Clinical Policy Title: Propel (drug eluting devices after sinus surgery)

Transcription

1 Clinical Policy Title: Propel (drug eluting devices after sinus surgery) Clinical Policy Number: Effective Date: July 1, 2017 Initial Review Date: May 19, 2017 Most Recent Review Date: May 1, 2018 Next Review Date: May 2019 Policy contains: Drug-eluting sinus implants. Propel. Steroids for rhinosinusitus. Related policies: None. ABOUT THIS POLICY: Prestige Health Choice has developed clinical policies to assist with making coverage determinations. Prestige Health Choice s clinical policies are based on guidelines from established industry sources, such as the Centers for Medicare & Medicaid Services (CMS), state regulatory agencies, the American Medical Association (AMA), medical specialty professional societies, and peer-reviewed professional literature. These clinical policies along with other sources, such as plan benefits and state and federal laws and regulatory requirements, including any state- or plan-specific definition of medically necessary, and the specific facts of the particular situation are considered by Prestige Health Choice when making coverage determinations. In the event of conflict between this clinical policy and plan benefits and/or state or federal laws and/or regulatory requirements, the plan benefits and/or state and federal laws and/or regulatory requirements shall control. Prestige Health Choice s clinical policies are for informational purposes only and not intended as medical advice or to direct treatment. Physicians and other health care providers are solely responsible for the treatment decisions for their patients. Prestige Health Choice s clinical policies are reflective of evidence-based medicine at the time of review. As medical science evolves, Prestige Health Choice will update its clinical policies as necessary. Prestige Health Choice s clinical policies are not guarantees of payment. Coverage policy Prestige Health Choice considers the use of PROPEL drug-eluting devices after sinus surgery to be investigational/experimental, and therefore, not medically necessary (Huang, 2015; Rizan, 2016). Limitations: Coverage determinations are subject to benefit limitations and exclusions as delineated by the state Medicaid authority. The Florida Medicaid website may be accessed at Alternative covered services: Medicinal treatments to relieve mucosa edema and wound healing after endoscopic sinus surgery. 1

2 Background Chronic rhinosinusitis is an inflammation of the nasal and paranasal sinus mucosa. Medical treatments (topical or oral steroids) offer relief to many persons with the condition, but some cases require surgery, most often endoscopic surgery. Post-operative inflammation, formation of polyps, and adhesions of the nasal mucous lining are not uncommon, and require treatment to decrease edema of the mucosa and hasten wound healing, and restore sinus ventilation and drainage (Huang, 2015). The PROPEL mometasone-eluting stent, created by Intersect ENT of Palo Alto CA, is the first device for delivering a sustained steroid medication localized into the ethmoid cavity after surgery approved by the U.S. Food and Drug Administration (FDA). The implant is a biodegradable polymer that expands in a spring-like fashion to conform to the walls of a dissected ethmoid cavity. Mometasone furoate (370 mg) is released gradually over a 30 day period, directly into the sinus (Wei, 2012). FDA approved PROPEL, an implant for ethmoid sinus surgery, on August 11, Approval for PROPEL Mini, an implant for ethmoid and frontal sinus surgery, followed on September 21, The most recent product, PROPEL Contour for frontal and maxillary sinus surgery received FDA approval on February 23, All are indicated for persons age 18 or over (FDA, 2017). Intersect ENT Inc. asserts that more than 150,000 patients have been treated with PROPEL products as of early 2017 (Intersect ENT, 2017). Other instruments to gradually release steroids into sinuses include the Stratus MicroFlow Spacer and the Sinu-Foam Spacer. In May, 2013, Acclarent (maker of the Stratus device) stopped sales of the product and withdrew FDA approvals, and thus the device is no longer available for sale in the U.S. The Sinu-Foam Spacer has yet to demonstrate improvement in endoscopic outcomes (Rudmik, 2012). Searches Prestige Health Choice searched PubMed and the databases of: UK National Health Services Centre for Reviews and Dissemination. Agency for Healthcare Research and Quality s National Guideline Clearinghouse and other evidence-based practice centers. The Centers for Medicare & Medicaid Services (CMS). We conducted searches on March 21, Search terms were: drug eluting device, drug eluting sinus implant mometasone furoate implant and PROPEL sinus. We included: Systematic reviews, which pool results from multiple studies to achieve larger sample sizes and greater precision of effect estimation than in smaller primary studies. Systematic 2

