CurrentGeorgia Department of Community HealthPolicy N/A

Georgia Medicaid FFS — Oncology, Oral - Breast PA Summary

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Defines prior authorization coverage criteria and authorization length for specified oral and related breast cancer oncology therapies for Georgia Medicaid Fee-For-Service members.

Policy Summary

PayerGeorgia Department of Community Health

PolicyOncology, Oral - Breast PA Summary (Georgia Medicaid FFS)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization requests via OptumRx (call 1-866-525-5827 or follow online PA process); approvals granted when member meets drug-specific diagnosis and therapy criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

15+listed drugs/agents

1 yearauth length

Stage IVadvanced disease note

OptumRxPA vendor

OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

CurrentGeorgia Department of Community HealthPolicy N/A

Georgia Medicaid FFS — Oncology, Oral - Breast PA Summary

Customize your policy alerts

Sign up for all Georgia Department of Community Health policy alerts

Know when Georgia Department of Community Health releases new policies or updates existing guidance.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

Defines prior authorization coverage criteria and authorization length for specified oral and related breast cancer oncology therapies for Georgia Medicaid Fee-For-Service members.

Policy Summary

PayerGeorgia Department of Community Health

PolicyOncology, Oral - Breast PA Summary (Georgia Medicaid FFS)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization requests via OptumRx (call 1-866-525-5827 or follow online PA process); approvals granted when member meets drug-specific diagnosis and therapy criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

15+listed drugs/agents

1 yearauth length

Stage IVadvanced disease note

OptumRxPA vendor

Drug-specific Coverage Criteria

Ibrance — Initial/continued use

Ibrance (palbociclib) — covered when ALL of the following are met

Ibrance approval criteria: Diagnosis of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative recurrent, advanced or metastatic breast cancer; used in combination with an aromatase inhibitor or with fulvestrant (Faslodex); male and pre/perimenopausal members must be receiving a luteinizing hormone–releasing hormone (LHRH) agonist unless a LHRH agonist is not appropriate for the member.

Itovebi — Biomarker and prior therapy requirement

Itovebi (inavolisib) — covered when ALL of the following are met

Itovebi approval criteria: Diagnosis of PIK3CA-mutated, HR-positive, HER2-negative recurrent, advanced or metastatic breast cancer; used in combination with fulvestrant (Faslodex) and palbociclib (Ibrance); member is endocrine-resistant and has experienced disease recurrence while on or after completing adjuvant endocrine therapy; male and pre/perimenopausal members must be receiving a luteinizing hormone–releasing hormone (LHRH) agonist unless a LHRH agonist is not appropriate for the member.

Kisqali / Kisqali Femara Co-Pack

Kisqali (ribociclib) and Kisqali Femara Co-Pack — covered when ALL of the following are met

Kisqali approval criteria: Diagnosis of HR-positive, HER2-negative breast cancer; used in combination with an aromatase inhibitor or with fulvestrant (Faslodex); male and pre/perimenopausal members must be receiving a luteinizing hormone–releasing hormone (LHRH) agonist unless a LHRH agonist is not appropriate for the member.

Kisqali Femara Co-Pack approval criteria: Diagnosis of postmenopausal HR-positive, HER2-negative breast cancer; male and pre/perimenopausal members must be receiving a luteinizing hormone–releasing hormone (LHRH) agonist unless a LHRH agonist is not appropriate for the member.

Nerlynx — Early and late-stage criteria

Nerlynx (neratinib) — covered when ANY of the following specific scenarios are met

Nerlynx scenario A: Early-stage (Stage I, II or III) HER2-positive breast cancer when the member has completed adjuvant trastuzumab (Herceptin)-based therapy.

Nerlynx scenario B: Late-stage (Stage IV) advanced, metastatic or recurrent HER2-positive breast cancer when used in combination with capecitabine (Xeloda) and the member has received two or more prior anti-HER2 based regimens.

