CurrentCignaPolicy N/A

Rituximab products prior authorization intake and coverage criteria (Riabni, Ruxience, Truxima)

Documentation and prior authorization intake form for requests of rituximab products (biosimilars Riabni, Ruxience, Truxima) across oncology and selected non-oncology indications; intended for providers submitting requests to Cigna.

Policy Summary

PayerCigna

PolicyRituximab products prior authorization intake and coverage criteria (Riabni, Ruxience, Truxima)

Policy CodePolicy N/A

Change TypeInformational (no material coverage changes)

Effective DateN/A

Next Review DateN/A

Key ActionComplete and fax the indication-specific prior authorization form (or submit via CoverMyMeds/SureScripts) including prescriber specialty, prior therapies, timing since prior rituximab courses, and required attestation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3rituximab product names listed

~30diagnoses/indications listed

1fax number for completed form

800.88.CIGNAurgent request phone number

24 weeksILD minimum interval between courses

6 monthsITP/MS/SLE minimum interval between courses

Coverage criteria and indication-specific intake

Intake criteria (information collection)

Form requests indication-specific details; approval is contingent on completion of these intake fields.

Indication selection: Provider must select one oncology or non-oncology diagnosis for which a rituximab product is requested (examples: acute lymphoblastic leukemia, B‑cell NHL, CLL/SLL, follicular lymphoma, mantle cell lymphoma, pemphigus vulgaris, ITP, MS, SLE, solid organ transplant, TTP, and others)

Selection of an indication is required to route subsequent form questions

Patient and prescriber information: Form must include patient identifiers and completed prescriber information (physician name, specialty, DEA/NPI/TIN as applicable), urgency (standard vs urgent), where medication will be obtained, and facility/administration site details

Required for prior authorization submission and processing

Indication-specific follow-up items: For the selected indication the provider must complete the follow-up questions on disease status, relevant biomarkers (for example CD20, del(17p)/TP53 where applicable), prior rituximab exposure, prior therapies/trials, prescriber specialty/consultation, and timing since prior course where applicable

These items are used to support medical necessity determinations

Indication-specific authorization criteria (form-driven)

Coverage consideration is determined by indication-specific ALL/conditional criteria captured on the form; each indication below preserves the form logic.

Hematopoietic cell transplantation: If used as part of conditioning for allogeneic transplant: prescriber must indicate intent and be/consult an oncologist, hematologist, or physician affiliated with a transplant center

See transplant-specific consultation requirement

Immune or idiopathic thrombocytopenia (ITP): Provider must indicate whether request is initial therapy or repeat course. For initial therapy: prescriber must be/consult a hematologist and patient must have tried at least one other ITP therapy. For repeat course: at least 6 months must elapse since the first dose of the previous course and prescriber must attest to prior response and relapse as applicable.>= 6 months between courses for repeat

Repeat-course interval and prior therapy requirements

Immunotherapy‑related toxicities from checkpoint inhibitors: Prescriber must be/consult an appropriate specialist (oncologist, hematologist, nephrologist, neurologist, rheumatologist, or dermatologist). For initial therapy: prescriber must confirm the toxicity occurred while on a checkpoint inhibitor and that the patient is symptomatic despite a trial of at least one systemic corticosteroid. Repeat-course options are captured if previously treated.

The document provided is an intake/prior authorization form that collects indication-specific information to support a coverage decision for rituximab products. This portion of the source does not include an explicit, standalone list of coverage criteria or approval rules; instead, the form requests clinical details (diagnosis, prescriber specialty, prior therapies, timing since prior rituximab courses, diagnostic confirmation, and treatment intent) that will be used to determine medical necessity on a case-by-case basis.

There are no explicit blanket exclusions stated in the chunks provided. The form does, however, note that product availability and plan-specific benefits may affect whether a specific rituximab product is covered and directs providers to plan resources to confirm benefit availability.

Within the supplied pages, there are no explicit statements labeling particular uses of rituximab as not medically necessary. The content focuses on information collection and attestation rather than issuing NMN determinations.

In the provided chunks there are no explicit not medically necessary (NMN) declarations. The form instead documents required clinical information and includes an attestation and audit statement indicating submitted information may be verified.

