Diagnosis: Dermatomyositis

Treatment: Intravenous Immune Globulin (IVIG) at a dose of 140 grams

The insurer denied coverage for Intravenous Immune Globulin (IVIG) at a dose of 140 grams.

The denial is overturned.

The patient has a diagnosis of dermatomyositis by laboratory tests and clinical symptoms. The patient has failed therapy with oral steroids and methotrexate and has previously been treated with Intravenous Immune Globulin (IVIG). The patient has had flares off of IVIG. The medical care team would like to treat with IVIG at 1 gram per kilogram per day (g/kg/day) (=50 g) days 1-5 as a loading dose followed by a maintenance dose of IVIG 50 g on Day 1 and 2 every 4 weeks. The patient's weight is approximately 50 Kg.

Based on the submitted material the use of IVIG is medically appropriate. Based on the package insert for IVIG, the standard dosing is IVIG 2g/kg divided in equal doses and given over 5 days. The dosing would equate to 100g total given over 5 days, representing a dosing of 20g IVIG/day. The patient was initially treated at a dosing of 1g/kg/day x 2 days repeated each month (50g and 50g on two consecutive days). The documentation indicates that the patient continued to have symptoms and flared despite this dose and supplemental therapies. The request for a higher than standard dosing is due to clinical determination that the patient did not respond appropriately to the original dosing. The standard practice in these cases is to either increase the frequency of treatments or increase the overall dosing. Based on the standard of care, the use of IVIG appears within the standard of care based on the medical determination of the caring physician. The use of IVIG will require close physician monitoring and laboratory testing. The use of IVIG at the higher dose recommended by the caring physician is within the standard of care and is approved based on these criteria.

Based on the above, the insurer's denial must be reversed. The health care plan did not act reasonably and with sound medical judgment and in the best interest of the patient.

The medical necessity for Intravenous Immune Globulin (IVIG) at a dose of 140 grams is substantiated.