PRIOR AUTHORIZATION CRITERIA for APPROVAL Initial Evaluation Target Agent(S) Will Be Approved When ONE of the Following Is Met: 1
Total Page:16
File Type:pdf, Size:1020Kb
Self-Administered Oncology Agents Through Preferred Prior Authorization Program Summary FDA APPROVED INDICATIONS3-104 Please reference individual agent product labeling. CLINICAL RATIONALE For the purposes of the Self -Administered Oncology Agents criteria, indications deemed appropriate are those approved in FDA labeling and/or supported by NCCN Drugs & Biologics compendia with a category 1 or 2A recommendation, AHFS, or DrugDex with level of evidence of 1 or 2A. SAFETY3-104 Agent(s) Contraindication(s) Afinitor/Afinitor Disperz Hypersensitivity to everolimus, to other rapamycin (everolimus) derivatives None Alecensa (alectinib) Alunbrig (brigatinib) None Ayvakit (avapritinib) None Balversa (erdafitinib) None Hypersensitivity to bosutinib Bosulif (bosutinib) Braftovi (encorafenib) None Brukinsa (zanubrutinib) None Cabometyx None (cabozantinib) Calquence None (acalabrutinib) Caprelsa Congenital long QT syndrome (vandetanib) Cometriq None (cabozantinib) Copiktra (duvelisib) None Cotellic (cobimetinib) None Daurismo (glasdegib) None None Erivedge (vismodegib) Erleada (apalutamide) Pregnancy None Farydak (panobinostat) Fotivda (tivozanib) None Gavreto (pralsetinib) None None Gilotrif (afatinib) Gleevec None (imatinib) Hycamtin Severe hypersensitivity to topotecan (topotecan) None Ibrance (palbociclib) KS_PS_SA_Oncology_PA_ProgSum_AR1020_r0821v2 Page 1 of 19 © Copyright Prime Therapeutics LLC. 08/2021 All Rights Reserved Effective: 10/01/2021 Agent(s) Contraindication(s) None Iclusig (ponatinib) Idhifa (enasidenib) None Imbruvica (ibrutinib) None Inlyta (axitinib) None Inqovi (decitabine/ None cedazuridine) Inrebic (fedratinib) None None Iressa (gefitinib) Jakafi None (ruxolitinib) Kisqali (ribociclib) None Kisqali Femara Pack (ribociclib and letrozole Hypersensitivity to letrozole, or any excipients of Femara co-packaged) Koselugo (selumetinib) None None Lenvima (lenvatinib) Lonsurf None (trifluridine/tipiracil) Concomitant use with a strong CYP3A inducer, due to Lorbrena (lorlatinib) potential for serious hepatotoxicity Lumakras (sotorasib) None Lynparza (olaparib) None capsules Lynparza (olaparib) None tablets Lysodren None (mitotane) Known hypersensitivity to procarbazine, inadequate Matulane marrow reserve (procarbazine) None Mekinist (trametinib) Mektovi (binimetinib) None Nerlynx (neratinib) None Known severe hypersensitivity to sorafenib or its components, use in combination with carboplatin and Nexavar (sorafenib) paclitaxel in patients with squamous cell lung cancer Ninlaro (ixazomib) None Nubeqa (darolutamide) None None Odomzo (sonidegib) Known severe hypersensitivity to azacitidine or its Onureg (azacitidine) components Orgovyx (relugolix) None Pemazyre (pemigatinib) None Severe hypersensitivity to Piqray or to any of its Piqray (alpelisib) components Pomalyst Pregnancy (pomalidomide) Qinlock (ripretinib) None Retevmo None (selpercatinib) KS_PS_SA_Oncology_PA_ProgSum_AR1020_r0821v2 Page 2 of 19 © Copyright Prime Therapeutics LLC. 08/2021 All Rights Reserved Effective: 10/01/2021 Agent(s) Contraindication(s) Pregnancy, severe hypersensitivity to lenalidomide Revlimid (lenalidomide) Rozlytrek (entrectinib) None Rubraca (rucaparib) None Rydapt (midostaurin) Hypersensitivity to midostaurin or any of the excipients None Sprycel (dasatinib) None Stivarga (regorafenib) Sutent None (sunitinib) Autoimmune hepatitis, hepatic decompensation (Child- Sylatron (peginterferon Pugh score >6, Class B and C), hypersensitivity to alfa-2b) peginterferon alfa-2b or interferon alfa-2b Tabrecta (capmatinib) None Tafinlar (dabrafenib) None None Tagrisso (osimertinib) Talzenna (talazoparib) None Tarceva None (erlotinib) Pregnancy; known serious hypersensitivity to bexarotene Targretin (bexarotene) or other components of the product capsules Targretin (bexarotene) known serious hypersensitivity to bexarotene or other gel components of the product Tasigna Hypokalemia, hypomagnesemia, long QT syndrome (nilotinib) Tazverik None (tazemetostat) Hypersensitivity to dacarbazine (DTIC) or Temodar Temodar components (temozolomide) Tepmetko (tepotinib) None Pregnancy, hypersensitivity to thalidomide or its Thalomid (thalidomide) components Tibsovo (ivosidenib) None known hypersensitivity to tretinoin, any of its Tretinoin (oral) components, or other retinoids; sensitivity to parabens Truseltiq (infigratinib) None Tukysa (tucatinib) None Turalio (pexidartinib) None Tykerb Known hypersensitivity to lapatinib or its components (lapatinib) Ukoniq (umbralisib) None Concomitant use with strong CYP3A inhibitors at initiation Venclexta (venetoclax) and during ramp-up phase in patients with CLL/SLL KS_PS_SA_Oncology_PA_ProgSum_AR1020_r0821v2 Page 3 of 19 © Copyright