CurrentmediviewcurativePolicy MM-PNP-025

Testosterone Replacement Therapy (injectable and pellets)

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Defines medical necessity criteria and utilization management requirements for injectable testosterone and Testopel (testosterone pellets) for members receiving pharmacy or medical benefits under the plan.

Policy Summary

Payermediviewcurative

PolicyTestosterone Replacement Therapy (injectable and pellets)

Policy CodePolicy MM-PNP-025

Change TypeNo material change

Effective DateDec 1, 2023

Next Review DateN/A

Key ActionObtain prior authorization and document diagnosis plus required laboratory confirmation (two early‑morning total testosterone values <300 ng/dL or one calculated free/bioavailable <50 pg/mL when indicated).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 moinitial authorization duration

12 mocontinuing authorization duration

<300 ng/dLpre-treatment total T threshold

<50 pg/mLpre-treatment free T threshold

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CurrentmediviewcurativePolicy MM-PNP-025

Testosterone Replacement Therapy (injectable and pellets)

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Sign up for mediviewcurative Policy MM-PNP-025 alerts

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Policy Summary

Payermediviewcurative

PolicyTestosterone Replacement Therapy (injectable and pellets)

Policy CodePolicy MM-PNP-025

Change TypeNo material change

Effective DateDec 1, 2023

Next Review DateN/A

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 moinitial authorization duration

12 mocontinuing authorization duration

<300 ng/dLpre-treatment total T threshold

<50 pg/mLpre-treatment free T threshold

Coverage Criteria

Initial Therapy — Covered Indications

Covered when ONE of the following patient history criteria OR laboratory criteria are met and all additional conditions (age, exclusions, documentation) apply:

Primary history indications: Any one of: bilateral orchiectomy; panhypopituitarism (defined as two or more pituitary hormone insufficiencies prior to the diagnosis of hypogonadism); a genetic disorder known to cause hypogonadism (e.g., congenital anorchia, Klinefelter's syndrome)

Meeting any one suffices

Laboratory diagnostic pathway: Either two pre-treatment early morning serum total testosterone levels < 300 ng/dL (or below lab reference range) measured on separate occasions (document values and dates), OR when a condition that may alter SHBG is present, one pre-treatment calculated free or bioavailable testosterone < 50 pg/mL (or below lab reference range)see thresholds

May require treatment to be temporarily held; document lab values and dates

Additional required conditions: All of the following: patient was male at birth; diagnosis of hypogonadism; patient is not taking growth hormones (unless diagnosed with panhypopuitarism) or an aromatase inhibitor; presence of supporting clinical features (e.g., significant weight loss <90% ideal body weight, osteopenia/osteoporosis/decreased bone density, decreased libido, or an organic cause of testosterone deficiency); dosing per FDA labeling; initial authorization limited to no more than 6 months for new starts (12 months for continuing therapy)

All listed must be met

Continuation Therapy — Monitoring Criteria

Covered when ONE of the following monitoring criteria are met and other conditions (adherence to dosing, absence of exclusions) apply:

Total testosterone monitoring: Follow-up total serum testosterone drawn within the past 6 months for patients on therapy < 1 year, or within the past 12 months for patients on therapy ≥ 1 year, that is within or below the normal male limits of the reporting lab; OR follow-up total serum testosterone in that timeframe that is above the upper male limit provided the dose is adjustedtiming: 6 or 12 months

Documents must show timing and results; dose adjustment required if above upper limit

Monitoring with altered SHBG: If patient has a condition that may alter SHBG (e.g., thyroid disorder, HIV, liver disease, diabetes, obesity), then follow-up calculated free or bioavailable testosterone drawn within the past 6 months for patients on therapy < 1 year, or within 12 months for patients on therapy ≥ 1 year, that is within or below normal male limits OR is above upper male limits and the dose is adjustedtiming: 6 or 12 months

Also requires patient not taking excluded concomitant medications (listed growth hormones unless panhypopituitarism; aromatase inhibitors) and dosing per FDA labeling

This policy excludes use of androgens and anabolic steroids when prescribed for the purpose of performance enhancement in otherwise healthy, non‑diseased individuals. Most plan benefit documents explicitly exclude steroids for performance enhancement; where a plan does not include that explicit exclusion, requests for androgens or anabolic steroids for performance enhancement remain not covered because such use is not treatment of disease or injury. Coverage for any given request depends on the member's benefit plan description.

