Neuromuscular RX denials: what the review data shows

Where the denial was overturned

Findings: The physician reviewer found that Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for glatiramer acetate. The McDonald criteria are used for diagnosing multiple sclerosis (MS) in patients who have a typical clinically isolated syndrome suggesting the onset of relapsing-remitting MS. The McDonald criteria define an MS attack as a single-phase clinical episode with patient-reported symptoms and objective findings typical of MS, reflecting a focal or multifocal inflammatory demyelinating event in the central nervous system. Development can be acute or sub-acute, with a duration of at least 24 hours, with or without recovery, and in the absence of fever or infection. The most common initial attacks are sensory disturbances, motor weakness, and visual complaints.

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Kesimpta. The American Academy of Neurology (AAN) practice guideline recommendations for disease-modifying therapies (DMTs) for adults with multiple sclerosis note that as numerous studies of DMTs in patients with relapsing forms of multiple sclerosis who have had recent relapses or magnetic resonance imaging (MRI) activity, or both, have shown a benefit with DMT in terms of reducing relapses and reducing MRI activity, clinicians should offer DMTs to patients with relapsing forms of multiple sclerosis with recent clinical relapses or MRI activity. The guidelines further note that when a patient shows breakthrough disease activity, such as continued relapses and/or MRI activity, trying a medication with a different mechanism or efficacy profile may be beneficial.

Where the denial was upheld

Findings: The physician reviewer found that the patient has requested authorization and coverage for Xywav oral solution. The American Academy of Sleep Medicine (AASM) notes that idiopathic hypersomnia is a diagnosis of exclusion. In this case, the diagnosis of idiopathic hypersomnia remains in question as polysomnography (PSG) multiple sleep latency test (MSLT) testing showed normal findings on both tests, whereas a 24-hour PSG showed over 660 minutes of total sleep time over 24 hours, which may meet one of the criteria for idiopathic hypersomnia. However, the submitted documentation did not include sleep logs or actigraphy showing a stable sleep schedule with sufficient sleep time prior to the testing. The patient was noted to work frequent night shifts, so shift work sleep disorder cannot be entirely excluded.

Nature of Statutory Criteria/Case Summary: The patient is a 56-year-old female with Parkinson’s disease (PD). The patient was diagnosed with PD. She was started on carbidopa/levodopa (Sinemet) 25/100mg three times a day. Per a letter from her provider, she was unable to tolerate a full dose of the drug due to side effects. She then tried one-half tablet three times per day, but this was not effective for symptom control. She was then started on a treatment course of one-half tablet every three hours. Per the provider, this dosing schedule was only partially effective. The record indicated that while the patient had an improvement on Sinemet IR, there was also noted to be a degree of fluctuation in her symptomatic control. The patient was started on a trial of Rytary ER. The patient has subsequently reported improvement in control of her motor symptoms.

These are outcomes from California’s external review program — an independent physician panel that binds the insurer. Every state has an equivalent process, and internal appeals succeed even more often. Cite the outcome record for Neuromuscular RXwhen you appeal: reviewers routinely find that denials like yours didn’t hold up.