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News Release - May 12, 2021
Centers for Medicare and Medicaid Services (CMS) Issues Permanent J-Code for Tolmar's FENSOLVI(R) Effective July 1, 2021BUFFALO GROVE, Ill., May 12, 2021 -- (Healthcare Sales & Marketing Network) -- Tolmar Pharmaceuticals, Inc., a specialty pharmaceutical company, today announced that the Centers for Medicare and Medicaid Services (CMS) has assigned a new product-specific billing code to identify FENSOLVI® (leuprolide acetate) for injectable suspension, indicated for the treatment of pediatric patients 2 years of age and older with Central Precocious Puberty (CPP). The new J-code is J1951 and becomes effective on July 1, 2021.
The Healthcare Common Procedure Coding System (HCPCS) is a standardized coding system necessary for medical providers to submit healthcare claims to Medicare and other health insurances. J-codes are permanent, product specific reimbursement codes designed to help facilitate and streamline billing.
This announcement is significant given the recent unexpected events, such as a global shortage of existing leuprolide acetate products from another manufacturer that started in the second half of 2020. Such events heightened the need to have alternative product options with easy access to meet clinical needs of the CPP patient population.
"Given the importance of adhering to a consistent dosing schedule for children with CPP, it is important for patients to be able to access FENSOLVI in a timely manner," said Steve Griffin, President, North America, Tolmar Pharmaceuticals. "We are pleased to receive this new J-code assignation as it will enable a more efficient billing process, which will ultimately help facilitate patient access to FENSOLVI and allow uninterrupted therapy for this complex condition during an unprecedented time."
The J-code for FENSOLVI (J1951) has been published online in the CMS Healthcare Common Procedure Coding System (HCPCS) Application Summaries and Coding Decisions, First Quarter 2021 Coding Cycle for Drug and Biological Products. Click here to view the publication.
About Central Precocious Puberty
Gonadotropin releasing hormone (GnRH)-dependent central precocious puberty (CPP) is the premature development of signs of sexual maturation occurring in girls younger than eight and in boys younger than nine years of age. CPP patients are at risk of having significantly short stature as adults in addition to social, psychological, and emotional issues, including lower self-esteem, stress, anxiety and depression, all of which may negatively impact quality of life. CPP is believed to have a five- to twenty-fold higher incidence in girls than in boys and is estimated to occur in one in 5,000-10,000 children.
About Fensolvi® (leuprolide acetate) for injectable suspension
Fensolvi (leuprolide acetate) for injectable suspension is a gonadotropin releasing hormone (GnRH) agonist indicated for the treatment of pediatric patients two years of age and older with CPP. It is a prescription drug, given by injection.
Fensolvi is the first and only six-month, subcutaneous leuprolide acetate with a small injection volume that allows flexibility in selection of injection site and enables administration in an office setting. Fensolvi represents an effective, safe and convenient treatment option for this vulnerable patient group, and its profile aligns with twice-yearly visits to the pediatric endocrinologist's office.
Information about Fensolvi is available at fensolvi.com
About Tolmar Pharmaceuticals
"Tolmar" refers to Tolmar Holding, Inc. and its wholly owned operating subsidiaries, Tolmar Inc., Tolmar Therapeutics, Inc., and Tolmar Pharmaceuticals, Inc. Tolmar global headquarters, product development and manufacturing facilities are based in northern Colorado, while Tolmar Pharmaceuticals' U.S. commercial business is based in Buffalo Grove, Illinois. For more information about the company, please visit tolmar.com
For more information: visit the article in the Journal of Clinical Endocrinology & Metabolism
Important Safety Information for FENSOLVI® (leuprolide acetate) for injectable suspension
FENSOLVI® (leuprolide acetate) for injectable suspension is a gonadotropin releasing hormone (GnRH) agonist used to treat patients 2 years of age and older with central precocious puberty (CPP). CPP may be diagnosed when signs of sexual maturity begin to develop in girls under the age of 8 or in boys under the age of 9.
FENSOLVI is contraindicated in individuals with hypersensitivity to any drug that is in the same class as FENSOLVI, in individuals who are allergic to any of the ingredients in FENSOLVI, or in individuals who are pregnant. FENSOLVI may cause fetal harm when administered to a pregnant patient.
During the first few weeks of treatment, increases in gonadotropins and sex steroids above baseline may result in an increase in signs and symptoms of puberty including vaginal bleeding in girls.
Psychiatric events have been reported in patients taking GnRH agonists. Events include emotional lability, such as crying, irritability, impatience, anger, and aggression. Patients should be monitored for development or worsening of psychiatric symptoms.
Convulsions have been observed in patients treated with GnRH agonists with or without a history of seizures, epilepsy, cerebrovascular disorders, central nervous system anomalies or tumors, and in patients on concomitant medications that have been associated with convulsions such as bupropion and SSRIs.
The most common adverse events seen with FENSOLVI were injection site pain, nasopharyngitis, pyrexia, headache, cough, abdominal pain, injection site erythema, nausea, constipation, vomiting, upper respiratory tract infection, bronchospasm, productive cough and hot flush.
Please see the Full Prescribing Information for additional important safety information.
To report suspected adverse reactions, contact Tolmar at 1-844-4TOLMAR (486-5627) or the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.
Source: Tolmar Pharmaceuticals
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