medicare-approved resources do contain citations to support the use of the requested drug for treatment of the noted condition. Therefore, the requested drug is being prescribed for a medically accepted indication. The enrollee satisfies the Plan's coverage criteria. Our Physician Reviewer's opinion is that prior authorization criteria are met.Additionally, we asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for a tiering exception for Lyrica. The drug is requested to treat diabetic neuropathy. The drug is on tier four of the Plan's formulary. There are no available (branded, equivalent) lower tier drugs on the Plan'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.For coverage under Part D, Medicare requires that the drug must be prescribed for a medically accepted indication. A medically accepted indication means a use that is approved by the FDA or a use that is supported by one or more citations in Medicare approved compendia. Our Physician Reviewer reviewed this file and determined that there are citations in the Medicare approved compendia that support the use of Lyrica for the diagnosed condition. As a result, Lyrica is being prescribed for a medically accepted indication as defined by Medicare law.Medicare rules allow a Part D Plan to manage its formulary by requiring prior approval for certain drugs. Based on the available documentation, our Physician Reviewer's opinion is that prior approval criteria are met. Therefore, our decision is the Plan is required to cover Lyrica 100 mg.Medicare rules permit a Plan to grant an exception to its tiering structure so long as there is a drug of the same type (such as brand or biologic drugs when considering an exception for a brand or biologic drug) in a lower cost-sharing tier approved for treating the same condition that the higher cost-sharing tiered drug is being used to treat. Our Physician Reviewer's opinion is that tiering exception criteria are not met because there 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 Lyrica.