Health Net palbociclib Coverage & Prior Auth

Coverage Criteria

Initial Therapy - Breast Cancer

Covered when ALL of the following are met for breast cancer (initial approval):

Breast Cancer Initial Criteria: 1) Diagnosis of breast cancer; 2) Age ≥ 18 years; 3) Prescribed by or in consultation with an oncologist; 4) Disease is hormone receptor (HR)-positive and HER2-negative and is advanced (including locally advanced), recurrent, or metastatic; 5) Ibrance (palbociclib) is prescribed in combination with one of the following: (a) an aromatase inhibitor (letrozole, anastrozole, exemestane) as initial endocrine-based therapy; (b) fulvestrant; or (c) in combination with inavolisib and fulvestrant for endocrine-resistant, PIK3CA‑mutated disease (PIK3CA mutation must be present when using the inavolisib combination); 6) If male, palbociclib is prescribed with an agent that suppresses testicular steroidogenesis; 7) Premenopausal or perimenopausal females receiving an aromatase inhibitor have received ovarian ablation or are receiving ovarian suppression; 8) Member has not previously experienced disease progression on a CDK4/6 inhibitor; 9) Palbociclib is not prescribed concurrently with another CDK4/6 inhibitor; 10) Dose does not exceed 125 mg once daily on days 1–21 of a 28‑day cycle (one capsule or tablet per day); 11) For brand Ibrance requests, member must use generic palbociclib if available unless contraindicated or clinically significant adverse effects are experienced;

Prescribed regimen must be FDA‑approved or recommended by NCCN.

Off-label - Retroperitoneal Liposarcoma

Covered when ALL of the following are met for off-label retroperitoneal well-differentiated/dedifferentiated liposarcoma:

Retroperitoneal Liposarcoma Off-label Criteria: 1) Diagnosis of retroperitoneal well‑differentiated or dedifferentiated liposarcoma; 2) Age > 18 years; 3) Disease is unresectable; 4) Prescribed by or in consultation with an oncologist; 5) Prescribed as a single agent; 6) Palbociclib is not prescribed concurrently with another CDK4/6 inhibitor; 7) Dose is within the FDA maximum limit for any FDA‑approved indication or is supported by practice guidelines or peer‑reviewed literature for the relevant off‑label use (prescriber must submit supporting evidence); 8) For brand Ibrance requests, member must use generic palbociclib if available unless contraindicated or clinically significant adverse effects are experienced;

Prescribed regimen must be FDA‑approved or recommended by NCCN.

Continuation Therapy

Covered when ALL of the following are met for continuation/renewal:

Continuation Criteria: 1) Member is currently receiving palbociclib via the benefit or documentation supports member has been receiving palbociclib for at least 30 days; 2) Member is responding positively to therapy; 3) Palbociclib is not prescribed concurrently with another CDK4/6 inhibitor; 4) If indication is breast cancer, current dose is ≥ 75 mg/day; 5) If request is for a dose increase, the new dose does not exceed 125 mg once daily on days 1–21 of a 28‑day cycle (one capsule or tablet per day) or the new dose is supported by practice guidelines or peer‑reviewed literature for the relevant off‑label use (prescriber must submit supporting evidence); 6) For brand Ibrance requests, member must use generic palbociclib if available unless contraindicated or clinically significant adverse effects are experienced;

Approval durations listed separately (commercial: up to 12 months or duration of request).

Coverage conditions and restrictions

Coverage is allowed when consistent with FDA and NCCN indications and when policy requirements below are met.

Breast cancer advanced/metastatic: Use in HR‑positive, HER2‑negative advanced or metastatic breast cancer when combined with endocrine therapy as per FDA and NCCN indications, including allowance for first‑line use with fulvestrant per NCCN category 1; premenopausal/perimenopausal women receiving an aromatase inhibitor must receive ovarian ablation or suppression.

Updated to include endocrine‑resistant PIK3CA‑mutated indication per 05.06.25

Liposarcoma: Use in CDK4‑amplified well‑differentiated or dedifferentiated liposarcoma is allowed for unresectable retroperitoneal disease per NCCN category 2A; prior metastatic/progressive indications were removed per review.

Based on cited trials and NCCN guidance

Exclusions: Not covered as adjuvant therapy for early‑stage (stage II–III) breast cancer based on the PALLAS trial results (no demonstrated benefit in invasive disease‑free survival).

Explicit exclusion added in 4Q2020 review

Use of palbociclib as adjuvant therapy in early-stage (stage 0–III) breast cancer is excluded. The Phase 3 PALLAS trial randomized patients with stage II–III HR-positive, HER2‑negative early breast cancer to receive adjuvant palbociclib plus endocrine therapy versus endocrine therapy alone and did not demonstrate a benefit in invasive disease‑free survival at the second interim analysis (3‑year iDFS 88.2% versus 88.5%; HR 0.93, 95% CI 0.76–1.15), crossing the pre‑specified futility boundary. Based on those results, adjuvant use for early‑stage disease is not supported by the evidence and is therefore excluded from coverage.

