Utilization Management Review Criteria Reference #: DD 2024-H1 Signature/Date/Last Approved: Rick J. Dean, 7/16/2019 Department/Approved By: Organization Wide, CEO Effective: 12/10/2014 Copyright © Oncology Analytics, Inc. All rights reserved. Last Revised: 7/16/2019 Purpose: To explicitly state the criteria on which reviews are based. Process: Oncology Analytics Inc. (OA) evaluates the management of cancer patients receiving cancer chemotherapy and associated treatments, including radiation, biologic and gene therapy. To properly perform this function, OA evaluates the medical literature and reviews national guideline and compendia recommendations. Based on this information, OA has developed a database comprised of treatment protocols. Treating physicians and supportive staff assign the appropriate chemotherapy ± supportive agent protocol(s) to patients to initiate prior authorization requests. OA’s clinical staff maintains the database. The OA clinical staff, comprised of board-certified hematologists/medical oncologists and board-certified oncology pharmacists, review the database at least annually and update the protocols as necessary. OA recognizes that the field of oncology is changing rapidly. Accordingly, new protocols are evaluated and added to the database on an ongoing basis. The following highlights the criteria on which protocol reviews for adult oncology patients are based: • New drugs or regimens (combinations of drugs) approved by the FDA (on-label use) • Drugs or regimens may be used off-label (without FDA approval) and considered medically accepted if supported by any of the following compendia below and not listed as unsupported, not indicated, or not recommended within any compendia below. o NCCN Drugs & Biologics Compendium® § Category 1-2A recommendations are considered medically accepted uses § Category 2B recommendations will be considered if identified as medically accepted in an alternative compendium or supported by peer-reviewed scientific literature eligible for coverage (meeting abstracts and case reports are excluded from consideration) § Category 3 listings are considered not medically accepted uses • OA subscribes to the NCCN Flash Updates™, which informs OA when NCCN Guidelines® and the NCCN Drugs & Biologics Compendium® are updated o Clinical Pharmacology § Medically accepted uses are identified by narrative text is supportive § Not medically accepted uses are identified by narrative text that is “not supportive.” o American Hospital Formulary Service-Drug Information (AHFS-DI) 2 | Page Copyright © 2020 Oncology Analytics, Inc. All rights reserved § Medically accepted uses are identified by narrative text is supportive § Not medically accepted uses are identified by narrative text that is “not supportive.” o Thompson Micromedex DrugDex® § Class I, IIA, or IIb recommendations are considered medically accepted uses § Class III listings are considered not medically accepted uses o Wolters Kluwer Lexi-Drugs® § Medically accepted uses are identified by an indication listed as “Use: Off-Label” and rated as “Evidence Level A” § Not medically accepted uses are those indications listed as “Use: Unsupported” • Off-label use of drugs or regimens may also be considered medically accepted if supported as safe and effective according to peer-reviewed scientific literature eligible for coverage from one of the following publications: o American Journal of Medicine; o Annals of Internal Medicine; o Annals of Oncology; o Annals of Surgical Oncology; o Biology of Blood and Marrow Transplantation; o Blood; o Bone Marrow Transplantation; o British Journal of Cancer; o British Journal of Hematology; o British Medical Journal; o Cancer; o Clinical Cancer Research; o Drugs; o European Journal of Cancer (formerly the European Journal of Cancer and Clinical Oncology); o Gynecologic Oncology; o International Journal of Radiation, Oncology, Biology, and Physics; o The Journal of the American Medical Association; o Journal of Clinical Oncology; o Journal of the National Cancer Institute; o Journal of the National Comprehensive Cancer Network (NCCN); o Journal of Urology; o Lancet; o Lancet Oncology; o Leukemia; o The New England Journal of Medicine; or o Radiation Oncology § Meeting abstracts and case reports are excluded from consideration • Coverage determination may also be directed by the Centers of Medicare & Medicaid Services (CMS) National Coverage Determinations (NCD) or Local Coverage Determinations (LCD), state- specific Medicaid drug utilization requirements, and/or health plan specific drug coverage policies, where applicable. 