Mometasone Furoate Sinus Implant (Sinuva)

Number: 0935

Policy

Aetna considers mometasone furoate sinus implant (Sinuva) medically necessary for the treatment of recurrent nasal polyps in members 18 years of age and older who have had ethmoid sinus surgery and would otherwise be candidates for revision sinus surgery and have nasal obstruction/congestion symptoms despite use of intranasal steroid irrigations or sprays.

Aetna considers mometasone furoate sinus implant (Sinuva) experimental and investigational for all other indications because of insufficient evidence in the peer-reviewed literature.

See also CPB 0840 - Devices for Post-Operative Use Following Endoscopic Sinus Surgery.

Dosing Recommendations

One Sinuva Sinus Implant system contains 1,350 mcg of mometasone furoate and a sterile Delivery System.

The Sinuva Sinus Implant is loaded into a Delivery System and placed in the ethmoid sinus under endoscopic visualization.  The Implant may be left in the sinus to gradually release the corticosteroid over 90 days.  The Implant can be removed at Day 90 or earlier at the physician's discretion using standard surgical instruments.

According to the labeling, the Sinuva Sinus Implant is to be inserted by physicians trained in otolaryngology.

The labeling states that repeat administration has not been studied.

Source: Prescribing Information. Sinuva (mometasone furoate) sinus implant. 2017.

Background

Sinuva is an in-office drug treatment for recurrent nasal polyps. It is a physician-administered drug treatment for patients who have had previous ethmoid sinus surgery. This drug implant delivers 1,350 mcg of mometasone furoate directly to the ethmoid sinus. Sinuva is a corticosteroid demonstrating anti-inflammatory activity. Corticosteroids have been shown to have a wide range of effects on multiple cells and mediators involved in inflammation.

On December 8, 2017, the U.S. Food and Drug Administration (FDA) approved mometasone furoate sinus implant (Sinuva) for the treatment of nasal polyps in patients 18 years of age and older who have had ethmoid sinus surgery. Nasal and sinus complaints are among the most common reasons for visits to primary care clinicians, otolaryngologists, and allergists. Although some clinicians consider nasal obstruction to imply a blockage within the nasal cavity, nasal obstruction is most commonly defined as a patient symptom manifested as a sensation of insufficient airflow through the nose. Nasal obstruction may be the cardinal presenting symptom of many common disease processes, such as rhinitis, sinusitis, septal deviation, adenoid hypertrophy, and nasal trauma. The ethmoid sinuses are located between the eyes, behind the bridge of the nose, and are composed of numerous small air cells that are filled with fluid at birth. Inflammation of the ethmoid sinuses can cause pain between the eyes, tenderness along the sides of the nose, loss of smell, nasal congestion, and swelling of the periocular tissues.

Mometasone furoate is a corticosteroid demonstrating potent anti-inflammatory activity. The precise mechanism of corticosteroid action on inflammation is not known. Corticosteroids have been shown to have a wide range of effects on multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, and lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, and cytokines) involved in inflammation.

Sinuva Sinus Implant is made from bioabsorbable polymers designed to soften over time Placed during a routine physician office visit, Sinuva expands into the sinus cavity and delivers an anti-inflammatory steroid directly to the site of polyp disease. As the implant softens and polyps decrease, the implant may be expelled out of the nose on its own or with actions such as sneezing or forceful nose blowing. The implant can be removed 90 days after placement or earlier at the physician’s discretion. Repeat administration of Sinuva has not been studied. Sinuva should be inserted by physicians trained in otolaryngology. The safety and effectiveness of the Sinuva Sinus Implant have not been established in children or adolescents less than 18 years of age. A total of 33 patients 65 years of age or older received the Sinuva Sinus Implant in 2 controlled randomized clinical trials. However, the studies did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. The FDA submission for the Sinuva Sinus Implant was supported by the results from a trial of 90 days duration (Study 2: NCT02291549; Kern et al 2018) and another trial of 6 months duration (Study 1: NCT01732536; Forwith et al 2016).

