ModifiedPremera BluecrossPolicy 5.01.540

Miscellaneous Oncology Drugs

Coverage criteria for a broad set of oral oncology (chemotherapy and targeted) drugs — when they are considered medically necessary for Premera Blue Cross members and what limits/dosing apply; intended for providers.

Policy Summary

PayerPremera Bluecross

PolicyMiscellaneous Oncology Drugs

Policy CodePolicy 5.01.540

Change TypeMultiple additions and revisions (coverage criteria, age limits, quantity limits, coding updates)

Effective DateMar 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of diagnosis, biomarker test results, prior therapies, and required clinical labs when requesting coverage.

SourceLink

POLICY UPDATE CHANGES

Added coverage criteria for numerous new drugs (examples: Epkinly, Talvey, Elrexfio, Amtagvi, Hepzato Kit, Ogsiveo, Lonsurf, Iwilfin, Tepylute, Tecelra, Vyloy, Rytelo, Xeloda, Komzifti).

Added coverage criteria for Komzifti (ziftomenib) for relapsed or refractory AML with susceptible NPM1 mutation.

Updated age and indication requirements for multiple targeted agents (examples: Rozlytrek age lowered to 1 month; Retevmo age changes).

Removed certain coverage criteria when products were withdrawn or discontinued (e.g., Truseltiq removed; Temodar oral removed).

Clarified that non-formulary exception authorizations may be approved up to 12 months and added or updated quantity limits for multiple agents (examples include Zejula, Lumakras, Pemazyre, Romvimza).

Updated Ibrance (palbociclib) criteria to require inadequate response or intolerance to Verzenio or Kisqali prior to coverage.

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

distinct agents listed

yesmaterial changes this revision

multiplebiomarker-directed therapies

manyquantity/dose limits noted

12 monthsmax non-formulary approval

Coverage Criteria (Drug- and Indication-Specific)

Erivedge (vismodegib) — medically necessary when ALL are met

Covered when ALL of the following are met

Erivedge (vismodegib) medical necessity: Individual is aged 18 years or older AND has been diagnosed with metastatic basal cell carcinoma (BCC) OR locally advanced BCC that has recurred following surgery OR locally advanced BCC in individuals who are not candidates for surgery or radiation therapy.

Odomzo (sonidegib) — medically necessary when ALL are met

Covered when ALL of the following are met

Odomzo (sonidegib) medical necessity: Individual is aged 18 years or older AND has been diagnosed with locally advanced basal cell carcinoma (BCC) that has recurred following surgery or radiation therapy OR locally advanced BCC in individuals who are not candidates for surgery or radiation therapy AND dose is limited to 200 mg per day.

Idhifa (enasidenib) — relapsed/refractory AML with IDH2 mutation

Covered when ALL of the following are met

Idhifa (enasidenib): Treatment of relapsed or refractory acute myeloid leukemia (AML) in adults with a documented IDH2 mutation.

Tibsovo (ivosidenib) — multiple indications

Covered when ALL of the following are met per indication

Tibsovo newly-diagnosed AML: Adults aged ≥75 OR with comorbidities precluding intensive induction chemotherapy AND newly diagnosed AML with a susceptible IDH1 mutation AND used in combination with azacitidine or as monotherapy.

Tibsovo relapsed/refractory AML: Adults aged ≥18 AND relapsed or refractory AML with a susceptible IDH1 mutation.

Tibsovo cholangiocarcinoma: Adults aged ≥18 AND previously treated, locally advanced or metastatic cholangiocarcinoma with a susceptible IDH1 mutation.

PARP inhibitors (Lynparza, Rubraca, Talzenna, Zejula) — maintenance and treatment criteria

Covered when ALL criteria for each drug/indication are met

Lynparza maintenance ovarian cancer: Adults ≥18 with advanced epithelial ovarian/fallopian tube/primary peritoneal cancer AND deleterious or suspected deleterious BRCA mutation confirmed by genetic testing AND in complete or partial response to first-line platinum-based chemotherapy AND quantity limited to 4 tablets daily.

Lynparza with bevacizumab: Adults ≥18 in complete or partial response to first-line platinum-based chemotherapy AND cancer associated with HRD-positive status defined by BRCA mutation and/or genomic instability/microsatellite instability or loss-of-heterozygosity testing; quantity limited to 4 tablets daily.

Lynparza metastatic breast cancer: Adults ≥18 with HER2-negative metastatic breast cancer AND deleterious or suspected deleterious BRCA or PALB2 mutation confirmed by testing AND prior chemotherapy in neoadjuvant, adjuvant or metastatic setting AND if HR-positive, prior endocrine therapy or inappropriate for endocrine therapy; quantity limited to 4 tablets daily.

CDK4/6 inhibitors (Ibrance, Kisqali, Verzenio) — sequencing and use

Covered when ALL criteria for each agent are met

Ibrance (palbociclib): Hormone receptor–positive, HER2-negative advanced or metastatic breast cancer AND trialed and had inadequate response or intolerance to Kisqali (ribociclib) or Verzenio (abemaciclib) AND used in combination with an aromatase inhibitor or fulvestrant per label.

Kisqali (ribociclib): Used in combination with an aromatase inhibitor as initial endocrine therapy for pre/postmenopausal HR+, HER2- advanced/metastatic breast cancer OR for postmenopausal patients in combination with fulvestrant after progression OR with an aromatase inhibitor for adjuvant high-risk early breast cancer.

Verzenio (abemaciclib): Adjuvant with endocrine therapy for HR+, HER2- node-positive early breast cancer at high risk OR in combination with aromatase inhibitor as initial endocrine therapy for advanced/metastatic disease OR with fulvestrant after progression OR as monotherapy after progression and prior chemotherapy.

Xpovio (selinexor) — multiple myeloma and DLBCL

Covered when ALL criteria for each indication are met

Xpovio for multiple myeloma (combination): Adults ≥18 AND used in combination with bortezomib and dexamethasone.

Xpovio for relapsed/refractory MM (heavily pretreated): Adults ≥18 AND received ≥4 prior therapies and disease refractory to ≥2 proteasome inhibitors AND ≥2 immunomodulatory agents AND an anti-CD38 monoclonal antibody AND used in combination with dexamethasone.

Xpovio for DLBCL: Adults ≥18 with relapsed/refractory DLBCL including transformed from follicular lymphoma AND had at least 2 lines of systemic therapy.

TRK and ROS1 inhibitors (Rozlytrek, Vitrakvi) — tumor-agnostic and ROS1 NSCLC

Covered when ALL criteria for each indication are met

Rozlytrek (entrectinib): Adults with metastatic NSCLC that are ROS1-positive OR adults and pediatrics ≥1 month with NTRK fusion solid tumors without known acquired resistance mutation that are metastatic or would have surgery causing severe morbidity and have no satisfactory alternatives.

Vitrakvi (larotrectinib): Adults and pediatrics with NTRK gene fusion solid tumors without known acquired resistance mutation AND metastatic or surgery would cause severe morbidity AND no satisfactory alternative treatments.

Vonjo (pacritinib) — myelofibrosis with low platelets

Covered when ALL criteria are met

Vonjo (pacritinib): Adults ≥18 with intermediate- or high-risk primary or secondary myelofibrosis AND platelet count below 50 × 10^9/L AND dose limited to 400 mg per day (200 mg twice daily).

Onureg (oral azacitidine) — AML maintenance

Covered when ALL criteria are met

Onureg (azacitidine): Adults ≥18 with acute myeloid leukemia (AML) who achieved first complete remission (CR) or CR with incomplete blood count recovery (CRi) following intensive induction chemotherapy and are not able to complete intensive curative therapy AND dose limited to 300 mg once daily for 14 days on/14 days off in 28-day cycles.

Vonjo (pacritinib) — Initial coverage

Vonjo (pacritinib) — covered when ALL of the following are met

Vonjo (pacritinib) coverage: The individual is aged 18 years or older AND has intermediate or high-risk primary or secondary myelofibrosis with a platelet count below 50 × 10^9/L AND dose is limited to 400 mg per day (200 mg twice daily).platelets <50 x10^9/L

Documentation should include risk stratification/GIPSS (>2 or 1-2 plus MIPPS70 >4 for primary MF).

Gavreto (pralsetinib)

Gavreto (pralsetinib) — covered for RET fusion-positive tumors when ANY of the following tumor-specific indications apply

Gavreto indications: Adult metastatic RET fusion-positive NSCLC OR age ≥12 with advanced/metastatic RET fusion-positive thyroid cancer requiring systemic therapy and radioactive iodine-refractory when appropriate.

Dose limited to 400 mg once daily (4 capsules).

Retevmo (selpercatinib)

Retevmo (selpercatinib) — covered when ALL applicable criteria are met

Retevmo indications and dosing: Indicated for adult locally advanced/metastatic NSCLC with RET fusion; age ≥2 for advanced/metastatic medullary thyroid cancer with RET mutation requiring systemic therapy; age ≥2 for advanced/metastatic thyroid cancer with RET fusion refractory to radioactive iodine when appropriate; locally advanced/metastatic solid tumors with RET fusion progressed on or after prior systemic treatment or with no satisfactory alternatives.

Dose: 120 mg twice daily if <50 kg; 160 mg twice daily if ≥50 kg; quantity limit 60 tablets or capsules per 30 days.

Onureg (azacitidine) — maintenance after CR/CRi

Onureg (oral azacitidine) — covered when ALL criteria are met

Onureg coverage: Adult (≥18) with acute myeloid leukemia (AML) who achieved first CR or CRi after intensive induction chemotherapy and are not able to complete intensive curative therapy.

