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For Patients and Caregivers

Prescribing Information

Helpful Resources for Your Practice

RITUXAN HYCELA Access Solutions offers a range of access and reimbursement resources for your patients and practice after RITUXAN HYCELA is prescribed, including help with benefits investigations (BIs), resources for prior authorizations (PAs), sample billing and coding information, resources for denials and appeals, information about distribution and referrals to potential financial assistance options.

Quick Links

Help with coverage (BIs and PAs)
Reimbursement (billing, coding and appeals)
Online patient enrollment
RITUXAN HYCELA Distribution

Coverage

Get help understanding insurance benefits and coverage, such as with benefits investigations and prior authorization resources.

Benefits investigations

RITUXAN HYCELA Access Solutions can conduct a benefits investigation (BI) which can determine:

  • If treatment is covered
  • If treatment is denied
  • If a prior authorization or pre-determination is required*
  • If your patient's insurance plan has a mandated or preferred SP

*If your patient’s request for a prior authorization is not granted, your RITUXAN HYCELA Access Solutions Specialist can work with you to determine your next steps.

Get started with enrollment by following the steps below.

Option 1: Submit forms online

If your practice has a registered account for My Patient Solutions, you can get started by logging into your account.

Don't have an account?

Your patient is required to complete the Patient Consent Form. You can either upload their Patient Consent Form as part of your application or have your patient submit the form via fax, text or e-submit.

  • An online tool to help you enroll patients in RITUXAN HYCELA Access Solutions and manage your service requests at your convenience.

Option 2: Print forms and fax or text

Step 1: Print one of the Patient Consent Forms below for your patient to complete.

Step 2: Print and complete the Prescriber Service Form below.

Step 3: Submit the completed forms via fax or text.

Both forms are required. We must have both the Patient Consent Form and the Prescriber Service Form before we can help you.

What to expect next:

  • The request will be processed within five business days upon receipt of both required forms.
  • Your office will be contacted to discuss the application outcome and any next steps.

Genentech reserves the right to modify or discontinue the program at any time and to verify the accuracy of information submitted.

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

RITUXAN HYCELA Case Managers

A Case Manager may assist during your patient's treatment with access, reimbursement, and injection training support.

Learn more about RITUXAN HYCELA Case Managers

Reimbursement

Sample coding information and resources for denials and appeals

RITUXAN HYCELA Sample Coding

This coding information may assist you as you complete the payer forms for RITUXAN HYCELA. These tables are provided for informational purposes only. Please visit CMS.gov or other payers’ websites to obtain additional guidance on their processes related to billing and coding.

Download sample coding and the important safety information for RITUXAN HYCELA below.

Sample Coding: Follicular Lymphoma (FL)
Sample Coding: Diffuse Large B-cell Lymphoma (DLBCL)
Sample Coding: Chronic Lymphoid Leukemia (CLL)

Correct coding is the responsibility of the provider submitting the claim for the item or service. Please check with the payer to verify codes and special billing requirements. Genentech does not make any representation or guarantee concerning reimbursement or coverage for any service or item.

Appeals

If your patient’s health insurance plan has issued a denial, your RITUXAN HYCELA Access Solutions Specialist can provide resources as you prepare an appeal submission, as per your patient’s plan requirements. 

If a plan issues a denial: 

  1. The denial should be reviewed, along with the health insurance plan’s guidelines to determine what to include in your patient’s appeal submission.
  2. Your RITUXAN HYCELA Access Solutions Specialist has local payer coverage expertise and can help you determine specific requirements for your patient.

A sample appeal letter and additional considerations are available on the Practice Forms and Documents page.

Appeals cannot be completed or submitted by Genentech on your behalf.

Online patient enrollment

My Patient Solutions is an online tool to help you enroll patients in RITUXAN HYCELA Access Solutions and manage your service requests, all through one portal. It allows you the flexibility to work with RITUXAN HYCELA Access Solutions when it’s convenient for you.

