ModifiedPremera BluecrossPolicy N/A

Miscellaneous Oncology Drugs (oral and related specialty agents) — Coverage Criteria and Limits

Coverage criteria and limits for a large set of oral oncology and related specialty drugs, describing when therapy is considered medically necessary and dose/quantity limits for Premera Bluecross members and their providers.

Policy Summary

PayerPremera Bluecross

PolicyMiscellaneous Oncology Drugs (oral and related specialty agents) — Coverage Criteria and Limits

Policy CodePolicy N/A

Change TypeMultiple coverage additions and coding updates (material)

Effective DateApr 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of diagnosis, age, prior therapies and any related biomarker/genetic test results or dosing/quantity limits.

SourceLink

POLICY UPDATE CHANGES

Added coverage criteria for Nipent (pentostatin) for treatment of certain individuals with hairy cell leukemia.

Removed HCPCS code J1246 as this new code was never implemented by CMS.

Added coverage criteria for Oncaspar (pegaspargase) for treatment of certain individuals with acute lymphoblastic leukemia.

Updated Ibrance (palbociclib) criteria to require inadequate response or intolerance to Verzenio (abemaciclib), Kisqali (ribociclib) or Kisqali Femara Co-Pack.

Added multiple HCPCS codes (examples: J9026, J0870, J3490, J9034, J9036, J9056, J9153, J9266, J9268, C9303, J9054, Q2057, J1326, J9341, J9174, J9179, J0893, J9120, J9172, Q2050, J9246, J2425, J9200, J9295, J9017, J9033, J9249, J0614, J8999, J9999, J0897 removals/additions).

Added coverage criteria for many drugs including Xeloda, Rytelo (Imetelstat), Tepylute (thiotepa), Tecelra (afamitresgene autoleucel), Vyloy (zolbetuximab-clzb), Beizray (docetaxel), Revuforj (revumenib), Romvimza (vimseltinib), Leukeran (chlorambucil), Treanda (bendamustine), dactinomycin, Docivyx (docetaxel), Doxil and generic doxorubicin liposome, Evomela (melphalan), Kepivance (palifermin), Khapzory (levoleucovorin), floxuridine, Portrazza (necitumumab), Trisenox (arsenic trioxide), Ixempra (ixabepilone), clofarabine products, Zepzelca (lurbinectedin) new indication, Komzifti (ziftomenib), Blenrep (belantamab mafodotin-blmf), Cosmegen (dactinomycin).

Updated age and indication criteria for multiple agents (e.g., Retevmo age changes to 2 years for several indications; Blincyto age requirement to one month; Rozlytrek age requirement to 1 month).

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

Added new HCPCS code J9183, effective April 1, 2026.

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30+distinct drugs/groups listed (partial)

manydrugs added/updated

12 momax NFE approval length

numerousdose/quantity limits present

~40+HCPCS coding changes noted

Drug-specific Coverage Criteria

inv-21: Menin inhibitors (Komzifti, Revuforj)

Menin inhibitor oral agents may be considered medically necessary when the criteria below are met.

ALL of the following

The medication is Komzifti (ziftomenib) OR Revuforj (revumenib).
Medication is prescribed by or in consultation with an oncologist or hematologist.
Indication-specific criteria
- Komzifti (ziftomenib)
  - The individual is aged 18 years or older.
  - Has relapsed or refractory acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 (NPM1) mutation.
  - There are no satisfactory alternative treatment options.
  - Dose is limited to 600 mg daily (3 tablets daily).
- Revuforj (revumenib)
  - The individual is aged 1 year or older (pediatric and adult dosing criteria apply).
  - Has relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene (KMT2A) translocation OR relapsed or refractory acute myelocytic leukemia (AML) with a susceptible NPM1 mutation.
  - There are no satisfactory alternative treatment options.
  - Dose is limited to 540 mg daily.
  - Quantity limits (by tablet strength): 160 mg tablet: 2 tablets daily; 110 mg tablet: 4 tablets daily; 25 mg tablet: 8 tablets daily.

ALL of the following

Documentation of the relevant molecular biomarker (eg, NPM1 mutation or KMT2A translocation) must be provided in the medical record.
For pediatric individuals on revumenib, dosing and quantity limits should follow product labeling and be documented.
Treatment will be discontinued or reauthorization will be denied if there is disease progression or unacceptable toxicity as documented in chart notes.

Actions, Documentation & Authorization Requirements

Prior Authorization

Prior Authorization Required — Documentation & Dose Limits

Prior authorization is required for many drugs in this policy. Providers must document the diagnosis, patient age, prior therapies (including lines of therapy and trials of alternatives), and relevant biomarker/genetic test results. Quantity and dose limits noted in the drug-specific criteria apply; requests that exceed those limits may be denied.

