CurrentPremera BluecrossPolicy 5.01.540

PHARMACY / MEDICAL POLICY -5.01.540 Miscellaneous Oncology Drugs

Defines medical necessity coverage criteria, age limits, diagnosis-specific indications, dose and quantity limits, and required prior therapies for a wide range of oral oncology drugs (selected agents shown in this part). Applies to pharmacy/medical benefit coverage determinations.

Policy Summary

PayerPremera Bluecross

PolicyPHARMACY / MEDICAL POLICY -5.01.540 Miscellaneous Oncology Drugs

Policy CodePolicy 5.01.540

Change TypeMultiple additions, revisions, coding updates

Effective DateMay 1, 2026

Next Review DateN/A

Key ActionDocument genetic test results and prior therapies when requesting coverage and follow prescriber/specialist and dose/quantity requirements per the policy.

SourceLink

POLICY UPDATE CHANGES

Added coverage criteria for Vistogard for emergency treatment of fluorouracil or capecitabine overdose or severe toxicity within 96 hours (2023 Update).

Added coverage criteria for Voranigo (vorasidenib) for Grade 2 astrocytoma or oligodendroglioma with susceptible IDH1/2 mutation (2024/2025 Updates).

Added coverage criteria for Vyloy (zolbetuximab-clzb) for CLDN18.2-positive advanced unresectable or metastatic HER2-negative G/GEJ adenocarcinoma (2025 Update).

Revised Zejula (niraparib) coverage limits (2023 and 2025/2026 Updates).

Added biomarker testing guidance for Lynparza (olaparib) selection listing HRR gene alterations and acceptable sample types.

Multiple updates across years (2013–2026) adding, removing, or updating coverage criteria for many drugs (e.g., added/removed products, moved drugs between policies, adjusted age requirements and ECOG requirements).

Select individuals for Talzenna based on HRR gene list (ATM, ATR, BRCA1, BRCA2, CDK12, CHEK2, FANCA, MLH1, MRE11A, NBN, PALB2, RAD51C).

Statement that FDA-approved test to detect HRR gene mutation for use with Talzenna is not available.

Extensive coding updates across multiple dates adding and removing numerous HCPCS codes through 2026.

Biomarker testing mapping for Lynparza and sample-type indicators for BRCA/HRR mutation selection.

Added coverage criteria for Blenrep (belantamab mafodotin-blmf) for adult relapsed/refractory multiple myeloma after ≥2 prior lines including PI and immunomodulatory agent.

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

Updated Rozlytrek (entrectinib) age requirement from 12 years to 1 month and older for solid tumors.

Updated initial authorization for oral drugs from 3 months to 6 months.

Designated HCPCS code J9019 effective 2026-01-01 and added new HCPCS code J9183 effective 2026-04-01.

Removed ECOG requirement across multiple drug criteria (Darzalex, Hepzato Kit, Ibrance, Romvimza, Tecelra, Vyloy).

Removed coverage criteria for Temodar (temozolomide) oral as product discontinued.

Updated quantity limits for multiple agents (Lumakras, Ojjaara, Pemazyre, Romvimza).

Clarified Blenrep use in combination with bortezomib and dexamethasone is for first 8 cycles then monotherapy.

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.

~60+Oral oncology agents with criteria in part

ManyIndications requiring genetic testing

5Notable additions in excerpt

~90HCPCS/J-codes listed in this part

96%Vistogard trial survival endpoint

Coverage Summary

This policy (effective 2026-05-01, last reviewed 2026-04-14) defines medical necessity coverage criteria for a broad set of miscellaneous oral oncology drugs and is issued as covered with criteria. It applies to many oral oncology agents (dozens of agents/indications summarized) and specifies age requirements (commonly ≥18 years), diagnosis‑specific indications, required prior therapies, biomarker/genetic testing where indicated, and explicit dose and quantity limits. Headline points: most systemic oral oncology indications require documentation of age and prior therapy; many indications require genetic or biomarker testing (PARP/HRR/BRCA, IDH1/2, FGFR, RET, NPM1, KMT2A, KRAS G12C, etc.); the policy lists specific dose/quantity limits (per day or per 28/30 days) for numerous agents; and several agents require prescription by or consultation with a specialist (oncologist/hematologist).

