CurrentUnitedHealthcarePolicy N/A

Oral PI3K (Phosphatidylinositol 3‑Kinase) Inhibitors — Washington Prior Authorization Request Form

Washington state prior authorization request form for oral PI3K inhibitors used in oncology and hematology indications; requests prescriber and pharmacy information, diagnosis, biomarker status, prior therapy history, and supporting clinical documentation for coverage decisions.

Policy Summary

PayerUnitedHealthcare

PolicyOral PI3K Inhibitors — Washington Prior Authorization Request Form (coverage criteria)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionComplete and submit the prior authorization form with prescriber and pharmacy information, diagnosis, prior therapy history, biomarker results, and attach chart notes, labs, and diagnostic tests.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3diagnoses listed as selectable options

24/7fax and phone contact provided

must attachsupporting documentation required

Coverage Criteria for Oral PI3K Inhibitors

inv-01: Breast cancer coverage criteria

Coverage considerations recorded on the form for each diagnosis — covered when ALL required items documented:

Breast cancer (HR+, HER2-, PIK3CA-mutated): 1) Diagnosis: advanced or metastatic hormone receptor-positive, HER2-negative, PIK3CA-mutated breast cancer; 2) Will the prescribed medication be used in combination with fulvestrant? (Yes/No); 3) Documentation that tumor is hormone receptor-positive; 4) Documentation that tumor is HER2-negative; 5) Documentation that a PIK3CA mutation is confirmed; 6) Documentation that cancer progressed on or after endocrine therapy (e.g., anastrozole, letrozole, exemestane, tamoxifen)all items answered/confirmed on the form

Form items 5–7 request biomarker confirmation and prior endocrine progression; combination use with fulvestrant is captured.

inv-02: Chronic lymphoid leukemia coverage criteria

For Chronic lymphoid leukemia (CLL):

CLL - PI3K agent (e.g., duvelisib, idelalisib):

Policy Summary

PayerUnitedHealthcare

PolicyOral PI3K Inhibitors — Washington Prior Authorization Request Form (coverage criteria)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

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1) Indicate diagnosis of chronic lymphoid leukemia (CLL); 2) For duvelisib: indicate whether patient has relapsed and/or is refractory; 3) Document history of failure, contraindication, or intolerance to at least two prior chemotherapy regimens that include agents such as a Bruton tyrosine kinase inhibitor (BTKi), a BCL2 inhibitor (BCL2i), monoclonal antibody (e.g., obinutuzumab, rituximab), or other specified agents; 4) For idelalisib: indicate whether patient has relapsed and whether the patient previously took another PI3K inhibitor without evidence of progression; 5) Indicate if the prescribed medication will be used in combination with rituximab (Yes/No)

all required documentation present on the form

Form distinguishes agent-specific questions (duvelisib vs idelalisib) and asks about prior regimen failure/intolerance.

inv-03: Small lymphocytic lymphoma coverage criteria

For Small lymphocytic lymphoma, relapsed or refractory:

SLL relapsed/refractory: 1) Indicate diagnosis of small lymphocytic lymphoma (SLL) and that disease is relapsed or refractory; 2) Indicate whether the medication is being used in combination with other chemotherapeutic, radiotherapeutic, or adjuvant agents and list those therapies if yes; 3) Document history of failure, contraindication, or intolerance to at least two prior chemotherapy regimens that include agents such as a Bruton tyrosine kinase inhibitor (BTKi), a BCL2 inhibitor (BCL2i), monoclonal antibody (e.g., obinutuzumab, rituximab), or other specified agentsall items completed and supporting documentation provided

Form asks to list combination therapies when applicable and requires prior-regimen history.

The form does not list any explicit coverage exclusions. It presents selectable diagnosis options (breast cancer, chronic lymphoid leukemia, small lymphocytic lymphoma, or other) and asks for documentation and prior-therapy history to determine eligibility, but it does not include a separate exclusions section or items that explicitly state conditions that are not covered.

Appropriateness of therapy is contingent on documented clinical factors requested on the form. The form requires confirmation of biomarker status (e.g., PIK3CA-mutated, hormone receptor-positive, HER2-negative for breast cancer) and, for hematologic indications, documentation of relapse/refractory status and history of failure, contraindication, or intolerance to prior regimens (e.g., BTKi, BCL2i, monoclonal antibodies). Requests lacking these prior-therapy or biomarker confirmations, or evidence of progression where requested, may be deemed inappropriate and risk delay or denial.

Regimen	Indication	Coverage status	Required documentation / notes
PI3K inhibitor + fulvestrant
Advanced/metastatic hormone receptor-positive, HER2-negative, PIK3CA-mutated breast cancer
Covered
Documentation of hormone receptor–positive status; HER2‑negative status; PIK3CA mutation confirmed; indication that medication will be used in combination with fulvestrant; evidence of progression on or after endocrine therapy (e.g., anastrozole, letrozole, exemestane, tamoxifen). Chart notes, labs, and diagnostic tests must be attached.

Regimen	Indication	Coverage status	Required documentation / notes
PI3K inhibitor + rituximab
Certain hematologic indications (e.g., chronic lymphoid leukemia or small lymphocytic lymphoma when used per form prompts)
Covered
Document relapse or refractory status as applicable; history of failure, contraindication, or intolerance to required prior regimens (e.g., BTKi, BCL2i, monoclonal antibody) — at least one or two prior regimens as specified by diagnosis/agent; indicate combination use with rituximab when applicable. Chart notes, labs, and diagnostic tests confirming diagnosis must be attached.