Dose limited to 300 mg once daily for 14 days on/14 days off in 28-day cycles.

Welireg (belzutifan)

Welireg (belzutifan) — covered for VHL-associated tumors and advanced RCC when ALL criteria are met

Welireg for VHL disease: Adult (≥18) with VHL disease and one of RCC, CNS hemangioblastomas, or pNET, not requiring immediate surgery, diagnosis confirmed by germline VHL alteration.

Dose limited to 120 mg once daily (3 tablets).

Welireg for advanced RCC: Adult (≥18) with advanced RCC with clear cell component previously treated with a PD-1/PD-L1 inhibitor and a VEGF TKI.

Dose limited to 120 mg once daily (3 tablets).

IDH-directed agents (Rezlidhia, Voranigo)

Rezlidhia (olutasidenib) and Voranigo (vorasidenib) — mutation-specific AML/brain tumor coverage

Rezlidhia (olutasidenib): Adult (≥18) with relapsed or refractory AML with susceptible IDH1 mutation.

Voranigo (vorasidenib): Individuals aged ≥12 with Grade 2 astrocytoma or oligodendroglioma with susceptible IDH1 or IDH2 mutation, used following surgery and prescribed by or in consultation with an oncologist.

Menin inhibitors (Komzifti, Revuforj)

Menin inhibitors (Komzifti, Revuforj) — covered when ALL criteria met for specified genomic subtypes

Komzifti (ziftomenib): Adult (≥18) with relapsed or refractory AML with a susceptible NPM1 mutation AND no satisfactory alternative treatment options AND prescribed by or in consultation with an oncologist or hematologist AND dose limited to 600 mg daily (3 tablets).

Revuforj (revumenib) indications: Age ≥1 with relapsed or refractory acute leukemia with KMT2A translocation OR age ≥1 with relapsed or refractory AML with susceptible NPM1 mutation and no satisfactory alternatives; dose limited to 540 mg daily with quantity limits by tablet strength.

FGFR-directed agents (Balversa, Pemazyre, Pemigatinib, Lytgobi)

FGFR-targeted therapies — covered when ALL biomarker and prior therapy criteria met

Balversa (erdafitinib): Adult (≥18) with locally advanced or metastatic urothelial carcinoma harboring susceptible FGFR3 alterations and progressed during or after at least 1 prior systemic therapy.

Pemazyre (pemigatinib): Adults with previously treated unresectable locally advanced or metastatic cholangiocarcinoma with FGFR2 fusion/rearrangement detected by an FDA-approved test; dose 13.5 mg once daily for 14 days on/7 days off in 21-day cycles; quantity limited to 28 tablets per 28 days.

Lytgobi (futibatinib): Adult (≥18) with previously treated unresectable locally advanced or metastatic intrahepatic cholangiocarcinoma harboring FGFR2 fusions/rearrangements; dose limited to 20 mg per day.

KRAS G12C inhibitors (Krazati, Lumakras)

KRAS G12C inhibitors (Krazati, Lumakras) — covered when ALL criteria met

Krazati (adagrasib) for NSCLC: Adult (≥18) with KRAS G12C-mutated locally advanced or metastatic NSCLC who have received at least 1 prior systemic therapy; dose limited to 1,200 mg/day (600 mg twice daily).

Also covered for KRAS G12C-mutated colorectal cancer with prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy and used with cetuximab.

Lumakras (sotorasib): Adult (≥18) with KRAS G12C-mutated locally advanced or metastatic NSCLC as determined by an FDA-approved test, who have received at least 1 prior systemic therapy; dose limited to 960 mg/day with specified tablet quantity limits per 30 days.

Also covered for KRAS G12C-mutated metastatic colorectal cancer with prior fluoropyrimidine-based therapy.

Cytotoxic oral agents with prior therapy requirements (Lonsurf, Xeloda, others)

Cytotoxic oral agents with prior therapy requirements

Lonsurf (trifluridine/tipiracil): Adult with metastatic colorectal cancer previously treated with fluoropyrimidine, oxaliplatin, and irinotecan, an anti-VEGF biologic, and if RAS wild-type an anti-EGFR therapy; or metastatic gastric/GEJ adenocarcinoma after at least 2 prior lines including fluoropyrimidine, platinum, and taxane or irinotecan and if appropriate HER2 therapy.

Trial dosing: 35 mg/m2 orally twice daily Days 1-5 and 8-12 of 28-day cycle; prior lines required as specified.

Xeloda (capecitabine): Adult (≥18) with listed tumor types who have tried and had inadequate response or intolerance to generic capecitabine.

Selected mutation-directed and specialty agents (Rydapt, Tazverik)

Selected mutation-directed and specialty agents

Rydapt (midostaurin): Adults with newly diagnosed FLT3 mutation-positive AML in combination with cytarabine and daunorubicin induction and cytarabine consolidation; documentation of genetic testing required. Also indicated for ASM, SM-AHN, or MCL.

Rydapt is not indicated as single-agent induction therapy.

Tazverik (tazemetostat) indications: Age ≥16 with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection and previously tried/failed chemo or radiation OR adult with relapsed/refractory follicular lymphoma whose tumors are EZH2 mutation-positive detected by FDA-approved test and who have received ≥2 prior systemic therapies OR adult with relapsed/refractory follicular lymphoma with no satisfactory alternatives; quantity limited to 240 tablets per 30 days.

Injectable specialty agents (Amtagvi, Aphexda, etc.)

Cellular and specialty injectable agents — covered when ALL criteria met

Amtagvi (lifileucel): Adult (≥18) with unresectable or metastatic melanoma who have been treated with a PD-1/PD-L1 blocking antibody and are BRAF V600 mutation-positive having been treated with a BRAF inhibitor (with or without MEK inhibitor); not previously treated with lifileucel; prescribed by or in consultation with an oncologist.

Aphexda (motixafortide): May be used to mobilize hematopoietic stem cells for autologous transplant in multiple myeloma when the individual is eligible and there is documentation why generic plerixafor cannot be used.

Agent-specific medical necessity examples — selection from chunks

Examples of agent-specific covered indications (selection from these chunks).

Amtagvi (lifileucel) example: Covered when ALL of the following are met: individual is BRAF V600 mutation-positive; has been treated with a BRAF inhibitor with or without a MEK inhibitor; has not been previously treated with Amtagvi (lifileucel); Amtagvi is prescribed by or in consultation with an oncologist.

Daratumumab / Darzalex Faspro coverage sets

Daratumumab / Darzalex Faspro coverage sets.

Darzalex (daratumumab) multiple myeloma indications: Covered when used in combination with lenalidomide and dexamethasone as first-line therapy and in relapsed/refractory multiple myeloma after ≥1 prior therapy; in combination with bortezomib/melphalan/prednisone as first-line; various other combinations as specified; monotherapy for individuals with ≥3 prior lines or refractory to a PI and an immunomodulatory agent.

Darzalex Faspro (AL amyloidosis / high-risk smoldering MM): For AL amyloidosis: combination with bortezomib, cyclophosphamide and dexamethasone as first-line. For high-risk smoldering MM: age ≥18 AND clonal plasma cells ≥10% AND at least one listed risk factor (e.g., M-protein ≥30 g/L, IgA subtype, immunoparesis of two isotypes, FLC ratio 8–99, or clonal plasma cells 51–59%).

Blenrep (belantamab mafodotin) — criteria excerpt

Blenrep (belantamab mafodotin) criteria excerpt.

Blenrep relapsed/refractory multiple myeloma: Covered when ALL are met: age ≥18; received ≥2 prior lines including a proteasome inhibitor and an immunomodulatory agent; no documented corneal epithelial disease; Blenrep is used in combination per label.

Leukine (sargramostim) coverage logic for supportive use

Leukine (sargramostim) coverage logic for supportive use.

Leukine indications: Covered for AML after induction, mobilization/following autologous PBPC transplant, myeloid reconstitution after transplant, bone marrow transplant failure/engraftment delay, hematopoietic syndrome of acute radiation, and in combination with specific immunotherapies for neuroblastoma. Also may be considered second-line for individuals at risk of severe febrile neutropenia when Granix or Nivestym tried and failed or contraindicated, with specific risk categories enumerated.

Hepzato Kit (melphalan hepatic delivery)

Hepzato Kit (melphalan hepatic delivery) palliative criteria.

Hepzato Kit for unresectable/metastatic uveal melanoma: Covered when ALL are met: age ≥18; histologic/cytologic proof of ocular melanoma liver metastases affecting <50% of liver parenchyma; disease limited elsewhere amenable to resection/radiation; platelets ≥100,000/µL and ANC ≥1,500/µL at time of treatment.

Leukine (sargramostim) — GM-CSF for prevention of severe febrile neutropenia

Covered when ANY one of the following risk conditions is documented and either Granix or Nivestym have failed or are contraindicated for second-line use of Leukine:

Risk conditions for severe febrile neutropenia: 1) Prior febrile neutropenia on current regimen OR 2) Receiving chemotherapy with ≥20% expected FN incidence (per ASCO) OR 3) Bone marrow impairment OR 4) Received ≥2 prior chemotherapy regimens or extensive radiation OR 5) Other serious comorbidities reviewed case-by-case

AND Granix (tbo-filgrastim) or Nivestym (filgrastim-aafi) has been tried and failed OR there is a contraindication to those agents; applies when at risk to decrease incidence of infection

Rytelo (imetelstat) for transfusion-dependent MDS

Covered when ALL of the following are met

Rytelo (imetelstat) criteria: Age ≥18 AND low- to intermediate-1 risk MDS AND transfusion-dependent anemia (≥4 RBC units/8 weeks) AND not responded to/lost response or ineligible for an ESA AND tried and had inadequate response or intolerance to luspatercept (Reblozyl) AND no del(5q) cytogenetic abnormality AND not used in combination with an ESA or luspatercept AND prescribed by/with oncologist or hematologist AND dose limited to 7.1 mg/kg every 4 weeks.

