{"answer":{"query":"Ocrevus","resolved_as":"applications","packages":1,"applications":["BLA761053"],"identity":{"application_numbers":["BLA761053"],"marketing_categories":["BLA"],"labelers":[],"dosage_forms":[{"text":"INJECTION","untrusted":true}],"marketing_start":{"earliest":"2017-03-28","latest":"2017-03-28","packages_with_a_start_date":1}},"label_history":{"events_total":14,"non_cmc_events":14,"counts_by_class":{"EFFICACY":2,"LABELING":12},"cmc_events":0,"recent_non_cmc_events":[{"application":"BLA761053","submission_no":38,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2026-05-08","documents":[{"type":"Label","date":"2026-05-18","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761053s038lbl.pdf","untrusted":true}},{"type":"Letter","date":"2026-05-11","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761053Orig1s038ltr.pdf","untrusted":true}}],"fact_id":"380c80961b8020fc832cdb7d"},{"application":"BLA761053","submission_no":36,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2025-08-18","documents":[{"type":"Letter","date":"2025-08-19","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761053Orig1s036ltr.pdf","untrusted":true}},{"type":"Label","date":"2025-08-20","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761053s036lbl.pdf","untrusted":true}}],"fact_id":"86d5d505c685ff94ac21f2cb"},{"application":"BLA761053","submission_no":35,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2024-06-21","documents":[{"type":"Label","date":"2024-06-24","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761053s035lbl.pdf","untrusted":true}},{"type":"Letter","date":"2024-06-24","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761053Orig1s035ltr.pdf","untrusted":true}}],"fact_id":"911588325fa682f0c67691ea"},{"application":"BLA761053","submission_no":34,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2024-01-19","documents":[{"type":"Label","date":"2024-01-22","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761053s034lbl.pdf","untrusted":true}},{"type":"Letter","date":"2024-01-23","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761053Orig1s034ltr.pdf","untrusted":true}}],"fact_id":"de907f21fe7736c298f0f615"},{"application":"BLA761053","submission_no":31,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2023-08-18","documents":[{"type":"Label","date":"2023-08-22","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761053s031lbl.pdf","untrusted":true}},{"type":"Letter","date":"2023-08-22","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761053Orig1s031ltr.pdf","untrusted":true}}],"fact_id":"98752589ca8624e975b4ffdd"}],"note":"a dated list of FDA supplements and their classes, not a reading of what changed in the label"},"substitution":{"products_total":1,"te_code_counts":{"NOT_PROVIDED":1},"marketing_status_counts":{"Prescription":1},"meaning":"raw FDA codes; the therapeutic equivalence code says whether FDA rates a generic as substitutable, and what that means for a given prescription is for a pharmacist or prescriber","products":[{"application":"BLA761053","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"OCREVUS","untrusted":true},"form":{"text":"INJECTABLE;INJECTION","untrusted":true},"strength":{"text":"30MG/1ML","untrusted":true}}]},"assistance_and_offers":{"programs_listing_this_drug":[{"name":{"text":"Genentech/Roche Access Solutions","untrusted":true},"type":"manufacturer","url":"https://www.gene.com/patients/patient-foundation","status":null,"needs_status_check":false,"has_offer":false}],"manufacturer_offers":[{"program":"ocrevus-copay-program","kind":"copay_card","price_figures":{"payAsLittleAsPerTreatment":0,"drugCopayAssistancePerCalendarYear":20000,"administrationAssistanceFirstYear":1500,"administrationAssistanceEachYearAfter":1000},"conditions":{"text":"The page states the programs are for patients with commercial insurance, that benefits reset every January 1st, and that patients who begin receiving government-funded prescription coverage no longer qualify.","untrusted":true},"limited_time":false,"expires_note":null,"stated_end_date":null,"expired":false,"detail":{"text":"The Ocrevus financial-support page states a Co-pay Program for