CurrentBlue Cross Blue Shield - IowaPolicy 05.01.45

Testosterone agents (drug policy)

Policy governing medical necessity and coverage criteria for testosterone products (topical, buccal, nasal, implant, oral, injectable, and implanted pellets) for Wellmark Blue Cross and Blue Shield members. Affects prescribers and prior authorization decisions for testosterone therapies.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyTestosterone agents (drug policy)

Policy CodePolicy 05.01.45

Change TypeNo material change

Effective Date

Next Review Date

Key ActionDocument two confirmed low morning total testosterone levels on separate days before initiating testosterone therapy (unless anorchia or bilateral orchidectomy).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2Confirmed low morning T required

36 moOral methyltestosterone approval duration

12 moTypical initial approval duration

13+Testopel minimum age

320-1000Male T target range

Coverage Criteria

inv-01: Oral methyltestosterone - Initial Approval

Oral methyltestosterone will be considered medically necessary when ALL of the following are met:

Oral methyltestosterone - Initial: A. Member has primary or hypogonadotropic hypogonadism (or other listed indication such as breast cancer or delayed puberty) AND has had an inadequate treatment response, intolerance, or contraindication to one non-oral form of testosterone supplementation.

From Criteria for Initial Approval

Laboratory confirmation: B. Before the start of therapy, the member has at least two confirmed low morning total testosterone levels drawn on separate days according to current practice guidelines or standard laboratory reference values.Two low morning measurements

Unless the member has anorchia or has undergone bilateral orchidectomy

Age-related hypogonadism exclusion: C. The requested drug is NOT being prescribed for age-related (late-onset) hypogonadism.

Safety and efficacy not established for age-related hypogonadism

inv-02: Testopel (implanted pellets) - Approval Criteria

Subcutaneously implanted Testopel will be considered medically necessary when ALL of the following are met for the requested indication:

Indications: 1. Primary hypogonadism with signs/symptoms; 2. Hypogonadotropic (secondary) hypogonadism with qualifying diagnoses; 3. Delayed puberty (age ≥13); 4. Gender dysphoria for gender-affirming therapy.

See specific subnodes for requirements

Primary hypogonadism specific: A. Member has signs and symptoms of testosterone deficiency. B. Before starting therapy the member has at least two confirmed low total testosterone levels drawn on separate mornings in a fasted state. C. Member does not have risk factors that are a contraindication to therapy. D. Not prescribed for age-related hypogonadism. E. Dosing will not exceed FDA labeling/accepted compendia/evidence-based guidelines.Two low morning measurements

Chunk 16

Hypogonadotropic hypogonadism specific: A. Member has congenital hypogonadotropic hypogonadism, LHRH deficiency, or pituitary-hypothalamic injury. B. Signs and symptoms of testosterone deficiency. C. Two confirmed low total testosterone levels drawn on separate mornings in a fasted state before therapy. D. No contraindication risk factors. E. Functional reversible causes assessed. F. Not for age-related hypogonadism. G. Dosing within FDA/compendia/guidelines.

inv-03: Primary hypogonadism (Initial approval)

Covered when ALL of the following are met

Primary hypogonadism criteria: A. Member has signs and symptoms of testosterone deficiency. B. Before the start of therapy, the member has at least two confirmed low total testosterone levels drawn on separate mornings in a fasted state (unless anorchia or bilateral orchidectomy). C. Member does not have risk factors that are a contraindication to therapy. D. For requests for Xyosted, Jatenzo, Kyzatrex, Natesto, or Tlando: trial and failure of, or contraindication/intolerance to, two generic testosterone products. E. The requested drug is NOT being prescribed for age-related hypogonadism.Two low morning testosterone levels

See Appendix A/B for signs and contraindications

inv-04: Hypogonadotropic (secondary) hypogonadism (Initial approval)

