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Home , Enasidenib, Glasdegib, Ribociclib, Umbralisib

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 , to other rapamycin (everolimus) derivatives None Alecensa ()

Alunbrig () None Ayvakit () None Balversa () None Hypersensitivity to Bosulif (bosutinib)

Braftovi () None Brukinsa () None Cabometyx None () Calquence None () Caprelsa Congenital long QT syndrome () Cometriq None (cabozantinib) Copiktra () None

Cotellic () None

Daurismo () None None Erivedge ()

Erleada (apalutamide) Pregnancy None Farydak ()

Fotivda () None Gavreto () None None Gilotrif ()

Gleevec None () Hycamtin Severe hypersensitivity to (topotecan) None Ibrance ()

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 ()

Idhifa () None Imbruvica () None Inlyta () None Inqovi (/ None cedazuridine) Inrebic () None None Iressa ()

Jakafi None () Kisqali () None Kisqali Femara Pack (ribociclib and Hypersensitivity to letrozole, or any excipients of Femara co-packaged) Koselugo () None None Lenvima ()

Lonsurf None (trifluridine/tipiracil) Concomitant use with a strong CYP3A inducer, due to Lorbrena () potential for serious hepatotoxicity Lumakras () None Lynparza () None capsules Lynparza (olaparib) None tablets Lysodren None () Known hypersensitivity to , inadequate Matulane marrow reserve (procarbazine)

None Mekinist ()

Mektovi () None Nerlynx () None Known severe hypersensitivity to or its components, use in combination with and Nexavar (sorafenib) in patients with squamous cell lung cancer

Ninlaro () None Nubeqa (darolutamide) None None Odomzo ()

Known severe hypersensitivity to or its Onureg (azacitidine) components Orgovyx (relugolix) None Pemazyre () None Severe hypersensitivity to Piqray or to any of its Piqray () components Pomalyst Pregnancy (pomalidomide) Qinlock () None Retevmo None () 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 () None Rubraca () None Rydapt () Hypersensitivity to midostaurin or any of the excipients None Sprycel ()

None Stivarga ()

Sutent None () 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 () None

Tafinlar () None

None Tagrisso ()

Talzenna () None Tarceva None () Pregnancy; known serious hypersensitivity to 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 () Tazverik None (tazemetostat) Hypersensitivity to (DTIC) or Temodar Temodar components ()

Tepmetko () None Pregnancy, hypersensitivity to thalidomide or its Thalomid (thalidomide) components

Tibsovo () None known hypersensitivity to , any of its Tretinoin (oral) components, or other ; sensitivity to parabens

Truseltiq () None Tukysa () None Turalio () None Tykerb Known hypersensitivity to or its components (lapatinib) Ukoniq () None Concomitant use with strong CYP3A inhibitors at initiation Venclexta () 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 () None Vitrakvi () None Vizimpro () None None Votrient ()

Welireg (belzutifan) None None Xalkori ()

Severe renal failure, hypersensitivity to or Xeloda (capecitabine) any of its components, hypersensitivity to 5-

Xospata () Hypersensitivity to gilteritinib or any of the excipients Xpovio (selinexor) None Pregnancy Xtandi (enzalutamide)

Yonsa (abiraterone Pregnancy acetate) Zejula () None None Zelboraf ()

None Zolinza ()

History of serious allergic reactions including anaphylaxis Zydelig () and toxic epidermal necrolysis

Zykadia () 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. . 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.

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© 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 information. Incyte Corp. April 2020. 56. Piqray prescribing information. Novartis Pharmaceuticals Corp. May 2019. 57. Pomalyst prescribing information. Celgene Corporation. May 2020. 58. Qinlock prescribing information. Deciphera Pharmaceuticals, LLC. May 2020. 59. Retevmo prescribing information. Lilly USA, LLC. May 2020. 60. Revlimid prescribing information. Celgene Corporation. December 2019. 61. Rozlytrek prescribing information. Genentech USA, Inc. August 2019. 62. Rubraca prescribing information. Clovis Oncology. May 2020. 63. Rydapt prescribing information. Novartis. March 2020. 64. Sprycel prescribing information. E.R. Squibb & Sons, L.L.C. December 2018. 65. Stivarga prescribing information. Bayer Healthcare Pharmaceuticals. February 2020. 66. Sutent prescribing information. Pfizer. July 2020. 67. Sylatron prescribing information. Schering Corporation. December 2018. 68. Tabrecta prescribing information. Novartis Pharmaceuticals Corp. May 2020. 69. Tafinlar prescribing information. GlaxoSmithKline. April 2020. 70. Tagrisso prescribing information. AstraZeneca. May 2020. 71. Talzenna prescribing information. Pfizer Inc. March 2020. 72. Tarceva prescribing information. Genentech. October 2016. 73. Targretin capsule prescribing information. Valeant. April 2020. 74. Targretin gel prescribing information. Bausch Health US, LLC. February 2020. 75. Tasigna prescribing information. Novartis. September 2019. 76. Tazverik prescribing information. Epizyme Inc. January 2020. 77. Temodar prescribing Information. Merck Sharp & Dohme Corp. November 2019. 78. Tepmetko prescribing information. EMD Serono, Inc. February 2021. 79. Thalomid prescribing information. Celgene Corporation. December 2019. 80. Tibsovo prescribing information. Agios Pharmaceuticals, Inc. May 2019. 81. Tretinoin prescribing information. Glenmark Pharmaceuticals, Inc. January 2018.