Prime Therapeutics LLC. 08/2021 All Rights Reserved Effective: 10/01/2021 Agent(s) Contraindication(s) Verzenio (abemaciclib) None Vitrakvi (larotrectinib) None Vizimpro (dacomitinib) None None Votrient (pazopanib) Welireg (belzutifan) None None Xalkori (crizotinib) Severe renal failure, hypersensitivity to capecitabine or Xeloda (capecitabine) any of its components, hypersensitivity to 5-fluorouracil Xospata (gilteritinib) Hypersensitivity to gilteritinib or any of the excipients Xpovio (selinexor) None Pregnancy Xtandi (enzalutamide) Yonsa (abiraterone Pregnancy acetate) Zejula (niraparib) None None Zelboraf (vemurafenib) None Zolinza (vorinostat) History of serious allergic reactions including anaphylaxis Zydelig (idelalisib) and toxic epidermal necrolysis Zykadia (ceritinib) None Zytiga (abiraterone) None REFERENCES 1. Sacco Jj, Botten J, Macbeth F, et al. The average body surface area of adult cancer patients in the UK: A multicentre retrospective study. PLoS ONE 5(1):e8933. Doi:10.1371/journal.pone.0008933. 2. Verbraecken J et al. Body surface area in normal-weight, overweight, and obese adults. A Comparison study. Metabolism Clinical and Experimental 2006;55:515-524. 3. Afinitor/Afinitor Disperz prescribing information. Novartis. February 2020. 4. Alecensa prescribing information. Hoffmann-La Roche. June 2018. 5. Alunbrig prescribing information. Ariad Pharmaceuticals Inc. May 2020. 6. Ayvakit prescribing information. Blueprint Medicines Corp. June 2021. 7. Balversa prescribing information. Janssen Pharmaceutical Companies. April 2020. 8. Bosulif prescribing information. Pfizer Inc. June 2020. 9. Braftovi prescribing information. Array BioPharma Inc. April 2020. 10. Brukinsa prescribing information. BeiGene, Ltd. November 2019. 11. Cabometyx prescribing information. Exelixis Inc. July 2020. 12. Calquence prescribing information. AstraZeneca. November 2019. 13. Caprelsa prescribing information. AstraZeneca Pharmaceuticals. June 2020. 14. Cometriq prescribing information. Exelixis, Inc. January 2020. 15. Copiktra prescribing information. Verastem, Inc. September 2019. 16. Cotellic prescribing information. Genentech. January 2018. 17. Daurismo prescribing information. Pfizer Inc. March 2020. 18. Erivedge prescribing information. Genentech. February 2019. 19. Erleada prescribing information. Janssen Ortho LLC. June 2020. 20. Farydak prescribing information. Novartis. December 2017. 21. Fotivda prescribing information. Aveo Pharmaceuticals, Inc. March 2021. 22. Gavreto prescribing information. Blueprint Medicines. September 2020. 23. Gilotrif prescribing information. Boehringer Ingelheim Pharmaceuticals. October 2019. 24. Gleevec prescribing information. Novartis. July 2018. KS_PS_SA_Oncology_PA_ProgSum_AR1020_r0821v2 Page 4 of 19 © Copyright Prime Therapeutics LLC. 08/2021 All Rights Reserved Effective: 10/01/2021 25. Hycamtin prescribing Information. GSK. September 2018. 26. Ibrance prescribing information. Pfizer. November 2019. 27. Iclusig prescribing Information. ARIAD Pharmaceuticals. December 2020. 28. Idhifa prescribing information. Celgene. September 2019. 29. Imbruvica prescribing information. Pharmacyclics, Inc. April 2020. 30. Inlyta prescribing information. Pfizer. New York, NY. June 2020. 31. Inqovi prescribing information. Otsuka Pharmaceutical Co., LTD. July 2020. 32. Inrebic prescribing information. Impact Biomedicines, Inc. August 2019. 33. Iressa prescribing information. AstraZeneca. August 2018. 34. Jakafi prescribing information. Incyte. January 2020. 35. Kisqali Femara Pack prescribing information. Novartis. July 2020. 36. Kisqali prescribing information. Novartis. July 2020. 37. Koselugo prescribing information. AstraZeneca. April 2020. 38. Lenvima prescribing information. Eisai. April 2020. 39. Lonsurf prescribing information. Taiho Oncology. December 2019. 40. Lorbrena prescribing information. Pfizer Inc. May 2020. 41. Lumakras prescribing information. Amgen Inc. May 2021. 42. Lynparza capsules prescribing information. AstraZeneca. September 2018. 43. Lynparza tablets prescribing information. AstraZeneca. May 2020. 44. Lysodren prescribing Information. E.R. Squibb & Sons, L.L.C. July 2018. 45. Matulane prescribing Information. Sigma-tau. August 2018. 46. Mekinist prescribing information. GlaxoSmithKline. June 2020. 47. Mektovi prescribing information. Array BioPharma Inc. January 2019. 48. Nerlynx prescribing information. Puma Biotech. February 2020. 49. Nexavar prescribing information. Bayer. July 2020. 50. Ninlaro prescribing information. Millennium. February 2020. 51. Nubeqa prescribing information. Bayer HealthCare Pharmaceuticals Inc. July 2019. 52. Odomzo prescribing information. Novartis. May 2019. 53. Onureg prescribing information. Celgene Corporation. September 2020. 54. Orgovyx prescribing information. Myovant Sciences, Inc. December 2020. 55. Pemazyre prescribing