Oncology Medication Clinical Coverage
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UnitedHealthcare Commercial Medical Benefit Drug Policy
Effective 07/01/2024
Proprietary Information of UnitedHealthcare. Copyright 2024 United HealthCare Services, Inc.
UnitedHealthcare
®
Commercial
Medical
Benefit
Drug
Policy
Oncology Medication Clinical Coverage
Policy Number: 2024D0030AJ
Effective Date: July 1, 2024
Instructions for Use
Table of Contents Page
Coverage Rationale .............................................................. 1
Applicable Codes .................................................................. 3
Background ........................................................................... 4
Benefit Considerations .......................................................... 4
Centers for Medicare and Medicaid Services ....................... 5
References ............................................................................ 5
Policy History/Revision Information ...................................... 5
Instructions for Use ............................................................... 5
Coverage Rationale
See Benefit Considerations
Description
This policy provides parameters for coverage of injectable oncology medications (including, but not limited to octreotide
acetate, leuprolide acetate, leucovorin and levoleucovorin), including therapeutic radiopharmaceuticals, covered under the
medical benefit based upon the National Comprehensive Cancer Network (NCCN) Drugs & Biologics Compendium
®
(NCCN Compendium
®
). The Compendium lists the appropriate drugs and biologics for specific cancers using US Food
and Drug Administration (FDA)-approved disease indications and specific NCCN panel recommendations. Each
recommendation is supported by a level of evidence category. Coverage of White Blood Cell Colony Stimulating Factors
and Erythropoiesis-Stimulating Agents are addressed in separate policies. This policy does not provide coverage criteria
for Chimeric Antigen Receptor (CAR)-T Cell products. Coverage determinations are based on the member’s benefits and
the OptumHealth Transplant Solutions criteria for covered transplants; refer to the Clinical Guideline titled Chimeric
Antigen Receptor T-cell Therapy.
Coverage Rationale
Medical Necessity Plans
The Oncology Products table below lists the UnitedHealthcare preferred oncology products and respective non-preferred
products. Coverage will be provided for the UnitedHealthcare preferred oncology product contingent on the coverage
criteria in the Diagnosis-Specific Criteria section.
Coverage for any respective non-preferred oncology product will be provided contingent on the criteria in the Preferred
Product Criteria and the Diagnosis-Specific Criteria sections. Members new to therapy will be required to utilize the
UnitedHealthcare preferred oncology product unless they meet the criteria in this section.
Related Commercial Policies
Antiemetics for Oncology
Denosumab (Prolia
®
& Xgeva
®
)
Erythropoiesis-Stimulating Agents
Molecular Oncology Testing for Solid Tumor
Cancer Diagnosis, Prognosis, and Treatment
Decisions
Rituximab (Riabni
®
, Rituxan
®
, Ruxience
®
, &
Truxima
®
)
White Blood Cell Colony Stimulating Factors
Community Plan Policy
Oncology Medication Clinical Coverage
Related Clinical Guideline
Chimeric Antigen Receptor T-cell Therapy
Oncology Medication Clinical Coverage
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UnitedHealthcare Commercial Medical Benefit Drug Policy
Effective 07/01/2024
Proprietary Information of UnitedHealthcare. Copyright 2024 United HealthCare Services, Inc.
