Cigna Oncology Medications Policy Update: Coverage

Coverage Criteria and Product-specific Requirements

General medical necessity criteria — Oncology Medications

Oncology Medications are considered medically necessary when BOTH of the following are met:

ALL of the following

1.
- Use is an approved indication by the Food and Drug Administration (FDA)
- Use is a category 1, 2A, or 2B recommendation by the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology or the NCCN Drugs & Biologics Compendium
- For Pediatric Oncology use
  - The drug is FDA approved for at least one indication
  - The drug has not been contraindicated or not recommended by the FDA for the off-label use
  - ANY of the following
    Compendia recognized by CMS as part of an anticancer chemotherapeutic regimen (e.g., AHFS, Clinical Pharmacology, DrugDex)
    Results of at least two different controlled clinical studies published in peer-reviewed English-language biomedical journals supporting the off-label use (considering quality, validity, efficacy, and safety)
    Established as standard of care as analyzed in clinical practice guidelines from professional or medical specialty societies or national government supported evidence assessments/guidelines
If required, preferred product criteria are met as listed in the product-specific requirements below (for example, trials of formulary alternatives or documented inability to use alternatives due to formulation differences).

Product-specific coverage conditions (selected examples)

Each product below requires the Oncology Medications general criteria above AND the product-specific conditions listed.

ALL of the following

When the Oncology Medications criteria above are met
Product-specific entries
- Abraxane (paclitaxel albumin-bound IV infusion) — Approve if any one of listed disease-specific conditions is met (e.g., breast, cervical, endometrial, melanoma, NSCLC, ovarian) including: currently receiving therapy; trial of paclitaxel IV; hypersensitivity to paclitaxel IV or docetaxel IV; contraindication to standard premedications; or use as subsequent therapy in advanced/metastatic disease.
- Akeega (niraparib + abiraterone) — For BRCA‑mutated prostate cancer: trial/intolerance/contraindication to Lynparza (olaparib) with/without generic abiraterone, OR BRCA2‑mutated metastatic castration‑sensitive prostate cancer, OR already started on Akeega; All other conditions — approve if Oncology criteria met.

Braftovi — melanoma and other conditions

Braftovi is considered medically necessary when BOTH of the following are met:

ALL of the following

When the Oncology Medications criteria above the table are met
2.
- A.
  - Trial of, contraindication, significant intolerance, or other exceptional clinical circumstance to ONE of the following: Tafinlar or Zelboraf (may require prior authorization)
  - Patient is currently receiving Braftovi
- B.: All Other Conditions — Approve Braftovi if the patient meets the Oncology Medications criteria above the table.

Cyclophosphamide tablets — interchange with capsules

Cyclophosphamide tablets are considered medically necessary when BOTH of the following are met:

ALL of the following

When the Oncology Medications criteria above the table are met
Documented trial of, contraindication, or intolerance to cyclophosphamide capsules.

Danziten — CML and other conditions

Danziten is considered medically necessary when BOTH of the following are met:

ALL of the following

When the Oncology Medications criteria above the table are met
2.
- a.
  - Trial of, contraindication, or significant intolerance to imatinib or dasatinib (prior use of brand Gleevec, Imkeldi, Phyrago, or Sprycel counts).
  - Patient has tried AND cannot take generic nilotinib HCl capsules due to a formulation difference in inactive ingredients which, per the prescriber, would result in a significant allergy or serious adverse reaction.
  - Patient has a resistance mutation in which imatinib and dasatinib should not be used.

Herceptin Hylecta and other trastuzumab products — formulation/generic alternatives and criteria

Herceptin Hylecta and other trastuzumab products — formulation/generic alternatives and criteria:

ALL of the following

When the Oncology Medications criteria above the table are met
ANY of the following
- - Trial of, contraindication, or intolerance to ONE of: Kanjinti (trastuzumab-anns), Ogivri (trastuzumab-dkst), or Trazimera (trastuzumab-qyyp) (may require prior authorization).
  - Patient is unable to obtain or maintain intravenous access.
  - Currently receiving Herceptin Hylecta.

