Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Myelomalacia, Parkinson's disease.
Treatment: Dalfampridine ER (extended release) 10 MG (milligram) tablet, Quantity: 30 - Day supply: 30).

The insurer denied Dalfampridine ER (extended release) 10 MG (milligram) tablet, Quantity: 30 - Day supply: 30).  The denial is upheld.

The records indicate that the patient is an adult male. He has a history of cervical spinal cord injury years ago while windsurfing. More recently, there has been progressive neurological decline, due to myelomalacia in the setting of progressive spinal arthropathy and myelopathy for which he has undergone multiple surgical procedures for the past three years. He has also been diagnosed with Parkinson's disease. The patient has had spasticity affecting both arms and legs. He was taking baclofen 5 milligrams three times a day, then the dose was increased to 10 milligrams, 10 milligrams, and 5 milligrams, which he tolerated.

Three months ago, the patient asked a physician again about dalfampridine. He was felt to be an excellent candidate for this medication, "given the incomplete status of his neurological condition and likelihood that he would benefit positively from the agent." He was working with physical therapy. Two months ago, he was noted to now be taking dalfampridine (10 milligrams in the mornings), with "no reports of adverse effects or other complaints." Later in the month, he was noted to be taking dalfampridine 10 milligrams twice per day and tolerating the increased dose without difficulty. He was working with physical therapy. Last month, the patient was noted to be taking dalfampridine and tolerating the medication without difficulty. His spasticity was stable. He was also on baclofen 10 milligrams three times per day. The health plan denied coverage of the service under review (dalfampridine), indicating that the 
service is not covered in the absence of a qualifying condition (i.e., multiple sclerosis). The reason for appeal is that the physician believes that the patient would benefit from the medication.

The Dalfampridine is not medically necessary.

Dalfampridine is an extended-release form of 4-aminopyridine (4-AP), which is a potassium channel blocker used to block potassium channels in the central nervous system in order to improve conduction in focally demyelinated axons (1).  The medical literature, notably, largely supports their use in this clinical setting (i.e., multiple sclerosis) and dalfampridine has earned United States Food and Drug Administration (FDA) approval for use for persons with multiple sclerosis (2,3). 4-AP (4-aminopyridine) and its extended-release form have also been the subject of study for the management of chronic spinal cord injury, particularly in persons who have incomplete cord injuries. The support in the literature for this indication, however, is less robust. A systematic review in November 2022 only identified 10 primary studies for this patient population, with a median sample size of 23 participants. The studies that were identified were short-term studies investigating a heterogeneous selection of outcomes (essentially precluding formal meta-analysis) with promising albeit variable results (4). The authors of this review concluded that there is "a dearth of literature on the efficacy and safety of 4-AP [4-aminopyridine] in treating individuals with traumatic [spinal cord injury]," and further trials with larger sample sizes were opined to be needed. The clinical effectiveness of this intervention for this indication remains under investigation. There are no unique issues in the present clinical case moreover to warrant an exception to the lack of definitive literature on the subject matter. The patient in this case has been responding and tolerating oral baclofen for spasticity management as well as physical therapy. There are no convincing data presented that would indicate that the medication in question, which the patient has been taking since around 2 months ago, has provided any meaningful clinical benefit. The only specific clinical information provided with respect to the drug in this case is that the patient has tolerated the drug and increases in its dosage. Therefore, the requested health service is not medically necessary.