Appeal type: Prescription Drug
Decision: Favorable

You asked the Plan to cover Gabapentin 100 mg, 180 per 30 days. 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 Gabapentin 100 mg, 180 per 30 days. The drug is requested to treat neuropathic pain due to spinal injury. For coverage under the prescription drug benefit, Medicare requires that the drug prescribed be used for a medically accepted indication. American Hospital Formulary Service Drug Information (AHFS DI) cites the following reference in their discussion about the use of Gabapentin for treatment of Other Types of Neuropathic Pain: Serpell MG. Gabapentin in neuropathic pain syndromes: a randomized, double-blind, placebo-controlled trial. Pain. 2002; 99:557-66. [PubMed 12406532]. This double-blind, randomized, placebo-controlled 8-week study was conducted to evaluate the efficacy and safety of Gabapentin in the treatment of neuropathic pain, using doses up to 2400 mg/day. The study used a novel design that was symptom- rather than syndrome-based; an approach that aimed to reflect the realities of clinical practice. Participants had a wide range of neuropathic pain syndromes, with at least two of the following symptoms: allodynia, burning pain, shooting pain, or hyperalgesia. The study concluded that Gabapentin reduces pain and improves some quality-of-life measures in patients with a wide range of neuropathic pain syndromes. This study supports the use of Gabapentin for treatment of neuropathic pain irrespective of the etiology of the symptoms. 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 Plan limits the amount of the drug to 90 capsules per 30 days. The prescriber stated that the enrolleerequires 200 mg three times a day and that if the plan were to offer 200 mg capsules then they would writefor it. However, the Plan does not offer 200 mg capsules and as such the prescriber must write for a total ofsix 100 mg capsules per day. The prescriber went on to state that in the future a taper may be possible. Theprescriber stated that on the current dosing schedule the enrollee has progressed through rehabilitation andphysical therapy and gained greater functional status.The prescriber has indicated that the number of doses of the requested drug allowed by the Plan has beenineffective in treating the enrollee's condition. Therefore, an exception to the Plan's coverage criteria ismedically necessary. Our Physician Reviewer's opinion is that quantity limit exception criteria are met.Medicare rules allow a Part D Plan to manage its formulary by covering a limited quantity of certain drugs.A Plan must grant an exception if it determines that the requested dosage is medically reasonable andnecessary, consistent with the prescriber's statement. Based on a review of the available documentation,our Physician Reviewer's opinion is that an exception to the quantity limit criteria is met. Therefore, thePlan is required to cover the requested quantity of Gabapentin 100 mg, 180 per 30 days.