With My Patient Solutions, you can:

  • Enroll and re-enroll patients in financial assistance programs entirely online
  • Communicate with your RITUXAN HYCELA Access Solutions Specialist
  • Easily identify next steps for service requests
  • View Benefits Investigation reports for all your enrolled patients
  • Follow up on prior authorizations or appeals
  • View co-pay assistance outcomes and referral information

How to register

Account registration can be completed by one person for the entire practice and for multiple practice locations. For help with registration or if you have questions, call us at 877-GENENTECH (877-436-3683) (6AM-5PM PST, Monday through Friday).

Register for My Patient Solutions

RITUXAN HYCELA Distribution

Genentech has contracted with a network of authorized specialty distributors and specialty pharmacies (SPs) to service practices choosing to prescribe RITUXAN HYCELA. 

These partners have made a commitment to product integrity and have agreed to distribute only products purchased directly from Genentech and not to distribute RITUXAN HYCELA through secondary channels.

Authorized Distributors and Specialty Pharmacies

For a full list of authorized distributors and in-network specialty pharmacies, please visit the Genentech Access Solutions website or contact RITUXAN HYCELA Access Solutions at 888-249-4918.

About Buy and Bill

With Buy and Bill, the practice purchases the medication in advance, then bills the patient's health insurance plan for reimbursement. The practice is responsible for storing and handling the drug as well as collecting the patient's co-pay for both the drug and its administration. With Buy and Bill, practices can maintain a stock of the drug, giving them the flexibility to treat patients when clinically appropriate.

About Specialty Pharmacies

RITUXAN HYCELA Access Solutions works with specialty pharmacies (SPs) to help patients receive their prescribed Genentech medicines.

In addition to distributing medicines, an SP may provide the following services:

  • Reimbursement resources
  • Clinical services to support patients throughout their treatment
  • The ability to manage the specialty handling and shipping needs linked with many specialty therapies

You can work with your preferred SP or contact RITUXAN HYCELA Access Solutions to learn which SP the patient’s health insurance plan mandates or prefers.

Genentech does not influence or advocate the use of any one specialty distributor or specialty pharmacy. We make no representation or guarantee of service or coverage of any item. For any product-specific distribution questions, call RITUXAN HYCELA Access Solutions at 888-249-4918 (6AM-5PM PST, Monday through Friday).

Product issues

We are serious about patient safety. If your Genentech product is spoiled, expired or damaged, we may be able to help you replace it.

Need more help? Click here to find the latest information.

Please contact Genentech Customer Service at (800) 551-2231 for any order or return-related questions.

Contact Us

Questions? Contact RITUXAN HYCELA Access Solutions

Call 888-249-4918 (Mon.–Fri., 6AM–5PM PST)

NEXT: Practice Forms and Documents

    • RITUXAN HYCELA full Prescribing Information. South San Francisco, CA: Genentech, Inc.; June 2021.

      RITUXAN HYCELA full Prescribing Information. South San Francisco, CA: Genentech, Inc.; June 2021.

    • Data on file. Genentech, Inc.

      Data on file. Genentech, Inc.

    Important Safety Information & Indications

    Indications

    RITUXAN HYCELA® (rituximab/hyaluronidase human) is indicated for the treatment of adult patients with:

    • Relapsed or refractory, follicular lymphoma (FL) as a single agent
    • Previously untreated follicular lymphoma in combination with first-line chemotherapy and, in patients achieving a complete or partial response to rituximab in combination with chemotherapy, as single-agent maintenance therapy
    • Non-progressing (including stable disease) follicular lymphoma as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy
    • Previously untreated diffuse large B-cell lymphoma (DLBCL) in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or other anthracycline-based chemotherapy regimens
    • Previously untreated and previously treated chronic lymphocytic leukemia (CLL) in combination with fludarabine and cyclophosphamide (FC)

    Limitations of Use

     

    • Initiate treatment with RITUXAN HYCELA only after patients have received at least one full dose of a rituximab product by intravenous infusion
    • RITUXAN HYCELA is not indicated for the treatment of non-malignant conditions