Prior authorization required — include diagnosis, age, prior therapies, biomarker/genetic test results, and dosing/quantity information.
Dose/quantity limits in drug criteria are enforceable; exceeding limits may trigger denial.

Prior Authorization

Indication-specific Prior Authorization & Biomarker / Prior-Therapy Verification

Prior authorization review will verify indication-specific requirements: age, diagnosis, prior therapy trials (including sequencing or required step therapies), and presence of required biomarkers (e.g., BRCA, HRR, FGFR, RET, IDH, NPM1, FLT3). Chart notes must support the stated indication and show specialist involvement when required (oncologist, hematologist, nephrologist, or rheumatologist as specified).

Biomarker verification required where specified (examples: BRCA/HRR for PARP inhibitors; FGFR alterations for Pemazyre; RET fusions for Retevmo/Gavreto; IDH1/IDH2 for Rezlidhia/Idhifa; NPM1 for Komzifti; FLT3 for Rydapt).

HCPCS / J-codes and Coding History

HCPCS and J-codes (selection)HCPCS

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 mc

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1/2

Additional HCPCS/J-codesHCPCS

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

1–10 of 20

1/2

Selected additional J-codesHCPCS

J9205	Injection, irinotecan liposome (Onivyde), 1 mg
J9207	Injection, ixabepilone (Ixempra), 1 mg
J9214	Injection, interferon, alfa-2b, recombinant (Intron A), 1 million units
J9223	Injection, lurbinectedin (Zepzelca) 0.1 mg
J9227	Injection, isatuximab-irfc (Sarclisa) 10 mg
J9246	Injection, melphalan (Evomela), 1 mg
J9248	Injection, melphalan (Hepzato), 1 mg
J9249	Injection, melphalan (Apotex), 1 mg (use to report: IVRA infusion)
J9258	Injection, paclitaxel protein-bound particles (Teva), not therapeutically equivalent to J9264, 1 mg

Additional J-codes continuedHCPCS

J9264	Injection, paclitaxel protein-bound particles (Abraxane), 1 mg
J9261	Injection, nelarabine (Arranon), 50 mg
J9266	Injection, pegaspargase (Oncaspar), per single dose vial
J9268	Injection, pentostatin (Nipent), 10 mg
J9269	Injection, tagraxofusp-erzs (Elzonris), 10 mcg
J9274	Injection, tebentafusp-tebn (Kimmtrak), 1 mcg
J9281	Mitomycin pyelocalyceal instillation (Jelmyto), 1 mg
J9295	Injection, necitumumab (Portrazza), 1 mg
J9301	Injection, obinutuzumab (Gazyva), 10 mg
J9317	Injection, sacituzumab govitecan-hziy (Trodelvy), 2.5 mg

Final HCPCS/Q-codesHCPCS

J9328	Injection, temozolomide (Temodar), 1 mg
J9341	Injection, thiotepa (Tepylute), 1 mg (new code effective 07/01/25)
J9348	Injection, naxitamab-gqgk (Danyelza), 1 mg
J9352	Injection, trabectedin (Yondelis), 0.1 mg
J9999	Not otherwise classified, antineoplastic drugs (use to report: Hepzato, Zusduri and Inlexzo)
Q2050	Injection, doxorubicin HCl, liposomal, not otherwise specified (Doxil and generic Doxil), 10 mg
Q2057	Afamitresgene autoleucel, including leukapheresis and dose preparation procedures (Tecelra), per therapeutic dose

Coding history referencesHCPCS

J3380	HCPCS code referenced in history (added earlier)
J9299	HCPCS code referenced in history (added earlier)
J9271	HCPCS code referenced in history (added earlier)
J9022	HCPCS code added 1/1/18
J9023	HCPCS code added 1/1/18
J9285	HCPCS code added 1/1/18

HCPCS codes added/removed in historyHCPCS

J9022	HCPCS code (removed)
J9023	HCPCS code (removed)
J9285	HCPCS code (removed)
J9057	HCPCS code (added then removed later)
J9118	HCPCS code (added)
J9214	HCPCS code (added)
J9280	HCPCS code (added for Jelmyto)
J9227	HCPCS code (added)
C9069	HCPCS code (added)
J9317	HCPCS code (added)

1–10 of 18

1/2

Policy HCPCS/Coding changesHCPCS

J1246	HCPCS code removed - never implemented by CMS
J9026	Added (then later removed in history entries)
J0870	Rytelo (Imetelstat) added
J3490	Tepylute (thiotepa) added
J9034	Added
J9036	Added
J9056	Added
J9153	Added
J9266	Added
J9268	Added

1–10 of 34

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Clonal plasma cells in bone marrow — numeric thresholds for risk