Policy-level facts

Policy number5.01.540

Effective date2026-05-01

Last review2026-04-14

StatusCURRENT

Authorization duration for oral drugsInitial authorization: 6 months (updated from 3 months)

~60+Oral agents with criteria in this part

~70+Agents/indications listed in this part

~90HCPCS / J-codes listed in this part

96%Vistogard trial: survival at 30 days or resumed chemo

Medical-Necessity Criteria (per agent)

Erivedge (vismodegib)

Erivedge (vismodegib) — Hedgehog pathway inhibitor. Covered when ALL of the following are met:

ALL of the following

The individual is aged 18 years or older.
Has been diagnosed with one of the following: - Metastatic basal cell carcinoma (BCC) - Locally advanced BCC that has recurred following surgery - Locally advanced BCC in individuals who are not candidates for surgery or radiation therapy.

Odomzo (sonidegib)

Odomzo (sonidegib) — Hedgehog pathway inhibitor. Covered when ALL of the following are met:

ALL of the following

The individual is aged 18 years or older.

Provider Actions & Operational Requirements

Documentation Required

Genetic / biomarker confirmation required

Genetic / biomarker confirmation is required for selection of multiple targeted agents. Document the test name, result (including variant and allele fraction where relevant), test date, and laboratory performing the test.

Affected agents (representative): PARP inhibitors (Lynparza, Rubraca, Talzenna) — BRCA/Homologous Recombination Deficiency testing
PARP selection biomarker: germline or somatic BRCA and HRR panel results required
IDH inhibitors (Tibsovo, Idhifa) — IDH1/IDH2 mutation confirmation
RET inhibitors — RET fusion/mutation confirmation
NTRK inhibitors (Rozlytrek) — NTRK gene fusion confirmation (include age documentation for pediatric use)
FGFR inhibitors (Pemazyre) — FGFR2/FGFR1 alteration confirmation
KRAS G12C agents (Lumakras) — KRAS G12C mutation confirmation
NPM1-targeted agents (Komzifti) — NPM1 mutation required
KMT2A-targeted agents — KMT2A rearrangement/fusion confirmation

Coding

HCPCS / J-codes listed for drugs referenced in this partHCPCS

C9303	Injection, zolbetuximab-clzb (Vyloy), 1 mg
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 68

1/7

HCPCS/Coding changes referenced in historymixed

J3380	mentioned as added then removed (2016)
J9271	added 2016
J9022	added 1/1/18 (later removed)
J9023	added 1/1/18 (later removed)
J9285	added 1/1/18 (later removed)
J9118	added effective 10/1/19
J9213	added then removed
J9057	added 1/1/19 then removed
J9227	added 10/1/20
J9041	added 10/2/20

1–10 of 51

1/6

New/Updated HCPCS codesHCPCS

J9019	HCPCS code termed effective January 1, 2026 (as indicated in document)
J9183	New HCPCS code added effective April 1, 2026 (coding update)

Confirm that the HCPCS/CPT and other billing codes in use are active for the date of service — the policy history documents extensive code additions, removals, and term dates across 2013–2026. Review the policy history/timeline for exact effective and termination dates for specific codes before finalizing billing or authorization.

Background & Evidence Highlights

Background: this policy outlines medical necessity criteria for a wide range of miscellaneous oral oncology drugs, specifying when agents may be considered medically necessary by indication. The Introduction provides general chemotherapy context (routes, goals, and that the Introduction is informational and not policy criteria) while the remainder of the document contains the agent‑specific coverage requirements.

