According to the American Heart Association, adults with diabetes are two to four times more likely to die from heart disease than adults without diabetes. Of those age 65 or older with diabetes, at least 68% of them die from some form of heart disease, and 16% die of stroke.
On October 30, 2018, Janssen Pharmaceutical Companies announced that the US Food & Drug Administration (FDA) has approved their drug canagliflozin (INVOKANA®) for a new indication for the prevention of myocardial infarction, stroke, and death among patients with type 2 diabetes who have established cardiovascular disease. Canagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor that was originally approved in 2013 to, along with diet and exercise, improve glycemic control in adults with type 2 diabetes (T2D). The new indication allows the prescribing of this drug to “reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease.”
Of this win for the company, the Global Therapeutic Area Head, Dr. James List, stated, “Not only does [canagliflozin] enable patients to control their diabetes symptoms by lowering their A1C levels, but it now also helps protect them from potentially devastating cardiovascular events.” This is a breakthrough for the manufacturer as this drug is the first to market and the only oral T2D treatment indicated to reduce the risk of heart attack, stroke, or cardiovascular death. First to market and first as a pill formulation for this indication on the market make for a competitive advantage.
While this is a big win for the manufacturer, the next hurdle will be obtaining favorable coverage with insurance companies for this new indication, a feat that is far too often overlooked. GIRS will continue to track the progress of coverage, and subsequently reimbursement, for this and other medical technologies seeking expanded indications.
Do you have a drug that addresses an unmet need? Do you have clinical studies revealing data that support expanding an indication for your pharmaceutical or medical device? Are you unsure how to penetrate the market or increase market uptake once your medical technology has received FDA approval?
GIRS has been providing reimbursement expertise to drug and device manufacturers for more than 15 years. Our Payer Advocacy Compass® team includes experts who will work directly with public and private payers at the national, state, and regional level to inform them of the data and the value that your product presents for their clients. To prove clinical effectiveness, we assist our clients to present safety, efficacy, and outcomes data in order to not only gain, but maintain ongoing coverage and reimbursement.
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FDA Clears Canagliflozin for CV Prevention in T2D