Clonal plasma cells in bone marrow>= 10% (criterion for high‑risk smoldering multiple myeloma); 51%–59% also listed as an alternate risk feature

Alternate marrow proportion51%–59% clonal plasma cells noted as an additional risk criterion

Age contextApplied in adult individuals (aged >=18 years) when assessing high‑risk smoldering multiple myeloma

Chemotherapy regimen febrile neutropenia risk threshold

Chemotherapy FN risk threshold

Required Prior Trials / Step Therapy Table

Coverage requirement	Details
Try and fail or intolerance to specified CDK4/6 inhibitors
Ibrance (palbociclib) requires the individual to have tried and had an inadequate response or intolerance to Kisqali (ribociclib) or Verzenio (abemaciclib) before coverage is allowed; policy history further updated to require inadequate response or intolerance to Verzenio, Kisqali, or Kisqali Femara Co-Pack.

Coverage requirement	Details
Trial of generic sorafenib required prior to Ogsiveo
Ogsiveo (nirogacestat) coverage requires that the individual has tried and had an inadequate response or intolerance to generic sorafenib prior to approval; dose limited to 150 mg twice daily.

Coverage requirement	Details / examples
Prior trial of generic or alternative agent required
Examples: brand Dacogen (decitabine) requires prior trial of generic decitabine; Leukine (sargramostim) is second-line when filgrastim products (Granix, Nivestym) have been tried and failed or are contraindicated.

Step	Requirement
Leukine step
Leukine (sargramostim) may be considered medically necessary as second-line therapy to decrease incidence of infection for individuals at risk of severe febrile neutropenia when Granix (tbo-filgrastim) or Nivestym (filgrastim-aafi) has been tried and failed OR there is a contraindication to those filgrastim products.

Requirement	Details
Document prior lines of therapy
Lonsurf (trifluridine and tipiracil) pivotal trial eligibility required prior treatment with at least two lines of standard chemotherapy for metastatic colorectal cancer; prior lines of therapy should be documented before approval.

Requirement	Details
Prior endocrine therapy progression may be expected
Abemaciclib (Verzenio is abemaciclib — context indicates Verzenio has evidence for use after progression on endocrine therapy); when abemaciclib is used in combination with fulvestrant, documentation of prior endocrine therapy progression may be expected per step/coverage logic.

Coverage requirement	Details
Try generic sorafenib first
Ogsiveo (nirogacestat) coverage includes a requirement to try generic sorafenib first and document inadequate response or intolerance prior to Ogsiveo; dose limited to 150 mg twice daily.

Updated step	Requirement / details
Ibrance updated step requirement
Ibrance (palbociclib) coverage was updated to require prior inadequate response or intolerance to Verzenio (abemaciclib), Kisqali (ribociclib), or Kisqali Femara Co-Pack (letrozole-ribociclib) before use.

Prior therapy / trial required	When indicated
Prior therapy or trial of specified agents where indicated
Several agents require prior trial or inadequate response to specified alternatives (e.g., generic decitabine before brand Dacogen; filgrastim biosimilars before Leukine); documentation of prior therapies is required when listed.

Ibrance prior step	Requirement / status
Ibrance requires prior inadequate response or intolerance to Verzenio, Kisqali, or Kisqali Femara Co-Pack
Policy language states Ibrance (palbociclib) may be considered medically necessary when the individual has tried and had an inadequate response or intolerance to Kisqali or Verzenio; history entries update this to include Verzenio, Kisqali, or Kisqali Femara Co-Pack as required prior CDK4/6 agents.

Per-Drug Quantity / Dose Limits

Examples of per-agent quantity/dose limits (PARP agents, Gavreto, Odomzo, etc.)

PARP agents (example quantity/dose limit)Many PARP agents (e.g., Lynparza, Rubraca) — quantity limited to 4 tablets daily

Gavreto (pralsetinib)Dose limited to 400 mg once daily (4 capsules)

Odomzo (sonidegib)Dose limit example cited as 200 mg per day (1 tablet daily) in policy excerpts

Pemazyre (pemigatinib)Dose limited to 13.5 mg once daily (14 on/7 off); quantity 28 tablets per 28 days

Lumakras (sotorasib)Quantity varies by tablet strength (120 mg:240; 240 mg:120; 320 mg:90 per 30 days) as example

Inlexzo (gemcitabine intravesical)225 mg every 3 weeks up to 6 months (intravesical administration)

Administration & Benefit Assignment

Note

Background & Definitions

Background — chemotherapy/systemic treatment: Chemotherapy is systemic treatment using drugs to treat cancer and can be delivered by multiple routes. This policy covers a wide range of oral and parenteral chemotherapy and targeted agents and provides criteria for when therapy is considered medically necessary.