Preferred Product Criteria (For Medicare reviews, refer to the CMS section.***)
Treatment with the respective non-preferred product specified in the Oncology Products table below is medically
necessary for oncology indications when both of the following are met:
History of intolerance or contraindication to one of the UnitedHealthcare’s preferred oncology products; and
Physician attests that, in their clinical opinion, the same intolerance, contraindication, or adverse event would not be
expected to occur with the respective non-preferred product
Oncology Products
Below are UnitedHealthcare preferred oncology products with therapeutically equivalent and/or biosimilar* non-preferred
products as determined by the UnitedHealthcare P&T Committee:
UnitedHealthcare Preferred Oncology Product
UnitedHealthcare Non-Preferred Oncology Product
Mvasi (bevacizumab-awwb) Avastin (bevacizumab)
Zirabev (bevacizumab-bvzr)
Alymsys (bevacizumab-maly)
Vegzelma (bevacizumab-adcd)
Kanjinti (trastuzumab-anns)
Trazimera (trastuzumab-qyyp)
Ogivri (trastuzumab-dkst)
Herceptin (trastuzumab)
Herceptin Hylecta (trastuzumab and hyaluronidase-oysk)
Herzuma (trastuzumab-pkrb)
Ontruzant (trastuzumab-dttb)
Kanjinti (trastuzumab-anns) + Perjeta (pertuzumab)
Phesgo (pertuzumab, trastuzumab, hyaluronidase-zzxf)**
Trazimera (trastuzumab-qyyp) + Perjeta (pertuzumab)
Ogivri (trastuzumab-dkst) + Perjeta (pertuzumab)
Herceptin (trastuzumab) + Perjeta (pertuzumab)
Herceptin Hylecta (trastuzumab and hyaluronidase-oysk)
+ Perjeta (pertuzumab)
Herzuma (trastuzumab-pkrb) + Perjeta (pertuzumab)
Ontruzant (trastuzumab-dttb) + Perjeta (pertuzumab)
Ruxience (rituximab-pvvr)
Truxima (rituximab-abbs)
Rituxan (rituximab)
Rituxan Hycela (rituximab/hyaluronidase human,
recombinant)
Riabni (rituximab-arrx)
Gemcitabine
Infugem (gemcitabine in sodium chloride injection)
Leucovorin
Levoleucovorin
Eligard (leuprolide acetate), Lupron Depot 7.5 mg
(leuprolide acetate for depot suspension - J9217, J1954),
Zoladex (Goserelin acetate)
Lupron Depot 3.75 mg (leuprolide acetate for depot
suspension - J1950)
Somatuline Depot (Lanreotide - J1930)
Lanreotide (J1932)
Alimta, Pemetrexed (J9294, J9296, J9297, J9305, J9314)
Pemfexy (pemetrexed - J9304)
*Biosimilar means that the biological product is FDA-approved based on data demonstrating that it is highly similar to an
already FDA-approved biological product, known as a reference product, and that there are no clinically meaningful
differences between the biosimilar product and the reference product.
**Phesgo is a combination product of pertuzumab + trastuzumab.
Diagnosis-Specific Criteria
Injectable Oncology Medications
UnitedHealthcare recognizes indications and uses of injectable oncology medications, including therapeutic
radiopharmaceuticals, listed in the NCCN Drugs and Biologics Compendium with Categories of Evidence and Consensus
of 1, 2A, and 2B as proven and medically necessary, and Categories of Evidence and Consensus of 3 as unproven and
not medically necessary.
UnitedHealthcare will cover all chemotherapy agents for individuals under the age of 19 years for oncology indications.
The majority of pediatric patients receive treatments on national pediatric protocols that are quite similar in concept to the
NCCN patient care guidelines.
Refer to Preferred Product Criteria for the UnitedHealthcare preferred oncology products that have therapeutically
equivalent and/or biosimilar products available.
Oncology Medication Clinical Coverage
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UnitedHealthcare Commercial Medical Benefit Drug Policy
Effective 07/01/2024
Proprietary Information of UnitedHealthcare. Copyright 2024 United HealthCare Services, Inc.
Applicable Codes
The following list(s) of procedure and/or diagnosis codes is provided for reference purposes only and may not be all
inclusive. Listing of a code in this policy does not imply that the service described by the code is a covered or non-covered
health service. Benefit coverage for health services is determined by the member specific benefit plan document and
applicable laws that may require coverage for a specific service. The inclusion of a code does not imply any right to
reimbursement or guarantee claim payment. Other Policies and Guidelines may apply.
Description
Lutetium lu 177, dotatate, therapeutic, 1 millicurie
Iodine i-131, iobenguane, 1 millicurie
Radium Ra-223 dichloride, therapeutic, per microcurie
A9607 Lutetium Lu 177 vipivotide tetraxetan, therapeutic, 1 millicurie
A9699 Radiopharmaceutical, therapeutic, not otherwise classified
Injection, leucovorin calcium, 50 mg
J0641 Injection, levoleucovorin, not otherwise specified, 0.5 mg
Injection, levoleucovorin (khapzory), 0.5 mg
J1930 Lanreotide injection
J1932 Inj, lanreotide, (cipla), 1mg
Injection, leuprolide acetate (for depot suspension), 3.75 mg
J1954 Injection, leuprolide acetate for depot suspension (cipla), 7.5 mg
Injection, bevacizumab, 10 mg
Injection, gemcitabine hydrochloride, (infugem), 100 mg
J9199 Injection, gemcitabine hydrochloride (infugem), 200 mg
Injection, gemcitabine hydrochloride, 200 mg
J9202 Goserelin acetate implant
J9217 Injection, leuprolide acetate (for depot suspension), 7.5 mg