3 reviews use predetermined transparent methods to minimize bias, effectively treating the review as a scientific endeavor, and are thus rated highest in evidence-grading hierarchies. Guidelines based on systematic reviews. Economic analyses, such as cost-effectiveness, and benefit or utility studies (but not simple cost studies), reporting both costs and outcomes sometimes referred to as efficiency studies which also rank near the top of evidence hierarchies. Findings The National Institute for Health and Care Excellence (NICE) has generated the only guideline with recommendations for use of drug-eluting sinus implants. Based on limited evidence of efficacy, the lack of long-term evidence, and inadequate evidence on patient-reported outcomes and quality of life, the NICE panel recommended that the procedure should be used only with special arrangements for clinical governance, consent, and audit or research (NICE, 2016). A 2014 consensus statement for pediatric rhinosinusitis did not address drug-eluting sinus implants after surgery; PROPEL is not FDA approved for persons under age 18 (Brietzke, 2014). Results of use of the PROPEL devices have appeared in some peer-reviewed articles, but studies to date are relatively few, include small and heterogeneous populations that often lack controls, and have short follow up periods. The first of two systematic reviews or meta-analyses of drug-eluting sinus implants was attempted by the Cochrane group in The panel identified no randomized controlled trials (RCTs) that met their inclusion criteria, although 21 of 159 trials met some of the criteria, and thus it could not assess any advantages or disadvantages of the technology. Authors conclude that well-structured RCTs are needed to assess any potential benefits (Huang, 2015). The second systematic review, by researchers from the United Kingdom, identified 7 studies, including 5 RCTs, that followed patients from 2 to 6 months after steroid-eluting intranasal devices. Six (6) of the 7 demonstrated effectiveness in reducing adhesion formation, polyp formation, inflammation, Lund- Kennedy scores, and perioperative sinus endoscopy scores. Study conclusions were that data on this procedure were limited, and that further studies are needed to optimize dosing regimens, compare devices, and provide long-term outcomes (Rizan, 2016). In the ADVANCE trial that was the basis for FDA approval of PROPEL, 90 sinuses given PROPEL after endoscopic sinus surgery and followed for 1 month showed a low prevalence of polypoid edema (10.0 percent), significant adhesions (1.1), and middle turbinate lateralization (4.4), indicating the implant was safe and effective (Forwith, 2011), which corroborated results of 86 sinuses published several months earlier (Murr, 2011). The ADVANCE II trial included 210 sinuses given PROPEL, compared to sinuses given implants that did not release drugs; significant decreases in post-operative infections, lysis of adhesions, and frank polyposis were observed in the drug group (Marple, 2012). 3