Definition — systemic therapy

DefinitionSystemic therapy: treatment that travels through the bloodstream to treat the whole body (e.g., most chemotherapy)

Routes includedOral, intravenous, intramuscular, intrathecal, intraperitoneal, intra-arterial, topical (cream)

PurposeUsed to cure, decrease recurrence risk, slow growth, or provide palliative symptom relief

Definition — Risk stratification (GIPSS/MIPSS70)

GIPSS/MIPSS70 useDocumentation of intermediate or high‑risk primary myelofibrosis should include GIPSS >2 or GIPSS 1–2 plus MIPSS70 >4

Policy Changes & History

01/01/22policy_update

Added Vonjo (pacritinib) and Kimmtrak (tebentafusp) indications; expanded Lynparza and Verzenio indications and removed prior CDK4/6 requirement for Kisqali Femara Co-Pack

07/01/23coding_update

Added HCPCS codes J9205 and J9269 and other coding updates associated with Onivyde and Elzonris coverage additions

10/01/23coding_update

Added HCPCS codes C9155 and J9051 and implemented policy changes to Temodar IV and Unituxin IV effective December 7, 2023

Policy Summary

PayerPremera Bluecross

PolicyMiscellaneous Oncology Drugs (oral and related specialty agents) — Coverage Criteria and Limits

Policy CodePolicy N/A

Change TypeMultiple coverage additions and coding updates (material)

Effective DateApr 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of diagnosis, age, prior therapies and any related biomarker/genetic test results or dosing/quantity limits.

SourceLink

On This Page

Prior-therapy sequencing and line-of-therapy documentation required (e.g., Lonsurf prior lines; CDK4/6 sequencing for Ibrance/Kisqali/Verzenio).

Some agents require prescriber specialty or consultation (oncologist, hematologist, nephrologist, rheumatologist) — include notes to confirm.

Trial-based eligibility (when policy cites trial enrollment or trial-designed criteria) may limit coverage — document trial criteria and eligibility if claiming trial-based coverage.

Prior Authorization

Authorization Lengths & Non‑Formulary Exceptions

Non-formulary exception reviews and many authorizations have defined approval lengths. Non-formulary exception reviews for drugs listed in this policy may be approved up to 12 months; oral drug reviews are generally approved up to 3 months for initial authorizations unless a non-formulary exception is granted. Re-authorizations may be approved up to 12 months when drug-specific criteria are met and chart notes demonstrate ongoing clinical benefit.

Non-formulary exception review authorizations: up to 12 months.
Initial authorizations for orally-administered drugs: typically up to 3 months unless non-formulary exception granted.
Re-authorizations: may be approved up to 12 months with documentation of continued benefit.

Denial Risk

Denial Risk from Unmet Coverage Criteria

Coverage may be denied if required clinical criteria or documentation are missing. Common denial triggers include absence of required biomarker/genetic testing, lack of documentation of prior therapies or failure/intolerance trials, exceeding dose/quantity limits, absence of specialist involvement when required, or use outside the FDA‑labeled dosing/administration.

Denial triggers: missing biomarker test results (e.g., FLT3 for Rydapt), absent prior therapy trials or documentation of intolerance/failure, lack of diagnosis-supporting chart notes.
Requests exceeding dose/quantity limits may be denied.
Provider should include ECOG PS, lab results, and chart notes where indicated to reduce denial risk.

Denial Risk

Gazyva — Coverage & Denial Risks for Lupus Nephritis

Gazyva (obinutuzumab) for lupus nephritis has specific concurrent-therapy exclusions and prescriber requirements. Coverage requires use with specified immunosuppressants and corticosteroid, specified lupus nephritis classes, no dialysis in the prior 12 months, and it must not be used concurrently with Lupkynis (voclosporin) or Benlysta (belimumab). Prescriber should be a nephrologist or rheumatologist.

Gazyva coverage limited to class III/IV/V lupus nephritis and specified combination regimens.
Concurrent use with Lupkynis or Benlysta for active lupus nephritis is excluded.
Prescriber requirement: nephrologist or rheumatologist.

Note

Safety Warning — Agents with Boxed Warnings or Serious Toxicities

Several drugs in this policy carry Boxed Warnings or other serious safety risks; providers must counsel patients and monitor appropriately and include safety monitoring plans in prior authorization documentation when relevant.

Examples: Amtagvi prescribing information includes a Boxed Warning for treatment‑related mortality, prolonged severe cytopenia, severe infection, and cardiopulmonary/renal impairment.
Follow manufacturer boxed warnings and monitoring guidance (e.g., hospitalization/monitoring windows for CAR-T or cell therapies).

