RITUXAN Coverage

Benefits Investigations

RITUXAN Access Solutions can conduct a benefits investigation (BI) to help you determine if RITUXAN is covered, if prior authorizations (PAs) are required, which specialty pharmacy (SP) the health insurance plan prefers and if patient assistance might be needed.

Potential outcomes of a BI:

  • Treatment is covered
  • PA is required
  • Treatment is denied

Both the Prescriber Service Form and the Patient Consent Form must be received before RITUXAN Access Solutions can begin helping your patient.

These can be downloaded from Forms and Documents or submitted online via My Patient Solutions

The completion and submission of coverage- or reimbursement-related documentation are the responsibility of the patient and health care provider. Genentech and Biogen make no representation or guarantee concerning coverage or reimbursement for any service or item.

Prior Authorization

RITUXAN Access Solutions can help you identify if a prior authorization (PA) is necessary and offer resources as you obtain it for your patient. Both the Prescriber Service Form and the Patient Consent Form must be received before RITUXAN Access Solutions can begin helping your patient.

If your patient’s request for a PA is not granted, your BioOncology Field Reimbursement Manager (BFRM) or RITUXAN Access Solutions Specialist can work with you to determine your next steps. You can find more tips like this in Forms and Documents.

The completion and submission of coverage- or reimbursement-related documentation are the responsibility of the patient and health care provider. Genentech and Biogen make no representation or guarantee concerning coverage or reimbursement for any service or item.

Important Safety Information & Indication

Indication

RITUXAN® (Rituximab) is indicated for the treatment of patients with:

  • Relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL as a single agent
  • Previously untreated follicular, CD20 positive, B cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy
  • Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL, as a single agent, after first-line CVP chemotherapy
  • Previously untreated diffuse large B-cell, CD20-positive NHL in combination with CHOP or other anthracycline-based chemotherapy regimens
  • Previously untreated and previously treated CD20-positive CLL in combination with fludarabine and cyclophosphamide (FC)

BOXED WARNINGS

WARNING: FATAL INFUSION-RELATED REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY

  • Infusion-related reactions: RITUXAN administration can result in serious, including fatal infusion-related reactions. Deaths within 24 hours of RITUXAN infusion have occurred. Approximately 80% of fatal infusion reactions occurred in association with the first infusion. Monitor patients closely. Discontinue RITUXAN infusion for severe reactions and provide medical treatment for Grade 3 or 4 infusion-related reactions
  • Severe Mucocutaneous Reactions: Severe, including fatal, mucocutaneous reactions can occur in patients receiving RITUXAN
  • Hepatitis B Virus (HBV) Reactivation: HBV reactivation can occur in patients treated with RITUXAN, in some cases resulting in fulminant hepatitis, hepatic failure, and death. Screen all patients for HBV infection before treatment initiation, and monitor patients during and after treatment with RITUXAN. Discontinue RITUXAN and concomitant medications in the event of HBV reactivation
  • Progressive Multifocal Leukoencephalopathy (PML), including fatal PML, can occur in patients receiving RITUXAN

Warnings and Precautions

  • Tumor Lysis Syndrome: Acute renal failure, hyperkalemia, hypocalcemia, hyperuricemia, or hyperphosphatemia from tumor lysis, some fatal, can occur within 12−24 hours after the first infusion of RITUXAN in patients with NHL. Administer aggressive intravenous hydration, anti-hyperuricemic agents, monitor renal function
  • Infections: Serious, including fatal, bacterial, fungal, and new or reactivated viral infections can occur during and following the completion of RITUXAN-based therapy. RITUXAN is not recommended for use in patients with severe, active infections
  • Cardiovascular Adverse Reactions: Discontinue infusions in case of serious or life-threatening events
  • Renal Toxicity: Severe, including fatal, renal toxicity can occur after RITUXAN administration in patients with NHL. Discontinue in patients with rising serum creatinine or oliguria
  • Bowel Obstruction and Perforation: Abdominal pain, bowel obstruction and perforation, in some cases leading to death, can occur in patients receiving RITUXAN in combination with chemotherapy. Consider and evaluate for abdominal pain, vomiting, or related symptoms
  • Immunization: Live virus vaccinations prior to or during RITUXAN treatment not recommended
  • Embryo-Fetal Toxicity: Can cause neonatal harm. Advise of potential risk to neonates and use of effective contraception.

Additional Important Safety Information

  • The most common Grade 3 or 4 adverse reactions in clinical trials of NHL and CLL were infusion-related reactions, neutropenia, leukopenia, anemia, thrombocytopenia, and infections. Additionally, lymphopenia and lung disorder were seen in NHL trials; and febrile neutropenia, pancytopenia, hypotension, and hepatitis B were seen in CLL trials
  • The most common adverse reactions (incidence ≥25%) in clinical trials of NHL and CLL were infusion-related reactions. Additionally, fever, lymphopenia, chills, infection, and asthenia were seen in NHL trials; and neutropenia was seen in CLL trials

For additional safety information, please see the full prescribing information, including BOXED WARNINGS and Medication Guide.

Attention Healthcare Provider: Provide Medication Guide to patient prior to RITUXAN infusion.

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.