Injection, pemetrexed (Hospira), not therapeutically equivalent to J9305, 10 mg
J9296 Injection, pemetrexed (Accord), not therapeutically equivalent to J9305, 10 mg
J9297 Injection, pemetrexed (sandoz) 10mg
Injection, pemetrexed, 10 mg
J9305 Injection, pemetrexed nos 10mg
J9310 Injection, rituximab, 100 mg
Injection, rituximab, hyaluronidase, 10 mg
J9312 Injection, rituximab, 10 mg
J9314 Injection, pemetrexed (Teva), not therapeutically equivalent to J9305, 10 mg
J9316 Injection, pertuzumab, trastuzumab, and hyaluronidase-zzxf, 10 mg
J9355 Injection, trastuzumab, 10 mg
Injection, trastuzumab, 10 mg and Hyaluronidase-oysk
Q5107 Injection, bevacizumab-awwb, biosimilar (mvasi), 10 mg
Injection, trastuzumab-dttb, biosimilar (ontruzant), 10 mg
Injection, trastuzumab-pkrb, biosimilar (herzuma), 10 mg
Injection, trastuzumab-dkst, biosimilar (ogivri), 10 mg
Injection, rituximab-abbs, biosimilar (truxima), 10 mg
Q5116 Injection, trastuzumab-qyyp, biosimilar (trazimera), 10 mg
Oncology Medication Clinical Coverage
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UnitedHealthcare Commercial Medical Benefit Drug Policy
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Description
Q5117 Injection, trastuzumab-anns, biosimilar (kanjinti), 10 mg
Injection, bevacizumab-bvzr, biosimilar (zirabev), 10 mg
Q5119 Injection, rituximab-pvvr, biosimilar (ruxience), 10 mg
Q5123 Injection, rituximab-arrx, biosimilar (riabni), 10mg
Injection, bevacizumab-maly, biosimilar, (alymsys), 10 mg
Q5129 Injection, bevacizumab-adcd, biosimilar, (vegzelma), 10 mg
Background
The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines
®
) are comprehensive guidelines documenting
management decisions and interventions that apply to 97% of cancers affecting U.S. patients.
NCCN Categories of Evidence and Consensus
Category 1: The recommendation is based on high-level evidence (i.e., high-powered randomized clinical trials or
meta-analyses), and the panel has reached uniform consensus that the recommendation is indicated. In this context,
uniform means near unanimous positive support with some possible neutral positions.
Category 2A: The recommendation is based on lower level evidence, but despite the absence of higher level studies,
there is uniform consensus that the recommendation is appropriate. Lower level evidence is interpreted broadly and
runs the gamut from phase II to large cohort studies to case series to individual practitioner experience. Importantly, in
many instances, the retrospective studies are derived from clinical experience of treating large numbers of patients at
a member institution, so panel members have first-hand knowledge of the data. Inevitably, some recommendations
must address clinical situations for which limited or no data exist. In these instances the congruence of experience-
based opinions provides an informed if not confirmed direction for optimizing patient care. These recommendations
carry the implicit recognition that they may be superseded as higher level evidence becomes available or as
outcomes-based information becomes more prevalent.
Category 2B: The recommendation is based on lower level evidence, and there is nonuniform consensus that the
recommendation should be made. In these instances, because the evidence is not conclusive, institutions take
different approaches to the management of a particular clinical scenario. This nonuniform consensus does not
represent a major disagreement, rather it recognizes that given imperfect information, institutions may adopt different
approaches. A Category 2B designation should signal to the user that more than one approach can be inferred from
the existing data.
Category 3: The recommendation has engendered a major disagreement among the panel members. Several
circumstances can cause major disagreements. For example, if substantial data exists about two interventions but
they have never been directly compared in a randomized trial, adherents to one set of data may not accept the
interpretation of the other side's results. Another situation resulting in a Category 3 designation is when experts
disagree about how trial data can be generalized. A Category 3 designation alerts users to a major interpretation
issue in the data and directs them to the manuscript for an explanation of the controversy.
Therapeutic radiopharmaceuticals [e.g., Azedra
®
(iobenguane I 131), Lutathera
®
(lutetium Lu 177 dotatate), Xofigo
®
(radium-223)] used to treat cancer are medications that contain radioactive material. The radioactive agent selectively
accumulates within the tumor releasing radiation which then kills cancer cells.
Benefit Considerations
If the coverage review using the NCCN Compendium determines that the drug is unproven, then further review is
indicated. Some Certificates of Coverage allow for coverage of experimental/investigational/unproven treatments for life-
threatening illnesses when certain conditions are met. The member specific benefit plan document must be consulted to
make coverage decisions for this service. Some states mandate benefit coverage for off-label use of medications for
some diagnoses or under some circumstances. Some states also mandate usage of other Compendium references.
