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ph-1178

Topical Psoriasis Quantity Limit

Policy Number: PH-1178

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

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

90250025003710	CALCIPOTRIENE*Calcipotriene Cream 0.005%	0.005 %	120.0	GRAMS	30	Days
90250025003920	CALCIPOTRIENE*Calcipotriene Foam 0.005%	0.005 %	120.0	GRAMS	30	Days
90250025004210	CALCIPOTRIENE*Calcipotriene Oint 0.005%	0.005 %	120.0	GRAMS	30	Days
90250025002020	CALCIPOTRIENE*Calcipotriene Soln 0.005% (50 MCG/ML)	0.005 %	120.0	MLS	30	Days
90559902324225	CALCIPOTRIENE/BETAMETHASO*Calcipotriene-Betamethasone Dipropionate Oint 0.005-0.064%	0.005 %	120.0	GRAMS	30	Days
90559902321825	CALCIPOTRIENE/BETAMETHASO*Calcipotriene-Betamethasone Dipropionate Susp 0.005-0.064%	0.005 %	120.0	GRAMS	30	Days
90250028004220	CALCITRIOL*Calcitriol Oint 3 MCG/GM	3 MCG/GM	200.0	GRAMS	30	Days
90550025203920	CLOBETASOL PROPIONATE*Clobetasol Propionate Emulsion Foam 0.05%	0.05 %	100.0	GRAMS	30	Days
90550025103920	CLOBETASOL PROPIONATE*Clobetasol Propionate Foam 0.05%	0.05 %	100.0	GRAMS	30	Days
90550025104110	CLOBETASOL PROPIONATE*Clobetasol Propionate Lotion 0.05%	0.05 %	118.0	MLS	30	Days
90550025104520	CLOBETASOL PROPIONATE*Clobetasol Propionate Shampoo 0.05%	0.05 %	118.0	MLS	30	Days
90550025100910	CLOBETASOL PROPIONATE*Clobetasol Propionate Spray 0.05%	0.05 %	125.0	MLS	30	Days
905599024841	DUOBRII*halobetasol propionate-tazarotene lotion	0.01 %	200.0	GRAMS	30	Days
90559902323930	ENSTILAR*Calcipotriene-Betamethasone Dipropionate Foam 0.005-0.064%	0.005 %	120.0	GRAMS	30	Days
90550020001620	SERNIVO*Betamethasone Dipropionate Spray Emulsion 0.05% (Base Equiv)	0.05 %	120.0	MLS	30	Days
90559902323720	WYNZORA*Calcipotriene-Betamethasone Dipropionate Cream 0.005-0.064%	0.005 %	120.0	GRAMS	30	Days
90250045003720	ZORYVE*Roflumilast Cream 0.3%	0.3 %	60.0	GRAMS	30	Days

CLIENT SUMMARY – QUANTITY LIMITS

Agent Names	Strength	Client Formulary
CALCIPOTRIENE*Calcipotriene Cream 0.005%	0.005 %	Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
CALCIPOTRIENE*Calcipotriene Foam 0.005%	0.005 %	Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
CALCIPOTRIENE*Calcipotriene Oint 0.005%	0.005 %	Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
CALCIPOTRIENE*Calcipotriene Soln 0.005% (50 MCG/ML)	0.005 %	Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
CALCIPOTRIENE/BETAMETHASO*Calcipotriene-Betamethasone Dipropionate Oint 0.005-0.064%	0.005 %	Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
CALCIPOTRIENE/BETAMETHASO*Calcipotriene-Betamethasone Dipropionate Susp 0.005-0.064%	0.005 %	Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
CALCITRIOL*Calcitriol Oint 3 MCG/GM	3 MCG/GM	Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
CLOBETASOL PROPIONATE*Clobetasol Propionate Emulsion Foam 0.05%	0.05 %	Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
CLOBETASOL PROPIONATE*Clobetasol Propionate Foam 0.05%	0.05 %	Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
CLOBETASOL PROPIONATE*Clobetasol Propionate Lotion 0.05%	0.05 %	Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
CLOBETASOL PROPIONATE*Clobetasol Propionate Shampoo 0.05%	0.05 %	Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
CLOBETASOL PROPIONATE*Clobetasol Propionate Spray 0.05%	0.05 %	Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
DUOBRII*halobetasol propionate-tazarotene lotion	0.01 %	Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
ENSTILAR*Calcipotriene-Betamethasone Dipropionate Foam 0.005-0.064%	0.005 %	Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
SERNIVO*Betamethasone Dipropionate Spray Emulsion 0.05% (Base Equiv)	0.05 %	Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
WYNZORA*Calcipotriene-Betamethasone Dipropionate Cream 0.005-0.064%	0.005 %	Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
ZORYVE*Roflumilast Cream 0.3%	0.3 %	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

