Strontium89 Now Reimbursed in Hospital and Outpatient Settings for Metastatic Bone Pain Treatment
Strontium89 Now Reimbursed in All Treatment Settings
NEW YORK, Jan. 7, 2021 /PRNewswire/ -- 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
Strontium Chloride Sr-89 Injection, USP is indicated for the relief of bone pain in patients with painful skeletal metastases. The presence of bone metastases should be confirmed prior to therapy.
Use of Strontium-89 Chloride Injection in patients with evidence of seriously compromised bone marrow from previous therapy or disease infiltration is not recommended unless the potential benefit of the treatment outweighs its risks. Bone marrow toxicity is to be expected following the administration of Strontium-89 Chloride Injection, particularly white blood cells and platelets. The extent of toxicity is variable. It is recommended that the patient's peripheral blood cell counts be monitored at least once every other week. Typically, platelets will be depressed by about 30% compared to pre-administration levels. The nadir of platelet depression in most patients is found between 12 and 16 weeks following administration of Strontium-89 Chloride Injection. White blood cells are usually depressed to a varying extent compared to pre-administration levels. Thereafter, recovery occurs slowly, typically reaching pre-administration levels six months after treatment unless the patient's disease or additional therapy intervenes. In considering repeat administration of Strontium-89 Chloride Injection, the patient's hematologic response to the initial dose, current platelet level and other evidence of marrow depletion should be carefully evaluated. Verification of dose and patient identification is necessary prior to administration because Strontium-89 Chloride Injection delivers a relatively high dose of radioactivity.
Strontium-89 Chloride Injection may cause fetal harm when administered to a pregnant woman. There are no adequate and well-controlled studies in pregnant women. If this drug is used during pregnancy, or if the patient becomes pregnant while receiving this drug, the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant.
Strontium-89 Chloride Injection is not indicated for use in patients with cancer not involving bone.
Strontium-89 Chloride Injection should be used with caution in patients with platelet counts below 60,000 and white cell counts below 2,400.
Radiopharmaceuticals should only be used by physicians who are qualified by training and experience in the safe use and handling of radionuclides and whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides.
Strontium-89 Chloride Injection, like other radioactive drugs, must be handled with care and appropriate safety measures taken to minimize radiation to clinical personnel.
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.
Teratogenic effects. Pregnancy Category D. See Warnings section.
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.
Safety and effectiveness in children below the age of 18 years have not been established.
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.
1. STRONTIUM CHLORIDE Sr-89 INJECTION, USP THERAPEUTIC 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.
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