Cigna Testosterone Coverage Update: Prior Auth

Coverage Criteria

Medical Necessity — Hypogonadism and Gender-Dysphoria

Covered when ONE of the following is met.

Main groups

Hypogonadism in Males
- Age 18 years or older
- Documentation
  - Initial Therapy Requirements: Has persistent pre-treatment signs/symptoms of androgen deficiency (e.g., depressed mood, decreased energy, progressive decrease in muscle mass, osteoporosis, loss of libido); has TWO pre-treatment early-morning serum testosterone measurements (total or free; free by equilibrium dialysis); both measurements are low per laboratory reference
  - Currently Receiving with Records: Has persistent pre-treatment signs/symptoms and has at least ONE pre-treatment early-morning serum testosterone (total or free) that was low per laboratory reference
  - Currently Receiving without Records: Has a recent on-therapy serum testosterone (total or free) measurement within the normal laboratory reference range while receiving testosterone replacement therapy
    Free testosterone measured by equilibrium dialysis when applicable
- No Concurrent Product Use: No concurrent use with other testosterone products
- Preferred Product Criteria: Preferred product criteria is met for products listed in the below table(s)
  See formulary/preferred-product tables in document
FTM Gender-Affirming Therapy
- Prescriber: Medication is prescribed by, or in consultation with, an endocrinologist or a physician who specializes in the treatment of transgender individuals
- Preferred Product: Preferred product criteria is met for products listed in the below table(s)
  See formulary/preferred-product tables in document
Currently Receiving Therapy: Individual is currently receiving testosterone therapy with documentation as specified under the hypogonadism group (either available pre-treatment records or recent on-therapy level) and meets no-concurrent-use and preferred-product requirements

Initial therapy requirement for certain branded products (Individual and Family Plans)

Coverage for specific branded topical/oral testosterone products is allowed when documentation shows ALL of the following:

IFP branded product requirement: Documentation of failure, contraindication, or intolerance to ONE of the listed topical testosterone formulations is providedtrial of 1 listed product

Applies to Axiron (generic listed), Tlando, Vogelxo and similar branded topical/oral products as specified; receipt of sample does not satisfy criteria

Reauthorization criteria

Continuation of therapy is considered medically necessary when ALL of the following are met:

Beneficial response for continuation: Medical necessity criteria were previously met and documentation of beneficial response to therapy is provideddocumented benefit

Reauthorization approvals up to 12 months

Injectable testosterone products, including implantable pellets, are not covered under this policy. These formulations are governed by a separate coverage policy (see related policy: Testosterone - Injectables and Implantable Pellets).

Use of testosterone products to enhance athletic performance is explicitly listed as a condition not covered and is considered not medically necessary.

Any use not specifically listed as covered in this policy is considered not medically necessary. In particular, use for enhancing athletic performance will be denied. Note that injectable and implantable pellet formulations are excluded from this policy and are addressed in a separate coverage policy.

Coding and Lab Requirements

Coding notemixed

No codes listed

Pre-treatment testosterone measurements

Required measurementsTwo early-morning serum testosterone measurements (total or free) on two separate days; free testosterone must be measured by equilibrium dialysis assay

TimingEach sample must be an early-morning specimen

Analyte optionsTotal testosterone or free testosterone (when free is used, equilibrium dialysis is required)

Laboratory referenceBoth measurements must be low as defined by the laboratory's normal reference values

Total testosterone threshold

Total testosterone cutoffBelow 300 ng/dL (per AUA guidance cited)

Provider Actions and Authorization

Prior Authorization

Prior authorization and duration

Prior authorization may be required for certain testosterone oral, topical, and nasal products. Initial and reauthorization approvals are granted for up to 12 months when criteria are met. Many branded or non-preferred topical, oral, and nasal products require documentation of failure, contraindication, or intolerance to preferred agents as specified by plan type (Employer vs Individual & Family Plans).

Initial approval duration: up to 12 months
Reauthorization approval duration: up to 12 months
Many branded/non-preferred topical, oral, and nasal products may require prior authorization

Step Therapy

Step therapy summary

Plan-specific step therapy applies. For Employer Plans some branded/topical products require documentation of failure, contraindication, or intolerance to TWO or THREE listed generic/topical alternatives before coverage. For Individual and Family Plans most branded/topical/oral/nasal products require documentation of failure, contraindication, or intolerance to ONE listed alternative before coverage. Refer to the product tables for the exact number of required trialed alternatives by plan and product.

Background

This policy addresses diagnosis and treatment of male hypogonadism and use of masculinizing hormone therapy for gender-dysphoric individuals (FTM gender-affirming therapy) using oral, topical, and nasal testosterone formulations. Coverage requires meeting the clinical and laboratory criteria specified for hypogonadism (including required early-morning testosterone measurements) or the documentation requirements for gender-affirming therapy. Injectable testosterone products, including implantable pellets, are managed under a separate policy and are not included here.

