CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Testosterone Transdermal Gel 1%

Coverage and prior authorization criteria for testosterone transdermal gel 1% for Medicaid members, addressing use for primary/hypogonadotropic hypogonadism and gender dysphoria, and quantity limits.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTestosterone Transdermal Gel 1%

Policy CodePolicy N/A

Change TypeNo material change

Effective DateDec 1, 2017

Next Review DateN/A

Key ActionObtain prior authorization for up to 12 months after documenting required low testosterone levels and trial/intolerance/contraindication to formulary injectable testosterone.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 moauthorization period

300 g/30dmax qty 50mg/5gm

150 g/30dmax qty pump

Medicaidpayer population

Coverage Criteria for Testosterone Transdermal Gel 1%

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Primary/Hypogonadotropic Hypogonadism Criteria

The requested formulary drug is being prescribed for primary or hypogonadotropic hypogonadism (safety and efficacy for age-related/late-onset hypogonadism have not been established).
Confirmed low testosterone levels: Patient meets either: (a) before the start of testosterone therapy, the patient has at least two confirmed low testosterone levels according to current practice guidelines or standard lab reference values; OR (b) 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 standard lab reference values.
Patient has experienced an inadequate treatment response, intolerance, or contraindication to formulary injectable testosterone (testosterone cypionate or testosterone enanthate).

Operational note: Prior authorization may be granted for up to 12 months when all above criteria are documented; required documentation includes lab results and evidence of trial/intolerance/contraindication to injectable testosterone.

Gender dysphoria

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

Gender Dysphoria Criteria

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).

Operational note: Prior authorization may be granted for up to 12 months when criteria are met; documentation should include evidence of informed consent and trial/intolerance/contraindication to injectable testosterone.

Coding and Product Identifiers

Covered product GPIsmixedCovered

GPI 23100030004030	Testosterone transdermal gel 50mg/5gm (1%)
GPI 23100030004040	Testosterone transdermal gel pump 12.5mg/act (1%)

Confirmed low testosterone levels (inv-05)

RequirementAt least two confirmed low testosterone levels before start of therapy (or one confirmed level prior to start for continuation cases) according to current practice guidelines or standard lab reference values.

ApplicabilityApplies to primary or hypogonadotropic hypogonadism treatment requests; continuation cases may rely on one confirmed pre-therapy level.

Documentation standardConfirmation must follow current practice guidelines or the provider’s standard laboratory reference values.

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization: 12-month approval

Prior authorization: 12-month approval — Prior authorization may be granted for 12 months when criteria for either primary/hypogonadotropic hypogonadism or gender dysphoria are met.

Authorization of 12 months may be granted when ALL required criteria for the indicated condition are met.
Primary/hypogonadotropic hypogonadism: see documentation requirements below.
Gender dysphoria: see documentation requirements below.

Step Therapy

Step therapy: injectable testosterone required first

Step therapy: injectable testosterone required first — Members must have experienced inadequate response, intolerance, or contraindication to formulary injectable testosterone before non-injectable/formulary agents will be authorized.

Required trial: formulary injectable testosterone (testosterone cypionate or testosterone enanthate).
Step may be bypassed only if documented intolerance, contraindication, or inadequate response to injectable testosterone is provided.

Documentation Required

Required clinical documentation

Required clinical documentation — Documentation of confirmed low testosterone levels per guidelines is required prior to initiation for primary or hypogonadotropic hypogonadism; informed consent and capacity for decision-making required for gender dysphoria.

Primary or hypogonadotropic hypogonadism: at least two confirmed low testosterone levels prior to initiation per current practice guidelines, or for continuation therapy a prior confirmed low level before therapy start.
Gender dysphoria: documentation that the patient is able to make an informed decision to engage in hormone therapy.
Include clinical notes supporting diagnosis, prior treatment trials, and any documentation of intolerance or contraindication to injectable testosterone.

Denial Risk

Potential denial triggers

Potential denial triggers — Requests lacking required documentation or missing step-therapy evidence may be denied.

Missing two confirmed low testosterone levels for initiation in primary/hypogonadotropic hypogonadism.
No documentation of inadequate response, intolerance, or contraindication to formulary injectable testosterone (testosterone cypionate or enanthate).
Lack of documentation of capacity/informed decision-making for gender dysphoria.

Background

Testosterone replacement is indicated when used to treat primary or hypogonadotropic hypogonadism with documented biochemical evidence of low testosterone. Prior authorization may be granted for up to 12 months when criteria are met, including laboratory confirmation (typically at least two confirmed low testosterone levels before initiation, or a single confirmed level prior to the start of therapy for continuation cases) and documentation of inadequate response, intolerance, or contraindication to formulary injectable testosterone (testosterone cypionate or testosterone enanthate). The policy also reiterates that testosterone use for age-related (late-onset) hypogonadism lacks established safety and efficacy and is not considered an appropriate indication under these coverage criteria.

Definitions

Age-related hypogonadism (inv-11)

DefinitionAlso referred to as late-onset hypogonadism; safety and efficacy of testosterone products for this condition have not been established.

Policy noteUse of testosterone for age-related (late-onset) hypogonadism is not established and is explicitly noted in the coverage criteria.

ImplicationRequests solely for age-related hypogonadism should reference the policy’s exclusionary language and may not meet criteria for approval.

Gender dysphoria — informed decision (inv-12)

Authorization conditionPatient is able to make an informed decision to engage in hormone therapy as a condition for authorization.

ContextThis requirement applies to requests for testosterone for gender dysphoria as part of the coverage criteria.

Related requirementIn addition to informed decision capacity, patient must have inadequate response, intolerance, or contraindication to formulary injectable testosterone for approval.