Exhibit 99.1
![LOGO](https://capedge.com/proxy/8-K/0001193125-23-030337/g447282dsp12x.jpg)
Spectrum Pharmaceuticals Receives Permanent J-Code for ROLVEDON™ (eflapegrastim-xnst) Injection (J1449) from U.S. Centers for Medicare & Medicaid Services
Boston, MA, February 8, 2023 – Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology announced today that a permanent J-code, J1449, has been issued for ROLVEDON (eflapegrastim-xnst) Injection by the U.S. Centers for Medicare & Medicaid Services (CMS) effective as of April 1, 2023.
“This is an important milestone in the ROLVEDON launch. A permanent J-code will enable a more efficient and predictable reimbursement in the outpatient setting. The combination of a permanent J-code on April 1, 2023 and ROLVEDON’S inclusion in the National Comprehensive Cancer Network® Supportive Care Guidelines (NCCN Guidelines) announced on December 6, 2022 are key elements in establishing brand awareness and building customer confidence in our novel product,” said Tom Riga, President and Chief Executive Officer of Spectrum Pharmaceuticals.
J-codes are permanent reimbursement codes used by commercial insurance plans, Medicare, Medicare Advantage, and other government payers for Medicare Part B drugs like ROLVEDON that are administered by a physician. Claims submission and documentation are simplified with a permanent J-code, facilitating and streamlining the billing and reimbursement process.
The permanent J-code for ROLVEDON, J1449 (Injection, eflapegrastim-xnst, 0.1 mg), will take effect April 1, 2023. The permanent J-code is published online on the CMS website here.
About ROLVEDON™
ROLVEDON™ (eflapegrastim-xnst) injection is a long-acting granulocyte colony-stimulating factor (G-CSF) with a novel formulation. Spectrum has received an indication to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia. ROLVEDON is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. The BLA for ROLVEDON was supported by data from two identically designed Phase 3, randomized, open-label, noninferiority clinical trials, ADVANCE and RECOVER, which evaluated the safety and efficacy of ROLVEDON in 643 early-stage breast cancer patients for the management of neutropenia due to myelosuppressive chemotherapy. In both studies, ROLVEDON demonstrated the pre-specified hypothesis of non-inferiority (NI) in mean duration of severe neutropenia (DSN) and a similar safety profile to pegfilgrastim. ROLVEDON also demonstrated non-inferiority to pegfilgrastim in the mean DSN across all four cycles (all NI p<0.0001) in both trials.
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