Ibrance (palbociclib) — breast cancer and other uses

Ibrance (palbociclib) — breast cancer and other uses:

ALL of the following

When the Oncology Medications criteria above the table are met
ANY of the following
- A.
  - Trial of, contraindication, or intolerance to ONE of: Kisqali (ribociclib) or Verzenio (abemaciclib) (may require prior authorization).
  - For premenopausal patients using in combination with fulvestrant as subsequent therapy (not initial therapy), approve if the patient has tried Verzenio.
  - Patient will be using Ibrance in combination with Itovebi.

Iclusig (ponatinib) — CML and ALL

Iclusig (ponatinib) — CML and ALL medical necessity criteria:

ALL of the following

When the Oncology Medications criteria above the table are met
ANY of the following
- A.: For Chronic Myeloid Leukemia (CML): Trial of, contraindication, or significant intolerance to TWO tyrosine kinase inhibitors (examples: dasatinib, imatinib, nilotinib HCl, Danziten, Imkeldi, Scemblix) OR patient has intermediate- to high‑risk chronic phase CML, accelerated phase CML, or blast phase CML and has tried at least two other TKIs; OR resistance mutation precluding use of other TKIs; OR T315I mutation in accelerated/blast phase; OR currently receiving Iclusig.
- B.: For Acute Lymphoblastic Leukemia (ALL): Trial of, contraindication, or significant intolerance to imatinib or dasatinib (prior use of Gleevec, Imkeldi, Phyrago, or Sprycel counts); OR patient ≥18 years with newly diagnosed disease taking requested medication with chemotherapy; OR T315I‑positive mutation; OR history of serious chronic lung disease or risk of pleural effusion; OR currently receiving Iclusig.

Imkeldi (imatinib oral solution) — swallowing issues and formulation differences

Imkeldi (imatinib oral solution) — swallowing issues and formulation differences:

ALL of the following

When the Oncology Medications criteria above the table are met
ANY of the following
- A.
  - Patient has tried imatinib tablets (prior use of Gleevec counts).
  - Patient cannot take generic imatinib due to a formulation difference in inactive ingredients between the brand and generic which, per the prescriber, would result in a significant allergy or serious adverse reaction.
- B.:

Jemperli (dostarlimab) — dMMR/MSI‑H and other solid tumors

Jemperli (dostarlimab) — dMMR/MSI‑H indications and other solid tumors:

ALL of the following

When the Oncology Medications criteria above the table are met
ANY of the following
- A.: For Mismatch Repair Deficient (dMMR) or Microsatellite Instability-High (MSI‑H) Endometrial Cancer — Monotherapy: Patient has tried Keytruda (may require prior authorization) OR patient has already been started on Jemperli.
- B.: For dMMR/MSI‑H Solid Tumors — Monotherapy: Patient has tried Keytruda (may require prior authorization) OR patient has already been started on Jemperli. Note: Examples of solid tumors include ampullary adenocarcinoma, biliary tract cancer, breast cancer, esophageal and esophagogastric junction cancer, gastric cancer, hepatocellular cancer, and ovarian cancer.

Jobevne (bevacizumab) medical necessity and biosimilar pathway

Jobevne (bevacizumab biosimilar pathway) and Jobevne (bevacizumab) medical necessity:

ALL of the following

When the Oncology Medications criteria above the table are met
ALL of the following
- Patient has tried BOTH Mvasi (bevacizumab-awwb) and Zirabev (bevacizumab-bvzr) (documentation required).
- Patient cannot continue to use each formulary alternative due to a formulation difference in inactive ingredients (e.g., stabilizing agent, buffering agent, surfactant) which, according to the prescriber, would result in a significant allergy or serious adverse reaction.

Ontruzant (trastuzumab-dttb) medical necessity — criteria

Ontruzant (trastuzumab-dttb) medical necessity — criteria:

ALL of the following

When the Oncology Medications criteria above the table are met
Documentation of ONE of the following: Trial of AND cannot continue to use the alternative(s) due to a formulation difference in the inactive ingredient(s) which, according to the prescriber, would result in a significant allergy or serious adverse reaction to ALL of the following: Kanjinti, Ogivri, Trazimera (may require prior authorization).