Kern et al (2018) stated topical intranasal corticosteroid sprays (INCSs) are standard treatment for nasal polyps (NPs), but their efficacy is reduced by poor patient compliance and impaired access of drug to the sinus mucosa. A corticosteroid-eluting sinus implant was designed to address these limitations in patients with recurrent polyposis after sinus surgery by delivering 1350 μg of mometasone furoate (MF) directly to the ethmoid sinus mucosa over approximately 90 days. A randomized, sham-controlled, double-blind trial was undertaken in 300 adults with refractory chronic rhinosinusitis with NPs (CRSwNP), who were candidates for repeat surgery. Eligible patients were randomized (2:1) and underwent in-office bilateral placement of 2 implants or a sham procedure. All patients used the MF INCS 200 μg once daily. Co-primary efficacy endpoints were the change from baseline in nasal obstruction/congestion score and bilateral polyp grade, as determined by an independent panel based on centralized, blinded videoendoscopy review. Patients treated with implants experienced significant reductions in both nasal obstruction/congestion score (p = 0.0074) and bilateral polyp grade (p = 0.0073) compared to controls. At day 90, implants were also associated with significant reductions in 4 of 5 prespecified secondary endpoints compared to control: proportion of patients still indicated for repeat sinus surgery (p = 0.0004), percent ethmoid sinus obstruction (p = 0.0007), nasal obstruction/congestion (p = 0.0248), and decreased sense of smell (p = 0.0470), but not facial pain/pressure (p = 0.9130). One patient experienced an implant-related serious adverse event (epistaxis). The authors concluded that significant improvements over a range of subjective and objective endpoints, including a reduction in the need for sinus surgery by 61%, suggest that MF sinus implants may play an important role in management of recurrent NP.

Forwith et al (2016) Patients with recurrent sinonasal polyposis after endoscopic sinus surgery (ESS) have limited treatment options. Safety and efficacy were previously reported for a bioabsorbable sinus implant that elutes mometasone furoate for 3 months. Here the authors summarize longer-term outcomes. A randomized, controlled, blinded study with 100 chronic rhinosinusitis with nasal polyps (CRSwNP) patients who failed medical treatment and were considered candidates for revision ESS. Treated patients (n = 57) underwent in-office implant placement. Control patients (n = 43) underwent a sham procedure. Endoscopic grading at 3 months by clinicians was corroborated by an independent review of randomized videoendoscopies by a panel of 3 sinus surgeons. Six-month follow-up included endoscopic grading and patient-reported outcomes. At 6 months, treated patients experienced significant improvement in Nasal Obstruction Symptom Evaluation (NOSE) score (p = 0.021) and >2-fold improvement in mean nasal obstruction/congestion score (-1.06 ± 1.4 vs -0.44 ± 1.4; p = 0.124). Endoscopically, treated patients experienced significant reduction in ethmoid sinus obstruction (p < 0.001) and bilateral polyp grade (p = 0.018) compared to controls. Panel review confirmed a significant reduction in ethmoid sinus obstruction (p = 0.010) and 2-fold improvement in bilateral polyp grade (p = 0.099), which reached statistical significance (p = 0.049) in a subset of 67 patients with baseline polyp burden ≥2 bilaterally. At 6 months, control patients were at 3.6 times higher risk of remaining indicated for ESS than treated patients. The authors concluded that the symptomatic and endoscopic improvements observed confirm the efficacy of the steroid-eluting implant for in-office treatment of CRSwNP after ESS. These longer-term 6-month study results demonstrate that the steroid-eluting implant represents a durable, safe, and effective treatment strategy for this patient population.