QUANTITY LIMIT CLINICAL CRITERIA FOR APPROVAL

Module	Clinical Criteria for Approval
	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

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

QUANTITY LIMIT CLINICAL CRITERIA OPERATIONAL LEVEL OF EVIDENCE REQUIREMENTS

Module	Ops Set Up	Validation Options	Other Explanation
	Validation: Apply Baseline and go to Validation Options

DOCUMENT HISTORY

Approval Date MM/YYYY	Approved By	Notes
-		Original Client Specific Review Client Specific criteria, approved by BCBS AL 04/2018 Original Implementation 7/1/2018 Administrative Action (addition of Duobrii) 05/2019 Client Specific Annual Review Client Specific criteria, maintained, reviewed by BCBS AL 08/2019 Administrative Action (note branded generic of Sorilux, Taclonex) 01/2020 Client Specific Mid-Year Review Client Specific criteria, with changes to question set, approved by BCBS AL 03/2020 Client Specific Annual Review, Prime Standard criteria, no changes, approved by BCBS AL 07/2020 Client Specific Mid-Year Review Client Specific criteria, with changes, approved by BCBS AL 10/2020 Client Specific Annual Review Client Specific criteria, with changes, approved by BCBS AL 10/2021 Administrative Action (addition of Vtama) 05/2022 Administrative Action (addition of Zoryve) 08/2022 Client Specific Mid-Year Review Client Specific criteria, with changes (removal of Vtama), approved by BCBS AL 09/2022
10-2022	BCBS AL	Client Specific Annual Review Client Specific criteria, criteria maintained, approved by BCBS AL 10/2022

Approval Date MM/YYYY

Approved By

Notes

Original Client Specific Review Client Specific criteria, approved by BCBS AL 04/2018

Original Implementation 7/1/2018

Administrative Action (addition of Duobrii) 05/2019

Client Specific Annual Review Client Specific criteria, maintained, reviewed by BCBS AL 08/2019

Administrative Action (note branded generic of Sorilux, Taclonex) 01/2020

Client Specific Mid-Year Review Client Specific criteria, with changes to question set, approved by BCBS AL 03/2020

Client Specific Annual Review, Prime Standard criteria, no changes, approved by BCBS AL 07/2020

Client Specific Mid-Year Review Client Specific criteria, with changes, approved by BCBS AL 10/2020

Client Specific Annual Review Client Specific criteria, with changes, approved by BCBS AL 10/2021

Administrative Action (addition of Vtama) 05/2022

Administrative Action (addition of Zoryve) 08/2022

Client Specific Mid-Year Review Client Specific criteria, with changes (removal of Vtama), approved by BCBS AL 09/2022

10-2022

BCBS AL

Client Specific Annual Review Client Specific criteria, criteria maintained, approved by BCBS AL 10/2022

POLICY REVIEW CYCLE

Effective Date	Date of Origin	Status
1/1/2023		Draft

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 _ CS _ Topical Psoriasis Quantity Limit _ 1/1/2023