3 | Page Copyright © 2020 Oncology Analytics, Inc. All rights reserved • Unique cases that do not fit standard criteria o Non-standard protocols may be approved based on unique clinical circumstances, especially for rare diseases which may lack guideline-based treatment recommendations. o Non-standard protocols are entered into the database as needed. In addition, any practicing oncologist can request that a protocol be added to the database. Also, based on ongoing reviews of the medical literature and the ASCO and NCCN guidelines, obsolete treatment protocols are inactivated making them no longer available for view by the treating party. Table 1: This policy applies to the following agents that require prior authorization: Generic Name HCPCS ado-trastuzumab emtansine J9354 aldesleukin J9015 amifostine crystalline J0207 aprepitant J0185 arsenic trioxide J9017 asparaginase (Erwinia chrysanthemi) J9019 atezolizumab J9022 avelumab J9023 Axicabtagene ciloleucel Q2041 azacitidine J9025 BCG live J9030 belinostat J9032 bendamustine inj, 1 MG J9033 bendeka, 1 mg J9034 belrapzo inj, 1 mg J9036 bevacizumab J9035 bevacizumab-awwb Q5107 bevacizumab-bvzr Q5118 bleomycin sulfate J9040 blinatumomab J9039 bortezomib J9041 bortezomib J9044 brentuximab vedotin J9042 busulfan J0594 cabazitaxel J9043 calaspargase pegol-mknl J9118 carboplatin J9045 4 | Page Copyright © 2020 Oncology Analytics, Inc. All rights reserved carfilzomib J9047 carmustine J9050 cemiplimab-rwlc J9119 cetuximab J9055 cisplatin J9060 cladribine J9065 clofarabine J9027 copanlisib di-HCl J9057 cyclophosphamide J9070 cytarabine J9100 cytarabine liposome/PF J9098 dacarbazine J9130 dactinomycin J9120 daratumumab J9145 darbepoetin alfa J0881 daunorubicin citrate liposomal J9151 daunorubicin HCl J9150 daunorubicin/cytarabine liposomal J9153 decitabine J0894 degarelix acetate J9155 denileukin diftitox J9160 denosumab J0897 dexrazoxane HCl J1190 docetaxel J9171 dolasetron mesylate J1260 doxorubicin HCl J9000 doxorubicin HCl pegylated liposomal Q2049 doxorubicin HCl pegylated liposomal Q2050 durvalumab J9173 elotuzumab J9176 enfortumab vedotin-ejfv J9999 epirubicin HCl J9178 epoetin alfa J0885 epoetin alfa-epbx Q5106 eribulin mesylate J9179 etoposide J9181 etoposide phosphate J9181 fam-trastuzumab deruxtecan-nxki J9999 filgrastim J1442 filgrastim-aafi Q5110 filgrastim-sndz Q5101 floxuridine J9200 5 | Page Copyright © 2020 Oncology Analytics, Inc. All rights reserved fludarabine phosphate J9185 fluorouracil J9190 fosaprepitant dimeglumine J1453 fosnetupitant chloride HCl/palonosetron HCl J1454 fulvestrant J9395 gemcitabine HCl J9201 gemcitabine HCl (Infugem) J9201 gemtuzumab ozogamicin J9203 goserelin acetate J9202 granisetron J1627 granisetron HCl J1626 histrelin acetate J9225 idarubicin HCl J9211 ifosfamide J9208 immune globulin J1560 immune globulin J1566 immune globulin J1555 immune globulin J1569 immune globulin J1568 immune globulin J1557 immune globulin J1459 immune globulin J1559 immune globulin J1572 immune globulin J1561 immune globulin J1575 immune globulin J1460 immune globulin J3590 inotuzumab ozogamicin J9229 interferon alfa-2b,recomb. J9214 interferon gamma-1b,recomb. J9216 iobenguane iodine 131 A9699 ipilimumab J9228 irinotecan HCl J9206 irinotecan liposomal J9205 isatuximab-irfc J9999 ixabepilone J9207 kit for prep yttrium-90/ibritumomab tiuxetan/albumin human A9543 lanreotide acetate J1930 leucovorin calcium J0640 levoleucovorin J0642 levoleucovorin calcium J0641 6 | Page Copyright © 2020 Oncology Analytics, Inc. All rights reserved leuprolide acetate J1950 leuprolide acetate J9217 leuprolide acetate J9218 leuprolide acetate/lidocaine HCl J9219 lutetium Lu 177 dotatae A9513 lymphocyte IG,antithymocyt,equ/thimerosal J7504 mechlorethamine HCl J9230 melphalan HCl J9245 melphalan HCl/betadex sulfobutyl ether sodium J9245 mesna J9209 methotrexate sodium J9250 methotrexate sodium J9260 mitomycin J9280 mitoxantrone HCl J9293 mogamulizumab-kpkc J9204 moxetumomab pasudotox-tdfk J9313 nab-paclitaxel J9264 necitumumab J9295 Netuiptant/palonosetron J8655 nelarabine J9261 nivolumab J9299 obinutuzumab J9301 octreotide acetate J2354 octreotide acetate, microspheres J2353 ofatumumab J9302 olaratumab J9285 omacetaxine mepesuccinate J9262 oxaliplatin J9263 paclitaxel J9267 palifermin J2425 palonosetron J2469 pamidronate disodium J2430 panitumumab J9303 pegaspargase J9266 pegfilgrastim J2505 pegfilgrastim-apgf J3590 pegfilgrastim-bmez J3590 pegfilgrastim-cbqv Q5111 pegfilgrastim-jmdb Q5108 peginterferon alfa-2b J9999 pembrolizumab J9271 pemetrexed disodium J9305 7 | Page Copyright © 2020 Oncology Analytics, Inc. All rights reserved pentostatin J9268 pertuzumab J9306 plerixafor J2562 polatuzumab vedotin-piiq J9309 porfimer sodium J9600 pralatrexate J9307 radium-223 dichloride A9606 ramucirumab J9308 rasburicase J2783 rituximab J9312 rituximab-abbs Q5115 rituximab-pwr J9999 rituximab/hyaluronidase, human recombinant J9311 rolapitant HCl J2797