    BOXED WARNINGS: SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY

    • Severe Mucocutaneous Reactions: Severe, including fatal, mucocutaneous reactions can occur in patients receiving rituximab-containing products, including RITUXAN HYCELA
    • Hepatitis B Virus (HBV) Reactivation: HBV reactivation can occur in patients treated with rituximab-containing products, including RITUXAN HYCELA, 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 HYCELA. Discontinue RITUXAN HYCELA and concomitant medications in the event of HBV reactivation
    • Progressive Multifocal Leukoencephalopathy (PML), including fatal PML, can occur in patients receiving rituximab-containing products, including RITUXAN HYCELA
    WARNINGS AND PRECAUTIONS

    Severe Mucocutaneous Reactions

    • Mucocutaneous reactions, some with fatal outcome, can occur in patients treated with rituximab-containing products, including RITUXAN HYCELA. These reactions include paraneoplastic pemphigus, Stevens-Johnson syndrome, lichenoid dermatitis, vesiculobullous dermatitis, and toxic epidermal necrolysis
    • Discontinue RITUXAN HYCELA in patients who experience a severe mucocutaneous reaction. The safety of re-administration of a rituximab-containing product, including RITUXAN HYCELA, to patients with severe mucocutaneous reactions has not been determined

    Hepatitis B Virus Reactivation

    • Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients treated with CD20-directed cytolytic antibodies, including rituximab-containing products
    • HBV reactivation is defined as an abrupt increase in HBV replication manifesting as a rapid increase in serum HBV DNA levels or detection of HBsAg in a person who was previously HBsAg negative and anti-HBc positive. Reactivation of HBV replication is often followed by hepatitis, i.e., increase in transaminase levels. In severe cases, increase in bilirubin levels, liver failure, and death can occur
    • Screen all patients for HBV infection by measuring HBsAg and anti-HBc before initiating treatment with a rituximab-containing product. For patients who show evidence of prior hepatitis B infection (HBsAg positive [regardless of antibody status] or HBsAg negative but anti-HBc positive), consult with physicians with expertise in managing hepatitis B regarding monitoring and consideration for HBV antiviral therapy before and/or during treatment with a rituximab-containing product. Monitor patients with evidence of current or prior HBV infection for clinical and laboratory signs of hepatitis or HBV reactivation during and for several months following RITUXAN HYCELA. HBV reactivation has been reported up to 24 months following completion of therapy containing rituximab
    • In patients who develop reactivation of HBV while on RITUXAN HYCELA, immediately discontinue treatment and any concomitant chemotherapy, and institute appropriate treatment. Insufficient data exist regarding the safety of resuming RITUXAN HYCELA treatment in patients who develop HBV reactivation. Resumption of RITUXAN HYCELA treatment in patients whose HBV reactivation resolves should be discussed with physicians with expertise in managing HBV

    Progressive Multifocal Leukoencephalopathy (PML)

    • JC virus infection resulting in PML and death has been observed in patients receiving rituximab-containing products, including RITUXAN HYCELA
    • Consider the diagnosis of PML in any patient presenting with new-onset neurologic manifestations. Evaluation of PML includes, but is not limited to, consultation with a neurologist, brain MRI, and lumbar puncture
    • Discontinue RITUXAN HYCELA and consider discontinuation or reduction of any concomitant chemotherapy or immunosuppressive therapy in patients who develop PML

