CurrentHawaii Medical Service Association (HMSA)Policy N/A

Rituxan; Riabni; Ruxience, Truxima Prior Authorization Request

Authorization and clinical screening form used by CVS Caremark/HMSA to determine medical necessity for rituximab and listed biosimilars across multiple indications (RA, AAV/MPA, NHL, CLL, SLL, pemphigus vulgaris, CNS lymphoma/leptomeningeal metastases, Waldenstrom's, ALL, Hodgkin's, myasthenia gravis, immunotherapy-related toxicities, autoimmune cytopenias, TTP, oncologic indications). The document routes condition-specific questions to establish initial or re-authorization criteria and documents provider/patient demographics and site of care.

Policy Summary

PayerHawaii Medical Service Association (HMSA)

PolicyRituxan; Riabni; Ruxience, Truxima Prior Authorization Request

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionAuthorization required via CVS Caremark prior authorization request form; submit diagnosis, relevant lab/biomarker results, prior treatment history, and supporting documentation for oncology indications.

POLICY UPDATE CHANGES

No material clinical or coverage changes identified.

MultipleIndications covered (conditional)

4Products listed

RequiredPrior Authorization

Coverage Summary

This document is a CVS Caremark prior authorization form used for HMSA members to request coverage of rituximab (Rituxan) and listed biosimilars (Riabni, Ruxience, Truxima) across multiple autoimmune, hematologic, and oncologic indications. It routes condition-specific questions (e.g., RA, AAV/MPA, NHL, CLL, SLL, pemphigus vulgaris, CNS lymphoma, Waldenstrom's, ALL, Hodgkin's, myasthenia gravis, immunotherapy-related toxicities, autoimmune cytopenias, TTP, and other oncology uses) to determine initial authorization or re-authorization.

Coverage stance is mixed: approvals are condition- and criteria-dependent and may be subject to dosing limits and other restrictions. The form requires prior authorization and requests supporting clinical information (diagnosis, prior treatment history, labs/biomarkers, and for oncology, ICD‑10 and supportive diagnostic data) to make coverage determinations.

Key thresholds included in the criteria: for rheumatoid arthritis, documentation that the patient has received at least two full doses of rituximab/biosimilar with the most recent dose within 6 months of the request; and for methotrexate, documentation of an inadequate response after at least 3 months of treatment or a documented contraindication/intolerance.

Quick facts

Products listedRituxan; Riabni; Ruxience; Truxima

Prior Authorization requiredRequired via CVS Caremark prior authorization request

Last review date2025-04

Confidence (brief)0.86

Medical‑Necessity Criteria

General Routing / Diagnosis Selection

Select patient's diagnosis to route to condition-specific criteria

ANY of the following

Rheumatoid arthritis (RA) -> Continue to #2
Wegener's granulomatosis (granulomatosis with polyangiitis) or microscopic polyangiitis -> Continue to #100
Non-Hodgkin's lymphoma (NHL) -> Continue to #900
Chronic lymphocytic leukemia (CLL) -> Continue to #900
Small lymphocytic lymphoma (SLL) -> Continue to #900
Pemphigus vulgaris -> Continue to #750
Leptomeningeal metastases from lymphomas -> Continue to #900
Primary central nervous system (CNS) lymphoma -> Continue to #900
Waldenstrom's macroglobulinemia/lymphoplasmacytic lymphoma (LPL) -> Continue to #900
Acute lymphoblastic leukemia (ALL) -> Continue to #900
Hodgkin's lymphoma -> Continue to #900
Myasthenia gravis -> Continue to #700
Immunotherapy-related toxicities -> Continue to #800
Autoimmune hemolytic anemia -> Continue to #800
Immune or idiopathic thrombocytopenic purpura -> Continue to #800
Thrombotic thrombocytopenic purpura -> Continue to #800
Other -> No Further Questions

ref': 'b1_0

title': 'General Routing / Diagnosis Selection'

ref": "b1_0"

title": "General Routing / Diagnosis Selection"

Rheumatoid Arthritis - Initial Authorization

Covered when route-specific and all applicable criteria met for initial authorization

ALL of the following

Requested product is one of: Rituxan, Riabni, Ruxience, Truxima
Prescriber specialty: Is prescribed by or in consultation with an immunologist, rheumatologist or nephrologist
(Q2)
Prior rituximab authorization: If rituximab previously authorized by HMSA/CVS for this member -> Continue to #21 (re-authorization flow); If no/unknown prior authorization -> continue initial flowmost recent dose within 6 months
(Q4)

Rheumatoid Arthritis - Re-authorization (Q21)

Re-authorization requires evidence of benefit since starting rituximab

Evidence of benefit: Low disease activity OR improvement in signs and symptoms OR maintenance of improvement in signs and symptoms (If no benefit -> No Further Questions)

(Q21)

ref": "b1_2"

title": "Rheumatoid Arthritis - Re-authorization (Q21)"

ref":

title":

ref": "b1_2"

Granulomatosis with Polyangiitis / Microscopic Polyangiitis (AAV/MPA)

Initial and re-authorization routing

ref":

title":

ref": "b1_3"

title": "Granulomatosis with Polyangiitis / Microscopic Polyangiitis (AAV/MPA)"

ref": "b1_3"

Myasthenia Gravis

Routing and re-authorization

ref":

title":

ref": "b1_4"

title": "Myasthenia Gravis"

ref": "b1_4"

Pemphigus Vulgaris

Initial and re-authorization criteria

ref":

title":

ref": "b1_5"

title": "Pemphigus Vulgaris"

ref": "b1_5"

