CurrentColorado Rocky Mountain Health PlansPolicy N/A

Coverage criteria for Buprenorphine/Naloxone films, buprenorphine sublingual tablets, Zubsolv, and Lucemyra (lofexidine)

Prior authorization/medical necessity form and coverage criteria for buprenorphine/naloxone sublingual films and Zubsolv, buprenorphine sublingual tablets (when unable to use film), and lofexidine (Lucemyra) for opioid withdrawal; documents required prescriber attestation and specific clinical justification and duration limits for certain indications.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyCoverage criteria for Buprenorphine/Naloxone films, buprenorphine sublingual tablets, Zubsolv, and Lucemyra (lofexidine)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateMar 1, 2024

Next Review Date

Key ActionProvider must indicate which justification applies for non-preferred products and provide supporting clinical details on the prior authorization form.

POLICY UPDATE CHANGES

No material changes to clinical coverage or criteria

3Drug groups covered

7Justification categories for film/Zubsolv

7Therapy length options (days)

Coverage Summary

This policy is a prior authorization/medical necessity form and coverage criteria for buprenorphine/naloxone sublingual films and Zubsolv, buprenorphine sublingual tablets (when unable to use film), and lofexidine (Lucemyra). It is covered with criteria: approval requires documentation of the specific clinical justification selected on the form and any required attestations. The three drug groups covered are buprenorphine/naloxone SL films and Zubsolv; buprenorphine sublingual tablets used when film cannot be used; and Lucemyra (lofexidine) for opioid withdrawal.

Medical Necessity Criteria

Coverage criteria for Buprenorphine/Naloxone SL Films and Zubsolv

Covered when ANY one of the following justification criteria is met and documented:

ANY of the following

Failed one preferred drug
Provider must list drug and indicate reason (allergic reaction, drug-drug interaction, unacceptable side effect or therapeutic failure)
Allergic reaction to preferred drug(s)
Describe reaction
Drug-to-drug interaction with preferred drug(s)
Describe interaction
Previous episode of unacceptable side effect or therapeutic failure with preferred drug(s)
Provide clinical information
Clinical contraindication, co-morbidity, or unique patient circumstance that contraindicates preferred drug(s)
Provide clinical information
Age specific indications requiring an alternative
Provide patient age and explanation
Unique clinical indication supported by FDA approval or peer-reviewed literature
Explain and provide reference
Unacceptable clinical risk associated with therapeutic change
Explain

Coverage criteria for Buprenorphine Sublingual Tablets (when unable to use Suboxone film)

Covered when ALL of the following are met:

ALL of the following

Beneficiary has a diagnosis of Opioid Dependence
Patient unable to use Suboxone Film due to one or more of
- Beneficiary is pregnantMax Length of Therapy is 270 Days
  Provide estimated due date
- Beneficiary is breastfeedingMax Length of Therapy is 60 Days (can be renewed)

Coverage criteria for Lucemyra (lofexidine) tablets

Covered when ALL of the following are met:

ALL of the following

Beneficiary has a diagnosis of opioid withdrawal symptoms
Trial and failure of preferred agents are not required

Provider Actions & Prior Authorization

Prior Authorization

Submit clinical justification for non-preferred product

Provider must indicate which justification applies and provide supporting clinical details on the form. The prescriber should select the applicable reason for avoiding the preferred product and document relevant clinical information.

Failed one preferred drug
Allergic reaction to preferred drug(s)
Drug-to-drug interaction with preferred drug(s)
Previous unacceptable side effect or therapeutic failure with preferred drug(s)
Clinical contraindication, co-morbidity, or unique patient circumstance
Age-specific indication requiring an alternative
Unique clinical indication supported by FDA approval or peer‑reviewed literature
Unacceptable clinical risk associated with therapeutic change

Prior Authorization

Documentation for buprenorphine sublingual tablets when film unusable

For buprenorphine sublingual tablets when the film is unusable, the prescriber must document a diagnosis of opioid dependence, specify the reason the Suboxone film cannot be used (select pregnancy with estimated due date, breastfeeding, naloxone allergy, or other), and confirm they reviewed the Controlled Substances Reporting System prior to prescribing.

Documentation Required

Prescriber signature and patient identifiers required

Prescriber signature is mandatory on the form. The prescriber must include required beneficiary and prescription identifiers.

Beneficiary name
Beneficiary ID number
Beneficiary date of birth
Beneficiary gender
Drug name
Strength
Quantity per 30 days
Length of therapy (in days)
Prescribing provider NPI

Billing Rule

Therapy length selection required

Provider must select the requested length of therapy on the prior authorization form from the allowed options.

Up to 30 days
60 days
90 days
120 days
180 days
270 days
365 days

Background

This form-style policy defines clinical reasons to approve non-preferred buprenorphine formulations and lofexidine and requires the prescriber to indicate which justification applies and provide supporting clinical details. For buprenorphine/naloxone SL Films and Zubsolv, acceptable justifications include: failed one preferred drug; allergic reaction to a preferred drug; drug-to-drug interaction with a preferred drug; previous unacceptable side effect or therapeutic failure; clinical contraindication, co-morbidity, or unique patient circumstance; age-specific indication; unique clinical indication supported by FDA approval or peer-reviewed literature; or unacceptable clinical risk associated with therapeutic change. The provider must list the specific drug and describe the reaction or clinical details on the form.

For buprenorphine sublingual tablets (used only when the film cannot be used), the prescriber must document a diagnosis of opioid dependence, specify the reason the Suboxone film is unusable (options include pregnancy with estimated due date, breastfeeding, naloxone allergy, or other), confirm review of the Controlled Substances Reporting System database prior to writing the prescription to ensure no concomitant opioid use, and attest that the maximum daily buprenorphine dose is ≤ 32 mg/day. Duration limits for these special circumstances are: pregnancy – Max Length of Therapy is 270 days; breastfeeding – Max Length of Therapy is 60 days (can be renewed); naloxone allergy – Max Length of Therapy is 365 days. The prescriber must sign the form and provide patient identifiers, drug details, and select the requested length of therapy from the listed options.

Controlled Substances Reporting System: State prescription drug monitoring program which prescriber must review prior to writing buprenorphine tablets to ensure no concomitant opioid use.