HMSA biologic targeted therapy Prior Auth

Coverage Criteria and Medical Necessity

Exception / preferred-agent failure criteria

Coverage for a non‑preferred (exception) product is allowed only when ALL of the following are met:

Exception criteria general

Preferred products list per indication: Preferred-agent lists are provided by indication (e.g., ankylosing spondylitis, Crohn's disease, plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis) and the provider must document trials/failures or contraindications to all agents listed for the relevant indication.N/A
See form sections B–U for indication-specific preferred product lists and action-required statements

Rheumatoid arthritis — initial and continuation

Rheumatoid arthritis requests are covered when specified prescribing, diagnostic, prior‑therapy, and response criteria are met.

RA general: Requested drug prescribed by or in consultation with a rheumatologist; diagnosis of moderately to severely active rheumatoid arthritis; patient age documented (adult status queried).N/A

Form questions #100–#103

Continuation criteria: For continuation: patient is currently receiving the requested drug (excluding samples/PAP) OR if receiving via samples/PAP noted; document positive clinical response and at least ~20% improvement in disease activity measures (tender/swollen joint count, pain, or disability).>=20% improvement example

Form questions #103–#106

Initial therapy - prior biologic: If initial therapy, indicate prior or current receipt of a biologic or targeted synthetic indicated for RA (excluding samples/PAP); prior biologic use affects pathway.N/A

Form question #107

Methotrexate requirement and alternatives: Patient has had inadequate response after >=3 months of methotrexate at >=15 mg/week OR has intolerance or contraindication to methotrexate (specific contraindications include pregnancy/planning pregnancy, liver disease, drug interactions, significant comorbidity, hypersensitivity, etc.).>=3 months at >=15 mg/week

Form questions #108–#113 and #121–#123 capture RF/anti-CCP/CRP/ESR and methotrexate trial/intolerance/contraindication

AOSD and sJIA

Adult‑onset Still's disease (AOSD) and systemic juvenile idiopathic arthritis (sJIA) requests require specialty prescribing and documentation of clinical features, prior therapy, and response.

AOSD/sJIA prescribing and continuation: Requested drug prescribed by or in consultation with a rheumatologist; for continuation, document current use (samples/PAP flag) and evidence of positive clinical response such as low disease activity or improvement in signs/symptoms since starting treatment.N/A

Form questions #150–#154 and #151–#153

Initial therapy - prior treatments: For initial therapy, document prior biologic use (if any) and inadequate response to NSAIDs, systemic corticosteroids, or conventional synthetic DMARDs (e.g., methotrexate) as applicable for AOSD and sJIA pathways.N/A

Form questions #155–#157 for AOSD and #205–#208 for sJIA

Recurrent pericarditis — continuation

Recurrent pericarditis continuation requests require specialist involvement and evidence of clinical benefit or objective improvement.

Recurrent pericarditis prescribing: Requested drug prescribed by or in consultation with a cardiologist, rheumatologist, or immunologist.N/A

Form question #300

Continuation - clinical response: For continuation: document current receipt (samples/PAP status) and that the patient has achieved or maintained a positive clinical response as evidenced by decreased recurrence of pericarditis or improvement in signs/symptoms or objective findings (pericarditic/pleuritic chest pain, pericardial rubs, ECG findings, pericardial effusion, or CRP).clinical response

Form questions #301–#305

Recurrent pericarditis — Continuation Therapy

Covered when ALL of the following are met for continuation requests:

Recurrent pericarditis continuation: 1) Request is for continuation of therapy. 2) Patient is currently receiving the requested drug (unless obtained via samples/PAP). 3) Patient has achieved or maintained a positive clinical response demonstrated by decreased recurrence of pericarditis or improvement in signs/symptoms or objective findings (pain, rubs, ECG, effusion, CRP).clinical response

Form question flow #301–#305

Recurrent pericarditis — Initial Therapy

Covered when ALL of the following are met for initial (new‑start) requests:

Recurrent pericarditis initial: 1) Patient has had at least two episodes of pericarditis. 2) Patient has failed at least two agents of standard therapy (e.g., colchicine, non‑steroidal anti‑inflammatory drugs, corticosteroids).>=2 episodes; >=2 standard therapy failures

Form questions #310–#311

Multicentric Castleman's disease — Initial/Continuation

Multicentric Castleman's disease requests differentiate initial and continuation logic and require oncology/hematology involvement.

