The product is designated on Anthem’s formulary as “LD” – limited distribution – and is only available to certain pharmacies or wholesalers. Intersect ENT launched the product in the U.S. in April this year.
The company’s drug-eluting device is designed to treat nasal polyp disease in patients who have undergone previous sinus surgery. Sinuva is placed during a routine doctor’s office visit and releases an anti-inflammatory steroid, mometasone furoate, directly to the patient’s nasal polyps for up to 90 days.
Intersect ENT estimates that nearly 635,000 Americans have undergone surgery to remove nasal polyps and ultimately have to return to their ENT physicians due to recurring symptoms.
In a 300-patient pivotal trial, participants treated with Sinuva had a statistically significant reduction in bilateral polyp grade from baseline to 90 days and a signification reduce in nasal obstruction score after 30 days. The drug-device combo won FDA approval in December last year.