Opdivo (nivolumab) and Opdivo Qvantig criteria

Opdivo (nivolumab) and Opdivo Qvantig criteria — IV and Qvantig product criteria:

ALL of the following

When the Oncology Medications criteria above the table are met
ANY of the following
- Opdivo IV: For Nasopharyngeal Carcinoma: patient has been started on Opdivo; OR patient has recurrent, unresectable, oligometastatic, or metastatic disease and Opdivo is used in combination with cisplatin and gemcitabine and prescriber documents inadequate efficacy/contraindication/intolerance to Loqtorzi (may require prior authorization); OR patient has recurrent/metastatic non‑keratinizing disease and medication is used for subsequent therapy. All other conditions — approve if Oncology criteria met.
- Opdivo Qvantig: Documentation that patient has tried and cannot take Opdivo IV (may require prior authorization) OR patient is unable to obtain IV access; All other conditions — approve if Oncology criteria met.

Multiple product-specific criteria (Keytruda, Krazati, Mektovi, nilotinib, Scemblix, etc.)

Multiple product-specific criteria (selected):

ALL of the following

When the Oncology Medications criteria above the table are met
ANY of the following
- Keytruda IV / Keytruda Qlex — Product-specific approvals require either trial and inability to take IV Keytruda for Qlex, prior trial of alternatives where specified, or documentation that patient was started on product; Keytruda approvals include tumor‑specific and biomarker-based criteria per NCCN/FDA guidance.
- Krazati (adagrasib), Mektovi (binimetinib), Talzenna (talazoparib), and others — Approve when Oncology criteria met and product-specific trials/biomarker/disease requirements listed in product entry are satisfied.
- Nilotinib (and nilotinib d‑tartrate), Tasigna, Sprycel, Scemblix, Bosulif, Iclusig, and similar TKIs — Many CML/ALL entries require trials of preferred generic/brand alternatives, documentation of inability to take preferred due to formulation differences, prior-use counting (e.g., prior use of Gleevec, Phyrago, Sprycel, Tasigna), resistance mutation exceptions (including T315I), or specific disease‑phase requirements. Review individual product entries for exact step/step‑down logic and plan (Employer vs Individual & Family).

Paclitaxel albumin‑bound (Abraxane) coverage

Paclitaxel albumin‑bound (Abraxane) coverage — Cigna Pathwell Specialty Drug List Plans:

ALL of the following

When the Oncology Medications criteria above the table are met
ANY of the following
- Breast/Cervical/Endometrial/Melanoma/NSCLC/Ovarian: For these tumor types, ONE of the following: patient is currently receiving Abraxane; patient has tried paclitaxel IV; patient had hypersensitivity to paclitaxel IV or docetaxel IV; patient has contraindication to standard premedications (e.g., dexamethasone, ranitidine, famotidine, diphenhydramine). For NSCLC, additional option: Abraxane is being used as subsequent therapy in advanced/metastatic disease.
- G.: All Other Conditions — Approve paclitaxel albumin‑bound IV infusion if the patient meets the Oncology Medications criteria above the table.

Pazopanib 400 mg and Phyrago (dasatinib) distinctions

Pazopanib 400 mg and Phyrago (dasatinib) coverage distinctions:

ALL of the following

When the Oncology Medications criteria above the table are met
ANY of the following
- Pazopanib 400 mg — Approve when patient has tried and experienced inadequate efficacy or significant intolerance with pazopanib 200 mg tablets.
- Phyrago (dasatinib) — Approve when patient has tried AND cannot take generic dasatinib tablets due to a formulation difference in inactive ingredients causing significant allergy or adverse reaction; OR prescriber documents need for co‑administration with an H2 antagonist or PPI (examples: famotidine, cimetidine, nizatidine; PPIs: omeprazole, esomeprazole, pantoprazole, rabeprazole).

