Strontium89 Now Reimbursed in All Treatment Settings
NEW YORK, January 7, 2021 - Q BioMed Inc. (OTCQB: QBIO), a commercial stage biotech company, announced today that the Centers for Medicare and Medicaid Services (CMS) updated the Outpatient Prospective Payment System (OPPS) reimbursement rate for its FDA approved non-opioid metastatic bone pain drug Strontium89 (Strontium Chloride Sr-89 Injection, USP) on January 3, 2021. The update ensures all Medicare patients have access to Strontium89 in the appropriate setting.
The Q1 2021 Strontium89 reimbursement update was expected by Q BioMed as part of the standard CMS quarterly OPPS update, and is an important milestone. While Strontium89 has been appropriately reimbursed in the free standing clinic setting since launch, it was under-reimbursed in the hospital outpatient setting where many patients receive treatment. With the CMS update, all Medicare providers are now able to be reimbursed appropriately for providing Strontium89 treatment.
In the Strontium89 pivotal trial, as many as 79% of patients had pain relief with Strontium89, and twice as many patients treated with Strontium89 had no pain for 3 months compared with placebo. Further, new pain sites were less frequent in patients treated with Strontium891,2. Strontium89 is administered once every 3 months via injection, and patients can be re-treated if needed. Please see Important Safety Information below.
“Q BioMed is energized by this important reimbursement milestone as part of the ongoing Strontium89 launch. We are now able to meet the needs of patients being treated across different care settings and ensure all qualified patients have the ability to choose treatment with Strontium89. We are confident that this will enable us to engage with hospitals and providers throughout the US and we'll see increasing use of Strontium89,” stated Q BioMed CEO Denis Corin.
Learn more at www.Strontium89.com
INDICATIONS AND IMPORTANT SAFETY INFORMATION:
INDICATIONS AND USAGE
In view of the delayed onset of pain relief, typically 7 to 20 days post injection, administration of Strontium-89 Chloride Injection to patients with very short life expectancy is not recommended.
A calcium-like flushing sensation has been observed in patients following a rapid (less than 30 second injection) administration.
Special precautions, such as urinary catheterization, should be taken following administration to patients who are incontinent to minimize the risk of radioactive contamination of clothing, bed linens and the patient’s environment.
Strontium-89 Chloride Injection is excreted primarily by the kidneys. In patients with renal dysfunction, the possible risks of administering Strontium-89 Chloride Injection should be weighed against the possible benefits.
PREGNANCY
Teratogenic effects. Pregnancy Category D. See Warnings section.
NURSING MOTHERS
Because Strontium-89 Chloride Injection acts as a calcium analog, secretion of Strontium-89 Chloride Injection into human milk is likely. It is recommended that nursing be discontinued by mothers about to receive intravenous Strontium-89 Chloride Injection. It is not known whether this drug is excreted in human milk.
PEDIATRIC USE
Safety and effectiveness in children below the age of 18 years have not been established.
ADVERSE REACTIONS
A single case of fatal septicemia following leukopenia was reported during clinical trials. Most severe reactions of marrow toxicity can be managed by conventional means.
A small number of patients have reported a transient increase in bone pain at 36 to 72 hours after injection. This is usually mild and self-limiting, and controllable with analgesics. A single patient reported chills and fever 12 hours after injection without long-term sequelae.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call (800) FDA-1088.
Please see full Prescribing Information for Strontium-89 Chloride Injection.
References:
1. STRONTIUM CHLORIDE Sr-89 INJECTION, USP THERAPEUTIC [package insert]. Angleton, TX: IsoTherapeutics Group, LLC; 2020.
2. Porter AT, McEwan AJB, Powe JE, et al. Results of a randomized phase-III trial to evaluate the efficacy of strontium-89 adjuvant to local field external beam irradiation in the management of endocrine resistant metastatic prostate cancer. Int J Radiat Oncol Biol Phys. 1993;25(5):805-813.
About Q BioMed Inc.
Q BioMed Inc is a biotech acceleration and commercial stage company. Q BioMed is focused on licensing and acquiring undervalued biomedical assets in the healthcare sector. Q BioMed is dedicated to providing these target assets the strategic resources, developmental support, and expansion capital needed to ensure they meet their developmental potential, enabling them to provide products to patients in need.
Please visit http://www.QBioMed.com and sign up for regular updates.
Forward-Looking Statements:
This press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs and any other statements that are not historical facts. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated are: risks related to our growth strategy; risks relating to the results of research and development activities; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; uncertainties relating to preclinical and clinical testing; our dependence on third-party suppliers; our ability to attract, integrate, and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.
Q BioMed Media Contact:
Denis Corin
CEO
Investor Relations:
Keith Pinder
+1(404) 995-6671
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