CurrentHawaii Medical Service Association (HMSA)Policy N/A

CVS Caremark Prior Authorization Request — Biologic Therapy for SLE and Lupus Nephritis

This is a CVS Caremark prior authorization form used by HMSA to collect clinical and demographic information to determine coverage for certain medications (notably biologics) for patients with systemic lupus erythematosus (SLE) or active lupus nephritis; it affects prescribers and pharmacy/specialty benefit administrators processing prior authorizations.

Policy Summary

PayerHawaii Medical Service Association (HMSA)

PolicyCVS Caremark Prior Authorization Request — Biologic Therapy for SLE and Lupus Nephritis

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionFax the completed prior authorization form and supporting records (chart notes, labs, biopsy when applicable) to CVS Caremark at 1-866-237-5512 to request coverage.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2primary covered diagnoses listed (SLE, lupus nephritis)

3sections for initial, continuation, and demographic information

≥1required supporting documentation items

Coverage Criteria for Biologic Therapy in SLE / Lupus Nephritis

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Initial and continuation medical necessity criteria

Covered when the following branching initial and continuation conditions are met. Start by indicating diagnosis and whether the patient is currently receiving the requested medication; follow the continuation pathway if currently receiving, otherwise follow the initial pathway.

Entry: Start: indicate diagnosis and whether patient is currently receiving the requested medication; if currently receiving, follow continuation pathway (Q3-4); if not, follow initial pathway (Q10+).

Supported by form flow

Continuation Criteria: For patients currently receiving the medication: provider must document a positive clinical response as evidenced by low disease activity or improvement in signs and symptoms and attach supporting medical records (e.g., chart notes, lab reports). Additionally, the form queries whether the requested drug will be used in combination with other biologics; if 'Yes', no further questions (combination biologic use halts evaluation).

Q3-4

Initial Criteria - CNS lupus check: Prior to initiation: determine whether the patient has severe active central nervous system (CNS) lupus (including seizures attributed to CNS lupus, psychosis, organic brain syndrome, cerebritis, or CNS vasculitis requiring therapeutic intervention). The form also queries planned combination use with other biologics and proceeds accordingly.

Q10-11

Initial Criteria - Diagnosis branch: If diagnosis is Active SLE, proceed to SLE-specific initial requirements (Q20+); if Active lupus nephritis, proceed to lupus nephritis–specific initial requirements (Q30+).

Q12

SLE initial requirements: Before initiating therapy for SLE: document presence of autoantibodies relevant to SLE (e.g., ANA, anti-dsDNA, anti-Sm, antiphospholipid antibodies, complement proteins) with attached medical records if positive (options also include 'No' or 'Unknown'). Confirm the patient is currently receiving a standard SLE treatment regimen (examples listed: glucocorticoids, antimalarials, immunosuppressives). If on standard therapy, no further questions per the form flow.

Q20-21

Lupus nephritis initial requirements: Before initiating therapy for active lupus nephritis: document autoantibody positivity relevant to SLE or provide kidney biopsy confirming lupus nephritis (attach records if positive/available). Confirm the patient is currently receiving a standard lupus nephritis therapy (examples listed: cyclophosphamide, mycophenolate mofetil, azathioprine, glucocorticoids). If on standard therapy, no further questions per the form flow.

Q30-31

Provider Actions, Prior Authorization and Documentation

Prior Authorization

Prior authorization and submission

Prior authorization is required for certain medications administered through CVS Caremark. Fax completed prior authorization forms and supporting documentation to CVS Caremark toll-free at 1-866-237-5512. For questions regarding prior authorization determinations, contact CVS Caremark at 1-808-254-4414. For patient eligibility, copay, or medication delivery inquiries, contact CaremarkConnect® Specialty Customer Care Team at 1-800-237-2767. Provide the most accurate diagnosis for the prescribed medication when submitting the request. Approvals may be subject to dosing limits per FDA labeling, accepted compendia, and evidence-based practice guidelines.