Portrazza (necitumumab) for metastatic squamous NSCLC

Covered when ALL of the following are met

Portrazza criteria: Age ≥18 AND diagnosis of metastatic squamous non-small cell lung cancer AND used as first-line treatment in combination with gemcitabine and cisplatin AND dose limited to 800 mg on Days 1 and 8 of each 3-week cycle.

Sarclisa (isatuximab-irfc) for multiple myeloma

Covered when ANY of the following regimen/line conditions are met

Sarclisa regimens: 1) In combination with pomalidomide and dexamethasone and received ≥2 prior therapies including lenalidomide and a proteasome inhibitor OR 2) In combination with carfilzomib and dexamethasone and received 1-3 prior lines OR 3) In combination with bortezomib, lenalidomide, and dexamethasone for newly diagnosed MM when ineligible for autologous stem cell transplant.

Vyloy (zolbetuximab-clzb) for CLDN18.2+ gastric/GEJ adenocarcinoma

Covered when ALL of the following are met

Vyloy criteria: Age ≥18 AND HER2-negative gastric or gastroesophageal junction adenocarcinoma documented as CLDN18.2+ (moderate to high overexpression in ≥75% of tumor cells) AND used in combination with fluoropyrimidine- and platinum-containing chemotherapy for first-line treatment AND prescribed by or in consultation with an oncologist.

Vyxeos (cytarabine-daunorubicin) for AML

Covered when ALL of the following are met

Vyxeos criteria: Age ≥1 AND newly diagnosed therapy-related AML or AML with myelodysplasia-related changes.

Trodelvy (sacituzumab govitecan-hziy) indications

Covered when ANY of the following are met

Trodelvy indications: 1) Unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received ≥2 prior systemic therapies (≥1 for metastatic disease) OR 2) Unresectable locally advanced or metastatic HR+/HER2- breast cancer after endocrine-based therapy and ≥2 additional systemic therapies in the metastatic setting OR 3) Locally advanced or metastatic urothelial cancer after platinum-containing chemotherapy and PD-1/PD-L1 inhibitor.

Unituxin (dinutuximab) for high-risk neuroblastoma (pediatric)

Covered when ALL of the following are met

Unituxin criteria: Used in combination with GM-CSF, IL-2, and 13-cis-retinoic acid AND patient has achieved at least a partial response to prior first-line multiagent, multimodality therapy.

Pediatric indication per policy; prescribed by or in consultation with pediatric oncology specialists as appropriate.

Onivyde, Portrazza, Trisenox and other agent-specific indications

Multiple agent-specific coverage conditions are listed for various tumor types and lines of therapy

Examples: Onivyde for metastatic pancreatic adenocarcinoma in combination regimens (post-gemcitabine progression or first-line with oxaliplatin/5-FU/LV); Portrazza for 1L metastatic squamous NSCLC with gemcitabine/cisplatin; Trisenox for APL with t(15;17) in combination with tretinoin or refractory/relapsed APL.

See specific agent entries for full criteria.

Trial eligibility and key outcomes (per-drug)

Trial-based eligibility and key outcomes summarized for referenced agents

Lonsurf trial cohort: Randomized 2:1 (N=800) metastatic CRC patients previously treated with ≥2 lines of standard chemotherapy; ECOG 0-1; exclusion of brain metastasis and recent ascites drainage; dosing 35 mg/m2 orally twice daily on Days 1-5 and 8-12 of 28-day cycles; demonstrated statistically significant OS and PFS benefit vs placebo.

Lynparza ovarian cancer evidence: Evidence includes non-randomized single-arm and randomized open-label studies in gBRCAm advanced ovarian cancer with ORR ~31% and median duration of response 7–8 months; maintenance after chemo not well supported by evidence in some contexts and requires monitoring for MDS/AML.

Retevmo RET fusion-positive tumors: LIBRETTO-001 showed ORR 64% in previously treated RET fusion-positive NSCLC with durable responses; efficacy also reported for RET-mutant medullary thyroid cancer and RET fusion-positive thyroid cancer cohorts.

Revuforj KMT2A-translocated acute leukemia:

Agent-specific coverage rationale (evidence summaries)

Evidence summaries for specific agents (biomarker or diagnosis-driven):

Tibsovo (ivosidenib) for AML: Indicated for AML with IDH1 mutation based on Phase I data showing ORR 41.6% and CR/CRh 30.4%; molecular confirmation of IDH1 mutation required; adverse events include diarrhea, leukocytosis, QT prolongation, differentiation syndrome.molecular confirmation of IDH1 mutation required

Talzenna (talazoparib): Studied in germline BRCA-mutated HER2-negative locally advanced or metastatic breast cancer with improved PFS and in HRR-mutated mCRPC showing rPFS benefit; selection based on HRR/BRCA status per trial.BRCA or HRR mutation status per trial

Vyloy (zolbetuximab-clzb): Approved for CLDN18.2-positive, advanced unresectable or metastatic HER2-negative gastric/GEJ adenocarcinoma based on SPOTLIGHT and GLOW showing PFS and OS benefit; CLDN18.2 positivity required.CLDN18.2 positive tumor required

Aggregate coverage criteria changes (examples)

The following are examples of coverage criteria actions taken in the updates (not exhaustive in this excerpt):

New drug coverage added: Added coverage criteria for specific new drugs and indications (examples include Epkinly, Talvey, Elrexfio, Amtagvi, Hepzato Kit, Ogsiveo, Lonsurf, Komzifti).

See individual drug sections in full policy.

Age/indication revisions: Updated age/indication requirements for Rozlytrek, Retevmo and others (e.g., Rozlytrek age lowered to 1 month).

Supports pediatric use expansions noted in updates.

Removal of requirements: Removed prior therapy or ECOG performance status requirements for several drugs; removed coverage for products withdrawn or discontinued (e.g., Truseltiq, Temodar oral).

Operational details in main policy.

Talzenna (talazoparib) — biomarker-based coverage

Selection criteria based on HRR gene mutation testing for PARP inhibitor therapy (Talzenna/Lynparza) as described:

Talzenna selection based on HRR mutation: Select individuals for treatment of HRR gene-mutated metastatic castration-resistant prostate cancer with Talzenna based on presence of one or more pathogenic HRR gene mutations including ATM, ATR, BRCA1, BRCA2, CDK12, CHEK2, FANCA, MLH1, MRE11A, NBN, PALB2, or RAD51C.presence of one or more listed pathogenic HRR gene mutations

FDA-approved companion test for Talzenna not available currently.

Lynparza (olaparib) — biomarker/sample guidance

Document lists sample types acceptable for various biomarkers in Lynparza selection.

Lynparza biomarker/sample mapping: Mapping of biomarkers (germline or somatic HRR genes including ATM, BRCA1, BRCA2, BARD1, BRIP1, CDK12, CHEK1, CHEK2, FANCL, PALB2, RAD51B/C/D, RAD54L) to sample types (tumor, blood, plasma ctDNA) is provided; for gBRCA1/2 blood testing is indicated; for some genes ctDNA plasma testing is indicated.detection of listed mutation in indicated sample type

Presented as a table in source.

Summary of selected updated coverage criteria

Updates and added coverage criteria summarized (examples only as full criteria reside elsewhere in the policy):

New agent coverage: Added coverage criteria for multiple newly FDA-approved agents (examples: Imdelltra for ES-SCLC; Amtagvi for unresectable/metastatic melanoma; Tecelra; Tepylute).

See full policy sections for agent-specific criteria.

Ibrance sequencing requirement: Coverage for Ibrance requires inadequate response or intolerance to Verzenio, Kisqali, or Kisqali Femara Co-Pack when used as specified (updated 01/01/25).

Material change to sequencing/step therapy.

Retevmo pediatric age criteria: Retevmo coverage age requirements updated to include children 2 years and older for several indications; adult metastatic NSCLC with RET fusion criteria clarified to 'locally advanced or metastatic'.

Changed age thresholds and indication wording.

Selected updated coverage criteria (history highlights)

History notes additions and revisions to coverage criteria for many oncology agents; selected highlights:

Ibrance (palbociclib) sequencing: Coverage updated to require inadequate response or intolerance to Verzenio (abemaciclib), Kisqali (ribociclib) or Kisqali Femara Co-Pack (letrozole-ribociclib) before Ibrance.

from history entries

Zejula (niraparib) maintenance: First-line maintenance for advanced ovarian cancer limited to HRD-positive tumors; dose/quantity limits applied.HRD-positive

from history entries

Retevmo (selpercatinib): Indication updated to adult individuals with locally advanced or metastatic NSCLC with RET gene fusion; pediatric age limits for some indications lowered to 2 years.

from history entries

Use of systemic oncology agents solely as maintenance therapy following response to chemotherapy regimens is considered not medically necessary. This NMN statement applies to oral agents in this policy when a labeled or evidence-based maintenance indication is not specified. (See product-specific entries for agents with supported maintenance indications.)

Prior authorization and documentation requirements described elsewhere in the policy remain applicable; approvals for non-formulary exception reviews may be limited in duration (see policy length of approval guidance).

Rydapt (midostaurin) is not indicated as a single-agent induction therapy for acute myeloid leukemia. Rydapt’s approved AML use is in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation for FLT3 mutation–positive disease, with documentation of genetic testing required for coverage consideration.