Revlimid (lenalidomide) — Employer Plans

Revlimid (lenalidomide) coverage for Employer Plans:

ALL of the following

When the Oncology Medications criteria above the table are met
ALL of the following
- Patient has tried generic lenalidomide (documentation required).
- Patient cannot take generic lenalidomide due to a formulation difference in inactive ingredients between the brand and generic which, per the prescriber, would result in a significant allergy or serious adverse reaction (documentation required).

Rituxan (rituximab) and Rituxan Hycela — criteria

Rituxan (rituximab) and Rituxan Hycela criteria — formulary alternative trials and Hycela-specific requirements:

ALL of the following

When the Oncology Medications criteria above the table are met
ALL of the following
- Rituxan (rituximab) — Documentation that patient has trialed AND cannot continue to use all listed alternatives due to formulation differences in inactive ingredients which would result in significant allergy or serious adverse reaction: Riabni, Ruxience, Truxima (may require prior authorization).
- Rituxan Hycela (rituximab + hyaluronidase) — Documentation of ONE of the following: (A) BOTH: has received at least one dose of IV rituximab AND trial of and cannot continue to use listed alternatives (Riabni, Ruxience, Truxima) due to formulation differences; OR (B) currently receiving Rituxan Hycela.

Onivyde (irinotecan liposomal) medical necessity — general criteria

Onivyde (irinotecan liposomal) medical necessity — general criteria:

ALL of the following

When the Oncology Medications criteria above the table are met
2.
- A.: For Pancreatic Adenocarcinoma: documentation of ONE of the following: prescriber documents inadequate response or significant intolerance or contraindication to irinotecan IV; prescriber documents baseline neuropathy; patient has been started on Onivyde; OR medication will be used as subsequent therapy and patient meets ECOG and prior regimen requirements (see product entry for options including ECOG 0–2 and prior gemcitabine‑ or fluoropyrimidine‑based regimens).
- B.: For Ampullary Adenocarcinoma: documentation of inadequate response/intolerance/contraindication to irinotecan IV; prescriber documents baseline neuropathy; OR patient has been started on Onivyde.

Rituxan Hycela — specific criteria

Rituxan Hycela specific Hycela criteria:

ALL of the following

When the Oncology Medications criteria above the table are met
ANY of the following
- Has received at least one dose of intravenous rituximab; AND trial of and cannot continue to use listed alternatives (Riabni, Ruxience, Truxima) due to formulation differences per prescriber; OR
- Currently receiving Rituxan Hycela.

Scemblix — CML and related criteria

Scemblix is considered medically necessary when BOTH of the following are met:

ALL of the following

When the Oncology Medications criteria above the table are met
2.
- a.
  - Patient meets ONE of: trial/intolerance/contraindication to imatinib (prior use of Gleevec or Imkeldi counts); OR newly diagnosed disease; OR intermediate‑ to high‑risk chronic phase CML, accelerated CML or blast phase CML; OR patient has tried at least one other TKI for CML.
  - Patient has a resistance mutation in which imatinib should not be used; OR trial/intolerance to dasatinib (prior use of Phyrago or Sprycel counts); OR patient has tried at least two other TKIs; OR history of serious chronic lung disease or risk of pleural effusion; OR patient is at risk of bleeding; OR patient has T315I mutation; OR patient is currently receiving Scemblix.

Multiple branded oncology agents — common conditions

Multiple branded oncology agents — common template:

ALL of the following

When the Oncology Medications criteria above the table are met
Product approvals commonly require ONE of: trial of a specified preferred alternative (often a generic or biosimilar) with documentation; inability to use preferred alternatives due to formulation differences in inactive ingredients as documented by prescriber; prior use of the requested product; or disease‑ or biomarker‑specific criteria (e.g., mutation status, prior lines of therapy, ECOG).

