ModifiedmhnPolicy CP.PHAR.413

Glasdegib (Daurismo) coverage for AML

Defines medical necessity and authorization criteria for glasdegib (Daurismo) in combination with low‑dose cytarabine for treatment of newly diagnosed acute myeloid leukemia in adults, and describes prior authorization and continuation criteria for affected lines of business.

Policy Summary

Payermhn

PolicyGlasdegib (Daurismo) coverage for AML

Policy CodePolicy CP.PHAR.413

Change TypeMaterial revisionclarification

Effective DateAug 1, 2019

Next Review Date

Key ActionSubmit prior authorization with documentation showing AML diagnosis, prescriber specialty, required age or inability to receive intensive induction chemotherapy, combination with low‑dose cytarabine, and use generic glasdegib when available.

SourceLink

POLICY UPDATE CHANGES

Per 1Q 2026 annual review, removed use of Daurismo for relapsed/refractory disease and updated initial authorization duration from 6 months to 12 months for Medicaid/HIM.

Clarified that for Daurismo requests the member must use generic glasdegib, if available, unless contraindicated or adverse effects are experienced.

100 mg/dayMaximum FDA daily dose

12 monthsInitial approval duration (Medicaid/HIM)

Boxed: embryo‑fetal toxicitySafety warning

25 mg, 100 mg

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Product availability

Coverage Criteria for Glasdegib (Daurismo)

inv-01: Initial Therapy (AML)

Covered when ALL of the following are met:

Initial AML criteria: 1. Diagnosis of acute myeloid leukemia (AML). 2. Prescribed by or in consultation with an oncologist or hematologist. 3. Age ≥ 18 years. 4. Member meets one of: (a) Age ≥ 75 years OR (b) medical justification supports inability to use intensive induction chemotherapy (see Appendix D for examples). 5. Prescribed in combination with low‑dose cytarabine. 6. Member must use generic glasdegib if available unless contraindicated or clinically significant adverse effects are experienced. 7. Request meets one of: (a) dose does not exceed 100 mg (1 tablet) per day OR (b) dose is supported by practice guidelines or peer‑reviewed literature for the relevant off‑label use (prescriber must submit supporting evidence). Note: Prescribed regimen must be FDA‑approved or recommended by NCCN.

inv-02: Continuation Therapy (AML)

Covered for continuation when ALL of the following are met:

Continued therapy criteria: 1. Member is currently receiving Daurismo via the Centene benefit, or documentation supports the member has received Daurismo for at least 30 days for a covered indication. 2. Member is responding positively to therapy. 3. Member must use generic glasdegib if available unless contraindicated or clinically significant adverse effects are experienced. 4. Prescribed in combination with low‑dose cytarabine. 5. If request is for a dose increase, request meets one of: (a) new dose does not exceed 100 mg (1 tablet) per day OR (b) new dose is supported by practice guidelines or peer‑reviewed literature for the relevant off‑label use (prescriber must submit supporting evidence). Note: Prescribed regimen must be FDA‑approved or recommended by NCCN.

Approval duration: Medicaid/HIM - 12 months; Commercial - 12 months or duration of request, whichever is less.

Requests for coverage of indications that are not FDA‑approved and not specifically addressed in this policy are excluded unless the requestor provides sufficient documentation of efficacy and safety in accordance with applicable off‑label use policies (for example, CP.CPA.09 for commercial, CP.PMN.53 for Medicaid) or other evidence of coverage. Operationally, prior authorization for glasdegib (Daurismo) requires submission of clinical documentation demonstrating the diagnosis, prescriber specialty, treatment regimen, and supporting rationale; dose limitations and generic substitution requirements described elsewhere in this policy also apply.

Coverage determinations for glasdegib are subject to the terms, conditions, exclusions, and limitations of the member's applicable coverage documents (for example, evidence of coverage, certificate of coverage, policy or contract). Where state Medicaid provisions conflict with this policy, the state Medicaid requirements take precedence and will govern the member's benefit and authorization process.

Per the 1Q 2026 annual review, the policy has been operationally revised to remove authorization of Daurismo for relapsed/refractory disease in alignment with NCCN guidance. This change is material to the policy and therefore use of Daurismo for relapsed/refractory AML is not authorized under this policy unless future guidance or evidence supports reconsideration.

Regimen	Notes
Glasdegib 100 mg PO QD days 1–28 + cytarabine 20 mg SC BID days 1–10 of each 28‑day cycle	Dose: glasdegib 100 mg once daily (maximum 100 mg/day); cytarabine 20 mg subcutaneously twice daily on days 1–10 of each 28‑day cycle.

Coding and Dosing Information

No explicit CPT/HCPCS/NDC codes listed in this sectionmixed

No codes listed

inv-07: Maximum daily dose — 100 mg/day

Maximum daily dose100 mg/day

Dosing regimen (AML)100 mg PO once daily on days 1–28 in combination with cytarabine 20 mg SC BID on days 1–10 of each 28‑day cycle

Regimen maximum listedMaximum dose for AML listed as 100 mg/day

Provider Actions, Prior Authorization and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Daurismo (glasdegib). Requests must include clinical documentation supporting the diagnosis of AML, prescriber specialty (oncologist or hematologist), member age, rationale if the member cannot receive intensive induction chemotherapy (see Appendix D), and confirmation that therapy will be given in combination with low-dose cytarabine. For dose requests, documentation must support the requested dose and any off‑label justification when applicable.