Immunotherapy-related toxicities and Autoimmune Cytopenias (Initial Authorization)

Criteria for autoimmune encephalitis, AIHA, ITP, TTP and immunotherapy-related toxicities

ref":

title":

ref": "b1_6"

title": "Immunotherapy-related toxicities and Autoimmune Cytopenias (Initial Authorization)"

ref": "b1_6"

Immunotherapy-related toxicities and Autoimmune Cytopenias (Re-authorization Q890)

Re-authorization requires evidence of benefit

Evidence of benefit: Low disease activity as measured by standardized disease activity tool (eg, BVAS) OR improvement in signs and symptoms OR maintenance of improvement in signs and symptoms (If no benefit -> No Further Questions)

(Q890)

ref":

title":

ref": "b1_7"

title": "Immunotherapy-related toxicities and Autoimmune Cytopenias (Re-authorization Q890)"

Oncologic Indications

Oncology regimen and documentation requirements

ref":

title":

ref": "b1_8"

title": "Oncologic Indications"

ref": "b1_8"

Requested Products / Codes

Requested productsmixedCovered

Rituxan	Rituximab (reference biologic)
Riabni	Rituximab biosimilar
Ruxience	Rituximab biosimilar
Truxima	Rituximab biosimilar

Provider Actions

Prior Authorization

Prior authorization required

Authorization required via CVS Caremark prior authorization request form; submit diagnosis, relevant lab/biomarker results, prior treatment history, and supporting documentation for oncology indications.

Documentation Required

Attach supportive diagnostic data for oncology

For oncologic uses, attach the patient's diagnosis and ICD-10 code and include relevant supportive diagnostic data as required to proceed with the request.

Documentation Required

Document biomarker and lab results for RA

For RA initial requests, document rheumatoid factor (RF) and/or anti-CCP testing results, CRP and/or ESR results, duration of methotrexate trial (≥3 months) or documented contraindication/intolerance, and history of prior biologic use.

Prior Authorization

Re-authorization evidence of benefit

Re-authorization requires documentation that the member has benefited from rituximab since starting treatment, evidenced by low disease activity, improvement in signs and symptoms, or maintenance of prior improvement.

Documentation Required

Prescriber attestation

Prescriber or authorized signature attesting that the information is accurate and that supporting documentation is available for review by CVS Caremark or the benefit plan sponsor.

Background

This is a CVS Caremark-administered prior authorization request/form for HMSA members to document clinical criteria and support coverage determinations for rituximab and its biosimilars (Rituxan, Riabni, Ruxience, Truxima) across autoimmune, hematologic, and oncologic indications.

Approvals documented on the form may be subject to dosing limits in accordance with FDA‑approved labeling, accepted compendia, and/or evidence‑based practice guidelines. The form requires submission of diagnosis, provider specialty, site of care, and relevant supporting documentation (labs/biomarkers, prior treatments, and for oncology, ICD‑10 code and diagnostic data) to process authorization requests.

Definitions & thresholds

Re-authorization (definition)Continuation request requiring demonstration of clinical benefit since starting rituximab (eg, low disease activity, improvement, or maintenance of improvement)

Prior rituximab dosing recency for RAMost recent rituximab dose given within 6 months of this request

Methotrexate trial requirementInadequate response after at least 3 months of methotrexate (or documented intolerance/contraindication)

Revision History

2025-04last_reviewLatest

Clinical criteria and prior authorization form last reviewed

CURRENTdocument_statusLatest

Document status: CURRENT

Policy Summary

PayerHawaii Medical Service Association (HMSA)

PolicyRituxan; Riabni; Ruxience, Truxima Prior Authorization Request

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

On This Page

Will the drug be used in combination with methotrexate or leflunomide? (Yes -> #7) If not, is there a contraindication or history of intolerance to methotrexate or leflunomide?

Biologic use exclusion: Has the patient ever received a biologic or targeted synthetic indicated for moderately to severely active RA (e.g., Rinvoq, Xeljanz)? If yes -> No Further Questions

(Q7)

Prior rituximab doses for RA: Has the patient received at least two full doses of Rituxan/Ruxience/Truxima/Riabni for RA, where the most recent dose was within 6 months of this request? (If yes -> No Further Questions; if no -> proceed to biomarker and labs testing criteria)most recent dose within 6 months

(Q8)

Serologic biomarker criteria (one of)

RF positive: Patient was tested for rheumatoid factor (RF) AND RF biomarker test was positive
(Q9)
anti-CCP positive: Patient was tested for anti-CCP AND anti-CCP test was positive
(Q10)

Inflammatory markers: Testing for CRP and/or ESR may be documented; indicate result

(Q13-Q15)

Methotrexate response/intolerance

Inadequate methotrexate response: Has the patient experienced an inadequate response after at least 3 months of treatment with methotrexate? If yes -> continue>= 3 months
(Q16)
Methotrexate contraindication/intolerance: Intolerance to methotrexate OR specific contraindication (history of intolerance, alcohol use disorder/liver disease, elevated transaminases, interstitial pneumonitis/pulmonary fibrosis, renal impairment, pregnancy/planning, breastfeeding, blood dyscrasias, myelodysplasia, hypersensitivity, significant drug interaction, other)
(Q17-Q19)

Conventional DMARD failure: Inadequate response to another conventional DMARD (e.g., hydroxychloroquine, leflunomide, sulfasalazine) meets criterion

(Q20)

title": "Rheumatoid Arthritis - Initial Authorization"