OCREVUS Distribution

Authorized Distributors and Specialty Pharmacies

Genentech has contracted with a network of authorized specialty distributors to service practices choosing to purchase OCREVUS through the buy and bill model. Customers can purchase OCREVUS through authorized specialty distributors and wholesalers that have made a commitment to product integrity. These partners have agreed to distribute only products purchased directly from Genentech and not to distribute OCREVUS through secondary channels.

OCREVUS Access Solutions works with SPs to help patients receive their medicines. SPs can dispense Genentech medicines to your office. The SPs can also provide coverage and reimbursement support.

Distributor Telephone Fax Web Orders
AmerisourceBergen Specialty Group (ASD Healthcare) 800-746-6273 800-547-9413 www.asdhealthcare.com
Cardinal Specialty Distribution 866-677-4844 888-345-4916 orderexpress.cardinalhealth.com
Dakota Drug 866-210-5887 763-421-0661 www.dakdrug.com
DMS 877-788-1100 847-518-1105 www.dmspharma.com
McKesson Plasma & Biologics (MPB) 877-625-2566 800-289-9285 www.mckesson.com
Distributor Telephone Fax Web Orders
AmerisourceBergen Specialty Group (ASD Healthcare) 800-746-6273 800-547-9413 www.asdhealthcare.com
Cardinal Specialty Distribution 866-677-4844 888-345-4916 orderexpress.cardinalhealth.com
CuraScript Specialty Distribution 877-599-7748 800-862-6208 www.curascriptsd.com
McKesson Plasma & Biologics (MPB) 877-625-2566 800-289-9285 www.mckesson.com
M&D Specialty Distribution 800-710-6100 318-524-3096 www.mdspecialtydist.com
Distributor Telephone Fax Web Orders
AmerisourceBergen Specialty Group (Besse Medical, BioSolutions Direct, Oncology Supply) 800-543-2111
866-860-3565
800-633-7555
800-543-8695
888-899-0063
800-248-8205
www.besse.com www.biosolutionsdirect.com www.oncologysupply.com
CuraScript Specialty Distribution 877-599-7748 800-862-6208 www.curascriptsd.com
McKesson Specialty Health 855-477-9800 888-752-7626 mscs.mckesson.com
Metro Medical (A Cardinal Health Specialty Solution Company for Community Specialty Physicians) 800-768-2002 615-256-4194 www.metromedicalorder.com

 

 

Distributor Telephone Fax Web Orders
AmerisourceBergen Specialty Group (ASD Healthcare, BioSolutions Direct) 800-746-6273
866-860-3565
800-547-9413
888-899-0063
www.asdhealthcare.com www.biosolutionsdirect.com
Cardinal Specialty Distribution 866-677-4844 888-345-4916 orderexpress.cardinalhealth.com
CuraScript Specialty Distribution 877-599-7748 800-862-6208 www.curascriptsd.com
Humana Specialty Pharmacy
800-486-2668
877-405-7940
www.humanapharmacy.com/specialty
McKesson Specialty Health 855-477-9800 888-752-7626 mscs.mckesson.com
M&D Specialty Distribution 800-710-6100 318-524-3096 www.mdspecialtydist.com
Distributor Telephone Fax Web Orders
Cardinal Health Puerto Rico 787-625-4200 787-625-4398 www.cardinalhealth.pr
Cesar Castillo Inc. 787-641-5082 787-999-1614 www.cesarcastillo.com
Specialty Pharmacy Telephone Fax Web Orders
Acaria 877-928-5120 877-928-5121 www.acariahealth.com
Accredo 800-803-2523 888-302-1028 www.accredo.com
Advanced Care Scripts 866-681-7131 888-679-7131 www.omnicarescg.com/OmnicareSCG/ACS
Aetna 866-782-2779 866-329-2779 www.aetna.com/individuals-families/pharmacy/specialty-pharmacy.html
AllianceRx Walgreens Prime 888-347-3416 877-231-8302 https://www.alliancerxwp.com
Axium Healthcare Puerto Rico/Kroger Specialty Pharmacy (Puerto Rico Only) 787-780-7200 800-546-2163 www.axiumhealthcare.com/about-us/contact-us/
Best Option Healthcare (Puerto Rico Only) 787-723-6868 787-723-6987 bestoptionpr.com
BriovaRx 855-427-4682 800-218-3221 www.briovarx.com
Cardinal Health Specialty Pharmacy 888-662-6779 877-800-4790 https://chsprx.com
Cigna 800-351-3606 800-351-3616 www.cigna.com/specialty-pharmacy-services
CVS/Specialty 855-821-0356 844-847-8585 www.cvsspecialty.com
Diplomat Specialty Pharmacy 866-311-9966 866-208-4142 www.diplomat.is
Humana Specialty Pharmacy 800-486-2668 877-405-7940 http://www.humanapharmacy.com/specialty
Special Care Pharmacy Services (Puerto Rico Only) 787-783-8579 787-783-2951 scpspr.com

