CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Prior Authorization Criteria — Testosterone Products

Defines prior authorization requirements for topical, nasal, oral, and injectable testosterone products for use in adults (and select uses in adolescents and females) including indications covered, required documentation, and special criteria for gender dysphoria, delayed puberty, and metastatic breast cancer. Affects prescribers and pharmacists submitting PA requests to the payer.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyPrior Authorization Criteria — Testosterone Products

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document at least two confirmed low morning testosterone levels before initiating therapy (or confirm pre-treatment level for continuation).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2confirmed low morning testosterone measurements required before initiation (minimum)

adult malesprimary indicated population for replacement therapy

age <18safety and efficacy not established for pediatric males for most products

gender dysphoriacompendial use explicitly mentioned

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Coverage Criteria

Initial therapy — Covered when ALL of the following are met

Covered when ALL of the following are met

Indication: Requested drug is prescribed for primary hypogonadism or hypogonadotropic hypogonadism

Requested drug must NOT be prescribed for age-related (late-onset) hypogonadism; the request must NOT be for continuation of therapy

Laboratory confirmation for initiation: Before the start of testosterone therapy the patient has at least two confirmed low morning testosterone levels according to current practice guidelines or the lab's reference values>=2 low morning levels

Documentation of morning timing and method per guidelines recommended

Continuation therapy — Covered when ALL of the following are met

Covered when ALL of the following are met

Continuation: The request is for continuation of therapy and documentation exists that before starting therapy the patient had a confirmed low morning testosterone level according to current practice guidelines or the lab's reference values

Provide prior laboratory documentation confirming low morning level prior to therapy initiation

Gender dysphoria — Covered when ALL of the following are met

Covered when ALL of the following are met

Informed consent and capability: Patient is able to make an informed decision to engage in hormone therapy and has been educated on contraindications and side effects and informed of fertility preservation options prior to therapy

Documentation of counseling and informed consent required

Comorbid control and provider involvement: Patient's comorbid conditions are reasonably controlled; for patients <18 years, the drug must be prescribed by or in consultation with a provider specialized in care of transgender youth with collaboration with a mental health provider

If <18, Tanner stage >=2 must be documented

Formulation for adolescents: The request is for intramuscular testosterone enanthate injection (generic Delatestryl)

This formulation is specified for patients <18 when applicable

Metastatic breast cancer / delayed puberty — 1 top-level node

Other covered uses: Inoperable metastatic breast cancer in a patient who is >5 years postmenopausal with incomplete response to other therapy for metastatic breast cancer; OR a premenopausal patient with breast cancer who has benefited from oophorectomy and is considered to have a hormone-responsive tumor; OR delayed puberty

Testopel (testosterone propionate implant pellets) is specifically listed for delayed puberty

Approved Indications (excerpt) — Covered when ANY of the following clinical scenarios are met

Covered when ANY of the following clinical scenarios are met:

Indication list: 1) Prescribed for inoperable metastatic breast cancer in a patient who is >5 years postmenopausal and had an incomplete response to other therapy for metastatic breast cancer; 2) Prescribed for a premenopausal patient with breast cancer who has benefited from oophorectomy and is considered to have a hormone-responsive tumor; 3) Prescribed for delayed puberty; 4) The request is specifically for testosterone propionate implant pellets (Testopel) for delayed puberty.

Each listed scenario must be documented

Requests for testosterone prescribed for age-related hypogonadism (late-onset) are excluded from coverage. The policy requires that the requested drug not be prescribed for age-related hypogonadism as a condition of authorization for replacement therapy in adults.

No additional exclusions are explicitly stated in the excerpt provided here. The full policy may include other exclusions not present in this extract.

Safety and efficacy of topical, nasal, and injectable testosterone products have not been established in males aged <18 years for many formulations. Use in this age group is therefore limited and product labeling should be consulted; specific preparations (for example, testosterone undecanoate or Xyosted) also state that pediatric safety and efficacy have not been established.

Within the provided extract there are no explicit statements labeling uses as 'not medically necessary.'

Coding and Lab Requirements

Provider Actions / Prior Authorization Requirements

Prior Authorization

Prior Authorization Required

Authorization required unless criteria met. Prior authorization is required for testosterone implants (Testopel) and for select indications listed below. Submit supporting clinical documentation with all requests.

Prior authorization required for testosterone propionate implant pellets (Testopel).
Prior authorization required for requests when the indication is inoperable metastatic breast cancer, premenopausal breast cancer post-oophorectomy with hormone-responsive tumor, delayed puberty, or gender dysphoria as specified in criteria.

Denial Risk

Potential Denial Triggers

Coverage may be denied for requests that do not meet documented medical necessity or that fall under exclusions. Common denial triggers include requests for testosterone to treat age-related (late-onset) hypogonadism, requests for Testopel without adequate justification, and requests for delayed puberty without appropriate specialist evaluation or documentation.

Background

Testosterone replacement therapy is indicated for adult males with deficiency or absence of endogenous testosterone due to primary hypogonadism (testicular failure) or hypogonadotropic hypogonadism (pituitary/hypothalamic causes). Therapy is intended to restore normal testosterone levels and treat clinical signs and symptoms associated with testosterone deficiency.

Definitions

Primary hypogonadism

DefinitionTesticular failure due to congenital or acquired causes leading to low serum testosterone and elevated gonadotropins (examples include cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy).

Additional causesKlinefelter syndrome, chemotherapy, or toxic damage from alcohol or heavy metals may cause primary hypogonadism.

Clinical effectThese men usually have low serum testosterone concentrations with follicle-stimulating hormone (FSH) and luteinizing hormone (LH) above the normal range.

Hypogonadotropic hypogonadism

DefinitionGonadotropin or luteinizing hormone–releasing hormone (LHRH) deficiency or pituitary–hypothalamic injury (congenital or acquired) causing low serum testosterone with normal or low gonadotropin levels.

Causes