Kevzara (sarilumab) Letter of Medical Necessity
Kevzara (sarilumab) is a self-injected IL-6 receptor antagonist for rheumatoid arthritis and polymyalgia rheumatica. Payers usually require a methotrexate trial and often a preferred TNF inhibitor first, and many prefer tocilizumab. A Letter of Medical Necessity that documents prior failures and why IL-6 blockade fits this patient overturns most denials.
FDA-Approved Indications
- ● moderately to severely active rheumatoid arthritis after inadequate response or intolerance to one or more DMARDs
- ● polymyalgia rheumatica after inadequate response to corticosteroids or inability to taper
- ● polyarticular juvenile idiopathic arthritis (patients weighing 63 kg or more)
Why Kevzara Prior Authorization Gets Denied
The most common denial reasons across major payers:
- 1. Step therapy: conventional DMARD (methotrexate) and preferred TNF inhibitor not tried first
- 2. Preferred IL-6 agent (tocilizumab or a tocilizumab biosimilar) on formulary
- 3. Baseline ANC, platelets, and liver enzymes not documented
- 4. TB screening not on file
- 5. For PMR: corticosteroid taper failure not documented with dates and doses
What to Include in a Kevzara Letter of Medical Necessity
Document the diagnosis with ICD-10 specificity and disease activity (DAS28, CDAI) or, for PMR, the relapse history during corticosteroid taper with doses and dates. List prior csDMARD and biologic trials with outcomes, TB screening, baseline ANC, platelets, and LFTs, and explain why sarilumab is preferred — for example monotherapy need when methotrexate is not tolerated, supported by MONARCH data.
Key clinical evidence to cite:
- ✓ MOBILITY and TARGET trials — improved ACR20/50/70 vs placebo in methotrexate- and TNF-inadequate responders
- ✓ MONARCH trial — sarilumab monotherapy superior to adalimumab monotherapy on DAS28-ESR change
- ✓ SAPHYR trial — sustained remission and reduced cumulative glucocorticoid exposure in relapsing polymyalgia rheumatica
Relevant guidelines:
- 📖 ACR 2021 RA Guidelines
- 📖 EULAR 2022 RA Recommendations
- 📖 ACR/EULAR 2015 Polymyalgia Rheumatica Recommendations
Kevzara Prior Authorization Criteria
Standard criteria across major US payers for Kevzara. Specific criteria vary by plan — RxCheckUp tailors each LMN to your patient's exact payer policy.
Typical step therapy requirements:
- → Step therapy: conventional DMARD (methotrexate) and preferred TNF inhibitor not tried first
Required documentation:
- ✓ ICD-10 diagnosis code with specificity
- ✓ Prior therapy history with dates, doses, and discontinuation reasons
- ✓ Specialist evaluation (where applicable)
- ✓ Baseline disease activity or biomarker results
- ✓ Clinical rationale citing FDA labeling or guidelines
Approval details:
Initial approval: typically 6 months. Renewal: 12 months with documented clinical response.
Payers Covering Kevzara
RxCheckUp tailors each LMN to the specific payer's medical policy and step therapy requirements:
Kevzara Prior Authorization FAQ
Why was my Kevzara prior authorization denied?
The most common denial reasons for Kevzara are: Step therapy: conventional DMARD (methotrexate) and preferred TNF inhibitor not tried first; Preferred IL-6 agent (tocilizumab or a tocilizumab biosimilar) on formulary; Baseline ANC, platelets, and liver enzymes not documented; TB screening not on file; For PMR: corticosteroid taper failure not documented with dates and doses.
What should a Kevzara Letter of Medical Necessity include?
Document the diagnosis with ICD-10 specificity and disease activity (DAS28, CDAI) or, for PMR, the relapse history during corticosteroid taper with doses and dates. List prior csDMARD and biologic trials with outcomes, TB screening, baseline ANC, platelets, and LFTs, and explain why sarilumab is preferred — for example monotherapy need when methotrexate is not tolerated, supported by MONARCH data.
Which payers cover Kevzara?
Kevzara is covered by major US payers including UnitedHealthcare, Aetna, Cigna, Anthem BCBS, Humana, Medicare Part D, though formulary tier and prior authorization criteria vary.