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Biologics denials: what the review data shows
Independent reviewers have decided 527 published cases where an insurer denied Biologics — and they overturned the insurer 78.2% of the time. A denial for Biologics is a starting position, not a final answer.
Published decisions
527
2001–2026
Overturned
78.2%
412 denials reversed
Conditions behind biologics denials
What insurers denied — and how those fights ended.
| Category | Decisions | Overturned |
|---|---|---|
| Crohn's Disease | 83 | 86.7% |
| Psoriasis | 49 | 91.8% |
| Ulcerative Colitis | 40 | 90% |
| Dermatitis | 37 | 89.2% |
| Arthritis | 26 | 57.7% |
| Multiple Sclerosis | 24 | 95.8% |
| Autoimmune Disease | 22 | 90.9% |
| Lupus | 13 | 76.9% |
| Alopecia | 10 | 70% |
What the insurer actually argued
Denials fall into different categories, and they don’t succeed equally — so the reason on your letter changes how you should answer it.
| Reason given | Decisions | Overturned |
|---|---|---|
Medical Necessity The plan said the care wasn’t medically necessary. The most common fight, and the most winnable. | 466 | 80.3% |
Experimental/Investigational The plan called the treatment unproven. These turn on published evidence, so the appeal is a literature argument. | 61 | 62.3% |
Typical time to a decision
6 days
Most land between 3 and 17 days
Handled as urgent
60.7%
Expedited when a delay would cause harm
Recent direction
Rising
76.8% → 84.5% overturned, last three years
What the reviewers wrote
Excerpts from the independent reviewers’ published findings — the actual reasoning, quoted, not summarised.
Where the denial was overturned
Nature of Statutory Criteria/Case Summary: The parent of a patient has requested authorization and coverage for Synagis. In 2014, the American Academy of Pediatrics (AAP) issued guidelines for the administration of Synagis for RSV prophylaxis based on review of current peer-reviewed literature related to burden of RSV in infants and children with emphasis on those at highest risk of severe disease. Under these guidelines, the following groups of patients are considered at highest risk, with recommendations for administration of Synagis: infants born before 29 weeks’ gestation younger than 12 months of age at the start of RSV season; infants with chronic lung disease of prematurity born before 32 weeks’ gestation during the first year of life, with some consideration during the second year of life if continued medical support is necessary; infants 12 months of age or younger with hemodyna…
Nature of Statutory Criteria/Case Summary: The patient has been diagnosed with Crohn’s disease. In an undated letter, the provider noted that the patient has ileocolonic and perianal Crohn's disease, status post subtotal colectomy and end-ileostomy. Per the provider, an ileostomy revision was performed due to abscess and fistula. The patient has tried and failed multiple medications, including Humira, Remicade, 6-mercaptopurine, and methotrexate. The patient was noted to have had a response to Tysabri, but this medication was stopped after the patient moved abroad. The patient also tried and failed treatment with Entyvio. The patient began treatment with Stelara. The provider noted that an ileoscopy in November showed active Crohn’s disease in the distal ileum.
Where the denial was upheld
Worth reading too — these show what an appeal has to overcome.
Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Tepezza infusions beyond a lifetime total of eight infusions. The European Group on Graves’ Orbitopathy (EUGOGO) recommends intravenous steroids as first-line treatment of moderate-to-severe thyroid eye disease followed by immunomodulating drugs such as cyclosporine and biologic drugs such as Tepezza. The records provided for review suggest that systemic steroid therapy was largely ineffective for this patient, who still required orbital decompression surgery. The patient has also been treated with Tepezza. The provider has recommended additional treatment with Tepezza beyond the lifetime recommended total of eight infusions.
Findings: The physician reviewer found that The patient has requested authorization and coverage for Adbry solution prefilled syringe 150 mg/mL. The U.S. Food and Drug Administration (FDA) has approved Adbry for the treatment of moderate-to-severe atopic dermatitis in adult patients whose disease is not adequately controlled with topical prescription therapies. A recent consensus article on atopic dermatitis experts defined moderate-to-severe atopic dermatitis as greater than 10% body surface area (BSA) involvement and/or involvement of highly visible areas or those important for function and significantly impaired quality of life. The records document that this patient has moderate-to-severe atopic dermatitis given involvement of the face and involvement of the trunk. Several recent randomized clinical trials have shown the efficacy of Adbry in treating atopic dermatitis.
Figures and quotations on this page come from 42,749 published decisions in the California DMHC Independent Medical Review dataset. These are California outcomes — every state runs an equivalent external review, but the rates here are California’s. Excerpts are quoted verbatim from the public record and describe this treatment generally, not any individual case.
How to use this in your appeal
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 Biologicswhen you appeal: reviewers routinely find that denials like yours didn’t hold up.
SOURCE: CALIFORNIA DMHC INDEPENDENT MEDICAL REVIEW OUTCOMES (CHHS OPEN DATA) · DERIVED AGGREGATE STATISTICS ONLY · METHODOLOGY
Not legal or medical advice. Coverage Rights is a self-help tool that helps you prepare your own appeal. For advice about your specific situation, talk to a licensed attorney or your doctor.