CurrentCignaPolicy IP0586

Non-covered antitussive products (specific opioid and nonopioid cough medicines)

Defines medical necessity criteria and authorization rules for formulary exceptions to specified non-covered antitussive products for members of Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyNon-covered antitussive products (specific opioid and nonopioid cough medicines)

Policy CodePolicy IP0586

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionObtain prior authorization and document required prior therapies and failures or contraindications as specified for the requested product.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

~15 productslisted non-covered antitussive products

18+minimum age for most covered indications

3 moauthorization duration (initial)

3 moauthorization duration (reauthorization)

Fail 2 nonopioidscommon prerequisite for opioid-containing products

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Coverage Criteria

Initial Therapy — Covered when ALL of the following product-specific criteria are met

Covered when ALL of the following product-specific criteria are met (criteria vary by product):

Benzonatate 150 mg: Documented failure or intolerance to BOTH benzonsatate 100 mg capsule and benzontate 200 mg capsule.both

See FDA labeling for age/dosing; policy requires failure of both listed strengths before approval.

Hycodan (hydrocodone-homatropine) and listed hydrocodone/codeine combination products: 1) Age 18 years or older; AND 2) Documented failure, contraindication, or intolerance to TWO nonopioid pharmacologic therapies intended to treat cough (examples: benzonatate 100 mg or 200 mg, promethazine/dextromethorphan).age >=18 AND failed 2 nonopioids

Applies to the hydrocodone- and codeine-containing products listed in the policy (e.g., hydrocodone–chlorpheniramine, hydrocodone–guaifenesin, promethazine–codeine, TussiCaps, Tuxarin ER, Tuzistra XR).

Continuation Therapy — Reauthorization (Continuation) criteria

Reauthorization (Continuation) criteria:

Reauthorization: Initial medical necessity criteria from the initial approval remain met AND there is documentation of beneficial response to the therapy.beneficial response documented

Reauthorization approval duration: up to 3 months.

Conditions Not Covered

Not covered when:

Experimental/Unproven Uses: Any other use is considered experimental, investigational, or unproven.N/A

Such uses may be denied as not medically necessary.

Any use of the listed antitussive products other than the indications and criteria specified in this policy is considered experimental, investigational, or unproven and is not covered.

Uses that fall outside the specified indications and the medical necessity criteria outlined in this policy are considered not medically necessary (i.e., experimental or investigational) and may be denied.

Initial Therapy — Product-specific Criteria

Initial Therapy Criteria — product-specific initial criteria

Product-specific initial criteria

Benzonatate 150 mg initial: Documented failure or intolerance to BOTH benzontate 100 mg and benzontate 200 mg.both failed

Policy specifies failure of both strengths prior to approval.

Opioid-containing combination products initial: Age 18 years or older AND documented failure, contraindication, or intolerance to TWO nonopioid pharmacologic therapies intended to treat cough (examples include benzonatate 100 mg or 200 mg, promethazine/dextromethorphan).age >=18 AND 2 nonopioid failures

Applies to listed hydrocodone- and codeine-containing products in the policy.

Provider Actions and Requirements

Prior Authorization

Prior Authorization Requirement

Prior authorization is required for formulary exceptions to the listed non-covered antitussive products. Approval is granted only when the applicable medical necessity criteria (see Medical Necessity Criteria) are met and required documentation is provided.

Applies to formulary exception requests for non-covered antitussive products

Step Therapy

Step Therapy Requirement

For most opioid-containing antitussive products, step therapy applies. The individual must have documented failure, contraindication, or intolerance to two nonopioid pharmacologic therapies intended to treat cough (for example, benzonatate 100 mg or 200 mg, promethazine / dextromethorphan) before opioid-containing options will be approved.

Step therapy requires trial of TWO nonopioid therapies
Examples: benzonatate 100 mg or 200 mg, promethazine / dextromethorphan

Documentation Required

Required Documentation

Providers must submit documentation demonstrating that the medical necessity criteria are met. For initial requests, include age, diagnoses, prior therapies tried (with dates and reasons for failure/ intolerance/contraindication), and clinical rationale for the requested agent. For reauthorization/continuation, documentation must show the above medical necessity criteria are met AND there is documentation of beneficial response to the therapy.

Initial requests: patient age, diagnosis, prior nonopioid therapies tried with dates and reasons for failure/contraindication/intolerance, clinical rationale
Reauthorization: documentation of beneficial response and continued fulfillment of medical necessity criteria

Denial Risk

Conditions Not Covered

Any use of these products outside the specified covered indications is considered experimental, investigational or unproven and may be denied.

Off-label or other uses not listed in the covered indications are not supported

Step Therapy Requirements

Requirement	Details
Step therapy requirement	Must be documented for approval of most opioid-containing antitussive products: documented failure, contraindication, or intolerance to TWO nonopioid pharmacologic therapies intended to treat cough (examples: benzonatate 100 mg or 200 mg, promethazine/dextromethorphan).
Age criterion	For opioid-containing products (most hydrocodone- and codeine-containing preparations listed), individual must be age 18 years or older.
Product-specific exception (benzonatate 150 mg)	Benzonatate 150 mg requires documented failure or intolerance to BOTH benzonatate 100 mg and benzonatate 200 mg prior to approval.

Definitions

Antitussive products — Definition and key examples

DefinitionPrescription medicines indicated for symptomatic relief of cough and associated upper respiratory symptoms (includes benzonatate; hydrocodone- and codeine-containing preparations and listed combination products).

Examples (listed products)Benzonatate (100 mg, 150 mg, 200 mg); Hydrocodone-containing combinations (e.g., hydrocodone-chlorpheniramine-pseudoephedrine; hydrocodone-guaifenesin; hydrocodone-homatropine; hydrocodone polistirex combinations such as TussiCaps; Tuxarin ER; Tuzistra XR); Promethazine-codeine and promethazine-phenylephrine-codeine products.

FDA age restrictionUse of codeine- or hydrocodone-containing cough and cold products is limited to adults 18 years and older per FDA safety communication (January 2018).

Clinical roleUsed for symptomatic relief of cough and temporary relief of upper respiratory symptoms such as nasal congestion associated with allergy or the common cold (per FDA labeling).

Safety noteFDA requires Boxed Warning on codeine- and hydrocodone-containing products about risks of misuse, abuse, addiction, overdose, death, and respiratory depression.