ModifiedColorado Rocky Mountain Health Plans | UnitedHealthcare Pharmacy Clinical Pharmacy ProgramsPolicy N/A

Pa Med Nec Testosterone

Defines prior authorization and medical necessity criteria for testosterone products (topical gels/solutions/patches/oral/certain injectables like Xyosted) for treatment of hypogonadism and for gender dysphoria (female-to-male), including initial authorization, Xyosted-specific rules, and reauthorization requirements. Applies to covered members under the plan's pharmacy benefit; some products may be excluded.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyPa Med Nec Testosterone

Policy CodePolicy N/A

Change TypeModified — material updates (product additions, criteria and lab thresholds)

Effective DateFeb 1, 2026

Next Review Date

Key ActionObtain prior authorization and document required pre-treatment and follow-up testosterone lab values and dates; authorizations are issued for 12 months.

SourceLink

POLICY UPDATE CHANGES

Added requirement male at birth to orchiectomy, panhypopituitarism and genetic disorders requirement section (11/2025).

Added Undecatrex to program (2/2025).

Kyzatrex added to program (1/2023).

Increased initial authorization to 12 months and changed reauthorization to require a lab value within the past 12 months (1/2023).

Updated required testosterone level to less than 300 ng/dL based on 2018 guidelines (2/2019).

12 monthsAuthorization duration

300 ng/dLTotal testosterone threshold

50 pg/mLFree/bioavailable threshold

YesXyosted prior failures required

Coverage Summary

This policy defines prior authorization and medical necessity criteria for testosterone products used as replacement therapy for hypogonadism and for gender dysphoria (female-to-male / transgender masculinizing therapy). It applies to topical gels/solutions/patches, oral testosterone, and certain injectables (including Xyosted) under the plan's pharmacy benefit. The program's stance is covered with criteria; coverage is provided when the policy's clinical and documentation requirements are met, while use for performance enhancement or bodybuilding is explicitly excluded. Examples of covered product names include Androgel, Jatenzo, Natesto, Kyzatrex, Testim, Tlando, Undecatrex, Vogelxo, Xyosted, testosterone cypionate and enanthate injections, though the policy notes some products may be excluded (products marked with *). Effective date is 2026-02-01; last review occurred in 11/2025.

Quick facts & thresholds

Authorization duration12 months

Total testosterone thresholdTwo pre-treatment serum total testosterone levels < 300 ng/dL (<10.4 nmol/L) (or below lab reference range) taken at separate times

Free/bioavailable thresholdOne pre-treatment calculated free or bioavailable testosterone < 50 pg/mL (<5 ng/dL or <0.17 nmol/L) (or below lab reference range) when SHBG‑altering condition present

Reauthorization lab windowFollow-up testosterone level (total or calculated free/bioavailable when applicable) drawn within the past 12 months (document value and date)

Xyosted prior failures noteXyosted generally requires documented failure, contraindication, or intolerance to specified injectable products (testosterone cypionate and enanthate) and to specified topical products (testosterone 1.62% gel and Testim) or meeting lab-criteria branch

Medical-Necessity Criteria — Initial Authorization

A. Initial Authorization - Xyosted (testosterone enanthate)

Approved when either branch a OR b is satisfied (both include multiple conditions), plus listed requirements; authorization 12 months.

ANY of the following

a. Xyosted - etiology-based approval
- Patient has a history of one of the following: Bilateral orchiectomy; Panhypopituitarism; A genetic disorder known to cause hypogonadism (eg, congenital anorchia, Klinefelter's syndrome)
- Patient was male at birth
  Requirement added 11/2025
- History of failure, contraindication, or intolerance to both of the following: testosterone cypionate injection (generic Depo‑Testosterone); testosterone enanthate injection

Medical-Necessity Criteria — Reauthorization

C. Reauthorization (for both hypogonadism and gender dysphoria)

Reauthorization approved when ONE of the branches (a OR b) is satisfied and patient is not taking excluded meds:

ANY of the following

a. Reauthorization based on persistent etiologies
- Patient has a history of one of the following: Bilateral orchiectomy; Panhypopituitarism; A genetic disorder known to cause hypogonadism (eg, congenital anorchia, Klinefelter's syndrome)
b. Reauthorization based on laboratory follow-up
- Follow-up testosterone evidence (one of)
  - Follow-up total serum testosterone level drawn within the past 12 months is within or below the normal male limits of the reporting labDrawn within past 12 months