Han et al (2014) stated patients with recurrent sinonasal polyposis after endoscopic sinus surgery (ESS) have limited treatment options. This study evaluated the safety and efficacy of a bioabsorbable steroid-eluting implant with 1350 μg of mometasone furoate for its ability to dilate obstructed ethmoid sinuses, reduce polyposis, and reestablish sinus patency. This was a randomized, controlled, blinded study including 100 patients chronic rhinosinusitis with nasal polyposis (CRSwNP) refractory to medical therapy and considered candidates for revision ESS. Follow-up included endoscopic grading by investigators and patient-reported outcomes. Treated patients (n = 53; age as mean ± standard deviation [SD] 47.8 ± 12.6 years; 55% male) underwent in-office bilateral placement. Control patients (n = 47; age 51.6 ± 13.1 years; 66% male) underwent a sham procedure. At 3 months, treated patients experienced a significant reduction in bilateral polyp grade (p = 0.0269) and ethmoid sinus obstruction (p = 0.0001) compared to controls. Treated patients also experienced a 2-fold improvement in the mean nasal obstruction/congestion score (-1.33 ± 1.47 vs -0.67 ± 1.45; p = 0.1365). This improvement reached statistical significance (p = 0.025) in patients with greater polyp burden (grade ≥2 bilaterally; n = 74). At 3 months, 53% of treated patients compared to only 23% of controls were no longer indicated for repeat ESS. There was no serious adverse event or clinically significant increases in intraocular pressure or cataract formation. The authors concluded that the symptomatic improvement and statistically significant reduction in polyp grade and ethmoid sinus obstruction supported the efficacy of the steroid-eluting implant for in-office treatment of CRS patient with recurrent polyposis after ESS. The study results demonstrated that the steroid-eluting implant represents a safe and effective alternative to current management for this patient population.

Lavigne et al (2014) stated treatment options for chronic rhinosinusitis with recurrent polyposis (CRSwNP) after endoscopic sinus surgery (ESS) are limited, and include frequent use of systemic steroids and revision surgery. A bioabsorbable, steroid-eluting implant was studied for its ability to dilate sinuses obstructed by polyps and provide localized, controlled steroid delivery to reestablish sinus patency. This study assessed the initial feasibility, safety, and efficacy of steroid-eluting implants placed in the office setting in patients who were candidates for revision ESS. This was a prospective, multicenter study enrolling 12 patients who had prior ESS but experienced recurrent polyposis refractory to medical therapy. Implants were placed bilaterally under topical anesthesia in-office. Follow-up through 6 months included endoscopic grading, patient-reported outcomes (22-item Sino-Nasal Outcomes Test [SNOT-22]) and need for revision ESS. Implants were successfully inserted in 21 of 24 (88%) ethmoid sinuses, resulting in 11 evaluable patients. No serious adverse events occurred. Within 1 month, mean bilateral polyp grade was reduced from 4.5 at baseline to 2.3 (p = 0.008) and sustained through 6 months (2.33; p = 0.008). Mean SNOT-22 score was significantly improved from 2.19 at baseline to 0.90 within 1 month (p = 0.001) and sustained to 6 months (1.03; p = 0.012). Sixty-four percent of patients were no longer revision ESS candidates at 6 months. The authors concluded that the study provided initial clinical evidence of the feasibility, safety, and efficacy of in-office steroid-eluting implant placement in CRS patients with recurrent polyposis after ESS. Although further studies are needed, the results suggest this therapy may provide a safe and effective, office-based option for the treatment of obstructive polyposis.

