CurrentNeighborhood Health Plan of Rhode IslandPolicy 2596-A

Yonsa (fine-particle abiraterone acetate) — coverage and prior authorization for metastatic castration‑resistant prostate cancer

This policy governs coverage and prior authorization for Yonsa (fine-particle abiraterone acetate) for FDA‑approved and compendial uses in members of Neighborhood Health Plan of Rhode Island, including criteria for authorization, continuation, and exclusions.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyYonsa (fine-particle abiraterone acetate) — coverage and prior authorization for metastatic castration‑resistant prostate cancer

Policy CodePolicy 2596-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain prior authorization for up to 12 months for Yonsa when used for metastatic castration‑resistant prostate cancer with required documentation of orchiectomy or concurrent LHRH agonist/antagonist use.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsinitial auth duration

12 monthsreauthorization

1FDA indication(s)

1Compendial uses

Coverage Criteria for Yonsa (abiraterone acetate)

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inv-01: Initial therapy — Metastatic castration‑resistant prostate cancer

Covered when ALL of the following are met:

Initial authorization criteria: 1) Diagnosis of metastatic castration‑resistant prostate cancer (CRPC) as indicated in FDA labeling; 2) Use in combination with methylprednisolone; 3) Member has had bilateral orchiectomy OR will use the requested medication in combination with an LHRH agonist (e.g., goserelin, leuprolide) or LHRH antagonist (e.g., degarelix, relugolix); 4) No exclusions to the prescribed therapy (see exclusions).

Authorization of up to 12 months may be granted.

inv-02: Continuation of therapy / Reauthorization

Covered for reauthorization when ALL of the following are met:

Reauthorization criteria: 1) Previously authorized indication listed in the coverage criteria; 2) No evidence of unacceptable toxicity while on the current regimen; 3) No evidence of disease progression while on the current regimen.

Authorization of up to 12 months may be granted for continued treatment.

Coverage will not be provided for requests to use Yonsa in combination with a second‑generation oral antiandrogen (for example, apalutamide) or with an oral androgen metabolism inhibitor (for example, abiraterone acetate [Zytiga]). Prior authorization for Yonsa when used for metastatic castration‑resistant prostate cancer (CRPC) may be granted for up to 12 months and requires that the medication be used in combination with methylprednisolone and that the member has had a bilateral orchiectomy or will use an LHRH agonist/antagonist concurrently. Documentation supporting orchiectomy or concurrent LHRH therapy is required at initial authorization.

Yonsa is positioned as a therapy for metastatic castration‑resistant prostate cancer when used in combination with methylprednisolone; coverage is conditional on meeting the policy’s specific initiation and continuation criteria and on avoidance of the prohibited concomitant agents listed above.

All indications other than the FDA‑approved indication and the listed compendial use for prostate cancer are considered experimental/investigational and not medically necessary. Additionally, combinations with the prohibited agents listed in this policy (for example, second‑generation oral antiandrogens or oral androgen metabolism inhibitors such as abiraterone acetate) are excluded from coverage.

Provider Requirements and Actions

Prior Authorization

Prior Authorization Required

Prior authorization is required and may be granted for up to 12 months for treatment of metastatic castration‑resistant prostate cancer (mCRPC).

Authorization duration: up to 12 months
Indication: metastatic castration‑resistant prostate cancer (mCRPC)

Step Therapy

Step therapy is not specified for this medication; step therapy is not required.

Documentation Required

Clinical Documentation for Initiation and Continuation

Clinical documentation must confirm orchiectomy status or concurrent use of a luteinizing hormone‑releasing hormone (LHRH) agonist or antagonist for initiation, and for continuation show lack of unacceptable toxicity or disease progression while on therapy.

For initiation: documentation of bilateral orchiectomy OR plan to use in combination with an LHRH agonist (e.g., goserelin, leuprolide) or antagonist (e.g., degarelix, relugolix).
For continuation/reauthorization: documentation showing no evidence of unacceptable toxicity and no disease progression on the current regimen.
Authorization for both initiation and continuation may be granted for up to 12 months.

Denial Risk

Prohibited Concomitant Therapies

Coverage will not be provided if used in combination with listed agents.

Prohibited concomitant therapies include second‑generation oral antiandrogens (e.g., apalutamide [Erleada])
and oral androgen metabolism inhibitors (e.g., abiraterone acetate [Zytiga]).

Definitions

Metastatic castration‑resistant prostate cancer (CRPC) — definition and relation to indication

DefinitionProstate cancer that has metastasized and progresses despite medical or surgical castration (castration‑resistant).

FDA‑approved relationYonsa (fine‑particle abiraterone acetate) is indicated in combination with methylprednisolone for treatment of metastatic castration‑resistant prostate cancer (CRPC).

Compendial useProstate cancer is listed as a compendial use; other indications are considered experimental/investigational and not medically necessary.

Clinical implicationMembers must meet the metastatic CRPC diagnosis to qualify for coverage under the FDA‑approved indication for Yonsa.

Coverage scopePolicy covers Yonsa for the FDA‑approved indication (metastatic CRPC) and listed compendial prostate cancer uses only; all other uses are not covered.