Where such mandates apply, they supersede language in the member specific benefit plan document or in this policy.
Chimeric Antigen Receptor (CAR)-T Cell Therapy may be eligible for coverage as an autologous stem cell therapy under
a member’s Transplantation Services benefit. Coverage determinations are based on the OptumHealth Transplant
Solutions criteria for covered transplants; refer to the Clinical Guideline titled Chimeric Antigen Receptor T-cell Therapy.
Oncology Medication Clinical Coverage
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UnitedHealthcare Commercial Medical Benefit Drug Policy
Effective 07/01/2024
Proprietary Information of UnitedHealthcare. Copyright 2024 United HealthCare Services, Inc.
Benefit coverage for an otherwise unproven service for the treatment of serious rare diseases may occur when certain
conditions are met. Refer to the Policy and Procedure addressing the treatment of serious rare diseases.
Centers for Medicare and Medicaid Services (CMS)
Medicare does not have a National Coverage Determination (NCD) that specifically addresses preferred or non-preferred
medications used to treat cancer. However, Medicare does have an NCD for Anti-Cancer Chemotherapy for Colorectal
Cancer (110.17). Local Coverage Determinations (LCD)/Local Coverage Articles (LCA) exist; refer to the LCDs/LCAs for
the following at https://www.cms.gov/medicare-coverage-database/new-search/search.aspx:
Trastuzumab Trastuzumab Biologics
Luteinizing Hormone-Releasing Hormone (LHRH) Analogs
Drugs and Biologicals, Coverage of, for Label and Off-Label Uses
Rituximab
Medicare may cover outpatient (Part B) drugs that are furnished “incident to” a physician’s service provided that the drugs
are not usually self-administered by the patients who take them. Refer to the Medicare Benefit Policy Manual, Chapter 15,
§50 - Drugs and Biologicals. (Accessed October 9, 2023)
***Preferred therapy criteria for Medicare Advantage members, refer to Medicare-Part-B-Step-Therapy-Programs.
References
1. The NCCN Drugs and Biologics Compendium (NCCN Compendium
®
). https://www.nccn.org/compendia-
templates/compendia/drugs-and-biologics-compendia.
2. The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines
®
).
http://www.nccn.org/professionals/physician_gls/f_guidelines.asp.
3. Pazdur R. Endpoints for assessing drug activity in clinical trials. Oncologist. 2008;13 Suppl 2:19-21.
4. Therasse P, Arbuck SG, Eisenhauer EA, et al. New guidelines to evaluate the response to treatment in solid tumors.
European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States,
National Cancer Institute of Canada. J Natl Cancer Inst. 2000 Feb 2;92(3):205-16.
5. Center for Drug Evaluation and Research. Biosimilars. Retrieved from https://www.fda.gov/drugs/therapeutic-
biologics-applications-bla/biosimilars.
Policy History/Revision Information
Date
Summary of Changes
07/01/2024
Applicable Codes
Updated list of applicable HCPCS codes to reflect quarterly edits; revised description for J9294,
J9296, and J9314
Supporting Information
Archived previous policy version 2024D0030AI
Instructions for Use
This Medical Benefit Drug Policy provides assistance in interpreting UnitedHealthcare standard benefit plans. When
deciding coverage, the member specific benefit plan document must be referenced as the terms of the member specific
benefit plan may differ from the standard plan. In the event of a conflict, the member specific benefit plan document
governs. Before using this policy, please check the member specific benefit plan document and any applicable federal or
state mandates. UnitedHealthcare reserves the right to modify its Policies and Guidelines as necessary. This Medical
Benefit Drug Policy is provided for informational purposes. It does not constitute medical advice.
This Medical Benefit Drug Policy may also be applied to Medicare Advantage plans in certain instances. In the absence of
a Medicare National Coverage Determination (NCD), Local Coverage Determination (LCD), or other Medicare coverage
guidance, CMS allows a Medicare Advantage Organization (MAO) to create its own coverage determinations, using
objective evidence-based rationale relying on authoritative evidence (Medicare IOM Pub. No. 100-16, Ch. 4, §90.5).
Oncology Medication Clinical Coverage
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UnitedHealthcare Commercial Medical Benefit Drug Policy
Effective 07/01/2024
Proprietary Information of UnitedHealthcare. Copyright 2024 United HealthCare Services, Inc.
UnitedHealthcare may also use tools developed by third parties, such as the InterQual
®
criteria, to assist us in
administering health benefits. UnitedHealthcare Medical Benefit Drug Policies are intended to be used in connection with
the independent professional medical judgment of a qualified health care provider and do not constitute the practice of
medicine or medical advice.