Coding

Covered product list (examples mentioned in policy)mixedCovered

Androgel	testosterone gel (brand Androgel)
Jatenzo	oral testosterone (brand Jatenzo)
Natesto	testosterone nasal gel (brand Natesto)
Kyzatrex	oral testosterone (brand Kyzatrex)
Testim	testosterone transdermal gel (brand Testim)
Fortesta (generic)	testosterone gel (generic Fortesta)
Axiron (generic)	testosterone topical solution (generic Axiron)
Tlando	oral testosterone (brand Tlando)
Undecatrex	testosterone product Undecatrex
Vogelxo	testosterone gel (brand Vogelxo)

1–10 of 12

1/2

May be excluded from coveragemixedNot Covered

Testim (generic)

testosterone transdermal gel — generic Testim may be excluded from coverage

ICD-10/diagnosis codes used for automated approvals (referenced generally)ICD-10

unspecified

ICD-10 diagnosis codes (various) may be used for automated approvals and claim logic

Provider Actions

Prior Authorization

Prior authorization required

Testosterone products require prior authorization. Authorizations (initial and reauthorization) will be issued for 12 months. Xyosted has additional step-through and specific failure requirements before approval.

Documentation Required

Laboratory documentation required

Document laboratory values and dates for required pre-treatment and follow-up testosterone tests. For pre-treatment: two serum total testosterone levels <300 ng/dL taken at separate times, or when SHBG‑altering conditions are present a single calculated free or bioavailable level <50 pg/mL — testing may require temporarily holding treatment to obtain accurate labs. For reauthorization: document follow-up total or free/bioavailable testosterone drawn within the past 12 months with values and dates.

Background & Definitions

Testosterone products are FDA-approved for replacement therapy in males with primary or hypogonadotropic hypogonadism. The program provides coverage for medically indicated androgen therapy and specifically excludes coverage for use for performance enhancement or bodybuilding. The policy also indicates that certain products may be excluded from coverage (items marked with *), and the change history documents marketplace-driven removals and additions (for example, removal of Androderm and brand Fortesta as off-market and additions such as Kyzatrex and Undecatrex).

Definitions

Male at birthPolicy-specified requirement for certain etiology-based approvals (e.g., orchiectomy, panhypopituitarism, genetic disorders).

SHBGSex‑hormone binding globulin; conditions that may alter SHBG (eg, thyroid disorder, HIV, liver disorder, diabetes, obesity) prompt use of calculated free or bioavailable testosterone testing.

Guideline and evidence references cited include the WPATH Standards of Care v8 (2022) and clinical practice guidelines from the Endocrine Society and AUA (2017–2018). The policy uses these guidelines to support clinical thresholds such as a total serum testosterone < 300 ng/dL (documented on two separate occasions) and a free/bioavailable testosterone < 50 pg/mL for situations with altered SHBG.

Revision History

11/2025added_requirementLatest

Added requirement that patient was male at birth for approvals based on bilateral orchiectomy, panhypopituitarism, or genetic disorders; also added step-through topical products for Xyosted and removed Androderm and brand Fortesta as off market. Detail: Also added step through topical products for Xyosted and removed Androderm and brand Fortesta as off market.

2/2025added_product

Undecatrex added to program. Detail: Added Undecatrex to program.

1/2023added_product

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyPa Med Nec Testosterone

Policy CodePolicy N/A

Change TypeModified — material updates (product additions, criteria and lab thresholds)

Effective DateFeb 1, 2026

Next Review Date

Key ActionObtain prior authorization and document required pre-treatment and follow-up testosterone lab values and dates; authorizations are issued for 12 months.

SourceLink

On This Page

Document prior treatment failures

History of failure, contraindication, or intolerance to both of the following: testosterone 1.62% gel (generic Androgel 1.62%); Testim