commercially insured patients: as little as $0 per treatment, with co-pay assistance of up to $20,000 per calendar year, and administration assistance up to $1,500 per calendar year in the first year and up to $1,000 each calendar year after. Maximum benefits reset every January 1st.","untrusted":true},"read_on":"2026-11-07T07:23:55.567Z","source_url":"https://www.ocrevus.com/patient/financial-support/assistance-options.html","proof_state":"verified","fact_id":"cb1bfab409cff8fc72bac906"}],"note":"A program that lists a drug has not decided anything about any person: each program decides who qualifies, and a status other than open means it may not take new patients. Offers change and expire; read each offer's source and stated end date. A price figure is what the page states, not a quote."},"spending":{"reported_under":{"generic":{"text":"Ocrelizumab","untrusted":true},"brand":{"text":"Ocrevus","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":81042686.71,"claims":2524,"beneficiaries":1577,"average_spending_per_claim_usd":32108.829917,"fact_id":"10a0c9541cd73bb1baaa999c"},{"year":2021,"gross_spending_usd":96636442.05,"claims":2858,"beneficiaries":1758,"average_spending_per_claim_usd":33812.610934,"fact_id":"e0890c1b5463dff4b557b0aa"},{"year":2022,"gross_spending_usd":123045547.82,"claims":3433,"beneficiaries":2079,"average_spending_per_claim_usd":35841.988879,"fact_id":"c32db3fe863a9ea03ed1e199"},{"year":2023,"gross_spending_usd":157049386.07,"claims":4169,"beneficiaries":2492,"average_spending_per_claim_usd":37670.757033,"fact_id":"7f92675d9770357ce09ce1b3"},{"year":2024,"gross_spending_usd":195066361.89,"claims":5163,"beneficiaries":3085,"average_spending_per_claim_usd":37781.592464,"fact_id":"b3194ed0afdfdd4ca25ec959"}],"rebate_caveat":"CMS's dataset states spending is gross drug cost and does not reflect manufacturers' rebates or other price concessions.","not_a_patient_price":"Spending is the total paid by Medicare, plans and beneficiaries for the drug's claims, not what a patient pays.","meaning":"a drug-level aggregate of Medicare Part D claims for all manufacturers combined; not a formulary, not coverage","source":{"dataset":{"text":"data-year-2024, modified 2026-06-25","untrusted":true},"link":{"text":"https://data.cms.gov/summary-statistics-on-use-and-payments/medicare-medicaid-spending-by-drug/medicare-part-d-spending-by-drug","untrusted":true}}},"biologic_status":{"products":[{"application":"BLA761053","status":"Reference","name":{"text":"Ocrevus","untrusted":true},"proper_name":{"text":"ocrelizumab","untrusted":true},"license_status":"Licensed","approval_date":"2017-03-28","reference_product":null,"interchangeable_date":null,"biosimilars_listed":0,"interchangeables_listed":0,"biosimilars":[],"interchangeables":[],"purple_book_version":"purplebook-2026-10","read_on":"2026-11-07T07:33:31.186Z","fact_id":"2f9b3034e478acad446e597a"}],"reading":"what the FDA Purple Book lists on its read date, a record and not a forecast of launch or substitution"},"payment_limit":{"codes":[{"hcpcs":"J2350","quarter":"2026Q4","effective":"October 1, 2026 through December 31, 2026","payment_limit_usd":60.689,"dosage_descriptor":{"text":"1 MG","untrusted":true},"packages_matched":1,"read_on":"2026-11-07T07:31:28.000Z","source_url":{"text":"https://www.cms.gov/medicare/payment/part-b-drugs/asp-pricing-files","untrusted":true},"fact_id":"2d23e296861535180a97f75c"}],"codes_total":1,"meaning":"a Medicare Part B payment ceiling for providers billing a HCPCS code, per dosage descriptor unit; not a price a patient pays, and the presence of a code does not indicate that Medicare covers a product"},"medicaid_state_utilization":{"year":2025,"states_with_data":1,"all_states_medicaid_reimbursed_usd":2299827.62,"all_states_medicaid_paid_prescriptions":107,"top_states":[{"state":"WY","medicaid_paid_prescriptions":107,"medicaid_reimbursed_usd":2299827.62,"total_reimbursed_usd":3028776.68,"packages":1,"covers":"all_record_types","fact_id":"34a3f615cdb8fa37a90ffb4e"}],"unlabelled_state_code_xx":null,"built_from_facts":1,"facts_fee_for_service_only":0,"older_year_facts_not_used":41,"dataset":"State Drug Utilization Data 