Blenrep (belantamab mafodotin) coverage requires that the individual do not currently have documented corneal epithelial disease. Presence of corneal epithelial disease is an exclusion and Blenrep should not be used in such individuals per the policy criteria.

All uses of medications not explicitly listed with an FDA‑approved indication and matched coverage criteria within this policy are considered investigational. Each drug entry is subject to the product’s FDA dosing and administration prescribing information; off‑label or unlisted uses should be submitted for review but are presumptively investigational unless specifically addressed.

Amtagvi (lifileucel) carries a Boxed Warning in the prescribing information citing risks of treatment‑related mortality, prolonged severe cytopenias, severe infections, and cardiopulmonary and renal impairment. These serious risks are relevant to authorization decisions and to monitoring requirements for individuals considered for Amtagvi.

Komzifti (ziftomenib) includes a Boxed Warning for differentiation syndrome. This safety risk is an important consideration for coverage and requires that appropriate monitoring and management plans be available when Komzifti is prescribed.

The Lonsurf (trifluridine/tipiracil) pivotal trial excluded individuals with brain metastases and those with ascites requiring drainage in the prior four weeks; these trial exclusions inform patient selection considerations for coverage in metastatic colorectal cancer after prior lines of therapy.

Ninlaro (ixazomib) pivotal study excluded patients who were refractory to lenalidomide or to proteasome inhibitors. Where coverage relies on trial evidence, prior‑therapy refractory status consistent with trial exclusions should be considered in authorization decisions.

Rydapt (midostaurin) is contraindicated in individuals with known hypersensitivity to midostaurin or any formulation ingredients and should not be used in pregnant or breastfeeding women because of potential harm to a fetus or newborn. These contraindications should be checked during authorization and prescribing.

Coverage criteria for Truseltiq (infigratinib) were removed because the product has been withdrawn from the market. Withdrawn products are not covered under this policy.

For Talzenna (talazoparib) and related PARP inhibitor selection, the policy notes the absence of an FDA‑approved companion test for some HRR genes; testing guidance and listed HRR gene panels are provided in the policy rationale to support selection where coverage is tied to HRR mutations.

Coverage was removed for multiple drugs that were withdrawn from the market (examples include Lartruvo, Pepaxto, Truseltiq) and for products discontinued (for example, oral Temodar). Requests for withdrawn or discontinued products are not covered.

Certain products that have been discontinued were removed from the policy’s coverage tables. Providers should not expect coverage for discontinued formulations (for example, Temodar oral where discontinued) and should refer to current product availability when requesting authorization.

Maintenance therapy with oral oncology agents is not medically necessary when used solely to maintain response following chemotherapy unless a specific, evidence‑based maintenance indication is listed for that agent in the policy. See drug‑specific entries for exceptions where maintenance use is supported and explicitly covered.

Reiterating Blenrep guidance: use is only appropriate when there is no documented corneal epithelial disease. Documentation of ophthalmologic evaluation and corneal status is expected during prior authorization for Blenrep.

Olaparib (Lynparza) evidence does not support routine use as maintenance following objective response to chemotherapy in the settings reviewed; the policy therefore does not endorse olaparib as general maintenance outside specified, evidence‑based indications. For agents such as olaparib, coverage is guided by the specific trial‑based indications and biomarker requirements documented in the policy.

This policy is a coverage guideline for systemic chemotherapy and targeted oncology agents; it describes medical necessity criteria, biomarker requirements, prior therapy sequencing, and limits that apply to Premera coverage determinations. Member benefits vary by contract and this document does not itself determine benefits — consult the member’s benefit booklet for plan‑specific coverage rules.

Treatment combinations, sequencing, and line‑of‑therapy indications are constrained to the specific combinations and lines described for each agent. If an intended use does not meet the specified line, combination, or sequencing criteria in an agent’s coverage entry, coverage would not be provided under this policy.

There are no additional explicit 'not medically necessary' statements beyond those listed throughout the policy excerpts; each agent entry should be reviewed for agent‑specific NMN or exclusion language.

Indications removed from the policy reflect market withdrawals and discontinuations; such removed or withdrawn agents are not covered. Providers seeking coverage for an indication removed because of market withdrawal should note the product is unavailable and requests will be denied.

This policy is intended as a guide to assist Company staff in coverage determination and is not a substitute for the member’s benefit booklet. Benefit coverage is subject to the limits and conditions of the member’s contract; contact customer service or consult the benefit booklet to determine plan‑specific coverage.

Coding (HCPCS / J-Codes and Dosage Limits)

HCPCS/J-codes (selected)HCPCS

C9303	Injection, zolbetuximab-clzb (Vyloy), 1 mg (new code effective 04/01/25)
C9399	Unspecified drugs or biologicals (use to report: Hepzato, Tecelra, Zusduri, Inlexzo and Modeyso)
J0614	Injection, treosulfan (Grafapex), 50 mg (new code effective 10/01/25)
J0870	Injection, imetelstat (Rytelo), 1 mg
J0893	Injection, decitabine (Sun Pharma), not therapeutically equivalent to J0894, 1 mg
J0894	Injection, decitabine (Dacogen), 1 mg
J1326	Injection, zolbetuximab-clzb (Vyloy), 2 mg (new code effective 07/01/25)
J1448	Injection, trilaciclib (Cosela), 1 mg
J2277	Injection, motixafortide (Aphexda), 0.25 mg
J2425	Injection, palifermin (Kepivance), 50 mcg

1–10 of 19

1/2

HCPCS/J-codes (continued)HCPCS

J9033	Injection, bendamustine HCl (Treanda), 1 mg
J9034	Injection, bendamustine HCl (Bendeka), 1 mg
J9036	Injection, bendamustine HCl, (Belrapzo/bendamustine), 1 mg
J9041	Injection, bortezomib (Velcade), 0.1 mg
J9046	Injection, bortezomib (Dr. Reddy's), not therapeutically equivalent to J9041, 0.1 mg
J9047	Injection, carfilzomib (Kyprolis), 1 mg
J9048	Injection, bortezomib (Fresenius Kabi), not therapeutically equivalent to J9041, 0.1 mg
J9049	Injection, bortezomib (Hospira), not therapeutically equivalent to J9041, 0.1 mg
J9051	Injection, bortezomib (Maia), not therapeutically equivalent to J9041, 0.1 mg
J9054	Injection, bortezomib (Boruzu), 0.1 mg (new code effective 04/01/25)

1–10 of 48

1/5

No explicit CPT/HCPCS/ICD codes in this sectionmixed

No codes listed

Historical HCPCS/administrative codes referencedHCPCS

J9271	HCPCS code added (reference in history)
J3380	HCPCS code previously added then removed (reference in history)
J9299	HCPCS code added (reference in history)
J9022	HCPCS code added effective 1/1/18 (reference in history)
J9023	HCPCS code added effective 1/1/18 (reference in history)
J9285	HCPCS code added effective 1/1/18 (reference in history)

HCPCS/Codes added or removed (historical log)HCPCS

J9022	HCPCS code removed (historical)
J9023	HCPCS code removed (historical)
J9280	HCPCS for Jelmyto (added)
J9214	HCPCS code added (noted 2020)
C9069	HCPCS code added 1/1/21
C9078	HCPCS code added
J9205	HCPCS code added
J9269	HCPCS code added
J9274	HCPCS code added 10/1/22
C9095	HCPCS code added 7/1/22

1–10 of 16

1/2

HCPCS codes added/removed/updated in historyHCPCS

J1246	HCPCS code removed — never implemented by CMS
J9026	Added HCPCS code
J0870	Rytelo (Imetelstat) HCPCS code added
J9034	Added HCPCS code
J9036	Added HCPCS code
J9056	Added HCPCS code
J9153	Added HCPCS code
J9266	Added HCPCS code
J9268	Added HCPCS code
C9303	Added HCPCS code

1–10 of 32

1/4

Zejula (niraparib) dose limit

Zejula (niraparib) dose limit300 mg daily

Indication contextMaintenance treatment of adults with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are HRD-positive and in CR/PR after first-line platinum-based chemotherapy

Quantity notePolicy history notes a quantity limit was added/updated (see coding/quantity limits section)

Lynparza (olaparib) tablet limit

Lynparza (olaparib) tablet limitQuantity limited to 4 tablets daily

Provider Actions — Prior Authorization, Documentation, Step Therapy

Prior Authorization

Prior Authorization Required

Prior authorization is required when the policy’s drug‑specific coverage criteria apply. Providers should submit documentation that demonstrates the member meets the clinical criteria (age, diagnosis, biomarker/diagnostic test results when applicable, prior therapies and treatment response or intolerance). Failure to provide required documentation may result in denial.

Prior authorization required when criteria apply
Include age, diagnosis, biomarker/diagnostic results, prior therapy history

Prior Authorization

Biomarker- and Line-Dependent Agents — Authorization Requirement

Prior authorization is required for agents whose coverage depends on specific molecular biomarkers or prior line(s) of therapy (for example, FLT3, IDH1/2, NPM1, FGFR2, RET, BRCA, HRD). Documentation of the biomarker testing method and result (FDA‑approved test or equivalent) must be provided.

