ModifiedEmblemHealthPolicy MG.MM.PH.134

Aveed (testosterone undecanoate) Intramuscular

Clinical coverage criteria and authorization requirements for Aveed (testosterone undecanoate) intramuscular injections for adult males with testosterone deficiency and for gender-dysphoria indications, as applied by EmblemHealth and ConnectiCare.

Policy Summary

PayerEmblemHealth

PolicyAveed (testosterone undecanoate) Intramuscular

Policy CodePolicy MG.MM.PH.134

Change TypeMaterial revisions — added ICD‑10 gender identity codes, REMS requirement, dosing limits for gender dysphoria, and updated diagnostic/renewal criteria

Effective Date

Next Review DateFeb 18, 2025

Key ActionSubmit prior authorization with evidence of prescriber AVEED REMS enrollment, baseline labs (testosterone, PSA, CBC, lipids), diagnostic confirmation, and prior trial documentation.

SourceLink

POLICY UPDATE CHANGES

Addition to ICD Codes including F64.0, F64.1, F64.2, F64.8, F64.9.

Addition of dosing limits for Gender Dysphoria: 1500 billable units at weeks 0 and 6 initially, then every 12 weeks thereafter.

Dosing limits for Gender Dysphoria: 1500 billable units at weeks 0 and 6 then every 12 weeks thereafter.

Universal Criteria requiring prescriber enrollment in the AVEED REMS Program, single androgen agent only, and baseline/periodic measurement of hemoglobin, hematocrit, and lipids.

Primary/hypogonadotropic hypogonadism criteria updated to require prescriber is or consults with an endocrinologist or urologist; exclusion of age-related hypogonadism; baseline PSA must be ≤ 4.0 ng/mL.

Initial testosterone diagnostic requirement changed from two confirmed low morning totals to a single pre-treatment morning total < 300 ng/dL or free testosterone < 50 pg/mL.

Renewal criteria updated to require absence of unacceptable toxicity and testosterone levels not exceeding the upper limit of normal within preceding 28 days, plus improvement in signs/symptoms and PSA change limits.

6 monthsinitial authorization length

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

renewal authorization length

<300 ng/dLpre-treatment testosterone threshold

≤4.0 ng/mLbaseline PSA max

1500 unitsgender dysphoria dosing limit

J3145applicable HCPCS code

Coverage Criteria for Aveed (testosterone undecanoate)

Initial Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met

Universal criteria: 1) Prescriber is enrolled in the AVEED REMS Program; 2) Patient will receive only one androgen/anabolic agent; 3) Baseline and periodic measurement of hemoglobin, hematocrit, and lipid concentrations are documented.

See policy Universal Criteria

Primary and hypogonadotropic hypogonadism criteria: A) Member is at least 18 years of age; B) Prescribed by, or in consultation with, an endocrinologist or urologist; C) Patient does not have age-related hypogonadism; D) Baseline PSA ≤ 4.0 ng/mL; E) Pre-treatment morning total testosterone < 300 ng/dL (or below lab lower limit of normal); F) Signs and symptoms consistent with hypogonadism (e.g., low libido, decreased morning erections, loss of body hair, low bone mineral density, gynecomastia, small testes); G) Diagnosis confirmed by either a repeat morning total testosterone (as above) OR pre-treatment free testosterone < 50 pg/mL (or below lab lower limit of normal); H) Inadequate response, contraindication, or intolerance to a ≥3-month trial of a topical testosterone agent; I) Inadequate response, contraindication, or intolerance to a ≥3-month trial of an alternative injectable agent (testosterone cypionate or enanthate).

See policy Initial Criteria details

Gender-dysphoria / gender-incongruent persons criteria: A) For patients <18 years: Tanner stage ≥ 2; B) Diagnosis of gender dysphoria confirmed by a qualified mental health professional or DSM-V-TR criteria; C) Qualified mental health professional documents persistence, addressed coexisting issues, and capacity to consent; D) Patient informed of irreversible effects and potential loss of fertility and options to preserve fertility; E) Informed consent obtained and guardians involved as applicable; F) Adolescents received pubertal suppression where indicated (GnRH analogues) prior to testosterone when appropriate; G) For adolescents, pediatric endocrinologist or clinician experienced in pubertal induction confirms indication and absence of medical contraindications.

