CurrentCignaPolicy N/A

Oncology - Tibsovo Prior Authorization Policy

Defines Cigna's prior authorization requirements and medical necessity criteria for prescription benefit coverage of Tibsovo (ivosidenib) for FDA‑approved indications and other uses with supportive evidence; applies to Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyOncology - Tibsovo Prior Authorization Policy

Policy CodePolicy N/A

Change TypeClinical expansion and clarifications (CNS broadenedcholangiocarcinoma examples clarified)

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and submit documentation demonstrating age, IDH1 mutation positivity by an approved test, and indication‑specific requirements (e.g., prior chemotherapy for cholangiocarcinoma).

SourceLink

POLICY UPDATE CHANGES

Central nervous system cancer criteria were broadened by removing the requirement for recurrent/progressive disease and removing WHO grade requirements for oligodendroglioma and astrocytoma.

The Cholangiocarcinoma chemotherapy examples list was revised to name individual agents (cisplatin, durvalumab, gemcitabine, pembrolizumab, 5‑fluorouracil, oxaliplatin, capecitabine).

4FDA‑approved indications listed

3Supportive-evidence cancer types

1 yearTypical approval duration

2025-03-12Policy last reviewed

Coverage Criteria

inv-01: FDA-Approved Indications

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

AML (FDA-approved)

A: Patient is >= 18 years of age
B: Patient has isocitrate dehydrogenase-1 (IDH1) mutation-positive disease as detected by an approved test

Cholangiocarcinoma (FDA-approved)

A: Patient is >= 18 years of age

Policy Summary

PayerCigna

PolicyOncology - Tibsovo Prior Authorization Policy

Policy CodePolicy N/A

Change TypeClinical expansion and clarifications (CNS broadenedcholangiocarcinoma examples clarified)

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

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B: Patient has isocitrate dehydrogenase-1 (IDH1) mutation-positive disease

C: Patient has been previously treated with at least one chemotherapy regimen

Examples of a chemotherapy regimen include one or more of the following agents: cisplatin, durvalumab (Imfinzi), gemcitabine, pembrolizumab (Keytruda), 5-fluorouracil, oxaliplatin, capecitabine.

Myelodysplastic Syndrome (FDA-approved)

A: Patient is >= 18 years of age
B: Patient has isocitrate dehydrogenase-1 (IDH1) mutation-positive disease
C: Patient has relapsed or refractory disease

inv-02: Other Uses with Supportive Evidence

Covered when ALL of the following are met for each supportive indication:

Bone cancer (chondrosarcoma)

A: Patient has chondrosarcoma
B: Patient has isocitrate dehydrogenase-1 (IDH1) mutation-positive disease

Central nervous system cancer

A: Patient is >= 18 years of age
B
- i: Oligodendroglioma
  WHO grade requirements removed per history
- ii: Astrocytoma
  WHO grade requirement removed per history

Tibsovo (ivosidenib) is considered experimental, investigational, or unproven for any uses not specifically listed in this policy. Criteria in this policy will be updated as new published data become available.

Indication	Regimen (NCCN categories cited)	Coverage status
Acute Myeloid Leukemia (AML)	Tibsovo single agent (NCCN category 2A) or Tibsovo + azacitidine (NCCN category 1) for induction, follow-up after induction, and consolidation; single‑agent Tibsovo for relapsed/refractory disease (category 2A).	Covered
Cholangiocarcinoma	Tibsovo as subsequent‑line therapy for IDH1‑mutant disease (NCCN category 1); used after prior chemotherapy (examples of agents provided).	Covered
Myelodysplastic Syndrome (MDS)	Tibsovo recommended for IDH1‑mutant MDS when patients have not responded to other therapies (NCCN category 2A/2B).	Covered

Coding

No billing codes provided in documentmixed

No codes listed

Provider Actions & Requirements

Prior Authorization

Prior authorization required

Prior authorization is recommended for prescription benefit coverage of Tibsovo. All approvals are provided for the duration noted (typically 1 year) when the coverage criteria are met.

