Cuvitru denials: what the review data shows

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for infusion of Cuvitru (10 gm/50 mL Soln – Inject 80 mL (16 g) under skin twice a week with maximum infusion rate of 60 mL/hour per infusion site). Dysautonomia is an umbrella term referring to any disorder associated with dysfunction of the autonomic nervous system. Autoimmune autonomic dysfunction may be peripheral due to an immune-mediated small fiber polyneuropathy and may manifest clinically as postural orthostatic tachycardia syndrome (POTS), inappropriate sinus tachycardia, complex regional pain syndrome, and/or neurogenic bladder. Intravenous immunoglobulin (IVIG) is considered a first-line treatment for patients with immune-mediated neuropathies such as Guillain-Barre syndrome, chronic inflammatory demyelinating polyneuropathy, and multifocal motor neuropathy.

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Cuvitru 10 mg every seven days for treatment of the enrollee’s non-specified immunodeficiency disorder. Findings: The physician reviewer found that Selective antibody deficiency with normal serum immunoglobulin concentrations is a deficiency of specific antibody response to polysaccharide antigens with intact response to protein antigens and normal serum level of IgG and IgG subclass. Immunoglobulin replacement therapy with intravenous immunoglobulin (IVIG) or subcutaneous immunoglobulin preparations is a treatment option for this group of patients with recurrent infections that persist after immunizing and providing antibiotic treatment.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Cuvitru. Findings: The physician reviewer found that support a diagnosis of selective antibody deficiency, titers against pneumococcal vaccine serotypes must be measured pre-immunization and post-immunization approximately four weeks after vaccination. According to the provider’s notes, this patient has experienced recurrent pneumonia, upper respiratory infections, and sinopulmonary infections. The patient was evaluated, at which time laboratory data revealed normal serum immunoglobulin levels and 50% response to the polysaccharide vaccine. The patient’s pneumococcal titer drawn was five months after receiving the vaccine.

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Cuvitru. The American Academy of Allergy, Asthma and Immunology (AAAAI) and the American College of Allergy, Asthma and Immunology (ACAAI) practice parameters for the diagnosis of management of primary immunodeficiency note that the diagnosis of specific antibody deficiency (SAD) should be given to patients who are (1) older than two years of age with recurrent respiratory tract infections, (2) with normal immunoglobulin (Ig) A, IgM, IgG, and IgG subclass levels, and (3) impaired response to pneumococcal capsular polysaccharide. In this case, the patient has a history of recurrent sinopulmonary infections and impaired response to pneumococcal vaccine with only 65% of the titer. However, the submitted records note that the patient has a low IgA level.

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 Cuvitruwhen you appeal: reviewers routinely find that denials like yours didn’t hold up.