CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Fulvestrant (Faslodex) — Coverage Criteria

Defines medical necessity criteria, indications, and authorization durations for fulvestrant (Faslodex) for members of Neighborhood Health Plan of Rhode Island when used for FDA-approved and compendial oncology indications.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyFulvestrant (Faslodex) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain and submit hormone receptor (HR) status when initiating prior authorization for fulvestrant.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthstypical authorization duration

FDA + compendiacovered indication sources

HR+/HER2- breast cancerprimary FDA indication

Compendial usesother covered tumor types

Coverage Criteria for Fulvestrant (Faslodex)

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ALL of the following

Medication is fulvestrant (Faslodex).
Indication is one of the FDA‑approved or compendial uses listed below.
FDA‑approved indications
- Hormone receptor (HR)‑positive, human epidermal growth factor receptor 2 (HER2)‑negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy.
- HR‑positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy.
- HR‑positive, HER2‑negative advanced or metastatic breast cancer in combination with palbociclib or abemaciclib in women with disease progression after endocrine therapy.
- HR‑positive, HER2‑negative advanced or metastatic breast cancer in postmenopausal women in combination with ribociclib, as initial endocrine‑based therapy or following disease progression on endocrine therapy.
Compendial uses
- Breast cancer (compendial use).
- Low‑grade serous ovarian carcinoma.
- Endometrial carcinoma.
- Uterine sarcoma.

First‑line | Second‑line

Initial versus subsequent therapy — covered when ALL of the following are met:

ALL of the following

Fulvestrant is prescribed for HR‑positive, HER2‑negative advanced or metastatic breast cancer as either first‑line or subsequent endocrine therapy as specified in the FDA‑approved indications above.
When used in combination with a CDK4/6 inhibitor (palbociclib, abemaciclib, or ribociclib), the combination must match an FDA‑approved regimen: fulvestrant plus palbociclib; fulvestrant plus abemaciclib; or fulvestrant plus ribociclib per the indication.

Salvage

Salvage therapy — covered when ALL of the following are met:

ALL of the following

Use is for recurrent or progressive disease after prior endocrine therapy for HR‑positive disease and other standard treatments have been considered or tried, consistent with the FDA‑approved indications.
Clinical documentation supports need for fulvestrant as salvage therapy (e.g., progression on or intolerance to prior endocrine therapy).

Continuation therapy

ALL of the following

Member has received prior authorization and initial approval for fulvestrant for an FDA‑approved or compendial indication.
Clinical response or disease stabilization is documented while on fulvestrant therapy and continuation is requested to maintain benefit.
No unacceptable toxicity or adverse effects that would contraindicate continued therapy are documented.
For low‑grade serous ovarian carcinoma: authorization of up to 12 months may be granted for treatment of recurrence as a single agent for members who previously received an aromatase inhibitor (e.g., letrozole, anastrozole, exemestane).
Operational: enter prior authorization request citing prior therapy and response; request may specify 12‑month duration for this indication.

Regimen	Covered?
Fulvestrant + palbociclib
Fulvestrant + abemaciclib
Fulvestrant + ribociclib

Provider Actions and Authorization

Prior Authorization

Prior Authorization and Authorization Duration

Prior authorization is required for the indications below. Typical authorization duration: up to 12 months for initial and continued therapy when criteria are met.

Authorization duration: 12 months for treatment of recurrent, advanced, or metastatic HR-positive breast cancer.
Authorization duration: 12 months for treatment of low-grade serous ovarian carcinoma as a single agent for members who previously received an aromatase inhibitor (e.g., letrozole, anastrozole, exemestane).
Authorization duration: 12 months for treatment of endometrial carcinoma as a single agent when applicable.
Authorization duration: 12 months for treatment of low-grade endometrial stromal sarcoma (ESS), adenosarcoma without sarcomatous overgrowth, or ER/PR-positive uterine sarcomas as a single agent.
Authorization of 12 months may be granted for continued treatment (reauthorization) for an approved indication when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.

Denial Risk

Non-covered Indications

Requests for indications that are not listed as FDA‑approved or compendial uses are considered experimental/investigational and are not medically necessary; these requests will be denied.

Documentation Required

Prior Aromatase Inhibitor and Required Documentation

Submission of hormone receptor (HR) status is required to initiate prior authorization review where applicable. For low-grade serous ovarian carcinoma, prior treatment with an aromatase inhibitor (e.g., letrozole, anastrozole, exemestane) must be documented to qualify for authorization.

Biomarker Requirements

inv-14: Hormone receptor (HR) — key/value requirement

DefinitionHormone receptor (HR) status — tumor biomarker indicating estrogen and/or progesterone receptor expression required to document eligibility for fulvestrant treatment.

Required forAll breast cancer indications and relevant gynecologic malignancies where HR status is applicable (e.g., low-grade serous ovarian carcinoma, endometrial carcinoma, uterine sarcoma).

PurposeSubmitted to initiate prior authorization review and to confirm member meets biomarker-driven coverage criteria for fulvestrant.

Accepted documentationPathology report or laboratory results indicating estrogen receptor (ER) and/or progesterone receptor (PR) status.

When not requiredNot applicable for indications where HR status is irrelevant; follow specific indication guidance in the policy.

inv-11: Hormone receptor (HR) status — tumor biomarker required for eligibility and prior authorization review

RequirementSubmission of hormone receptor (HR) status is necessary to initiate the prior authorization review, where applicable.

What to submitClinical documentation such as pathology report or lab results showing ER/PR status at diagnosis or most recent relevant specimen.

TimingProvide HR status with the initial prior authorization request to avoid delays or potential denial for lack of required documentation.

Supports coverage forHR-positive, HER2-negative advanced/metastatic breast cancer and compendial gynecologic indications when HR is relevant.

Covered Regimens and Combinations

Regimen	Indication / Line of Therapy	Coverage status
Fulvestrant + palbociclib
HR-positive, HER2-negative advanced or metastatic breast cancer in combination with palbociclib for disease progression after endocrine therapy
Fulvestrant + abemaciclib
HR-positive, HER2-negative advanced or metastatic breast cancer in combination with abemaciclib for disease progression after endocrine therapy
Fulvestrant + ribociclib
HR-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women as initial endocrine-based therapy or following disease progression on endocrine therapy

Background

Fulvestrant is an estrogen receptor antagonist used primarily in hormone receptor–positive disease and is addressed in this policy for its FDA‑approved and compendial oncology indications. The policy covers fulvestrant when the member’s diagnosis matches an FDA‑approved indication or a compendial use (for example, low‑grade serous ovarian carcinoma, certain endometrial malignancies, uterine sarcoma, or breast cancer) and required documentation such as hormone receptor (HR) status is submitted for prior authorization review.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyFulvestrant (Faslodex) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain and submit hormone receptor (HR) status when initiating prior authorization for fulvestrant.

SourceLink

On This Page

OpenPayer

Fulvestrant (Faslodex) — Coverage Criteria

Coverage Criteria for Fulvestrant (Faslodex)

Coding

Provider Actions and Authorization

Biomarker Requirements

Covered Regimens and Combinations

Background