Get answers to common questions about support and resources from Genentech for patients who have been prescribed OCREVUS or OCREVUS ZUNOVO.
Regardless of the type of health insurance your patients have – and even if they don't have any – there may be options available to help them afford OCREVUS or OCREVUS ZUNOVO.
You can check patient eligibility online. The financial assistance tool will guide the patient through some of their options and let them know which financial support programs may be right for them.
Here are a few things you or your patient may need on hand:
Each program has its own time period in which eligible patients will receive assistance.
OCREVUS Access Solutions may be able to help patients understand how to get the medicine they need. OCREVUS Access Solutions can find out:
Even with health insurance, there may be concerns about the cost of treatment. OCREVUS Access Solutions can refer patients to financial assistance options.
To learn more about potential financial assistance options, visit the Financial Assistance Options page.
Patients facing a coverage delay may be eligible for the OCREVUS ZUNOVO Starter Program while awaiting insurance verification. If you would like your patient considered for the Starter Program, you can indicate that when enrolling in OCREVUS Access Solutions with the OCREVUS Start Form. You will also need to have your patient complete the Patient Consent Form.
Eligible patients can receive up to 1 dose of OCREVUS ZUNOVO Starter medicine. The patient is required to be new to OCREVUS products or been off of an OCREVUS product for at least 12 months.
Subject to eligibility requirements and terms and conditions. This program is void where prohibited by law and may not be used in or by residents of restricted states, if applicable.
The OCREVUS ZUNOVO Starter Program provides eligible patients who have experienced an insurance coverage delay of 5 business days minimum with up to one (1) dose of OCREVUS ZUNOVO Starter medicine. There is no obligation to purchase any future product and receipt of free product is not contingent on any past or future purchase. Requests for OCREVUS ZUNOVO Starter medicine cannot be processed without a completed and signed 1) Prescriber Service Form and 2) Patient Consent Form. Patients must be prescribed OCREVUS ZUNOVO medicine for a valid FDA-approved indication. Neither the prescriber, the pharmacy, nor any patient receiving free Genentech medicine via the OCREVUS ZUNOVO Starter Program may seek reimbursement or credit for any part of the benefit received by the patient through this offer from any insurer, health plan, or government program.
The OCREVUS ZUNOVO Starter Program cannot be counted towards any out-of-pocket costs under any plan (such as true out-of-pocket cost under a Medicare Part D prescription drug plan). The OCREVUS ZUNOVO Starter Program enrollment team may notify the patient’s insurer that the patient is receiving a free supply of product from the Program. Prescribers may not advertise or otherwise use the Program as a means of promoting their services or Genentech’s medicines to patients. The OCREVUS ZUNOVO Starter Program is void where prohibited by law and may not be used in or by residents of restricted states, where applicable. The free supply may not be sold, purchased or traded or offered for sale. The OCREVUS ZUNOVO Starter Program is not a health insurance or benefit plan. Genentech reserves the right to rescind, revoke or amend the program without notice at any time.
We are open from 6AM-5PM PST, Mon. through Fri., except for the following holidays:
Patient Navigators can help with access, reimbursement, and treatment coordination. For more information, please visit the OCREVUS Patient Navigator page.
A Clinical Education Manager, or CEM, provides personalized support and helps answer patient questions about their treatment. Your patients will receive:
Support to help them prepare for their first treatment
Access to resources and disease state information
Check-ins along their treatment journey to see if they have questions or would like additional information
Visit the OCREVUS Clinical Education Manager page to learn more
This program is intended primarily for patients prescribed OCREVUS or OCREVUS ZUNOVO who are in their first year of treatment. Clinical Education Managers are Genentech employees and do not give medical advice.
No matter what type of health insurance your patients have, and even if they have none at all, there may be options available to help afford OCREVUS or OCREVUS ZUNOVO.
OCREVUS Access Solutions is your resource for access and reimbursement support after OCREVUS or OCREVUS ZUNOVO is prescribed. You can:
No. If the patient's health insurance plan denied coverage for OCREVUS or OCREVUS ZUNOVO (after submission of a Prior Authorization, if required), the patient can apply for help from the Genentech Patient Foundation. The patient does not need to send proof of the appeal to get help.
