CurrentWashington State Health Care AuthorityPolicy 21.30.00-1

Oncology Agents: Antimetabolites - Oral

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This policy governs prior authorization and medical necessity review for oral antimetabolite agents used for acute myeloid leukemia in Apple Health Medicaid fee-for-service, including azacitidine (Onureg) and thioguanine (Tabloid).

Policy Summary

PayerWashington State Health Care Authority

PolicyOncology Agents: Antimetabolites - Oral

Policy CodePolicy 21.30.00-1

Change TypeNew policy

Effective DateAug 1, 2026

Next Review DateN/A

Key ActionDocument inadequate response or intolerance to the required preferred agents before requesting a non-preferred agent.

SourceLink

POLICY UPDATE CHANGES

A new policy was created establishing coverage criteria for oral antimetabolite oncology agents.

2Oral antimetabolite agents addressed

6 monthsInitial authorization period

6 monthsReauthorization period

300 mgOnureg approved dose

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CurrentWashington State Health Care AuthorityPolicy 21.30.00-1

Oncology Agents: Antimetabolites - Oral

Customize your policy alerts

Sign up for Washington State Health Care Authority Policy 21.30.00-1 alerts

Get alerted when Policy 21.30.00-1 changes without checking for updates manually.

Monitor payer policy activity

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Policy Summary

PayerWashington State Health Care Authority

PolicyOncology Agents: Antimetabolites - Oral

Policy CodePolicy 21.30.00-1

Change TypeNew policy

Effective DateAug 1, 2026

Next Review DateN/A

Key ActionDocument inadequate response or intolerance to the required preferred agents before requesting a non-preferred agent.

SourceLink

POLICY UPDATE CHANGES

A new policy was created establishing coverage criteria for oral antimetabolite oncology agents.

2Oral antimetabolite agents addressed

6 monthsInitial authorization period

6 monthsReauthorization period

300 mgOnureg approved dose

Onureg trial participants

Authorization and Reauthorization Criteria

Initial Therapy

Azacitadine (Onureg) or thioguanine (Tabloid) may be approved when all of the following documented criteria are met:

ALL of the following

ONE of the following age criteria
- For azacitadine (Onureg), the patient is 18 years of age or older.
- For thioguanine (Tabloid), there is no age requirement.
The medication is prescribed by, or in consultation with, an oncologist or hematologist.
The patient has a diagnosis of acute myeloid leukemia.
The patient is being prescribed therapy for ONE of the following
- For azacitadine (Onureg), ONE of the following
  - The patient is receiving continued treatment after achieving first complete remission.
  - The patient has achieved complete remission with incomplete blood count recovery following intensive induction chemotherapy and is unable to complete intensive curative therapy.
- For thioguanine (Tabloid), the patient is receiving induction or consolidation therapy.

Reauthorization

Azacitadine (Onureg) or thioguanine (Tabloid) may be approved when all of the following documented criteria are met:

ALL of the following

Documentation is submitted demonstrating disease stability or a positive clinical response, such as the patient remaining in remission, stabilization of disease, or lack of disease progression.

Treatment Line Requirements

First-Line | Second-Line | Salvage

The applicable line of therapy is determined by the treatment setting documented in the request.

Therapy setting

Azacitidine (Onureg): Continued treatment after achieving first complete remission.
Azacitidine (Onureg): Complete remission with incomplete blood count recovery following intensive induction chemotherapy when the patient is unable to complete intensive curative therapy.
Thioguanine (Tabloid): Induction or consolidation therapy.

Covered Oral Antimetabolite Regimens

Regimen	Covered indication	Coverage
Azacitidine (Onureg)	Acute myeloid leukemia; continued treatment after achieving first complete remission, or complete remission with incomplete blood count recovery following intensive induction chemotherapy when unable to complete intensive curative therapy.	Covered with criteria

Regimen	Covered indication	Coverage
Thioguanine (Tabloid)	Acute myeloid leukemia; induction or consolidation therapy.	Covered with criteria

Request Requirements and Decision Risks

Prior Authorization

Prior Authorization for New-to-Market Non-Preferred Drugs

New-to-market drugs added to this class based on the Apple Health Preferred Drug List are non-preferred and require prior authorization before coverage can be approved.

Confirm the requested agent's current preferred or non-preferred status on the Apple Health Preferred Drug List.
Submit the clinical documentation required by this policy with the prior authorization request.

Documentation Required

Oncology or Hematology Prescriber Required

The requested therapy must be prescribed by, or provided in consultation with, an oncologist or hematologist.

Document the oncology or hematology prescriber or consultant involved in the request.
This requirement applies to initial authorization for azacitidine (Onureg) or thioguanine (Tabloid).

Clinical Background

This policy addresses oral antimetabolite therapy for acute myeloid leukemia (AML). Onureg (azacitidine) demonstrated an overall-survival benefit in a randomized, placebo-controlled trial of 472 participants with AML who had achieved complete remission or complete remission with incomplete blood count recovery after induction chemotherapy. Median overall survival was 24.7 months with Onureg compared with 14.8 months with placebo.

Tabloid (thioguanine) has been studied for AML induction and consolidation therapy. Its most frequent adverse effect is myelosuppression; reported risks also include hyperuricemia and gastrointestinal effects. Long-term thioguanine use is not recommended because of reported liver toxicity with vascular endothelial damage.

Policy Summary

PayerWashington State Health Care Authority

PolicyOncology Agents: Antimetabolites - Oral

Policy CodePolicy 21.30.00-1

Change TypeNew policy

Effective DateAug 1, 2026

Next Review DateN/A

Key ActionDocument inadequate response or intolerance to the required preferred agents before requesting a non-preferred agent.

SourceLink

On This Page

Step Therapy

Preferred-Agent Sequencing Required

A non-preferred agent requires an inadequate response, documented intolerance due to a severe adverse reaction, or a contraindication to the required preferred agents before approval.

If at least two preferred agents are available, document the required outcome for at least two preferred agents.
If only one preferred agent is available, document an inadequate response to that one preferred agent.

Documentation Required

Preferred-Agent Trial History

Document the patient's history with each required preferred agent, including the treatment outcome and the reason the preferred therapy cannot be used.

Include evidence of inadequate response, severe adverse reaction, or contraindication, as applicable.
Use the current Apple Health Preferred Drug List to identify the applicable preferred agents.

Documentation Required

Initial Clinical Documentation

Initial authorization requests must include sufficient clinical information to establish eligibility for the requested therapy.

Document the diagnosis of acute myeloid leukemia.
Document the patient's age: at least 18 years for azacitidine (Onureg); no age requirement applies to thioguanine (Tabloid).
Identify the oncologist or hematologist who prescribed or is consulting on therapy.
Describe the requested drug and the applicable treatment purpose: continued treatment after first complete remission; complete remission with incomplete blood count recovery after intensive induction chemotherapy when intensive curative therapy cannot be completed; or induction or consolidation therapy for thioguanine.

Documentation Required

Reauthorization Response Documentation

Reauthorization requires documentation demonstrating that the patient has disease stability or a positive clinical response to therapy.

Examples include remaining in remission, stabilization of disease, or lack of disease progression.
When criteria are met, authorization is for 6 months.

Denial Risk

Preferred-Agent Requirement Not Met

Failure to document the required preferred-agent history may prevent approval of a non-preferred agent.

Document the required trial or trials of preferred agents and the outcome of each trial.
If only one preferred agent is available, document an inadequate response to that agent.

Unsupported block type: denial_risk 宛?

Unsupported block type: denial_risk

Unsupported block type: prior_auth