Definitions

Hypogonadism (male) — coverage criteria

Age requirementAge 18 years or older

Clinical documentationPersistent pre-treatment signs/symptoms of androgen deficiency (e.g., depressed mood, decreased energy, loss of libido, decreased muscle mass, osteoporosis)

Laboratory confirmationTwo early-morning serum testosterone measurements (total or free; free by equilibrium dialysis) that are both low per laboratory reference values

Coverage conditionCovered when the individual meets the specified clinical and laboratory criteria and preferred product criteria is met

FTM gender-affirming therapy — coverage requirements

Prescriber requirementMedication must be prescribed by, or in consultation with, an endocrinologist or a clinician who specializes in transgender care

Initial Therapy Criteria

Initial therapy criteria for hypogonadism in males

Initial Therapy: (a) Persistent pre-treatment signs/symptoms of androgen deficiency (e.g., depressed mood, decreased energy, decreased muscle mass, osteoporosis, loss of libido); (b) TWO pre-treatment early-morning serum testosterone measurements (total or free; free by equilibrium dialysis); (c) Both measurements low per laboratory reference

Age ≥18 also required and no concurrent testosterone products; see preferred-product tables

Initial therapy requirement

Initial coverage rules for certain branded products (Individual and Family Plans)

IFP initial trial: Documentation of failure, contraindication, or intolerance to ONE of the specified topical testosterone products (e.g., Androgel 1% or 1.62%, Fortesta, Testim, Vogelxo) is required prior to coverage of certain branded products such as Axiron, Tlando, Vogelxo as listedtrial of 1 listed product

Continuation / Reauthorization Criteria

Continuation/Reauthorization

Criteria for individuals currently receiving testosterone therapy

Continuation scenarios: Either: (a) currently receiving therapy with available pre-treatment records (requires persistent pre-treatment signs/symptoms and at least ONE pre-treatment low early-morning testosterone measurement), or (b) currently receiving therapy with loss of records (requires a recent on-therapy testosterone level within the normal laboratory reference indicating appropriate treatment)

Free testosterone measured by equilibrium dialysis when applicable

Continuation/Reauthorization

Continuation (reauthorization) rules

Continuation requirement: Documentation of prior meeting of medical necessity criteria and documentation of beneficial response to therapydocumented benefit

Authorizations (initial and reauthorization) may be granted for up to 12 months when criteria are met

Step Therapy Requirements

Product / Plan Type	Step therapy requirement
Androgel (testosterone gel) — Employer Plans
Patient must have tried the bioequivalent generic testosterone gel AND cannot take the brand due to formulation differences in inactive ingredients; employer plans may require failure of 2–3 listed alternatives for some branded products (see specific plan criteria).
Fortesta (testosterone topical gel) — Employer Plans
Documentation of failure, contraindication, or intolerance to THREE of the following: Androgel 1% (or generic), Androgel 1.62% (or generic), Testosterone 30mg/1.5ml solution (generic for Axiron), Testosterone 10mg/0.5gm gel pump (generic for Fortesta), Testosterone 50mg/5gm tube (generic for Testim), Testosterone 50mg/5gm gel packet/tube or 12.5gm pump (generic for Vogelxo).
Jatenzo (testosterone undecanoate capsules) — Employer Plans
Documentation of failure, contraindication, or intolerance to TWO of the following: Androgel 1% (or generic), Androgel 1.62% (or generic), Testosterone 30mg/1.5ml solution (generic for Axiron), Testosterone 10mg/0.5gm gel pump (generic for Fortesta), Testosterone 50mg/5gm tube (generic for Testim), Testosterone 50mg/5gm gel packet/tube or 12.5gm pump (generic for Vogelxo).
Kyzatrex (testosterone undecanoate capsules) — Employer Plans
Documentation of failure, contraindication, or intolerance to TWO of the following: Androgel 1% (or generic), Androgel 1.62% (or generic), Testosterone 30mg/1.5ml solution (generic for Axiron), Testosterone 10mg/0.5gm gel pump (generic for Fortesta), Testosterone 50mg/5gm tube (generic for Testim), Testosterone 50mg/5gm gel packet/tube or 12.5gm pump (generic for Vogelxo).
Natesto, Testim, Vogelxo and other listed branded products — Employer Plans
For several employer-plan listed branded/topical products, documentation of failure, contraindication, or intolerance to THREE of the specified topical/generic formulations is required (see product-specific list).

Product / Plan Type	Required prior trial
Androderm (testosterone transdermal system) — Individual & Family Plans
Documentation of failure, contraindication, or intolerance to ONE of the following topical formulations: testosterone 1% (generic for Androgel 1%), testosterone 1.62% (generic for Androgel 1.62%), testosterone 10mg/0.5gm gel pump (generic for Fortesta), testosterone 50mg/5gm tube (generic for Testim), or testosterone 50mg/5gm gel packet/tube or 12.5gm pump (generic for Vogelxo).
Androgel, Fortesta, Jatenzo, Kyzatrex, Tlando, Vogelxo, Natesto, Testim — Individual & Family Plans
Coverage requires documentation of failure, contraindication, or intolerance to ONE of the listed topical testosterone formulations (Androgel 1% or 1.62%, Fortesta pump, Testim tube, Vogelxo generics, or Axiron generic solution) prior to approval.
Axiron (generic for Axiron) and other branded topical/oral products — Individual & Family Plans
Documentation of failure, contraindication, or intolerance to ONE listed topical gel/solution (see list above) is required before coverage of the branded product.

Site of Care and Administration

Note

Site of care and therapy parameters must be clinically appropriate

Dosage, frequency, duration of therapy, and site of care must be reasonable, clinically appropriate, and supported by evidence-based literature; orders should reflect appropriate dosing and duration for the diagnosis and patient response.

Adjust dosing and duration based on severity, alternative treatments, and prior response to therapy.
Receipt of sample product does not satisfy coverage criteria.