Castleman's continuation: Requested drug prescribed by or in consultation with an oncologist or hematologist; for continuation, document current receipt (samples/PAP) and whether the patient has experienced disease progression or unacceptable toxicity while on therapy.disease progression or unacceptable toxicity

Form questions #350–#353

Castleman's initial: For initial therapy, indicate whether the drug will be used as single agent and whether disease has progressed following treatment of relapsed, refractory, or progressive disease.progression after prior treatment

Form questions #354–#355

HIDS/MKD — Initial and Continuation

Coverage for hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency (MKD) depends on specialist prescribing and objective disease activity measures.

HIDS/MKD continuation: Requested drug prescribed by or in consultation with a rheumatologist or immunologist; for continuation, document current receipt (samples/PAP) and that the patient has achieved or maintained a positive clinical response (low disease activity or improvement in signs/symptoms).clinical response

Form questions #400–#403

HIDS/MKD initial: For new starts: document active flares within the last 6 months, record the Physician's Global Assessment (PGA) score (less than 2 versus 2 or greater), and report the C‑reactive protein (CRP) level (<=10 mg/L versus >10 mg/L) as part of the assessment of disease activity and necessity.PGA and CRP thresholds

Form questions #410–#412

Schnitzler's syndrome — Initial and Continuation

Schnitzler's syndrome coverage requires specialist involvement and specific diagnostic features for new starts; continuation requires evidence of ongoing benefit.

Schnitzler continuation: Requested drug prescribed by or in consultation with a rheumatologist, dermatologist, or immunologist; for continuation, document current receipt (samples/PAP) and evidence of maintained positive clinical response (low disease activity or improvement in signs/symptoms).clinical response

Form questions #450–#453

Schnitzler initial: For initial therapy, document presence of an urticarial rash and monoclonal IgM or IgG gammopathy plus at least two of the following systemic signs: fever, joint pain/inflammation, bone pain, lymphadenopathy, hepatosplenomegaly, leukocytosis, elevated ESR, or abnormalities on bone morphological study; other possible causes (e.g., HIDS, AOSD, hypocomplementemic urticarial vasculitis, acquired C1 inhibitor deficiency, cryoglobulinemia) must be ruled out.>=2 systemic signs and exclusion of other causes

Form questions #460–#462

Gout/Pseudogout flares — Initial and Continuation

Gout and pseudogout flare treatment is covered when flare frequency and prior therapy requirements are satisfied; continuation requires ongoing benefit.

Gout/pseudogout continuation: Requested drug prescribed by or in consultation with a rheumatologist; for continuation, document current receipt (samples/PAP) and that the patient has achieved or maintained a positive clinical response (low disease activity or improvement in signs/symptoms).clinical response

Form questions #500–#504

Gout/pseudogout initial: For initial therapy, patient must have experienced at least three flares in the prior 12 months AND have inadequate response to, intolerance of, or contraindication to NSAIDs, colchicine, and corticosteroids (document each).>=3 flares; failed NSAID, colchicine, corticosteroid

Form questions #510–#513

Deficiency of IL-1 Receptor Antagonist (DIRA) — Initial and Continuation

DIRA coverage requires specialty prescribing and, for new starts, genetic confirmation when applicable.

DIRA continuation: Requested drug prescribed by or in consultation with a rheumatologist or immunologist; for continuation, document current receipt (samples/PAP) and that the patient has achieved or maintained a positive clinical response (low disease activity or improvement in signs/symptoms).clinical response

Form questions #550–#553

DIRA initial: For initial therapy, the diagnosis of deficiency of interleukin‑1 receptor antagonist (DIRA) must be genetically confirmed; if DIRA is due to IL1RN mutations, attach documentation of IL1RN mutation status per the form's action‑required instruction.genetic confirmation of DIRA and IL1RN mutation report when applicable

Form questions #554–#555 and action required: attach IL1RN mutation documentation

The prior authorization form uses a preferred-product / step-therapy approach: for many immunologic indications the form lists specific preferred agents (by indication) that are covered and asks whether the patient's therapy can be switched to one of those products. If the patient can be switched, the provider is instructed to obtain and submit the preferred product’s PA form. If the patient cannot be switched, the provider must document a failure, intolerance, or contraindication to ALL preferred products listed for that indication and attach supporting clinical documentation to meet the exception pathway.