4 Several studies were controlled and randomized. In the treatment arm, 53 post-surgical patients with recurrent sinonasal polyposis treated with a steroid-eluting implant had a significantly lower polyp burden, a lower ethmoid sinus obstruction, and a greater improvement in nasal obstruction after 3 months, compared to 47 controls (Han, 2014). The treated group had a significantly greater percent of patients no longer indicated for repeat surgery (53 to 23 percent), compared to controls. Another randomized controlled study that compared 57 implant with 43 control patients for 6 months after surgery resulted in significantly lower nasal obstruction and bilateral polyp grade among the treated group (Forwith, 2016). A Canadian study of 24 steroid-eluting implants in sinuses found significantly lower polyp grades after 6 months, when 64 percent of patients were no longer candidates for sinus surgery (Lavigne, 2014). Other 2014 studies of 20 implants (Matheny, 2014), and 10 implants (Ow, 2014) tracked for 1 month found the treatment to be effective and safe. While earlier studies tested efficacy of drug-eluting implants into the ethmoid sinus, more recent studies have begun to review effects on the frontal sinus. One randomized blinded trial of 80 sinuses, known as the PROGRESS study, documented a reduced need for post-operative interventions (oral steroid, surgery, and restenosis), lower inflammation score, and greater diameter of the frontal sinus compared to surgery alone after 90 days (Smith, 2016). A February 2017 evaluation of post-operative sinus implants for patients undergoing frontal sinus surgery found a significant potential for growth in the use of these implants (Bury, 2017). Average costs of steroid-eluting and nonsteroid-eluting sinus implant strategies were estimated at $1, and $ (Rudmik, 2014). A recent analysis found that for a hypothetical U.S. health plan of 1.5 million members, incorporating PROPEL into its covered services ranged from -$.003 to +$.036 per member per month (Rizzo, 2016). Policy updates: In March, 2018, we did not identify any new guidelines or peer-reviewed publications. Summary of clinical evidence: Citation Smith (2016) Review of effectiveness of steroid-releasing implant in the frontal sinus opening Content, Methods, Recommendations Key points: Randomized controlled trial, 80 adults, each given steroid releasing implant in one frontal sinus opening, with the other side given no implant At 30 days after endoscopic sinus surgery, implants had significant reduction in need for postoperative interventions vs. surgery alone (p = 0.007) Implants also reported a 55.6% reduction in need for oral steroid interventions, 75.0% 4

5 Citation Huang (2015) Literature review of improving symptoms after endoscopic sinus surgery Han (2014) Safety and efficacy of drug eluting sinus implants following endoscopic sinus surgery Marple (2012) Content, Methods, Recommendations reduction in need for surgical interventions, 54.3% reduction in restenosis rate, 32.2% greater diameter of frontal sinus opening, and 16.7% reduction in inflammation score all but the latter are statistically significant Key points: Cochrane Ear, Nose, and Throat Disorders Group literature review of steroid-eluting sinus stents after surgery Search returned 159 trials, of which 21 had potential to be included None of the 21 trials had all criteria for inclusion (several had some of the criteria) Future RCTs are needed to assess (any) benefits over those of surgery alone, or when compared to non-steroid sinus stents Key points: Randomized, controlled, blinded study of 100 patients given bilateral sinus surgery in a physician s office 53 patients given drug-eluting sinus implant, 47 given sham procedure After 3 months, treated patients had significantly greater reduction in bilateral polyp grade Treated patients had greater improvement in average nasal obstruction/congestion 53% of treated patients no longer indicated for repeat surgery, vs. 23% of controls Key points: Advance II study to compare drug-releasing vs. non-drugreleasing sinus implant Prospective, multicenter, randomized, controlled, double-blind trial 105 patients with chronic rhinosinusitis undergoing bilateral ethmoidectomy, half with drug-releasing and half with non-drug-releasing sinus implant; surgeons blinded Drug-releasing implants showed a 29.0% greater reduction in postoperative interventions, a 52% greater decrease in lysis of adhesions, and a 44.9% reduction in frank polyposis compared to controls, all of which are significant References Professional society guidelines/other: Brietzke SE, Shin JJ, Choi S, et al. Clinical consensus statement: pediatric chronic rhinosinusitis. Otolaryngol Head Neck Surg. 2014;151(4): Accessed March 21, Intersect ENT. Entersect ENT announced FDA approval of newest steroid releasing implant, PROPEL Contour, for use in treating the frontal and maxillary sinuses. Menlo Park CA: Intersect ENT, February Accessed March 21, National Institute for Health and Care Excellence (NICE). Corticosteroid-eluting bioabsorbable stent or spacer insertion during endoscopic sinus surgery to treat chronic rhinosinusitis. NICE, Scheduled for review March, Accessed March 21,

