Injectable Oncology

POLICY NUMBER

L.5.01.561

Anktiva (nogapendekin alfa inbakicept-pmln)Bizengri (zenocutuzumab-zbco)Boruzu (bortezomib)Columvi (glofitamab-gxbm)Danyelza (naxitamab-gqgk)Datroway (datopotamab deruxtecan-dlnk)Elahere (mirvetuximab soravtansine-gynx)Emrelis (telisotuzumab vedotin-tllv)Enhertu (fam-trastuzumab deruxtecan-nxki)Epkinly (epcoritamab-bysp)Hepzato Kit (melphalan)Imdelltra (tarlatamab-dlle)Jemperli (dostarlimab-gxly)Kimmtrak (tebentafusp-tebn)Loqtorzi (toripalimab-tpzi)Lunsumio (mosunetuzumab-axgb)Margenza (margetuximab-cmkb)Monjuvi (tafasitamab-cxix)Opdivo (nivolumab)Opdivo Qvantig (nivolumab and hyaluronidase-nvhy)Opdualag (nivolumab-relatlimab-rmbw)Padcev (enfortumab vedotin-ejfv)Rybrevant (amivantamab-vmjw)Rylaze (asparaginase erwinia chrysanthemi- recombinant-rywn)Rytelo (imetelstat)Sarclisa (isatuximab-irfc)Tevimbra (tislelizumab-jsgr)Tivdak (tisotumab vedotin-tftv)Trodelvy (sacituzumab govitecan-hziy)Vyloy (zolbetuximab-clzb)Zepzelca (lurbinectedin)Ziihera (zanidatamab-hrii)Zynyz (retifanlimab-dlwr)

Please perform a formulary drug search on your patient’s member ID to ensure the prescription drug is covered under their benefit plan. The medication(s) in this medical policy may not be covered under a specific member’s benefit plan.

DESCRIPTION

This policy outlines coverage criteria for injectable oncology medications which are covered under the medical benefit. Coverage guidelines are based on the National Comprehensive Cancer Network (NCCN) Drugs & Biologics Compendium (NCCN) and FDA-approved prescribing information.

This policy does not address coverage for White Blood Cell Stimulating Factors, Erythropoiesis-Stimulating Agents, or Chimeric Antigen Receptor (CAR)-T Cell Products.

FDA Approval

The Food and Drug Administration (FDA) oversees drug and biologic evaluation process. FDA approval of a drug/biologic means the FDA’s Center for Drug Evaluation and Research (CDER) has determined the health benefit outweighs the known risks of the drug/biologic. Accelerated approval can be applied to a drug/biologic that demonstrates a promising therapeutic benefit over available therapies for a serious or life-threatening condition or disease. Drugs/biologics approved under an accelerated approval require post-marketing clinical trials to verify and describe its benefit.

National Comprehensive Cancer Network

The National Comprehensive Cancer Network (NCCN) is an organization of cancer centers that develops resources to improve and facilitate quality, effective, efficient, and accessible cancer care. The recommendations contained in the Library of NCCN Compendia are extracted directly from the NCCN Guidelines, the recognized standard for clinical policy in cancer care, to support clinical decision-making related to the use of drugs and biologics, biomarker testing, imaging, and radiation therapy for patients with cancer. The NCCN Categories of Evidence and Consensus are defined as:

• Category 1: Based upon high-level evidence, there is uniform NCCN consensus that the intervention is appropriate.

• Category 2A: Based upon lower-level evidence, there is uniform NCCN consensus that the intervention is appropriate.

• Category 2B: Based upon lower-level evidence, there is NCCN consensus that the intervention is appropriate.

• Category 3: Based upon any level of evidence, there is major NCCN disagreement that the intervention is appropriate. 

