CurrentcareoregonPolicy N/A

Prior authorization guideline — Testosterone topical gels and pumps

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Prior authorization guideline for generic testosterone topical products (1.62% gel and 1% gel/pump) describing coverage criteria for diagnoses including AIDS wasting syndrome, metastatic breast cancer palliation, gender dysphoria, and hypogonadism. Applies to CareOregon members requesting covered testosterone topical formulations.

Policy Summary

Payercareoregon

PolicyPrior authorization guideline — Testosterone topical gels and pumps

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJul 1, 2026

Next Review DateN/A

Key ActionPrior authorization is required and submit medical records documenting trial and failure of injectable testosterone or clinical justification/contraindication to injections.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

4distinct approved indications listed

Lifetimeapproval length for listed indications

>=10%AIDS wasting weight loss threshold

50%hematocrit cutoff (exclusion)

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CurrentcareoregonPolicy N/A

Prior authorization guideline — Testosterone topical gels and pumps

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Policy Summary

Payercareoregon

PolicyPrior authorization guideline — Testosterone topical gels and pumps

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJul 1, 2026

Next Review DateN/A

Key ActionPrior authorization is required and submit medical records documenting trial and failure of injectable testosterone or clinical justification/contraindication to injections.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

4distinct approved indications listed

Lifetimeapproval length for listed indications

>=10%AIDS wasting weight loss threshold

50%hematocrit cutoff (exclusion)

Coverage Criteria for Testosterone Topical Products

AIDS wasting syndrome (Initial)

Covered when ALL of the following are met for AIDS wasting syndrome:

AIDS wasting syndrome criteria: 1) Diagnosis of AIDS wasting syndrome defined by involuntary loss of >10% body weight AND 2) Submission of medical records (e.g., chart notes) documenting at least one of: trial and failure of injectable testosterone OR clinical justification to avoid injections OR contraindication to injectable testosterone.

Metastatic breast cancer (palliative)

Covered when ALL of the following are met for metastatic breast cancer palliation:

Metastatic mammary cancer palliation: 1) Treatment is for palliation of inoperable metastatic (skeletal) mammary cancer in a patient 1 to 5 years post‑menopausal AND 2) Submission of medical records (e.g., chart notes) documenting at least one of: trial and failure of injectable testosterone OR clinical justification to avoid injections OR contraindication to injectable testosterone.

Gender dysphoria

Covered when ALL of the following are met for gender dysphoria:

Gender dysphoria: 1) Diagnosis of gender dysphoria.

Hypogonadism

Covered when ALL of the following are met for hypogonadism:

Diagnosis of either: (1) Primary hypogonadism (congenital or acquired) as defined OR (2) Hypogonadotropic hypogonadism (congenital or acquired) as defined.

Safety exclusions: Patient does NOT have any of the following: breast cancer or known or suspected prostate cancer; elevated hematocrit (greater than 50%); untreated severe obstructive sleep apnea; severe lower urinary tract symptoms; uncontrolled or poorly‑controlled heart failure.

Cardiovascular history: Patient has not experienced a recent major cardiovascular event (e.g., myocardial infarction).

Coverage is subject to clinical exclusions. Patients with breast cancer or known or suspected prostate cancer are excluded from approval of testosterone topical therapy. Coverage is also denied when the member has an elevated hematocrit (greater than 50%), untreated severe obstructive sleep apnea, severe lower urinary tract symptoms, or uncontrolled or poorly-controlled heart failure. Additionally, a history of a recent major cardiovascular event (for example, myocardial infarction) excludes the patient from therapy.

Provider Actions and Documentation Requirements

Prior Authorization

Prior authorization required for listed topical testosterone products

Prior authorization is required for requests for generic testosterone topical products listed in the guideline (generic testosterone 1.62% gel; generic testosterone gel 50 mg/5 g [1%]; generic testosterone pump [1%]).

Applies to the product names listed in the guideline: generic testosterone 1.62% gel and pump; generic testosterone gel 50 mg/5 g (1%); generic testosterone pump (1%).

Step Therapy

Injectable testosterone trial/failure or documented contraindication may be required

For certain indications (e.g., AIDS wasting syndrome and palliative metastatic breast cancer), the guideline requires documentation of trial and failure of injectable testosterone or documentation of a clinical justification/contraindication to injections prior to approval of topical testosterone.

Documentation must show trial and failure of injectable testosterone OR clinical justification to avoid injections OR a contraindication to injectable testosterone.

Covered Products and Key Clinical Thresholds

Covered productsNDC | product namesCovered

generic testosterone 1.62% gel	Product name listed in guideline
generic testosterone gel 50 mg/5 g (1%)	Product name listed in guideline
generic testosterone pump (1%)	Product name listed in guideline

inv-07: AIDS wasting syndrome weight loss threshold

ThresholdInvoluntary loss of more than 10% of body weight

Applies toAIDS wasting syndrome initial authorization for generic testosterone topical products

Documentation requirementSubmission of medical records documenting trial and failure of injectable testosterone OR clinical justification to avoid injections OR contraindication to injectable testosterone

inv-08: Elevated hematocrit cutoff

Cutoff valueElevated hematocrit defined as greater than 50%

ConsequencePresence of hematocrit >50% is an exclusion to coverage

Initial Authorization Requirements

Initial therapy documentation — initial authorization requirements for certain indications

Initial authorization requirements for certain indications

Documentation requirement: Submission of medical records documenting trial and failure of injectable testosterone OR clinical justification to avoid injections OR contraindication to injectable testosterone.

Specified for AIDS wasting syndrome and metastatic breast cancer indications.

Step Therapy Requirements

Step	Required prior step(s)	Applicable indications	Notes / required documentation
1	Trial and failure of injectable testosterone OR documentation of clinical justification to avoid injections OR contraindication to injectable testosterone	AIDS wasting syndrome; Palliative treatment of inoperable metastatic (skeletal) mammary cancer in patients 1 to 5 years post‑menopausal	Submission of medical records (e.g., chart notes) documenting trial and failure of injectable testosterone or clinical justification/contraindication to avoid injections is required prior to approval of topical products.

Key Definitions

inv-14: AIDS wasting syndrome definition (involuntary weight loss >10% body weight)

DefinitionAIDS wasting syndrome defined as an involuntary loss of more than 10 percent of body weight

Related coverageUsed as diagnostic criterion for initial authorization of topical testosterone products

Evidence requiredMedical records documenting trial and failure of injectable testosterone OR clinical justification/contraindication to injections

inv-15: Primary hypogonadism definition

DefinitionPrimary hypogonadism: testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchidectomy, Klinefelter's syndrome, chemotherapy, trauma, or toxic damage from alcohol or heavy metals

Scope

Background

Testosterone topical gels and pumps are used for several clinical purposes relevant to this guideline. They provide testosterone replacement for patients with documented hypogonadism (primary or hypogonadotropic, congenital or acquired). Topical formulations are also used as part of gender-affirming hormone therapy for persons with gender dysphoria. In addition, topical testosterone may be used for palliative treatment of inoperable metastatic mammary (breast) cancer in appropriately selected postmenopausal patients, and to address significant involuntary weight loss in AIDS wasting syndrome when criteria are met and injectable therapy is unsuitable or has failed.