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202206-150788

2022

CVS Caremark

Self-Funded

Immunologic Disorders

Pharmacy/ Prescription Drugs

Medical necessity

Upheld

Case Summary

Diagnosis: Rheumatoid arthritis.
Treatment: Humira.
The insurer denied Humira.
The determination is upheld.

The patient has rheumatoid arthritis (RA). She had prior treatment with Plaquenil and nonsteroidal anti-inflammatory drugs (NSAIDs). Per a letter from the patient's provider, the patient is not a candidate for methotrexate (MTX) as she drinks alcohol daily and she is unwilling to stop drinking. Humira was denied by the health plan as the patient has not tried formulary alternatives, specifically methotrexate (MTX) 15 milligrams (mg) weekly times (x) 90 days. At issue is the medical necessity of Humira.
The requested health service/treatment of Humira is not medically necessary for this patient. There is no medical reason the patient cannot undergo a trial of methotrexate (MTX). Per a letter from the patient's provider, the patient drinks alcohol daily and is unwilling to stop drinking, which is not the same as a clinical diagnosis of alcohol use disorder but rather patient preference. MTX is a staple drug used in the treatment of rheumatoid arthritis (RA) and is commonly used as first-line therapy unless there is an absolute contraindication (e.g. elevated liver function tests (LFTs), cirrhosis, pulmonary fibrosis, pregnancy). Per UpToDate, 'we suggest MTX as the disease-modifying anti-rheumatic drug (DMARD) of choice for the initial treatment of patients with active RA. MTX typically serves as the "anchor" drug for the most commonly used DMARD combinations.' Moreover, 'randomized head-to-head trials have found that MTX has a faster onset of action, comparable or greater efficacy, and better long-term tolerance compared with other nonbiologic DMARD monotherapy. MTX has also been shown to improve survival (both cardiovascular and all-cause mortality) in patients with RA compared with other nonbiologic DMARDs'. Additionally, the Cochrane Database Syst Rev (4) published a report in 2014 that found that 'based on mainly moderate to high-quality evidence, methotrexate (weekly doses ranging between 5 milligrams (mg) and 25 mg) showed a substantial clinical and statistically significant benefit compared to placebo in the short-term treatment (12 to 52 weeks) of people with RA, although its use was associated with a 16% discontinuation rate due to adverse events.

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