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.

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

OCREVUS Access Solutions works with specialty pharmacies (SPs) to help patients receive their 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 OCREVUS Access Solutions to learn which SP the patient’s health insurance plan requires.

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.

Spoilage Replacement Program

The Genentech Spoilage Replacement Program provides for replacement of infused, injected and self-administered products, which are prescribed and prepared for a labeled indication, yet not administered due to unforeseen patient clinical circumstances, subject to certain limitations and conditions set forth by Genentech.

Please contact Genentech Customer Service at (800) 551-2231 to submit a request for replacement of spoiled product or to obtain additional information about the Program.

To request replacement product:

  • Contact Genentech Customer Service at (800) 551-2231 to obtain the Genentech Spoilage Replacement Program Form
  • Complete the Genentech Spoilage Replacement Program Form and fax it back to Genentech Customer Service at (877) 329-6737 within 30 days of the spoilage event
  • The request may take up to 3 business days to review. If approved by Genentech, further instructions for returning product or completing a Certificate of Destruction will be provided
  • The spoiled product or completed Certificate of Destruction must be received by Genentech within 60 days of approval of the spoilage request
    • Replacement product generally ships within 11 business days following receipt of the spoiled product or completed Certificate of Destruction 

Important guidelines:

  • Each instance of spoilage replacement requires completion of the Spoilage Replacement Program Form. Replacement is on a case-by-case basis at the sole discretion of Genentech; please retain all original product packaging for returns processing
  • Genentech does not ship replacement product if the spoiled product has been used for an off-label indication
  • Genentech does not ship replacement product if ANY portion of the product has been administered
  • Genentech will only ship replacement product to licensed facilities
  • All spoilage replacement requests are subject to review by Genentech; returned product is subject to analysis
  • Replacement is not available if any amount has been billed to a patient or an insurance claim has been remitted to a payer
  • Requests are subject to certain limitations and conditions. Genentech has the right to modify or discontinue the Spoilage Replacement Program at any time without notice

How to Obtain OCREVUS: Considerations for Buy and Bill and Specialty Pharmacy

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PAN=Patient Authorization and Notice of Request for Transmission of Health Information to Genentech Access Solutions and Genentech® Access to Care Foundation.

SMN=Statement of Medical Necessity.

Important Safety Information & Indication

Indication

OCREVUS is indicated for the treatment of adult patients with relapsing or primary progressive forms of multiple sclerosis.

Contraindications

OCREVUS is contraindicated in patients with active hepatitis B virus infection and/or a in patients with a history of life threatening infusion reaction to OCREVUS.

Important Safety Information

WARNINGS AND PRECAUTIONS

Infusion Reactions

OCREVUS can cause infusion reactions, which can include pruritus, rash, urticaria, erythema, bronchospasm, throat irritation, oropharyngeal pain, dyspnea, pharyngeal or laryngeal edema, flushing, hypotension, pyrexia, fatigue, headache, dizziness, nausea, and tachycardia. In multiple sclerosis (MS) clinical trials, the incidence of infusion reactions in OCREVUS-treated patients [who received methylprednisolone (or an equivalent steroid) and possibly other pre-medication to reduce the risk of infusion reactions prior to each infusion] was 34-40%, with the highest incidence with the first infusion. There were no fatal infusion reactions, but 0.3% of OCREVUS-treated MS patients experienced infusion reactions that were serious, some requiring hospitalization.