Covered when ALL of the following are met

Secondary hypogonadism criteria: A. Member has congenital hypogonadotropic hypogonadism, LHRH deficiency, or pituitary-hypothalamic injury. B. Signs and symptoms of testosterone deficiency. C. At least two confirmed low total testosterone levels on separate mornings prior to therapy. D. No contraindication risk factors. E. Functional causes that may be managed without testosterone have been assessed. F. For specified branded products (Xyosted, Jatenzo, Kyzatrex, Natesto, Tlando): trial and failure of, or contraindication/intolerance to, two generic testosterone products. G. Not being used for age-related hypogonadism.Two low morning testosterone levels

Assess functional causes per Appendix C

inv-05: Gender dysphoria (Initial approval)

Covered when ALL of the following are met

Gender-affirming hormone therapy criteria: A. Drug prescribed for gender-affirming hormonal therapy for a transgender individual able to make an informed decision to engage in hormone therapy. B. If the member is <18 years old, the drug is prescribed by or in consultation with a provider specialized in transgender youth care with collaborative mental health involvement. C. The member has reached, or previously reached, Tanner stage 2 of puberty or greater. D. For specified branded products: trial and failure of, or contraindication/intolerance to, two generic testosterone products. E. Dosing will not exceed FDA labeling/accepted compendia/evidence-based guidelines.Tanner stage >=2 for minors

Endocrine Society guidance cited regarding initiation timing and informed decision-making

inv-06: Delayed puberty (Initial approval)

Covered when ALL of the following are met

Delayed puberty criteria: A. Member is 13 years of age or older. B. The requested drug is being prescribed for delayed puberty. C. Dosing will not exceed FDA labeling, accepted compendia, or evidence-based practice guidelines.

inv-07: Continuation criteria

Continuation covered when ALL of the following are met (separate rules for oral methyltestosterone vs other products)

Continuation - oral methyltestosterone: 1. Criteria for Initial Approval have been met. Note: For primary or hypogonadotropic hypogonadism, continuation requires only a confirmed low morning testosterone level before starting therapy.

Continuation - other testosterone products: 1. Signs and symptoms have responded to treatment. 2. Testosterone levels drawn within the past 12 months and are in the mid-normal range. 3. Member has been assessed for adverse effects within the past 12 months and has not developed adverse effects (e.g., elevated hematocrit or prostatic abnormality) requiring discontinuation. 4. The requested drug is NOT being prescribed for age-related hypogonadism.

inv-08: Initial and formulation considerations

Covered when the following clinical considerations are met

Informed consent and readiness: The individual is able to make an informed decision to engage in hormone therapy.

Endocrine Society guidance on timing and decision-making cited

Appropriate testosterone formulation: Use of injectable testosterone esters (cypionate or enanthate), transdermal testosterone, or subcutaneous implant pellets to achieve male physiologic testosterone levels.Target 320-1000 ng/dL

Choice of formulation may depend on serum variability and desired virilization

The policy states that use of testosterone products for age-related (late-onset) hypogonadism is not supported because safety and efficacy have not been established for this condition. This limitation applies across formulation types (topical, buccal, nasal, implant, oral, and injectable) and should be considered when evaluating requests for testosterone therapy in older adults presenting with age-related declines in testosterone.

Safety and effectiveness of testosterone products have not been established for members with age-related (late-onset) hypogonadism. Requests for testosterone therapy for this indication therefore do not meet the evidence threshold described in the policy and should be evaluated against the policy's exclusion for age-related hypogonadism.

Within the cited portions of the document there are no additional explicit exclusions beyond the stated limitation that safety and efficacy have not been established for age-related hypogonadism. Routine contraindications and risk factors are addressed elsewhere in the policy (e.g., Appendix B) but are not repeated in these specific chunks.

The policy highlights safety and efficacy limitations for certain populations: age-related (late-onset) hypogonadism is explicitly noted as unsupported, and the document also states that testosterone products have not been established as safe and effective in males under 18 years of age for many formulations. For transgender youth, separate criteria apply (see clinical rationale and age/maturity considerations) rather than blanket coverage for all minors.

