CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Testosterone Transdermal Gel 1%

Policy governs prior authorization and coverage criteria for testosterone transdermal gel 1% for Medicaid members, specifying indications (primary or hypogonadotropic hypogonadism and gender dysphoria), required laboratory confirmation, prior trial requirements, and quantity limits.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTestosterone Transdermal Gel 1%

Policy CodePolicy N/A

Change TypeReviewed / Revised

Effective DateDec 1, 2017

Next Review Date

Key ActionPrior authorization is required; approvals may be granted for 12 months when the specific clinical criteria for the indication are met.

POLICY UPDATE CHANGES

Policy revised on 12/2019 and subsequent reviews through 4/2025 noted.

2Covered Indications

12 monthsAuthorization Duration

300 gm / 150 gmQuantity Limits (per 30 days)

Coverage Summary

Policy governs prior authorization and coverage criteria for testosterone transdermal gel 1% for Medicaid members, specifying indications for primary or hypogonadotropic hypogonadism and gender dysphoria, required laboratory confirmation of low testosterone, prior trial or intolerance to formulary injectable testosterone, and quantity limits. Authorization may be granted for 12 months. Safety and efficacy have not been established for age-related (late-onset) hypogonadism. Effective date: 2017-12-01; Last review: 2025-04-01.

A. Primary or hypogonadotropic hypogonadism

Authorization of 12 months may be granted when all the following criteria are met:

ALL of the following

The requested formulary drug is being prescribed for primary or hypogonadotropic hypogonadism
Safety and efficacy not established for age-related (late-onset) hypogonadism
Patient meets either of the following
- Before the start of testosterone therapy, the patient has at least two confirmed low testosterone levels according to current practice guidelines or your standard lab reference valuesAt least two confirmed low testosterone levels before therapy per current practice guidelines or standard lab reference values
- For continuation of testosterone therapy: before the patient started testosterone therapy, the patient had a confirmed low testosterone level according to current practice guidelines or your standard lab reference valuesFor continuation: one confirmed low testosterone level per current practice guidelines or standard lab reference values
Patient has experienced an inadequate treatment response, intolerance or contraindication to formulary injectable testosterone (testosterone cypionate or testosterone enanthate)

B. Gender dysphoria

Authorization of 12 months may be granted when all of the following criteria are met:

ALL of the following

The requested formulary drug is being prescribed for gender dysphoria in a patient who is able to make an informed decision to engage in hormone therapy
Patient has experienced an inadequate treatment response, intolerance or contraindication to formulary injectable testosterone (testosterone cypionate or testosterone enanthate)

Provider Actions & Requirements

Prior Authorization

Authorization required for 12 months

Prior authorization is required; approvals may be granted for 12 months when the specific clinical criteria for the indication are met.

Documentation Required

Laboratory confirmation required

Provider must document at least two confirmed low testosterone levels before initiation (or one if continuation) consistent with current practice guidelines or standard lab reference values.

At least two confirmed low testosterone levels before therapy (or one if continuation) per current practice guidelines or standard lab reference values

Documentation Required

Prior trial of injectable testosterone required

Provider must document inadequate response, intolerance, or contraindication to formulary injectable testosterone (testosterone cypionate or testosterone enanthate) prior to approval.

Billing Rule

Quantity limits

Adhere to quantity limits per brief.

GPI 23100030004030 — 300 gm per 30 days
GPI 23100030004040 — 150 gm per 30 days

Clinical Evidence & Guidelines Referenced

Key guidelines referenced: Endocrine Society 2018; American Association of Clinical Endocrinologists (AACE) 2002; Endocrine Society guideline for gender dysphoria 2017; product labeling Androgel 1% (November 2020). The policy explicitly states that safety and efficacy are not established for age-related (late-onset) hypogonadism.

Background

This policy covers testosterone transdermal gel 1% when prescribed for primary or hypogonadotropic hypogonadism and for gender dysphoria. For primary or hypogonadotropic hypogonadism, authorization of 12 months may be granted when the patient has at least two confirmed low testosterone levels before initiation (or a prior confirmed low level for continuation) per current practice guidelines or standard lab reference values, and the patient has experienced inadequate response, intolerance, or contraindication to formulary injectable testosterone (testosterone cypionate or testosterone enanthate). For gender dysphoria, authorization of 12 months may be granted when the patient can make an informed decision to engage in hormone therapy and has had an inadequate response, intolerance, or contraindication to formulary injectable testosterone. Quantity limits apply: 300 g/30 days for gel 50mg/5gm (GPI 23100030004030) and 150 g/30 days for pump 12.5mg/act (GPI 23100030004040). Safety and efficacy are not established for age-related (late-onset) hypogonadism.

Policy scopePolicy governs prior authorization and coverage criteria for testosterone transdermal gel 1% for Medicaid members, specifying indications (primary or hypogonadotropic hypogonadism and gender dysphoria), required laboratory confirmation, prior trial requirements, and quantity limits.

Authorization duration12 months

Quantity limits (per 30 days)300 gm (50mg/5gm gel) / 150 gm (pump 12.5mg/act)

Revision History

2017-12-01effective_date

Policy effective date

2018-07revision

Policy revised

2019-12revision

Policy revised

2019-12-01review

Policy reviewed

2020-07-01review

Policy reviewed

2021-05-01review

Policy reviewed

2022-04-01review

Policy reviewed

2023-04-01review

Policy reviewed

2024-05-01review

Policy reviewed

2025-04-01reviewLatest

Most recent policy review

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTestosterone Transdermal Gel 1%

Policy CodePolicy N/A

Change TypeReviewed / Revised

Effective DateDec 1, 2017

Next Review Date

Key ActionPrior authorization is required; approvals may be granted for 12 months when the specific clinical criteria for the indication are met.

On This Page

OpenPayer

Testosterone Transdermal Gel 1%

Coverage Summary

Provider Actions & Requirements

Applicable Codes

Clinical Evidence & Guidelines Referenced

Background

Revision History

GPI 23100030004030	Testosterone transdermal gel 50mg/5gm (1%) - 300 gm / 30 days
GPI 23100030004040	Testosterone transdermal gel pump 12.5mg/act (1%) - 150 gm / 30 days