MENLO PARK, Calif.--(BUSINESS WIRE)--Intersect ENT®, Inc. (Nasdaq: XENT), a company dedicated to transforming care for patients with ear, nose and throat conditions, today announced that the Centers for Medicare and Medicaid Services (CMS) has approved SINUVA® (mometasone furoate) Sinus Implant for transitional pass-through payment status for reimbursement under the Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgery Center Payment System. The new code, C9122 Mometasone furoate sinus implant, 10 micrograms (Sinuva), is scheduled to take effect July 1, 2020. Pass-Through status lasts for three years.
“We are pleased that CMS has recognized SINUVA as being a novel treatment therapy and granted pass-through status with this new C code. Expanded payer coverage and payment is central to our vision of providing unencumbered access to all our products and making SINUVA the standard-of-care based upon both clinical benefit and availability to a majority of patients with recurrent nasal polyps,” states Thomas A. West, President & Chief Executive Officer of Intersect ENT. “With over 70 percent of commercial lives already covered for SINUVA, this new C Code assignment further expands access to SINUVA in a very important patient population, Fee for Service Medicare, comprised of approximately 40 million additional lives.”
Transitional pass-through payment status for Medicare reimbursement in the hospital outpatient setting was established by the U.S. Congress to incentivize access to novel therapies for Medicare patients. This new C Code for SINUVA will simplify the reimbursement process for ENT physicians and their practices, as well as provide Medicare patients easier access to this novel drug eluting sinus implant.
SINUVA is an alternative treatment option for patients with recurrent polyps who have had prior sinus surgery. Nasal polyps are soft, noncancerous growths on the lining of the nasal passages or sinuses and can result from chronic inflammation that persists in the ethmoid sinuses. Patients with nasal polyps can experience symptoms that include a decreased sense of smell, nasal obstruction, runny nose and facial pressure. Despite the use of medical management options to treat symptoms, recurrence of nasal polyps is common due to the inflammatory nature of the disease, resulting in the need for sinus surgery in many patients.
SINUVA is a non-surgical, corticosteroid-eluting implant for the treatment of nasal polyps in adult patients who have had ethmoid sinus surgery. Its innovative 2-in-1 design incorporates a self-expanding, bioabsorbable structure along with targeted delivery of an anti-inflammatory steroid (mometasone furoate) directly to the site of disease for 90 days. By nature of its design, SINUVA reduces the reliance on patient compliance while implanted. SINUVA is clinically proven to reduce polyps and improve the symptoms of nasal polyps, including nasal obstruction, congestion and sense of smell. In the clinical study, less than half of patients treated with SINUVA were still indicated for sinus surgery following treatment.
About Intersect ENT®
Intersect ENT is a company transforming care for patients with ear, nose and throat conditions. The Company’s steroid-releasing implants are designed to provide mechanical spacing and deliver targeted therapy to the site of disease. In addition, Intersect ENT is continuing to expand its portfolio of products based on the Company’s unique localized steroid releasing technology and is committed to broadening patient access to less invasive and more cost-effective care.
For additional information on the Company or the products including risks and benefits please visit www.IntersectENT.com. For more information about PROPEL® (mometasone furoate) sinus implants and SINUVA® (mometasone furoate) sinus implant, please visit www.PROPELOPENS.com and www.SINUVA.com.
Intersect ENT®, PROPEL® and SINUVA® are registered trademarks of Intersect ENT, Inc.
SINUVA Indication & Important Safety Information
SINUVA Sinus Implant is a prescription steroid-releasing (mometasone furoate) implant indicated for the treatment of nasal polyps in patients 18 years or older who have had ethmoid sinus surgery.
IMPORTANT SAFETY INFORMATION
Who should not use SINUVA?
Do not use SINUVA if you are allergic to mometasone furoate or any ingredients of the implant.
What should I tell my doctor before receiving SINUVA?
Before you receive SINUVA, tell your doctor about all medical conditions you have including nasal/sinus problems (such as nasal ulcers or trauma), eye problems (such as glaucoma or cataracts), or any untreated fungal, bacterial, or viral infections.
What are the possible side effects of SINUVA?
Serious side effects of SINUVA can include:
- Local reactions including nosebleed and injury to nerves or blood vessels in the nose/sinus.
- Serious allergic reactions have happened in patients using mometasone furoate including rash, itching or swelling of the lips, face, tongue, and throat, and breathing problems. Call your doctor right away if you have any of these reactions.
- Weakened immune system that may increase your risk of infections. Avoid contact with people who have contagious diseases such as chickenpox or measles. Call your doctor right away if you have been near someone with chickenpox or measles.
- Adrenal insufficiency is a condition in which the adrenal glands do not make enough steroid hormones and can cause tiredness, weakness, nausea and vomiting and low blood pressure. Talk to your doctor if steroid effects such as Cushing Syndrome and adrenal suppression appear.
The most common side effects of SINUVA in clinical studies were bronchitis, cold symptoms, middle ear infections, headache, lightheadedness or dizziness, asthma, and nosebleeds. The following adverse reactions have been identified during post-approval use of the SINUVA sinus implant. These events include implant migration, lack of efficacy, nasal pain, headache, and nosebleeds.
Tell your doctor if you have any side effects that bother you or don’t go away.
Risks related with the insertion and removal of SINUVA are similar to other endoscopic sinus procedures.
SINUVA is made from materials designed to soften over time and may fall out of the nose on its own as polyps decrease or if you sneeze or blow your nose forcefully. The implant will be removed 90 days after placement or earlier at your doctor’s discretion.
Contact your doctor immediately if you have any changes in vision, excessive nasal bleeding, symptoms of infection or symptoms suggesting that the implant has moved, such as irritation or a choking sensation in the back of the throat.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. For important risk and use information, please see Full Prescribing Information for SINUVA (www.SINUVA.com/PI)
This release contains forward-looking statements within the meaning of Sections 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. We may, in some cases, use terms such as “look forward,” confident,” “promises,” “predicts,” “believe,” “potential,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements should not be read as a guarantee of future performance or results and may not necessarily be accurate indications of the times at, or by, which such performance or results will be achieved. These forward-looking statements are based on Intersect ENT’s current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation those related to the safety, efficacy and patient and physician adoption of the company’s products and therapies, the ability to obtain and maintain reimbursement codes for its products, the company’s ability to procure and maintain required regulatory approvals for our products, the company’s ability to grow and expand its business, as well as other risks detailed from time to time in Intersect ENT’s filings with the Securities and Exchange Commission (SEC), including Intersect ENT’s filings on Form 10-K and Form 10-Q available at the SEC's Internet site (www.sec.gov). Intersect ENT does not undertake any obligation to update forward-looking statements and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein.