Oncology Agents Goal(s): To ensure appropriate use for oncology medications based on FDA-approved and compendia- recommended (i.e., National Comprehensive Cancer Network® [NCCN]) indications.
Length of Authorization: Up to 1 year
Requires PA: Initiation of therapy for drugs listed in Table 1 (applies to both pharmacy and physician administered claims). This does not apply to oncologic emergencies administered in an emergency department or during inpatient admission to a hospital.
Covered Alternatives: Current PMPDP preferred drug list per OAR 410-121-0030 at www.orpdl.org Searchable site for Oregon FFS Drug Class listed at www.orpdl.org/drugs/
Approval Criteria
1. What diagnosis is being treated? Record ICD10 code.
2. Is the request for treatment of an oncologic Yes: Approve for length No: Go to #3 emergency (e.g., superior vena cava of therapy or 12 syndrome [ICD-10 I87.1] or spinal cord months, whichever is compression [ICD-10 G95.20]) less. administered in the emergency department?
3. Is the request for any continuation of Yes: Approve for length No: Go to #4 therapy? of therapy or 12 months, whichever is less.
4. Is the diagnosis funded by OHP? Yes: Go to #5 No: Pass to RPh. Deny; not funded by the OHP.
5. Is the indication FDA-approved for the Yes: Pass to RPh. No: Go to #6 requested drug? Approve for length of therapy or 12 months, Note: This includes all information required whichever is less. in the FDA-approved indication, including but not limited to the following as applicable: diagnosis, stage of cancer, biomarkers, place in therapy, and use as monotherapy or combination therapy. Approval Criteria
6. Is the indication recommended by National Yes: Pass to RPh. No: Go to #7 Comprehensive Cancer Network (NCCN) Approve for length of Guidelines® for the requested drug? therapy or 12 months, whichever is less. Note: This includes all information required in the NCCN recommendation, including but not limited to the following as applicable: diagnosis, stage of cancer, biomarkers, place in therapy, and use as monotherapy or combination therapy.
7. Is there documentation based on chart Yes: Pass to RPh. No: Go to #8 notes that the patient is enrolled in a Deny; medical clinical trial to evaluate efficacy or safety of appropriateness. the requested drug? Note: The Oregon Health Authority is statutorily unable to cover experimental or investigational therapies.
8. Is the request for a rare cancer which is not Yes: Go to #9 No: Pass to RPh. addressed by National Comprehensive Deny; medical Cancer Network (NCCN) Guidelines® and appropriateness. which has no FDA approved treatment options?
9. All other diagnoses must be evaluated for evidence of clinical benefit.
The prescriber must provide the following documentation: medical literature or guidelines supporting use for the condition, clinical chart notes documenting medical necessity, and documented discussion with the patient about treatment goals, treatment prognosis and the side effects, and knowledge of the realistic expectations of treatment efficacy.
RPh may use clinical judgement to approve drug for length of treatment or deny request based on documentation provided by prescriber. If new evidence is provided by the prescriber, please forward request to Oregon DMAP for consideration and potential modification of current PA criteria.
Table 1. Oncology agents which apply to this policy (Updated 07/02/2021) New Antineoplastics are immediately subject to the policy and will be added to this table at the next P&T Meeting