Agent / Trial	Key efficacy metric
Vistogard (uridine triacetate) — two open‑label trials (n=135)
Primary endpoint: 96% (130/135) achieved survival at 30 days or resumption of chemotherapy; 5 deaths reported
Voranigo (vorasidenib) — INDIGO (randomized, placebo‑controlled, n=331)
Median PFS 27.7 vs 11.1 months (HR 0.39); TTNI HR 0.26 (both statistically significant)
Vyloy (zolbetuximab‑clzb) — SPOTLIGHT (n=565) & GLOW (n=507)
SPOTLIGHT: median PFS 10.6 vs 8.7 months; median OS 18.2 vs 15.5 months. GLOW: median PFS 8.2 vs 6.8 months; median OS 14.4 vs 12.2 months
Komzifti (ziftomenib) — KOMET‑001 (open‑label single‑arm)
CR + CRh rate 21.4% (95% CI: 14.2, 30.2); median duration of CR/CRh 5.0 months
Zejula (niraparib) — ENGOT‑OV16/NOVA (randomized, double‑blind, placebo‑controlled, n=553)
Demonstrated PFS benefit in platinum‑sensitive recurrent epithelial ovarian cancer irrespective of BRCA status (trial showed significant PFS improvement)
Krazati / Lumakras / Lynparza — selected trial evidence (examples)
Krazati (adagrasib): approved for KRAS G12C‑mutated NSCLC; Komzifti/Lumakras/Lynparza entries: reported ORR/PFS improvements in respective trials (e.g., Lynparza ORR ~31% in heavily pretreated ovarian cancer; Rucaparib rPFS 11.2 vs 6.4 mo HR 0.50 cited elsewhere) — see specific agent labeling for details

Selected definitions

BCG-unresponsive NMIBCNon-muscle invasive bladder cancer unresponsive to Bacillus Calmette-Guérin (BCG)

FGFR2/FGFR1 fusionGenetic alteration (FGFR2/FGFR1 fusion or rearrangement) detected by an FDA-approved test required for Pemazyre coverage

Transfusion-dependent anemiaRequiring transfusion of at least 4 red blood cell units over an 8-week period

CLDN18.2+Moderate-to-high overexpression in at least 75% of tumor cells

IPSS-R

Biomarker & Testing Guidance (selection rules)

Biomarker testing guidance: the policy lists HRR/BRCA and other gene panels and maps acceptable sample types for selection of PARP inhibitors and other targeted agents. It specifies HRR gene examples (e.g., ATM, BRCA1, BRCA2, PALB2, RAD51 family) and indicates tumor and/or blood (germline) sample acceptability per agent; where noted, plasma/ctDNA may be indicated. Providers must document the genetic/biomarker test used and the sample type when selecting these molecularly targeted therapies.

Revision History

2023added

Added coverage criteria for Vistogard (uridine triacetate) for emergency treatment of fluorouracil or capecitabine overdose or early-onset severe toxicity within 96 hours; dosing per trials (10 g PO every 6 hours x20 doses for adults; 6.2 g/m2/dose every 6 hours x20 doses for ages 1–7) and trial outcome (96% achieved survival at 30 days or resumption of chemotherapy).

2024added

Added coverage criteria for Voranigo (vorasidenib) for Grade 2 astrocytoma or oligodendroglioma with susceptible IDH1/2 mutation based on INDIGO trial (median PFS 27.7 vs 11.1 mo; HR 0.39; TTNI HR 0.26); initial 2024/2025 updates later added prescriber requirement and quantity limit.

2025

Policy Summary

PayerPremera Bluecross

PolicyPHARMACY / MEDICAL POLICY -5.01.540 Miscellaneous Oncology Drugs

Policy CodePolicy 5.01.540

Change TypeMultiple additions, revisions, coding updates

Effective DateMay 1, 2026

Next Review DateN/A

Key ActionDocument genetic test results and prior therapies when requesting coverage and follow prescriber/specialist and dose/quantity requirements per the policy.

SourceLink

On This Page

Has been diagnosed with one of the following: - Locally advanced basal cell carcinoma (BCC) that has recurred following surgery or radiation therapy - Locally advanced BCC in individuals who are not candidates for surgery or radiation therapy.

Dose limit: 200 mg per day (1 tablet daily).200 mg/day

Idhifa (enasidenib)

Idhifa (enasidenib). Covered for the following:

ALL of the following

Treatment of relapsed or refractory acute myeloid leukemia (AML) in adult individuals with an isocitrate dehydrogenase-2 (IDH2) mutation.