The policy clarifies that all testosterone products are considered not medically necessary for members who do not meet the specific coverage criteria laid out in the policy (for example, diagnostic laboratory confirmation, indication-specific requirements, and formulation-specific step therapy). Requests failing to satisfy those criteria should be denied as not medically necessary.

In the portions cited there are no additional, formulation-specific conditions explicitly labeled as 'not medically necessary.' The policy does, however, direct that products not meeting the stated criteria (including laboratory confirmation and indication requirements) are considered not medically necessary.

Initial Therapy Requirements

inv-41: Initial Therapy Requirements

Initial therapy requirements and formulation-specific limitations:

Oral methyltestosterone initial: See 'Criteria for Initial Approval' — requires prior trial failure/intolerance/contraindication to one non-oral form and two confirmed low morning testosterone levels; not for age-related hypogonadism. Approval duration: 36 months.

Chunks 11-15

Testopel and other formulations: Testopel (implanted pellets) and other testosterone products require indication-specific criteria, laboratory confirmation, contraindication assessment, and dosing within FDA/compendia/guidelines. Most other testosterone products approved for 12 months.

Chunks 15-19 and 20

inv-42: Initial therapy — criteria by indication

Initial therapy — covered when ALL of the following per indication are met:

Continuation Therapy Requirements

inv-44: Continuation Therapy Requirements

Continuation requests requirements:

Continuation monitoring: At least one confirmed, low morning total testosterone level before starting testosterone therapy must be documented for continuation requests, according to current practice guidelines or standard lab reference values.1 low morning measurement

Chunk 10

inv-45: Continuation therapy — different rules

Continuation therapy — different rules for oral methyltestosterone versus other testosterone products:

Oral methyltestosterone continuation: Criteria for Initial Approval have been met; approval duration for continuation will be 36 months.

Provider Actions and Prior Authorization

Prior Authorization

Prior Authorization Required and Approval Duration

Prior authorization is required for certain testosterone formulations. Approval durations vary by product: oral methyltestosterone (tablets/capsules) — approval for 36 months when criteria met; subcutaneous Testopel (implanted pellets, HCPCS J1073) — approval for 36 months when criteria met; most other testosterone products — typical approvals of 12 months when criteria met.

Oral methyltestosterone: prior authorization required; approval duration = 36 months.
Subcutaneous testosterone implants (Testopel, HCPCS J1073): prior authorization may be required for implantation and billing; approval duration = 36 months.
All other testosterone products: prior authorization required when criteria apply; approval duration = 12 months.

Coding and Diagnostic Thresholds

Procedures / HCPCSHCPCS

J1073

testosterone pellet, implant, 75 mg (effective 1/1/26)

Confirmed low total testosterone measurements

RequirementTwo confirmed low total testosterone measurements drawn on separate days during the morning and in a fasted state are required prior to initiation (unless the member has anorchia or has undergone bilateral orchidectomy).

Continuation requirementFor continuation requests, at least one confirmed low morning testosterone level before starting therapy is required.

TimingMeasurements must be drawn during the morning and in a fasted state per current practice guidelines or standard laboratory reference values.

Morning total testosterone diagnostic threshold

Diagnostic thresholdTotal testosterone <300 ng/dL (use laboratory-specific lower limits; some labs report 280–300 ng/dL as the lower limit).

Step Therapy Requirements

Requirement	Details
Non-oral formulation trial or documented intolerance/contraindication
Member has had an inadequate treatment response, intolerance, or contraindication to one non-oral form of testosterone supplementation before oral methyltestosterone will be approved.

Requirement	Details
Step therapy for specified branded products
Members requesting Xyosted, Jatenzo, Kyzatrex, Natesto, or Tlando must have trial and failure of, or clinical contraindication/intolerance to, two generic testosterone products prior to approval.