Learn more about the Genentech Patient Foundation, including eligibility criteria and how to apply.
When a medical treatment is authorized by the patient’s insurance plan for a limited period of time, it will generally require reverification of coverage for continued treatment. OCREVUS Access Solutions can help you obtain reverification for your patients.
OCREVUS and OCREVUS ZUNOVO are indicated for the treatment of:
Treatment with ocrelizumab is contraindicated in patients with active hepatitis B virus infection and in patients with a history of life-threatening administration reactions to ocrelizumab. OCREVUS ZUNOVO is also contraindicated in patients with a history of hypersensitivity to ocrelizumab, hyaluronidase, or any component of OCREVUS ZUNOVO.
OCREVUS ZUNOVO can cause injection reactions, which can be local or systemic. Common symptoms of local injection reactions reported by patients treated with OCREVUS ZUNOVO in multiple sclerosis (MS) clinical trials included erythema, pain, swelling, and pruritus. Common symptoms of systemic injection reactions reported by patients included headache and nausea. In an open-label, active-controlled trial, injection reactions were more frequently reported with the first injection; 49% of patients experienced an injection reaction with the first injection.
In OCREVUS MS clinical trials, the incidence of infusion reactions in patients [who received methylprednisolone (or an equivalent steroid) and possibly other pre-medication to reduce the risk of infusion reactions prior to infusion] was 34% to 40%, with the highest incidence with the first infusion. There were no fatal infusion reactions, but 0.3% of intravenous ocrelizumab-treated MS patients experienced infusion reactions that were serious, some requiring hospitalization. Symptoms of infusion reactions can include pruritus, rash, urticaria, erythema, bronchospasm, throat irritation, oropharyngeal pain, dyspnea, pharyngeal or laryngeal edema, flushing, hypotension, pyrexia, fatigue, headache, dizziness, nausea, tachycardia, and anaphylaxis.
Monitor OCREVUS ZUNOVO patients during and after injections. Observe patients treated with OCREVUS for infusion reactions during the infusion and for at least one hour after completion of the infusion. Inform patients that administration reactions can occur during or within 24 hours of treatment.
Reducing the Risk and Managing Injection or Infusion Reactions
For OCREVUS ZUNOVO, administer oral pre-medication (e.g., dexamethasone or an equivalent corticosteroid, and an antihistamine) at least 30 minutes prior to each OCREVUS ZUNOVO injection to reduce the risk of injection reactions. The addition of an antipyretic (e.g., acetaminophen) may also be considered.
For OCREVUS, administer pre-medication (e.g., methylprednisolone or an equivalent corticosteroid, and an antihistamine) to reduce the frequency and severity of infusion reactions. The addition of an antipyretic (e.g., acetaminophen) may also be considered.
Management recommendations depend on the type and severity of the reaction. For life-threatening reactions, immediately and permanently stop OCREVUS ZUNOVO or OCREVUS and administer appropriate supportive treatment. For less severe OCREVUS ZUNOVO injection reactions, the injection should be interrupted immediately, and the patient should receive symptomatic treatment. The injection should be completed at the healthcare provider’s discretion and only after all symptoms have resolved. For less severe OCREVUS infusion reactions, management may involve temporarily stopping the infusion, reducing the infusion rate, and/or administering symptomatic treatment.
Serious, including life-threatening or fatal, bacterial, viral, parasitic and fungal infections have been reported in patients receiving ocrelizumab. An increased risk of infections (including serious and fatal bacterial, fungal, and new or reactivated viral infections) has been observed in patients during and following completion of treatment with anti-CD20 B-cell depleting therapies.
A higher proportion of OCREVUS-treated patients experienced infections compared to patients taking REBIF or placebo. In RMS trials, 58% of OCREVUS-treated patients experienced one or more infections compared to 52% of REBIF-treated patients. In the PPMS trial, 70% of OCREVUS -treated patients experienced one or more infections compared to 68% of patients on placebo. OCREVUS was not associated with an increased risk of serious infections in MS patients in controlled trials.