Vectibix — colorectal cancer specifics

Vectibix (panitumumab) — colorectal cancer specifics and other conditions:

ALL of the following

When the Oncology Medications criteria above the table are met
ANY of the following
- A.: For Colon or Rectal Cancer: documentation of ONE of the following: prescriber documents inadequate response or intolerance/contraindication to Erbitux (cetuximab IV); patient has been started on Vectibix or has already been started on therapy with Lumakras; patient had a serious infusion reaction to Erbitux; OR patient lives in an area with high endemic alpha‑gal rates or has known alpha‑gal positivity.
- B.: All Other Conditions — Approve Vectibix if the patient meets the Oncology Medications criteria above the table.

All Other Conditions — blanket approval when oncology criteria met

All Other Conditions — blanket approval when oncology criteria met:

ALL of the following

For many agents added to this policy, include the following fallback: 'All Other Conditions — Approve [agent] if the patient meets the Oncology Medications criteria above the table.' This language has been added across multiple product entries to allow approval when the general Oncology criteria are satisfied and no additional product‑specific restriction applies.

TKI prior‑use / step therapy criteria

TKI prior‑use / step therapy criteria (CML / Ph+ and ALL):

ALL of the following

TKI products (e.g., Bosulif, Iclusig, Danziten, Tasigna, Scemblix, nilotinib variants, imatinib products) often require documented trials of one or more specified TKIs (counting prior use of brand or listed alternatives), or demonstration of resistance mutations (including T315I) or disease phase (intermediate/high‑risk chronic, accelerated, blast) that justify use. Documentation of trials, contraindications, or intolerances — or inability to use generics due to formulation differences — must be provided per product entry.

Checkpoint inhibitor (pembrolizumab) criteria — Keytruda family

Checkpoint inhibitor (pembrolizumab / Keytruda) criteria and Keytruda Qlex:

ALL of the following

When the Oncology Medications criteria above the table are met
ANY of the following
- Keytruda IV — Product‑ and biomarker‑specific approvals per individual entries; options include prior trial and inadequate response/intolerance to listed alternatives, having been started on product, or tumor/biomarker criteria (e.g., TMB‑H ≥10 mut/Mb, PD‑L1 CPS ≥1) where applicable.
- Keytruda Qlex (pembrolizumab + hyaluronidase subcutaneous) — Approve when patient has tried and cannot take Keytruda IV (may require prior authorization) OR patient is unable to obtain IV access; All other conditions — approve if Oncology criteria met.

Onivyde — pancreatic adenocarcinoma — revised criteria

Onivyde — pancreatic adenocarcinoma revised criteria including ECOG and prior regimens:

ALL of the following

When the Oncology Medications criteria above the table are met
For pancreatic adenocarcinoma, Onivyde approval options include prescriber‑documented inadequate response/intolerance/contraindication to irinotecan IV; baseline neuropathy; patient already started on Onivyde; OR use as subsequent therapy with ECOG performance status considerations (ECOG 0–2) and prior trial of gemcitabine‑based or fluoropyrimidine‑based regimens as specified in the product entry.

Provider Responsibilities, Prior Authorization, and Documentation

Billing Rule

Coding-related denials

Claims billed without covered diagnosis or procedure codes will be denied as not covered. When billing, providers must use the most appropriate codes as of the date of service; submissions without covered codes under this policy will be denied.

Use accurate covered ICD-10/CPT/HCPCS codes on all submissions
Claims without a covered diagnosis or procedure code will be denied

Denial Risk

Denial risk for missing criteria

Requests that do not meet the Oncology Medications criteria listed above the drug tables, or that fail to document required prior trials, intolerances, contraindications, or other required clinical information, are at risk of denial.