Quantity Limits by Product

Androderm 2 mg/24-hour patch — quantity limit

Standard limit1 patch/day

Per time periodDaily

ProductAndroderm 2 mg/24-hour patch

Jatenzo 158 mg capsule — quantity limit

Standard limit120 capsules/30 days

Per time period30 days

ProductJatenzo 158 mg capsule

Definitions

Primary hypogonadism — definition and examples

DefinitionTesticular failure from congenital or acquired causes leading to low serum testosterone and elevated gonadotropins (FSH, LH).

ExamplesCryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchidectomy, Klinefelter syndrome, chemotherapy, toxic damage from alcohol/heavy metals.

Clinical implicationThese patients typically have low serum testosterone and elevated FSH/LH; two morning low testosterone measurements are required prior to therapy (unless anorchia/orchidectomy).

Hypogonadotropic (secondary) hypogonadism — definition

DefinitionGonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency, or pituitary-hypothalamic injury resulting in low testosterone with normal or low gonadotropins.

Causes

Background

Background: Testosterone replacement therapy is indicated to treat deficiency or absence of endogenous testosterone due to primary or secondary (hypogonadotropic) hypogonadism and is used in select other clinical situations (delayed puberty, certain breast cancer cases, and gender-affirming therapy). The policy emphasizes that regimens aim to suppress endogenous hormones and maintain sex hormone levels appropriate for the affirmed gender; for transgender male persons, testosterone is used to achieve physiologic male serum levels (target range cited elsewhere as 320–1000 ng/dL), and formulation selection (injectable, transdermal, or subcutaneous implant pellets) should be individualized based on serum variability, desired virilization, and monitoring considerations.

Revision History

September 2012policy_created

Policy 05.01.45 was created.

2024-03-15effective_date

Current effective date set to March 15, 2024.

January 2026review_and_revisionLatest

Policy was reviewed and revised in January 2026.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyTestosterone agents (drug policy)

Policy CodePolicy 05.01.45

Change TypeNo material change

Effective Date

Next Review Date

Key ActionDocument two confirmed low morning total testosterone levels on separate days before initiating testosterone therapy (unless anorchia or bilateral orchidectomy).

SourceLink

On This Page

Two low morning measurements

Delayed puberty specific: A. Member is 13 years of age or older. B. Drug is prescribed for delayed puberty. C. Dosing will not exceed FDA labeling/accepted compendia/evidence-based guidelines.age >=13

Chunk 18

Gender dysphoria specific: A. Drug prescribed for gender-affirming hormonal therapy for a transgender individual able to make an informed decision. B. For members <18, prescription by or in consultation with a provider specialized in transgender youth care with collaborative mental health involvement. C. Member has reached or previously reached Tanner stage 2. D. Dosing will not exceed FDA labeling/accepted compendia/evidence-based guidelines.Tanner stage >=2 for minors

Chunk 19

Primary hypogonadism (initial): Member has signs/symptoms of testosterone deficiency; at least two confirmed low morning total testosterone levels prior to therapy (unless anorchia/bilateral orchidectomy); no contraindication risk factors; for select branded products, trial/failure of two generics; not for age-related hypogonadism.Two low morning measurements

Secondary hypogonadism (initial): Member has congenital hypogonadotropic hypogonadism, LHRH deficiency, or pituitary-hypothalamic injury; signs/symptoms of deficiency; two confirmed low morning testosterone levels prior to therapy; contraindications assessed; functional reversible causes assessed; for select branded products, trial/failure of two generics; not for age-related hypogonadism.Two low morning measurements

Gender dysphoria (initial): Prescribed for gender-affirming hormonal therapy in a transgender individual able to consent; if <18, prescribed by or in consultation with a provider specialized in transgender youth with collaborative mental health care; member has reached Tanner stage 2 or greater; for select branded products, trial/failure of two generics; dosing within guidelines.Tanner stage >=2 for minors

Delayed puberty (initial): Member is ≥13 years of age; drug prescribed for delayed puberty; dosing within FDA/compendia/guidelines.age >=13

inv-43: Initial therapy options

Initial therapy options and formulation guidance:

Formulation selection: Initiate testosterone using injectable esters (cypionate or enanthate), transdermal preparations, or subcutaneous implant pellets depending on clinical considerations such as serum variability, desired virilization, and patient preference.

