CurrentMass General Brigham Health PlanPolicy N/A

Testosterone Products - Step-Therapy and Coverage

This policy governs prior authorization, step-therapy, and benefit assignment for testosterone products under the payer's pharmacy and medical benefits and applies to plan members and prescribers covered by Mass General Brigham Health Plan.

Policy Summary

PayerMass General Brigham Health Plan

PolicyTestosterone Products - Step-Therapy and Coverage

Policy CodePolicy N/A

Change TypeStep-therapy additions (second-line agents added)

Effective DateApr 1, 2023

Next Review DateN/A

Key ActionObtain prior authorization for second-line testosterone products unless the member has documented trials of two different first-line products or other step-therapy criteria are met.

SourceLink

POLICY UPDATE CHANGES

Kyzatrex (testosterone undecanoate) was added to the step-therapy program as a second-line agent.

Xyosted (testosterone enanthate) auto-injector and Tlando (testosterone undecanoate) were added as second-line agents in prior updates.

First vs SecondStep-therapy tiers defined

>=2First-line trials required

180Lookback period (days)

Medical BenefitTestopel coverage

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Coverage Criteria for Testosterone Products

Step-therapy coverage criteria

Covered when the step-therapy logic is satisfied

Step therapy logic: Approval for a second-line testosterone medication is granted when EITHER: (1) the member has filled at least two different first-line testosterone medications within the past 180 days OR (2) the member has filled a second-line testosterone medication within the past 180 days OR (3) there is documented inadequate response or side effects to at least two different first-line testosterone products OR (4) there is documented clinical rationale to avoid all first-line agents.two different first-line products or 180 days lookback

First-line agents are covered without prior authorization; second-line requires prior authorization unless criteria met

Testopel (testosterone pellets) is assigned to the Medical Benefit and is not managed under the pharmacy step-therapy program. Providers should submit claims and authorization requests consistent with medical benefit processes and refer to the Medical Specialty Drug list criteria for coverage details.

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Second-line medications require prior authorization unless the member meets the step-therapy lookback requirements. Prior authorization is required when the member has not documented trials of the required first-line agents within the prior 180 days.

Lookback period: 180 days
Second-line agents pay only after meeting trials or approved override

Step Therapy

Initial Step-Therapy Requirements

First-line agents are covered without prior authorization. Second-line agents require either documented trials of first-line products (see lookback details) or an approved clinical rationale to avoid first-line therapy.

First-line = covered without PA
Second-line = PA required unless lookback satisfied or override approved

Documentation Required

Required Documentation for Overrides

To approve an override of step-therapy, the provider must document either: (1) dates and names of at least two different first-line testosterone products tried within the prior 180 days with evidence of inadequate response or intolerable side effects, OR (2) a clear clinical rationale explaining why all first‑line agents are contraindicated or must be avoided for this patient.

Document trial details: product names and dates (minimum two different first-line products)
Or provide clinical rationale to avoid all first-line agents (e.g., allergy, drug interaction, intolerance)
Testopel is covered under the Medical Benefit — refer to Medical Specialty Drug list criteria when applicable

Denial Risk

Denial Triggers for Step-Therapy

If required trials (two different first-line products within the 180-day lookback) are not documented, the request for a second-line medication will be denied. Failure to provide adequate trial documentation or a sufficient clinical rationale is a denial trigger.

Denial trigger: no documentation of two first-line trials within 180 days
Denial trigger: insufficient clinical rationale to avoid first-line agents

Definitions and Product Tiers

First-line testosterone products

Testosterone enanthate injectionCovered as a first-line agent (no prior authorization required)

Testosterone cypionate injectionCovered as a first-line agent (no prior authorization required)

Testosterone topical gel 1% (AndroGel/Testim)Covered as a first-line agent (no prior authorization required)

Testosterone topical gel pump 1% (Vogelxo)Covered as a first-line agent (no prior authorization required)

Testosterone topical gel 2% (Fortesta)Covered as a first-line agent (no prior authorization required)

Testosterone topical gel 1.62% (AndroGel Pump 1.62%)Covered as a first-line agent (no prior authorization required)

Second-line testosterone products

Testosterone topical solution 30 mg (Axiron)Designated second-line — requires prior authorization unless step-therapy criteria are met

Jatenzo (testosterone undecanoate)Designated second-line — requires prior authorization unless step-therapy criteria are met

Kyzatrex (testosterone undecanoate)Designated second-line — requires prior authorization unless step-therapy criteria are met

Tlando (testosterone undecanoate)Designated second-line — requires prior authorization unless step-therapy criteria are met

Xyosted (testosterone enanthate) auto-injectorDesignated second-line — requires prior authorization unless step-therapy criteria are met

Initial Therapy and First-Line Agents

First-Line agents

Medications listed as first-line are covered without prior authorization.

First-line coverage: Medications listed as first-line are covered without prior authorization.

Members must trial first-line agents prior to approval of listed second-line agents unless other step-therapy criteria are met.

Step-Therapy Operational Rules

Lookback period	Required prior trials (to approve a second-line agent)	Timing / operational rules
180 days
Either: (1) at least two different first-line testosterone medications filled within the prior 180 days; OR (2) a filled second-line testosterone medication within the prior 180 days; OR documented inadequate response or side effects to at least two different first-line products; OR documented clinical rationale to avoid all first-line agents.
First-line agents are covered without prior authorization. Second-line agents require prior authorization unless step-therapy criteria above are met. Documentation (dates and products of prior trials or clinical rationale) is required to approve overrides. Failure to document required trials within the 180-day lookback may result in denial. Program updates (e.g., additions of second-line agents such as Jatenzo, Tlando, Xyosted, Kyzatrex) took effect per review history.

Background

Testosterone replacement therapy treats androgen deficiency and is available in multiple formulations, including injections, topical gels and solutions, auto-injectors, oral undecanoate products, and subcutaneous pellets. The policy groups formulations into first-line and second-line tiers to encourage use of preferred products before higher-tier agents. First-line agents (examples: testosterone enanthate and cypionate injections and several topical gels/pumps) are covered without prior authorization. Second-line formulations (examples: topical solution such as Axiron, certain gels, oral undecanoate products like Jatenzo/Kyzatrex/Tlando, and the Xyosted auto-injector) require prior authorization unless step-therapy criteria are met.