CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Ibrance (palbociclib) — Coverage Criteria

Defines indications, usage limits, monitoring, and exclusions for palbociclib (Ibrance) for members receiving care under Neighborhood Health Plan of Rhode Island (via Evolent utilization management). Applies to providers requesting authorization for palbociclib.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyIbrance (palbociclib) — Coverage Criteria

Policy CodePolicy N/A

Change TypeExclusion criteria updatedreferences refreshed

Effective DateN/A

Next Review DateJune 2025

Key ActionSubmit prior authorization (J8999) demonstrating HR+/HER2- indication and adherence to dosing and monthly quantity limits.

SourceLink

POLICY UPDATE CHANGES

Converted to new Evolent guideline template and replaced UM ONC_1272 Ibrance (palbociclib).

Updated exclusion criteria.

Updated references.

125 mgsingle dose maximum

21monthly max

J8999billing code

HR+/HER2-covered phenotype

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Coverage Criteria for Palbociclib (Ibrance)

Breast Cancer Coverage Criteria

Covered when ALL of the following are met:

Eligibility for palbociclib in HR+/HER2- breast cancer: Member has ER/PR positive and HER2 negative recurrent unresectable or metastatic breast cancer; palbociclib is to be used in combination with an aromatase inhibitor (anastrozole, letrozole, or exemestane) as first‑line therapy in postmenopausal women or in premenopausal women receiving ovarian ablation/suppression OR palbociclib is to be used in combination with fulvestrant as subsequent therapy in postmenopausal women or in premenopausal women receiving ovarian ablation/suppression provided a CDK4/6 inhibitor (e.g., ribociclib, abemaciclib) has NOT been previously used.

First‑line: palbociclib + aromatase inhibitor; Subsequent: palbociclib + fulvestrant if no prior CDK4/6 inhibitor.

Continuation Therapy

Continuation requests are allowed when ALL of the following are met:

Continuation requirements: Member has not experienced disease progression on palbociclib; the requested medication was used within the last year without a lapse greater than 30 days of having an active authorization; and no additional medication(s) are being added to the continuation request.

Applies to continuation requests for previously authorized palbociclib.

Coverage is subject to the following high-level considerations and limits: requests will be denied if the member experienced disease progression while taking palbociclib or another CDK4/6 inhibitor. Dosing must not exceed a single dose of 125 mg, and total treatment must not exceed 21 capsules/tablets per month (applies across available strengths: 125 mg, 100 mg, or 75 mg). Prior authorization (see policy) is required and requests must document that the requested use aligns with the specified indications, line-of-therapy requirements, and monitoring expectations.

Use of palbociclib (Ibrance) for investigational or off-label indications that are not supported by sufficient evidence is considered not medically necessary. The policy defines sufficient evidence as support from CMS-recognized compendia or acceptable peer‑reviewed literature; absent such support, factors considered include the applicability of published clinical characteristics to the patient, representation of the regimen in the evidence, clinically meaningful outcomes (e.g., ASCO-recommended thresholds such as hazard ratio < 0.80 or at least 3 months benefit in OS or PFS), and the overall quality of study design and reporting. Case reports and meeting abstracts without full peer‑reviewed publication are generally insufficient to establish medical necessity.

Regimens and Combination Therapy

Regimen	Line of therapy	Population / ovarian suppression	Coverage status
Palbociclib + aromatase inhibitor (anastrozole, letrozole, or exemestane)
First-line
Postmenopausal OR premenopausal with ovarian ablation/suppression
Covered

Regimen	Line of therapy	Requirement / restriction	Coverage status
Palbociclib + fulvestrant
Subsequent therapy
Coverage contingent on no prior CDK4/6 inhibitor exposure (e.g., ribociclib, abemaciclib)
Covered

Billing and Dose Limits

Drug HCPCS CodesHCPCSCovered

J8999

palbociclib

inv-06: Single dose limit — 125 mg

Single dose limit125 mg

Applies to all strengthsLimit applies regardless of capsule strength (125 mg, 100 mg, 75 mg)

Exclusion triggerRequests exceeding this single dose will be denied

inv-07: Monthly maximum — 21 capsules/tablets per month

Monthly maximum quantity21 capsules/tablets per month

Counts all capsule strengthsMaximum of 21 applies to 125 mg, 100 mg, or 75 mg formulations

Exclusion trigger

Provider Requirements and Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for palbociclib (J8999). Requests must demonstrate the indication is aligned with the policy (ER/PR positive, HER2 negative recurrent unresectable or metastatic breast cancer) and include supporting documentation per policy.

Affected code: J8999 - palbociclib
Prior authorization required before therapy initiation

Step Therapy

Line-of-Therapy Sequencing

Palbociclib is authorized as first-line therapy when used in combination with an aromatase inhibitor in postmenopausal or premenopausal women receiving ovarian suppression/ablation. It is authorized as subsequent-line therapy in combination with fulvestrant for postmenopausal or premenopausal women treated with ovarian suppression/ablation only if the member has not previously received a CDK4/6 inhibitor (e.g., ribociclib, abemaciclib).

First-line: palbociclib + aromatase inhibitor (anastrozole, letrozole, exemestane)

First-line and Subsequent Therapy Rules

first-line and subsequent

Line of therapy options: First‑line: palbociclib in combination with an aromatase inhibitor (anastrozole, letrozole, or exemestane) for postmenopausal patients or premenopausal patients receiving ovarian ablation/suppression; Subsequent therapy: palbociclib in combination with fulvestrant for postmenopausal patients or premenopausal patients receiving ovarian ablation/suppression provided a CDK4/6 inhibitor has not been previously used.

Biomarker and Population Requirements

inv-16: ER/PR, HER2 — biomarker requirements for coverage

Hormone receptor status requiredER/PR positive (hormone receptor–positive)

HER2 status requiredHER2 negative

Documentation requirementER/PR and HER2 results must be provided to establish eligibility

Definitions and Population Notes

inv-13: Covered disease phenotype — ER/PR positive and HER2 negative recurrent unresectable or metastatic breast cancer

Covered phenotypeER/PR positive and HER2 negative recurrent unresectable or metastatic breast cancer

Therapy contextCovered when used in combination with appropriate endocrine therapy per line of therapy rules

Population specificsApplies to postmenopausal and premenopausal women (premenopausal require ovarian suppression for certain regimens)

inv-14: Ovarian suppression requirement — premenopausal women must receive ovarian ablation/suppression when receiving aromatase inhibitors or fulvestrant with palbociclib

Requirement for premenopausal womenPremenopausal women must receive ovarian ablation/suppression when receiving aromatase inhibitors or fulvestrant in combination with palbociclib

Applies to both first-line and subsequent regimens

Clinical Background

Palbociclib is a selective CDK4/6 inhibitor indicated for hormone receptor–positive, HER2‑negative advanced or metastatic breast cancer when used in combination with endocrine therapy. Its mechanism targets cyclin‑dependent kinases 4 and 6 to inhibit cell-cycle progression, thereby enhancing the effect of aromatase inhibitors or fulvestrant in appropriate patients. Clinical use requires adherence to approved combination regimens and monitoring for known toxicities (for example, neutropenia and potential interstitial lung disease/pneumonitis) as described in the prescribing information and supporting guidance.

Revision History and Policy Changes

June 2025administrative_revisionLatest

Converted to new Evolent guideline template and replaced prior policy identifier UM ONC_1272; exclusion criteria were updated and references refreshed to 2025.

June 2024administrative_update

Updated NCH verbiage to Evolent.