Tabloid (thioguanine)

Tabloid (thioguanine). Covered when ALL of the following are met:

ALL of the following

The individual has been diagnosed with acute myeloid leukemia.
Tabloid (thioguanine) will be used for remission induction or remission consolidation therapy.
Dose is limited to 3 mg/kg per day.3 mg/kg/day

Tibsovo (ivosidenib)

Tibsovo (ivosidenib). Coverage varies by indication; all branches below must be met for the specified use:

Indication-specific branches

Newly-diagnosed AML (non-intensive candidates)
- The individual is aged 75 years or older OR has comorbidities that preclude use of intensive induction chemotherapy.
- Has newly diagnosed AML with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation.
- Tibsovo is used in combination with azacitidine or as monotherapy.
Relapsed or refractory AML
- The individual is aged 18 years or older.
- Has been diagnosed with relapsed or refractory AML with a susceptible IDH1 mutation.
Previously treated, locally advanced or metastatic cholangiocarcinoma
- The individual is aged 18 years or older.
- Has previously treated, locally advanced, or metastatic cholangiocarcinoma with a susceptible IDH1 mutation.
Relapsed or refractory myelodysplastic syndromes
- The individual is aged 18 years or older.
- Has been diagnosed with relapsed or refractory myelodysplastic syndromes (susceptible IDH1 mutation as applicable).

Daurismo (glasdegib)

Daurismo (glasdegib). Covered when ALL of the following are met:

ALL of the following

The individual is aged 75 years or older OR has comorbidities that preclude use of intensive induction chemotherapy.
Daurismo is used in combination with low-dose cytarabine.

Rubraca (rucaparib)

Rubraca (rucaparib). Coverage and quantity limits apply per indication.

ALL of the following

Quantity limited to 4 tablets daily for applicable oral tablet formulation and indications.
Indication-specific criteria follow policy sections for PARP inhibitors and require appropriate biomarker testing where specified.

Talzenna (talazoparib)

Talzenna (talazoparib). Coverage requires HRR gene selection and testing guidance.

ALL of the following

Coverage limited to labeled indications for metastatic or locally advanced breast cancer with deleterious or suspected deleterious BRCA mutation as confirmed by genetic testing or other HRR gene criteria per policy appendix.
Refer to HRR gene selection guidance leaves in policy appendix for acceptable genes and testing methods.

Zejula (niraparib)

Zejula (niraparib). Covered for maintenance therapy and other labeled indications; dose limit applies for certain formulations.

ALL of the following

Coverage for maintenance therapy per labeled indications (e.g., ovarian cancer) when in response to platinum-based chemotherapy as specified in indication-specific branches.
Dose limit: follow product dosing limits (quantity/daily dose restrictions as specified per indication).
Maintenance therapy coverage statement: partial — see full policy for indication-specific duration and biomarker requirements.

CDK4/6 inhibitors (Ibrance, Kisqali, Verzenio)

CDK4/6 inhibitors block (Ibrance, Kisqali, Verzenio). Preserve nested indication-specific branches per individual agent.

ANY of the following

Ibrance (palbociclib)
- Cover when used in combination with endocrine therapy for HR-positive, HER2-negative advanced or metastatic breast cancer per labeled criteria.
Kisqali (ribociclib)
- Cover when used in combination with endocrine therapy for HR-positive, HER2-negative advanced or metastatic breast cancer per labeled criteria.
Verzenio (abemaciclib)
- Cover for appropriate labeled indications including monotherapy or combination use for HR-positive, HER2-negative advanced or metastatic breast cancer per labeled criteria.

Xpovio (selinexor)

Xpovio (selinexor) — see approved indication summaries and coverage branches.

ALL of the following

Coverage follows labeled indications for Xpovio (selinexor); see the Xpovio approved indication summary branch in the policy for details including combination regimens and prior therapy requirements.

Rozlytrek (entrectinib)

Rozlytrek (entrectinib). Coverage for NTRK and ROS1 indications per labeled criteria and testing.

ALL of the following

Coverage when tumor harbors the appropriate NTRK gene fusion or ROS1 rearrangement as confirmed by validated testing methods and when other labeled criteria are met.

Vitrakvi (larotrectinib) oral

Vitrakvi (larotrectinib) — oral. Covered when ALL of the following are met:

ALL of the following

The tumor harbors an NTRK gene fusion as confirmed by an FDA-approved or validated test and the therapy is used for an NTRK fusion-positive solid tumor for which the patient has no satisfactory alternative therapy or disease is refractory to standard therapy, per labeling.
For pediatric and adult age-appropriate dosing, the prescriber documents the lesion is NTRK fusion–positive and the indication is consistent with labeled or guideline-supported use.

Gleostine / generic lomustine

Gleostine / lomustine (generic). Covered per labeled oncology indications; follow dosing and monitoring guidance.

