ModifiedUnitedHealthcarePolicy N/A

Testosterone therapies (topical, transdermal, oral, injectable) prior authorization

Defines UnitedHealthcare pharmacy prior authorization and medical necessity criteria for testosterone products for hypogonadism and gender dysphoria, including initial and reauthorization rules and product-specific requirements (e.g., Xyosted). Affects providers prescribing testosterone for covered members.

Policy Summary

PayerUnitedHealthcare

PolicyTestosterone therapies prior authorization (topical, transdermal, oral, injectable) — coverage criteria

Policy CodePolicy N/A

Change TypeMaterial updates: authorization duration set to 12 months; Xyosted step requirement added; product list updated

Effective DateFeb 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization and document required diagnostic labs (two total testosterone <300 ng/dL or calculated free/bioavailable <50 pg/mL when SHBG altered) and prior treatment failures where applicable.

SourceLink

POLICY UPDATE CHANGES

Authorization will be issued for 12 months.

Added requirement male at birth to orchiectomy, panhypopituitarism and genetic disorders requirement section; added step through topical products for Xyosted; removed certain brands off market.

UnitedHealthcare may approve initial and reauthorization based solely on previous claim/medication history, diagnosis codes and/or claim logic.

12 monthsauthorization period for approved requests

tworequired pre-treatment measurements

free/bioavailable testosterone threshold

male at birthdocumented sex requirement

multipleproduct updates

Coverage Criteria

Initial Authorization — Hypogonadism (topical/transdermal/oral)

Covered when either A or B pathway is met.

Initial Authorization pathways: Pathway A: BOTH of the following: 1) Patient has history of one of: bilateral orchiectomy; panhypopituitarism; or a genetic disorder known to cause hypogonadism (eg, congenital anorchia, Klinefelter's syndrome). 2) Patient was male at birth.

Authorization issued for 12 months.

Pathway B (laboratory-based): 1) One of: (a) Two pre-treatment serum total testosterone levels < 300 ng/dL (or less than the lab reference range) taken at separate times (document values and dates); OR (b) patient has a condition that may alter SHBG (eg, thyroid disorder, HIV, liver disorder, diabetes, obesity) AND one pre-treatment calculated free or bioavailable testosterone < 50 pg/mL (or less than lab reference range) (document value and date). 2) Patient is not taking listed growth hormones unless diagnosed with panhypopituitarism (Genotropin, Humatrope, Norditropin FlexPro, Nutropin AQ, Omnitrope, Saizen) and not taking an aromatase inhibitor (eg, anastrozole, letrozole, exemestane). 3) Patient was male at birth. 4) Diagnosis of hypogonadism. 5) Presence of at least one clinical sign: significant weight reduction (<90% ideal body weight), osteopenia, osteoporosis, decreased bone density, decreased libido, or organic cause of testosterone deficiency (eg, injury, tumor, infection, genetic defects).see thresholds

Authorization issued for 12 months.

Initial Authorization — Xyosted

Covered when one of two branches is satisfied.

Xyosted pathways: Branch A: ALL of the following: 1) History of one of: bilateral orchiectomy; panhypopituitarism; or a genetic disorder causing hypogonadism. 2) Patient was male at birth. 3) History of failure, contraindication, or intolerance to both testosterone cypionate injection (Depo-Testosterone) AND testosterone enanthate injection. 4) History of failure, contraindication, or intolerance to both testosterone 1.62% gel (generic Androgel 1.62%) AND Testim.

Authorization issued for 12 months.

Branch B (laboratory-based plus prior therapy requirements): 1) One of: (a) Two pre-treatment serum total testosterone levels <300 ng/dL taken at separate times; OR (b) condition causing altered SHBG AND one pre-treatment calculated free or bioavailable testosterone <50 pg/mL. 2) Patient is not taking listed growth hormones (unless panhypopituitarism) or aromatase inhibitors. 3) Patient was male at birth. 4) Diagnosis of hypogonadism. 5) Presence of at least one clinical sign (eg, significant weight reduction, osteopenia/osteoporosis/decreased bone density, decreased libido, organic cause). 6) History of failure/contraindication/intolerance to both testosterone cypionate AND testosterone enanthate injections. 7) History of failure/contraindication/intolerance to both testosterone 1.62% gel AND Testim.see thresholds

Authorization issued for 12 months; program also requires step through topical products per recent update.

