CurrentWashington State Health Care AuthorityPolicy NC.0001-3

Brands with Biosimilars or A-rated Generics

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This general pharmacy program policy governs prior authorization for brand-name products when an A-rated generic, biosimilar, or interchangeable biosimilar is available. It applies to requests for non-preferred brand products and requires trials of available preferred alternatives unless a documented unique clinical circumstance supports an exception.

Policy Summary

PayerWashington State Health Care Authority

PolicyBrands with Biosimilars or A-rated Generics

Policy CodePolicy NC.0001-3

Change TypeRevised and added requirements

Effective DateJul 1, 2025

Next Review DateN/A

Key ActionBefore requesting a non-preferred brand, require trials of the applicable preferred agents and the A-rated generic, biosimilar, or interchangeable biosimilar from five manufacturers, or all manufacturers when fewer than five are available.

SourceLink

POLICY UPDATE CHANGES

Reauthorization criteria were revised to require that the patient previously met the initial authorization criteria.

The policy includes A-rated generics, biosimilars, and interchangeable biosimilars and directs providers to the Apple Health Preferred Drug List.

2Preferred agents generally requiring inadequate response

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CurrentWashington State Health Care AuthorityPolicy NC.0001-3

Brands with Biosimilars or A-rated Generics

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Policy Summary

PayerWashington State Health Care Authority

PolicyBrands with Biosimilars or A-rated Generics

Policy CodePolicy NC.0001-3

Change TypeRevised and added requirements

Effective DateJul 1, 2025

Next Review DateN/A

SourceLink

POLICY UPDATE CHANGES

Reauthorization criteria were revised to require that the patient previously met the initial authorization criteria.

The policy includes A-rated generics, biosimilars, and interchangeable biosimilars and directs providers to the Apple Health Preferred Drug List.

2Preferred agents generally requiring inadequate response

Preferred agent required when only one exists

5Manufacturers required for alternative-product trials

6 monthsInitial approval duration

12 monthsReauthorization duration

Coverage Criteria Overview

Initial Therapy

In addition to any applicable drug-class or drug-specific criteria, all initial therapy criteria must be met.

Initial therapy

Available alternative: An A-rated generic, biosimilar, or interchangeable biosimilar of the requested product is available.
Manufacturer trials: The patient has tried an A-rated generic, biosimilar, or interchangeable biosimilar of the product being requested from five manufacturers, or from all manufacturers if fewer than five are available.5 manufacturers, or all manufacturers if fewer than 5
Documentation must include the length and outcome of each trial.

Continuation Therapy

In addition to any applicable drug-class or drug-specific criteria, all continuation criteria must be met.

Continuation therapy

Prior initial authorization: The patient previously met the initial authorization criteria.
Positive clinical response: Documentation shows a positive clinical response to treatment.

Provider Requirements and Denial Risks

Step Therapy

Brand Alternative Trial Required

For a requested brand, document that the patient has tried the applicable generic, biosimilar, or interchangeable biosimilar and has also completed the required manufacturer trials.

Trial of an A-rated generic, biosimilar, or interchangeable biosimilar of the requested product is required.
Trial the requested product’s A-rated generic, biosimilar, or interchangeable biosimilar from five manufacturers; if fewer than five manufacturers exist, try all available manufacturers.

Prior Authorization

Non-Preferred Agent Requirements

A non-preferred agent requires documentation of an inadequate response to the required preferred agents and documented intolerance due to a severe adverse reaction or contraindication, in addition to any applicable drug-class or drug-specific criteria.

Document inadequate response to at least two preferred agents in the class or category.

Policy Background

This general pharmacy program policy applies to brand-name products when an A-rated generic, biosimilar, or interchangeable biosimilar is available.

Initial Authorization

In addition to any applicable drug-class or drug-specific policy criteria, all initial authorization criteria must be met.

Initial authorization

Available alternative: An A-rated generic, biosimilar, or interchangeable biosimilar of the requested product is available.
Manufacturer trials: The patient has tried an A-rated generic, biosimilar, or interchangeable biosimilar of the product being requested from five manufacturers, or from all manufacturers if fewer than five are available.5 manufacturers, or all manufacturers if fewer than 5
Documentation must include the length and outcome of each trial.

Reauthorization

All reauthorization criteria must be met.

