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Standard Oncology Criteria C16154-A Prior Authorization Criteria Standard Oncology Criteria Policy Number: C16154-A CRITERIA EFFECTIVE DATES: ORIGINAL EFFECTIVE DATE LAST REVIEWED DATE NEXT REVIEW DATE DUE BEFORE 03/2016 12/2/2020 1/26/2022 HCPCS CODING TYPE OF CRITERIA LAST P&T APPROVAL/VERSION N/A RxPA Q1 2021 20210127C16154-A PRODUCTS AFFECTED: See dosage forms DRUG CLASS: Antineoplastic ROUTE OF ADMINISTRATION: Variable per drug PLACE OF SERVICE: Retail Pharmacy, Specialty Pharmacy, Buy and Bill- please refer to specialty pharmacy list by drug AVAILABLE DOSAGE FORMS: Abraxane (paclitaxel protein-bound) Cabometyx (cabozantinib) Erwinaze (asparaginase) Actimmune (interferon gamma-1b) Calquence (acalbrutinib) Erwinia (chrysantemi) Adriamycin (doxorubicin) Campath (alemtuzumab) Ethyol (amifostine) Adrucil (fluorouracil) Camptosar (irinotecan) Etopophos (etoposide phosphate) Afinitor (everolimus) Caprelsa (vandetanib) Evomela (melphalan) Alecensa (alectinib) Casodex (bicalutamide) Fareston (toremifene) Alimta (pemetrexed disodium) Cerubidine (danorubicin) Farydak (panbinostat) Aliqopa (copanlisib) Clolar (clofarabine) Faslodex (fulvestrant) Alkeran (melphalan) Cometriq (cabozantinib) Femara (letrozole) Alunbrig (brigatinib) Copiktra (duvelisib) Firmagon (degarelix) Arimidex (anastrozole) Cosmegen (dactinomycin) Floxuridine Aromasin (exemestane) Cotellic (cobimetinib) Fludara (fludarbine) Arranon (nelarabine) Cyramza (ramucirumab) Folotyn (pralatrexate) Arzerra (ofatumumab) Cytosar-U (cytarabine) Fusilev (levoleucovorin) Asparlas (calaspargase pegol-mknl Cytoxan (cyclophosphamide) Gavreto (pralsetinib) injection) Dacogen (decitabine) Gazyva (obinutuzumab) Avastin (bevacizumab) Danyelza (naxitamab-gqgk) Gemzar (gemcitabine) Azedra (iobenguane l 131) Darzalex (daratumumab) Gilotrif (afatinib) Balversa (erdafitinib) Daurismo (glasdegib) Gleevec (imatinib) Bavencio (avelumab) Doxil (doxorubicin) Gleostine (lomustine) Beleodaq (belinostat) Elitek (rasburicase) Gliadel Wafer (carmustine implant) Bendeka (bendamustine) Ellence (epirubicin hcl) Halaven (eribulin mesylae) Besponsa (inotuzumab ozogamicin) Eloxatin (oxaliplatin) Herceptin (trastuzumab) Bicnu (carmustine) Emcyt (estramustine phosphate Hycamtin (topotecan) Blenoxane (bleomycin sulfate) sodium) Hydrea (hydroxyurea) Blenrep (belantamab) Empliciti (elotuzumab) Ibrance (palbociclib) Blincyto (blinatumomab) Erbitux (cetuximab) Iclusig (ponatinib) Bosulif (bosutinib) Ergamisol (levamisole) Idamycin (idarubicin) Braftovi (encorafenib) Erivedge (vismodegib) Ifex (ifosfamide) Busilvex (busulfan) Erleada (apalutamide) Imbruvica (ibrutinib) Molina Healthcare, Inc. confidential and proprietary © 2021 This document contains confidential and proprietary information of Molina Healthcare and cannot be reproduced, distributed, or printed without written permission from Molina Healthcare. This page contains prescription brand name drugs that are trademarks or registered trademarks of pharmaceutical manufacturers that are not affiliated with Molina Healthcare. Page 1 of 5 Prior Authorization Criteria Imfinzi (durvalumab) Mustargen (mechlorethamine) Sutent (sunitinib malate) Imlygic (talimogene laherparepvec) Mutamycin (mitomycin) Sylatron (peginterferon alfa-2b) Inqovi (decitabine;cedazuridine) Myleran (busulfan) Sylvant (siltuximab) Inlyta (axitinib) Nerliynx (neratinib) Synribo (omacetaxine mepesuccinate) Intron A (interferon alfa-2b) Nexavar (sorafenib) Tabrecta (capmatinib) Iressa (gefitinib) Nilandron (nilutamide) Tafinlar (dabrafenib) Istodax (romidepsin) Ninlaro (ixazomib) Tagrisso (osimertinib) Ixempra (ixabepilone) Nipent (pentostatin) Talzenna (talazoparib) Jevtana (cabazitaxel) Novantrone (mitoxantrone) Tarceva (erlotinib) Kadcyla (ado-trastuzumab emtansine) Odomzo (sonidegib) Targretin (bexarotene) Kepivance (palifermin) Ogivri (trastuzumab-dkst) Taxol (paclitaxel) Keytruda (pembrolizumab) Oncaspar (pegaspargase) Taxotere (docetaxel) Khapzory (levoleucovorin) Onivyde (irinotecan lipsome) Tecentriq (atezolizumab) Kisqali (ribociclib) Ontruzant (trastuzumab-dttb) Temodar(temozolomide) Kymriah (tisagenlecleucel) Opdivo (nivolumab) Tepadina (thiotepa) Kyprolis (carfilzomib) Paraplatin (carboplatin) Thalomid (thalidomide) Lartruvo (olaratumab) Pemazyre (pemigatinib) Tibsovo (ivosidenib) Lenvima (lenvatinib) Perjeta (pertuzumab) Tice BCG Leucovorin Phesgo (pertuzumab; Toposar (etoposide) Leukeran (chlorambucil) trastuzumab;hyaluronidase) Torisel (temsirolimus) Leustatin (cladribine) Photofrin (porfimer sodium) Totect (dexrazoxane) Libtayo (cemiplimab-rwlc) Platinol (cisplatin) Treanda (bendamustine) Lipodox (doxorubicin) Pomalyst (pomalidomide) Trelstar (triptorelin pamoate) Lonsurf (trifluridine and tipiracil) Portrazza (necitumamab) Trexall (methotrexate) Lorbrena (lorlatinib) Poteligeo(mogamulizumab) Trisenox (arsenic trioxide) Lumoxiti (moxetumomab) Proleukin (aldesleukin) Turalio (pexidartinib) Lutathera (lutetium LU 177dotatate) Purinethol (mercaptopurine) Tykerb (lapatinib) Lynparza (olaparib) Purixan (mercaptopurine) Unituxin (dinutuximab) Lysodren (mitotane) Qinlock (ripretinib) Valstar (valrubicin) Marqibo (vincristine sulfate liposome) Quadramet (samarium SM 153 Vantas (histrelin implant) Matulane(procarbazine) lexidronam) Vectibix (panitumumab) Megace (megestrol) Revlimid (lenalidomide) Velcade (bortezomib) Mekinist (trametinib) Rubraca (rucaparib) Venclexta (venetoclax) Mektovi (binimetinib) Rydapt (midostaurin) Verzenio (abemaciclib) Mesnex (mesna) Soltamox (tamoxifen) Vesanoid (tretinoin) Mitosol (mitomycin) Sprycel (dasatinib) Vidaza (azacitidine) Monjuvi (tafasitamab-cxix) Stivarga (regorafenib) Molina Healthcare, Inc. confidential and proprietary © 2021 This document contains confidential and proprietary information of Molina Healthcare and cannot be reproduced, distributed, or printed without written permission from Molina Healthcare. This page contains prescription brand name drugs that are trademarks or registered trademarks of pharmaceutical manufacturers that are not affiliated with Molina Healthcare. Page 2 of 5 Prior Authorization Criteria FDA-APPROVED USES: please refer to product package prescribing information COMPENDIAL APPROVED OFF-LABELED USES: please see individual compendia monographs COVERAGE CRITERIA: INITIAL AUTHORIZATION DIAGNOSIS: FDA-approved indications, medically accepted indications will also be considered for approval REQUIRED MEDICAL INFORMATION: IF THIS IS A NON-FORMULARY/NON-PREFERRED PRODUCT FOR INITIAL OR CONTINUATION OF THERAPY REQUEST: Documentation of trial/failure of or intolerance to a majority (not more than 3) of the preferred formulary BIOLOGIC/PDL alternatives for the given diagnosis. If yes, please submit documentation including medication(s) tried, dates of trial(s) and reason for treatment failure(s) BIOSIMILAR DRUGS are preferred when requested as a physician administered drug and/or pharmacy formulary product per applicable state regulations and there is a lack of data demonstrating clinical superiority of reference drugs over the FDA approved biosimilar drugs. A reference medication is approved under the following conditions: 1. Treatment with at least two (2) associated biosimilar drug(s) has been ineffective, not tolerated, or is contraindicated (i.e. an allergic reaction to a specific inactive ingredient in the preferred biologic product or biosimilar OR an adverse reaction to a specific inactive ingredient in the preferred biologic product or biosimilar OR therapeutic success while taking a non-preferred biologic product or biosimilar and therapeutic failure while taking the preferred biologic product or biosimilar documented by member diary or medical charted notes) [DOCUMENTATION REQUIRED-Document when the preferred biologic product or biosimilar was tried and the length of the trial period, Provide specific clinical documentation of therapeutic failure on the preferred biologic product or biosimilar whenever possible. Describe the medical problem caused by the preferred referenced biologic. Vague and non- descriptive symptoms are not adequate rationale (e.g., stomachache)] A. FOR ALL INDICATIONS: 1. Must have a documented diagnosis for a medically accepted indication including: Use of a drug which is FDA-approved. Use of which is supported by one or more citations included or approved for inclusion in any of the compendia: American Hospital Formulary Service Drug Information, DRUGDEX Information System, National Comprehensive Cancer Network (Categories 1 or 2Aonly). (NOTE: a category 2B therapy/regimen may be authorized on an exception basis with documented Molina Healthcare medical director or Molina Healthcare oncologist consultation) AND 2. Documentation of dose and dates of all previous therapies and the resulting outcomes where applicable AND 3. Documentation that the proper succession of the therapies has been considered OR have been tried and failed (i.e. intolerance, contraindication, or progression) (NOTE: the proper succession for this element can be found within compendia monographs, FDA label or NCCN guidelines; IF compendia monographs, FDA label or NCCN guidelines have a formulary/preferred product at therapeutic parity with requested agent a formulary/preferred product should be used first where state regulations allow) Molina Healthcare, Inc. confidential and proprietary © 2021 This document contains confidential and proprietary information of Molina Healthcare and cannot be reproduced, distributed, or printed without written permission from Molina Healthcare. This page contains prescription brand name drugs that are trademarks or
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