Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Rheumatoid Arthritis.
Treatment: Orencia.

The insurer denied the Orencia.  The denial is upheld.

This patient is a female with history of rheumatoid arthritis. The patient has previously tried and failed conventional disease modifying antirheumatic drugs (DMARDs) methotrexate and hydroxychloroquine. The patient has a recent history of latent tuberculosis (TB) and currently is taking isoniazid.

The request for Orencia was initially denied coverage by the health plan due to the patient not having tried and failed 2 of the preferred formulary alternatives including Enbrel, Humira, Remicade, Inflectra, Rinvoq or Simponi/Simponi Aria.  The reason the provider is appealing the determination is because the provider feels that Orencia would have the lowest risk of infection.

No, the requested Orencia is not medically necessary.

The patient has a diagnosis of rheumatoid arthritis and tried and failed conventional DMARDs (disease-modifying anti-rheumatic drugs) methotrexate and hydroxychloroquine. Therefore, the American College of Rheumatology guidelines in the treatment of rheumatoid arthritis would suggest advancement to a biologic DMARD (disease-modifying anti-rheumatic drug). There are no clinical studies specifically indicating that 1 biologic DMARD (disease-modifying anti-rheumatic drug) would be more efficacious or safer then another biologic DMARD (disease-modifying anti-rheumatic drug). Orencia is Food and Drug Administration (FDA) approved for the treatment of rheumatoid arthritis.

The use of Orencia for the treatment of the patient's rheumatoid arthritis is supported by the American College of Rheumatology guidelines. The formulary alternatives are also FDA (United States Food and Drug Administration) approved for the treatment of rheumatoid arthritis. These are not contraindicated in this patient, because the patient is currently treated for latent TB (tuberculosis).

In Iannone et al., "All guidelines recommend starting treatment with biologics 12 months after beginning LTBI [latent tuberculosis infection] prophylaxis (level of evidence II; strength of recommendation B). This evidence comes from the observation that initiation of anti-TNF [tumor necrosis factor]- therapy after 1 month of TB [tuberculosis] prophylaxis in patients with RA [rheumatoid arthritis] found positive for LTBI [latent tuberculosis infection] significantly reduced the risk of TB (tuberculosis) reactivation (level of evidence III). Nevertheless, if the activity of underlying disease and the global status of the patient allow, waiting 1 additional month is preferable because the side effects of the therapy with isoniazid occur mainly within the first 2 months."

The physician's concern for infection risk due to latent TB (tuberculosis) is inaccurate, as guidelines state any biologic can be used after one to two months of TB (tuberculosis) treatment, which this patient has had. There are no clinical studies indicating that Orencia is safer or more effective than the formulary alternatives. There are no articles either supporting or denying the provider's claim.

Biologic DMARDs (disease-modifying anti-rheumatic drugs) can be started 1 month after treatment has started for latent TB (tuberculosis). There is no indication that any of the biologic DMARDs (disease-modifying anti-rheumatic drugs) are contraindicated in a person who is being treated for latent TB (tuberculosis). Therefore, based on medical literature, the requested treatment with Orencia is not medically necessary.

Yes, the health plan did act reasonably, with sound medical judgment, and in the best interest of the patient.

The formulary alternatives are all medically appropriate for this patient. The patient has not tried and failed the formulary alternatives. There are no contraindications to the use of these formulary alternatives. There are no clinical studies indicating that Orencia would be more efficacious or safer for this patient than the formulary alternatives. Therefore, the health plan did act reasonably with sound medical judgement and in the best interest of the patient.