Documentation Required

Trial‑Based Eligibility May Limit Coverage — Document Trial Criteria

Trial‑based eligibility or evidence derived from clinical trials may limit coverage to patients meeting those trial criteria (e.g., prior lines of therapy, performance status, or biomarker status). When coverage is sought under trial‑designed indications, provide documentation demonstrating the member meets the trial-derived eligibility criteria.

If a drug’s evidence base is from a trial with specific entry criteria (ECOG, prior therapies, biomarker status), include documentation showing the member meets those criteria.
Examples: inclusion criteria from pivotal trials for Lonsurf, Amtagvi, Komzifti — include prior-line therapy history and performance status as applicable.

Denial Risk

Rydapt — Contraindications & Safety Considerations

Rydapt (midostaurin) contraindications and precautions must be verified prior to approval. Do not approve for individuals with known hypersensitivity to midostaurin or its ingredients; pregnant or breastfeeding women should not receive Rydapt. Monitor for pulmonary toxicity and other serious adverse events.

Contraindications: hypersensitivity to midostaurin or components; pregnancy and breastfeeding are excluded.
Prescribers should document pregnancy status where applicable and monitor for pulmonary toxicity and other noted serious AEs.

Billing Rule

Provider Notification & 90‑Day Implementation Requirement

Provider notification requirements: Certain drug or coding changes require provider notification and operational lead time. For some agents (e.g., Temodar IV, Unituxin IV) a 90‑day notification period is noted in the history and should be observed for implementation and coverage changes.

90 days notification required for Temodar IV and Unituxin IV when specified in policy history.
Providers should monitor policy history for HCPCS/J‑code updates that may affect prior authorization and billing.

Note

No Explicit Authorization/Denial Rules in Excerpt — Verify Member Benefits

If the policy excerpt does not state explicit authorization or denial rules for a specific scenario, use this medical policy as a coverage guide and consult the member benefit booklet or member services for plan‑specific limitations. This policy does not apply to Medicare Advantage.

When explicit operational authorization/denial rules are absent in this policy, contact member services or refer to the member benefit booklet for benefit‑specific limits.
Policy is a guide — member contracts differ; always verify benefits before approving or denying.

Step Therapy

Prior Therapy, Lines & Step Requirements — Document Sequencing

Providers should include prior lines of therapy and sequencing in requests. Where the policy implies sequencing from trial designs or labels, document the number and type of prior therapies, failure or intolerance rationale, and any required step‑therapy (for example, Ibrance requires prior inadequate response/intolerance to Verzenio, Kisqali, or Kisqali Femara co-pack where specified).

Document prior lines of therapy (e.g., Lonsurf requires prior fluoropyrimidine, oxaliplatin, irinotecan; many agents require prior VEGF or HER2 therapy when appropriate).
Step therapy example: Ibrance criteria require prior inadequate response or intolerance to Verzenio, Kisqali, or Kisqali Femara Co-Pack as specified in the policy updates.

Documentation Required

Drug Combinations & Concomitant Therapy — Document Regimen Details

Drug combinations and concomitant medication requirements must be documented (e.g., abiraterone with prednisone/prednisolone; Lynparza in combination with bevacizumab for HRD‑positive ovarian cancer; many regimens require specific companion agents). Provide regimen composition and prior response information for combination uses.

List concomitant agents and justification when approval depends on combination use (e.g., Lynparza + bevacizumab; abiraterone + prednisone).
If combination therapy is contraindicated by other covered drugs (see Gazyva exclusions), document alternative plans.

>= 20% expected incidence of febrile neutropenia for the regimen

Guideline source referencedThreshold aligned to ASCO guidelines cited in policy text

Use for growth factor considerationRegimens with >=20% FN risk identify individuals who may be considered for prophylactic interventions

Risk threshold for chemotherapy-associated febrile neutropenia

Defined risk thresholdChemotherapy regimen expected to result in >=20% incidence of febrile neutropenia

ImplicationMeets definition of high FN risk for consideration of supportive measures (e.g., prophylactic growth factor)

Assessment contextApplied in listing persons at risk within Leukine (sargramostim) criteria and related supportive care guidance

Transfusion dependence for MDS (>=4 RBC units over 8 weeks)

Transfusion dependence definitionRequires >=4 red blood cell (RBC) units over an 8‑week period

ApplicationUsed to define transfusion‑dependent anemia in Rytelo (imetelstat) coverage criteria for MDS

Prescriber requirementPrescribed by or in consultation with an oncologist or hematologist as specified in criteria

HRR mutation prevalence (statistic)

HRR mutation prevalence in mCRPC23%

Most frequent HRR genesBRCA2, ATM, CHEK2, BRCA1 (examples noted)