Orserdu — ESR1 mutation requirement

Orserdu (elacestrant) — covered when ALL of the following are met

Orserdu approval criteria: Male or postmenopausal female with a diagnosis of estrogen receptor (ER)-positive, HER2-negative recurrent, advanced or metastatic breast cancer with an ESR1 mutation who has disease progression following at least one line of endocrine therapy.

Phesgo — Combination chemotherapy contexts

Phesgo (pertuzumab/trastuzumab/hyaluronidase-zzxf) — covered when ALL of the following are met

Phesgo scenario A: HER2-positive breast cancer when used in combination with chemotherapy.

Phesgo scenario B: HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease when used in combination with docetaxel.

Piqray — PIK3CA mutation and progression requirement

Piqray (alpelisib) — covered when ALL of the following are met

Piqray approval criteria: Diagnosis of PIK3CA-mutated, HR-positive, HER2-negative recurrent, advanced or metastatic breast cancer; used in combination with fulvestrant (Faslodex); member has experienced disease progression while on or after an endocrine-based regimen.

Talzenna — BRCA and HRR indications

Talzenna (talazoparib) — covered when ANY of the following are met

Talzenna scenario A: BRCA-mutated recurrent, HER2-negative recurrent, advanced or metastatic breast cancer.

Talzenna scenario B: Homologous recombination repair (HRR) gene–mutated metastatic castration-resistant prostate cancer when used in combination with enzalutamide (Xtandi) and when used concurrently with a gonadotropin-releasing hormone (GnRH) analog or the member has had bilateral orchiectomy.

Truqap — Biomarker-driven and timing criteria

Truqap (capivasertib) — covered when ALL of the following are met

Truqap approval criteria: Diagnosis of HR-positive, HER2-negative recurrent, advanced or metastatic breast cancer with a PIK3CA/AKT1/PTEN alteration; experienced disease progression following at least one endocrine-based regimen or experienced recurrence on or within 12 months of completing adjuvant therapy; used in combination with fulvestrant (Faslodex); male and pre/perimenopausal members must be receiving a luteinizing hormone–releasing hormone (LHRH) agonist unless a LHRH agonist is not appropriate for the member.

Tukysa — Breast and colorectal indications

Tukysa (tucatinib) — covered when ANY of the following are met

Tukysa scenario A: HER2-positive unresectable, recurrent, advanced or metastatic breast cancer when used in combination with trastuzumab (Herceptin) and capecitabine (Xeloda) and who have received one or more prior anti-HER2-based regimens.

Tukysa scenario B: RAS wild-type, HER2-positive advanced, metastatic or unresectable colorectal cancer who have progressed following treatment with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy.

Verzenio — Early and advanced disease contexts

Verzenio (abemaciclib) — covered when ANY of the following are met

Verzenio scenario A: HR-positive, HER2-negative node-positive early breast cancer at high risk of recurrence when used in combination with tamoxifen or an aromatase inhibitor.

Verzenio scenario B: HR-positive, HER2-negative recurrent, advanced or metastatic breast cancer when used in combination with an aromatase inhibitor.

Verzenio scenario C: HR-positive, HER2-negative recurrent, advanced or metastatic breast cancer when used in combination with fulvestrant (Faslodex).

Verzenio scenario D: HR-positive, HER2-negative recurrent, advanced or metastatic breast cancer who have experienced disease progression following endocrine therapy and prior chemotherapy; male and pre/perimenopausal members must be receiving a luteinizing hormone–releasing hormone (LHRH) agonist unless a LHRH agonist is not appropriate for the member.

Exceptions to the coverage conditions in this policy are handled through the prior authorization process and are not excluded categorically. Providers must submit an exception request via the PA process for consideration; failure to obtain authorization may result in non-coverage. To initiate prior authorization, providers may call OptumRx at 1-866-525-5827.

