Nasal Steroids C4730-A

Prior Authorization Criteria

Nasal Steroids Policy Number: C4730-A

CRITERIA EFFECTIVE DATES: ORIGINAL EFFECTIVE DATE LAST REVIEWED DATE NEXT REVIEW DATE 03/2012 7/29/2020 7/29/2021 LAST P&T J CODE TYPE OF CRITERIA APPROVAL/VERSION Q4 2020 3490 (NOC) RxPA 20201028C4730-A

PRODUCTS AFFECTED: Flonase Sensimist (fluticasone furoate), Flunisolide, Qnasl (beclomethasone), Nasonex (mometasone), Omnaris (ciclesonide), Zetonna (ciclesonide), Beconase AQ (beclomethasone), Xhance (fluticasone propionate), Rhinocort (budesonide)

DRUG CLASS: Nasal Steroids ROUTE OF ADMINISTRATION: Intranasal

PLACE OF SERVICE: Retail Pharmacy The recommendation is that medications in this policy will be for pharmacy benefit coverage and member self-administered

AVAILABLE DOSAGE FORMS: 24 HR NASAL SPR ALLERGY, ALLER-FLO SPR 50MCG, ALLERGY RELF SPR 50MCG, BECONASE AQ SPR 42MCG, BUDESONIDE SPR NASAL BUDESONIDE SPR NASALOTC, BUDESONIDE SUS 32MCG, CLARISPRAY SPR 50MCG FLONASE ALGY SPR 50MCG, FLONASE SENS SPR 27.5MCG, FLONASE-OTC SPR 50MCG FLONASE-RX SPR 50MCG120, FLUNISOLIDE SPR 0.025%, FLUTICASONE SPR 50MCG FLUTICASONE SPR 50MCGOTC, MOMETASONE SPR 50MCG, NASACORT ALR SPR 55MCG/AC, NASACORT ALR SPR 55MCGOTC, NASAL ALLGY SPR 55MCG/AC, NASALIDE INH SPR 0.025%, NASONEX SPR 50MCG, OMNARIS SPR NASAL, PROPEL IMP 370MCG, QNASL CHILD SPR 40MCG, QNASL SPR 80MCG, RA NASAL SPR ALLERGY, RHINOCORT SPR ALRGYOTC, RHINOCORT SPR AQUA, TRIAMCINOLON AER 55MCGOTC, VERAMYST NSL SPR 27.5MCG, XHANCE SPR 93MCG, ZETONNA AER 37MCG

FDA-APPROVED USES: Allergic rhinitis; Seasonal and perennial, Non-allergic rhinitis XHANCE/NASONEX/RHINOCORT ONLY- nasal polyp treatment, QNASL/BECONASE AQ ONLY- prophylaxis of nasal polyp recurrence following surgical removal

COMPENDIAL APPROVED OFF-LABELED USES:

COVERAGE CRITERIA: INITIAL AUTHORIZATION

DIAGNOSIS:

Molina Healthcare, Inc. confidential and proprietary © 2020 This document contains confidential and proprietary information of Molina Healthcare and cannot be reproduced, distributed or printed without written permission from Molina Healthcare. This page contains prescription brand name drugs that are trademarks or registered trademarks of pharmaceutical manufacturers that are not affiliated with Molina Healthcare. Page 1 of 4

Prior Authorization Criteria

Allergic rhinitis; Seasonal and perennial, Non-allergic rhinitis XHANCE/NASONEX/RHINOCORT ONLY- nasal polyp treatment, QNASL/BECONASE AQ ONLY- prophylaxis of nasal polyp recurrence following surgical removal

REQUIRED MEDICAL INFORMATION: A. SEASONAL OR PERENNIAL ALLERGIC RHINITIS, NON-ALLERGIC RHINITIS: 1. Documentation of adequate trial (30 days)/failure or absolute contraindication to ALL formulary products.

B. FOR NASAL POLYPS: 1. Documentation of adequate trial (30 days)/failure or absolute contraindication to TWO formulary products.

DURATION OF APPROVAL: Initial authorization: 3 months, Continuation of Therapy: for up to 12 months

QUANTITY: OTC fluticasone propionate (Aller-Flo, Clarispray, Flonase Allergy Relief, Children’s Flonase Allergy Relief and all other commercially available OTCfluticasone propionate agents): 50mcg/actuation, 1 inhaler/30 days

OTC triamcinolone acetonide (Nasacort OTC, Children’s Nasacort, Nasal Allergy Spray and all other commercially available OTC triamcinolone acetonide agents): 55mcg/actuation, 1 inhaler/30 days budesonide (Rhinocort Aqua): 32 mcg/actuation, 2 inhalers/30 days

OTC budesonide: 32 mcg/actuation, 2 inhalers/30 days

OTC Rhinocort Allergy: 32 mcg/actuation, 2 inhalers/30 days

Beconase AQ (beclomethasone): 42 mcg/actuation, 2 inhalers/30 days

Flonase Sensimist, Children’s Flonase Sensimist (fluticasone furoate): 27.5mcg/actuation, 1 inhaler/30 days