Step Therapy

Prior systemic therapy required for cholangiocarcinoma

For cholangiocarcinoma, patient must have been previously treated with at least one chemotherapy regimen before approval is granted; examples of eligible chemotherapy agents include cisplatin, durvalumab (Imfinzi), gemcitabine, pembrolizumab (Keytruda), 5‑fluorouracil, oxaliplatin, and capecitabine.

Patient must have been previously treated with at least one chemotherapy regimen.
Examples listed: cisplatin; Imfinzi (durvalumab); gemcitabine; Keytruda (pembrolizumab); 5‑fluorouracil; oxaliplatin; capecitabine.

Documentation Required

Required clinical documentation

Document the patient’s age and confirm IDH1 mutation positivity by an approved test. Include indication‑specific documentation such as prior chemotherapy regimens for cholangiocarcinoma or evidence of relapsed/refractory disease for myelodysplastic syndrome; for bone and CNS cancers document tumor type and IDH1 mutation status.

Age (patient ≥ 18 years where required).
Confirmation of isocitrate dehydrogenase‑1 (IDH1) mutation–positive disease via an approved test.
For cholangiocarcinoma: list prior chemotherapy regimen(s).
For myelodysplastic syndrome: documentation of relapsed or refractory disease.
For bone/CNS indications: tumor type (e.g., chondrosarcoma, oligodendroglioma, astrocytoma) and IDH1 mutation status.

Denial Risk

Denial triggers

Requests that do not include documentation that the patient meets the specified indication criteria risk denial. Common denial triggers include missing proof of age (when required), lack of IDH1 mutation–positive test results, absence of prior therapies (e.g., prior chemotherapy for cholangiocarcinoma), or no evidence of relapsed/refractory disease where required. Use for any unlisted indication may be considered experimental/investigational and denied.

No documentation of IDH1 mutation‑positive disease.
No documentation of required age (≥ 18 years) when specified.
No documentation of prior chemotherapy for cholangiocarcinoma.
No documentation of relapsed or refractory disease for myelodysplastic syndrome.
Request for an indication not listed in the policy (considered experimental/investigational).

Background

Tibsovo (ivosidenib) is an oral IDH1 inhibitor used to target tumors harboring IDH1 mutations. It is indicated for multiple IDH1‑mutant malignancies described in this policy, including acute myeloid leukemia, cholangiocarcinoma, and relapsed/refractory myelodysplastic syndrome; NCCN guidance also discusses use in certain bone and central nervous system tumors with IDH1 mutations.

Definitions

IDH1 mutation-positive — definition/key facts

DefinitionIsocitrate dehydrogenase-1 (IDH1) mutation-positive disease

Context in this policyRequired biomarker for all covered indications of Tibsovo (ivosidenib)

Detection requirementMust be detected by an approved test (FDA‑approved test) as stated in the drug indication language

Applicable indicationsDefines eligibility for AML (newly diagnosed and relapsed/refractory), cholangiocarcinoma (previously treated), and myelodysplastic syndrome (relapsed/refractory)

Age considerationsFor some indications the policy also requires the patient to meet age criteria (e.g., AML: ≥18 years per criteria; newly diagnosed AML with azacitidine or monotherapy described for ≥75 or unfit in overview)

Line of Therapy Criteria

inv-11: subsequent-line

Cholangiocarcinoma line: Subsequent-line therapy after prior chemotherapy; patient must have been previously treated with at least one chemotherapy regimen

inv-12: first-line | salvage

AML settings: Newly diagnosed patients >=75 or unfit for intensive induction may receive Tibsovo with azacitidine or as monotherapy; relapsed/refractory adults are eligible as well

Biomarker Requirements

IDH1 — mutation-positive as detected by an approved test

Required test resultIDH1 mutation-positive as detected by an approved test (FDA‑approved test)

Policy applicationPresence of an IDH1 mutation by an approved test is required for coverage across all FDA‑approved indications listed in the policy (AML, cholangiocarcinoma, myelodysplastic syndrome)

DocumentationClinical documentation must demonstrate IDH1 mutation positivity via an approved test when requesting prior authorization

Source languageTibsovo is indicated for cancers with a susceptible IDH1 mutation as detected by an FDA‑approved test (policy mirrors FDA‑approved indication)