CurrentHawaii Medical Service Association (HMSA)Policy N/A

Rituximab and biosimilars prior authorization

Prior authorization criteria and forms for rituximab and specified biosimilars for multiple indications (rheumatologic, neurologic, hematologic, and oncologic) for HMSA members; governs providers requesting coverage through CVS Caremark.

Policy Summary

PayerHawaii Medical Service Association (HMSA)

PolicyRituximab and biosimilars prior authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit completed prior authorization form and supporting documentation to CVS Caremark (fax 1-866-237-5512) for rituximab and listed biosimilars.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

multipledistinct clinical indication pathways covered on form

stepwiseauthorization steps

requiredprior auth

listedsite of care options

Coverage and Medical Necessity Criteria

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inv-01: General and re-authorization

Covered when the indication-specific criteria are met per the question flow

General

Prior authorization history: Rituximab previously authorized for member? If yes, follow re-authorization pathway assessing benefit
Chunks 4,8,10,12

inv-02: Initial Therapy (Rheumatoid arthritis)

Rheumatoid arthritis — Initial authorization criteria

RA initial

Biomarker positivity: If RF positive OR anti-CCP positive then proceed; testing for CRP/ESR is requested
Chunks 5-6
Methotrexate trial: Inadequate response after >=3 months on methotrexate >=15 mg/week OR intolerance/contraindication to methotrexate
Chunk 6

inv-03: Re-authorization (Rheumatoid arthritis)

Rheumatoid arthritis — Re-authorization criteria

RA reauth: Member must have benefitted from rituximab as evidenced by low disease activity, improvement or maintenance of improvement in signs/symptoms

Chunk 7

inv-04: Initial and Re-authorization (Wegener's/Micro polyangiitis)

Granulomatosis with polyangiitis / microscopic polyangiitis

Vasculitis: Prescribed by appropriate specialist; if rituximab was previously authorized then re-authorization requires evidence of benefit (low disease activity via standardized tool or clinical improvement/maintenance)

Chunks 8-9

inv-05: Myasthenia gravis

Myasthenia gravis

MG: Prescribed by appropriate specialist (immunologist, neurologist, or rheumatologist); prior rituximab authorization triggers re-authorization pathway requiring evidence of benefit

Chunks 10-11

inv-06: Pemphigus vulgaris

Pemphigus vulgaris

Pemphigus: Prescribed by an immunologist or dermatologist; for initial authorization disease should be moderate to severe; re-authorization requires evidence of benefit (low disease activity, improvement, or maintenance)

Chunks 12-14

inv-07: Autoimmune hematologic indications and immunotherapy-related toxicities

Autoimmune hematologic conditions and immunotherapy-related toxicities

Autoimmune hematologic/TTP/ITP/Immunotherapy toxicities: Prescribed by hematology/oncology as appropriate; for specific diagnoses require refractory status to first-line therapies (e.g., steroids, IVIG, plasma exchange) or failure to respond to methylprednisolone +/- IVIG for encephalitis; re-authorization requires evidence of benefit

Chunks 15-16

inv-08: Oncologic indications

Oncology indications

Oncology requests require documentation of regimen agents, ICD-10 diagnosis, evidence supporting use (NCCN I or IIA recommendation, FDA-approved indication, or supporting data), and prior authorization history; demonstrate benefit for re-authorization

Chunk 17

The prior authorization form includes an explicit oncology pathway that bypasses non-oncology question sets when the requested drug is for an oncology diagnosis. The form asks whether the product is being requested for an oncology diagnosis and, if so, directs the requestor to the oncology section (#900–905) where documentation of the oncology regimen, ICD-10 diagnosis, supporting evidence (e.g., NCCN I or IIA, FDA approval, or other supporting data), and prior authorization history must be provided. Providers should therefore select the oncology route when applicable and attach the required supporting documentation rather than completing the non-oncology indication flow.

Requests missing required documentation or incomplete responses to the form’s questions risk denial. The form requires documentation of prior therapies (for example, methotrexate use or intolerance and prior biologic/tsdm use for rheumatoid arthritis), specific biomarker testing when indicated (e.g., RF, anti-CCP, CRP, ESR for RA), and evidence of intolerable adverse events to preferred biosimilars when claiming exceptions. Where the form asks about intolerable adverse events to preferred products, supporting chart notes must be attached. If these items are not completed or provided, the request may not meet medical necessity criteria.