ImplicationApproximately 23% of mCRPC individuals have HRR mutations relevant to PARP inhibitor selection

Vonjo (pacritinib) — 30 tablets

Quantity limit30 tablets per 30 days

Indication contextVonjo (pacritinib) for adults with intermediate or high‑risk primary or secondary myelofibrosis with platelets <50 x10^9/L

Dose limitDose limited to 400 mg per day (200 mg twice daily)

Retevmo (selpercatinib) — 60 tablets or capsules

Quantity limit60 tablets or capsules per 30 days

Dose (weight-based)120 mg twice daily if <50 kg; 160 mg twice daily if >=50 kg

IndicationsRetevmo for RET fusion/mutation–positive NSCLC, MTC, thyroid and select solid tumors

Onureg (oral azacitidine) — dosing schedule and dose

Dosing schedule300 mg once daily for 14 consecutive days followed by 14 days off (14 on/14 off) in 28‑day cycles

IndicationOnureg (oral azacitidine) for adults with AML in first CR/CRi following intensive induction who are not able to complete intensive curative therapy

Dose per dosing days300 mg daily during the 14 dosing days

Pemazyre (pemigatinib) — 28 tablets

Quantity limit28 tablets per 28 days

Dose schedule13.5 mg once daily for 14 days followed by 7 days off (21‑day cycle)

IndicationsPemazyre (pemigatinib) for FGFR2 fusion/rearrangement cholangiocarcinoma and select MLNs

Tazverik (tazemetostat) — 240 tablets

Quantity limit240 tablets per 30 days (example: 4 x 200 mg taken orally twice daily formulation noted in policy)

IndicationsTazverik (tazemetostat) for epithelioid sarcoma and select follicular lymphoma indications

Dose contextQuantity limit corresponds to dosing schedule referenced in coverage criteria

Lumakras (sotorasib) — varies by tablet strength

Quantity by strengthVaries by tablet strength: 120 mg: 240 tablets/30 days; 240 mg: 120 tablets/30 days; 320 mg: 90 tablets/30 days

Dose limitDose limited to 960 mg per day for KRAS G12C‑mutated NSCLC indication

Policy historyQuantity limits for Lumakras added/updated in 2026 history entries

Revuforj (revumenib) — quantity specified by tablet strengths

Quantity specified by tablet strengthsRevuforj (revumenib) dosing examples: 160 mg tablet x2 daily; 110 mg tablet x4 daily; 25 mg tablet x8 daily (total 540 mg/day)

Dose limitTotal dose limited to 540 mg daily for indicated AML and KMT2A‑translocated disease

Age indicationApproved for individuals aged 1 year and older for specific translocation‑driven leukemias

Inlexzo (gemcitabine intravesical) — 225 mg

Dose per instillation225 mg every 3 weeks up to 6 months (intravesical)

IndicationInlexzo (gemcitabine intravesical) for BCG‑unresponsive NMIBC with CIS with or without papillary tumors in adults

Route of administrationIntravesical administration (medical benefit) — instillation in bladder

Doxil (doxorubicin liposome) — 50 mg/m2

Dose limit50 mg/m2 (example dosing for ovarian cancer: every 4 weeks)

Indications and schedulesDoxil (doxorubicin liposome) dosing examples: 50 mg/m2 q4w for ovarian cancer; 20 mg/m2 q3w for Kaposi's sarcoma; 30 mg/m2 q3w for multiple myeloma

Administration routeIV liposomal formulation (medical benefit)

Ixempra (ixabepilone) — 40 mg/m2

Dose limit40 mg/m2 every 3 weeks

IndicationIxempra (ixabepilone) for metastatic or locally advanced breast cancer as single agent or in combination as specified

Use contextDose limit provided in coverage criteria to guide medical necessity and quantity limits

Kepivance (palifermin) — 60 mcg/kg/day

Dose per day60 mcg/kg/day for 3 consecutive days before and 3 consecutive days after myelotoxic therapy (total 6 doses)

IndicationKepivance (palifermin) to decrease incidence and duration of severe oral mucositis in individuals receiving myelotoxic therapy with autologous HSCT

Administration contextIV administration under medical benefit per prescribing schedule

Lumakras quantity limit added (history)

History noteQuantity limit for Lumakras was added (policy update noted in 2026 history)

Related updatesHistory also records quantity limit additions for Ojjaara and Pemazyre in same update

Effective contextRecorded in 2026 Update history (chunk 143)

Ojjaara quantity limit added (history)

History noteQuantity limit for Ojjaara (momelotinib) was added (policy history entry)

Related contextOjjaara is addressed as a myelofibrosis agent with a quantity limit per 30 days noted in history

Recorded in2026 Update history entries

Pemazyre quantity limit added (history)