Prior initial criteria: The patient previously met the initial authorization criteria.
Positive clinical response: Documentation shows a positive clinical response to treatment.

Required Product Trials

Step	Required trial	Additional requirements
1	Before requesting a non-preferred agent, trial the applicable preferred agents identified on the current Apple Health Preferred Drug List.	Document an inadequate response to at least 2 preferred agents. If only 1 preferred agent exists in the class or category, document an inadequate response to that 1 agent. For a non-preferred agent, also document intolerance due to a severe adverse reaction or contraindication.

Step	Required trial	Documentation and exceptions
2	Trial an A-rated generic, biosimilar, or interchangeable biosimilar of the requested product from 5 manufacturers. If fewer than 5 manufacturers exist, trial products from all manufacturers.	Document the length and outcome of each trial. Exceptions may be made for unique circumstances supported by clinical judgment and documentation.

Policy Summary

PayerWashington State Health Care Authority

PolicyBrands with Biosimilars or A-rated Generics

Policy CodePolicy NC.0001-3

Change TypeRevised and added requirements

Effective DateJul 1, 2025

Next Review DateN/A

SourceLink

On This Page

If only one preferred agent exists in the class or category, document inadequate response to that one agent.

Document intolerance due to a severe adverse reaction or contraindication.

Step Therapy

Preferred-Product Step Therapy

Apply the current Apple Health Preferred Drug List (AHPDL) when determining the preferred products that must be tried before authorization of a non-preferred agent or requested brand.

Use the current AHPDL: https://www.hca.wa.gov/assets/billers-and-providers/applehealth-preferred-drug-list.xlsx
Require the applicable preferred-agent trials and any additional drug-class or drug-specific policy criteria.

Documentation Required

Preferred-Agent History

Document the patient’s preferred-agent history, including inadequate response and the basis for intolerance when applicable. The record must support a severe adverse reaction or contraindication for an intolerance-based request.

Identify each preferred agent tried and document the inadequate clinical response.
Document intolerance due to a severe adverse reaction or contraindication when relied upon.
When only one preferred agent is available, documentation for that one agent satisfies the preferred-agent trial count.

Documentation Required

Alternative-Product Trial Documentation

Document the required alternative-product trials in sufficient detail to support the request, including the trial duration and outcome for each applicable manufacturer or product.

Document the length of each trial.
Document the clinical outcome of each trial.
Include the applicable A-rated generic, biosimilar, or interchangeable biosimilar and manufacturer; trial all manufacturers when fewer than five are available.

Documentation Required

Reauthorization Documentation

For reauthorization, document that the patient previously met the initial authorization criteria and has had a positive clinical response to treatment, in addition to any applicable drug-class or drug-specific criteria.

All reauthorization criteria must be met for approval.
If no additional criteria apply, reauthorization may be approved for 12 months.

Documentation Required

Exception Documentation

Exceptions may be considered only for unique clinical circumstances supported by clinical judgment and documentation. The record must explain why the standard alternative trials or other policy requirements are not appropriate for the patient.

Document the unique clinical circumstances.
Provide supporting clinical judgment and relevant documentation.
Address any applicable drug-class or drug-specific policy criteria.

Denial Risk

Insufficient Preferred-Agent History

Requests may be denied when the required preferred-agent history is insufficient. The provider must document the required number of preferred-agent trials and inadequate response before requesting a non-preferred agent.

Deny when at least two preferred agents have not been tried or an inadequate response has not been documented.
When only one preferred agent exists in the class or category, deny if that agent has not been tried or inadequate response has not been documented.

Denial Risk

Required Alternative Trials Not Documented

Requests may be denied when the required A-rated generic, biosimilar, or interchangeable biosimilar trials are not documented for the requested brand.

Deny when the applicable alternative product has not been tried.
Deny when trials from five manufacturers are not documented, unless fewer than five manufacturers exist and all available manufacturers were tried.
Deny when trial duration or outcome is missing.

Denial Risk

Continuation Criteria Not Met

Continuation may be denied when the patient no longer meets the initial authorization criteria or when the record does not document a positive clinical response to treatment.

Deny reauthorization when prior satisfaction of the initial criteria is not documented.
Deny reauthorization when positive clinical response is not documented.
For initial authorization, if no additional criteria apply, approval is for 6 months.