Ocrelizumab increases the risk for upper respiratory tract infections, lower respiratory tract infections, skin infections, and herpes-related infections. Delay administration of ocrelizumab in patients with an active infection until the infection has resolved.
Respiratory Tract Infections
A higher proportion of OCREVUS-treated patients experienced respiratory tract infections compared to patients taking REBIF or placebo. In RMS trials, 40% of OCREVUS-treated patients experienced upper respiratory tract infections compared to 33% of REBIF-treated patients, and 8% of OCREVUS-treated patients experienced lower respiratory tract infections compared to 5% of REBIF-treated patients. In the PPMS trial, 49% of OCREVUS-treated patients experienced upper respiratory tract infections compared to 43% of patients on placebo and 10% of OCREVUS-treated patients experienced lower respiratory tract infections compared to 9% of patients on placebo. The infections were predominantly mild to moderate and consisted mostly of upper respiratory tract infections and bronchitis.
Herpes
In active-controlled (RMS) clinical trials, herpes infections were reported more frequently in OCREVUS-treated patients than in REBIF-treated patients, including herpes zoster (2.1% vs. 1.0%), herpes simplex (0.7% vs. 0.1%), oral herpes (3.0% vs. 2.2%), genital herpes (0.1% vs. 0%), and herpes virus infection (0.1% vs. 0%). Infections were predominantly mild to moderate in severity. In the placebo-controlled (PPMS) clinical trial, oral herpes was reported more frequently in the OCREVUS-treated patients than in the patients on placebo (2.7% vs 0.8%).
Serious cases of infections caused by herpes simplex virus and varicella zoster virus, including central nervous system infections (encephalitis and meningitis), intraocular infections, and disseminated skin and soft tissue infections, have been reported in the postmarketing setting in multiple sclerosis patients receiving ocrelizumab. Serious herpes virus infections may occur at any time during treatment with ocrelizumab. Some cases were life-threatening.
If serious herpes infections occur, treatment with ocrelizumab should be discontinued or withheld until the infection has resolved, and appropriate treatment should be administered.
Hepatitis B Virus Reactivation
Hepatitis B virus (HBV) reactivation has been reported in MS patients treated with ocrelizumab in the postmarketing setting. Fulminant hepatitis, hepatic failure, and death caused by HBV reactivation have occurred in patients treated with anti-CD20 antibodies. Perform HBV screening in all patients before initiation of treatment with ocrelizumab. Do not administer ocrelizumab to patients with active HBV confirmed by positive results for HBsAg and anti-HB tests. For patients who are negative for surface antigen [HBsAg] and positive for HB core antibody [HBcAb+] or are carriers of HBV [HBsAg+], consult liver disease experts before starting and during treatment.
Possible Increased Risk of Immunosuppressant Effects With Other Immunosuppressants
When initiating treatment with ocrelizumab after an immunosuppressive therapy or initiating an immunosuppressive therapy after ocrelizumab-containing products, consider the potential for increased immunosuppressive effect. Treatment with ocrelizumab has not been studied in combination with other MS therapies.
Vaccinations
Administer all immunizations according to immunization guidelines at least 4 weeks prior to initiation of ocrelizumab treatment for live or live-attenuated vaccines and, whenever possible, at least 2 weeks prior to initiation of ocrelizumab treatment for non-live vaccines. Ocrelizumab may interfere with the effectiveness of non-live vaccines. The safety of immunization with live or live-attenuated vaccines following treatment with ocrelizumab has not been studied, and vaccination with live-attenuated or live vaccines is not recommended during treatment and until B-cell repletion.
Vaccination of Infants Born to Mothers Treated With Ocrelizumab Products During Pregnancy
In infants of mothers exposed to ocrelizumab during pregnancy, do not administer live or live-attenuated vaccines before confirming the recovery of B-cell counts as measured by CD19+ B-cells. Depletion of B-cells in these infants may increase the risks from live or live-attenuated vaccines.
You may administer non-live vaccines, as indicated, prior to recovery from B-cell depletion, but you should consider assessing vaccine immune responses, including consultation with a qualified specialist, to assess whether a protective immune response was mounted.