Biomarker/diagnostic test results required (e.g., FLT3, IDH1/2, NPM1, FGFR2, RET, BRCA, HRD)
Specify test used (FDA‑approved test when indicated)

Covered Regimens and Combination Therapies

Regimen	Indication / key criteria	Coverage status
{"text":"Palbociclib (Ibrance) + aromatase inhibitor","status":""},{"text":"HR-positive, HER2-negative advanced or metastatic breast cancer; individual has tried and had an inadequate response or intolerance to Kisqali (ribociclib) or Verzenio (abemaciclib); used in combination with an aromatase inhibitor as initial endocrine-based therapy.","status":""},{"text":"Ibrance in combination per criteria","status":"covered"}
{"text":"Palbociclib (Ibrance) + fulvestrant (Faslodex)","status":""},{"text":"HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy; individual has tried and had an inadequate response or intolerance to Kisqali or Verzenio; used in combination with fulvestrant.","status":""},{"text":"Ibrance in combination per criteria","status":"covered"}

Regimen	Indication / key criteria	Coverage status
{"text":"Lifileucel (Amtagvi) — single-dose cellular therapy","status":""},{"text":"Adults ≥18 with unresectable or metastatic melanoma; prior treatment with a PD-1 or PD-L1 blocking antibody (e.g., pembrolizumab, nivolumab, atezolizumab) AND BRAF V600 mutation–positive with prior treatment with a BRAF inhibitor with or without a MEK inhibitor; not previously treated with lifileucel; prescribed by or in consultation with an oncologist.","status":""},{"text":"Amtagvi (lifileucel) per criteria","status":"covered"}

Regimen	Indication / key criteria	Coverage status
{"text":"Motixafortide (Aphexda) — subcutaneous adjunct for mobilization","status":""},{"text":"Mobilization of hematopoietic stem cells for collection and subsequent autologous transplantation in individuals with multiple myeloma who are eligible for transplant and when documentation provides a valid medical rationale why generic plerixafor cannot be used.","status":""},{"text":"Aphexda (motixafortide) per criteria","status":"covered"}

Regimen	Indication / key criteria	Coverage status
{"text":"Docetaxel (single-agent or combination)","status":""},{"text":"Indications include: single agent for locally advanced or metastatic breast cancer after chemotherapy failure; combination with doxorubicin and cyclophosphamide as adjuvant for operable node-positive breast cancer; single agent for locally advanced or metastatic NSCLC after platinum failure; combination regimens for prostate, gastric, and head and neck cancers as specified in policy.","status":""},{"text":"Docetaxel regimens per policy","status":"covered"}
{"text":"Daratumumab combinations (e.g., daratumumab + lenalidomide + dexamethasone; daratumumab + bortezomib + melphalan + prednisone)","status":""},{"text":"Multiple myeloma: daratumumab in combination with lenalidomide and dexamethasone as first-line and for relapsed/refractory disease after ≥1 prior therapy; daratumumab with bortezomib/melphalan/prednisone as first-line in transplant-ineligible individuals per specified criteria.","status":""},{"text":"Daratumumab combinations per criteria","status":"covered"}

Regimen	Indication / key criteria	Coverage status
{"text":"Tebentafusp (Kimmtrak) — intravenous therapy","status":""},{"text":"HLA-A02:01–positive adult individuals with unresectable or metastatic uveal melanoma.","status":""},{"text":"Kimmtrak restricted to HLA-A02:01-positive adults","status":"covered"}

Regimen	Indication / key criteria	Coverage status
{"text":"Irinotecan liposome (Onivyde) + 5‑FU/leucovorin","status":""},{"text":"Metastatic pancreatic adenocarcinoma following progression on a gemcitabine-based therapy; use in adults only; dosing and administration per product labeling and trial regimens.","status":""},{"text":"Onivyde + 5-FU/LV post-gemcitabine per criteria","status":"covered"}
{"text":"Irinotecan liposome (Onivyde) + oxaliplatin + 5‑FU/leucovorin (first-line option)","status":""},{"text":"First-line treatment of certain adults with metastatic pancreatic adenocarcinoma in combination with oxaliplatin, 5‑FU and leucovorin per updated coverage criteria; see product labeling for specifics.","status":""},{"text":"Onivyde + oxaliplatin + 5-FU/LV per criteria","status":"covered"}

Regimen	Indication / key criteria	Coverage status
{"text":"Isatuximab + pomalidomide + dexamethasone","status":""},{"text":"Adults with multiple myeloma who have received ≥2 prior therapies including lenalidomide and a proteasome inhibitor.","status":""},{"text":"Isatuximab (Sarclisa) + pomalidomide + dexamethasone per criteria","status":"covered"}
{"text":"Isatuximab + carfilzomib + dexamethasone","status":""},{"text":"Adults with relapsed/refractory multiple myeloma with 1–3 prior lines of therapy.","status":""},{"text":"Isatuximab + carfilzomib + dexamethasone per criteria","status":"covered"}
{"text":"Isatuximab + bortezomib + lenalidomide + dexamethasone","status":""},{"text":"For newly diagnosed multiple myeloma in individuals ineligible for autologous stem cell transplant when specified criteria met.","status":""},{"text":"Isatuximab-containing regimens per criteria","status":"covered"}

Regimen	Indication / key criteria	Coverage status
{"text":"Daratumumab + lenalidomide + dexamethasone (DRd)","status":""},{"text":"Multiple myeloma: used as first-line therapy and in relapsed/refractory settings per policy; DRd demonstrated PFS improvement in transplant-ineligible individuals.","status":""},{"text":"Daratumumab (DRd) per criteria","status":"covered"}
{"text":"Daratumumab + bortezomib + melphalan + prednisone (D-VMP)","status":""},{"text":"Used as first-line therapy in transplant-ineligible multiple myeloma; demonstrated PFS improvement versus VMP alone.","status":""},{"text":"Daratumumab (D-VMP) per criteria","status":"covered"}

Regimen	Indication / key criteria	Coverage status
{"text":"Palbociclib (Ibrance) + letrozole","status":""},{"text":"Postmenopausal women with ER-positive, HER2-negative advanced breast cancer as initial endocrine-based therapy for metastatic disease; PALOMA-2 showed PFS benefit (palbociclib plus letrozole vs placebo plus letrozole).","status":""},{"text":"Ibrance + letrozole per PALOMA-2 data","status":"covered"}

Regimen	Indication / key criteria	Coverage status
{"text":"Trifluridine/tipiracil (Lonsurf) + best supportive care","status":""},{"text":"Adults with metastatic colorectal cancer previously treated with at least 2 lines of standard chemotherapy (including fluoropyrimidine-, oxaliplatin-, and irinotecan-based regimens) and appropriate biologics; trial eligibility included ECOG 0–1 and excluded brain metastases and recent draining ascites; demonstrated OS and PFS benefit. Dosing in trial: 35 mg/m2 twice daily Days 1–5 and 8–12 of a 28‑day cycle (see next row for dosing detail).","status":""},{"text":"Lonsurf + BSC per trial and criteria","status":"covered"}

Regimen	Indication / key criteria	Coverage status
{"text":"Lonsurf trial dosing","status":""},{"text":"35 mg/m2 orally twice daily after meals on Days 1–5 and 8–12 of each 28‑day cycle until disease progression or unacceptable toxicity (as used in the pivotal randomized trial in previously treated metastatic CRC).","status":""},{"text":"Informational: trial dosing","status":"informational"}

Regimen	Indication / key criteria	Coverage status
{"text":"Ixazomib (Ninlaro) 4 mg Days 1,8,15 + lenalidomide 25 mg Days 1–21 + dexamethasone 40 mg per protocol","status":""},{"text":"Relapsed and/or refractory multiple myeloma in individuals with ≥1 prior line of therapy who are not refractory to lenalidomide or proteasome inhibitors (trial population); dosing per trial: ixazomib 4 mg Days 1,8,15 of 28‑day cycle with lenalidomide and dexamethasone.","status":""},{"text":"Ninlaro combination per protocol (informational)","status":"informational"}

Regimen	Indication / key criteria	Coverage status
{"text":"Midostaurin (Rydapt) 50 mg twice daily with food","status":""},{"text":"First-line treatment of adults with FLT3‑mutation–positive AML in combination with cytarabine and daunorubicin induction and cytarabine consolidation; recommended dose for AML is 50 mg twice daily with food.","status":""},{"text":"Rydapt per labeled dosing for FLT3+ AML","status":"covered"}

Regimen	Indication / key criteria	Coverage status
{"text":"Zolbetuximab (Vyloy) + mFOLFOX6","status":""},{"text":"CLDN18.2‑positive (moderate–high expression in ≥75% of tumor cells) advanced unresectable or metastatic HER2‑negative gastric/GEJ adenocarcinoma; used in combination with mFOLFOX6 per SPOTLIGHT trial showing PFS and OS benefit.","status":""},{"text":"Vyloy + mFOLFOX6 per SPOTLIGHT","status":"covered"}
{"text":"Zolbetuximab (Vyloy) + CAPOX","status":""},{"text":"CLDN18.2‑positive advanced unresectable or metastatic HER2‑negative gastric/GEJ adenocarcinoma; used in combination with CAPOX per GLOW trial showing benefit.","status":""},{"text":"Vyloy + CAPOX per GLOW","status":"covered"}

Regimen	Indication / key criteria	Coverage status
{"text":"Afamitresgene autoleucel (Tecelra) — single infusion","status":""},{"text":"Adults with previously treated inoperable or metastatic synovial sarcoma who have progressed following at least one prior systemic chemotherapy; therapy requires inpatient monitoring for cytokine release syndrome (CRS) and immune effector cell–associated neurotoxicity syndrome (ICANS) with at least 7 days of observation post-treatment per trial experience.","status":""},{"text":"Tecelra per SPEARHEAD‑1 with inpatient monitoring","status":"covered"}

Regimen	Indication / key criteria	Coverage status
{"text":"Daratumumab + carfilzomib + dexamethasone","status":""},{"text":"Relapsed or refractory multiple myeloma after 1–3 prior lines of therapy; added as an indication in 2022 updates to daratumumab coverage.","status":""},{"text":"Darzalex + carfilzomib + dexamethasone per criteria","status":"covered"}