Related Medical Policies -

• Adoptive Immunotherapy

• Erythropoiesis-Stimulating Agents

• Somatic Biomarker Testing (Including Liquid Biopsy) for Targeted Treatment and Immunotherapy in Non-Small-Cell Lung Cancer (EGFR, ALK, BRAF, ROS1, RET, MET, KRAS, HER2, PD-L1, TMB)

• Genetic Testing for FLT3, NPM1, and CEBPA, IDH1 and IDH2 Variants in Cytogenetically Normal Acute Myeloid Leukemia

• Germline and Somatic Biomarker Testing (Including Liquid Biopsy) for Targeted Treatment and Immunotherapy in Breast Cancer

• Somatic Biomarker Testing (Including Liquid Biopsy) for Targeted Treatment and Immunotherapy in Metastatic Colorectal Cancer (KRAS, NRAS, BRAF, MMR/MSI, HER2, and TMB)

• Comprehensive Genomic Profiling for Selecting Targeted Cancer Therapies

• Somatic Genetic Testing To Select Individuals with Melanoma or Glioma for Targeted Therapy or Immunotherapy

POLICY

Prior authorization is required (See Policy Exceptions).

The use of samples by an individual will not be considered current or stable therapy to satisfy Medical Policy requirements.

The requested agent may be considered medically necessary when ALL of the following criteria are met:

1. ONE of the following:

   1. There is documentation that the individual is currently receiving the requested agent and the requested agent is being used for an FDA approved diagnosis or a use supported by compendia (NCCN Compendium level of evidence 1 or 2A, AHFS, DrugDex level of evidence 1 or 2A);

   2. The prescriber states the individual is using the requested agent AND is at risk if therapy is changed;

   3. ALL of the following:

      1. ONE of the following:

         1. The individual has an FDA approved diagnosis for the requested agent; OR

         2. The use of the requested agent is for an indication that is supported by compendia. (NCCN Compendium level of evidence 1 or 2A, AHFS, DrugDex level of evidence 1 or 2A);

      2. Genetic testing has been completed (if applicable) using an FDA approved genetic test if required for therapy with the requested agent and results indicate therapy with requested agent is appropriate; AND

      3. ONE of the following:

         1. The individual has tried and failed the first line agent for the intended indication (if applicable); OR

         2. The individual has a documented intolerance, FDA labeled contraindication, or hypersensitivity to the first line agent;

2. If requested medication is not being used as monotherapy, drug must be used in combination with other chemotherapeutic or adjuvant agent(s) as approved by the FDA prescribing information or regimen is supported by national compendia and/or medical literature;

3. The individual does not have an FDA-labeled contraindication to therapy with the requested agent;

4. The individual does not have an FDA-labeled limitation of use for the requested agent that is otherwise not supported in the National Comprehensive Cancer Network (NCCN); AND

5. The prescribed dosage is within the program quantity limits based on FDA approved labeled dosage. 

Length of Approval: Up to 3 months for dose titration requests                                  Up to 12 months for all other requests

 Anktiva (nogapendekin alfa inbakicept-pmln), Bizengri (zenocutuzumab-zbco), Boruzu (bortezomib), Emrelis (telisotuzumab vedotin-tllv), Hepzato Kit (melphalan), Imdelltra (tarlatamab-dlle), Jemperli (dostarlimab-gxly), Kimmtrak (tebentafusp-tebn), Margenza (margetuximab-cmkb), Opdivo Qvantig (nivolumab and hyaluronidase-nvhy), Opdualag (nivolumab-relatlimab-rmbw injection), Rylaze (asparaginase erwinia chrysanthemi- recombinant-rywn), Tivdak (tisotumab vedotin-tftv), and Ziihera (zanidatamab-hrii) are considered not medically necessary for all indications as there are other formulary alternatives which are covered by the Plan and listed in treatment guidelines of equal level of evidence.

Services related to delivery and/or administration of a medication which has not been approved through the BCBSMS PA review process will be considered not medically necessary.

POLICY EXCEPTIONS

Opdivo (nivolumab) and Enhertu (fam-trastuzumab deruxtecan-nxki) do not require prior authorization. However, all claims will be reviewed for medical necessity based on the medical policy guidelines.

State Health Plan (State and School Employees) Participants

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

1. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

2. appropriate with regard to standards of good medical practice; and

3. not solely for the convenience of the Member, his or her Provider; and

4. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [ie, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

BCBSMS determines patient medication trials and adherence by a review of pharmacy claims data over the preceding twelve months. Additional information may be requested on a case-by-case basis to allow for proper review. If individual is new to BCBSMS and pharmacy records are needed to confirm medication trials and adherence, it is the responsibility of the individual and/or the requesting provider to obtain said records and submit them to BCBSMS upon request. Medical records from the provider that list previously prescribed medications will not be sufficient to show medication trials or adherence.

