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Coverage for SINUVA (mometasone furoate) sinus implant is better than ever

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Discover how access to SINUVA (mometasone furoate) sinus implant has been made easier

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SINUVA patients experienced a 74% relative improvement in bilateral polyp grade (from baseline to Day 90)^1,2*

Mean change (SD) for SINUVA –0.56 (1.06) vs –0.15 (0.91) with MF nasal spray alone (P=0.0073)^1,3

Learn more about SINUVA

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

Patients with known hypersensitivity to mometasone furoate and any of the ingredients of the SINUVA Sinus Implant.

Please see additional Important Safety Information below.

Is SINUVA covered?

Coverage and access to SINUVA have never been better.

Intersect ENT has made it easier for physicians to access SINUVA and help nasal polyp patients discover relief.

•		public lives covered^†
•		commercial lives covered

Top commercial payers

Coverage with payers is better than ever

^†	CMS has approved Pass-through status for Fee for Service Medicare patients.

New partnership with CONNECT Hub provides:

Dedicated experts. Dependable resources. Insightful solutions.

Personal case manager

can assist you throughout the patient journey from start to finish.

Expedited case conversion

from time of enrollment to shipment now averaging only ~13 days.

Enhanced eConsent form

will allow case managers to work with patients directly and ensure a smooth access process.

Learn more about SINUVA coverage

Study Design: The RESOLVE II study was a randomized, controlled, double-blind, multicenter study with 300 patients. Patients were ≥ 18 years of age with chronic sinusitis who had prior bilateral total ethmoidectomy, and were indicated for revision endoscopic surgery because they presented with moderate to severe nasal obstruction/congestion symptoms and recurrent bilateral sinus obstruction due to sinonasal polyposis despite the use of intranasal corticosteroid sprays and recent high dose steroids. 201 patients were randomized to the SINUVA treatment arm where they underwent bilateral placement of SINUVA in the ethmoid sinuses. 99 patients were randomized to the control arm where they received a sham procedure. Patients in both study arms received once daily mometasone furoate nasal spray (200 μg) through Day 90.^1,3

MF, mometasone furoate; SD, standard deviation.

INDICATION

SINUVA Sinus Implant is a corticosteroid-eluting (mometasone furoate) implant indicated for the treatment of nasal polyps, in patients ≥ 18 years of age who have had ethmoid sinus surgery.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

Patients with known hypersensitivity to mometasone furoate and any of the ingredients of the SINUVA Sinus Implant.

WARNINGS AND PRECAUTIONS

Local Effects: Monitor nasal mucosa adjacent to the SINUVA Sinus Implant for any signs of bleeding (epistaxis), irritation, infection, or perforation. Avoid use in patients with nasal ulcers or trauma.

Ocular Effects: Monitor patients with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts closely.

Hypersensitivity Reactions: Hypersensitivity reactions, including rash, pruritus, and angioedema have been reported with the use of corticosteroids.

Immunosuppression: Persons who are using drugs that suppress the immune system are more susceptible to infections than healthy individuals. Corticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculosis infection of the respiratory tract; untreated systemic fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex.

Hypercorticism and Adrenal Suppression: If corticosteroid effects such as hypercorticism and adrenal suppression appear in patients, consider sinus implant removal.

ADVERSE REACTIONS

The most common adverse reactions observed (> 1% of subjects and that occurred more frequently in the treatment group compared to control) in clinical studies were asthma, headache, epistaxis, presyncope, bronchitis, otitis media, and nasopharyngitis.

POSTMARKETING EXPERIENCE

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, epistaxis.

Rx only. Please see Full Prescribing Information for SINUVA.

References: 1. SINUVA [Prescribing Information]. Menlo Park, CA: Intersect ENT; 2020. 2. Data on file, Intersect ENT, Inc. CR-00014; Supplemental Statistical Analyses Rev 1.0 January 17, 2018. 3. Kern RC, Stolovitzky JP, Silvers SL, et al. A phase 3 trial of mometasone furoate sinus implants for chronic sinusitis with recurrent nasal polyps. Int Forum Allergy Rhinol. 2018;8(4):471-481. 4. Ow R, Groppo E, Clutter D, Gawlicka AK. Steroid-eluting sinus implant for in-office treatment of recurrent polyposis: a pharmacokinetic study. Int Forum Allergy Rhinol. 2014;4(10):816-822.

Developed under the direction and sponsorship of Intersect ENT, Inc.
©2022 Intersect ENT, Inc. All rights reserved. Intersect ENT and SINUVA are registered trademarks of Intersect ENT, Inc. in the United States and other countries. MPM-12413 Rev 1.0