CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Testopel (testosterone pellets) coverage — Prior authorization and coverage criteria

Policy governs prior authorization, coverage criteria, dosing limits, and continuation requirements for Testopel (testosterone pellets) for adult males with testosterone deficiency under Neighborhood Health Plan of Rhode Island (Medicaid, Commercial, and Medicare-Medicaid Plan).

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTestopel (testosterone pellets) coverage — Prior authorization and coverage criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJun 1, 2023

Next Review DateN/A

Key ActionSubmit prior authorization requests with required laboratory reports and documentation and bill using code S0189.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

18+minimum patient age

450 mg / 3 momaximum dose allowed

Initial: 6 moinitial coverage duration

Continuation: 12 mocontinuation coverage duration

S0189applicable HCPCS/CPT code

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Coverage Criteria

Initial Therapy

Covered when ALL of the following are met for initial therapy:

Population and prescriber: Patient is male and age 18 years or older; prescribed by, or in consultation with, an endocrinologist or urologist; patient does not have breast or prostate cancer.

Diagnosis: Confirmed diagnosis of primary hypogonadism (congenital or acquired) or secondary (hypogonadotropic) hypogonadism (congenital or acquired).

Laboratory criteria: Pre-treatment morning total testosterone < 300 ng/dL (or below lab lower limit of normal) OR pre-treatment free testosterone < 50 pg/mL (or below lab lower limit of normal).

Patient laboratory reports supporting diagnosis must be provided with request.

Symptoms: Patient presents with at least one symptom associated with hypogonadism (examples include reduced libido, decreased spontaneous erections, breast discomfort/gynecomastia, loss of body hair, very small or shrinking testes, infertility/low sperm count, height loss/low BMD/low-trauma fracture, hot flushes/sweats, or other less specific symptoms such as decreased energy, depressed mood, sleep disturbance, poor concentration).

At least one symptom required.

Prior therapy: Documented contraindication to or therapeutic failure of at least a 3-month trial of BOTH topical testosterone (e.g., patch or gels) AND injectable testosterone (e.g., testosterone cypionate or enanthate).3 months each

Members who received Testopel in the past 365 days are exempt from step therapy requirements.

Dose limit: Requested dose does not exceed 450 mg (6 pellets) every 3 months.<=450 mg / 3 months

1 billable unit = 75 mg.

Continuation Therapy

Covered when ALL of the following are met for continuation of therapy:

Ongoing eligibility: Patient continues to meet the initial therapy criteria and is tolerating treatment; absence of unacceptable toxicity related to the drug.

Examples of unacceptable toxicity include hepatotoxicity, hepatic neoplasms, stroke, myocardial infarction, fluid/electrolyte disturbances, prostatic hypertrophy/carcinoma, polycythemia, venous thromboembolic events, edema, gynecomastia, implant site infection or pellet extrusion.

Clinical response: Patient is responding to therapy with improvement in hypogonadal signs and symptoms.

Laboratory target: Patient has a serum total testosterone level greater than 300 ng/dL (>10.4 nmol/L).>300 ng/dL

Dose limit:

Investigational/Not Covered Uses

Not covered (investigational) when:

Investigational use: Therapy is used at a dose or for a condition other than those recognized as medically accepted indications in standard reference compendia or peer-reviewed literature.

Neighborhood does not provide coverage for investigational uses.

Patients with active breast or prostate cancer are excluded from coverage for Testopel. Requests must include supporting laboratory reports and documentation of diagnosis and prior therapies; absence of required documentation may result in denial. Uses that fall outside the recognized indications or dosing limits described in standard compendia are considered investigational and are not covered.

Therapies are considered investigational and not covered when administered at a dose or for a condition other than those recognized as medically accepted indications in standard reference compendia (e.g., AHFS-DI, Micromedex DrugDex, Clinical Pharmacology, Wolters Kluwer Lexi-Drugs) or supported by peer‑reviewed literature. Neighborhood does not provide coverage for investigational uses.

Coding

Applicable HCPCS/CPT CodesHCPCSCovered

S0189

Testosterone pellet, 75mg

inv-07: Morning total testosterone

ThresholdPre-treatment morning total testosterone < 300 ng/dL (or below laboratory lower limit of normal)

ContextRequired as part of initial therapy diagnostic criteria for Testopel prior authorization

DocumentationPatient laboratory reports showing the pre-treatment morning total testosterone must be provided with the request

inv-08: Free testosterone

ThresholdPre-treatment free testosterone < 50 pg/mL (or below laboratory lower limit of normal)

ContextAccepted alternative laboratory criterion for diagnosis when morning total testosterone is not definitive

Provider Actions

Prior Authorization

Prior Authorization Required

Prior authorization required — Testopel (testosterone pellets) requires prior authorization. Requests must include required laboratory reports that support the diagnosis (see criteria) and documentation of prior trials/failures of topical and injectable testosterone. Applicable billing/coding: HCPCS S0189 (Testosterone pellet, 75 mg).

Applicable code: S0189 (Testosterone pellet, 75 mg)

Step Therapy

Step Therapy Exemption for Previously Treated Members

Members who have previously received Testopel within the past 365 days are not subject to step therapy requirements.

Documentation Required

Background

Testopel is an implantable testosterone replacement therapy supplied as subcutaneous pellets for use in adult males with testosterone deficiency due to primary or secondary (hypogonadotropic) hypogonadism. Clinical administration is described as 150 mg to 450 mg subcutaneously every 3–6 months, with a maximum of 6 units (1 unit = 75 mg) every 3 months. Clinical evidence and labeling indicate that Testopel increases serum testosterone and can improve signs and symptoms of hypogonadism; common adverse effects include implant‑site pain, bruising, and irritation. Coverage requires documentation of diagnosis, pretreatment laboratory results, and trials of topical and injectable testosterone per policy criteria.

Definitions

inv-15: Primary hypogonadism

DefinitionCongenital or acquired testicular failure causing low testosterone (primary hypogonadism)

Eligible whenConfirmed diagnosis with supporting laboratory reports and presence of hypogonadal symptoms

Dose guidanceRecommended dosing for eligible patients: 150 mg to 450 mg subcutaneously every 3–6 months (maximum 6 pellets/450 mg per 3 months)

inv-16: Secondary (hypogonadotropic) hypogonadism

DefinitionCongenital or acquired hypothalamic or pituitary dysfunction causing low testosterone (secondary or hypogonadotropic hypogonadism)

Eligible whenConfirmed diagnosis with supporting laboratory reports and presence of hypogonadal symptoms