POLICY HISTORY

08/07/2020: New policy added.

09/23/2020: Code Reference section updated to add new HCPCS code J9227, effective 10/01/2020.

11/01/2020: Policy description extensively revised. Policy statement criteria updated to add that the requested agent is being used for an FDA approved diagnosis or a use supported by compendia (NCCN Compendium level of evidence 1 or 2A, AHFS, DrugDex level of evidence 1 or 2A). Policy Guidelines updated to remove definition of medication failure and to change "Nervous/Mental Conditions" to "Mental Health Disorders." Sources updated. Code Reference section updated to add HCPCS code C9066.

05/01/2021: Policy updated to include Blenrep (belantamab), Danyelza (naxitamab), and Monjuvi (tafasitamab-cxix). Opdivo (nivolumab) moved from separate policy, L.5.01.487, to this one. Policy statement updated to add that if requested medication is not being used as monotherapy, drug must be used in combination with other chemotherapeutic or adjuvant agent(s) as approved by the FDA prescribing information or regimen is supported by national compendia and/or medical literature. Policy Exceptions updated to state that Opdivo does not require prior authorization. However, all claims will be reviewed for medical necessity based on the medical policy guidelines. Sources updated. Code Reference section updated to add HCPCS Codes J9037, J9223, J9299, J9317, and J9349.

07/01/2021: Code Reference section updated to add new HCPCS code J9348, effective 07/01/2021.

08/17/2021: Added Margenza (margetuximab-cmkb) and Pepaxto (melphalan) to the top of the policy. Medically necessary criteria updated to state that the member does not have an FDA-labeled contraindication to therapy with the requested agent. Policy Exceptions updated to add "nivolumab." Sources updated. Code Reference section updated to add HCPCS codes C9080 and J9353.

10/01/2021: Code Reference section updated to add new HCPCS code J9247, effective 10/01/2021.

11/03/2022: Policy updated to include Kimmtrak (tebentafusp-tebn) and Opdualag (nivolumab-relatlimab-rmbw). Policy section updated to add the following statements: 1) Opdualag (nivolumab-relatlimab-rmbw injection) and Kimmtrak (tebentafusp-tebn) are considered not medically necessary for all indications as there are other formulary alternatives which are covered by the Plan and listed in treatment guidelines of equal level of evidence. 2) Services related to delivery and/or administration of a medication which has not been approved through the BCBSMS PA review process will be considered not medically necessary. Sources updated. Code Reference section updated to remove deleted HCPCS codes C9066 and C9080. Added HCPCS codes J9274 and J9298 as not medically necessary.

02/01/2023: Policy Exceptions updated to add the following: State Health Plan (State and School Employees): The prescription drug(s) in this medical policy may be covered under a prescription drug benefit plan administered by the State Health Plan’s Pharmacy Benefit Manager. Please perform a formulary drug search at https://www.dfa.ms.gov/cvs-caremark and submit any required Prior Authorization Requests for coverage determination to the Plan’s Pharmacy Benefit Manager. Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary. Services related to delivery and/or administration of a self-administered drug are not covered.

05/15/2023: Removed Blenrep (belantamab) from the policy and added Elahere (mirvetuximab soravtansine-gynx). Policy description updated to add related medical policies. Policy section updated to add Jemperli (dostarlimab), Margenza (margetuximab-cmkb), and Rylaze (asparaginase erwinia chrysanthemi- recombinant-rywn) as not medically necessary for all indications as there are other formulary alternatives which are covered by the Plan and listed in treatment guidelines of equal level of evidence. Sources updated. Code Reference section updated to add HCPCS codes J9021, J9272, and J9353 as not medically necessary.

05/22/2023: Policy updated to remove Pepaxto (melphalan). Sources updated. Code Reference section updated to remove HCPCS codes J9037 and J9247.

06/05/2023: Code Reference section updated to add HCPCS code C9146.

07/01/2023: Policy Exceptions updated regarding State Health Plan (State and School Employees) Participants. Code Reference section updated to add new HCPCS code J9063.

07/12/2023: Policy description updated to add related medical policy.

01/10/2024: Policy section updated to add Tivdak (tisotumab vedotin) as not medically necessary for all indications as there are other formulary alternatives which are covered by the Plan and listed in treatment guidelines of equal level of evidence. Sources updated. Code Reference section updated to add HCPCS code J9273 as not medically necessary.

