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ph-1190

Nasal Inhalers Quantity Limit Program Summary

Policy Number: PH-1190

This program applies to Commercial, Blue Partner, GenPlus, NetResults A series, SourceRx and Health Insurance Marketplace.

POLICY REVIEW CYCLE

Effective Date	Date of Origin
4/1/2023

FDA APPROVED INDICATIONS AND DOSAGE

See package insert for FDA prescribing information: https://dailymed.nlm.nih.gov/dailymed/index.cfm

POLICY AGENT SUMMARY QUANTITY LIMIT

Target Brand Agent Name(s)	Target Generic Agent Name(s)	Strength	QL Amount	Dose Form	Days Supply	Duration	Addtl QL Info	Allowed Exceptions	Targeted NDCs When Exclusions Exist	Effective Date

	Azelastine HCl Nasal Spray 0.1% (137 MCG/SPRAY)	0.1 % ; 137 MCG/SPRAY	2.0	BOTTS	30	Days				11-17-2022
	Flunisolide Nasal Soln 25 MCG/ACT (0.025%)	0.025 %	3.0	BOTTS	30	Days				11-17-2022
	Ipratropium Bromide Nasal Soln 0.03% (21 MCG/SPRAY)	0.03 %	2.0	BOTTS	30	Days
	Ipratropium Bromide Nasal Soln 0.06% (42 MCG/SPRAY)	0.06 %	3.0	BOTTS	30	Days
Allergy nasal spray 24 ho ; Allergy relief ; Clarispray ; Cvs fluticasone propriona ; Eq allergy relief ; Eql fluticasone propionat ; Flonase allergy relief ; Flonase allergy relief ch ; Gnp fluticasone propionat ; Hm allergy relief nasal s ; Kls aller-flo ; Qc allergy relief ; Sm allergy relief nasal s	Fluticasone Propionate Nasal Susp ; fluticasone propionate nasal susp	50 ; 50 MCG/ACT	1.0	BOTT	30	Days
Astepro ; Astepro childrens	Azelastine HCl Nasal Spray 0.15% (205.5 MCG/SPRAY)	0.15 % ; 205.5 MCG/SPRAY	2.0	BOTTS	30	Days				11-17-2022
Astepro ; Astepro childrens	Azelastine HCl Nasal Spray 0.15% (205.5 MCG/SPRAY)	0.15 % ; 205.5 MCG/SPRAY	2.0	BOTTS	30	Days				11-17-2022
Astepro ; Astepro childrens	Azelastine HCl Nasal Spray 0.15% (205.5 MCG/SPRAY)	0.15 % ; 205.5 MCG/SPRAY	2.0	BOTTS	30	Days				11-17-2022
Astepro ; Astepro childrens	Azelastine HCl Nasal Spray 0.15% (205.5 MCG/SPRAY)	0.15 % ; 205.5 MCG/SPRAY	2.0	BOTTS	30	Days				11-17-2022
Beconase aq	Beclomethasone Dipropionate Monohyd Nasal Susp 42 MCG/SPRAY	42 MCG/SPRAY	2.0	INHLRS	30	Days				11-17-2022
Dymista	Azelastine HCl-Fluticasone Prop Nasal Spray 137-50 MCG/ACT	137 MCG/ACT	1.0	BOTT	30	Days				11-17-2022
Dymista	Azelastine HCl-Fluticasone Prop Nasal Spray 137-50 MCG/ACT	137 MCG/ACT	1.0	BOTT	30	Days				11-17-2022
Nasonex	Mometasone Furoate Nasal Susp 50 MCG/ACT	50 MCG/ACT	2.0	BOTTS	30	Days				11-17-2022
Nasonex	Mometasone Furoate Nasal Susp 50 MCG/ACT	50 MCG/ACT	2.0	BOTTS	30	Days				11-17-2022
Omnaris	Ciclesonide Nasal Susp 50 MCG/ACT	50 MCG/ACT	1.0	INHLR	30	Days				11-17-2022
Patanase	Olopatadine HCl Nasal Soln 0.6%	0.6 %	1.0	BOTT	30	Days				11-17-2022
Patanase	Olopatadine HCl Nasal Soln 0.6%	0.6 %	1.0	BOTT	30	Days				11-17-2022
Patanase	Olopatadine HCl Nasal Soln 0.6%	0.6 %	1.0	BOTT	30	Days				11-17-2022
Qnasl	Beclomethasone Dipropionate Nasal Aerosol 80 MCG/ACT	80 MCG/ACT	1.0	INHLR	30	Days
Qnasl childrens	Beclomethasone Dipropionate Nasal Aerosol 40 MCG/ACT	40 MCG/ACT	1.0	INHLR	30	Days
Ryaltris	Olopatadine HCl-Mometasone Furoate Nasal Susp	665 MCG/ACT	1.0	BOTT	30	Days				11-17-2022
Zetonna	Ciclesonide Nasal Aerosol Soln 37 MCG/ACT (50 MCG/Valve)	37 MCG/ACT	1.0	INHLR	30	Days				11-17-2022