    Hypersensitivity and Other Administration Reactions
    Systemic Reactions

    • Patients must receive at least one full dose of RITUXAN before receiving RITUXAN HYCELA due to the higher risk of hypersensitivity and other acute reactions during the first infusion. Beginning therapy with RITUXAN allows management of hypersensitivity and other administration reactions by slowing or stopping the intravenous infusion
    • Rituximab-containing products, including RITUXAN HYCELA, are associated with hypersensitivity and other administration reactions, which may be related to release of cytokines and/or other chemical mediators. Cytokine release syndrome may be clinically indistinguishable from acute hypersensitivity reactions. This set of reactions which includes syndrome of cytokine release, tumor lysis syndrome, and anaphylactic and hypersensitivity reactions are described below. They are not specifically related to the route of administration of a rituximab-containing product
    • Severe infusion-related reactions with fatal outcome have been reported with the use of RITUXAN, with an onset ranging within 30 minutes to 2 hours after starting the first intravenous infusion. They were characterized by pulmonary events in addition to fever, chills, rigors, hypotension, urticaria, angioedema, and other symptoms. Anaphylactic and other hypersensitivity reactions can also occur. In contrast to cytokine release syndrome, true hypersensitivity reactions typically occur within minutes after starting infusion
    • Severe cytokine release syndrome is characterized by severe dyspnea, often associated by bronchospasm and hypoxia, in addition to fever, chills, rigors, urticaria, and angioedema. This syndrome may be associated with acute respiratory failure and death. Cytokine release syndrome may occur within 1-2 hours of initiating the infusion. Patients with a history of pulmonary insufficiency or those with pulmonary tumor infiltration may be at a greater risk of poor outcome. Rituximab product administration should be interrupted immediately and aggressive symptomatic treatment initiated
    • During RITUXAN HYCELA administration, the injection should be interrupted immediately when observing signs of a severe reaction and aggressive symptomatic treatment should be initiated. Closely monitor the following patients: those with pre-existing cardiac or pulmonary conditions, those who experienced prior cardiopulmonary adverse reactions, and those with high numbers of circulating malignant cells (≥25,000/mm3)
    • Premedicate patients with an antihistamine and acetaminophen prior to each administration of RITUXAN HYCELA. Premedication with glucocorticoids should also be considered. Observe patients for at least 15 minutes following RITUXAN HYCELA. A longer period may be appropriate in patients with an increased risk of hypersensitivity reactions

    Local Cutaneous Reactions

    • Local cutaneous reactions, including injection site reactions, have been reported in patients receiving RITUXAN HYCELA. Symptoms included pain, swelling, induration, hemorrhage, erythema, pruritus, and rash. Some local cutaneous reactions occurred more than 24 hours after RITUXAN HYCELA administration. The incidence of local cutaneous reactions following administration of RITUXAN HYCELA was 16%. Reactions were mild or moderate and resolved without any specific treatment. Local cutaneous reactions of any Grade were most common during the first RITUXAN HYCELA cycle (Cycle 2: 5%), with the incidence decreasing with subsequent injections

    Tumor Lysis Syndrome (TLS)

    • TLS can occur within 12-24 hours after administration of a rituximab-containing product, including RITUXAN HYCELA
    • A high number of circulating malignant cells (≥25,000/mm3) or high tumor burden confers a greater risk of TLS. Administer aggressive intravenous hydration and anti-hyperuricemic therapy in patients at high risk for TLS. Correct electrolyte abnormalities, monitor renal function and fluid balance, and administer supportive care, including dialysis, as indicated

    Infections

    • Serious, including fatal, bacterial, fungal, and new or reactivated viral infections can occur during and following the completion of therapy with rituximab-containing products, including RITUXAN HYCELA. The incidence of infections with RITUXAN HYCELA vs. RITUXAN was 56% and 49% respectively in patients with CLL, and 46% and 41% respectively in patients with FL/DLBCL in combination with chemotherapy. Infections have been reported in some patients with prolonged hypogammaglobulinemia (defined as hypogammaglobulinemia >11 months after rituximab exposure)
    • New or reactivated viral infections included cytomegalovirus, herpes simplex virus, parvovirus B19, varicella zoster virus, West Nile virus, and hepatitis B and C. Discontinue RITUXAN HYCELA for serious infections and institute appropriate anti-infective therapy