See policy Other Uses with Supportive Evidence

Continuation/Renewal Therapy — Renewal covered when ALL of the following are met

Renewal covered when ALL of the following are met

Renewal requirements: 1) Patient continues to meet initial approval criteria; 2) Absence of unacceptable toxicity from the drug (examples include serious POME reactions and anaphylaxis, prostatic hypertrophy/carcinoma, polycythemia, venous thromboembolism, azoospermia, myocardial infarction, stroke, edema with/without congestive heart failure in those with preexisting disease, gynecomastia, hepatic dysfunction, sleep apnea, severe lipid changes, hypercalcemia, signs of abuse or dependence); 3) Patient's testosterone levels within the preceding 28 days do not exceed the upper limit of normal for the testing laboratory (generally mid-range targeted); 4) Improvement in signs and symptoms of hypogonadism; 5) Patient has not had a PSA increase > 1.4 ng/mL above baseline and absolute PSA is not > 4.0 ng/mL.

See policy Renewal Criteria for monitoring intervals

Initial Therapy (alternate/related criteria) — Covered when ALL of the following are met:

Covered when ALL of the following are met:

Universal criteria added per revision history

Diagnostic criteria: Pre-treatment morning total testosterone < 300 ng/dL (or below the testing laboratory's lower limit of normal) OR pre-treatment free testosterone < 50 pg/mL (or below lab lower limit); AND signs and symptoms consistent with hypogonadism (e.g., low libido, decreased morning erections, loss of body hair, low BMD, gynecomastia, small testes).

See revised diagnostic thresholds

Prior therapy (step therapy): Documentation of inadequate response, contraindication, or intolerance to a ≥3-month trial of a topical testosterone agent AND to a ≥3-month trial of an alternative injectable agent (testosterone cypionate or enanthate).

Step therapy required per policy

Continuation/Renewal Therapy (alternate/related criteria) — Renewal covered when ALL of the following are met:

Renewal covered when ALL of the following are met:

Clinical response and safety: Absence of unacceptable toxicity as defined in policy (examples provided); AND improvement in signs and symptoms of hypogonadism.

See Renewal Criteria revisions

Laboratory monitoring: Patient's testosterone level within the preceding 28 days does not exceed the upper limit of normal for the testing laboratory (generally mid-range targeted); AND hemoglobin, hematocrit, and lipid concentrations are monitored periodically.

Laboratory targets per policy

PSA monitoring: No PSA increase > 1.4 ng/mL above baseline and absolute PSA ≤ 4.0 ng/mL.

PSA change limits from policy

Aveed is not considered medically necessary for members who meet any of the following exclusions: men with carcinoma of the breast or known or suspected carcinoma of the prostate; women who are or may become pregnant; or women who are breastfeeding. The policy notes that testosterone can cause fetal harm if administered during pregnancy and may cause serious adverse reactions in nursing infants, including virilization of a female fetus or nursing infant.

Use of Aveed is not considered medically necessary for men with age-related hypogonadism. The policy also specifies that safety and efficacy have not been established for use in males under 18 years of age, and therefore those uses are excluded from coverage.

Limitations and exclusions in this policy include: men with carcinoma of the breast or known or suspected carcinoma of the prostate; age-related hypogonadism (use considered not established); males younger than 18 years (safety and efficacy not established); and women who are pregnant or breastfeeding, due to potential fetal harm and adverse effects in nursing infants.

The policy states that the safety and efficacy of Aveed have not been established for men with age-related hypogonadism and for males less than 18 years of age; consequently these indications are not supported for coverage under this policy.

Use of Aveed for age-related hypogonadism is explicitly described as not established / not supported by safety and efficacy data in the policy, and therefore is considered not medically necessary.

Procedure, Drug, and Diagnosis Codes

Applicable Procedure CodesHCPCSCovered

J3145

Injection, testosterone undecanoate, 1 mg, 1 billable unit = 1 mg

Applicable NDCsNDCCovered

67979-0511-43

Aveed single use vial; 250 mg/ml solution

Applicable ICD-10 DiagnosesICD-10

E29.1	Testicular hypofunction
E89.3	Postprocedural hypopituitarism
E89.5	Postprocedural testicular hypofunction
F64.0	Transsexualism
F64.1	Dual role transvestism
F64.2	Gender identity disorder of childhood
F64.8	Other gender identity disorders
F64.9	Gender identity disorder, unspecified

Added ICD-10 Codes (gender identity related)ICD-10

F64.0	Transsexualism
F64.1	Dual role transvestism
F64.2	Gender identity disorder of childhood
F64.8	Other gender identity disorders
F64.9	Gender identity disorder, unspecified

Referenced drug codingNDC

NDC	See Aveed package insert for NDCs

Pre-treatment morning total testosterone threshold for initial criteria

ThresholdPre-treatment morning total testosterone < 300 ng/dL (or below lower limit of normal by the testing laboratory)

ContextRequired for initial diagnosis of primary or hypogonadotropic hypogonadism prior to Aveed initiation

TimingMorning (pre-treatment) specimen as specified in policy

Pre-treatment free testosterone threshold for initial criteria

ThresholdPre-treatment free testosterone < 50 pg/mL (or below lower limit of normal by the testing laboratory)

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Authorization requirement — prior authorization required

Prior authorization is required. The request must document that the prescriber is enrolled in the AVEED REMS Program, baseline and periodic monitoring (hemoglobin, hematocrit, and lipids) are arranged, diagnostic confirmation of low testosterone is present, and prior trials of specified topical and injectable testosterone agents have been tried or are contraindicated/intolerant as applicable.