Permitted regimens and administration contexts

Regimen / Permutation	Documented on form (yes/no)	Qualifiers / Notes
Rituximab as single‑agent therapy	— captured as 'Is the requested medication being given as single agent therapy?'	Applicable to NHL, FL, and low‑grade B‑cell lymphoma sections where single‑agent use is queried
Rituximab in combination with chemotherapy	— captured as 'Will this medication be used in combination with chemotherapy?'	Form asks this for B‑cell NHL (chunk 10) and FL if previously untreated (chunk 12); used to document response status (e.g., achieving response to rituximab + chemotherapy)
Rituximab combined with lenalidomide + tafasitamab‑cxix	— captured as 'Is this medication being given in combination with lenalidomide and tafasitamab‑cxix?'	Specifically queried for B‑cell NHL (chunk 10), FL (if relapsed/refractory and not single‑agent) (chunk 12), and low‑grade B‑cell lymphoma (chunk 13)
Rituximab as maintenance therapy following prior chemo/response	— captured as 'Is the requested medication being used as maintenance therapy?'	Form asks maintenance status for B‑cell NHL (chunk 10) and FL (chunk 12)
Rituximab for patients 'achieving a complete or partial response' to rituximab + chemotherapy	— captured as selectable option 'Achieving a complete or partial response to a rituximab product in combination with chemotherapy'	Used to document clinical context of current request (chunks 10 and 12)
Rituximab for previously untreated, relapsed, or refractory disease	— captured as selectable disease‑status options ('Previously untreated disease', 'Relapsed or refractory disease')	Queried across NHL (chunk 10), FL (chunk 12), and low‑grade B‑cell lymphoma (chunk 13)

Line of therapy and use restrictions

Line-of-therapy rules (form-driven)

Form captures disease status and line-of-therapy descriptors to characterize intended oncologic use.

Disease status / line of therapy: Form asks whether disease is previously untreated, relapsed/refractory, achieving response to rituximab plus chemotherapy, being used as maintenance, or being given as single‑agent therapy; also captures whether rituximab will be combined with chemotherapy or with lenalidomide plus tafasitamab‑cxix

Used to characterize line of therapy; no explicit line‑based coverage rules provided in this portion of the form

Intervals and timing between courses

inv-07: Minimum interval between rituximab courses

Interstitial lung disease (associated with systemic autoimmune rheumatic disease)>= 24 weeks between courses (minimum of 24 weeks since first dose of previous course and first dose of next course)

Pemphigus vulgaris (relapse or maintenance)>= 16 weeks between courses (minimum of 16 weeks since first dose of previous course and first dose of next course)

Rheumatoid arthritis (retreatment)>= 16 weeks between courses (minimum of 16 weeks since first dose of previous course and first dose of next course)

Immune/Idiopathic thrombocytopenia (ITP) (repeat course)>= 6 months between courses (minimum of 6 months since first dose of previous course and first dose of requested course)

Multiple sclerosis (MS) (retreatment)>= 6 months between courses (minimum of 6 months separating first dose of previous and first dose of requested course)

Systemic lupus erythematosus (SLE) (retreatment)

Submission, documentation, and provider responsibilities

Prior Authorization

Prior Authorization Submission

Prior authorization is required for the requested rituximab products. Complete and submit the Cigna prior authorization form (electronic submission via CoverMyMeds or SureScripts is available) or fax the completed form to the plan. For urgent requests, call the phone number on the form and indicate urgency; attest when marking urgent that standard timelines may jeopardize the patient.

Fax number: 888.302.1028 (Accredo specialty pharmacy fax for orders)
Phone (Accredo verbal orders): 866.759.1557

Prior Authorization

Prior Authorization Questionnaire and Submission

Complete the indication-specific questionnaire sections on the form. Provide prescriber specialty and consultation details, specify whether request is a new start or continuation, document medication name, dose, frequency, duration, ICD-10 code, and whether the medication will be given concurrently with other agents.