History noteQuantity limit for Pemazyre (pemigatinib) was added (policy history)

Current limit28 tablets per 28 days as stated in coverage criteria

Recorded in2026 Update history entries

Romvimza (vimseltinib) — 2 capsules weekly

Dosing/quantityRomvimza (vimseltinib) dose limited to 30 mg twice weekly with quantity limited to 2 capsules weekly

IndicationRomvimza for symptomatic TGCT when surgery would cause severe morbidity

Prescriber requirementPrescribed by or in consultation with an oncologist as noted

Lumakras — quantity limit per 30 days (history)

History noteLumakras quantity limit per 30 days added/updated in policy history

Policy effectUsed to enforce per‑30‑day dispensing limits for Lumakras in pharmacy benefit management

Reference entriesSee 2026 Update history (chunk 143) and coverage criteria (chunk 27)

Ojjaara — quantity limit per 30 days (history)

History noteOjjaara quantity limit per 30 days was added/updated in policy history

Agent classMomelotinib for myelofibrosis with transfusion‑dependent anemia indications

See alsoQuantity/limit context in quantity limits module

Pemazyre — quantity limit per 28 days (history)

History notePemazyre quantity limit per 28 days was added/updated in policy history

Current stated limit28 tablets per 28 days in coverage criteria

Recorded in2026 Update history entries (chunk 143)

Voranigo (vorasidenib) — quantity limit (history)

History noteVoranigo (vorasidenib) quantity limit and prescriber requirement were added in prior updates

Policy contextVoranigo coverage criteria updated to include prescriber requirement and quantity limit (see history entries)

IndicationVoranigo for residual or recurrent grade 2 nonenhancing glioma with susceptible IDH1/2 mutation

Secondary MFDocumentation of intermediate or high‑risk secondary myelofibrosis should include equivalent risk stratification and prior disease history (post‑PV or post‑ET)

PurposeRequired to support Vonjo, Inrebic and other myelofibrosis agent coverage criteria

Definition — BCG-unresponsive NMIBC

BCG‑unresponsive NMIBC definitionNon‑muscle invasive bladder cancer unresponsive to Bacillus Calmette‑Guérin therapy used as indication for intravesical gemcitabine (Inlexzo)

RequirementIncludes carcinoma in situ with or without papillary tumors in adults

Dose limit225 mg every 3 weeks up to 6 months

Definition — HLA-A*02:01-positive

HLA subtype requirementHLA‑A*02:01‑positive (HLA‑A*02:01) required for tebentafusp (Kimmtrak) in unresectable/metastatic uveal melanoma

Age contextApplicable to adult individuals per coverage criteria

Testing implicationHLA typing must be documented to support coverage

Definition — IPSS-R reference

IPSS‑R referenceRevised International Prognostic Scoring System (IPSS‑R) table referenced to stratify MDS risk based on cytogenetics, blasts, hemoglobin, platelets, and neutrophils

Risk groupsVery low, Low, Intermediate, High, Very high defined by IPSS‑R score ranges

UseReferenced to support diagnosis and treatment decisions in MDS criteria

Definition — IPSS-R (duplicate)

IPSS‑R (duplicate)Revised International Prognostic Scoring System for MDS used for risk grouping and scoring (table included in policy)

ParametersIncludes cytogenetics, bone marrow blasts, hemoglobin, platelets, ANC

Clinical useSupports myelodysplastic syndrome risk stratification for coverage decisions

Definition — Best supportive care (BSC)

Best supportive care (BSC)Supportive measures provided alongside investigational or active treatment arms in trials (used as comparator in Lonsurf trial)

Trial contextBSC often used as comparator in oncology randomized trials to evaluate added benefit of active agents

Implication for coverageTrial eligibility based on BSC comparators may affect applicability of trial‑based coverage criteria

Definition — rPFS / PFS / ORR

rPFS / PFS / ORR definitionsRadiological progression‑free survival (rPFS), progression‑free survival (PFS), and objective response rate (ORR) are efficacy endpoints referenced across trials

Use in trialsEndpoints used to support efficacy claims in PROpel, LIBRETTO and other pivotal studies cited

DocumentationReported endpoint values (e.g., ORR, rPFS) are used in coverage rationale for specific agents

Definition — PARP inhibitor

PARP inhibitor definitionAgent that inhibits poly (ADP‑ribose) polymerase enzymes involved in DNA repair (example: Talzenna targets PARP1 and PARP3)

Clinical implicationUsed in tumors with defective homologous recombination repair (HRR) such as BRCA‑mutated cancers

SelectionBiomarker testing (germline or somatic HRR gene mutations) guides use

Definition — CRS / ICANS

CRS / ICANSCytokine release syndrome (CRS) and immune effector cell‑associated neurotoxicity syndrome (ICANS) — serious immune toxicities requiring monitoring (noted with Tecelra)