Generic Name Brand Name Generic Name Brand Name abemaciclib VERZENIO daratumumab/hyaluronidase- DARZALEX abiraterone fihj FASPRO YONSA acet,submicronized darolutamide NUBEQA abiraterone acetate ZYTIGA decitabine and cedazuridine INQOVI acalabrutinib CALQUENCE degarelix acetate FIRMAGON ado-trastuzumab emtansine KADCYLA dostarlimab-gxly JEMPERLI afatinib dimaleate GILOTRIF dinutuximab UNITUXIN alectinib HCl ALECENSA durvalumab IMFINZI amivantamab-vmjw RYBREVANT duvelisib COPIKTRA alpelisib PIQRAY elotuzumab EMPLICITI apalutamide ERLEADA enasidenib mesylate IDHIFA asparaginase (Erwinia ERWINAZE encorafenib BRAFTOVI chrysanthemi) enfortumab vedotin-ejfv PADCEV atezolizumab TECENTRIQ entrectinib ROZLYTREK avapritinib AYVAKIT enzalutamide XTANDI avelumab BAVENCIO erdafitinib BALVERSA axicabtagene ciloleucel YESCARTA eribulin mesylate HALAVEN axitinib INLYTA everolimus AFINITOR azacitidine ONUREG AFINITOR everolimus belantamab mafodotin-blmf BLENREP DISPERZ fam-trastuzumab deruxtecan- belinostat BELEODAQ ENHERTU BENDAMUSTINE nxki bendamustine HCl HCL fedratinib INREBIC bendamustine HCl TREANDA gilteritinib XOSPATA bendamustine HCl BENDEKA glasdegib DAURISMO binimetinib MEKTOVI ibrutinib IMBRUVICA blinatumomab BLINCYTO idecabtagene vicleucel ABECMA bosutinib BOSULIF idelalisib ZYDELIG brentuximab vedotin ADCETRIS infigratinib TRUSELTIQ brexucabtagene autoleucel TECARTUS ingenol mebutate PICATO brigatinib ALUNBRIG inotuzumab ozogamicin BESPONSA cabazitaxel JEVTANA ipilimumab YERVOY cabozantinib s-malate CABOMETYX Isatuximab SARCLISA cabozantinib s-malate COMETRIQ ivosidenib TIBSOVO calaspargase pegol-mknl ASPARLAS ixazomib citrate NINLARO capmatinib TABRECTA larotrectinib VITRAKVI carfilzomib KYPROLIS lenvatinib mesylate LENVIMA cemiplimab-rwlc LIBTAYO lisocabtagene maraleucel BREYANZI ceritinib ZYKADIA loncastuximab tesirine-lpyl ZYNLONTA cobimetinib fumarate COTELLIC lorlatinib LORBRENA copanlisib di-HCl ALIQOPA lurbinectedin ZEPZELCA crizotinib XALKORI lutetium Lu 177 dotate LUTATHERA dabrafenib mesylate TAFINLAR margetuximab-cmkb MARGENZA dacomitinib VIZIMPRO melphalan flufenamide PEPAXTO daratumumab DARZALEX midostaurin RYDAPT
Generic Name Brand Name Generic Name Brand Name moxetumomab pasudotox-tdfk LUMOXITI tagraxofusp-erzs ELZONRIS naxitamab-gqgk DANYELZA talazoparib TALZENNA necitumumab PORTRAZZA talimogene laherparepvec IMLYGIC neratinib maleate NERLYNX tazemetostat TAZVERIK niraparib tosylate ZEJULA tepotinib TEPMETKO nivolumab OPDIVO tisagenlecleucel KYMRIAH obinutuzumab GAZYVA tivozanib FOTIVDA ofatumumab ARZERRA trabectedin YONDELIS olaparib LYNPARZA trametinib dimethyl sulfoxide MEKINIST olaratumab LARTRUVO trastuzumab-anns KANJINTI olatuzumab vedotin-piiq POLIVY trastuzumab-dkst OGIVRI omacetaxine mepesuccinate SYNRIBO trastuzumab-dttb ONTRUZANT osimertinib mesylate TAGRISSO trastuzumab-hyaluronidase- HERCEPTIN palbociclib IBRANCE oysk HYLECTA panobinostat lactate FARYDAK trastuzumab-pkrb HERZUMA pazopanib HCl VOTRIENT trastuzumab-qyyp TRAZIMERA trifluridine/tipiracil HCl LONSURF pembrolizumab KEYTRUDA trilaciclib COSELA pemigatinib PEMAZYRE tucatinib TUKYSA pertuzumab PERJETA pertuzumab/trastuzumab/halur umbralisib UKONIQ PHESGO onidase-zzxf vandetanib VANDETANIB pexidartinib TURALIO vandetanib CAPRELSA polatuzumab vedotin-piiq POLIVY vemurafenib ZELBORAF pomalidomide POMALYST venetoclax VENCLEXTA ponatinib ICLUSIG VENCLEXTA venetoclax pralatrexate FOLOTYN STARTING PACK vismodegib ERIVEDGE pralsetinib GAVRETO zanubrutinib BRUKINSA ramucirumab CYRAMZA ziv-aflibercept ZALTRAP regorafenib STIVARGA relugolix ORGOVYZ ribociclib succinate KISQALI KISQALI FEMARA ribociclib succinate/letrozole CO-PACK ripretinib QINLOCK romidepsin ISTODAX romidepsin ROMIDEPSIN rucaparib camsylate RUBRACA ruxolitinib phosphate JAKAFI sacitizumab govitecan-hziy TRODELVY selinexor XPOVIO selpercatinib RETEVMO siltuximab SYLVANT sipuleucel-T/lactated ringers PROVENGE sonidegib phosphate ODOMZO sotorasib LUMAKRAS tafasitamab-cxix MONJUVI
P&T/DUR Review: 6/2020 (JP) Implementation: 10/1/20