ALL of the following

Coverage for labeled indications (e.g., brain tumors, certain lymphomas) when prescriber documents indication and dosing consistent with product labeling and safety monitoring is in place.

Jakafi (ruxolitinib)

Jakafi (ruxolitinib). Coverage per labeled indications (e.g., myelofibrosis, polycythemia vera, graft-versus-host disease) with required documentation.

ALL of the following

Coverage when used for FDA-labeled indications with documentation of diagnosis and prior therapies per labeling and clinical guidelines.

Ojjaara (momelotinib)

Ojjaara (momelotinib). Coverage per labeled indications and documentation requirements.

ALL of the following

Coverage when used for labeled indications with documentation consistent with prescribing information and prior therapy requirements.

Vonjo (pacritinib)

Vonjo (pacritinib). Covered when ALL of the following are met:

ALL of the following

Coverage for indicated use in patients with appropriate diagnosis per labeling.
Vonjo platelet count requirement: prescriber documents baseline platelet count meets labeled threshold (see Vonjo platelet count requirement).Vonjo platelet count requirement

Gavreto (pralsetinib)

Gavreto (pralsetinib). Coverage requires documented RET alteration per testing and indication-consistent use.

ALL of the following

Tumor harbors a RET alteration confirmed by validated testing and use is consistent with labeled indications.

Retevmo (selpercatinib)

Retevmo (selpercatinib). RET inhibitor — include weight-based dosing branch and quantity limits.

ALL of the following

Indication-consistent use for RET fusion-positive solid tumors or RET-mutant medullary thyroid carcinoma per labeling and validated testing confirming RET alteration.
Dose by weight branch
- Pediatric dosing: follow weight-based dosing per product labeling; prescriber must document patient weight for dose determination.
- Adult dosing: follow adult recommended dosing per product labeling including any tablet-strength quantity limits.
Quantity limits apply per tablet strength and labeled dosing schedule.
See quantity limit leaf for Retevmo (selpercatinib).

Onureg (oral azacitidine)

Onureg (oral azacitidine). Coverage includes dosing schedule threshold.

ALL of the following

Coverage for maintenance therapy in appropriate patients per labeling; prescriber must document dosing schedule consistent with Onureg dosing schedule (oral azacitidine).
Onureg dosing schedule

Purixan (mercaptopurine)

Purixan (mercaptopurine). Coverage per labeled hematologic oncology indications.

ALL of the following

Coverage for appropriate indications (e.g., maintenance therapy in ALL) when dosing and monitoring follow product labeling and standard practice.

Welireg (belzutifan)

Welireg (belzutifan). VHL disease branches and dose limit apply.

ANY of the following

VHL-associated renal cell carcinoma
- Coverage when used for VHL-associated clear cell renal cell carcinoma per labeling and validated VHL mutation testing where required.
- Dose limit applies per product labeling and tablet strengths.
Other VHL-related tumors
- Coverage when used for other VHL-related tumors per labeling and specialist recommendation and VHL mutation confirmation.
- Dose limit applies per product labeling.

Rezlidhia (olutasidenib)

Rezlidhia (olutasidenib). Coverage per labeled AML indication requiring IDH1 mutation.

ALL of the following

Coverage for relapsed or refractory AML with an IDH1 mutation per product labeling and validated mutation testing.

Voranigo (vorasidenib)

Voranigo (vorasidenib). Includes age, susceptible IDH mutation, prescriber requirement, dose limit and INDIGO trial branch.

ALL of the following

Coverage for indicated glioma patients per labeling where age and susceptible IDH mutation are documented and prescriber meets specialist requirements.
Dose limit applies per product labeling and tablet strengths.
INDIGO trial-supported criteria: coverage additions supported by trial evidence may be considered where trial criteria are met and documented (see INDIGO trial branch in policy).

Komzifti (ziftomenib)

Komzifti (ziftomenib). Coverage requires NPM1 mutation for specific indications and dose limit.

ALL of the following

Coverage for labeled indications where NPM1 mutation is present as documented by validated testing.
Dose limit applies per product labeling and tablet strength quantity limits.

Revuforj (revumenib)

Revuforj (revumenib). Coverage includes KMT2A and NPM1 branches with tablet-strength quantity limits.

