Privigen denials in California external review

What the reviewers wrote

Where the denial was overturned

Findings: The physician reviewer found that Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Privigen intravenous immunoglobulin (IVIG) in-home infusion. The standard of care treatment for patients with small fiber neuropathy is dependent on the underlying etiology as well as treatment of associated neuropathic pain. Many medications have also been tried in the treatment of painful polyneuropathy with varying success including duloxetine, pregabalin, carbamazepine, phenytoin, topiramate, baclofen, mexiletine, and dextromethorphan. In small fiber neuropathy, current neuropathic pain treatment options are generally insufficient to relieve the pain. Small fiber polyneuropathy has various underlying causes, including associations with systemic autoimmune conditions.

Nature of Statutory Criteria/Case Summary: The patient’s parent has requested authorization and coverage for Privigen [intravenous immunoglobulin (IVIG)]. In a review paper on the clinical approach to the diagnosis of autoimmune encephalitis in children, Cellucci and colleagues report that behavioral changes, such as repetitive or stereotypical behaviors, irritability, hyperactivity, hypersexuality, insomnia and anger outbursts, are common in pediatric autoimmune encephalitis. Psychiatric symptoms may range from mood swings and mild personality changes to fulminant psychosis and occur in over 50% of autoimmune encephalitis patients. New-onset psychosis in children younger than 13 years of age is uncommon and considered a red flag for an underlying medical, rather than primary psychiatric, condition.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: The patient requested authorization and coverage for Privigen 100-gram infusions over 5 days every 4 weeks for 1 year.The medical condition of autoimmune encephalitis (AE) cannot be confirmed as it does not meet the standard diagnostic criteria. The authors of a study indicated the diagnostic criteria for autoimmune encephalitis indicates that there must be a subacute onset of rapid progression of less than three months of working memory deficits or short-term memory loss, altered mental status, or psychiatric symptoms.

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Privigen intravenous immunoglobulin (IVIG) 40 mg x one day, every week for three months. The records document that this patient has a diagnosis of infertility. Based on the submitted information, there is a lack of support for a diagnosis of recurrent pregnancy loss since the patient has a history of one spontaneous abortion. As noted in the medical literature, recurrent pregnancy loss is defined as at least two losses. In addition, the patient’s positive copy of the methylenetetrahydrofolate reductase (MTHFR) gene, does not affect her risk of thrombosis. Per the American College of Obstetricians and Gynecologists (ACOG), MTHFR gene mutation analysis is not recommended to determine a patient’s risk for pregnancy loss in this clinical setting.

These outcomes describe eligible cases completed through California DMHC’s Independent Medical Review program. They do not estimate the chance that an internal appeal, an external review in another jurisdiction, or your individual case will succeed. Use the record to identify evidence patterns involving Privigen, then check the rights and deadlines that apply to your plan.