Endocrine Society guidance: injectables commonly used; transdermal and implants considered for less serum variability or different virilization profiles

Dosing and targets: Select dosing to achieve male physiologic testosterone values (target range 320-1000 ng/dL) and follow FDA labeling, accepted compendia, or evidence-based practice guidelines.320-1000 ng/dL

Other testosterone products continuation: Signs and symptoms have responded to treatment; testosterone levels drawn within past 12 months and are in the mid-normal range; member assessed for adverse effects within past 12 months with no adverse effects requiring discontinuation; not prescribed for age-related hypogonadism; approval duration 12 months.

inv-46: Continuation therapy — ongoing considerations

Ongoing therapy considerations for continuation requests and monitoring:

Monitoring and targets: Maintain serum testosterone in the male physiologic range; monitor levels periodically to ensure mid-normal values and assess for adverse effects (hematocrit, prostate).320-1000 ng/dL

Transdermal formulations may produce low-normal levels and less virilization compared with injectables

Formulation reassessment: Consider switching formulation if cyclic variation, inadequate virilization, or unacceptable serum variability is observed; document rationale for formulation selection and monitoring plan.

Not Medically Necessary When Criteria Not Met

Requests may be denied or considered not medically necessary when required documentation and criteria are not met. Testosterone products are considered not medically necessary for members who do not meet the stated coverage criteria.

If attestation of required laboratory tests, prior trials, or formulary step requirements are missing, the request may be denied.
Products prescribed for age‑related (late‑onset) hypogonadism are NOT covered/are considered not medically necessary.

Prior Authorization

Continuation Prior Authorization and Duration

Continuation prior authorization rules differ by formulation: continuation of oral methyltestosterone requires that initial approval criteria have been met; approval on continuation may be for 36 months. Continuation for other testosterone products requires evidence of clinical response, recent testosterone levels in the mid‑normal range, assessment for adverse effects within the prior 12 months, and is typically approved for 12 months.

Oral methyltestosterone continuation: initial criteria met; continuation approval = 36 months.
Other testosterone products continuation: 1) clinical response documented; 2) testosterone level drawn within past 12 months in mid‑normal range; 3) adverse effects assessed within past 12 months; continuation approval = 12 months.

Billing Rule

Prior Authorization and Billing for Testosterone Implants

For implanted testosterone pellets (Testopel), prior authorization and applicable billing rules apply. Use HCPCS code J1073 for reporting testosterone pellet implants (effective 1/1/26). Document indication and that clinical criteria for implants are met.

HCPCS J1073 — testosterone pellet, implant, 75 mg (effective 1/1/26).
Document two confirmed low morning total testosterone levels (unless anorchia/bilateral orchidectomy) and other implant-specific criteria per policy.

Documentation Required

Laboratory and Prior‑Treatment Documentation Required

Requests require laboratory and prior‑treatment documentation. For initial therapy (primary or hypogonadotropic/secondary hypogonadism and most indications), provide at least two confirmed low total testosterone levels drawn on separate days in the morning (fasted) per current practice guidelines or the laboratory's reference values, unless the member has anorchia or has undergone bilateral orchidectomy. Continuation requests require at least one confirmed low morning testosterone level before the start of therapy (if applicable) or recent documented levels as specified for continuation.

Initial therapy: two low morning total testosterone levels on separate days (fasted) required except in anorchia/bilateral orchidectomy.
Continuation: at least one confirmed low morning testosterone level prior to initiating therapy (if not previously documented); continuation monitoring as described in continuation criteria.