Ow et al (2014) long-term use of systemic glucocorticoid therapy has been associated with hypothalamic-pituitary-adrenal axis suppression and other systemic adverse events. This pharmacokinetic study evaluated the systemic safety and performance of a bioabsorbable sinus implant that gradually releases 1350 μg of mometasone furoate directly to the sinus mucosa. This was a prospective, single-center study treating 5 adult patients with recurrent polyposis after bilateral total ethmoidectomy. Each patient received 2 steroid-releasing implants in-office under local/topical anesthesia. Plasma concentrations of mometasone furoate and cortisol were determined before placement and through 30-day follow-up, which also included endoscopic grading and patient-reported outcomes. Five patients (mean age 46.2 ± 9.2 standard deviation [SD] years; 60% male) underwent successful placement in all 10 ethmoid sinuses. There were no serious adverse events. The plasma concentrations of mometasone furoate were generally below the lower limit of quantification (LLOQ) of the assay (30 pg/mL). Cortisol concentrations at follow-up ranged from 3.9 to 5.7 mg/dL compared to 4.7 mg/dL at baseline. At 1 month, there was a significant improvement in bilateral polyp grade (p = 0.037), nasal obstruction score (p = 0.002), and 22-item Sino-Nasal Outcome Test (SNOT-22) (p = 0.010) compared to baseline. The authors concluded that the reported 100% placement success, negligible systemic exposure to mometasone furoate released over time, lack of adrenal suppression, and the absence of serious adverse events suggest that the implant provides a valid and safe option for the in-office treatment of recurrent polyposis. Randomized, controlled, blinded clinical studies are underway to provide further evidence of safety and efficacy.

Goshtasbi and colleagues (2019) noted that recently, there has been increasing evidence suggesting the effectiveness of steroid-eluting stents (SES) for management of chronic rhinosinusitis (CRS) following endoscopic sinus surgery (ESS). In a meta-analysis, these researchers examined the effectiveness of SES in improving post-operative outcomes following ESS. They carried out a systematic literature search of PubMed for articles published between 1985 and 2018. The outcome variables were reported at, on average, 30 days post-intervention. A total of 7 of the 76 published studies, all of which were industry-sponsored, were included for a collective cohort of 444 SES and 444 control sinuses. In patients who received SES versus controls, collective ORs for post-operative need for intervention, surgery, and oral steroid were 0.45 (95 % CI: 0.33 to 0.62; p < 0.001), 0.30 (95 % CI: 0.18 to 0.52; p < 0.001), and 0.58 (95 % CI: 0.40 to 0.84; p = 0.004), respectively. In addition, collective ORs for frontal sinus ostia (FSO) patency, moderate-to-severe adhesion/scarring, and increase in polyp score were 2.53 (95 % CI: 1.61 to 3.97; p < 0.001), 0.28 (95 % CI: 0.13 to 0.59; p < 0.001), and 0.42 (95 % CI: 0.25 to 0.74; p = 0.002), respectively. Collective MDs for FSO/ethmoid inflammation and FSO diameter were -10.86 mm (p < 0.001) and +1.34 mm (p < 0.001), respectively. The authors concluded that aggregate evidence suggested that SES could improve ESS outcomes by reducing rates of post-operative intervention and recurrent polyposis and inflammation, while promoting FSO patency. Moreover, these researchers stated that all included and analyzed studies were industry-sponsored and ruling-out publication bias was impossible. They stated that future independent and non-sponsored studies to further evaluate SES's long-term efficacy are needed.

One Sinuva Sinus Drug Implant contains 1,350 mcg of mometasone furoate, embedded in a bioabsorbable polymer matrix that provides for gradual release of the drug over 90 days. The Sinuva Sinus Drug Implant is administered intranasally. It is supplied as single-use and is packaged in a foil pouch with a sterile disposable applicator.

Sinuva Sinus Implant is contraindicated in patients with known hypersensitivity to mometasone furoate and any of the ingredients of the Sinuva Sinus Implant. Sinuva Sinus Implant should not be used in patients with nasal ulcers or trauma. Consider removing the implant if corticosteroid effects such as hypercorticism and adrenal suppression appear in patients. The most common adverse reactions due to Sinuva (in more than 1% of subjects) were bronchitis, nasopharyngitis, otitis media, headache, presyncope, asthma, and epistaxis. However, monitor the nasal mucosa adjacent to the Sinuva Sinus Implant for any signs of bleeding (epistaxis), irritation, infection, or perforation. Also monitor patients for a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts closely. Hypersensitivity reactions, including rash, pruritus, and angioedema, have been reported with use of corticosteroids. Use Sinuva with caution with the following due to the potential for worsening of these infections: existing tuberculosis; fungal, bacterial, viral, or parasitic infection, ocular herpes simplex, more serious or even fatal course of chickenpox, or measles in susceptible patients.