The policy explicitly states that palbociclib is not authorized for adjuvant use in early‑stage (stage II–III) breast cancer based on the PALLAS trial findings and the 4Q2020 policy update that added this exclusion. Providers requesting therapy for early‑stage adjuvant indications should expect denial and are directed to follow established adjuvant endocrine therapy pathways without palbociclib.

Policy modification: adjuvant use of palbociclib for early‑stage (stage II–III) breast cancer is designated not medically necessary. This change was incorporated in the 4Q2020 annual review and is applied to requests for coverage of palbociclib in the adjuvant early‑stage setting.

Coding

No codes listed in this document segmentmixed

No codes listed

inv-09: Maximum Dose

Maximum daily dose125 mg per day (125 mg PO once daily on days 1–21 of a 28-day cycle)

Cycle schedule21 days on treatment followed by 7 days off per 28-day cycle

Dose reduction ruleIf a dose reduction to 75 mg/day is required, therapy should be discontinued

inv-10: Approval duration

Commercial approval duration12 months or duration of request, whichever is less

Medicaid typical durationsMedicaid approvals noted in reviews as 6–12 months (referenced in stats)

Approval duration change history

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Provider must submit documentation (such as office chart notes, lab results, or other clinical information) supporting that the member has met all approval criteria. Requests must be prescribed by or in consultation with an oncologist and include clinical evidence of diagnosis, staging, receptor status (HR-positive and HER2-negative), and treatment intent.

Prescriber: oncologist or consult documentation required
Required documentation: office notes, labs, pathology, imaging, PIK3CA mutation status when applicable
Age requirement: ≥ 18 years

Denial Risk

Adjuvant Early‑Stage Breast Cancer Exclusion

Use of palbociclib (Ibrance) as adjuvant therapy for early-stage breast cancer (stage 0–III) is excluded. This exclusion was added based on trial results (PALLAS) and applies to requests for adjuvant use in early-stage disease.

Background

Palbociclib (Ibrance) is an oral CDK4/6 inhibitor indicated for hormone receptor‑positive, HER2‑negative advanced or metastatic breast cancer in combination with endocrine therapy. Clinical guidance (NCCN) supports combinations with aromatase inhibitors or fulvestrant depending on line of therapy, and the policy reflects NCCN/FDA recommendations including first‑line use with fulvestrant (category 1). Palbociclib dosing for breast cancer is typically 125 mg once daily on days 1–21 of a 28‑day cycle, with dose modifications per product guidance; formulations (capsules/tablets) are bioequivalent.

Definitions

inv-20: hormone receptor

Definition (abbreviation)HR = hormone receptor

Related markersIncludes ER (estrogen receptor) and PR (progesterone receptor) as hormone receptor components

Clinical contextHR-positive status required for palbociclib use in covered breast cancer indications

inv-21: human epidermal growth factor receptor 2

Definition (abbreviation)HER2 = human epidermal growth factor receptor 2

Clinical relevancePalbociclib coverage is specified for HER2-negative disease in breast cancer indications

Source of term

Line of Therapy

first-line | second-line

Line of therapy notes: Palbociclib is indicated in combination with an aromatase inhibitor as initial endocrine‑based therapy or with fulvestrant for disease progressing following endocrine therapy; NCCN supports the fulvestrant combination in first or second line (category 1).

first-line

First-line breast cancer: Allowed first‑line use with fulvestrant per NCCN category 1 recommendation; palbociclib may be used first line in combination with fulvestrant or with an aromatase inhibitor as initial endocrine‑based therapy (see ovarian suppression requirement for pre/perimenopausal women).

Referenced in 4Q2020 annual review and NCCN guidance

Biomarker Requirements

inv-25: PIK3CA

BiomarkerPIK3CA

Use caseRequired when palbociclib is prescribed in combination with inavolisib and fulvestrant for endocrine‑resistant disease

Policy noteNewly approved endocrine‑resistant PIK3CA‑mutated indication added to criteria (RT4 05.06.25)

inv-26: PIK3CA

Required statusPIK3CA must be mutated when using the inavolisib + fulvestrant combination (PIK3CA‑mutated disease)

DocumentationPrescriber must document PIK3CA mutation status to support use of inavolisib combination

Scope

Covered Regimens and Dosing

Regimen	Notes
Palbociclib 125 mg orally once daily, days 1–21 of a 28‑day cycle	Maximum dose: 125 mg/day; if a dose reduction to 75 mg/day is required, therapy should be discontinued per product guidance
Toxicity-based dose adjustments per prescribing information; follow product labeling for neutropenia and other adverse events	If clinical management requires dose reduction to 75 mg/day, discontinue therapy (per dosing guidance).

Combination	Patient population / requirement
Palbociclib in combination with an aromatase inhibitor (letrozole, anastrozole, exemestane)	Use as initial endocrine‑based therapy; premenopausal/perimenopausal women must receive ovarian ablation or suppression per NCCN guidance
Palbociclib in combination with fulvestrant	For disease progressing following endocrine therapy; NCCN allows first‑line use with fulvestrant (category 1) per policy update

OpenPayer

Palbociclib (Ibrance) — Coverage Criteria