Denial Risk

Denial Risk for Missing Documentation

Lack of required documentation — including the two confirmed low morning total testosterone levels, documentation of prior trials or intolerances to non‑oral formulations where required, or evidence of informed consent/ability to consent for gender‑affirming therapy — may result in denial.

Requests without two confirmed low morning total testosterone levels (unless exception applies) may be denied.
For transgender patients, absence of documentation of informed consent or absence of specialist involvement for members <18 may lead to denial.
Lack of documentation of prior inadequate response/intolerance to non‑oral testosterone when required (e.g., oral methyltestosterone or delayed puberty indications) may result in denial.

Step Therapy

Non‑Oral Trial and Step Therapy Requirements

Before prescribing oral formulations (including oral methyltestosterone) or certain branded products, document trial and inadequate response, intolerance, or contraindication to non‑oral testosterone formulations. Select branded products (Xyosted, Jatenzo, Kyzatrex, Natesto, Tlando) require trial and failure of, or intolerance/contraindication to, two generic testosterone products before approval.

Non‑oral trial requirement: oral forms often require prior inadequate response/intolerance/contraindication to at least one non‑oral formulation.
Step therapy for select branded products: trial and failure/intolerance to two generic testosterone products required for Xyosted, Jatenzo, Kyzatrex, Natesto, or Tlando.

Documentation Required

Document Clinical Rationale and Formulation‑Specific Considerations

Clinical documentation should support informed consent, rationale for the chosen formulation, and formulation‑specific considerations (e.g., route‑specific risks, monitoring plan). Providers should weigh factors such as pharmacokinetics, dosing frequency, patient preference, risk of hematocrit elevation, prostate monitoring, and ease of adherence; document the clinical rationale and any prior trials or reasons for selecting a particular formulation.

Document informed consent and the clinical rationale for the selected formulation.
Consider formulation‑specific factors (injectable vs transdermal vs implant vs oral) and document why alternatives were unsuitable or attempted.

Serum total testosterone should be determined in the morning; repeat testing is recommended for subnormal values.

Use of lab referenceClinicians should use the lower limit of normal established by their laboratory/assay when interpreting results.

Target male serum testosterone range for transmasculine therapy

Target range320-1000 ng/dL (physiologic male serum testosterone range for transmasculine therapy).

Goal of therapyAchieve and maintain testosterone values in the normal male range to induce affirmed‑gender secondary sex characteristics.

Formulation noteEither parenteral or transdermal preparations can be used to achieve these target levels; choice depends on clinical considerations.

Male serum testosterone target

Male serum testosterone target320-1000 ng/dL (physiologic male serum testosterone range cited in clinical rationale).

MonitoringContinued therapy requires monitoring of serum testosterone to maintain levels within this male physiologic range.

Formulation implicationConsider switching formulation if cyclic variation or inadequate virilization prevents reaching target range.