Background and scope

Rituximab products are requested across a broad set of oncology and autoimmune indications. The intake form captures indication-specific details — for example diagnosis, prescriber specialty, prior response, prior therapies, and timing since prior rituximab courses — so that coverage decisions can be evaluated in the context of the specific disease and treatment history.

Terminology and biomarker definitions

inv-17: Philadelphia chromosome-negative (Ph-) ALL

Form field labelPhiladelphia chromosome-negative (PH-) ALL — Yes/No checkbox

PurposeUsed to identify ALL subtype for rituximab eligibility as captured on the prior authorization form

Context of useAppears under the ALL section prompting prescriber to indicate PH- ALL status

inv-18: del(17p)/TP53 mutation

Form field labeldel(17p)/TP53 mutation — Yes/No checkbox

IndicationChronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL)

Biomarkers and testing

inv-21: CD20

BiomarkerCD20 — Yes/No checkbox for CD20 positive B-cell Non-Hodgkin's lymphoma (NHL)

ContextAsked in the B-cell NHL section to confirm CD20 positivity for intended rituximab use

ActionProvider must indicate CD20 status on form to support indication-specific authorization

inv-22: del(17p)/TP53

Biomarkerdel(17p)/TP53 — Yes/No checkbox for CLL/SLL

ContextQueried in the CLL/SLL section because mutation status may influence treatment decisions

Action

Policy Summary

PayerCigna

PolicyRituximab products prior authorization intake and coverage criteria (Riabni, Ruxience, Truxima)

Policy CodePolicy N/A

Change TypeInformational (no material coverage changes)

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

Steroid trial requirement for initial therapy

Interstitial lung disease associated with systemic autoimmune rheumatic disease: Prescriber must be/consult a pulmonologist or rheumatologist. For initial treatment diagnosis must be confirmed by high‑resolution CT. For repeat course at least 24 weeks must elapse since the first dose of the prior course and prescriber must attest to a beneficial response to prior rituximab when applicable.>= 24 weeks between courses for repeat

Imaging confirmation and repeat-course interval

Membranous nephropathy: Prescriber must be/consult a nephrologist. If no prior rituximab course, prescriber must attest the patient is at moderate or high risk for progressive loss of kidney function.

Risk stratification for initial therapy

Multiple sclerosis (MS): Prescriber must be/consult a neurologist or MS specialist. The form captures whether rituximab will be combined with another disease‑modifying therapy. If not currently on rituximab, prescriber must attest inadequate efficacy or intolerance to at least two other DMTs. If currently receiving rituximab, patient should have been treated ≥1 year with evidence of objective benefit or stabilization; if previously treated, at least 6 months must elapse between courses.>= 6 months between courses for retreatment

DMT trial and on‑therapy response requirements

Myasthenia gravis (MG): Prescriber must be/consult a neurologist. If previously treated with rituximab, prescriber must attest ongoing benefit. If treatment-naive: confirm anti‑MuSK antibody positivity or prior pyridostigmine trial (or contraindication/intolerance) and trial of at least one immunosuppressant; document unresolved symptoms when applicable.

Serology and prior‑therapy requirements for treatment‑naive patients

Neuromyelitis optica spectrum disorder (NMO): Prescriber must be/consult a neurologist.

Specialist consultation requirement

Pediatric nephrotic syndrome (PNS): Prescriber must be/consult a nephrologist. Document prior rituximab course status, trial of at least one systemic corticosteroid, and trial of at least one glucocorticoid‑sparing agent prior to approval for initial therapy.

Sequential therapy requirements for pediatric patients

Pemphigus vulgaris and other refractory autoimmune blistering diseases: Prescriber must be/consult a dermatologist. Indicate initial, relapse, or maintenance therapy. For initial therapy rituximab should be initiated with a corticosteroid unless contraindicated. For relapse/maintenance, subsequent infusions must be administered no sooner than 16 weeks after the prior infusion.>= 16 weeks between courses for relapse/maintenance

Corticosteroid co‑therapy for initial treatment and minimum interval for repeat courses

Refractory autoimmune hemolytic anemia: Prescriber must be/consult a hematologist.