Prescriber enrolled in AVEED REMS Program
Baseline and periodic hemoglobin/hematocrit/lipid measurements
Diagnostic confirmation (testosterone thresholds) and prior therapy trials

Prior Authorization

Prior authorization requirements — REMS, monitoring, diagnostics, prior trials

Prior authorization must show adherence to the universal REMS and monitoring criteria, diagnostic testosterone thresholds, prior trial documentation (or documented contraindication/intolerance), and absence of unacceptable toxicity.

Universal criteria: REMS enrollment; only one androgen/anabolic agent; baseline and periodic Hgb/Hct/lipids

Background on Aveed and Indications

Aveed (testosterone undecanoate) is an intramuscular testosterone replacement product indicated for adult males with primary hypogonadism or hypogonadotropic hypogonadism. Dosing and monitoring differ by indication, and the policy requires baseline and ongoing surveillance for hematologic, lipid, and prostate-related adverse effects.

Key Definitions and Clinical Terms

Definition — Primary hypogonadism (testicular failure) description

DefinitionPrimary hypogonadism — testicular failure due to congenital or acquired causes (e.g., cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals)

Laboratory patternLow serum testosterone with elevated gonadotropins (FSH, LH) above the normal range

Clinical relevanceIndication for testosterone replacement (Aveed) in adult males when other policy criteria are met

Definition — Hypogonadotropic hypogonadism description

DefinitionHypogonadotropic hypogonadism — gonadotropin or LHRH deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation

Laboratory pattern

Policy Revision History

2025-02-18ICD-10 additionsLatest

Added gender identity–related ICD-10 codes F64.0, F64.1, F64.2, F64.8, and F64.9 to the policy's applicable diagnosis list.

2025-02-18Dosing limits added

Operational dosing limits for gender dysphoria were added: 1500 billable units at weeks 0 and 6 initially, then every 12 weeks thereafter.

2025-02-18Universal REMS and monitoring criteria added

Policy Summary

PayerEmblemHealth

PolicyAveed (testosterone undecanoate) Intramuscular

Policy CodePolicy MG.MM.PH.134

Change TypeMaterial revisions — added ICD‑10 gender identity codes, REMS requirement, dosing limits for gender dysphoria, and updated diagnostic/renewal criteria

Effective Date

Next Review DateFeb 18, 2025

Key ActionSubmit prior authorization with evidence of prescriber AVEED REMS enrollment, baseline labs (testosterone, PSA, CBC, lipids), diagnostic confirmation, and prior trial documentation.

SourceLink

On This Page

Specialist involvement and exclusions: For primary/hypogonadotropic hypogonadism in males, therapy prescribed by or in consultation with an endocrinologist or urologist; patient must not have age-related hypogonadism; baseline PSA must be ≤ 4.0 ng/mL.

See revision history and initial criteria

Accepted alternative diagnostic confirmation when repeat morning total testosterone is not used

TimingPre-treatment specimen as specified in policy

Pre-treatment morning total testosterone threshold (alternate/updated)

Threshold (updated)Pre-treatment morning total testosterone < 300 ng/dL

Change noteRevision removed prior requirement for two confirmed low morning totals; single pre-treatment morning total <300 ng/dL now accepted

UseApplies to primary and hypogonadotropic hypogonadism initial criteria

Pre-treatment free testosterone threshold (alternate/updated)

Threshold (updated)Pre-treatment free testosterone < 50 pg/mL

RoleServes as diagnostic confirmation alternative to repeat morning total testosterone

ApplicabilityApplies when confirming low testosterone for initiation of Aveed

Baseline PSA threshold for eligibility

ThresholdBaseline PSA ≤ 4.0 ng/mL

PurposeRequired baseline criterion for eligibility for Aveed therapy

Renewal monitoringOn renewal, PSA must not have increased >1.4 ng/mL above baseline and must remain ≤ 4.0 ng/mL

Diagnostic: pre-treatment morning total testosterone < 300 ng/dL or free testosterone < 50 pg/mL

Prior therapy: documented inadequate response or intolerance to required trials

Step Therapy

Step therapy prior trials — ≥3-month trials required

For primary and hypogonadotropic hypogonadism, the patient must have an inadequate response (or documented contraindication/intolerance) to a ≥3-month trial of a topical testosterone agent and to a ≥3-month trial of an alternative injectable agent (testosterone cypionate or enanthate).

