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ph-1195

Antitussive Combination Products Quantity Limit Program Summary

Policy Number: PH-1195

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

POLICY REVIEW CYCLE

Effective Date	Date of Origin
04-01-2024

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	Day Supply	Duration	Addtl QL Info	Allowed Exceptions	Targeted NDCs When Exclusions Exist

	Hydrocod Polst-Chlorphen Polst Cap ER 12HR 10-8 MG		20	Capsules	30	DAYS	Not covered for patients less than 18 years of age.
	Hydrocod Polst-Chlorphen Polst ER Susp 10-8 MG/5ML	10-8 MG/5ML	100	mLs	30	DAYS	Not covered for patients less than 18 years of age.
Tuxarin er	Codeine Phos-Chlorpheniramine Maleate Tab ER 12HR 54.3-8 MG	54.3-8 MG	20	Tablets	30	DAYS	Not covered for patients less than 18 years of age.
Tuzistra xr	Codeine Polist-Chlorphen Polist ER Susp 14.7-2.8 MG/5ML	14.7-2.8 MG/5ML	200	mLs	30	DAYS	Not covered for patients less than 18 years of age.

ADDITIONAL QUANTITY LIMIT INFORMATION

Wildcard	Target Brand Agent Name(s)	Target Generic Agent Name(s)	Strength	Additional QL Information	Targeted NDCs When Exclusions Exist	Effective Date	Term Date

43995202366930		Hydrocod Polst-Chlorphen Polst Cap ER 12HR 10-8 MG		Not covered for patients less than 18 years of age.			04-01-2024
4399520236G110		Hydrocod Polst-Chlorphen Polst ER Susp 10-8 MG/5ML	10-8 MG/5ML	Not covered for patients less than 18 years of age.
43995202327430	Tuxarin er	Codeine Phos-Chlorpheniramine Maleate Tab ER 12HR 54.3-8 MG	54.3-8 MG	Not covered for patients less than 18 years of age.
4399520231G120	Tuzistra xr	Codeine Polist-Chlorphen Polist ER Susp 14.7-2.8 MG/5ML	14.7-2.8 MG/5ML	Not covered for patients less than 18 years of age.

CLIENT SUMMARY – QUANTITY LIMITS

Target Brand Agent Name(s)	Target Generic Agent Name(s)	Strength	Client Formulary
	Hydrocod Polst-Chlorphen Polst Cap ER 12HR 10-8 MG		Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
	Hydrocod Polst-Chlorphen Polst ER Susp 10-8 MG/5ML	10-8 MG/5ML	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Tuxarin er	Codeine Phos-Chlorpheniramine Maleate Tab ER 12HR 54.3-8 MG	54.3-8 MG	Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx
Tuzistra xr	Codeine Polist-Chlorphen Polist ER Susp 14.7-2.8 MG/5ML	14.7-2.8 MG/5ML	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 BOTH of the following are met: The patient is 18 years of age or older AND ONE of the following: 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 BOTH of the following are met:

The patient is 18 years of age or older AND
ONE of the following:
1. The requested quantity (dose) does NOT exceed the program quantity limit OR
2. 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 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.