Health Net buprenorphine injection Prior Auth Update

Coverage Criteria

Initial Therapy

Covered when ALL of the following are met

Initial approval - Opioid Dependence: 1) Diagnosis of opioid dependence; 2) Age >= 18 years; 3) Member meets one of: (a) switching from another non‑transmucosal buprenorphine-containing product; OR (b) has tolerated a single 4 mg dose of a transmucosal buprenorphine-containing product; for Brixadi requests, OR member is currently being treated with a transmucosal buprenorphine-containing product; for Sublocade requests, OR member is currently being treated with 8 mg to 24 mg daily of transmucosal buprenorphine; 4) Medical justification supports inability to continue transmucosal formulations as evidenced by one of: documentation of non-compliance, treatment failure, history of diversion, or contraindication/clinically significant adverse effects to excipients of transmucosal formulations; 5) Requested dose does not exceed product-specific dosing limits (see dosing criteria).

Dosing

Sublocade dosing: Initiation: two monthly initial doses of 300 mg subcutaneously (first dose on day 1, second dose between 8 days and 1 month after the first dose as indicated) followed by maintenance dosing; Maintenance: typical maintenance is 100 mg monthly but may be increased to 300 mg monthly when benefits outweigh risks; Maximum monthly dose = 300 mg.300 mg per month

Second initiation dose may be given between 8 days and 1 month per product PI.

Brixadi dosing: Options include weekly and monthly regimens per PI: weekly regimens commonly start with a transmucosal 4 mg test dose then weekly Brixadi titration to 24 mg in week one (16 mg then additional dosing) with possible escalation to 32 mg/week; monthly option: 128 mg every 28 days. Maximums: 32 mg/week or 128 mg per 28 days.128 mg every 28 days or 32 mg weekly

Weekly doses must be given in 7-day intervals; monthly doses in 28-day intervals; weekly doses cannot be combined to yield a monthly dose.

Continuation Therapy

Continued therapy (must meet all):

Continuation of therapy - Opioid Dependence: 1) Member is currently receiving medication via the benefit or has previously met initial approval criteria; 2) Member is responding positively to therapy; 3) Member has not received an analgesic since last approval or prescriber documents any opioid use during the approval period was for acute pain; 4) Requested dose does not exceed product-specific limits (see dosing criteria).

Initial Therapy

Covered when ALL of the following are met:

Initial therapy general: Member has opioid use disorder and documentation supports prior transmucosal buprenorphine exposure OR member tolerated a single 4 mg transmucosal buprenorphine test dose per product prescribing information.tolerated 4 mg test dose

See product-specific initiation protocols below.

Sublocade initiation: Initiation follows either two monthly initial doses of 300 mg subcutaneously (first dose day 1, second dose between 8 days and 1 month as needed) with subsequent maintenance dosing; patients not already receiving buprenorphine should receive a transmucosal 4 mg test dose and be observed for tolerability before the first injection per PI.max 300 mg/month

Maintenance may be increased to 300 mg/month when benefits outweigh risks.

Brixadi initiation: For patients not currently receiving buprenorphine: administer a transmucosal 4 mg test dose and observe for tolerability; then initiate weekly Brixadi titration to reach recommended 24 mg/week in week one (may escalate to 32 mg/week if needed) or initiate monthly regimens per PI; patients already on transmucosal buprenorphine may transition directly to weekly or monthly Brixadi per prescribing information.

Continuation Therapy

Covered when ALL of the following are met:

Maintenance dosing: Member is maintained on an approved dosing schedule: Sublocade maintenance commonly 100 mg monthly after initiation (may be increased to 300 mg monthly if clinically justified); Brixadi maintenance administered weekly or monthly per established dosing with dose adjustments per PI. Doses must remain within product maximums.per product max dosing limits

Dose adjustments should follow prescribing information and clinical judgment.