04/18/2024: Policy updated to add Columvi (glofitamab-gxbm), Epkinly (epcoritamab-bysp), Loqtorzi (toripalimab-tpzi), and Zynyz (retifanlimab-blwr). Policy statements unchanged. Sources updated. Code Reference section updated to add HCPCS codes J9286 and J9345 to the Medically Necessary Codes table.

06/04/2024: Added Rybrevant (amivantamab) to the top of the policy. Policy statements unchanged. Sources updated. Code Reference section updated to add HCPCS code J9061 to the Medically Necessary Codes table.

07/25/2024: Policy updated to move Enhertu (fam-trastuzumab derutecan-nxki) from individual policy to the IV Oncology policy; coverage criteria unchanged. Sources updated. Code Reference section updated to add HCPCS code J9358 to the Medically Necessary Codes table. Removed deleted HCPCS code C9146.

09/05/2024: Code Reference section updated to add HCPCS code J9321.

10/01/2024: Policy reviewed and approved by the Pharmacy & Therapeutics (P&T) Committee. Policy updated to add Padcev (enfortumab vedotin-ejfv). Policy language updated to change "member" to "individual." Medically necessary statement revised to remove criteria regarding dose requirements and FDA approved labeling. Added the following medically necessary criteria: The prescribed dosage is within the program quantity limits based on FDA approved labeled dosage. Sources updated. Code Reference section updated to add HCPCS codes J3263 and J9177 to the medically necessary codes table.

01/15/2025: Policy title changed from "IV Oncology" to "Injectable Oncology." Added Anktiva (nogapendekin alfa inbakicept-pmln) and Imdelltra (tarlatamab-dlle) as not medically necessary for all indications as there are other formulary alternatives which are covered by the Plan and listed in treatment guidelines of equal level of evidence. Sources updated. Code Reference section updated to add HCPCS codes C9169 and C9170 to the Not Medically Necessary Codes table.

03/01/2025: Policy updated to add Lunsumio (mosunetuzumab-axgb). Policy statements unchanged. Sources updated. Code Reference section updated to add HCPCS code J9350 to the Medically Necessary Codes table and HCPCS code J9026 to the Not Medically Necessary Codes table.

04/15/2025: Policy updated to add Tevimbra (tislelizumab-jsgr). Policy statements unchanged. Policy Exceptions updated to state that Opdivo (nivolumab) and Enhertu (fam-trastuzumab derutecan-nxki) do not require prior authorization. However, all claims will be reviewed for medical necessity based on the medical policy guidelines. Sources updated. Code Reference section updated to add HCPCS code J9329 to the Medically Necessary Codes table.

05/14/2025: Policy updated to add Vyloy (zolbetuximab-clzb) and to make minor corrections to generic drug names. Sources updated. Code Reference section updated to add HCPCS code C9303.

08/01/2025: Policy updated to add Rytelo (imetelstat). Added Boruzu (bortezomib), Hepzato Kit (melphalan), and Ziihera (zanidatamab-hrii) as not medically necessary for all indications as there are other formulary alternatives which are covered by the Plan and listed in treatment guidelines of equal level of evidence. Sources updated. Code Reference section updated to add HCPCS codes J0870 and J1326 to the Medically Necessary Codes table. Added HCPCS codes C9302, J9054, and J9248 to the Not Medically Necessary Codes table.

09/01/2025: Policy updated to add Bizengri (zenocutuzumab-zbco), Datroway (datopotamab deruxtecan-dlnk), and Opdivo Qvantig (nivolumab and hyaluronidase-nvhy). Revised policy statement to add Bizengri (zenocutuzumab-zbco) and Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) as not medically necessary for all indications as there are other formulary alternatives which are covered by the Plan and listed in treatment guidelines of equal level of evidence. Sources updated. Code Reference section updated to add HCPCS code C9174 to the Medically Necessary Codes table. Added HCPCS codes J9289 and J9382 to the Not Medically Necessary Codes table.

10/01/2025: Code Reference section updated to add new HCPCS code J9011.