Monitoring requirementPatients receiving Tecelra must be monitored at the healthcare facility for at least 7 days post‑infusion for CRS and ICANS

Clinical implicationPresence of CRS/ICANS may necessitate specialized infusion/cell therapy center care

Definition — HRR gene mutation

HRR gene mutation definitionHomologous recombination repair (HRR) gene mutation: genetic alterations in DNA repair genes (examples listed) implicated in PARP inhibitor sensitivity

Example genesATM, ATR, BRCA1, BRCA2, CDK12, CHEK2, FANCA, MLH1, MRE11A, NBN, PALB2, RAD51C

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

Definition — use of term 'individual' instead of 'patient'

Terminology standardizationPolicy uses the term 'individual' instead of 'patient' throughout the document

PurposeConsistent language across coverage criteria and documentation requirements

ApplicabilityAffects wording in all coverage and documentation sections

01/01/25policy_update

Updated Ibrance (palbociclib) criteria to require inadequate response/intolerance to other CDK4/6 inhibitors and clarified FDA dosing applicability; added multiple drug coverage criteria and new HCPCS J9026

03/01/25policy_update

Added Xeloda and Rytelo coverage criteria; updated Retevmo indications and age ranges; added Tepylute and Tecelra coverage criteria

04/01/25coding_update

Added HCPCS codes C9303, J9054, Q2057 and other quarterly coding updates

08/01/25policy_update

Added coverage criteria for Treanda, dactinomycin, Docivyx, Doxil and multiple intravenous agents; added associated HCPCS codes following provider notification

11/01/25coding_update

Added HCPCS codes J0614 and J8999; updated parentheticals for C9399 and J9999 to include Inlexzo and Modeyso

12/01/25policy_update

Added indications for Zepzelca and Revuforj, updated Kisqali Femara Co-Pack removal and added coverage for Blenrep; implemented coding and criteria refinements

02/06/26policy_update

Added coverage criteria for Ixempra and clofarabine (Clolar) effective after provider notification

03/01/26policy_update

Updated Rozlytrek pediatric age requirement to >=1 month; added Komzifti and removed oral Temodar coverage (discontinued); multiple quantity-limit and ECOG updates

04/01/26coding_updateLatest

Added new HCPCS code J9183 effective April 1, 2026

02/07/25policy_update

Added coverage criteria for Nipent (pentostatin) for hairy cell leukemia and Oncaspar (pegaspargase) for ALL; removed HCPCS code J1246 as it was never implemented by CMS

12/10/24interim_review

Interim review noted and new HCPCS J9026 added (later removed in subsequent coding updates)

03/01/26policy_update

Added numerous agents and coding entries across multiple updates (examples include addition of Tepylute, Tecelra, Vyloy and others) and clarified FDA dosing applicability

07/01/25coding_update

Quarterly coding updates added codes such as J1326, J9341, J9174 reflecting new/updated agent entries (e.g., zolbetuximab, thiotepa, docetaxel variants)

08/01/25policy_update

After provider notification effective November 7, 2025 additions included Treanda, dactinomycin, Docivyx, Doxil, Evomela, Kepivance and related HCPCS codes

04/01/26coding_updateLatest

Added new HCPCS code J9183 effective April 1, 2026 as part of ongoing coding updates

01/01/25policy_update

Interim review approved December 10, 2024; Ibrance criteria updated to require inadequate response or intolerance to specified CDK4/6 inhibitors and HCPCS J9026 was added

03/18/25coding_update

Minor update restored February 7, 2025 coding updates to coding table and added HCPCS codes J9034, J9036, J9056, J9153, J9266, and J9268

04/01/25coding_update

Added HCPCS codes C9303, J9054 and Q2057 as part of coding updates on April 1, 2025

07/01/25coding_update

Quarterly coding update added HCPCS codes J1326, J9341, and J9174 (effective July 1, 2025)

11/01/25coding_update

Added HCPCS codes J0614 (effective 10/01/25), J8999 and included Inlexzo and Modeyso in parentheticals for C9399 and J9999

12/01/25coding_update

Added/updated HCPCS entries with J9179, J0893 and others; implemented coding refinements following 90-day holds and provider notifications

04/01/26coding_updateLatest

Added new HCPCS code J9183 effective April 1, 2026, reflecting the latest coding updates

Drug removal notes referenced in history: the policy history documents removals and updates over time, including removal of certain products or formulations (for example, oral Temodar was removed when the product was discontinued) and removals when sponsors voluntarily withdrew indications (e.g., Lartruvo). These historical entries inform current applicability and coding changes.