For Schnitzler's syndrome the form requires both characteristic diagnostic features and exclusion of alternate causes. For new starts the provider must document presence of an urticarial rash with monoclonal IgM or IgG gammopathy plus at least two systemic signs (e.g., fever, joint pain/inflammation, bone pain, lymphadenopathy, hepatosplenomegaly, leukocytosis, elevated ESR, or bone morphological abnormalities). The form also requires confirmation that other possible causes (including hyperimmunoglobulin D syndrome/HIDS, adult-onset Still’s disease, hypocomplementemic urticarial vasculitis, acquired C1 inhibitor deficiency, and cryoglobulinemia) have been ruled out before approval is considered.

Coding, Diagnosis Codes and Related Fields

Diagnosis codes (form entry)ICD-10

ICD-10

Field provided for diagnosis code (blank in form)

Methotrexate trial duration and dose

Required duration and dose>= 3 months at >= 15 mg per week

Alternative pathwaysDocumentation of methotrexate intolerance or contraindication may substitute for the >=3 months requirement

Reference questionForm question #110 asks explicitly about inadequate response after at least 3 months at >=15 mg/week

Physician's Global Assessment (PGA) score

Actionable thresholdPGA score categorized as Less than 2 vs 2 or greater

Use casePGA is collected for initial HIDS/MKD assessment (Form question #411)

Prior Authorization Submission and Required Provider Actions

Prior Authorization

Prior Authorization Required

Prior authorization is required for certain specialty medications covered under the patient's prescription benefit. Fax the completed HMSACOM Prior Authorization Request form and all supporting documentation to CVS Caremark Specialty Programs at 1-866-237-5512. For prior authorization questions contact CVS Caremark at 1-808-254-4414. For eligibility, copay, or delivery questions contact CaremarkConnect Specialty Customer Care at 1-800-237-2767. Failure to submit a completed form and required supporting documentation may delay or prevent coverage determination.

Fax: 1-866-237-5512
PA questions: 1-808-254-4414
Specialty Customer Care: 1-800-237-2767

Documentation Required

Recurrent Pericarditis — Authorization Requirements

Requests for recurrent pericarditis must be prescribed by or in consultation with a cardiologist, rheumatologist, or immunologist. Initial therapy requests must document at least two prior episodes of pericarditis and failure of at least two standard agents (examples: colchicine, NSAIDs, corticosteroids). When applicable, include documentation of inadequate response, intolerance, or contraindication to prior agents. Specialist consultation notes and clear documentation of prior-agent use and outcomes are required.

Background and Scope

This prior authorization form is intended to standardize medical necessity review for biologic and targeted synthetic therapies across multiple immune-mediated conditions. It captures indication-specific elements — including whether a preferred product is available for the diagnosis, specialty involvement, prior therapy history, and objective signs/symptoms or laboratory findings — so reviewers can determine eligibility for initiation or continuation of therapy.

The form therefore applies broadly across immunology/rheumatology diagnoses (for example, rheumatoid arthritis, adult-onset Still’s disease, Schnitzler’s syndrome, recurrent pericarditis, gout/pseudogout) and is used to document the required diagnostic features, prior treatment failures or contraindications, and the exclusion of alternative diagnoses where applicable.

Definitions and Test Thresholds

TB testing — TST/IGRA within 6 months and treatment status

Required test(s) and timingTuberculosis screening via TST or IGRA within 6 months of initiating therapy

Report results and treatment statusForm asks for TB test result (positive/negative/unknown) and, if positive, whether latent TB treatment was initiated, completed, not initiated, or active TB

Form routingQuestion #3 asks if TB test was done within 6 months; question #4 records results and routes to subsequent questions

Methotrexate prior trial — RA requirement

RA methotrexate requirement>= 3 months at >= 15 mg per week

Alternate documentationDocumentation of methotrexate intolerance or contraindication may be accepted instead

OpenPayer

Prior authorization criteria for biologic and targeted synthetic therapies (Immunology/Rheumatology)

Coverage Criteria and Medical Necessity

Coding, Diagnosis Codes and Related Fields

Prior Authorization Submission and Required Provider Actions

Background and Scope

Definitions and Test Thresholds