CurrentUnitedHealthcarePolicy N/A

Daurismo (glasdegib) prior authorization

Defines UnitedHealthcare prior authorization and notification requirements for coverage of Daurismo (glasdegib) for treatment of newly-diagnosed acute myeloid leukemia (AML). Affects prescribers and pharmacists submitting coverage requests for members, with special handling for members under 19.

Policy Summary

PayerUnitedHealthcare

PolicyDaurismo (glasdegib) prior authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateApr 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization for Daurismo; approvals are issued for 12 months when coverage criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization period issued

≥75age criterion for coverage

low-dose cytarabinerequired with

ECOG ≥2example comorbidity

creatinine >1.3example comorbidity

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Coverage Criteria for Daurismo (glasdegib)

inv-01: Initial Authorization

Covered when ALL of the following are met

Initial Authorization: Diagnosis of newly-diagnosed acute myeloid leukemia (AML).

Initial Authorization: Daurismo (glasdegib) therapy to be given in combination with low-dose cytarabine.

One of the following

(a): Patient is ≥ 75 years old.
(b): Patient has significant comorbidities that preclude the use of intensive induction chemotherapy (examples: severe cardiac disease, ECOG performance status ≥ 2, baseline creatinine >1.3 mg/dL).

inv-02: Reauthorization

Covered when the following is met for reauthorization

Reauthorization: Patient does not show evidence of progressive disease while on Daurismo therapy.

Authorization will be issued for 12 months.

inv-03: Patients less than 19 years of age

Automatic approval condition for members under 19

Members <19: Patient is less than 19 years of age.

Authorization will be issued for 12 months.

Policy language and prior updates reflect that relapsed or refractory disease is no longer an indication for repeating the initial successful induction regimen per updated NCCN guidance. The program was amended in 2026 to remove relapsed/refractory disease as a permitted component of repeating induction therapy, aligning the coverage criteria with current NCCN recommendations and the referenced sources.

Initial Therapy Criteria

inv-11: Initial Therapy

Initial coverage criteria

Initial therapy: Diagnosis of newly-diagnosed AML; therapy given in combination with low-dose cytarabine; and patient is ≥75 years old or has significant comorbidities that preclude intensive induction chemotherapy.

Examples of comorbidities include severe cardiac disease, ECOG performance status ≥2, baseline creatinine >1.3 mg/dL.

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization/notification is required. Approval is issued for 12 months when criteria are met. State mandates and member benefit plan coverage may affect approval.

Authorization duration: 12 months
State mandates and member-specific benefit plans may impact coverage

Note

Automated Approval and Re-approval Processes

UnitedHealthcare may use automated approval and re-approval processes. Decisions for initial approval or reauthorization may be made based solely on prior claim or medication history, diagnosis codes (ICD-10), and claim logic. Use of automated processes varies by program and therapeutic class.

Automated approval/re-approval may rely on prior claims, medication history, ICD-10 diagnosis codes, and claim data
Use of automation varies by program and therapeutic class

Denial Risk

Requests That Do Not Meet Coverage Criteria

Supply limits may apply. If a request does not meet coverage criteria, the request will be denied and alternative treatment guidance may be provided per program rules and benefit plan.

Supply limits may be enforced
Requests that do not meet coverage criteria will be denied; alternative guidance may be provided

Background

Daurismo (glasdegib) is a hedgehog pathway inhibitor indicated, in combination with low‑dose cytarabine, for the treatment of newly‑diagnosed acute myeloid leukemia (AML) in adults who are ≥ 75 years or who have comorbidities that preclude intensive induction chemotherapy. The policy references the product label and NCCN recognition as supporting sources for this indication and for regimen recommendations.

Definitions

Newly-diagnosed AML — definition and scope for intended population and indication

DefinitionNewly-diagnosed acute myeloid leukemia (AML) treated with Daurismo (glasdegib) in combination with low‑dose cytarabine as indicated for adults who are ≥75 years or who have comorbidities that preclude intensive induction chemotherapy.

Intended populationAdult patients with newly-diagnosed AML who are age ≥75 or have comorbidities that preclude use of intensive induction chemotherapy.

Treatment contextUse is in combination with low‑dose cytarabine per the FDA indication and NCCN-recognized regimens.

Supporting guidanceThe regimen is recognized by the NCCN Drugs and Biologics Compendium (Categories 1, 2A, or 2B).

Clinical implicationEligibility assumes newly-diagnosed disease (not for relapsed/refractory use or repeating prior successful induction regimens per NCCN guidance).