Specialist consultation requirement

Rheumatoid arthritis (RA): Form captures whether rituximab will be used with a biologic/targeted synthetic/conventional synthetic DMARD or alone. Document prior rituximab courses and intervals (≥16 weeks between courses). For rituximab‑naive patients, require trial of one conventional synthetic DMARD for ≥3 months and one biologic DMARD for ≥3 months. If patient has had ≥2 prior rituximab courses, document objective clinical response to prior therapy.>= 16 weeks between courses; prior DMARD trials ≥3 months

Step therapy and response documentation for RA

Solid organ transplant: Form asks whether rituximab will be used for desensitization prior to/immediately after transplant or for antibody‑mediated rejection and requires prescriber affiliation with a transplant center.

Transplant‑specific use cases and affiliation requirement

Systemic lupus erythematosus (SLE): Prescriber must be/consult a rheumatologist, nephrologist, or neurologist for initial therapy. Initial therapy requires trial of at least one standard immunomodulating or immunosuppressant. If previously treated with rituximab, at least 6 months must elapse between courses.>= 6 months between courses for retreatment

Prior immunosuppressant trial and repeat‑course interval

Thrombotic thrombocytopenic purpura (TTP): Rituximab must be used in combination with systemic corticosteroids and therapeutic plasma exchange and be prescribed by or in consultation with a hematologist.

Concurrent therapy requirements for TTP

>= 6 months between courses (minimum of 6 months separating first dose of previous and first dose of requested course)

Indication-specific items include GvHD, Hematopoietic Cell Transplantation, ITP, MS, Pediatric Nephrotic Syndrome, SLE, and TTP questions
For GvHD, HCT, ITP, MS, PNS, SLE, and TTP complete the related questionnaire items on the form

Documentation Required

Prior Therapy Documentation

Document prior courses of therapy as requested for each indication. Complete the form fields about prior rituximab exposure, prior systemic or disease-specific therapies tried, timing (for example, minimum 6 months between courses when applicable), response to prior therapy, and prescriber consultations.

Record dates and outcomes of prior rituximab courses when applicable
For prior therapies, list agent names, treatment dates, and objective response measures (e.g., labs, symptom improvement)

Step Therapy

Required Prior Therapies

Many indications require documented trials of specific prior therapies before approval. Provide actionable details on the form about prior standard therapies tried and responses.

GvHD: try at least one systemic agent (examples listed on form)
ITP: try at least one other therapy (IVIG, corticosteroids, TPO-RA, etc.) or meet criteria for repeat course with ≥6 months separation
MS: inadequate efficacy or intolerance to ≥2 MS disease-modifying therapies prior to rituximab (if not currently receiving)
PNS: prior corticosteroid and at least one glucocorticoid-sparing agent
SLE: prior trial of ≥1 standard immunomodulating/immunosuppressant agent

Documentation Required

Required Submission Information

Ensure all required submission information is completed: prescriber name, specialty, DEA/NPI/TIN, office contact, office phone and fax, patient name, Cigna ID, date of birth, patient address and phone, medication requested and specifics, facility dispensing/administration details, and site-of-care.

Prescriber identifiers: DEA, NPI or TIN required
Patient identifiers: Cigna ID, DOB, address, phone
Medication details: drug name, dose, frequency, duration, ICD-10
Site-of-care and dispensing facility details: location, tax ID

Documentation Required

Attestation and Audit

Prescriber attestation and signature are required on the form. Cigna or its designees may perform routine audits and request medical records to verify information submitted; retain supporting documentation to expedite any audit.

Include prescriber signature and date on the submission
Be prepared to provide supporting medical records if audited

Collected because mutation status may affect treatment decisions for CLL/SLL

inv-19: Course of rituximab product

Definition on formCourse of rituximab product: the prior completed treatment course is dated by the first dose of the previous course and is used to calculate minimum intervals before the next course

Use in interval calculationsExamples cited: minimum intervals (e.g., 6, 16, or 24 weeks) are measured from the first dose of the previous course to the first dose of the requested course

DocumentationForm asks whether patient has already received a course of a rituximab product for the specific indication to trigger interval questions

Provider must indicate presence or absence of del(17p)/TP53 on the form to inform CLL/SLL management