Required documentation: office chart notes, laboratory results, and any relevant consultation notes.
Prescriber requirement: prescribed by or in consultation with an oncologist or hematologist.
Age requirement: member must be ≥ 18 years for initial approval; special criteria apply for ≥ 75 years or medical justification for inability to undergo intensive induction chemotherapy.
Therapy combination: must be prescribed in combination with low‑dose cytarabine.
Dose limits: standard dose ≤ 100 mg (1 tablet) per day unless supported by practice guidelines or peer‑reviewed literature (supporting evidence must be submitted).
Generic use: member must use generic glasdegib if available unless contraindicated or clinically significant adverse effects occur.

Background and Clinical Context

Glasdegib is a Hedgehog pathway inhibitor indicated for use in combination with low‑dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia in adults who are ≥ 75 years of age or who have comorbidities that preclude intensive induction chemotherapy. This regimen is intended for patients for whom standard intensive induction is unsuitable due to age or clinical status. Clinicians should be aware of the product's boxed warning for embryo‑fetal toxicity, and dosing for the FDA‑approved regimen is 100 mg PO once daily in combination with low‑dose cytarabine (cytarabine 20 mg subcutaneously twice daily on days 1–10 of each 28‑day cycle).

Definitions

inv-17: acute myeloid leukemia — AML definition/label

TermAcute myeloid leukemia (AML)

AbbreviationAML

ContextManagement divided into induction and postremission (consolidation) therapy; many adults unable to undergo intensive chemotherapy due to toxicity

inv-18: Eastern Cooperative Oncology Group performance status — ECOG definition

TermEastern Cooperative Oncology Group performance status (ECOG)

Example thresholdBaseline ECOG performance status ≥ 2 cited as a reason members may not qualify for intensive induction chemotherapy

Abbreviation

Line of Therapy

inv-20: first-line

Line of therapy: First‑line for newly diagnosed AML in adults ≥ 75 years or those with comorbidities precluding intensive induction; administered in combination with low‑dose cytarabine.

FDA‑approved indication

Policy Revision History

2026-02-26policy_revisionLatest

1Q 2026 annual review removed use of Daurismo (glasdegib) for relapsed/refractory disease per NCCN and updated the initial authorization duration for Medicaid/HIM from 6 months to 12 months.

2025-12-05references_updated

References reviewed and updated (part of 1Q 2026 review process).

Policy Summary

Payermhn

PolicyGlasdegib (Daurismo) coverage for AML

Policy CodePolicy CP.PHAR.413

Change TypeMaterial revisionclarification

Effective DateAug 1, 2019

Next Review Date

SourceLink

On This Page

Prior Authorization

Prior Authorization — Continuation Criteria

For continuation or renewal requests, submit documentation that the member has been receiving Daurismo for the covered indication for at least 30 days, is responding positively to therapy, and continues combination use with low‑dose cytarabine. If requesting a dose increase, provide evidence that the new dose does not exceed 100 mg per day or is supported by guidelines or peer‑reviewed literature.

Continuation documentation: treatment history showing at least 30 days of therapy for the covered indication and clinical response.
Dose increase: justification and supporting literature when dose exceeds standard dosing limits.

Denial Risk

Non‑FDA Indications May Be Denied

Requests for non‑FDA approved indications that are not addressed by this policy may be denied unless sufficient documentation of efficacy and safety is provided in accordance with the Health Plan's off‑label use policies (e.g., CP.CPA.09, HIM.PA.154, CP.PMN.53) or other applicable evidence of coverage documents.

Non‑FDA/off‑label requests must include supporting peer‑reviewed literature or other evidence per applicable off‑label policies.
If adequate documentation is not provided, the request may be denied.

Note

Coverage Decisions Subject to Coverage Documents

Coverage decisions are subject to all terms, conditions, exclusions, and limitations of the member's coverage documents and applicable Health Plan administrative policies and procedures. This clinical policy is a guide to medical necessity and does not guarantee payment.

Refer to the member's evidence of coverage, certificate of coverage, policy, or contract for benefit-specific determinations.
State and federal requirements and Health Plan-level administrative rules may also apply.

Billing Rule

Provider Administrative Obligations

Providers submitting claims are bound by the terms of the coverage document and must follow Health Plan administrative processes for claims submission, authorization verification, and any required prior authorization confirmation steps.

Providers remain responsible for exercising clinical judgment and for medical advice and treatment of members.
Providers are independent contractors and not agents of the Health Plan.

Documentation Required

Submit all supporting clinical documentation (office notes, labs, pathology, imaging, and consultation notes) with the prior authorization request to demonstrate that the member meets the approval criteria outlined in this policy.

Documentation should include diagnosis, prior treatments, performance status, rationale for not using intensive induction chemotherapy when applicable, and any literature supporting off‑label dosing.
Incomplete documentation may result in delay or denial of authorization.

inv-19: Health Plan — definition of the Health Plan operating or administering this policy

DefinitionHealth Plan: a health plan that has adopted this clinical policy operated or administered, in whole or in part, by Centene Management Company, LLC or affiliates.

PurposePolicy developed by licensed health care professionals based on accepted standards, guidelines, and evidence; Health Plan makes no representations regarding external content

ScopeApplies to the Health Plan(s) that have adopted this clinical policy