Provider Submission and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Complete and fax the Prior Authorization Request Form to 866-940-7328 or call 800-310-6826. Allow at least 24 hours for review. Include prescriber and pharmacy information (names, NPIs, telephone numbers), medication name and strength, directions, quantity/days supply, date of request, reference/MAS, patient name and date of birth, ProviderOne ID, and prescriber signature and specialty.

Fax: 866-940-7328; Phone: 800-310-6826
Include prescriber name, NPI, specialty, telephone, and signature
Include pharmacy name and NPI and telephone
Provide medication name, strength, directions, and qty/days supply
Provide date of request, reference #/MAS, patient DOB, ProviderOne ID

Step Therapy

Prior Regimen Prerequisites

Document prior therapy history showing failure, contraindication, or intolerance as applicable. For hematologic indications, list prior regimens and confirm number required (e.g., at least two prior chemotherapy regimens including BTKi, BCL2i, and/or a monoclonal antibody where specified). For idelalisib and other PI3K inhibitors, indicate prior PI3K exposure and relapse/refractory status. For breast cancer (HR+ HER2- PIK3CA-mutated), document progression on or after endocrine therapy.

Hematologic malignancies: history of failure/contraindication/intolerance to required prior regimens (check boxes for BTKi, BCL2i, monoclonal antibodies, or specify other)
At least two prior chemotherapy regimens for certain indications (as indicated on form)
Idelalisib: indicate prior relapse and prior PI3K inhibitor exposure/non-progression where applicable
Breast cancer (HR+ HER2- PIK3CA-mutated): cancer progressed while on or after endocrine therapy (e.g., anastrozole, letrozole, exemestane, tamoxifen)

Documentation Required

Required Clinical Documentation

Provide complete clinical documentation with the request. Chart notes, laboratory results, diagnostic test reports, and recent height/weight/BSA with dates are required. Missing documentation may delay review or result in denial.

Chart notes supporting diagnosis and treatment intent (initial vs refractory/relapsed vs continuation) with dates
Labs and diagnostic tests confirming the diagnosis
For breast cancer: documentation of hormone receptor-positive status, HER2-negative status, and confirmed PIK3CA mutation
Height (cm), weight (kg), and body surface area (m2) with dates taken
For combination regimens, list all concurrent therapies (e.g., fulvestrant, rituximab) and rationale

Patient Calculation and Coding Fields

Body surface area (BSA) — provider-calculated m2 value with date

Required dataProvider-calculated body surface area (BSA) in m2 must be provided

FormatBSA value entered as m2 with the date the measurement was taken

Supporting measurementsHeight (cm) and weight (kg) with dates should also be provided on the form

Biomarker and Diagnostic Requirements

PIK3CA — mutation confirmed (testing required)

RequirementPIK3CA mutation must be confirmed by testing to meet biomarker eligibility

IndicationRequired for advanced/metastatic HR+ HER2- PIK3CA‑mutated breast cancer requests

Documentation locationForm asks to provide documentation that 'PIK3CA‑mutated confirmed'

Hormone receptor status (ER/PR) — positive required for certain breast indications

RequirementHormone receptor (ER/PR) status must be documented as positive for breast cancer eligibility

IndicationSpecifically required for advanced/metastatic hormone receptor‑positive breast cancer requests

Form promptThe form lists 'Provide documentation of... Hormone receptor‑positive'

HER2 — negative required for HR+ HER2- breast cancer indication

RequirementHER2 status must be documented as negative for HR+ HER2‑ breast cancer indication

Form promptThe form requests 'Provide documentation of... HER2‑negative'

ContextRequired alongside ER/PR positivity and PIK3CA mutation confirmation for breast cancer requests

Line of Therapy Requirements

inv-16: second-line

Prior regimen requirement: History of failure, contraindication, or intolerance to at least one or two prior regimens as indicated on the form (form differentiates idelalisib vs other agents); example prior agents: BTKi, BCL2i, monoclonal antibodydocumented prior regimen failure/contraindication/intolerance

Recorded as the line-of-therapy condition ‘second-line’ on the form.

Key Definitions

PIK3CA‑mutated definition — presence of a PIK3CA mutation confirmed by testing

DefinitionPIK3CA‑mutated = presence of a PIK3CA mutation confirmed by testing

Use in decision-makingConfirmation is requested on the form under breast cancer documentation ('PIK3CA‑mutated confirmed')

Associated requirementsPIK3CA mutation confirmation is required along with ER/PR positive and HER2 negative status for the HR+ HER2‑ PIK3CA‑mutated breast cancer indication

Relapsed or refractory — disease progression or non-response after prior therapy as indicated on the form

DefinitionRelapsed or refractory = disease progression or non‑response after prior therapy as indicated on the form

Form useForm asks whether patient has relapsed and/or is refractory for CLL and SLL indications

ImplicationDocumentation of relapse/refractory status is required for coverage consideration in hematologic indications

Background

This prior authorization request form supports coverage evaluation for oral PI3K (phosphatidylinositol 3‑kinase) inhibitors used in oncology indications including advanced/metastatic hormone receptor‑positive, HER2‑negative, PIK3CA‑mutated breast cancer, chronic lymphoid leukemia (CLL), and relapsed or refractory small lymphocytic lymphoma (SLL). It collects diagnosis, stage/type, prescriber specialty, concurrent medication information (for example, use with fulvestrant or rituximab), biomarker confirmation (e.g., PIK3CA mutation, hormone receptor and HER2 status), and prior therapy history to establish line‑of‑therapy requirements and medical necessity. The form also instructs providers to attach supporting clinical documentation (chart notes, labs, diagnostic tests) and capture patient measurements (height, weight, BSA with dates) to complete the authorization review.