CurrentCignaPolicy N/A

Daurismo (glasdegib) for acute myeloid leukemia — Coverage Criteria

This policy governs Cigna coverage and prior authorization guidance for Daurismo (glasdegib tablets) when used for treatment of acute myeloid leukemia in adults, and applies to health benefit plans administered by Cigna companies.

Policy Summary

PayerCigna

PolicyDaurismo (glasdegib) for acute myeloid leukemia — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionPrior authorization is recommended; approve for 1 year when patient is ≥ 18 years and using Daurismo in combination with cytarabine for acute myeloid leukemia.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 yeartypical approval duration

≥18minimum age for FDA-approved coverage

cytarabinerequired concomitant therapy

Not coveredexplicit exclusion statement

Coverage Criteria — Daurismo (glasdegib)

FDA-Approved Indication

Covered when ALL of the following are met for the FDA-approved indication:

FDA-approved indication criteria: A) Patient is ≥ 18 years of age; AND B) Patient is using the medication in combination with cytarabine.

Approve for 1 year.

Daurismo™ (glasdegib) is considered not medically necessary for any use(s) other than the FDA‑approved indication described in this policy.

Any use other than the FDA‑approved indication—specifically, treatment of newly diagnosed acute myeloid leukemia in adults in combination with cytarabine—is considered not medically necessary under this policy.

Covered Regimens

Regimen	Indication	Coverage
Daurismo (glasdegib) in combination with cytarabine	Newly diagnosed acute myeloid leukemia in adults as part of lower‑intensity induction	Covered when ALL of the following are met: A) Patient is ≥ 18 years of age; AND B) Patient is using the medication in combination with cytarabine. Approve for 1 year.

Policy Summary

PayerCigna

PolicyDaurismo (glasdegib) for acute myeloid leukemia — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionPrior authorization is recommended; approve for 1 year when patient is ≥ 18 years and using Daurismo in combination with cytarabine for acute myeloid leukemia.

SourceLink

On This Page

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Coding

Covered CPT Codesmixed

No codes listed

Age threshold for NCCN recommendation

NCCN age threshold≥ 75 years

ContextRecommendation applies to newly diagnosed patients for lower-intensity induction per NCCN

Associated comorbiditiesIncludes patients with significant comorbid conditions (e.g., severe cardiac disease, ECOG ≥ 2, baseline creatinine > 1.3 mg/dL)

Provider Actions & Authorization

Prior Authorization

Prior authorization required for FDA‑approved use

Prior Authorization is recommended for prescription benefit coverage of Daurismo. Approve for 1 year when the patient is ≥ 18 years of age and the medication is used in combination with cytarabine for acute myeloid leukemia.

Step Therapy

No step therapy required; NCCN guidance referenced

No step therapy requirements are specified in this policy. NCCN guidance notes glasdegib plus low‑dose cytarabine as 'Useful in Certain Circumstances' for selected older or unfit patients (≥ 75 years or with significant comorbidities).

Prior Authorization

Authorization and approval duration

Prior authorization is recommended for prescription benefit coverage; approvals are provided for the duration noted (typically 1 year) for covered indications.

Denial Risk

Denial triggers and not‑medically‑necessary uses

Claims submitted for services without covered diagnosis or procedure codes under this policy will be denied; use of Daurismo for any indication other than the FDA‑approved combination with cytarabine for acute myeloid leukemia is considered not medically necessary.

Line of Therapy

First-line

Induction and follow-up uses per NCCN: Used for lower-intensity induction in newly diagnosed patients who are ≥ 75 years or have significant comorbidities; can be used following response to lower-intensity induction and as consolidation/continuation of low-intensity regimen in select patients.

NCCN category 2A in specified contexts

Definitions

Daurismo (glasdegib)

Drug classHedgehog pathway inhibitor (glasdegib)

Generic nameGlasdegib

Brand nameDaurismo

NCCN-recommended patient population

NCCN-recommended populationNewly diagnosed patients ≥ 75 years of age or with significant comorbid conditions may be candidates for lower-intensity induction with glasdegib plus low‑dose cytarabine

Indication contextUseful in Certain Circumstances (NCCN category 2A) for patients without IDH1 mutations who are not candidates for intensive remission induction or who decline intensive therapy

Additional uses per NCCNCan be used after response to lower‑intensity induction and as consolidation/continuation of low‑intensity regimen in select patients (category 2A)

Background

Daurismo (glasdegib) is a hedgehog pathway inhibitor indicated, in combination with low‑dose cytarabine, for treatment of newly diagnosed acute myeloid leukemia in adults who are older or have comorbidities that preclude intensive induction chemotherapy. NCCN recognizes this combination as a lower‑intensity induction option for selected patients (for example, those age ≥ 75 years or with significant comorbid conditions), and prior authorization is recommended with approvals typically provided for 1 year when the FDA‑approved criteria are met (patient is ≥ 18 years and using glasdegib in combination with cytarabine).