Pharmacy Benefit Coverage Criteria Effective Date ............................................ 9/1/2021 Next Review Date… ..................................... 9/1/2022 Coverage Policy Number ................................ P0083 Antitussives Table of Contents Related Coverage Resources Medical Necessity Criteria ................................... 1 Opioid Therapy FDA Approved Indications ................................... 3 Recommended Dosing ........................................ 5 Background .......................................................... 6 References .......................................................... 7 INSTRUCTIONS FOR USE The following Coverage Policy applies to health benefit plans administered by Cigna Companies. Certain Cigna Companies and/or lines of business only provide utilization review services to clients and do not make coverage determinations. References to standard benefit plan language and coverage determinations do not apply to those clients. Coverage Policies are intended to provide guidance in interpreting certain standard benefit plans administered by Cigna Companies. Please note, the terms of a customer’s particular benefit plan document [Group Service Agreement, Evidence of Coverage, Certificate of Coverage, Summary Plan Description (SPD) or similar plan document] may differ significantly from the standard benefit plans upon which these Coverage Policies are based. For example, a customer’s benefit plan document may contain a specific exclusion related to a topic addressed in a Coverage Policy. In the event of a conflict, a customer’s benefit plan document always supersedes the information in the Coverage Policies. In the absence of a controlling federal or state coverage mandate, benefits are ultimately determined by the terms of the applicable benefit plan document. Coverage determinations in each specific instance require consideration of 1) the terms of the applicable benefit plan document in effect on the date of service; 2) any applicable laws/regulations; 3) any relevant collateral source materials including Coverage Policies and; 4) the specific facts of the particular situation. Coverage Policies relate exclusively to the administration of health benefit plans. Coverage Policies are not recommendations for treatment and should never be used as treatment guidelines. In certain markets, delegated vendor guidelines may be used to support medical necessity and other coverage determinations. Medical Necessity Criteria This policy addresses coverage criteria for the following antitussive products: • Benzonatate 150 mg capsules • Opioid-containing cough suppressant regimens • TussiCapsTM (hydrocodone polistirex/chlorpheniramine polistirex) capsules Standard / Performance Plans Value / Advantage Plans Cigna Total Savings Plans Legacy Plans Hycodan Individual is 18 years of age or older AND day supply is greater than or equal to 21 (hydrocodone- days, then ALL of the following: homatropine) • Documented symptomatic relief of cough • Documented failure/inadequate response, contraindication per FDA label, Hydrocodone- intolerance, or not a candidate for nonopioid pharmacologic therapies intended to Chlorpheniramine- treat cough (for example, benzonatate*, dextromethorphan) Pseudoephedrine *May be subject to prior authorization. Page 1 of 7 Pharmacy Benefit Clinical Criteria: P0083 Hydrocodone bitrate- Chlorpheniramine maleate Hydrocodone polistirex- Chlorpheniramine polistirex Hydrocodone- Guaifenesin Hydrocodone- Homatropine Promethazine- Codeine Promethazine- Phenylepherine- Codeine Tuxarin ER (chlorpheniramine maleate-codeine phosphate) Tuzistra XR (chlorpheniramine polistirex-codeine polistirex) Coverage for the following products varies across plans: • Benzonatate 150 mg capsules • TussiCapsTM (hydrocodone polistirex/chlorpheniramine polistirex) capsules Refer to the customer’s benefit plan document for coverage details. Where coverage requires the use of preferred products, the following criteria apply: For Employer Group Plans: Standard / Performance Plans Value / Advantage Plans Cigna Total Savings Plans Legacy Plan Benzonatate 150 All of the following mg • Documented intolerance to BOTH of the following: o Benzonatate 100 mg capsule o Benzonatate 200 mg capsule Page 2 of 7 Pharmacy Benefit Clinical Criteria: P0083 Standard / Performance Plans Value / Advantage Plans Cigna Total Savings Plans Legacy Plan TussiCapsTM ALL of the following: (hydrocodone • Individual is 18 years of age or older polistirex / • Documented symptomatic relief of cough chlorpheniramine • Documented failure/inadequate response, contraindication per FDA label, polistirex) intolerance, or not a candidate for nonopioid pharmacologic therapies intended to treat cough (for example, benzonatate*, dextromethorphan) • Documented failure/inadequate response, contraindication per FDA label, intolerance, not a candidate for, or inability to use to ONE of the following: o chlorpheniramine/hydrocodone extended release suspension* o promethazine/codeine syrup* o Tuzistra XR (codeine/chlorpheniramine polistirex) extended release suspension* *May be subject to prior authorization Use of opioid-containing cough suppressants is considered not medically necessary if under the age of 18. Initial and reauthorization is up to 3 months unless otherwise stated. When coverage is available and medically necessary, the dosage, frequency, duration of therapy, and site of care should be reasonable, clinically appropriate, and supported by evidence-based literature and adjusted based upon severity, alternative available treatments, and previous response to therapy. Opioid-containing cough suppressant regimens are considered experimental, investigational or unproven for ANY other use. Note: Receipt of sample product does not satisfy any criteria requirements for coverage *If you’re a Cigna provider, please log in to the Cigna for Health Care Professionals website and search for specific patients to view their covered medications. FDA Approved Indications FDA Approved Indication FDA Safety Communication In January 2018, the FDA issued a drug safety communication restricting the use of prescription codeine and hydrocodone pain and cough medicines in children. The FDA required safety labeling changes for all cough and cold medicines containing codeine or hydrocodone to limit the use of these products to adults 18 years and older stating the risks of these medicines outweigh their benefits in children younger than eighteen. FDA gave an additional directive that all products are required to have a Boxed Warning regarding the risks of misuse, abuse, addiction, overdose, death , and slowed or difficult breathing (FDA website, 2018). Tussicaps’ product label has not yet been updated to reflect these FDA requirements. Brand Name Approved Indication Benzonatate Indicated for the symptomatic relief of cough. Hydrocodone- Indicated for the temporary relief of cough and upper respiratory symptoms, including Chlorpheniramine- nasal congestion, associated with allergy or the common cold in patients 18 years of Pseudoephedrine age and older. Limitations of Use: Page 3 of 7 Pharmacy Benefit Clinical Criteria: P0083 Brand Name Approved Indication • Not indicated for pediatric patients under 18 years of age • Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve hydrocodone-CPM-pseudoephedrine for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made Hydrocodone Indicated for the temporary relief of cough and upper respiratory symptoms associated polistirex- with allergy or the common cold in patients 18 years of age and older. Chlorpheniramine polistirex Limitations of Use: • Not indicated for pediatric patients under 18 years of age • Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve hydrocodone-chlorpheniramine extended-release for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made Hydrocodone Indicated for the temporary relief of cough and upper respiratory symptoms associated bitrate- with allergy or the common cold in patients 18 years of age and older. Chlorpheniramine maleate Limitations of Use: • Not indicated for pediatric patients under 18 years of age • Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve hydrocodone-chlorpheniramine for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made Hydrocodone- Indicated for the symptomatic relief of cough and to loosen mucus associated with the Guaifenesin common cold in patients 18 years of age and older. Limitations of Use: • Not indicated for pediatric patients under 18 years of age • Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve hydrocodone-guaifenesin for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made Hydrocodone- Indicated for the symptomatic relief of cough in patients 18 years of age and older. Homatropine Limitations of Use: • Not indicated for pediatric patients under 18 years