Regimen	Indication / key criteria	Coverage status
{"text":"Olaparib (Lynparza) + abiraterone + prednisone/prednisolone","status":""},{"text":"Adults with deleterious or suspected deleterious germline or somatic BRCA‑mutated metastatic castration‑resistant prostate cancer (mCRPC); must meet biomarker-defined criteria per policy.","status":""},{"text":"Lynparza + abiraterone per criteria","status":"covered"}

Regimen	Indication / key criteria	Coverage status
{"text":"PARP inhibitor therapy (olaparib, talazoparib) per labeled indications","status":""},{"text":"Use requires presence of appropriate biomarkers (deleterious or suspected deleterious BRCA or HRR gene mutations as specified for each indication); dosing and quantity limits (e.g., lynparza 4 tablets daily; Zejula 300 mg daily where applicable) per product labeling and policy.","status":""},{"text":"PARP inhibitors per labeled indications and biomarker presence","status":"covered"}

Regimen	Indication / key criteria	Coverage status
{"text":"Daratumumab combinations including with carfilzomib + dexamethasone; with bortezomib + lenalidomide + dexamethasone","status":""},{"text":"Darzalex Faspro coverage includes multiple combination regimens for newly diagnosed and relapsed/refractory multiple myeloma per updated indications; use per agent‑specific criteria.","status":""},{"text":"Darzalex Faspro combinations per criteria","status":"covered"}

Regimen	Indication / key criteria	Coverage status
{"text":"Onivyde-containing first-line regimens for metastatic pancreatic adenocarcinoma","status":""},{"text":"Policy updated to include first‑line treatment with Onivyde in certain adults with metastatic pancreatic adenocarcinoma in combination with oxaliplatin and 5‑FU/leucovorin; see product labeling and policy for full eligibility and adult‑only restriction.","status":""},{"text":"Onivyde first‑line combinations per updated criteria","status":"covered"}

Regimen	Indication / key criteria	Coverage status
{"text":"Daratumumab + bortezomib + lenalidomide + dexamethasone (quadruplet)","status":""},{"text":"Added coverage for daratumumab in combination with bortezomib, lenalidomide and dexamethasone for newly diagnosed individuals who are ineligible for autologous stem cell transplant per 2026 update; use per policy criteria.","status":""},{"text":"Darzalex + BVDd per criteria","status":"covered"}

Biomarker & Diagnostic Testing Requirements

IDH2 — biomarker listing

IDH2 biomarkerIDH2 mutation required for Idhifa (enasidenib) in relapsed/refractory AML

Test documentationIDH2 mutations may be identified by local diagnostic tests and confirmed by Abbott RealTime IDH2 assay when available

Age requirementAdults (aged 18 years or older) per coverage criteria

IDH1 — biomarker listing

IDH1 biomarkerIDH1 mutation required for Tibsovo (ivosidenib) indications (AML, cholangiocarcinoma, MDS as specified)

Use contextsNewly diagnosed AML in patients ≥75 or with comorbidities (with azacitidine or monotherapy); relapsed/refractory AML; previously treated cholangiocarcinoma

Line-of-Therapy Context (First-line, Second-line, Salvage, Maintenance)

Background and Scope

This policy addresses a broad set of oral and selected parenteral oncology drugs and defines medical necessity criteria, biomarker requirements, prior‑therapy sequencing, dosing/quantity limits, and documentation expectations used in coverage determinations. It is intended for clinicians and billing/authorization staff who submit or adjudicate requests for these agents.

Definitions and Terminology

Revision History & Policy Changes

2026-03-01policy_effectiveLatest

Policy effective date updated to 2026-03-01 following annual review; multiple coverage criteria and ECOG requirement removals implemented (see history entries).

2026-02-10annual_review

Annual review approved; updates include additions for Komzifti, quantity limits for Lumakras and Pemazyre, Rozlytrek pediatric age change, removal of oral temozolomide, and ECOG requirement removals for several agents.

2026-01-01interim_review

Policy Summary

PayerPremera Bluecross

PolicyMiscellaneous Oncology Drugs

Policy CodePolicy 5.01.540

Change TypeMultiple additions and revisions (coverage criteria, age limits, quantity limits, coding updates)

Effective DateMar 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of diagnosis, biomarker test results, prior therapies, and required clinical labs when requesting coverage.

SourceLink

On This Page

Rubraca ovarian and mCRPC: Adults ≥18 with BRCA-mutated epithelial ovarian/fallopian tube/primary peritoneal cancer after ≥2 chemotherapies OR recurrent disease in CR/PR to platinum-based chemo as maintenance OR BRCA-associated mCRPC after androgen receptor-directed therapy; quantity limited to 4 tablets daily.

Zejula maintenance ovarian cancer: Adults ≥18 with advanced epithelial ovarian/fallopian tube/primary peritoneal cancer in CR/PR to first-line platinum-based chemo AND HRD-positive (BRCA mutation or genomic instability) AND dose limited to 300 mg daily.

AUGMENT-101: CR+CRh 21.2%, median DOR 6.4 months, median time to CR/CRh 1.9 months.

Romvimza TGCT: Phase 3 MOTION: ORR 40% vs 0% placebo at Week 25; high proportion of responders with DOR ≥6 months and improvements in symptoms and function.

Rytelo IMerge trial design: Phase 2/3 IMerge: Part1 single-arm (N=57) and Part2 randomized double-blind (N=178 randomized 2:1) with extension and ventricular repolarization substudy; describes unblinding and extension rules.

Tibsovo AML data: Phase I dose-escalation/expansion showed ORR 41.6% and CR/CRh 30.4% in IDH1-mutant AML; median durations and safety events documented.molecular confirmation of IDH1 mutation required

Xpovio approvals: Accelerated approval for selinexor plus dexamethasone for R/R MM after ≥4 prior therapies and triple-class refractory disease (STORM); BOSTON trial ongoing for combination with bortezomib and dexamethasone.

Talzenna trials: EMBRACA showed PFS improvement in gBRCA-mutated breast cancer; TALAPRO-2 showed rPFS benefit in HRR-mutated mCRPC when combined with enzalutamide.mutation confirmation per trial

Voranigo (vorasidenib): For residual or recurrent grade 2 nonenhancing glioma with IDH1/2 mutation post-surgery; INDIGO trial showed median PFS 27.7 vs 11.1 months; adverse events include elevated ALT/AST and seizures.IDH1 or IDH2 mutation required

Rozlytrek (entrectinib): Pediatric age requirement updated to 1 month and older for solid tumors.age >= 1 month

from history entries

Acceptable biomarkerDeleterious or suspected deleterious BRCA mutation (germline or somatic) confirmed by genetic testing; also used for HRD-positive disease contexts

Indications examplesMaintenance for advanced ovarian cancer; maintenance pancreatic cancer for gBRCA; metastatic breast cancer with BRCA/PALB2

Odomzo (sonidegib) dose limit

Odomzo (sonidegib) dose limit200 mg per day (1 tablet daily)

IndicationLocally advanced basal cell carcinoma (BCC) recurrent after surgery/radiation or not candidate for surgery/radiation

Age requirementAdults aged 18 years or older

Vonjo (pacritinib) dosing

Vonjo (pacritinib) dosing400 mg per day (200 mg twice daily)

Indication thresholdFor adults with intermediate- or high-risk primary or secondary myelofibrosis and platelet count <50 x10^9/L

DocumentationRisk stratification/GIPSS documentation recommended (GIPSS >2 or GIPSS 1-2 plus MIPPS70 >4)

Hematologic thresholds for Hepzato Kit

Hepzato Kit hematologic thresholdsPlatelets ≥100,000/µL; ANC ≥1,500 cells/µL

Disease extent requirementHistologic/cytologic proof of ocular melanoma liver metastases with <50% liver parenchyma involvement

Age requirementAdults aged 18 years or older

Ixempra dosing limit

Ixempra (ixabepilone) dosing limit40 mg/m2 every 3 weeks

Use contextUsed as single agent or in combination with capecitabine for metastatic or locally advanced breast cancer when resistant to anthracycline and taxane

Administration noteDose and regimen per IV product labeling in policy section

Doxil dosing examples

Doxil dosing examples50 mg/m2 every 4 weeks (ovarian); 20 mg/m2 every 3 weeks (AIDS-related Kaposi's sarcoma); 30 mg/m2 every 3 weeks (multiple myeloma)

Indication contextDose examples provided per tumor type in IV/IM/SC agents section

Policy noteRefer to agent-specific section for full dosing and administration details

Kepivance dosing limit

Kepivance (palifermin) dosing limit60 mcg/kg/day for 3 consecutive days before and 3 consecutive days after myelotoxic therapy (total 6 doses)

IndicationTo decrease incidence and duration of severe oral mucositis in hematologic malignancy patients receiving myelotoxic therapy with autologous HSCT support

Age requirementPer policy adult individuals; see full policy for pediatric references where applicable

Risk of febrile neutropenia threshold

Risk of febrile neutropenia thresholdReceiving a chemotherapy regimen expected to result in a 20% or higher incidence of febrile neutropenia

Leukine sequencingLeukine (sargramostim) as second-line requires prior trial and failure of Granix (tbo-filgrastim) or Nivestym (filgrastim-aafi) or contraindication to them

Documentation requiredProvide clinical justification and prior agent trial/failure documentation for coverage consideration

Transfusion dependence (Rytelo)

Transfusion dependence (Rytelo) definitionRequires transfusion of at least 4 red blood cell (RBC) units over an 8‑week period

Rytelo dosingDose limited to 7.1 mg/kg every 4 weeks (policy entry) and must meet other eligibility criteria