CLIENT SUMMARY – QUANTITY LIMITS

Target Brand Agent Name(s)	Target Generic Agent Name(s)	Strength	Client Formulary
	Azelastine HCl Nasal Spray 0.1% (137 MCG/SPRAY)	0.1 % ; 137 MCG/SPRAY	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
	Flunisolide Nasal Soln 25 MCG/ACT (0.025%)	0.025 %	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
	Ipratropium Bromide Nasal Soln 0.03% (21 MCG/SPRAY)	0.03 %	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
	Ipratropium Bromide Nasal Soln 0.06% (42 MCG/SPRAY)	0.06 %	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Allergy nasal spray 24 ho ; Allergy relief ; Clarispray ; Cvs fluticasone propriona ; Eq allergy relief ; Eql fluticasone propionat ; Flonase allergy relief ; Flonase allergy relief ch ; Gnp fluticasone propionat ; Hm allergy relief nasal s ; Kls aller-flo ; Qc allergy relief ; Sm allergy relief nasal s	Fluticasone Propionate Nasal Susp ; fluticasone propionate nasal susp	50 ; 50 MCG/ACT	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Astepro ; Astepro childrens	Azelastine HCl Nasal Spray 0.15% (205.5 MCG/SPRAY)	0.15 % ; 205.5 MCG/SPRAY	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Astepro ; Astepro childrens	Azelastine HCl Nasal Spray 0.15% (205.5 MCG/SPRAY)	0.15 % ; 205.5 MCG/SPRAY	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Astepro ; Astepro childrens	Azelastine HCl Nasal Spray 0.15% (205.5 MCG/SPRAY)	0.15 % ; 205.5 MCG/SPRAY	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Astepro ; Astepro childrens	Azelastine HCl Nasal Spray 0.15% (205.5 MCG/SPRAY)	0.15 % ; 205.5 MCG/SPRAY	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Beconase aq	Beclomethasone Dipropionate Monohyd Nasal Susp 42 MCG/SPRAY	42 MCG/SPRAY	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Dymista	Azelastine HCl-Fluticasone Prop Nasal Spray 137-50 MCG/ACT	137 MCG/ACT	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Dymista	Azelastine HCl-Fluticasone Prop Nasal Spray 137-50 MCG/ACT	137 MCG/ACT	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Nasonex	Mometasone Furoate Nasal Susp 50 MCG/ACT	50 MCG/ACT	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Nasonex	Mometasone Furoate Nasal Susp 50 MCG/ACT	50 MCG/ACT	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Omnaris	Ciclesonide Nasal Susp 50 MCG/ACT	50 MCG/ACT	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Patanase	Olopatadine HCl Nasal Soln 0.6%	0.6 %	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Patanase	Olopatadine HCl Nasal Soln 0.6%	0.6 %	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Patanase	Olopatadine HCl Nasal Soln 0.6%	0.6 %	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Qnasl	Beclomethasone Dipropionate Nasal Aerosol 80 MCG/ACT	80 MCG/ACT	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Qnasl childrens	Beclomethasone Dipropionate Nasal Aerosol 40 MCG/ACT	40 MCG/ACT	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Ryaltris	Olopatadine HCl-Mometasone Furoate Nasal Susp	665 MCG/ACT	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Zetonna	Ciclesonide Nasal Aerosol Soln 37 MCG/ACT (50 MCG/Valve)	37 MCG/ACT	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

QUANTITY LIMIT CLINICAL CRITERIA FOR APPROVAL

Module	Clinical Criteria for Approval
	Evaluation Quantities above the program quantity limit for the Target Agent(s) will be approved when ONE of the following is met: The requested quantity (dose) does NOT exceed the program quantity limit OR The requested quantity (dose) is greater than the program quantity limit AND ONE of the following: BOTH of the following: The requested agent does NOT have a maximum FDA labeled dose for the requested indication AND Information has been provided to support therapy with a higher dose for the requested indication OR BOTH of the following: The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication AND Information has been provided to support why the requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does NOT exceed the program quantity limit OR BOTH of the following: The requested quantity (dose) is greater than the maximum FDA labeled dose for the requested indication AND Information has been provided to support therapy with a higher dose for the requested indication Length of Approval: up to 12 months

Module

Clinical Criteria for Approval

Evaluation

Quantities above the program quantity limit for the Target Agent(s) will be approved when ONE of the following is met:

The requested quantity (dose) does NOT exceed the program quantity limit OR
The requested quantity (dose) is greater than the program quantity limit AND ONE of the following:
1. BOTH of the following:
  1. The requested agent does NOT have a maximum FDA labeled dose for the requested indication AND
  2. Information has been provided to support therapy with a higher dose for the requested indication OR
2. BOTH of the following:
  1. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication AND
  2. Information has been provided to support why the requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does NOT exceed the program quantity limit OR
3. BOTH of the following:
  1. The requested quantity (dose) is greater than the maximum FDA labeled dose for the requested indication AND
  2. Information has been provided to support therapy with a higher dose for the requested indication

Length of Approval: up to 12 months

This program applies to Commercial, Blue Partner, GenPlus, NetResults A series, SourceRx and Health Insurance Marketplace

This pharmacy 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 pharmacy policies are based on (i) information in FDA approved package inserts (and black box warning, alerts, or other information disseminated by the FDA as applicable); (ii) research of current medical and pharmacy literature; and/or (iii) 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.

The purpose of Blue Cross and Blue Shield of Alabama’s pharmacy policies are to provide a guide to coverage. Pharmacy policies are not intended to dictate to physicians how to practice medicine. Physicians should exercise their medical judgment in providing the care they feel is most appropriate for their patients.

Neither this policy, nor the successful adjudication of a pharmacy claim, is guarantee of payment.

Commercial _ PS _ Nasal Inhalers Quantity Limit _ProgSum_ 4/1/2023