Fax prior authorization form and documentation to: 1-866-237-5512
Prior authorization questions: 1-808-254-4414
Specialty Customer Care (CaremarkConnect®): 1-800-237-2767

Step Therapy

Expectations about prior or concurrent standard therapy

Before initiating therapy for systemic lupus erythematosus (SLE) or active lupus nephritis, documentation of prior or concurrent standard treatment regimens is expected. For SLE, document use of glucocorticoids (e.g., prednisone), antimalarials (e.g., hydroxychloroquine), and/or immunosuppressives (e.g., azathioprine, methotrexate, mycophenolate). For lupus nephritis, document use of standard agents such as cyclophosphamide, mycophenolate mofetil, azathioprine, and/or glucocorticoids. Attach medical records demonstrating prior or current standard therapy when indicated on the form.

SLE — document prior/concurrent: glucocorticoids, antimalarials, and/or immunosuppressives
Lupus nephritis — document prior/concurrent: cyclophosphamide, mycophenolate mofetil, azathioprine, and/or glucocorticoids

Documentation Required

Required supporting documentation

Attach supporting clinical documentation with the prior authorization request. For continuation requests or where indicated, include chart notes, laboratory reports (including autoantibody testing such as ANA, anti-dsDNA, anti-Sm, antiphospholipid antibodies, complement levels), and biopsy results (e.g., kidney biopsy confirming lupus nephritis) as applicable. If the request is for continuation of therapy, include records demonstrating maintained or improved clinical response (disease stability or symptom improvement).

Attach chart notes and progress notes documenting clinical status
Include lab reports (e.g., ANA, anti-dsDNA, anti-Sm, antiphospholipid antibodies, complement proteins)
Include biopsy reports when relevant (e.g., kidney biopsy for lupus nephritis)
For continuation requests, attach documentation of disease stability or improvement

Denial Risk

Documentation-based denial risk

Failure to submit required supporting documentation or to provide an accurate and specific diagnosis may result in denial of the prior authorization request. Ensure all requested fields on the form are completed and that documentation is available for review upon request by CVS Caremark or the benefit plan sponsor.

Incomplete forms or missing attachments may lead to denial
Provide accurate diagnosis and attest to availability of supporting documentation

Definitions and Key Clinical Findings

inv-10: Severe active CNS lupus — enumerated serious CNS manifestations requiring therapeutic intervention

DefinitionSevere active CNS lupus includes seizures attributed to CNS lupus, psychosis, organic brain syndrome, cerebritis, or CNS vasculitis requiring therapeutic intervention before initiation of the requested drug.

Screening question locationAsked in Initial Criteria #10 on the form to determine need for further evaluation prior to initiation.

Action on positive findingIf present, the form directs continuation of evaluation (Continue to #11) prior to initiating the requested medication.

Documentation expectationClinical documentation should support attribution of the listed CNS manifestations to lupus and need for therapeutic intervention.

inv-11: Autoantibody positivity relevant to SLE — ANA, anti-dsDNA, anti-Sm, antiphospholipid, complement abnormalities

Included autoantibodies and markersAutoantibodies relevant to SLE include ANA, anti-dsDNA, anti-Sm, antiphospholipid antibodies, and complement proteins.

Form action when positiveIf 'Yes', attach medical records (e.g., chart notes, lab reports) documenting presence of the listed autoantibodies.

Lupus nephritis branch requirementFor lupus nephritis, either autoantibody positivity or kidney biopsy confirming lupus nephritis is requested prior to initiation.

Response options on formThe form allows responses of Yes, No, or Unknown for autoantibody status and directs continuation based on the answer.

OpenPayer

CVS Caremark Prior Authorization Request — Biologic Therapy for SLE and Lupus Nephritis

Coverage Criteria for Biologic Therapy in SLE / Lupus Nephritis

Requested Diagnosis and Coding

Provider Actions, Prior Authorization and Documentation

Definitions and Key Clinical Findings

Background