11/01/2025: Policy updated to add Emrelis (telisotuzumab vedotin-tllv) to the list of drugs. Policy statement revised to state that the use of samples by an individual will not be considered current or stable therapy to satisfy Medical Policy requirements. Added Emrelis (telisotuzumab vedotin-tllv) as not medically necessary for all indications as there are other formulary alternatives which are covered by the Plan and listed in treatment guidelines of equal level of evidence. Sources updated. Code Reference section updated to add new HCPCS code C9306 to the Not Medically Necessary Codes table.

01/01/2026: Code Reference section updated to add new HCPCS code J9326. Removed deleted HCPCS code C9170.

SOURCE(S)

1. Anktiva prescribing information. Altor BioScience, LLC. May 2024. Last accessed May 2025.

2. Bizengri prescribing information. Merus US, Inc. January 2025. Last accessed July 2025.

3. Boruzu prescribing information. Amneal Pharmaceuticals LLC. September 2024. Last accessed June 2025.

4. Columvi prescribing information. Genentech, Inc. January 2025. Last accessed May 2025.

5. Danyelza prescribing information. Y-mAbs Therapeutics, Inc. March 2024. Last accessed May 2025.

6. Datroway prescribing information. Daiichi Sankyo Inc. July 2025. Last accessed July 2025.

7. Drug Development & Approval Process. U.S. Food & Drug Administration. August 2022. https://www.fda.gov/drugs/development-approval-process-drugs . Last accessed May 2025.

8. Elahere prescribing information. ImmunoGen, Inc. October 2024 Last accessed May 2025.

9. Emrelis prescribing information. AbbVie Inc. May 2025. Last accessed October 2025.

10. Enhertu prescribing information. Daiichi Sankyo Inc. January 2025. Last accessed May 2025.

11. Epkinly prescribing information. Genmab US, Inc. July 2024. Last accessed May 2025.

12. Hepzato Kit prescribing information. Delcath Systems, Inc. May 2025. Last accessed June 2025. 

13. Imdelltra prescribing information. Amgen Inc. May 2024. Last accessed May 2025.

14. Jemperli prescribing information. GlaxoSmithKline, LLC. August 2024. Last accessed May 2025.

15. Kimmtrak prescribing information. Immunocore Commercial LLC. May 2025. Last accessed May 2025.

16. Loqtorzi prescribing information. Coherus BioSciences, Inc. October 2024. Last accessed May 2025.

17. Lunsumio prescribing information. Genentech, Inc. December 2024. Last accessed May 2025.

18. Margenza prescribing information. MacroGenics, Inc. January 2025. Last accessed May 2025.

19. Monjuvi prescribing information. Incyte Corporation. May 2024. Last accessed May 2025.

20. National Comprehensive Cancer Network. https://www.nccn.org/

21. Opdivo prescribing information. E.R. Squibb & Sons, L.L.C. October 2024. Last accessed May 2025.

22. Opdivo Qvantig prescribing information. E.R. Squibb & Sons, L.L.C.  June 2025. Last accessed July 2025.

23. Opdualag prescribing information. E.R. Squibb & Sons, L.L.C. March 2024. Last accessed May 2025.

24. Padcev prescribing information. Saegen Inc. February 2025. Last accessed May 2025.

25. Rybrevant prescribing information. Janssen Biotech, Inc. February 2025. Last accessed May 2025.

26. Rylaze prescribing information. Jazz Pharmaceuticals, Inc. April 2024. Last assessed May 2025.

27. Rytelo prescribing information. Geron Corporation. June 2024. Last accessed June 2025.

28. Sarclisa prescribing information. Sanofi-Aventis U.S. LLC. November 2024. Last accessed May 2025.

29. Tevimbra prescribing information. BeOne Medicine USA, Inc. May 2025. Last accessed May 2025.

30. Tivdak prescribing information. Seagen, Inc. October 2024. Last accessed May 2025.

31. Trodelvy prescribing information. Gilead Sciences. March 2025. Last accessed May 2025.

32. Vyloy prescribing information. Astellas Pharma IS, Inc. March 2025. Last accessed May 2025.

33. Zepzelca prescribing information. Jazz Pharmaceuticals Inc. July 2023. Last accessed May 2025.

34. Ziihera prescribing information. Jazz Pharmaceuticals, Inc. November 2024. Last accessed June 2025.

35. Zynyz prescribing information. Incyte Corporation. April 2024. Last accessed May 2025.

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.

Medically Necessary Codes

Not Medically Necessary Codes

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