Approval durations follow plan and line-of-business rules; typical approval durations: Medicaid/Commercial 6 months, HIM 12 months (and 12 months for NH where applicable).12 months where applicable

See policy history for plan-specific application and regulatory exceptions.

Non‑FDA approved indications not addressed in this policy are excluded from coverage unless the provider submits sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies (see CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid) or other evidence of coverage documents. Coverage will not be provided for indications that lack the required off‑label justification and supporting clinical documentation.

Use of buprenorphine extended‑release injections for pain management is explicitly not authorized. The 1Q 2025 policy update added pain management to the list of diagnoses/indications for which coverage is not permitted, and such requests will be evaluated as excluded from this policy.

Requests for buprenorphine injection for pain management or for other non‑FDA approved indications that do not include sufficient documentation of efficacy and safety per the referenced off‑label use policies are considered not authorized. Providers must follow off‑label documentation requirements to request coverage for indications not specifically addressed by this policy.

Requests for buprenorphine injection specifically for pain management will be considered not medically necessary / not authorized. This exclusion was added in the 2025 annual review and means such requests should not be approved under this policy.

Initial Therapy Criteria (Product-Agnostic and Product-Specific)

Initial Therapy — Initial therapy criteria for opioid dependence

Initial therapy criteria for opioid dependence

Initial: Diagnosis of opioid dependence; age >= 18 years; prior transmucosal buprenorphine exposure/tolerance (e.g., tolerated a single 4 mg transmucosal test dose) OR switching from another non‑transmucosal buprenorphine product; documentation of inability to continue transmucosal formulations (non‑compliance, treatment failure, history of diversion, or contraindication/clinically significant adverse effects to excipients); requested dose within product limits.

Initial Therapy (Product-specific)

Product-specific initiation requirements

Sublocade initiation (product-specific): Patients not already receiving buprenorphine should receive a transmucosal 4 mg test dose and be observed for one hour to confirm tolerability prior to the first Sublocade injection; standard initiation is two monthly doses of 300 mg followed by 100 mg monthly maintenance, with option per PI to give the second initiation dose between 8 days and 1 month; maximum monthly dose = 300 mg.

Continuation and Maintenance Criteria

Continuation Therapy

Continuation therapy requirements for opioid dependence

Continuation: Member is responding to therapy; currently receiving medication via the benefit or previously met initial criteria; no intervening analgesic use unless documented as acute pain; requested dose within product limits per PI.

Maintenance/Continuation Therapy

Maintenance and dose-adjustment rules per product prescribing information

Sublocade maintenance: Typical maintenance is 100 mg monthly after initiation; maintenance dose may be increased to 300 mg monthly when clinical benefit outweighs risk; maximum 300 mg/month.

Brixadi maintenance: Brixadi may be given weekly or monthly per established schedules; an additional 8 mg may be given during a dosing interval based on clinical judgment up to a maximum of 32 mg/week or 128 mg/month; weekly doses must be administered in 7-day intervals and monthly doses in 28-day intervals; weekly doses cannot be combined to create a monthly dose.

Coding

Sublocade Q-codesCPTCovered

Q9991	Injection, buprenorphine extended-release (Sublocade), less than or equal to 100 mg
Q9992	Injection, buprenorphine extended-release (Sublocade), greater than 100 mg

Brixadi J-codesHCPCSCovered

J0577	Injection, buprenorphine extended release (Brixadi), less than or equal to 7 days of therapy
J0578	Injection, buprenorphine extended release (Brixadi), greater than 7 therapy days

Sublocade dosing limits

Maximum monthly doseSublocade maximum dose = 300 mg per month

Typical initiation regimenTwo monthly initial doses of 300 mg subcutaneously followed by 100 mg monthly maintenance (second injection may be given as early as week 4 to 1 month)

Maintenance adjustmentMaintenance may be increased to 300 mg monthly if clinical benefits outweigh risks

Brixadi dosing limits

Maximum weekly/monthly doseBrixadi maximum dose = 32 mg per week; 128 mg per 28 days

Weekly titrationInitiation includes a transmucosal 4 mg test dose then weekly dosing to 24 mg in week one with option to escalate to 32 mg/week

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Sublocade and Brixadi. Requests must include clinical justification that the member meets the policy criteria for treatment of opioid dependence (see policy criteria). Failure to obtain prior authorization may result in denial of coverage.