Coding, Biomarkers, and Key Thresholds

Tumor mutational burden (TMB) threshold — Key fact

TMB-H thresholdTumor mutational burden-high (TMB-H) defined as ≥ 10 mutations/megabase

Context of useUsed as a biomarker for Keytruda (pembrolizumab) subsequent therapy approvals where specified in policy

Documentation implicationPrescriber must attest tumor meets TMB-H threshold when invoking this approval pathway

PD-L1 (CPS) threshold — Key fact

PD-L1 CPS thresholdProgrammed death-ligand 1 (PD-L1) combined positive score (CPS) ≥ 1

Context of useApplied for Keytruda subsequent therapy in recurrent/metastatic disease per policy revision

Required Biomarkers and Mutation-specific Criteria

BRAF V600 — biomarker references

BiomarkerBRAF V600 — required for Braftovi (encorafenib) in unresectable or metastatic melanoma

Required evidenceDocumentation of BRAF V600 mutation-positive disease required as part of product-specific criteria

Related therapiesMektovi and other BRAF-targeted regimens also reference BRAF V600 in their product rows

ROS1 — biomarker entry

BiomarkerROS1 — required for Augtyro (repotrectinib) in ROS1-positive NSCLC

Prior-trial requirementPolicy requires trial/contraindication/intolerance to Rozlytrek (entrectinib) or progression on listed ROS1 inhibitors as applicable

Line of Therapy Designations

Salvage — line of therapy designations

Salvage, first‑line and subsequent therapy designations (line‑of‑therapy nodes):

Salvage: Agents with salvage designation may be approved as subsequent or later‑line therapy per the product row when Oncology Medications criteria are met (example: Abraxane subsequent therapy allowance).

Refer to specific product rows for line‑of‑therapy conditions.

First-line: Certain products contain first‑line language or preferred product requirements for initial therapy; follow product‑specific criteria (examples: Bosulif, Tecentriq changes).

Plan‑specific exceptions may apply (see product entries).

Subsequent / combination: Some entries explicitly permit use as subsequent therapy or in combination (examples: Ibrance with Itovebi, Onivyde subsequent therapy with ECOG requirements).

Follow indication‑specific nodes for combination or subsequent use.

Covered Regimens and Regimen-specific Requirements

Regimen	Indication / requirement	Coverage status
Paclitaxel albumin-bound (Abraxane) intravenous infusion	For breast, cervical, endometrial, melanoma, non-small cell lung, and ovarian cancers: member is currently receiving Abraxane OR has tried paclitaxel intravenous infusion OR had hypersensitivity to paclitaxel IV or docetaxel IV OR has contraindication to standard premedications; for select NSCLC indications also acceptable as subsequent therapy in advanced/metastatic disease.	Covered

Regimen	Indication / requirement	Coverage status
Pembrolizumab (Keytruda) in combination with cisplatin and gemcitabine	For recurrent, unresectable, oligometastatic, or metastatic disease: used in combination with cisplatin and gemcitabine when, per the prescriber, the patient has inadequate efficacy, contraindication, or significant intolerance to Loqtorzi OR patient has been started on Keytruda IV/Qlex OR diagnosis is head and neck squamous cell carcinoma other than nasopharyngeal carcinoma; prescriber attestation pathways (TMB‑H, PD‑L1 CPS thresholds, or prior trial documentation) apply as specified in policy.	Covered

Background and Scope

This policy governs the use of medications primarily for cancer treatment and defines clinical coverage criteria, documentation requirements, and product‑specific conditions for oncology drugs under Cigna benefit plans. Oncology medications are considered medically necessary when one of the listed indications is FDA‑approved or supported by NCCN category 1, 2A, or 2B recommendations (with additional evidence requirements for pediatric off‑label use), and when any required preferred‑product or trial criteria in the drug‑specific table are met.

Definitions and Key Terms

Medically necessary (oncology medications) — definition

DefinitionMedically necessary oncology medications: use meets Oncology Medications criteria and is FDA‑approved or an NCCN Category 1/2A/2B recommendation (special pediatric off‑label evidence requirements apply)

Pediatric exceptionFor pediatric off‑label use, additional evidence requirements include FDA approval for at least one indication and supportive compendia or clinical studies per policy

DocumentationPrescriber must provide documentation where noted in criteria to support medical necessity

Formulation difference — definition and examples

DefinitionFormulation difference: a difference in inactive ingredient(s) (e.g., dyes, fillers, preservatives, stabilizing/buffering agents, surfactants, hyaluronidase) between products that, per the prescriber, would result in a significant allergy or serious adverse reaction