Table: CPT Codes / HCPCS Codes / ICD-10 Codes
Code Code Description

Information in the [brackets] below has been added for clarification purposes.   Codes requiring a 7th character are represented by "+" :

Other CPT codes related to the CPB:

31254 Nasal/sinus endoscopy, surgical with ethmoidectomy; partial (anterior)
31255 Nasal/sinus endoscopy, surgical with ethmoidectomy; total (anterior and posterior)
31257 Nasal/sinus endoscopy, surgical with ethmoidectomy; total (anterior and posterior), including sphenoidotomy
31259 Nasal/sinus endoscopy, surgical with ethmoidectomy; total (anterior and posterior), including sphenoidotomy, with removal of tissue from the sphenoid sinus

HCPCS codes covered if selection criteria are met:

J7402 Mometasone furoate sinus implant, (sinuva), 10 micrograms

ICD-10 codes covered if selection criteria are met:

J33.0 - J33.9 Nasal polyp

The above policy is based on the following references:

  1. Bhattacharyya N. Clinical presentation, diagnosis, and treatment of nasal obstruction. UpToDate [online serial]. Waltham, MA: UpToDate; reviewed May 2018.
  2. Centers for Medicare & Medicaid Services (CMS). Healthcare Common Procedure Coding System (HCPCS) Public Meeting Agenda for Drugs, Biologicals and Radiopharmaceuticals. Baltimore, MD, May 15, 2018.
  3. Forwith KD, Han JK, Stolovitzky JP, et al. RESOLVE: bioabsorbable steroid-eluting sinus implants for in-office treatment of recurrent sinonasal polyposis after sinus surgery: 6-month outcomes from a randomized, controlled, blinded study. Int Forum Allergy Rhinol. 2016;6(6):573-81.
  4. Goshtasbi K, Abouzari M, Abiri A, et al. Efficacy of steroid-eluting stents in management of chronic rhinosinusitis after endoscopic sinus surgery: Updated meta-analysis. Int Forum Allergy Rhinol. 2019 Sep 20 [Epub ahead of print].
  5. Han JK, Forwith KD, Smith TL, et al. RESOLVE: a randomized, controlled, blinded study of bioabsorbable steroid-eluting sinus implants for in-office treatment of recurrent sinonasal polyposis. Int Forum Allergy Rhinol. 2014;4(11):861-70.
  6. Intersect ENT, Inc. Sinuva (mometasone furoate) sinus implant. Prescribing Information. Menlo Park, California: Intersect ENT, Inc.; revised December 2017.
  7. Kern RC, Stolovitzky JP, Silvers SL, et al; RESOLVE II study investigators. 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.
  8. Lavigne F, Miller SK, Gould AR, et al. Steroid-eluting sinus implant for in-office treatment of recurrent nasal polyposis: a prospective, multicenter study. Int Forum Allergy Rhinol. 2014;4(5):381-9.
  9. Ow R, Groppo E, Clutter D, et al. Steroid-eluting sinus implant for in-office treatment of recurrent polyposis: a pharmacokinetic study. Int Forum Allergy Rhinol. 2014;4(10):816-22.
  10. Shen J, Welch K, Kern R. Mometasone furoate sinus implant - a new targeted approach to treating recurrent nasal polyp disease. Expert Rev Clin Pharmacol. 2018;11(12):1163-1170.
  11. Singh A, Luong AU, Fong KJ, et al. Bioabsorbable steroid-releasing implants in the frontal sinus ostia: A pooled analysis. Int Forum Allergy Rhinol. 2019;9(2):131-139.
  12. Wang MB. Etiologies of nasal symptoms: An overview. UpToDate [online serial]. Waltham, MA: UpToDate; reviewed May 2016.