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 infusion reactions can occur up to 24 hours after the infusion.

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. For life-threatening infusion reactions, immediately and permanently stop OCREVUS and administer appropriate supportive treatment. For less severe infusion reactions, management may involve temporarily stopping the infusion, reducing the infusion rate, and/or administering symptomatic treatment.

Infections

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 increased the risk for upper respiratory tract infections, lower respiratory tract infections, skin infections, and herpes-related infections. OCREVUS was not associated with an increased risk of serious infections in MS patients. Delay OCREVUS administration in patients with an active infection until the infection is 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. There were no reports of disseminated herpes.

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%).

Progressive Multifocal Leukoencephalopathy (PML)

PML is an opportunistic viral infection of the brain caused by the John Cunningham (JC) virus that typically only occurs in patients who are immunocompromised, and that usually leads to death or severe disability. Although no cases of PML were identified in OCREVUS clinical trials, JC virus infection resulting in PML has been observed in patients treated with other anti-CD20 antibodies and other MS therapies and has been associated with some risk factors (e.g., immunocompromised patients, polytherapy with immunosuppressants). At the first sign or symptom suggestive of PML, withhold OCREVUS and perform an appropriate diagnostic evaluation. MRI findings may be apparent before clinical signs or symptoms. 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. (per USPI)

Hepatitis B Virus (HBV) Reactivation

There were no reports of hepatitis B reactivation in MS patients treated with OCREVUS. Fulminant hepatitis, hepatic failure and death, caused by HBV reactivation have occurred in patients treated with other anti-CD20 antibodies. Perform HBV screening in all patients before initiation of treatment with OCREVUS. Do not administer OCREVUS 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 OCREVUS after an immunosuppressive therapy or initiating an immunosuppressive therapy after OCREVUS, consider the potential for increased immunosuppressive effect. OCREVUS has not been studied in combination with other MS therapies.

Vaccinations

Administer all immunizations according to immunization guidelines at least 6 weeks prior to initiation of OCREVUS.

The safety of immunization with live or live-attenuated vaccines following OCREVUS therapy has not been studied and vaccination with live-attenuated or live vaccines is not recommended during treatment and until B-cell repletion.

No data are available on the effects of live or non-live vaccination in patients receiving OCREVUS.

Malignancies

An increased risk of malignancy with OCREVUS 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.

USE IN SPECIFIC POPULATIONS

Pregnancy

There are no adequate data on the developmental risk associated with use of OCREVUS in pregnant women. There are no data on B-cell levels in human neonates following maternal exposure to OCREVUS. However, transient peripheral B-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other anti-CD20 antibodies during pregnancy. OCREVUS is a humanized monoclonal antibody of an immunoglobulin G1 subtype and immunoglobulins are known to cross the placental barrier.

Lactation

There are no data on the presence of ocrelizumab 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 OCREVUS and any potential adverse effects on the breastfed infant from OCREVUS or from the underlying maternal condition.

Females and Males of Reproductive Potential

Women of childbearing potential should use contraception while receiving OCREVUS and for 6 months after the last infusion of OCREVUS.

Most Common Adverse Reactions

RMS: The most common adverse reactions in RMS trials (incidence ≥ 10% and > REBIF) were upper respiratory tract infections (40%) and infusion reactions (34%)

PPMS: The most common adverse reactions in PPMS trials (incidence ≥ 10% and > placebo) were upper respiratory tract infections (49%), infusion reactions (40%), skin infections (14%), and lower respiratory tract infections (10%)

You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at 1-888-835-2555.

For additional safety information, please see the full Prescribing Information and Medication Guide.