Anti-inflammatories denials in California external review

What the reviewers wrote

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for rituximab-pvvr, biosimilar, (Ruxience) 1,000 mg. In this case, the patient's history appears most consistent with interstitial pneumonia with autoimmune features (IPAF). She has responded well to steroid therapy and demonstrated clinical improvement with a trial with Rituxan. In this clinical setting, while it appears that the patient may respond well to Rituximab therapy, most studies on using Rituximab are regarding connective tissues disease associated interstitial lung disease (CT-ILD). Few trials evaluate its use in the IPAF group. In CT-ILD, it has been demonstrated to be effective in both acute exacerbations as well as in chronic management to prevent decline.

Findings: The physician reviewer found that The patient’s parent has requested authorization and coverage for Emflaza 30 mg tablets. The American Academy of Neurology guideline on corticosteroid treatment of Duchenne muscular dystrophy (DMD) reports, “Prednisone 0.75 mg/kg/d has significant benefit in DMD management and should be considered the optimal prednisone dose. Prednisone 10 mg/kg/weekend is equally effective over a 12-month period, although long-term outcomes of this alternate regimen remain to be seen.” While the U.S. Food and Drug Administration (FDA) does not specifically approve the use of prednisone for the treatment of DMD, it approves the use of deflazacort (Emflaza) for the treatment of DMD in patients age five and older.

Where the denial was upheld

Physician 1The patient is a 69-year-old woman who has followed a typical course for Takayasu’s arteritis and has stenosis of the left subclavian artery, carotid arteries, right vertebral artery, left ulnar artery, and branches of the aorta supplying the kidneys. She has had numerous bypass surgeries to maintain blood flow to her upper extremities and stenting of her renal arteries. In September 2003, studies revealed 70% stenosis of her celiac axis and superior mesenteric artery. The patient’s disease continues to be very aggressive despite prednisone treatment and Plaquenil. The patient’s provider has recommended Enbrel. The Health Plan has denied authorization for Enbrel on the basis that it is considered investigational for treatment of Takayasu’s arteritis.The pathogenesis of Takayasu’s arteritis and temporal arteritis are very similar.

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.

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 Anti-inflammatories, then check the rights and deadlines that apply to your plan.