CurrentUnitedHealthcarePolicy N/A

Breast Cancer Prevention Zero Dollar Cost Share - generic tamoxifen, raloxifene, aromatase inhibitors

Defines UnitedHealthcare coverage and zero-dollar cost share criteria for specific generic medications when used for primary prevention of breast cancer for eligible members.

Policy Summary

PayerUnitedHealthcare

PolicyBreast Cancer Prevention Zero Dollar Cost Share - generic tamoxifen, raloxifene, aromatase inhibitors

Policy CodePolicy N/A

Change TypeEligibility and safety screening revisionsexpanded drug scope

Effective DateSep 1, 2025

Next Review DateJun 30, 2025

Key ActionSubmit prior authorization to obtain zero-dollar cost share and document that member meets all eligibility criteria (age ≥35, no prior breast cancer/DCIS, low risk for adverse medication effects, increased breast cancer risk, and drug-specific requirements).

SourceLink

POLICY UPDATE CHANGES

Removed requirement that member does not have a prior diagnosis of LCIS and replaced prior explicit risk assessment with 'increased risk of breast cancer'.

Replaced requirement of no prior history of thromboembolic events with language requiring member be 'at low risk for adverse medication effects'.

Added coverage of aromatase inhibitors (anastrozole, letrozole, exemestane) to the program scope.

>=35minimum member age for eligibility

60 monthsmaximum authorization duration

tamoxifen 20mgspecific dose covered

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anastrozole, letrozole, exemestanearomatase inhibitors included

Coverage Criteria for Primary Prevention Medications

Initial/Primary Prevention Coverage Criteria

Covered at zero-dollar cost share when ALL of the following are met:

Eligibility

Medication options: Option A: Request is for generic tamoxifen 20 mg once daily; OR Option B: Both of the following: (i) member is post-menopausal; AND (ii) one of: generic raloxifene 60 mg once daily; generic anastrozole; generic letrozole; generic exemestane (exemestane only if member has had failure, contraindication, or adverse reaction to anastrozole or letrozole).
a Not applicable to plans sitused in District of Columbia.

This program is not applicable to plans sitused in the District of Columbia. Prior policy exclusions that explicitly listed conditions such as lobular carcinoma in situ (LCIS) or prior thromboembolic events have been removed; the current criteria instead require that the member be at low risk for adverse medication effects rather than listing those specific historical exclusions. These changes are part of the 4/2024 and subsequent annual updates to the program criteria and references.

This zero-dollar cost share program covers medications only for primary prevention of breast cancer. Use of these agents for secondary prevention, treatment of diagnosed breast cancer, or treatment of ductal carcinoma in situ (DCIS) is excluded because the criteria require the member to have no prior diagnosis of breast cancer or DCIS.

Initial Therapy / Eligibility Details

Initial Therapy Criteria

Initial coverage conditions for zero-dollar cost share

Initial therapy criteria: Member is greater than or equal to 35 years of age; Member does not have a prior diagnosis of breast cancer or ductal carcinoma in situ (DCIS); Member is at low risk for adverse medication effects; Member is at increased risk for breast cancer; Medication must be one of: generic tamoxifen 20 mg once daily OR (member is post-menopausal AND one of: generic raloxifene 60 mg once daily, generic anastrozole, generic letrozole, generic exemestane provided the member has had failure, contraindication, or adverse reaction to anastrozole or letrozole).

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization required; approval granted when ALL eligibility criteria are met: age, absence of prior breast cancer/DCIS diagnosis, low risk for adverse medication effects, increased risk for breast cancer, and drug-specific requirements (including step requirement for exemestane). Authorization period: up to 60 months total (subtract prior therapy duration if applicable). Not applicable to plans sitused in District of Columbia.