Jatenzo 198 mg capsule — quantity limit

Standard limit60 capsules/30 days

Per time period30 days

ProductJatenzo 198 mg capsule

Kyzatrex 100 mg capsule — quantity limit

Standard limit60 capsules/30 days

Per time period30 days

ProductKyzatrex 100 mg capsule

Kyzatrex 150 mg capsule — quantity limit

Standard limit120 capsules/30 days

Per time period30 days

ProductKyzatrex 150 mg capsule

Kyzatrex 200 mg capsule — quantity limit

Standard limit120 capsules/30 days

Per time period30 days

ProductKyzatrex 200 mg capsule

Natesto 7.32 g nasal gel — quantity limit

Standard limit3 pump bottles/30 days

Per time period30 days

ProductNatesto 7.32 g nasal gel

Testopel 75 mg pellet — quantity limit

Standard limit6 pellets/90 days

Per time period90 days

ProductTestopel 75 mg pellet

Testosterone 1% gel 2.5 g or 5 g packet — quantity limit

Standard limit2 packets/day

Per time periodDaily

ProductTestosterone 1% gel 2.5 g or 5 g packet

Testosterone gel 1% 75 g pump bottle — quantity limit

Standard limit4 bottles/30 days

Per time period30 days

ProductTestosterone gel 1% 75 g pump bottle

Testosterone gel 1.62% 1.25 g packet — quantity limit

Standard limit1 packet/day

Per time periodDaily

ProductTestosterone gel 1.62% 1.25 g packet

Testosterone gel 1.62% 2.5 g packet — quantity limit

Standard limit2 packets/day

Per time periodDaily

ProductTestosterone gel 1.62% 2.5 g packet

Testosterone gel 1.62% 75 g pump bottle — quantity limit

Standard limit2 bottles/30 days

Per time period30 days

ProductTestosterone gel 1.62% 75 g pump bottle

Testosterone gel 2% 60 g pump bottle — quantity limit

Standard limit2 bottles/30 days

Per time period30 days

ProductTestosterone gel 2% 60 g pump bottle

Testosterone solution 30 mg/1.5 mL 90 mL pump bottle — quantity limit

Standard limit2 bottles/30 days

Per time period30 days

ProductTestosterone solution 30 mg/1.5 mL 90 mL pump bottle

Testim testosterone gel 1% 5 g tube — quantity limit

Standard limit2 tubes/day

Per time periodDaily

ProductTestim testosterone gel 1% 5 g tube

Tlando 112.5 capsule — quantity limit

Standard limit120 capsules/30 days

Per time period30 days

ProductTlando 112.5 capsule

Vogelxo transdermal gel — quantity limit

Standard limit2 tubes/day or up to 4 bottles/30 days depending on presentation

Per time periodDaily or 30 days depending on presentation

ProductVogelxo transdermal gel (various presentations)

Xyosted solution auto-injector — quantity limit

Standard limit4 pens/28 days

Per time period28 days

ProductXyosted 50 mg/0.5 mL and 100 mg/0.5 mL solution auto-injector

Congenital or acquired pituitary-hypothalamic injury from tumors, trauma, or radiation.

Testing implicationBefore therapy, at least two confirmed low morning total testosterone levels are required (unless anorchia or bilateral orchidectomy).

Age-related hypogonadism (late-onset) — definition and limitation

Definition & limitationAge-related (late-onset) hypogonadism: a condition for which safety and efficacy of topical, buccal, implant, and nasal testosterone products have not been established; use is not supported by policy.

Policy stanceTestosterone products are not supported for age-related hypogonadism as safety and efficacy have not been established.

Clinical noteIf requested drug is being prescribed for age-related hypogonadism, it is excluded from coverage per policy limitations of use.

Suggestive signs and symptoms of testosterone deficiency

Common signsReduced sexual desire (libido) and activity; decreased energy; loss of body (axillary and pubic) hair; decreased spontaneous erections; erectile dysfunction.

Other suggestive findingsVery small testes (<6 mL), eunuchoidal body proportions, infertility/low sperm count, decreased bone density, reduced muscle bulk and strength.

Nonspecific symptomsDepressed mood, poor concentration, sleep disturbance, increased body fat, mild anemia, hot flashes.

Gender-affirming hormone therapy — goal of therapy

Goal of therapySuppress endogenous hormone secretion and maintain sex hormone levels within the normal range for the person's desired gender.

Therapeutic principleReduce secondary sex characteristics of birth-assigned gender and replace endogenous sex hormone levels with those of the affirmed gender.

Initiation guidanceEndocrine Society suggests gradual dosing and individualized timing; individuals able to make an informed decision will be approved.

Male testosterone reference range

Physiologic male range320-1000 ng/dL (document-cited physiologic male serum testosterone range).

UseTarget range used for transgender male/transmasculine therapy and monitoring of replacement therapy.

Formulation noteBoth parenteral and transdermal preparations can be used to achieve this range; choice depends on clinical considerations.