6 U.S. Food and Drug Administration (FDA). Premarket approval. FDA, March 19, ename=&productcode=&pmanumber=p100044&supplementnumber=&advisorycommittee=&docketnu mber=&supplementtype=&expeditedreview=&ivdproducts=off&combinationproducts=off&decisiondate from=&decisiondateto=&noticedatefrom=&noticedateto=&pagenum=500&sortcolumn=pn_asc_sn_as c. Accessed March 21, Peer-reviewed references: Bury S, Singh A. Evaluation of a steroid releasing sinus implant for the treatment of patients undergoing frontal sinus surgery for chronic rhinosinusitis. Expert Rev Med Devices. 2017;14(2): Forwith KS, Chandra RK, Yun PT, Miller SK, Jampel HD. ADVANCE: a multisite trial of bioabsorbable steroid-eluting sinus implants. Laryngoscope. 2011;121(11): 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): Huang Z, Hwang P, Sun Y, Zhou B. Steroid-eluting sinus stents for improving symptoms in chronic rhinosinusitis patients undergoing functional endoscopic sinus surgery. Cochrane Database Syst Rev. 2015;(6):CD Lavigne F, Miller SK, Gould AR, Lanier BJ, Romett JL. Steroid-eluting sinus implant for in-office treatment of recurrent nasal polyposis: a prospective, multicenter study. Int Forum Allergy Rhinol. 2014;4(5): Marple BF, Smith TL, Han JK, et al. Advance II: a prospective, randomized study assessing safety and efficacy of bioabsorbable steroid-releasing sinus implants. Otolaryngol Head Neck Surg. 2012;146(6): Matheny KE, Carter KB Jr, Tseng EY, Fong KJ. Safety, feasibility, and efficacy of placement of steroideluting bioabsorbable sinus implants in the office seting: a prospective case series. Int Forum Allergy Rhinol. 2014;4(10): Murr AH, Smith TL, Hwang PH, et al. Safety and efficacy of a novel bioabsorbable, steroid-eluting sinus stent. Int Forum Allergy Rhinol. 2011;1(1): 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):

7 Parikh A, Anand U, Ugwu MC, et al. Drug-eluting nasal implants: formulation, characterization, clinical applications, and challenges. Pharmaecuticals. 2014;6(2): Rizan C, Elhassan HA. Post-sinus surgery insertion of steroid-eluting bioabsorbable intranasal devices: a systematic review. Laryngoscope. 2016;126(1): Rizzo JA, Rudmik L, Mallow PJ, Palli SR. Budget impact analysis of bioabsorbable drug-eluting sinus implants following endoscopic sinus surgery. J Med Econ. 2016;19(9): Rudmik L, Mace J, Mechor B. Effect of a dexamethasone Sinu-Foam middle meatal spacer on endoscopic sinus surgery outcomes: a randomized, double-blind, placebo-controlled trial. Int Forum Allergy Rhinol. 2012;2(3): Rudmik L, Smith TL. Econimic evaluation of a steroid-eluting sinus implant following endocscopic sinus surgery for chronic rhinosinusitis. Otolaryngol Head Neck Surg. 2014;151(2): Santarelli GD, Han JK. Evaluation of the PROPEL mini sinus implant for the treatment of frontal sinus disease. Expert Opin Drug Deliv. 2016;13(12): Smith TL, Singh A, Luong A, et al. Randomized controlled trial of a bioabsorbable steroid-releasing implant in the frontal sinus opening. Laryngoscope. 2016;126(12): Wei CC, Kennedy DW. Mometasone implant for chronic rhinosinusitis. Med Devices (Auckl). 2012;5: CMS National Coverage Determinations (NCDs): No NCDs identified as of the writing of this policy. Local Coverage Determinations (LCDs): No LCDs identified as of the writing of this policy. Commonly submitted codes Below are the most commonly submitted codes for the service(s)/item(s) subject to this policy. This is not an exhaustive list of codes. Providers are expected to consult the appropriate coding manuals and bill accordingly. CPT Code Description Comments 0406T Nasal endoscopy, surgical, ethmoid sinus, placement of drug eluting implant 7

8 CPT Code Description Comments 0407T Nasal endoscopy, surgical, ethmoid sinus, placement of drug eluting implant; with biopsy, polypectomy or debridement ICD-10 Code Description Comments J32.0-J32.9 J01.0-J01.91 Chronic Sinusitis Acute Sinusitis HCPCS Level II Code S1090 Description Mometasone furoate sinus implant, 370 micrograms Comments 8