Biomarker and Molecular Test Requirements

PIK3CA

DefinitionPIK3CA-mutated — alteration in the PIK3CA gene required for coverage of specific agents

Drugs requiring PIK3CAItovebi (inavolisib), Piqray (alpelisib), Truqap (capivasertib)

Indication contextRequired for HR-positive, HER2-negative recurrent, advanced or metastatic breast cancer when specified by drug criteria

Therapy combination examplesOften required when used in combination with fulvestrant (and palbociclib for Itovebi) per drug-specific criteria

ESR1

DefinitionESR1 mutation — estrogen receptor gene mutation required for coverage of elacestrant (Orserdu)

Drug requiring ESR1Orserdu (elacestrant)

Clinical contextMale or postmenopausal female with ER-positive, HER2-negative recurrent, advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy

BRCA

DefinitionBRCA-mutated — germline or somatic BRCA alteration required for coverage in specified indication

Drug requiring BRCATalzenna (talazoparib)

IndicationBRCA-mutated recurrent, HER2-negative recurrent, advanced or metastatic breast cancer

AKT1/PTEN

DefinitionPIK3CA/AKT1/PTEN alteration — alteration in one or more of these genes required for coverage

Drug requiring alterationTruqap (capivasertib)

Clinical requirementUsed in HR-positive, HER2-negative recurrent, advanced or metastatic breast cancer with disease progression following at least one endocrine-based regimen or recurrence within 12 months of completing adjuvant therapy

Indicated Line(s) of Therapy

second-line

Second-line — applicable when ANY of the following are met

Post-endocrine progression or endocrine-resistant: Coverage for certain agents requires disease progression on or after endocrine therapy or endocrine-resistant disease (examples include Itovebi, Piqray, Truqap).

adjuvant

Adjuvant/early-stage — applicable when ANY of the following are met

Adjuvant/early-stage use: Nerlynx is approvable after completion of adjuvant trastuzumab-based therapy for early-stage (Stage I–III) HER2-positive disease; Verzenio is approvable for node-positive, high-risk early breast cancer when used with tamoxifen or an aromatase inhibitor.

Permitted Drug Regimens and Combinations

Regimen	Indication	Coverage status
Ibrance (palbociclib) or Kisqali (ribociclib) or Verzenio (abemaciclib) combined with an aromatase inhibitor
HR-positive, HER2-negative recurrent, advanced or metastatic breast cancer; combination with an aromatase inhibitor
Covered when criteria met
Ibrance or Kisqali or Verzenio combined with fulvestrant (Faslodex)
HR-positive, HER2-negative recurrent, advanced or metastatic breast cancer; combination with fulvestrant
Covered when criteria met
Verzenio plus tamoxifen or an aromatase inhibitor
HR-positive, HER2-negative node-positive early breast cancer at high risk of recurrence; used with adjuvant endocrine therapy
Covered when criteria met

Regimen	Indication	Coverage status
Phesgo (pertuzumab/trastuzumab/hyaluronidase) with chemotherapy
HER2-positive breast cancer when used in combination with chemotherapy
Covered when criteria met
Phesgo with docetaxel for metastatic disease without prior anti-HER2 therapy or chemotherapy
HER2-positive metastatic breast cancer in members who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease
Covered when criteria met

Regimen	Indication	Coverage status
Tukysa (tucatinib) plus trastuzumab (Herceptin) and capecitabine (Xeloda)
HER2-positive unresectable, recurrent, advanced or metastatic breast cancer in combination with trastuzumab and capecitabine; for members who have received one or more prior anti-HER2-based regimens
Covered when criteria met

Prior Authorization and Provider Requirements

Prior Authorization

Prior authorization required — approvals tied to drug-specific criteria

Prior authorization is required for the listed oral and related breast cancer therapies; approvals are granted only when the member meets the specific diagnosis and therapy combination criteria listed per drug. The standard length of authorization is one year.

Approvals are tied to the drug-specific clinical criteria (diagnosis, biomarker status, line of therapy, and combination regimen) shown for each agent.

Step Therapy

Endocrine therapy failure requirement for certain agents

Certain agents require prior endocrine therapy failure or endocrine-resistant disease before approval (examples include Itovebi/inavolisib, Piqray/alpelisib, and Truqap/capivasertib).