ANY of the following

KMT2A-rearranged disease
- Coverage when KMT2A rearrangement is documented and use is consistent with labeled criteria.
- Tablet-strength quantity limits apply.
NPM1-mutated disease
- Coverage when NPM1 mutation is documented and use is consistent with labeled criteria.
- Tablet-strength quantity limits apply.

Miscellaneous oral agents (selected examples)

Miscellaneous oral agents — each named agent can be expanded to view agent-specific criteria. Examples include (not exhaustive): Ogsiveo, Pemazyre, Romvimza, Rydapt, Tazverik, temozolomide (generic), Thalomid, Vistogard (oral emergency use), Xeloda, interferon agents, and others.

ALL of the following

Each named agent below has agent-specific criteria in the policy. Providers should expand the agent to view the required documentation, biomarker testing, dose limits, and prior therapy requirements.
Selected examples (expandable)
- Pemazyre (pemigatinib) — oral: coverage when FGFR2 fusion/rearrangement is documented and used per labeled indications; confirm prior appropriate therapies where specified.
- Rydapt (midostaurin) — oral: coverage for FLT3-mutated AML in combination with standard chemotherapy and for systemic mastocytosis per labeling; document mutation status and therapy context.
- Tazverik (tazemetostat) — oral: coverage for epithelioid sarcoma or follicular lymphoma per labeled criteria; document indication and prior therapies as required.
- Thalomid (thalidomide) — oral: coverage when used for labeled hematologic or oncologic indications with pregnancy prevention program documentation where applicable.
- Vistogard (uridine triacetate) — oral emergency use: coverage for emergency treatment of known or suspected overdose of fluorouracil or capecitabine or to treat early-onset, severe or life-threatening toxicity; emergency treatment coverage applies and should be documented.
- Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) — IM: medical necessity when used for asparaginase therapy in patients with hypersensitivity to E. coli–derived asparaginase per labeling.
- Tepylute (thiotepa) — IV: medical necessity for indicated uses (e.g., conditioning regimens) per labeling and institutional protocols.
- Trisenox (arsenic trioxide) — IV: medical necessity for acute promyelocytic leukemia per labeled criteria and monitoring requirements.
- Trodelvy (sacituzumab govitecan-hziy) — IV: medical necessity for indicated metastatic cancers per labeling and prior therapy requirements.
- Unituxin (dinutuximab) — IV: medical necessity for pediatric high-risk neuroblastoma per labeled criteria and age-specific dosing.
- Yondelis (trabectedin) — IV: medical necessity for indicated sarcomas and ovarian cancer per labeling.
- Zepzelca (lurbinectedin) — IV: medical necessity for indicated small cell lung cancer per labeling.
- Zusduri (mitomycin) — intravesical: medical necessity for indicated bladder cancer uses per labeling and intravesical protocol.
- Interferon agents (Intron A, Sylatron) — IL/IM/IV/SC: coverage for labeled indications with documentation of diagnosis and dosing route; preserve route-specific requirements.

Miscellaneous IV/IM/SC Agents (selected examples)

Additional IV/IM/SC agents and selected parenteral entries: each agent listed below has medical necessity criteria consistent with labeled indications and documentation requirements.

ALL of the following

Vistogard (uridine triacetate) — emergency treatment coverage: coverage for emergency use for known or suspected overdose of fluorouracil or capecitabine or for early-onset, severe or life‑threatening toxicity when administered per labeling and documented as emergency use.
Interferon agents (Intron A, Sylatron) — IL/IM/IV/SC: coverage when used for labeled indications with appropriate route documented and dosing consistent with product labeling.
Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) — IM: medical necessity when used for asparaginase therapy in patients with hypersensitivity to E. coli–derived asparaginase per labeling.
Tepylute (thiotepa) — IV: medical necessity for indicated uses per labeling.
Trisenox (arsenic trioxide) — IV: medical necessity for acute promyelocytic leukemia per labeled criteria.
Trodelvy (sacituzumab govitecan-hziy) — IV: medical necessity for indicated metastatic cancers per labeling and required prior therapy documentation.
Unituxin (dinutuximab) — IV: medical necessity for pediatric high‑risk neuroblastoma per labeled criteria and age‑specific dosing.
Yondelis (trabectedin) — IV: medical necessity for indicated sarcoma and ovarian cancer uses per labeling.
Zepzelca (lurbinectedin) — IV: medical necessity for indicated small cell lung cancer per labeling.
Zusduri (mitomycin) — Intravesical: medical necessity when used per labeled intravesical protocols for bladder cancer.