Initial Authorization — Gender Dysphoria

Covered when ALL of the following are met.

Gender dysphoria initial: a) Using hormones to change physical characteristics to align with gender expression; AND b) Covered person has a DSM diagnosis of gender dysphoria; AND c) Patient is not taking listed growth hormones (unless panhypopituitarism) or an aromatase inhibitor. For Xyosted specifically, additionally requires history of failure/contraindication/intolerance to both testosterone cypionate and testosterone enanthate injections.n/a

Authorization issued for 12 months.

Reauthorization — All indications

Reauthorization will be approved based on either established history conditions OR laboratory follow-up demonstrating maintained or adjusted testosterone levels.

Reauthorization pathways: Pathway A: Patient has history of one of: bilateral orchiectomy; panhypopituitarism; or a genetic disorder known to cause hypogonadism. Pathway B: BOTH of the following: 1) One of: (a) Follow-up total serum testosterone drawn within the past 12 months is within or below normal male limits for the reporting lab (document value and date); (b) Follow-up total serum testosterone within past 12 months is above upper male limits for the reporting lab and the dose has been adjusted (document value and date); (c) When SHBG-altering condition present: follow-up calculated free or bioavailable testosterone within or below male limits OR above with dose adjustment (document value and date). 2) Patient is not taking listed growth hormones (unless panhypopituitarism) or aromatase inhibitors.follow-up labs within past 12 months

Authorization issued for 12 months.

Initial and reauthorization summary

Covered when ALL of the following are met (summary of items present in this segment):

Concomitant medication exclusions: Patient is not taking disallowed growth hormones unless diagnosed with panhypopituitarism (Genotropin, Humatrope, Norditropin FlexPro, Nutropin AQ, Omnitrope, Saizen). Patient is not taking an aromatase inhibitor (eg, anastrozole, letrozole, exemestane).

From medication exclusion list.

Authorization duration: Authorization will be issued for 12 months.12 months

State mandates and member benefit design may affect coverage.

Automated approval allowance: UnitedHealthcare may approve initial and reauthorization based solely on previous claim/medication history, diagnosis codes (ICD-10) and/or claim logic.

Use of automated approval varies by program/therapeutic class.

Coverage for use of testosterone products for the purpose of enhancement of athletic performance or bodybuilding is explicitly excluded.

Some services or product coverage may vary by member benefit plan; certain items are flagged as May be excluded from coverage depending on benefit design and plan-specific rules.

The policy does not present an explicit ‘not medically necessary’ statement in this excerpt, but program rules such as supply limits, plan-dependent exclusions, and use of automated claim logic may effectively render some requests not covered.

Laboratory & Diagnostic Thresholds

Pre-treatment total serum testosterone

ThresholdTwo pre-treatment serum total testosterone measurements < 300 ng/dL (< 10.4 nmol/L) or less than the lab reference range, taken at separate times; document lab value and date for both levels

Measurement timingTaken at separate times (may require treatment to be temporarily held to obtain measurements)

Documentation requirementDocument the lab value and date for both measurements

Pre-treatment calculated free or bioavailable testosterone (when SHBG‑altering condition present)

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

Context

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required for topical, transdermal, oral, and certain injectable testosterone products for hypogonadism and for use in gender dysphoria per policy. Authorization will be issued for 12 months unless otherwise specified by the member's benefit plan or state mandate.

Applies to topical gels/solutions, transdermal systems (patches), oral testosterone (capsules), and specified injectables (see criteria).
Authorization duration: 12 months.
State mandates and member benefit design may further affect coverage.

Documentation Required

Required Laboratory Documentation

Document pre-treatment laboratory testing. Requests that do not include required laboratory documentation may be denied.

Background

Testosterone replacement therapy is FDA-approved for males with primary hypogonadism (congenital or acquired) or hypogonadotropic (secondary) hypogonadism. Clinical benefits include improvements in muscle mass, bone density, and libido. The program provides coverage for androgen/anabolic steroid therapy when used for indicated clinical conditions within the pharmacy benefit; however, use for athletic enhancement or bodybuilding is excluded.