2025","read_on":"2026-11-07T22:41:44.201Z","reading":"Medicaid prescriptions and reimbursement by state (CMS State Drug Utilization Data). Reimbursement is before manufacturer rebates: not a net cost, not a patient price. Suppressed managed-care cells make a state figure fee-for-service only. An absent state was suppressed or unreported, not zero.","receipts_note":"a receipt is held for the largest fact behind each state shown; every figure is a sum of the built_from_facts facts, each recomputable from its recorded input hash"}},"receipts":[{"fact_id":"a7a8d78d08003002dd1a81d7","field":"ndc.listing","entity":"ndc:50242015001"},{"fact_id":"380c80961b8020fc832cdb7d","field":"drug.label_event","entity":"application:BLA761053"},{"fact_id":"86d5d505c685ff94ac21f2cb","field":"drug.label_event","entity":"application:BLA761053"},{"fact_id":"911588325fa682f0c67691ea","field":"drug.label_event","entity":"application:BLA761053"},{"fact_id":"de907f21fe7736c298f0f615","field":"drug.label_event","entity":"application:BLA761053"},{"fact_id":"98752589ca8624e975b4ffdd","field":"drug.label_event","entity":"application:BLA761053"},{"fact_id":"11311d09b57b86eba1433e1e","field":"drug.marketing_status","entity":"application:BLA761053"},{"fact_id":"cb1bfab409cff8fc72bac906","field":"program.offer","entity":"program:ocrevus-copay-program"},{"fact_id":"10a0c9541cd73bb1baaa999c","field":"drug.partd_spending","entity":"drug:ocrelizumab|ocrevus"},{"fact_id":"e0890c1b5463dff4b557b0aa","field":"drug.partd_spending","entity":"drug:ocrelizumab|ocrevus"},{"fact_id":"c32db3fe863a9ea03ed1e199","field":"drug.partd_spending","entity":"drug:ocrelizumab|ocrevus"},{"fact_id":"7f92675d9770357ce09ce1b3","field":"drug.partd_spending","entity":"drug:ocrelizumab|ocrevus"},{"fact_id":"b3194ed0afdfdd4ca25ec959","field":"drug.partd_spending","entity":"drug:ocrelizumab|ocrevus"},{"fact_id":"2f9b3034e478acad446e597a","field":"drug.biologic_status","entity":"application:BLA761053"},{"fact_id":"2d23e296861535180a97f75c","field":"drug.asp_price","entity":"hcpcs:J2350"},{"fact_id":"34a3f615cdb8fa37a90ffb4e","field":"ndc.medicaid_state_utilization","entity":"ndc_state:50242015001:WY"}],"as_of":{"newest_fact_retrieved_at":"2026-11-10T20:02:39.475Z"},"edition":{"id":"2026-11","merkleRoot":"006ab9a329709cbe7f56a0e1a7c4a02f897655cdfecf9ca34d199690095adcb6","factCount":212100,"manifestPresent":true},"licence":{"classes":["GREEN"],"note":"Source records are public; this compilation is cited with attribution. See the provenance tool for each fact's licence label."},"unknown":[{"code":"NO_DATA","field":"price","reason":"no NADAC price, negotiated price or federal upper limit for these packages"},{"code":"NO_DATA","field":"generic_entry:BLA761053","reason":"no generic-entry fact for this application: no patent or exclusivity is listed for it in the Orange Book edition read, so no date is stated"},{"code":"NO_DATA","field":"generic_entry","reason":"no application of this drug has a generic-entry fact; no date is stated"},{"code":"NO_DATA","field":"recalls","reason":"no FDA enforcement report naming a package of these applications is recorded"},{"code":"NO_DATA","field":"supply","reason":"no FDA shortage row and no termination date for these packages"},{"code":"NO_DATA","field":"trials","reason":"no ClinicalTrials.gov record set for this drug's ingredient is in the edition"},{"code":"NO_DATA","field":"policy","reason":"no Federal Register event in the edition names this drug or its programs"},{"code":"NO_DATA","field":"rems","reason":"no REMS@FDA program is tied to these applications in the edition (most drugs have none)"},{"code":"NO_DATA","field":"controlled_schedule","reason":"no DEA schedule entry matched this drug's ingredient in the edition"},{"code":"NO_DATA","field":"orphan_designation","reason":"no FDA orphan designation for this drug's ingredient is in the edition"},{"code":"NO_DATA","field":"safety_communication","reason":"no FDA Drug Safety Communication names this drug's ingredient in the edition"}],"disclaimer":"OmniRx is a reference layer of dated public facts, not clinical advice and not a guarantee of price, coverage or eligibility. Each answer lists the facts it rests on."}