Member >= 35 years of age
No prior diagnosis of breast cancer or ductal carcinoma in situ (DCIS)
Member at low risk for adverse medication effects
Member at increased risk for breast cancer
Drug-specific requests:
• Generic tamoxifen 20 mg once daily — eligible
• Post-menopausal AND one of: raloxifene 60 mg once daily, anastrozole (generic), letrozole (generic), or exemestane (generic) with documented failure/contraindication/intolerance to anastrozole or letrozole
Authorization: zero copay with deductible bypass for up to 60 months total (subtract prior therapy duration if applicable)

Reauthorization and Duration

Reauthorization/Duration

Duration and continuation rules

Duration: Authorization will be issued for up to a total of 60 months; if member has already received prior duration of therapy, subtract that time from the total approval period.60 months

Step Therapy Rules

Step	Requirement
Exemestane	Covered only after member has had failure, contraindication, or adverse reaction to anastrozole or letrozole

Key Definitions

Increased risk — definition and operational use

Program definition of 'Increased risk'The program requires the member to be 'at increased risk for breast cancer' as an eligibility criterion but does not specify a single numeric risk threshold in the document.

Age contextApplies to women aged >= 35 years as the population in which increased risk is evaluated (USPSTF recommendation referenced).

Role in authorizationBeing 'at increased risk for breast cancer' is required (along with other criteria) for prior authorization of zero-dollar cost share for preventive medications.

No numeric threshold providedThe policy intentionally omits a single numeric risk cutoff (e.g., 5-year risk percentage) and relies on clinical determination of 'increased risk'.

Low risk for adverse medication effects — operational definition

Operational definition

Background and Clinical Context

The U.S. Preventive Services Task Force (USPSTF) recommends shared, informed decision-making with women aged 35 and older who are at increased risk for breast cancer regarding risk‑reducing medications. This program implements those preventive care principles and Health Care Reform coverage requirements by providing zero-dollar cost share coverage for specific generic agents when all eligibility criteria are met. Covered medication options include generic tamoxifen 20 mg (for eligible members generally) and, for postmenopausal members, generic raloxifene 60 mg or generic aromatase inhibitors (anastrozole, letrozole, exemestane, with exemestane subject to a step requirement). Authorization for zero copay is available for up to 60 months, with prior duration of therapy subtracted from the total approval period when applicable.

Policy Summary

PayerUnitedHealthcare

PolicyBreast Cancer Prevention Zero Dollar Cost Share - generic tamoxifen, raloxifene, aromatase inhibitors

Policy CodePolicy N/A

Change TypeEligibility and safety screening revisionsexpanded drug scope

Effective DateSep 1, 2025

Next Review DateJun 30, 2025

SourceLink

On This Page

Step Therapy

Step Therapy Requirement for Exemestane

Exemestane requires documentation of prior failure, contraindication, or intolerance to anastrozole or letrozole before approval will be granted.

Applicable when request is for generic exemestane
Document prior trial(s) and reason for discontinuation of anastrozole or letrozole

Documentation Required

Automated Approval May Use Prior Claims/Med History

UnitedHealthcare may approve requests (initial or reauthorization) based solely on prior claims/medication history, diagnosis codes (ICD-10), and/or claim logic; automated approval processes vary by program or therapeutic class.

Ensure claims/medication history and diagnosis codes are up-to-date to support automated approval
Automated approval may bypass manual documentation when sufficient prior data exists

Denial Risk

Denial Risk if Criteria or Documentation Are Not Met

Requests that do not include all required eligibility elements or supporting documentation will be denied. Common denial reasons include missing age, prior cancer/DCIS, evidence of low medication risk, increased breast cancer risk, or lack of required step documentation for exemestane.

Denial triggers: missing age documentation, prior diagnosis of breast cancer or DCIS, inadequate evidence of low risk for adverse effects, no documentation of increased breast cancer risk
Denial trigger: absence of documented trial/failure/contraindication/intolerance to anastrozole or letrozole when requesting exemestane

'Low risk for adverse medication effects' is used as a required safety screening criterion in place of prior specific exclusions (e.g., history of thromboembolic events).

Source guidanceUSPSTF framework: clinicians should offer risk-reducing medications to women >=35 years who are at increased risk and at low risk of adverse medication effects.

Effect on exclusionsPrior explicit exclusions (such as a history of thromboembolic events or LCIS) were removed; the policy now requires a general low-risk assessment rather than listing specific contraindications.

Use in authorization decisionMember must be assessed as 'at low risk for adverse medication effects' for prior authorization of zero-dollar cost share to be approved.