Cases of progressive multifocal leukoencephalopathy (PML) have been reported in patients with MS treated with ocrelizumab in the postmarketing setting. PML is an opportunistic viral infection of the brain caused by the JC virus (JCV) that typically occurs only in patients who are immunocompromised, and that usually leads to death or severe disability. PML has occurred in ocrelizumab-treated patients who had not been treated previously with natalizumab, (which has a known association with PML), were not taking any immunosuppressive or immunomodulatory medications associated with risk of PML prior to or concomitantly with ocrelizumab and did not have any known ongoing systemic medical conditions resulting in compromised immune system function.
JCV infection resulting in PML has also been observed in patients treated with other anti-CD20 antibodies and other MS therapies.
At the first sign or symptom suggestive of PML, withhold treatment with ocrelizumab-containing products and perform an appropriate diagnostic evaluation. Typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes.
Magnetic resonance imaging (MRI) findings may be apparent before clinical signs or symptoms of PML. Monitoring with MRI for signs consistent with PML may be useful, and any suspicious findings should lead to further investigation to allow for an early diagnosis of PML, if present. If PML is confirmed, treatment with ocrelizumab should be discontinued.
As expected with any B-cell depleting therapy, decreased immunoglobulin levels are observed with ocrelizumab treatment. The pooled data of OCREVUS clinical studies (RMS and PPMS) and their open-label extensions (up to approximately 7 years of exposure) have shown an association between decreased levels of immunoglobulin G (IgG<LLN) and increased rates of serious infections. Monitor the levels of quantitative serum immunoglobulins during treatment with ocrelizumab and after discontinuation of treatment, until B-cell repletion, and especially in the setting of recurrent serious infections. Consider discontinuing treatment with ocrelizumab- in patients with serious opportunistic or recurrent serious infections, and if prolonged hypogammaglobulinemia requires treatment with intravenous immunoglobulins.
An increased risk of malignancy with ocrelizumab may exist. In controlled trials, malignancies, including breast cancer, occurred more frequently in OCREVUS-treated patients. Breast cancer occurred in 6 of 781 females treated with OCREVUS and none of 668 females treated with REBIF or placebo. Patients should follow standard breast cancer screening guidelines.
Immune-mediated colitis, which can present as a severe and acute-onset form of colitis, has been reported in patients receiving ocrelizumab in the postmarketing setting. Some cases of colitis were serious, requiring hospitalization, with a few patients requiring surgical intervention. Systemic corticosteroids were required in many of these patients. The time from treatment initiation to onset of symptoms in these cases ranged from a few weeks to years. Monitor patients for immune-mediated colitis during ocrelizumab treatment and evaluate promptly if signs and symptoms that may indicate immune-mediated colitis, such as new or persistent diarrhea or other gastrointestinal signs and symptoms, occur.
There are no adequate data on the developmental risk associated with use of ocrelizumab in pregnant women. There are no data on B-cell levels in human neonates following maternal exposure to ocrelizumab-containing products. However, transient peripheral B-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other anti-CD20 antibodies during pregnancy. Ocrelizumab is a humanized monoclonal antibody of an immunoglobulin G1 subtype and immunoglobulins are known to cross the placental barrier.
There are no data on the presence of ocrelizumab or hyaluronidase in human milk, the effects on the breastfed infant, or the effects of the drug on milk production. Ocrelizumab was excreted in the milk of ocrelizumab-treated monkeys. Human IgG is excreted in human milk, and the potential for absorption of ocrelizumab to lead to B-cell depletion in the infant is unknown. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ocrelizumab and any potential adverse effects on the breastfed infant from ocrelizumab or from the underlying maternal condition.
Women of childbearing potential should use effective contraception while receiving ocrelizumab and for 6 months after the last dose of ocrelizumab. Instruct patients that if they are pregnant or plan to become pregnant while taking OCREVUS or OCREVUS ZUNOVO, they should inform their healthcare provider.
In patients treated with OCREVUS:
The most common adverse reaction observed with OCREVUS ZUNOVO in patients with RMS and PPMS was injection reactions (incidence of 49%).
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.
Please see additional Important Safety Information throughout and click here for full OCREVUS Prescribing Information and Medication Guide. For OCREVUS ZUNOVO, click here for full Prescribing Information and Medication Guide.
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