Prior Authorization

Prior therapies required or prior progression

Prior therapies or evidence of disease progression / intolerance must be documented when required by the specific drug indication or this policy. Provide treatment dates, agents, reason for discontinuation (progression vs intolerance), and supporting radiology/pathology where applicable.

Examples (representative prior-therapy requirements): Rubraca (rucaparib) — prior lines as specified in indication; Lumakras (sotorasib) — prior systemic therapy for advanced disease as per labeling; Trodelvy (sacituzumab govitecan) — prior lines per indication; Blenrep — prior anti‑CD38 and other required lines
Document prior‑therapy attempts or intolerance (e.g., allergic reactions, toxicity) with dates and clinical rationale for switching

Billing Rule

Dose and quantity limits enforceable (billing)

Dose and quantity limits are enforceable and will be used for billing edits. Confirm and document prescribed dose, schedule, and total quantity dispensed on the claim.

Representative thresholds (examples): Zejula (niraparib) — 300 mg daily
Odomzo (sonidegib) — 200 mg/day (enforceable limit)
Pemazyre (pemigatinib) — typical 13.5 mg: 14 days on / 7 days off; typical dispensing = 28 tablets per 28-day cycle
Romvimza (amivantamab) — cap supply/weekly schedule (2 caps weekly representative)
Lumakras (sotorasib) — quantity limits per labeling and plan rules
Dose/quantity thresholds will be applied at claim adjudication and prior authorization review

Documentation Required

Genetic / testing documentation required (including Komzifti)

Genetic and molecular testing documentation is required for several agents. Include test type, platform (if relevant), result, and lab. Note tests that have no FDA‑approved companion diagnostic where applicable.

Rydapt (midostaurin/FLT3‑targeted context) — FLT3 mutation testing (ITD/TKD) required
Pemazyre (pemigatinib) — FGFR2/FGFR1 alteration testing (fusion or rearrangement) required
Tazemetostat — EZH2 mutation testing required for labeled indication
Komzifti (example NPM1‑targeted agent) — NPM1 mutation testing required
Talzenna (talazoparib) — no FDA‑approved companion test; document BRCA testing method and result despite absence of companion diagnostic
Ensure molecular reports include patient identifiers, specimen source, collection and report dates, and specific variant calls

Prior Authorization

Specialist prescribing / consultation requirements and PA considerations

Specialist prescribing or documented consultation is required for certain agents. Where required, include the specialist’s name, specialty, and documentation of the consult or that the prescriber is a board‑certified oncologist/hematologist.

Agents typically requiring oncology/hematology prescriber or consultation: Voranigo, Komzifti, Romvimza, Grafapex, Tecelra, Vistogard (when oncology oversight used), CAR‑T related agents (Tecelra)
Coverage additions and changes to coverage may require prior authorization per plan rules — confirm PA requirements at time of request

Billing Rule

HCPCS code usage and updates (billing)

HCPCS and miscellaneous code usage: use only appropriate, active codes and document code rationale on the claim. New HCPCS codes may become effective during the policy period; confirm code activation and payer acceptance at date of service.

Unspecified / unclassified billing codes: C9399, J3490, J3590, J8999, J9999 — use only when no specific code applies and include detailed supporting documentation
New HCPCS codes to note: J9019 — effective 2026-01-01; J9183 — effective 2026-04-01
Confirm active/accepted HCPCS at date of service; update claims and prior auths if codes change

Documentation Required

Vistogard administration window (documentation)

Vistogard (uracil/uridine triage) must be administered or made available within the recommended post‑exposure window. Document timing of administration relative to the causative fluoropyrimidine exposure and include dosing summary for adults and pediatrics in the medical record or prior authorization.

Administration/timing requirement: within 96 hours of fluoropyrimidine overdose or severe toxicity
Document adult and pediatric dosing and the exact time treatment initiated

Documentation Required

Post‑Tecelra monitoring for CRS / ICANS (documentation)

Post‑Tecelra (CAR‑T / cellular therapy) monitoring: individuals must be monitored in a healthcare facility for cytokine release syndrome (CRS) and immune effector cell‑associated neurotoxicity syndrome (ICANS). Document monitoring plan and observations.

