mp-708 - mp-708 - Medical Policies
SINUVA™ (mometasone furoate)
Policy Number: MP-708
Latest Review Date: July 2021
Policy Grade: A
The use of implantable nasal/sinus drug-eluting implants (i.e. SINUVA™) are considered investigational for the following, including, but not limited to:
- postoperative treatment following endoscopic sinus surgery;
- for treatment of recurrent sinonasal polyposis.
DESCRIPTION OF PROCEDURE OR SERVICE:
Placed during a routine physician office visit, Sinuva™ (mometasone furoate) expands into the sinus cavity and delivers an anti-inflammatory steroid directly to the site of polyp disease for 90 days. Sinuva may be an alternative to surgery and other treatment options for adults who have already had ethmoid sinus surgery. Sinuva is marketed to shrink nasal polyps and reduce nasal obstruction and congestion.
Literature review through July 2021.
Summary of Evidence:
Drug eluting sinus implants may prove to have a role in nasal polyposis; however, additional positive results from well-designed RCTs are needed to confirm the results of the available RCTs. The evidence is insufficient to determine the effects of the technology on health outcomes.
Practice Guidelines and Position Statements:
No guidelines or statements were identified.
U.S. Preventive Services Task Force Recommendations:
Sinuva (mometasone furoate), sinus implant, Intersect ENT, nasal polyp, ethmoid sinus surgery
APPROVED BY GOVERNING BODIES:
SINUVA™ Sinus Implant (Intersect ENT, Inc., Menlo Park, CA) was initially approved in 1987. In 2017, the SINUVA™ Sinus Implant was approved with a new dose (1350 μg mometasone furoate) under a New Drug Application (NDA 209310). The corticosteroid is released over 90 days and the bioabsorbable polymers soften over this time. The implant is removed at Day 90 or earlier using standard surgical instruments. The SINUVA™ Sinus Implant is indicated for the treatment of nasal polyps in adult patients who have had ethmoid sinus surgery.
Coverage is subject to member’s specific benefits. Group specific policy will supersede this policy when applicable.
ITS: Home Policy provisions apply
FEP contracts: FEP does not consider investigational if FDA approved and will be reviewed for medical necessity. Special benefit consideration may apply. Refer to member’s benefit plan.
Unlisted procedure, Nose
Unlisted procedure, accessory sinuses
Mometasone furoate sinus implant (Sinuva), 10 micrograms (Effective 4/01/21)
Mometasone furoate sinus implant, 10 micrograms (Effective 10/1/19, Deleted 03/31/21)
Mometasone furoate sinus implant, 370 micrograms (Deleted 9/30/19)
- 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.
- Goshtasbi K, Abouzari M, Abiri A, Yasaka T, Sahyouni R, Bitner B, Tajudeen BA, Kuan EC. Efficacy of steroid-eluting stents in management of chronic rhinosinusitis after endoscopic sinus surgery: updated meta-analysis. Int Forum Allergy Rhinol. 2019 Dec;9(12):1443-1450. doi: 10.1002/alr.22443. Epub 2019 Sep 20.
- 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. Nov 2014; 4(11):861-870.
- Han JK, Marple BF, Smith TL. Effect of steroid-releasing sinus implants on postoperative medical and surgical interventions: an efficacy meta-analysis. Int Forum Allergy Rhinol 2012; 2(4):271-9.
- https://www.sinuva.com/. Accessed December 31, 2019.
- IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
- 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.
Medical Policy Group, January 2020 (6): New medical policy created for SINUVA. All information related to SINUVA removed from MP #501 Implantable Sinus Stents and Drug-Eluting Implants for Postoperative Use Following Endoscopic Sinus Surgery and for Recurrent Sinus Disease.
Medical Policy Group, March 2021: Quarterly Coding Update. Added new code J7402. Moved deleted code J7401 from current coding to previous coding.
Medical Policy Group, May 2021 (5): Policy statement updated to remove “not medically necessary,” no change to policy intent.
Medical Policy Group, July 2021 (5): Updates to Key Points, and References. No change to Policy Statement.
This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.
This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.
The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.
As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.
The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:
1. The technology must have final approval from the appropriate government regulatory bodies;
2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;
3. The technology must improve the net health outcome;
4. The technology must be as beneficial as any established alternatives;
5. The improvement must be attainable outside the investigational setting.
Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:
1. In accordance with generally accepted standards of medical practice; and
2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and
3. Not primarily for the convenience of the patient, physician or other health care provider; and
4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.