Scleroderma denials in California external review

What the reviewers wrote

Where the denial was overturned

Findings: The physician reviewer found that The patient has requested authorization and coverage for Jakafi. Eosinophilic fasciitis is a rare condition in which the thickening of skin occurs rapidly. If untreated or if refractory to treatment, this thickening can lead to soft tissue contracture and loss of function, thus treatment is critical to avoid permanent disability. Currently, there are no U.S. Food and Drug Administration (FDA) approved drugs to treat eosinophilic fasciitis due to the uncommon nature and existence of the condition. There have been limited case series and case reports, but some studies have shown the efficacy of Janus kinase (JAK) inhibitors in treating refractory eosinophilic fasciitis.

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for evaluation for autologous systemic immune suppression trial #NCT01445821 for evaluation of the enrollee’s scleroderma. Findings: The physician reviewer found that when patients with advanced cancers have exhausted standard regimens, the National Cancer Institute Physician’s Data Query recommends enrollment in a clinical trial. In this case, the patient has a terminally progressive disease that has been resistant to standard treatment options. As requested, he would be enrolled in a clinical trial testing auto-HSCT versus pulse dose cyclophosphamide for his disease but the underlying treatment modality of auto-HSCT is considered standard for advanced scleroderma. All told, enrolling this patient in the clinical trial being considered is medically appropriate.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Gammaked at a hospital-associated infusion center.Findings: Two out of three physician reviewers found that the requested Gammaked at a hospital-associated infusion center is not likely to be more beneficial than any available standard treatment for the patient's medical condition.At this time, case series and small trials have suggested potential benefit from intravenous immunoglobulin (IVIG) for skin fibrosis as well as other symptoms, including gastrointestinal tract manifestations, of systemic sclerosis. Clinical trials are being planned, but the mechanism of action for antifibrotic activity remains unclear. Several small, uncontrolled studies have evaluated the effect of intravenous administration of immune globulin on dermal fibrosis, each with reported improvement.

Findings: The physician reviewer found that Nature of Statutory Criteria/Case Summary: The patient’s parent has requested authorization and coverage for Rasuvo. The submitted documentation does not support the medical necessity of the requested medication. One study explained that methotrexate, both oral and subcutaneous, is used in the standard management of linear scleroderma. However, Rasuvo is not indicated for linear scleroderma, and the authors do not note the use of Rasuvo as a treatment for linear scleroderma. In this case, the provider reports a shortage of injectable methotrexate. The researchers note that currently there are manufacturers producing generic methotrexate injectable solutions. Although the provider noted concerns regarding the availability of generic injectable methotrexate, the shortage has been predicted to be resolved.

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 scleroderma, then check the rights and deadlines that apply to your plan.