Prior authorization required for extended‑release buprenorphine injections (Sublocade, Brixadi).
HCPCS coding and billing implications apply; see Dosage and Administration and code tables in policy.

Documentation Required

Provider must submit supporting clinical documentation with the prior authorization request. Acceptable documentation includes office chart notes, laboratory results, medication administration records, and other clinical information that verify the member meets all approval criteria.

Documentation must demonstrate diagnosis of opioid dependence and relevant treatment history.

Step Therapy / Formulary Navigation

Step	Requirement	Notes / State-specific restrictions
1
Policy requires compliance with formulary/no-coverage/non‑formulary navigation or off‑label use policies prior to approval of extended‑release buprenorphine injections.
For members in Nevada, medical management techniques beyond step therapy (including quantity management beyond step) are not allowed per NV SB 439; follow applicable line-of-business no coverage or non‑formulary policies as referenced.

Step	Required evidence	Supporting documentation
1
Evidence of prior transmucosal buprenorphine exposure OR documentation that the member tolerated a single 4 mg transmucosal buprenorphine test dose.
Provider must submit chart notes or other clinical documentation confirming prior transmucosal use or observation of tolerability after a 4 mg test dose (per product prescribing information).

Quantity Limits and Available Strengths

Sublocade strengths

Available strengthsSublocade prefilled syringes: 100 mg (0.5 mL)

Available strengthsSublocade prefilled syringes: 300 mg (1.5 mL)

PresentationPrefilled subcutaneous syringes for administration by a healthcare provider

Brixadi strengths (weekly & monthly)

Weekly strengthsBrixadi prefilled single-dose syringes: 8 mg; 16 mg; 24 mg; 32 mg (weekly)

Monthly strengthsBrixadi prefilled single-dose syringes: 64 mg; 96 mg; 128 mg (monthly)

Presentation

Site of Care Requirements

Billing Rule

Site-of-care — healthcare setting required

Sublocade and Brixadi injections must be administered by healthcare providers in a healthcare setting (office, infusion center, or hospital outpatient) per the policy.

Administration settings authorized: office, infusion center, hospital outpatient.

Documentation Required

Administration requirements — REMS and avoid IV use

Injections must be administered following the REMS program requirements and product prescribing information; providers should follow REMS safeguards and avoid intravenous administration due to boxed warning risks.

Administer per REMS program requirements and PI instructions; do not administer intravenously.

Definitions

REMS

DefinitionREMS = Risk Evaluation and Mitigation Strategy

PurposeA FDA-required program to manage known or potential serious risks associated with a drug

Context in policySublocade and Brixadi are available only through restricted REMS programs (see boxed warning)

MAT

DefinitionMAT = medication-assisted treatment

ContextUsed as part of a comprehensive treatment program including counseling and psychosocial support

Acronym source

Background

Sublocade and Brixadi are extended‑release buprenorphine injections indicated as part of a comprehensive treatment program, including counseling, for the treatment of moderate to severe opioid use disorder. Both products are intended to be used under medical supervision in a healthcare setting and require prior stabilization on or demonstrated tolerability of transmucosal buprenorphine per product prescribing information.

OpenPayer

Buprenorphine Injection (Sublocade, Brixadi)

Coverage Criteria

Initial Therapy Criteria (Product-Agnostic and Product-Specific)

Continuation and Maintenance Criteria

Coding

Provider Actions and Authorization Requirements

Step Therapy / Formulary Navigation

Quantity Limits and Available Strengths

Site of Care Requirements

Definitions

Background