Acthar Gel denials in California external review
In the California DMHC record, independent physician reviewers decided 60 published external-review cases involving Acthar Geland overturned the plan’s denial in 58.3%. That is a historical result among cases that reached this program, not a forecast for an individual appeal.
Conditions behind Acthar Gel denials
| Category | Decisions | Overturned |
|---|---|---|
| Nephrotic Syndrome | 9 | 88.9% |
| Focal Segmental Glomerulosclerosis | 5 | 80% |
| Multiple Sclerosis | 5 | 80% |
| Rheumatoid Arthritis | 3 | 0% |
| Iga Nephropathy | 3 | 100% |
| Psoriatic Arthritis | 3 | 33.3% |
What the insurer actually argued
| Reason given | Decisions | Overturned |
|---|---|---|
Medical Necessity The plan said the care wasn’t medically necessary. The most common fight, and the most winnable. | 54 | 61.1% |
Experimental/Investigational The plan called the treatment unproven. These turn on published evidence, so the appeal is a literature argument. | 6 | 33.3% |
What the reviewers wrote
Where the denial was overturned
Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Acthar Gel. High-dose corticosteroid therapy is the mainstay of treatment for acute exacerbations of multiple sclerosis (MS). Findings: The physician reviewer found that the U.S. Food and Drug Administration (FDA) approves the use of Acthar Gel, an adrenocorticotropic hormone (ACTH), for the treatment of exacerbations of multiple sclerosis in adults. Other therapies include plasmapheresis, generally reserved for treatment of relapses that are severe or refractory to treatment with high-dose corticosteroids or ACTH, and intravenous immunoglobulin (IVIG), sometimes used in patients for whom high-dose corticosteroids are contraindicated or not tolerated, but for which there is no consistent evidence regarding use in relapse management.
Findings: The physician reviewer found that The patient has requested authorization and coverage for Acthar Gel 80 units/mL administered daily for two weeks. As noted in the medical literature, the recommended first-line therapy for patients with acute exacerbations of multiple sclerosis has been high-dose corticosteroid therapy. The U.S. Food and Drug Administration (FDA) has approved Acthar Gel for the treatment of exacerbations of multiple sclerosis in adult patients. Additional therapies include plasmapheresis and intravenous immunoglobulin (IVIG). Plasmapheresis is generally reserved for the treatment of severe relapses or patients who are refractory to treatment with high-dose corticosteroids or Acthar Gel. Intravenous immunoglobulin (IVIG) can be beneficial for patients when high-dose corticosteroids are contraindicated or not tolerated.
Where the denial was upheld
Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Acthar Gel.Findings: The physician reviewer found that American College of Rheumatology guideline on the treatment of psoriatic arthritis notes, “In treatment-naive patients with active psoriatic arthritis (PsA), a tumor necrosis factor inhibitor (TNFi) biologic agent is recommended over an oral small molecule (OSM) as a first-line option. OSMs may be used instead of a TNFi biologic in patients without severe PsA and without severe psoriasis, those who prefer an oral drug instead of parenteral therapy, or those with contraindications to TNFi treatment, including congestive heart failure, previous serious infections, recurrent infections, or demyelinating disease.
Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Acthar gel.Findings: A research team was formed to comprised of rheumatologists, neurologists and dermatologists to establish a multidisciplinary treatment consensus to standardize patient care for patients with polymyositis (PM) and dermatomyositis (DM). According to their treatment consensus, the first line treatment for polymyositis is glucocorticoids for remission induction. According to the consensus statement, immunosuppressants can be given to patients who are resistant to glucocorticoids. Immunosuppressants are also useful to assist with the tapering of glucocorticoids. Under the consensus statement, immunosuppressants which can be utilized for the treatment of polymyositis include tacrolimus, cyclosporine, CellCept, methotrexate and azathioprine.
Figures and quotations on this page come from 42,749 published decisions in the California DMHC Independent Medical Review dataset. These are California external-review outcomes. Other state and federal programs have different eligibility rules, processes, and current availability; the rates here do not transfer to those programs or predict an individual result. Excerpts are quoted verbatim from the public record and describe this treatment generally, not any individual case.
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 Acthar Gel, then check the rights and deadlines that apply to your plan.
SOURCE: CALIFORNIA DMHC INDEPENDENT MEDICAL REVIEW OUTCOMES (CHHS OPEN DATA) · AGGREGATES + DEIDENTIFIED DECISION EXCERPTS/REFERENCE IDS · METHODOLOGY