Document prior treatment failures

b. Xyosted - laboratory-based approval plus prior treatment failures

Pre-treatment testosterone evidence (one of)
- Two pre-treatment serum total testosterone levels less than 300 ng/dL (< 10.4 nmol/L) or less than the reference range for the lab, taken at separate times< 300 ng/dL (two separate times)
  Document lab value and date for both levels; treatment may need to be temporarily held
- OR when SHBG altered
  - Patient has a condition that may cause altered SHBG (eg, thyroid disorder, HIV disease, liver disorder, diabetes, obesity)
  - One pre-treatment calculated free or bioavailable testosterone level less than 50 pg/mL (<5 ng/dL or <0.17 nmol/L) or less than the reference range for the lab< 50 pg/mL (single)
    Document lab value and date
Patient is not taking any of the following: listed growth hormones unless panhypopituitarism; Aromatase inhibitor (anastrozole, letrozole, exemestane)
Patient was male at birth
Requirement added 11/2025
Diagnosis of hypogonadism
Clinical indication (one of)
- Significant reduction in weight (less than 90% ideal body weight)< 90% ideal body weight
- Osteopenia
- Osteoporosis
- Decreased bone density
- Decreased libido
- Organic cause of testosterone deficiency (eg, injury, tumor, infection, or genetic defects)
History of failure, contraindication, or intolerance to both of the following injectable products: testosterone cypionate injection (generic Depo-Testosterone) and testosterone enanthate injection
Document prior treatment failures
History of failure, contraindication, or intolerance to both of the following topical products: testosterone 1.62% gel (generic Androgel 1.62%) and Testim
Document prior treatment failures

B. Initial Authorization for Gender Dysphoria (female-to-male / transgender masculinizing therapy)

Topical/oral testosterone approved when ALL of the following are met:

ALL of the following

Using hormones to change physical characteristics to align with gender expression
The covered person must be diagnosed with gender dysphoria, as defined by the current DSM
Patient is not taking any of the following: One of the following growth hormones, unless diagnosed with panhypopituitarism: Genotropin, Humatrope, Norditropin FlexPro, Nutropin AQ, Omnitrope, Saizen; Aromatase inhibitor (eg, anastrozole, letrozole, exemestane)

B. Initial Authorization for Xyosted for Gender Dysphoria

Xyosted approved when ALL of the following are met:

ALL of the following

Using hormones to change physical characteristics to align with gender expression
The covered person must be diagnosed with gender dysphoria, as defined by the current DSM
Patient is not taking any of the following: One of the following growth hormones, unless diagnosed with panhypopituitarism: Genotropin, Humatrope, Norditropin FlexPro, Nutropin AQ, Omnitrope, Saizen; Aromatase inhibitor (eg, anastrozole, letrozole, exemestane)
History of failure, contraindication, or intolerance to both of the following: testosterone cypionate injection (generic Depo-Testosterone); testosterone enanthate injection
Document prior injectable treatment failures

Document value and date

Follow-up total serum testosterone level drawn within the past 12 months is outside of upper male limits of normal for the reporting lab and the dose is adjustedDrawn within past 12 months

Document value and date

If SHBG-altering condition present then free/bioavailable criteria (one of)

Patient has a condition that may cause altered SHBG (eg, thyroid disorder, HIV disease, liver disorder, diabetes, obesity)
Follow-up calculated free or bioavailable testosterone level drawn within the past 12 months is within or below the normal male limits of the reporting lab OR is outside upper male limits and dose adjustedDrawn within past 12 months
Document lab value and date

Patient is not taking any of the following: One of the following growth hormones, unless diagnosed with panhypopituitarism: Genotropin, Humatrope, Norditropin FlexPro, Nutropin AQ, Omnitrope, Saizen; Aromatase inhibitor (eg, anastrozole, letrozole, exemestane)

Documentation Required

Document prior treatment failures for Xyosted

For Xyosted, document history of failure, contraindication, or intolerance to the specified injectable products (testosterone cypionate injection and testosterone enanthate injection) and to the specified topical products (testosterone 1.62% gel and Testim) as applicable prior to approval.

Billing Rule

Automated approvals may apply

UnitedHealthcare may approve initial authorizations and reauthorizations based solely on prior claims or medication history, diagnosis codes (ICD‑10) and/or claim logic. Automated approval processes may be used and supply limits may apply.

Kyzatrex added to program. Detail: Kyzatrex added to program.

1/2023authorization_change

Increased initial authorization to 12 months and changed reauthorization to require a lab value within the past 12 months. Detail: Increased initial authorization to 12 months and changed reauthorization to require a lab value within the past 12 months.

2/2019threshold_update

Updated required total testosterone threshold to less than 300 ng/dL based on 2018 guidelines. Detail: Updated required testosterone level to less than 300 ng/dL based on 2018 guidelines.