Flunisolide: 25mcg/actuation, 3 inhalers/30 days prescription fluticasone: 27.5mcg/actuation, 1 inhaler/30 days mometasone (Nasonex): 50 mcg/actuation, 1 inhaler/30 days

Omnaris (ciclesonide): 50 mcg/actuation, 1 inhaler/30 days

QNASL (beclomethasone dipropionate): 80mcg/actuation, 1 inhaler/30 days

Qnasl Children’s: 40mcg/actuation, 1 inhaler/30 days prescription triamcinolone: 55 mcg/actuation, 1 inhaler/30 days

Veramyst (fluticasone furoate): 27.5 mcg/actuation, 1 inhaler/30 days

Xhance (fluticasone): 93 mcg/actuation, 2 inhalers/30 days

Prior Authorization Criteria

Zetonna (ciclesonide): 37mcg/actuation, 1 inhaler/30 days

PRESCRIBER REQUIREMENTS: None

AGE RESTRICTIONS: 2 or older: triamcinolone acetonide, Flonase Sensimist (fluticasone furoate) 4 or older: fluticasone propionate, Qnasl (beclomethasone) 6 or older: budesonide, flunisolide, Beconase AQ (beclomethasone), Omnaris (ciclesonide) 12 or older: Zetonna (ciclesonide) 18 or older: Xhance (fluticasone propionate)

CONTINUATION OF THERAPY: A. FOR ALL INDICATIONS: For members new to Molina Healthcare, Inc. 1. Documentation of failure of a consistent trial of all preferred products AND 2. Prescribed dosage is within the maximum FDA approved dose AND 3. Documentation of chart notes demonstrating member’s response to therapy and improvement or stabilization of symptoms (if used for prophylaxis

B. FOR ALL INDICAITONS: FOR RENEWALS OF CURRENT AUTHORIZATIONS 1. Documentation of chart notes demonstrating member’s response to therapy and improvement or stabilization of symptoms (if used for prophylaxis)

CONTRAINDICATIONS/EXCLUSIONS/DISCONTINUATION: All other uses of nasal corticosteroids are considered experimental/investigational and therefore, will follow Molina’s Off-Label policy.

OTHER SPECIAL CONSIDERATIONS: None

BACKGROUND: None

APPENDIX: None

Documentation Requirements: Molina Healthcare reserves the right to require that additional documentation be made available as part of its coverage determination; quality improvement; and fraud; waste and abuse prevention processes. Documentation required may include, but is not limited to, member records, test results and credentials of the provider ordering or performing a drug or service. Molina Healthcare may deny reimbursement or take additional appropriate action if the documentation provided does not support the initial determination that the drugs or services were medically necessary, not investigational or experimental, and otherwise within the scope of benefits afforded to the member, and/or the documentation demonstrates a pattern of billing or other practice that is inappropriate or excessive.

Prior Authorization Criteria

REFERENCES: 1. Jankowski R, Schrewelius C, Bonfils P, et al: Efficacy and tolerability of budesonide aqueous nasal spray treatment in members with nasal polyps. Arch Otolaryngol Head Neck Surg 2001; 127:447-452. 2. Holopainen E, Grahne B, Malmberg H, et al: Budesonide in the treatment of nasal polyposis. Eur J Respir Dis 1982; 63(suppl 122):221-228. 3. Product Information: RHINOCORT(R) AQUA nasal spray, budesonide nasal spray. AstraZeneca Pharmaceuticals, Wilmington, DE, 2005. 4. Product Information: OMNARIS(R) nasal spray, ciclesonide nasal spray. Sepracor Inc, Marlborough, MA, 2010. 5. Product Information: ZETONNA(TM) nasal aerosol, ciclesonide nasal aerosol. Sunovion Pharmaceuticals Inc. (per FDA), Marlborough, MA, 2012. 6. Product Information: NASONEX(R) nasal spray, mometasone furoate monohydrate nasal spray. Schering Corporation, Kenilworth, NJ, 2010. 7. Product Information: BECONASE AQ(R) nasal spray, beclomethasone dipropionate, monohydrate nasal spray. GlaxoSmithKline, Research Triangle Park, NC, 2005. 8. Product Information: QNASL(TM) nasal aerosol, beclomethasone dipropionate nasal aerosol. Teva Respiratory LLC (per FDA), Horsham, PA, 2014. 9. Product Information: BECONASE AQ(R) nasal spray, beclomethasone dipropionate monohydrate nasal spray. GlaxoSmithKline LLC (per DailyMed), Research Triangle Park, NC, 2011 10. Product Information: XHANCE(TM) nasal spray, fluticasone propionate nasal spray. OptiNose US, Inc (per manufacturer), Yardley, PA, 2017 11. Product Information: fluticasone propionate nasal spray, fluticasone propionate nasal spray. Prasco Laboratories (per DailyMed), Mason, OH, 2012. 12. UpToDate [Internet database]. Wolters Kluwer Health, St Louis, MO. Updated periodically. 13. Micromedex® Healthcare Series [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. 14. Clinical Pharmacology [Internet]. Tampa (FL): Elsevier. 2018. Available from: http://www.clinicalpharmacology.com