Definitions

Primary hypogonadism

DefinitionPrimary hypogonadism: deficiency or disorder originating in the testicles (congenital or acquired)

Clinical contextOne of the FDA‑recognized indications for testosterone replacement therapy in males

Use in criteriaQualifying anatomic/endocrine cause pathway (eg, bilateral orchiectomy) may rely on primary hypogonadism designation

Secondary (hypogonadotropic) hypogonadism

DefinitionSecondary (hypogonadotropic) hypogonadism: hypogonadism due to hypothalamic or pituitary dysfunction (congenital or acquired)

Clinical contextAlso an FDA‑recognized indication for testosterone replacement therapy in males

Initial Therapy Criteria

Initial therapy — Hypogonadism

Initial authorization requirements for topical/transdermal/oral testosterone for hypogonadism.

Initial hypogonadism: Either: A) BOTH: history of bilateral orchiectomy OR panhypopituitarism OR genetic disorder causing hypogonadism AND patient was male at birth; OR B) ALL: laboratory evidence (two pre-treatment total testosterone <300 ng/dL taken separately OR condition altering SHBG plus one pre-treatment calculated free/bioavailable testosterone <50 pg/mL), not taking excluded growth hormones or aromatase inhibitors, patient was male at birth, documented diagnosis of hypogonadism, and at least one clinical sign (eg, significant weight loss, osteopenia/osteoporosis, decreased bone density, decreased libido, organic cause).see thresholds

Document lab values and dates; authorization issued for 12 months.

Initial therapy — Gender Dysphoria

Initial therapy for gender dysphoria.

Initial gender dysphoria:

Reauthorization / Continuation Criteria

Reauthorization / Continuation Therapy

Reauthorization criteria for continuation of therapy.

Continuation/reauthorization: Either: history of qualifying anatomic/endocrine conditions (eg, bilateral orchiectomy, panhypopituitarism, genetic disorder); OR documentation of follow-up testosterone levels within the past 12 months showing levels within or below male normal limits or above male limits with dose adjustment (total or calculated free/bioavailable when SHBG altered). Patient must not be taking excluded growth hormones or aromatase inhibitors.follow-up labs within 12 months

Document lab values and any dose adjustments; authorization issued for 12 months.

Continuation therapy — Reauthorization/continuation rules

Reauthorization/continuation rules reflected in change history and authorization duration.

Reauthorization duration: Authorization and reauthorization periods are set to 12 months.

Step Therapy Requirements

Requirement	Details
Injectable testosterone products (both)
Document history of failure, contraindication, or intolerance to both testosterone cypionate injection (generic Depo-Testosterone) AND testosterone enanthate injection.
Topical testosterone products (both)
Document history of failure, contraindication, or intolerance to both testosterone 1.62% gel (generic Androgel 1.62%) AND Testim.

Program change	Effect on Xyosted step requirement
Added step through topical products (11/2025 change control)
Xyosted now requires trial and documented failure/contraindication/intolerance to topical products in addition to the listed injectable products before approval; prior language required failure of injectables and topical gels but the program update explicitly added step-through topical products.

Revision History & Changes

2014-02-??created

Prior authorization criteria for testosterone were created (Change Control entry).

2018-06-??clinical_threshold_update

Required total testosterone threshold updated to less than 300 ng/dL per 2018 American Urological Society guidelines.

2019-02-??program_update

Program name changed from Topical Androgens to Testosterone and Xyosted was added to the program.

Policy Summary

PayerUnitedHealthcare

PolicyTestosterone therapies prior authorization (topical, transdermal, oral, injectable) — coverage criteria

Policy CodePolicy N/A

Change TypeMaterial updates: authorization duration set to 12 months; Xyosted step requirement added; product list updated

Effective DateFeb 1, 2026

Next Review DateN/A

SourceLink

On This Page

Applies when the patient has a condition that may alter sex‑hormone binding globulin (SHBG) (e.g., thyroid disorder, HIV, liver disorder, diabetes, obesity)

Documentation requirementDocument the lab value and date; treatment may need to be temporarily held to obtain the test

Total testosterone level

ThresholdTotal testosterone level historically referenced as < 300 ng/dL

Source noteThreshold updated to < 300 ng/dL based on 2018 American Urological Society guidelines (see change history)

UseThreshold used in initial authorization pathways and reauthorization criteria

Two pre-treatment serum total testosterone measurements < 300 ng/dL (or below lab reference range) drawn on separate dates — document values and dates.
If a condition that alters SHBG is present (eg, thyroid disorder, HIV, liver disease, diabetes, obesity), provide one pre-treatment calculated free or bioavailable testosterone level < 50 pg/mL (or below lab reference range) — document value and date.
Labs may require holding therapy temporarily to obtain accurate results. Include dates and numeric results in the request.