Diagnosis and Procedure Coding

Diagnosis codingICD-10

ICD-10

Field on form requests the ICD-10 code for the diagnosis

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required through CVS Caremark for rituximab and listed biosimilars. Submit the completed prior authorization form and supporting documentation to CVS Caremark via fax at 1-866-237-5512. For prior authorization questions call CVS Caremark at 1-808-254-4414. For patient eligibility, copay or medication delivery inquiries, contact CaremarkConnect Specialty Customer Care at 1-800-237-2767.

Fax: 1-866-237-5512
Prior authorization phone: 1-808-254-4414
Specialty Customer Care (CaremarkConnect): 1-800-237-2767

Step Therapy

Preferred-product and Biosimilar Step

The plan implements a preferred-product step for rituximab requests. The preferred products for HMSA members are Riabni and Truxima. If an approved preferred product can be used, indicate selection on the form. If requesting a non-preferred product (e.g., Rituxan, Ruxience, or other listed alternatives), document why the patient cannot be switched to a preferred product.

Preferred products: Riabni and Truxima — selection should be indicated on the form when appropriate.
If selecting a non-preferred product, attach chart notes documenting intolerable adverse events or contraindications to both preferred products.
If the intolerable adverse event is NOT a known adverse reaction attributed to the active ingredient per prescribing information, attach supporting chart notes explaining rationale.

Documentation Required

Required Supporting Documentation

Attach all relevant supporting documentation with the prior authorization request. For oncology indications, include the full regimen, diagnosis with ICD-10 code, and current clinical documentation demonstrating benefit (e.g., office notes, relevant studies). For adverse-event exemptions to preferred-product switching, attach chart notes documenting the event and attribution. Incomplete documentation or missing required tests/previous-exposure evidence may result in denial or delay.

Oncology: list all agents in the regimen and attach supportive data; include ICD-10 diagnosis and evidence of benefit when applicable.
Adverse events: attach chart notes documenting intolerable adverse events to both preferred products when claiming exemption from step.
RA and other autoimmune indications: document prior biologic/targeted synthetic exposure and dosing history (e.g., at least two full doses where required), and attach RF or anti-CCP test results when applicable.
Failure to attach required documentation (chart notes, test results, prior treatment history) or to complete form questions may lead to denial.

Denial Risk

Incomplete Documentation or Unmet Criteria

Requests with incomplete responses to the exception criteria questions, missing attached chart notes, absent biomarker test results, or lacking prior exposure documentation (when required) may be denied. Ensure all applicable form questions are answered and supporting records are attached to avoid processing delays or denials.

Incomplete exception criteria (Questions A–E) or oncology checklist (900–905) increases denial risk.
If prior exposures (e.g., previous biologic therapy, documented dosing within 6 months) are claimed, include dates and supporting notes.
If claiming intolerance or contraindication to preferred products, include specific clinical details and supporting documentation.

Background and Clinical Context

Rituximab and its biosimilars are used across multiple specialties including rheumatology, hematology/oncology, neurology, dermatology, and immunology. The prior authorization form routes requests through indication-specific question sets to verify that the prescribing clinician is an appropriate specialist, to capture prior authorization history, prior therapies, and relevant biomarker testing, and to document clinical benefit for re-authorization. The form also incorporates a biosimilar/preferred-product step in which providers are asked whether the member can be switched to preferred biosimilars (Riabni or Truxima) or whether intolerable adverse events to preferred products are documented and supported by chart notes.

Preferred Products and Definitions

Preferred products and switch documentation prompt

Preferred rituximab biosimilarsRiabni and Truxima are identified as the plan's preferred products

Switch assessmentForm asks whether the patient's treatment can be switched to Riabni or Truxima (questions B and E)

Documentation of intoleranceIf unable to switch, form asks if patient has documented intolerable adverse events to both Riabni and Truxima and requires attaching supporting chart notes if 'Yes' (question C)

Expected adverse event attributionForm asks whether the documented intolerable adverse event is an expected adverse event attributed to the active ingredient per prescribing information; action required: attach chart note(s) if 'No' (question D)

Oncology pathway bypassIf the requested drug is for an oncology diagnosis the form directs to oncology-specific questions and skips non-oncology pathways (question E)