Use of testosterone or other androgenic/anabolic agents for the sole purpose of enhancing athletic performance, appearance, or other non‑therapeutic gains is considered not covered under most plans and may be denied. Providers should verify the member's specific benefit plan language, because final coverage determinations depend on the applicable benefit design.

Laboratory Thresholds and Coding

Pre-treatment total testosterone

ThresholdTwo pre-treatment early morning serum total testosterone levels < 300 ng/dL (< 10.4 nmol/L) OR below the laboratory reference range

TimingTwo separate measurements taken in the early morning at different times (document value and date for both)

NotesMay require temporarily holding testosterone treatment to obtain pre-treatment levels

Pre-treatment calculated free/bioavailable testosterone

ThresholdOne pre-treatment calculated free or bioavailable testosterone < 50 pg/mL (< 5 ng/dL or < 0.17 nmol/L) OR below the laboratory reference range

When to useUse when the patient has a condition that may alter SHBG (e.g., thyroid disorder, HIV, liver disease, diabetes, obesity)

Provider Actions and Documentation Requirements

Prior Authorization

Prior authorization required; time-limited approvals

Prior authorization is required for injectable testosterone and Testopel. Initial authorization for new starts will be for no more than 6 months; continuing therapy approvals may be for up to 12 months when criteria are met.

Note

Therapy contingent on diagnostic/lab criteria and excluded concomitant meds

Therapy is allowed only when diagnostic and laboratory criteria are met and the member is not taking excluded concomitant medications (growth hormone or aromatase inhibitors, except growth hormone when panhypopituitarism is documented). These are operational constraints for authorization rather than step edits.

Patient must meet the specified history or laboratory diagnostic pathways (see policy).
Member must not be taking listed growth hormones (unless panhypopituitarism) or an aromatase inhibitor.

Background

Testosterone replacement therapy is intended to treat conditions characterized by deficiency or absence of endogenous testosterone, such as primary hypogonadism and hypogonadotropic hypogonadism. The policy requires laboratory confirmation (e.g., morning total testosterone or calculated free/bioavailable testosterone when indicated) and appropriate clinical documentation to support a diagnosis of hypogonadism prior to approval. Treatments used solely for performance enhancement of otherwise healthy individuals do not meet the indication criteria and are not considered medically necessary under this guidance.

Definitions

Panhypopituitarism

DefinitionPanhypopituitarism is defined as two or more pituitary hormone insufficiencies prior to the diagnosis of hypogonadism

ContextListed as one of the history-based indications qualifying a patient for initial testosterone therapy

DocumentationDocument the history of pituitary hormone insufficiencies in the medical record for prior authorization review

Initial Therapy (Drug-Specific)

Initial therapy (drug-specific) — Authorization Requirements

Initial approval for specific injectable testosterone formulations or Testopel requires meeting history or laboratory confirmation plus the additional conditions below:

History-based approval (drug-specific): Any one of: bilateral orchiectomy; panhypopituitarism; genetic disorder causing hypogonadism

Meeting any one suffices for drug-specific initial approval

Lab-based approval (drug-specific): Either two early morning pre-treatment total testosterone values < 300 ng/dL on separate occasions OR (if condition alters SHBG) one calculated free or bioavailable testosterone < 50 pg/mLsee thresholds

Labs may require treatment to be temporarily held; document values and dates

Other drug-specific requirements: All of the following: patient male at birth; documented diagnosis of hypogonadism; not taking excluded growth hormones (unless panhypopituitarism) or aromatase inhibitors; presence of clinical features supporting deficiency (e.g., weight loss, decreased bone density, decreased libido, organic cause); dosing consistent with FDA labeling; initial authorization for new starts limited to 6 months

Continuation Therapy Monitoring

Continuation therapy monitoring (drug-specific)

Continuation authorization for specific injectable formulations or Testopel requires recent monitoring and adherence to dosing guidance:

Monitoring timeline (drug-specific): Follow-up total serum testosterone within 6 months for patients on therapy < 1 year, or within 12 months for patients on therapy ≥ 1 year; or follow-up calculated free/bioavailable testosterone if SHBG-altering condition present6 or 12 months

If levels are above the lab's upper limit, dose must be adjusted; patient must not be taking excluded concomitant medications and dosing must follow FDA labeling