Topical agent trial: ≥3 months (e.g., gel, patch, buccal, nasal, topical solution)
Alternative injectable trial: ≥3 months (testosterone cypionate or enanthate)

Step Therapy

Step therapy requirement — topical + alternative injectable prior trials

Policy requires documented prior trial (≥3 months) with a topical testosterone agent and an alternative injectable (testosterone cypionate or enanthate) with inadequate response or intolerance before approving Aveed.

Both topical and alternative injectable (cypionate/enanthate) trials must be documented as ≥3 months
Documented inadequate response, contraindication, or intolerance is required

Documentation Required

Clinical evidence for medical necessity — submit supporting clinical evidence

The prescriber must submit clinical evidence that the member meets the policy's medical necessity criteria; documentation must support diagnosis, laboratory thresholds, prior therapy trials, REMS enrollment, and specialist involvement when required.

Clinical evidence should demonstrate that all applicable coverage criteria are met
Include specialty consultation/ordering clinician when indicated

Documentation Required

Required clinical documentation — labs, REMS, diagnostic thresholds, prior trials

Required documentation includes prescriber REMS enrollment, baseline and periodic hemoglobin/hematocrit and lipid measurements, baseline pre-treatment morning total testosterone (<300 ng/dL) or free testosterone <50 pg/mL, baseline PSA measurement, and records of prior topical and injectable trials with outcomes.

Prescriber AVEED REMS enrollment
Baseline and periodic Hgb/Hct and lipid measurements
Baseline morning total testosterone <300 ng/dL or free testosterone <50 pg/mL
Baseline PSA measurement (see PSA threshold and monitoring)
Documentation of prior trials and reasons for inadequate response/intolerance

Denial Risk

Documentation submission required — missing documentation prevents review

Failure to submit the required clinical evidence and documentation will prevent EmblemHealth from properly reviewing the preauthorization or post-payment request.

Omissions may result in inability to complete review and potential denial or delayed decision

Denial Risk

Triggers for denial — REMS, concurrent agents, missing/abnormal labs, dosing limits

Denial is a risk if the prescriber is not enrolled in the AVEED REMS Program; if the member is receiving more than one androgen/anabolic agent; if baseline PSA is > 4.0 ng/mL; or if dosing exceeds specified limits for gender dysphoria.

Not enrolled in AVEED REMS Program
Concurrent use of more than one androgen/anabolic agent
Baseline PSA > 4.0 ng/mL
Dosing above the gender dysphoria limits (1500 billable units at weeks 0 and 6, then every 12 weeks)

Low serum testosterone with gonadotropins in the normal or low range

Clinical relevanceIndication for testosterone replacement (Aveed) in adult males when other policy criteria are met

Definition — Unacceptable toxicity examples (POME, anaphylaxis, polycythemia, VTE, azoospermia, etc.)

ExamplesSerious POME reactions and anaphylaxis

ExamplesProstatic hypertrophy or carcinoma and PSA concerns

ExamplesPolycythemia, venous thromboembolism (VTE), azoospermia, myocardial infarction or stroke

Other examplesEdema/heart failure exacerbation, hepatic dysfunction, sleep apnea, severe lipid changes, signs of abuse or dependence

Diagnostic testosterone thresholds — pre-treatment morning total < 300 ng/dL OR free < 50 pg/mL

Diagnostic rulePre-treatment morning total testosterone < 300 ng/dL (or below lower limit of normal by the testing laboratory) OR pre-treatment free testosterone < 50 pg/mL (or below lower limit of normal)

Specimen timingMorning pre-treatment measurements specified in policy

PurposeUsed to confirm testosterone deficiency for initiation of Aveed

Added universal criteria requiring prescriber enrollment in the AVEED REMS Program, restriction to a single androgen/anabolic agent, and baseline and periodic measurement of hemoglobin, hematocrit, and lipids.

2024-04-02Diagnostic threshold & dosing updates

Initial diagnostic requirement was revised to require a single pre-treatment morning total testosterone <300 ng/dL (or below lab lower limit) or free testosterone <50 pg/mL and dosing limits were added with other code adjustments noted in the annual review.

2023-07-28Renewal criteria clarified

Renewal criteria updated to require absence of unacceptable toxicity and to specify testosterone monitoring (within 28 days not to exceed lab upper limit) and PSA change limits (no increase >1.4 ng/mL above baseline and absolute PSA ≤4.0 ng/mL).