    Cardiovascular Adverse Reactions

    • Cardiac adverse reactions, including ventricular fibrillation, myocardial infarction, and cardiogenic shock, may occur with rituximab-containing products, including RITUXAN HYCELA
    • Discontinue RITUXAN HYCELA for serious or life-threatening cardiac arrhythmias. Perform cardiac monitoring during and after all administrations of RITUXAN HYCELA for patients who develop clinically significant arrhythmias, or who have a history of arrhythmia or angina

    Renal Toxicity

    • Severe, including fatal, renal toxicity can occur after administration of rituximab-containing products, including RITUXAN HYCELA. Renal toxicity has occurred in patients who experience tumor lysis syndrome and in patients with administered concomitant cisplatin therapy during clinical trials. The combination of cisplatin and RITUXAN HYCELA is not an approved treatment regimen. Monitor closely for signs of renal failure and discontinue RITUXAN HYCELA in patients with a 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 rituximab-containing products, including RITUXAN HYCELA, in combination with chemotherapy. In postmarketing reports, the mean time to documented gastrointestinal perforation was 6 (range 1-77) days. Evaluate if symptoms of obstruction such as abdominal pain or repeated vomiting occur

    Immunization

    • The safety of immunization with live viral vaccines following rituximab-containing products, including RITUXAN HYCELA, has not been studied and vaccination with live virus vaccines is not recommended before or during treatment

    Embryo-Fetal Toxicity

    • Based on human data, rituximab-containing products can cause fetal harm due to B-cell lymphocytopenia in infants exposed to rituximab in-utero. Advise pregnant women of the risk to a fetus. Females of childbearing potential should use effective contraception while receiving RITUXAN HYCELA and for 12 months following the last dose of rituximab-containing products, including RITUXAN HYCELA
    • Verify pregnancy status in females of reproductive potential prior to initiating RITUXAN HYCELA
    ADVERSE REACTIONS
    • The most common adverse reactions (≥20%) of RITUXAN HYCELA observed in patients with FL in SABRINA were: infections, neutropenia, nausea, constipation, cough, and fatigue
    • The most common adverse reactions (≥20%) of RITUXAN HYCELA observed in patients with DLBCL in MabEASE were: infections, neutropenia, alopecia, nausea, and anemia
    • The most common adverse reactions (≥20%) of RITUXAN HYCELA observed in patients with CLL in part 2 of SAWYER were: infections, neutropenia, nausea, thrombocytopenia, pyrexia, vomiting, and injection site erythema
    • With the exception of local cutaneous reactions, the incidence and profile of adverse reactions reported for RITUXAN HYCELA were comparable with those for RITUXAN. The overall incidence of adverse reactions for RITUXAN plus chemotherapy vs. RITUXAN HYCELA plus chemotherapy for FL/DLBCL was 93% vs. 95% (BSA ≤ 1.73 m2), 89% vs. 93% (1.73 < BSA ≤ 1.92 m2), and 94% vs. 94% (BSA > 1.92 m2). The overall incidence of adverse reactions for RITUXAN vs. RITUXAN HYCELA in CLL was 89% vs. 100% (BSA ≤ 1.81 m2), 97% vs. 88% (1.82 < BSA ≤ 1.99 m2), and 88% vs. 93% (BSA > 2.00 m2)
    PREGNANCY AND LACTATION
    • Based on human data, rituximab-containing products can cause adverse developmental outcomes including B-cell lymphocytopenia in infants exposed to rituximab in-utero. There are no available data on RITUXAN HYCELA use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. Advise pregnant women of the risk to a fetus
    • There are no data on the presence of hyaluronidase human in human milk or the effect of rituximab on milk production, and there is limited data on the effect of rituximab on the breastfed child. Rituximab has also been reported to be excreted at low concentrations in human breast milk. Advise women not to breastfeed during treatment and for 6 months after the last dose of RITUXAN HYCELA due to the potential for serious adverse reactions in breastfed children
    Please see the full Prescribing Information, including BOXED WARNINGS and Medication Guide, for additional Important Safety Information.

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


    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.