Step Therapy

Product-specific Step Requirements

Specific step-therapy requirements apply for product approval. Requests lacking required prior treatment trials or documentation of failure/contraindication/intolerance may be denied.

For Xyosted: document history of failure, contraindication, or intolerance to both testosterone cypionate injection (generic Depo-Testosterone) AND testosterone enanthate injection.
For Xyosted: document history of failure, contraindication, or intolerance to both testosterone 1.62% gel (generic Androgel 1.62%) AND Testim.
Program changes implemented a step through topical products for Xyosted; ensure topical trial documentation is included when applicable.

Note

Documentation and Automated Approval

UnitedHealthcare may approve initial and reauthorization requests based on available claims/medication history, diagnosis codes, and automated claim logic. Automated approval processes vary by program and may not apply in all cases.

Authorization decisions may use prior claims and ICD-10 diagnosis codes as supporting evidence.
Automated approval and re-approval processes differ by therapeutic class and program; do not assume automated approval will occur.
Supply limits or program exclusions (including exclusion of specific brands or formulations) may apply based on benefit design.

Denial Risk

Documentation-based Denial Triggers

Requests missing required diagnostic or clinical documentation are at high risk for denial. Review these common triggers before submission.

Absence of a documented diagnosis of hypogonadism or gender dysphoria (per DSM) as required by the specific indication.
Missing required pre-treatment testosterone lab values and dates (two total testosterone measurements <300 ng/dL or, when indicated, a calculated free/bioavailable testosterone result).
Lack of documentation of prior treatment failure, contraindication, or intolerance when step-therapy for Xyosted or other products requires it.
Requests that conflict with member benefit exclusions or state/federal mandates may be denied.

Denial Risk

Denial Risks and Limits

Denial risks and coverage limits: coverage may be excluded or limited depending on member benefit design, program exclusions, or supply limits.

Supply limits may be enforced; check member-specific benefit plan for quantity/posology limits.
Some products or brands may be excluded from coverage under the benefit design.
State mandates, federal requirements, or other utilization management programs may alter coverage or approval processes.
Automated approval may not occur for all requests; manual review may be required if documentation is incomplete.

Distinguishing featureOriginates in the hypothalamus or pituitary rather than the testes

Concomitant medication exclusions

Disallowed concomitant growth hormonesGenotropin, Humatrope, Norditropin FlexPro, Nutropin AQ, Omnitrope, Saizen (use allowed only if diagnosed with panhypopituitarism)

Disallowed aromatase inhibitorsExamples: anastrozole (Arimidex), letrozole (Femara), exemestane (Aromasin)

Clinical exceptionGrowth hormones may be permitted when patient has a diagnosis of panhypopituitarism

Documentation implicationPatient must not be taking these medications at initiation or reauthorization unless exception applies

All of: using hormones to change physical characteristics to align with gender expression; DSM diagnosis of gender dysphoria documented; patient is not taking excluded growth hormones (unless panhypopituitarism) or aromatase inhibitors. For Xyosted, additionally requires prior failure/contraindication/intolerance to specified injections.

Authorization issued for 12 months.

Initial therapy — Initial therapy considerations and exclusions

Initial therapy considerations and exclusions present in this excerpt.

Medication exclusions at initiation: Patient must not be taking specified growth hormones (Genotropin, Humatrope, Norditropin FlexPro, Nutropin AQ, Omnitrope, Saizen) unless diagnosed with panhypopituitarism. Patient must not be taking aromatase inhibitors (eg, anastrozole, letrozole, exemestane).

From policy medication list.

This change was made in program updates; state mandates and benefit design may affect coverage.

Program change implications: Reauthorization may require lab values within the past 12 months for continuing users; program updates also added requirements such as male-at-birth for certain criteria and step through topical products for Xyosted.

See policy change history.

2023-01-??authorization_duration_change

Initial authorization increased to 12 months and reauthorization changed to require a lab value within the past 12 months.

2025-02-??program_update

Undecatrex added to the program (annual review/references updated).

2025-11-??material_change

Required 'male at birth' added to orchiectomy, panhypopituitarism and genetic disorder pathways; step through topical products added for Xyosted; Androderm and brand Fortesta removed as off-market.

2026-02-01effective_dateLatest

Policy effective date recorded; authorization will be issued for 12 months per program update.