Itovebi: member must be endocrine-resistant with disease recurrence while on or after completing adjuvant endocrine therapy.
Piqray: member must have experienced disease progression while on or after an endocrine-based regimen.
Truqap: member must have experienced disease progression following at least one endocrine-based regimen or recurrence on or within 12 months of completing adjuvant therapy.

Documentation Required

How to request prior authorization

Initiate prior authorization requests via OptumRx; online PA submission guidance is also available through the Georgia DCH PA process page.

Telephone: call OptumRx at 1-866-525-5827 to begin the Prior Authorization process.
Online: see www.dch.georgia.gov/prior-authorization-process-and-criteria and click the Prior Authorization (PA) Request Process Guide for web submission instructions.

Denial Risk

Prior authorization exceptions and coverage risk if PA not obtained

Exceptions to coverage criteria are evaluated only through the prior authorization process; failure to obtain a required prior authorization may result in non-coverage of the drug.

Exceptions are considered via PA—do not assume coverage without an approved PA.

Listed Drugs / Codes

Listed drugs/agents in summaryNDC | drug names

Ibrance	palbociclib
Itovebi	inavolisib
Kisqali	ribociclib
Kisqali Femara Co-Pack	ribociclib/letrozole
Nerlynx	neratinib
Orserdu	elacestrant
Phesgo	pertuzumab/trastuzumab/hyaluronidase-zzxf
Piqray	alpelisib
Talzenna	talazoparib
Truqap	capivasertib

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Key Clinical Definitions

HR-positive, HER2-negative

DefinitionHormone receptor (HR)-positive, HER2-negative — primary clinical population for CDK4/6 inhibitors and endocrine-combination approvals

Common therapiesIbrance (palbociclib), Kisqali (ribociclib), Verzenio (abemaciclib) in combination with aromatase inhibitors or fulvestrant

Premenopausal/male specificationMale and pre/perimenopausal members must be receiving an LHRH agonist unless not appropriate

HER2-positive

DefinitionHER2-positive — disease status determining eligibility for HER2-targeted therapies

Early-stage use exampleNerlynx approvable after completion of adjuvant trastuzumab-based therapy for Stage I–III disease

Metastatic use examplesNerlynx with capecitabine after ≥2 prior anti‑HER2 regimens; Tukysa with trastuzumab and capecitabine after prior anti‑HER2 regimens

Background and Scope

This summary lists targeted oral therapies and related parenteral combination products for breast cancer and the specific clinical scenarios in which they are approvable under Georgia Medicaid Fee‑for‑Service prior authorization. Approvals are organized by receptor status (e.g., HR-positive, HER2-negative; HER2-positive), biomarker requirements (for example, PIK3CA, ESR1, BRCA, AKT1/PTEN), disease stage (early, adjuvant, recurrent, advanced or metastatic), and prior treatment history including endocrine therapy failure or number of prior anti‑HER2 regimens where specified.

The document covers a range of agents including CDK4/6 inhibitors (e.g., Ibrance, Kisqali, Verzenio) for HR+/HER2‑ disease when used with endocrine therapy, biomarker‑directed oral agents (e.g., Piqray, Itovebi, Truqap) requiring PIK3CA or related alterations and demonstration of progression on or after endocrine therapy, HER2‑targeted regimens (e.g., Phesgo, Tukysa, Nerlynx) for early or metastatic HER2‑positive disease, and agents for BRCA‑mutated disease (e.g., Talzenna).

Prior authorization is required for the listed agents and approvals are granted when the member meets the drug‑specific diagnosis and therapy combination criteria described in the policy; the standard length of authorization is 1 year unless otherwise specified.

Policy Summary

PayerGeorgia Department of Community Health

PolicyOncology, Oral - Breast PA Summary (Georgia Medicaid FFS)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization requests via OptumRx (call 1-866-525-5827 or follow online PA process); approvals granted when member meets drug-specific diagnosis and therapy criteria.

SourceLink

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