Monitoring requirement: at least 7 days of in‑facility monitoring following administration per institutional protocol
Document neurological and hemodynamic assessments performed and any interventions

Prior Authorization

Initial authorization period for oral drugs — 6 months

Initial authorization period for oral drugs: use the updated default duration when requesting authorizations. Document expected start date and planned monitoring/renewal schedule.

Updated initial authorization duration for oral agents: 6 months (use this period for initial PA requests unless a different interval is specified)
Include monitoring plan and criteria for continuation at time of initial request

Billing Rule

Medical vs pharmacy benefit mapping (billing)

Benefit mapping: correctly assign drug coverage to pharmacy vs medical benefit and document the expected benefit application on the prior authorization or claim.

General rule: oral oncology drugs are covered under the pharmacy benefit; intravenous and intravesical agents are medical benefit
Examples: Darzalex Faspro (daratumumab‑hyaluronidase) — medical benefit; Oncaspar (pegaspargase) — medical benefit
Document site of care, route of administration, and intended payer source to avoid denials

Revised International Prognostic Scoring System for Myelodysplastic Syndrome (risk groups based on cytogenetics, blasts, hemoglobin, platelets, ANC)

HRRHomologous recombination repair (examples: ATM, BRCA1/2, PALB2, RAD51 family)

TTNITime to next intervention

PFSProgression-free survival

mCRPCMetastatic castration-resistant prostate cancer

gBRCAGermline BRCA mutation

Added coverage criteria for Vyloy (zolbetuximab-clzb) for CLDN18.2-positive advanced unresectable or metastatic HER2-negative gastric/GEJ adenocarcinoma in combination with chemotherapy supported by SPOTLIGHT and GLOW trials (SPOTLIGHT PFS 10.6 vs 8.7 mo; OS 18.2 vs 15.5 mo; GLOW PFS 8.2 vs 6.8 mo; OS 14.4 vs 12.2 mo); prescriber/quantity requirements were updated in subsequent edits.

2023-2026revised

Revised Zejula (niraparib) coverage limits: 2023 limited maintenance in recurrent disease to deleterious/suspected germline BRCA-mutated; 2025/2026 limited first-line maintenance to HRD-positive tumors only and added a quantity limit and dose limit (300 mg daily).

2023-2026added

Added biomarker testing guidance and gene lists for PARP/HRR selection: Lynparza HRR gene list (ATM, BRCA1/2, PALB2, RAD51 family, etc.) and sample-type mapping; Talzenna HRR gene list (ATM, ATR, BRCA1/2, CDK12, CHEK2, FANCA, MLH1, MRE11A, NBN, PALB2, RAD51C) and note that an FDA-approved companion test for Talzenna is not available.

2013-2026revised

Extensive coding and policy housekeeping updates across years (2013–2026): many HCPCS/J-code additions, removals, termings and effective dates documented; new HCPCS codes designated including J9019 (termed 01/01/26) and J9183 (added 04/01/26).

2025added

Added coverage criteria for Blenrep (belantamab mafodotin-blmf) for adult relapsed/refractory multiple myeloma after ≥2 prior lines including a proteasome inhibitor and an immunomodulatory agent; clarified combination use with bortezomib and dexamethasone is for first 8 cycles then continued as monotherapy (later clarified in 2026).

2026-01-01added

Designated HCPCS code J9019 termed effective 2026-01-01 and continued coding updates through 2026 including addition of J9183 effective 2026-04-01.

2025added

Added coverage criteria for Komzifti (ziftomenib) for adult relapsed/refractory AML with susceptible NPM1 mutation (dose limit 600 mg daily).

2025revised

Updated Rozlytrek (entrectinib) age requirement for solid tumors from 12 years to 1 month and older (effective in 2026 updates and reflected in pediatric-use sections).

2026-04-01revised

Removed ECOG performance status requirement across multiple drug criteria (Darzalex, Hepzato Kit, Ibrance, Romvimza, Tecelra, Vyloy) and adjusted quantity limits for agents such as Romvimza (2 capsules weekly) and added/updated quantity limits for Lumakras, Ojjaara, Pemazyre, and others.

2026-05-01revisedLatest

Updated initial authorization duration for oral drugs from 3 months to 6 months (applies to 'all other reviews' for oral drugs listed); effective date May 1, 2026.