ExclusionMust not have del(5q) cytogenetic abnormality to be eligible

RBC transfusion independence durations

RBC transfusion independence (RBC-TI) durations reportedRBC-TI endpoints include at least 8 and 24 consecutive weeks (reporting: 39.8% / 28.0% with Rytelo vs 15.0% / 3.3% placebo)

Trial contextIMerge trial reported these RBC-TI outcomes and Grade 3/4 cytopenias; use supports coverage criteria documentation

Documentation tipProvide transfusion history and investigator-assessed benefit when requesting coverage

HRR mutation prevalence (metric)

HRR mutation prevalence metricHRR gene mutations found in approximately 23% of metastatic castration‑resistant prostate cancer

Common HRR genesFrequent mutations include BRCA2, ATM, CHEK2, and BRCA1

PARP selection panelTalzenna selection lists HRR genes including ATM, ATR, BRCA1/2, CDK12, CHEK2, FANCA, MLH1, MRE11A, NBN, PALB2, RAD51C

Quantity limits — multiple agents

Quantity limits—policy actionQuantity limits were added/updated for multiple agents (examples include Zejula, Lumakras, Pemazyre, Romvimza)

ExamplesPemazyre quantity limit: 28 tablets per 28 days; Retevmo quantity limit: 60 tablets per 30 days; Lumakras tablet-specific monthly quantities in policy

Provider noteRefer to each agent's dosing/quantity entry in the coding and thresholds sections for exact tablet counts per 30/28 days

Documentation Required

Prior Therapy Documentation — Required

Document prior therapies clearly: list agents, dates, responses, and reasons for discontinuation (progression, intolerance). Many drugs require prior lines of therapy or failure/intolerance to specific alternatives (e.g., palbociclib now requires inadequate response or intolerance to abemaciclib or ribociclib; Ogsiveo requires trial of generic sorafenib first).

List prior agents, lines of therapy, responses, and intolerance/contraindications
Note when specific step therapy or sequencing requirements apply (e.g., palbociclib, Ogsiveo)

Prior Authorization

Authorization Duration and Re-authorization

Length of approval varies by request type: non‑formulary exception reviews may be approved up to 12 months; most oral drug reviews up to 3 months for initial authorizations; IV/IM/SC agents have policy‑specified approval durations. Re‑authorization may be granted up to 12 months when clinical benefit is documented.

Non‑formulary exception approvals: up to 12 months
Initial oral drug approvals: typically up to 3 months
Re‑authorization: up to 12 months with ongoing clinical benefit

Documentation Required

Mutation- and Fitness-Based Authorization — Documentation Needed

Certain agents require mutation‑specific or functional eligibility documentation (e.g., Komzifti requires NPM1 mutation and fitness for therapy; Idhifa requires confirmed IDH2 mutation). Include the specific mutation subtype and testing method when relevant.

Komzifti (ziftomenib): NPM1 mutation documented (NGS or PCR) and patient meets fitness criteria
Idhifa (enasidenib): IDH2 mutation documented (local or Abbott RealTime IDH2 assay)

Documentation Required

Molecular/Biomarker Confirmation — Provide Test Reports

When coverage depends on a molecular confirmation (e.g., Ivosidenib/Tibsovo, Rydapt), include lab reports confirming the mutation and the test used. Absence of required molecular confirmation may lead to denial.

Provide lab report and testing method for IDH1/IDH2 and FLT3 where applicable
Reference FDA‑approved diagnostic tests when available

Prior Authorization

Notification Requirement for Select IV Agents

Providers must notify the payer for certain IV agents within the timeframe specified by the policy (90‑day provider notification is required for IV Temodar and Unituxin). Follow the policy’s notification instructions to avoid delays.

90 days provider notification required for Temodar IV and Unituxin IV
Follow policy notification procedures to prevent claim or authorization issues

Documentation Required

Specialist Prescribing / Consultation — Documentation

Prescribing specialist requirement: many agents must be prescribed by or in consultation with an oncologist or hematologist (e.g., Romvimza, Tecelra, Rytelo). Ensure documentation shows appropriate specialist involvement.

Indicate prescribing oncologist/hematologist or consultation note
Specialist prescribing requirement applies to several cellular and complex agents

Step Therapy

Supportive Growth Factor Sequencing — Document Prior Agents

Supportive care sequencing: for growth factors such as Leukine (GM‑CSF), document prior use and failure or contraindication to preferred filgrastim products (e.g., Granix, Nivestym) before approval as second‑line therapy.

Leukine approval requires trial and failure of Granix or Nivestym, or a contraindication to those agents
List prior supportive agents and reasons for failure/intolerance

Billing Rule

Coding, Withdrawn Products, and Billing — Verify Codes

Coding and administrative notes: providers should reference the policy’s coding table and most recent HCPCS updates when submitting claims. Withdrawn products are not covered and requests for withdrawn agents will be denied.

Reference coding table for current HCPCS/NDC codes
Withdrawn products (e.g., certain earlier removals) are not covered

Test confirmationMolecular confirmation of IDH1 mutation is required for authorization

BRCA (germline and/or somatic) — biomarker requirement

BRCA (germline and/or somatic) requirementDeleterious or suspected deleterious BRCA mutation (germline and/or somatic) confirmed by genetic testing required for PARP indications (e.g., Lynparza, Rubraca) and cited in HRR panels

Sample types guidancePolicy provides mapping of biomarkers to sample types: germline BRCA via blood; tumor and plasma (ctDNA) testing referenced for somatic HRR genes

Related genesBRCA inclusion within HRR panels alongside ATM, CHEK2, PALB2, RAD51C, etc., for PARP inhibitor selection

NTRK gene fusion — biomarker requirement

NTRK gene fusion requirementNTRK gene fusion (without known acquired resistance mutation) required for tumour‑agnostic TRK inhibitors (Rozlytrek, Vitrakvi)

Indication scopeApplicable to adult and pediatric solid tumors that are metastatic or where resection would cause severe morbidity and no satisfactory alternatives exist

Testing noteDetection by validated molecular testing is implied per tumor-agnostic criteria

ROS1 — biomarker requirement

ROS1 biomarkerROS1-positive tumor required for Rozlytrek indication in metastatic NSCLC

Clinical contextRozlytrek indicated for ROS1-positive NSCLC in adults; efficacy established in labeled trials

Age notesRozlytrek also has tumor‑agnostic NTRK indication down to 1 month of age per recent updates

RET fusion/mutation — biomarker requirement

RET fusion/mutation requirementRET fusion or RET mutation required for Gavreto (pralsetinib) and Retevmo (selpercatinib) indications

Retevmo dosing thresholds120 mg twice daily if <50 kg; 160 mg twice daily if ≥50 kg; quantity limit 60 tablets per 30 days

Age expansionsRetevmo pediatric age limits updated to as young as 2 years for several indications

RET — biomarker listing

RET listing (general)RET gene fusion presence required for RET-targeted agents (Gavreto, Retevmo) across NSCLC, thyroid, and solid tumor indications

Dose cap exampleGavreto dose limited to 400 mg once daily (4 capsules)

Testing/authorizationDocumentation of RET fusion/mutation and tumor type required for prior authorization

FGFR2 / FGFR1 / FGFR3 — biomarker listing

FGFR2/FGFR1/FGFR3 listingFGFR2, FGFR1 and FGFR3 alterations required for FGFR‑directed therapies such as Pemazyre (FGFR2 fusion), Balversa (FGFR3 alterations), and Pemazyre for FGFR1 MLNs

Dose/quantity examplePemazyre dose 13.5 mg once daily for 14 days on/7 days off; quantity limited to 28 tablets per 28 days

Test requirementFGFR fusions/rearrangements detected by FDA‑approved test are required where specified

IDH1 / IDH2 — biomarker listing

IDH1 / IDH2 listingIDH1 and IDH2 mutations required for multiple IDH‑directed agents (ivosidenib for IDH1; enasidenib for IDH2) and for vorasidenib in glioma

Indication examplesIdhifa (IDH2) for relapsed/refractory AML; Tibsovo (IDH1) for AML/cholangiocarcinoma; Voranigo for grade 2 glioma with IDH1/2 mutation

Testing noteMolecular confirmation of IDH mutation is expected for authorization

KRAS G12C — biomarker listing

KRAS G12C listingKRAS G12C mutation required for Krazati (adagrasib) and Lumakras (sotorasib) in NSCLC and select colorectal indications

Dose examplesKrazati dosing limited to 1,200 mg/day (600 mg twice daily); Lumakras dose limited to 960 mg/day with tablet-specific monthly quantity limits

Test requirementMutation detection by an FDA‑approved test is specified for Lumakras; policy references testing requirements

FLT3 — biomarker listing

FLT3 listingFLT3 mutation positivity (detected by an FDA‑approved test) required for Rydapt (midostaurin) in first‑line AML combination therapy

Dose exampleRydapt recommended dose for AML: 50 mg twice daily with food

DocumentationGenetic testing documentation is required for coverage consideration

BRAF V600 — biomarker listing

BRAF V600 listingBRAF V600 mutation required for certain BRAF‑targeted therapy contexts (e.g., eligibility elements noted related to lifileucel/Amtagvi)

Clinical notePolicy references BRAF V600 status in eligibility for therapies such as lifileucel in metastatic melanoma

Age/therapy sequencingTherapies often require prior BRAF inhibitor (with/without MEK inhibitor) exposure where indicated

HLA-A*02:01 — biomarker requirement (Kimmtrak)

HLA-A*02:01 requirement (Kimmtrak)HLA‑A*02:01 positivity required for Kimmtrak (tebentafusp‑tebn) in unresectable/metastatic uveal melanoma

