KIMYRSA™ Receives Product-Specific J-Code and Transitional Pass-Through Status from CMS
MORRISTOWN, N.J., September 20, 2021--(BUSINESS WIRE)--Melinta Therapeutics (Melinta), a commercial-stage company providing innovative therapies for acute and life-threatening illnesses, today announced two important milestones for KIMYRSA™ (oritavancin), a lipoglycopeptide antibiotic that was launched in July.
The Centers for Medicare & Medicaid Services (CMS) has issued a permanent product-specific J-code (J2406) for KIMYRSA Injection effective October 1, 2021. CMS has also granted transitional pass-through status for KIMYRSA in the Hospital Outpatient Department (HOPD) setting of care.1
KIMYRSA delivers a complete course of therapy for acute bacterial skin and skin structure infections (ABSSSI) in a single, one hour, 1,200 mg infusion. The U.S. Food and Drug Administration approved KIMYRSA on March 12, 2021, for the treatment of adult patients with ABSSSI caused by susceptible isolates of designated Gram-positive microorganisms, including methicillin-resistant Staphylococcus aureus (MRSA).
"We are thrilled to announce these two milestones that will expand reimbursement and access for KIMYRSA," said Christine Ann Miller, Melinta’s President and Chief Executive Officer. "Melinta has an unsurpassed commitment to providing innovative therapies to patients with an unmet need. That’s why we intentionally designed KIMYRSA to provide patients with more flexibility and accessibility in ABSSSI treatment. These achievements are one more significant step toward our vision that all patients who need our therapies will be able to receive them."
The unique J-code enables reimbursement for KIMYRSA in all outpatient treatment settings. Pass-through status is intended to protect Medicare beneficiaries’ access to innovative drugs, such as KIMYRSA, and ensures that KIMYRSA will be reimbursed at average sales price for three years, regardless of changes for other drugs.2 Drugs with pass-through status are not subject to the payment reduction applicable to drugs purchased through the 340B program.
Said John Harlow, Chief Commercial Officer for Melinta, "Having a unique J-code for KIMYRSA underscores the distinct value that KIMYRSA brings to the oritavancin franchise. The pass-through status helps ensure that access is not a barrier for our customers and their patients. Both of these milestones support our recent commercial launch of KIMYRSA by our experienced hospital sales team and further contribute to the commercial potential of this innovative product."
For more information about KIMYRSA, visit www.kimyrsa.com.
KIMYRSA™ INDICATION AND USAGE
KIMYRSA™ (oritavancin) for injection is indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused or suspected to be caused by susceptible isolates of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible [MSSA] and methicillin-resistant [MRSA] isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S. constellatus), and Enterococcus faecalis (vancomycin-susceptible isolates only).
To reduce the development of drug-resistant bacteria and maintain the effectiveness of KIMYRSA™ and other antibacterial drugs, KIMYRSA™ should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
IMPORTANT SAFETY INFORMATION
Use of intravenous unfractionated heparin sodium is contraindicated for 120 hours (5 days) after KIMYRSA™ administration because the activated partial thromboplastin time (aPTT) test results may remain falsely elevated for approximately 120 hours (5 days) after KIMYRSA™ administration.
KIMYRSA™ is contraindicated in patients with known hypersensitivity to oritavancin products.
Warnings and Precautions
Coagulation test interference: Oritavancin has been shown to artificially prolong aPTT for up to 120 hours, and may prolong PT and INR for up to 12 hours and ACT for up to 24 hours. Oritavancin has also been shown to elevate D-dimer concentrations up to 72 hours. For patients who require aPTT monitoring within 120 hours of KIMYRSA™ dosing, consider a non-phospholipid dependent coagulation test such as a Factor Xa (chromogenic) assay or an alternative anticoagulant not requiring aPTT.
Serious hypersensitivity reactions, including anaphylaxis, have been reported with the use of oritavancin products including KIMYRSA™. Discontinue infusion if signs of acute hypersensitivity occur. Closely monitor patients with known hypersensitivity to glycopeptides.
Infusion Related Reactions: Infusion reactions characterized by chest pain, back pain, chills and tremor have been observed with the use of oritavancin products (e.g. KIMYRSA™), including after the administration of more than one dose of oritavancin during a single course of therapy. Stopping or slowing the infusion may result in cessation of these reactions.
Clostridioides difficile-associated diarrhea: Evaluate patients if diarrhea occurs.
Concomitant warfarin use: Oritavancin has been shown to artificially prolong PT/INR for up to 12 hours. Patients should be monitored for bleeding if concomitantly receiving KIMYRSA™ and warfarin.
Osteomyelitis: Institute appropriate alternate antibacterial therapy in patients with confirmed or suspected osteomyelitis.
Prescribing KIMYRSA™ in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of development of drug-resistant bacteria.
The most common adverse reactions (≥3%) in patients treated with oritavancin products were headache, nausea, vomiting, limb and subcutaneous abscesses, and diarrhea. The adverse reactions occurring in >2 patients receiving KIMYRSA™ were hypersensitivity, pruritus, chills and pyrexia.
About Melinta Therapeutics
Melinta Therapeutics provides innovative therapies to people impacted by acute and life-threatening illnesses. Our portfolio currently includes five commercial-stage antibiotics: Baxdela® (delafloxacin), Kimyrsa™ (oritavancin), Minocin® (minocycline) for Injection, Orbactiv® (oritavancin), and Vabomere® (meropenem and vaborbactam). With an unsurpassed commitment to providers and the patients they serve, we work to ensure that all people who need our therapies can receive them. We focus our expanding portfolio on serving patients with an unmet need because that’s how we make the most meaningful impact. At Melinta, we’re visionaries dedicated to innovation while staying grounded in what matters most: patients. Visit www.melinta.com for more information.
For more information on this topic, please contact Susan Blum, Chief Financial Officer by phone at +1 312 767-0296, or by email at email@example.com.
Centers for Medicare & Medicaid Services. CMS website. MLN Matters MM11814 Revised July 2020. Update of the Hospital Outpatient Prospective Payment System (OPPS). https://www.cms.gov/files/document/mm11814.pdf. Accessed August 19, 2021; Centers for Medicare & Medicaid Services. CMS website. MLN Matters MM11842 Revised July 2020. Update of the Ambulatory Surgical Center Prospective Payment System (ASC). https://www.cms.gov/files/document/mm11842.pdf. Accessed August 19, 2021.
H. Rep. No. 106-479, at 867 (1999); Social Security Act (SSA) § 1833(t)(6).
View source version on businesswire.com: https://www.businesswire.com/news/home/20210920005513/en/
Chief Financial Officer
Melinta Therapeutics, LLC
+1 312 767-0296