Approval Establishes New S Code for PROPEL to Facilitate Specific Coding & Payment
“We are pleased that CMS recognized the benefit to payers and providers of decoupling the previously shared, and therefore potentially confusing, single J-Code for both SINUVA and PROPEL. These are distinct offerings with different uses and benefits. In addition, SINUVA is classified by FDA as a drug and PROPEL as a device. With the dedicated and updated SINUVA code, J7402, and a specific PROPEL code, S1091, payers can now more accurately delineate and reimburse based upon the specific use of each product. Moreover, Payers can accurately align each product’s National Drug Code (NDC) to the product-specific, CMS-assigned, code and the product’s actual use,” said
PROPEL® Steroid Releasing Sinus Implants
The PROPEL family of products are the first and only bioabsorbable steroid releasing sinus implants approved by the FDA to maintain patency and locally deliver steroid to the sinus mucosa in patients >18 years of age after sinus surgery. Clinically proven to improve outcomes for chronic sinusitis patients following sinus surgery, PROPEL sinus implants mechanically prop open the sinuses and release mometasone furoate, an advanced corticosteroid with anti-inflammatory properties, directly into the sinus lining then bioabsorb. PROPEL’s safety and effectiveness for use in ethmoid sinuses is supported by Level 1-A clinical evidence from multiple clinical trials, which demonstrates that PROPEL implants reduce inflammation and scarring after ethmoid sinus surgery, thereby lessening the need for post-operative oral steroids and surgical interventions. PROPEL is indicated for the ethmoid sinus; PROPEL Mini is indicated for the ethmoid and frontal sinuses; and PROPEL Contour is indicated for the frontal and maxillary sinuses.
SINUVA® Steroid Releasing Sinus Implant
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 implant structure along with the targeted delivery of an anti-inflammatory corticosteroid, mometasone furoate. It provides localized drug delivery for up to 90 days directly to the site of disease. By nature of its design as an office-administered implant with direct delivery of anti-inflammatory medication, SINUVA minimizes the reliance on patient compliance. SINUVA is clinically proven to reduce polyps and the need for revision nasal surgery, as well as improve the symptoms of nasal polyps, nasal obstruction, congestion and decreased sense of smell.
About Intersect ENT®
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
IMPORTANT SAFETY INFORMATION FOR PROPEL SINUS IMPLANTS
The PRROPEL sinus implants are indicated to maintain patency and locally deliver steroid to the sinus mucosa in patients >18 years of age after sinus surgery: PROPEL for the ethmoid sinus, PROPEL Mini for the ethmoid sinus/frontal sinus opening, and PROPEL Contour for the frontal/maxillary sinus ostia. Contraindications include patients with intolerance to mometasone furoate (MF) or hypersensitivity to bioabsorbable polymers. Safety and effectiveness of the implant in pregnant or nursing females have not been studied. Risks may include, but are not limited to pain/pressure, displacement of the implant, possible side effects of intranasal MF, sinusitis, epistaxis and infection. For full prescribing information see IFU at https://www.IntersectENT.com/techologies/. Rx only
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
Executive Vice-President & CFO