CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Testopel (testosterone) pellet therapy — Prior authorization and coverage criteria

This policy governs prior authorization, coverage criteria, dosing limits, and continuation criteria for Testopel (testosterone) pellet implants for adult males with testosterone deficiency under Neighborhood Health Plan of Rhode Island (Medicaid, Medicare, Commercial).

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTestopel (testosterone) pellet therapy — Prior authorization and coverage criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJun 1, 2023

Next Review DateApr 1, 2025

Key ActionSubmit prospective prior authorization with supporting labs showing pre-treatment morning total testosterone <300 ng/dL (or free testosterone <50 pg/mL) and documentation of prior trials of topical and injectable testosterone.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

18+minimum patient age

≤450 mg / 3 momax dose / interval

6 monthsinitial auth duration

12 monthsrenewal duration

S0189

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Coverage Criteria for Testopel (Testosterone Pellets)

Initial Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met:

Initial eligibility: Patient is a male age 18 years or older; prescribed by, or in consultation with, an endocrinologist or urologist; confirmed diagnosis of primary or secondary (hypogonadotropic) hypogonadism (congenital or acquired); patient does not have breast or prostate cancer; pre-treatment morning total testosterone <300 ng/dL or below the laboratory lower limit of normal OR pre-treatment free testosterone <50 pg/mL (or below the laboratory lower limit of normal); patient has at least one sign or symptom of hypogonadism (examples include decreased spontaneous erections; reduced libido; gynecomastia; small or atrophic testes; loss of axillary or pubic hair; infertility/low or absent sperm count; hot flushes or sweats; height loss, low-trauma fracture, or low bone mineral density; decreased energy, depressed mood, poor concentration, or reduced physical/work performance); patient has contraindication to or therapeutic failure after at least a 3-month trial of both topical testosterone (e.g., gels/patches) AND injectable testosterone (e.g., testosterone cypionate or enanthate); supporting laboratory reports confirming the diagnosis are provided with the request; proposed dose does not exceed 450 mg every 3 months (up to 6 x 75 mg pellets).age >=18; total testosterone <300 ng/dL or free testosterone <50 pg/mL; max dose 450 mg/3 months

Prescriber specialty, prior therapy trials, and supporting laboratory reports are required.

Continuation Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met:

Continuation eligibility: Patient continues to meet the initial therapy criteria; absence of unacceptable toxicity from therapy (examples include hepatotoxicity, hepatitis, hepatic neoplasms, stroke, myocardial infarction, fluid/electrolyte disturbances, prostatic hypertrophy or carcinoma, polycythemia, venous thromboembolism, edema, gynecomastia, implant site infection or extrusion, etc.); patient is tolerating treatment; patient is responding with improvement in hypogonadal signs and symptoms; serum total testosterone is >300 ng/dL; dose does not exceed 450 mg every 3 months (up to 6 x 75 mg pellets).total testosterone >300 ng/dL; max dose 450 mg/3 months

Continuation approvals are for 12 months.

Coverage is excluded for members with a diagnosis of breast cancer or prostate cancer. Requests for Testopel in patients with either of these malignancies do not meet the policy’s initial eligibility criteria and should be denied or redirected per standard oncology management.

Use of Testopel at doses or for indications that are not recognized as medically accepted (per standard reference compendia such as AHFS‑DI, Thomson Micromedex DrugDex, Clinical Pharmacology, Wolters Kluwer Lexi‑Drugs, or peer‑reviewed literature) is considered investigational and not covered. Coverage is limited to the labeled dose range and approved indications described in the policy.

Coding and Dosage Limits

Applicable HCPCS/CPT CodesHCPCSCovered

S0189

Testosterone pellet; 75mg

Maximum dose per interval

Maximum dose per interval450 mg every 3 months (6 pellets of 75 mg)

Per‑interval pellet countUp to 6 pellets per 3 months

Per‑pellet unit size75 mg per pellet (HCPCS code S0189)

Billing limit frequencyLimit applies to each 3‑month billing interval

Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization required for Testopel (testosterone) pellets. Requests must be submitted prospectively. Members who have received Testopel within the past 365 days are exempt from step-therapy requirements.

Effective Date: 2023-06-01
Dose limit: ≤ 6 pellets (450 mg) every 3 months
Scope: Medicaid MMP; Medical: Medicaid, Commercial, Medicare

Step Therapy

Step Therapy Requirement

A step-therapy requirement applies: prior to approval, the member must have a documented contraindication to or therapeutic failure of BOTH topical (e.g., gels, patches) and injectable testosterone (e.g., testosterone cypionate or enanthate) after at least a 3-month trial, unless the member received Testopel within the past 365 days.

Step requirement waived if member received Testopel in last 365 days

Background

Testopel is an implantable testosterone pellet intended for testosterone replacement in adult males with primary or secondary (hypogonadotropic) hypogonadism. The policy requires patients to be male and at least 18 years of age, have a confirmed diagnosis of primary or secondary hypogonadism, and present with clinical signs or symptoms of testosterone deficiency. Pre‑treatment laboratory evidence is required (morning total testosterone <300 ng/dL or free testosterone <50 pg/mL or below the laboratory lower limit of normal).

Dosing per the policy is 150–450 mg subcutaneously every 3–6 months, with billing tied to 75 mg pellets (HCPCS code S0189); the policy limits the maximum dose to 450 mg every 3 months (up to 6 pellets of 75 mg). Clinical trials and experience cited in the source support that Testopel increases serum testosterone and can improve hypogonadal symptoms; common adverse events include local pain, bruising, and irritation at the implant site.

Indications and Dosing Summary

Indications and dosing

IndicationTestopel is indicated for testosterone deficiency due to primary or secondary (hypogonadotropic) hypogonadism in males.

Dose range150–450 mg subcutaneously every 3–6 months (total dose expressed as multiple 75 mg pellets).

Maximum billing/administrationMaximum billable units correspond to 75 mg pellets; up to 6 pellets (450 mg) every 3 months.

Administration notesAdministered subcutaneously as implantable pellets; treatment interval typically every 3–6 months based on clinical response and serum testosterone levels.

Patient selectionFor adult males (≥18 years) with confirmed primary or secondary hypogonadism and supporting laboratory values/symptoms prior to initiation.