AgeRestricted to adult individuals per policy

Testing implicationHLA typing documentation expected for authorization

CLDN18.2 — biomarker requirement for Vyloy (>=75% tumor cells moderate/high expression)

CLDN18.2 requirement for VyloyModerate to high overexpression in at least 75% of tumor cells required for Vyloy (zolbetuximab‑clzb)

IndicationUsed for HER2‑negative gastric/GEJ adenocarcinoma in combination with chemotherapy per SPOTLIGHT/GLOW trials

Testing noteTumor immunohistochemistry demonstrating >=75% moderate/high expression is required

del(5q) — absence required for specific indications

del(5q) absence requirementAbsence of del(5q) cytogenetic abnormality is required for Rytelo (imetelstat) eligibility

ContextRytelo eligibility also requires transfusion dependence, prior ESA and luspatercept failure or ineligibility

Testing/documentationCytogenetic testing documenting absence of del(5q) expected for authorization

Transfusion dependence definition (>=4 RBC units/8 weeks)

Transfusion dependence definitionDefined as requiring transfusion of at least 4 RBC units over an 8‑week period

Use caseUsed as eligibility criterion for Rytelo (imetelstat) in transfusion‑dependent MDS

Documentation tipProvide transfusion records for the 8‑week period when requesting coverage

HLA-A*02:01/02:03/02:06 and MAGE-A4 — combined biomarker requirement

HLA-A*02:01/02:03/02:06 and MAGE-A4 requirementTecelra requires positivity for listed HLA alleles (A*02:01, A*02:02, A*02:03, or A*02:06) and MAGE‑A4 antigen positivity

IndicationTecelra indicated for adults with unresectable or metastatic synovial sarcoma after ≥1 prior systemic chemotherapy

DocumentationHLA typing and MAGE‑A4 antigen testing results are required for authorization

IDH2 biomarker listing (duplicate reference)

IDH2 listing (duplicate)IDH2 mutation required for Idhifa (enasidenib) in relapsed/refractory AML

ConfirmationIDH2 identified by local test and can be confirmed by Abbott RealTime IDH2 assay per trial context

AgeAdults aged 18 years or older

NPM1 — biomarker listing (Komzifti)

NPM1 listing (Komzifti)Susceptible NPM1 mutation required for Komzifti (ziftomenib) in relapsed/refractory AML

Dose limitDose limited to 600 mg daily (3 tablets daily)

Eligibility notesNo satisfactory alternative treatment options and prescribed by/with oncologist; trial eligibility included ECOG 0‑2 and baseline lab limits

FLT3 — molecular test requirement (Rydapt)

FLT3 molecular test requirement (Rydapt)FLT3 mutation-positive as detected by an FDA‑approved test required for Rydapt in first‑line AML combination therapy

Dose exampleRecommended dose for AML: 50 mg twice daily with food

DocumentationGenetic testing documentation is required for coverage consideration

BRCA (germline or somatic) and ATM listing

BRCA and ATM listingBRCA (germline or somatic) and ATM mutations are referenced within PARP inhibitor trial populations and biomarker panels for therapy selection

Use examplesRucaparib (Rubraca) TRITON3 included BRCA/ATM mutated mCRPC; Lynparza guidance maps BRCA and other HRR genes to sample types

Testing implicationDetection by appropriate tumor or blood/plasma assays per policy mapping is expected for authorization

RET fusion/mutation listing (duplicate)

RET fusion/mutation listing (duplicate)RET fusion or mutation listed as required biomarker for RET‑targeted therapies (Gavreto, Retevmo)

Dose exampleGavreto dose limited to 400 mg once daily (4 capsules)

Retevmo noteRetevmo dosing/quantity and pediatric age expansions documented elsewhere in policy

KMT2A translocation (Revuforj)

KMT2A translocation (Revuforj)KMT2A translocation required for Revuforj (revumenib) in relapsed/refractory acute leukemia

Trial efficacyAUGMENT‑101 showed CR+CRh 21.2% with median DOR 6.4 months

Age notesPolicy entries include pediatric eligibility for certain agents; check Revuforj section for age specifics

IDH1, IDH2 — biomarker listing (multiple entries)

IDH1, IDH2 listings (multiple)IDH1 and IDH2 mutations required across multiple IDH-directed agents (Tibsovo, Idhifa, Voranigo)

Indication contextsIncludes AML, cholangiocarcinoma (IDH1), and grade 2 gliomas (IDH1/2) per agent-specific criteria

Testing expectationMolecular confirmation required for authorization (per agent guidance)

BRCA, HRR — biomarker listing

BRCA, HRR listingBRCA and wider HRR gene mutations are required/used for PARP inhibitor selection (Talzenna, Lynparza)

HRR gene panel examplesHRR panels include BRCA1/2, ATM, CHEK2, PALB2, RAD51C, among others per policy

Clinical implicationPresence of deleterious or suspected deleterious mutations supports PARP therapy selection

INI1 loss (tazemetostat)

INI1 loss (tazemetostat)INI1 (SMARCB1) loss required for tazemetostat (Tazverik) indication in epithelioid sarcoma

Dose exampleTazverik 800 mg orally twice daily in study cohort; quantity limits provided in policy

Testing requirementINI1 loss detected using local testing expected for coverage

CLDN18.2 (additional reference)

CLDN18.2 listing (additional ref)CLDN18.2 positive defined as moderate to high overexpression in ≥75% tumor cells required for Vyloy

Trial basisApproval supported by SPOTLIGHT and GLOW trials demonstrating PFS/OS benefit when added to chemo

Testing implicationIHC testing showing ≥75% moderate/high expression required for authorization

NPM1 (susceptible mutation for Komzifti)

NPM1 (susceptible mutation) listingSusceptible NPM1 mutation required for Komzifti coverage in relapsed/refractory AML

Trial detailsKomzifti trial required NPM1 identified by NGS or PCR; eligibility included lab and ECG limits

Dose limitDose limited to 600 mg daily (3 tablets)

HRR gene panel listing (BRCA1/2, ATM, CHEK2, PALB2, RAD51C, etc.)

HRR gene panel listingHRR panel includes BRCA1, BRCA2, ATM, CHEK2, PALB2, RAD51C, and others for PARP inhibitor selection

Required mutation statusPresence of deleterious or suspected deleterious mutation in one or more listed genes supports PARP therapy selection

Prevalence noteHRR gene mutations occur in ~23% of mCRPC per policy metric

IDH1 biomarker listing (update entries)

IDH1 listing (updates)IDH1 mutation required for ivosidenib (Tibsovo) across AML and cholangiocarcinoma indications

Indication examplesNewly diagnosed AML in older/comorbid patients with IDH1; relapsed/refractory AML; previously treated cholangiocarcinoma

Testing/documentationMolecular confirmation expected for prior authorization

BRCA; PALB2 listing

BRCA; PALB2 listingBRCA and PALB2 mutations required/recognized for olaparib (Lynparza) in breast and ovarian indications

Indication contextLynparza indicated for HER2‑negative metastatic breast cancer with BRCA or PALB2 mutation after prior chemotherapy

Sample guidancePolicy maps sample types (tumor, blood, plasma) for BRCA and PALB2 testing in Lynparza selection

HRD — HRD-positive requirement (Zejula update)

HRD requirement (Zejula update)Zejula first‑line maintenance limited to HRD‑positive tumors (HRD-positive required)

Dose limitDose limited to 300 mg daily per dosing threshold

Biomarker definitionHRD-positive defined by BRCA mutation or genomic instability testing per policy

RET fusion presence requirement (update)

RET fusion presence requirement (update)Retevmo and Gavreto require presence of RET gene fusion or RET mutation for covered indications; Retevmo updated to include locally advanced or metastatic NSCLC with RET fusion

Pediatric age changesRetevmo pediatric age thresholds updated (some indications to 2 years and older)

Dose/quantityRetevmo dosing: 120 mg BID if <50 kg; 160 mg BID if ≥50 kg; quantity limit 60 tablets per 30 days

NPM1 mutation listing (duplicate)

NPM1 mutation listing (duplicate)Susceptible NPM1 mutation required for Komzifti in relapsed/refractory AML

Trial eligibility noteKomzifti pivotal trial required mutation identified by NGS or PCR and other fitness criteria

Dose600 mg daily (3 tablets)

Interim review approved December 9, 2025 adding indications and quantity limits (e.g., new indications for Zepzelca, Revuforj) and coding/coverage adjustments effective 01/01/26.

2025-11-07coverage_additions

Effective Nov 7, 2025 (after 90-day provider notification) numerous agents and HCPCS codes were added or updated including Treanda, Doxil, Portrazza, Trisenox and corresponding coding entries.

2025-09-01interim_review

Interim review approved Aug 12, 2025 updated Zejula maintenance to HRD-positive tumors in first-line and added quantity limits; other updates included HCPCS additions and Darzalex criteria changes.

2025-03-01annual_review

Annual review approved Feb 11, 2025 included Ibrance sequencing requirement changes, additions of Rytelo and Xeloda criteria, Retevmo pediatric age expansions and coding updates (J9026 added).

2025-02-07effective_date_notice

Policy changes effective Feb 7, 2025 following 90-day provider notification: additions for Nipent, Oncaspar and other agents; HCPCS J1246 removed as never implemented by CMS.

2013-01-01guideline_alignment

Policy updated in 2013 to reflect NCCN guideline change recommending abiraterone as initial therapy for metastatic castrate-resistant prostate cancer.

2014-10-31literature_search

Literature search (7/1/12–10/31/14) found no new evidence requiring policy changes; noted as clarification in history.