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© Copyright Prime Therapeutics LLC. 08/2021 All Rights Reserved Effective: 10/01/2021 82. Truseltiq prescribing information. QED Therapeutics Inc. May 2021. Tukysa prescribing information. Seattle Genetics. April 2020. 83. Tukysa prescribing information. Seattle Genetics. April 2020. 84. Turalio prescribing information. Daiichi Sankyo, Inc. April 2020. 85. Tykerb prescribing information. GSK. December 2018. 86. Ukoniq prescribing information. TG Therapeutics. February 2021. 87. Venclexta prescribing information. AbbVie Inc. May 2020. 88. Verzenio prescribing information. Eli Lilly and Company. March 2020. 89. Vitrakvi prescribing information. Loxo Oncology, Inc. November 2018. 90. Vizimpro prescribing information. Pfizer Inc. September 2018. 91. Votrient prescribing information. GSK. July 2020. 92. Welireg prescribing information. Merck Sharp & Dohme Corp. August 2021. 93. Xalkori prescribing information. Pfizer. January 2021. 94. Xeloda prescribing information. Hoffmann La Roche. February 2019. 95. Xospata prescribing information. Astellas Pharma Inc. May 2019. 96. Xpovio prescribing information. Karyopharm Therapeutics Inc. April 2021. 97. Xtandi prescribing information. Astellas Pharma US, Inc. August 2020. 98. Yonsa prescribing information. Sun Pharmaceuticals Inc. June 2018. 99. Zejula prescribing information. GSK. April 2020. 100. Zelboraf prescribing information. Genentech, USA. May 2020. 101. Zolinza prescribing information. Merck Sharp & Dohme Corp. December 2018. 102. Zydelig prescribing information. Gilead Sciences, Inc. October 2018. 103. Zykadia prescribing information. Novartis Pharmaceuticals. March 2019. 104. Zytiga prescribing information. Janssen Biotech, Inc. June 2019.

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Self-Administered Oncology Agents Prior Authorization - through Preferred

TARGET AGENT(S) Onureg® (azacitidine) Afinitor® (everolimus)a Orgovyx™ (relugolix) Afinitor® Disperz (everolimus) Pemazyre™ (pemigatinib) Alecensa® (alectinib) Piqray® (alpelisib) Alunbrig™ (brigatinib) Pomalyst® (pomalidomide) Ayvakit™ (avapritinib) Qinlock™ (ripretinib) Balversa™ (erdafitinib) Retevmo™ (selpercatinib) Bosulif® (bosutinib) Revlimid® (lenalidomide) Braftovi® (encorafenib) Rozlytrek™ (entrectinib) Brukinsa™ (zanubrutinib) Rubraca® (rucaparib) Cabometyx® (cabozantinib) Rydapt® (midostaurin) Calquence® (acalabrutinib) Sprycel® (dasatinib) Caprelsa® (vandetanib) Stivarga® (regorafenib) Cometriq® (cabozantinib) Sutent® (sunitinib)a Copiktra (duvelisib) Sylatron™ (peginterferon alfa-2b) Cotellic® (cobimetinib) Tabrecta™ (capmatinib) Daurismo™ (glasdegib) Tafinlar® (dabrafenib) Erivedge® (vismodegib) Tagrisso® (osimertinib) Erleada™ (apalutamide) Talzenna™ (talazoparib) Farydak® (panobinostat) Tarceva® (erlotinib)a Fotivda® (tivozanib) Targretin® (bexarotene)a Gavreto™ (pralsetinib) Tasigna® (nilotinib) Gilotrif® (afatinib) Tazverik™ (tazemetostat) Gleevec® (imatinib)a Temodar® (temozolomide)a Hycamtin® (topotecan) Tepmetko® (tepotinib) Ibrance® (palbociclib) Thalomid® (thalidomide) Iclusig® (ponatinib) Tibsovo® (ivosidenib) Idhifa® (enasidenib) Tretinoin (oral) Imbruvica® (ibrutinib) Truseltiq™ (infigratinib) Inlyta® (axitinib) Tukysa™ (tucatinib) Inqovi® (decitabine/cedazuridine) Turalio™ (pexidartinib) Inrebic® (fedratinib) Tykerb® (lapatinib)a Iressa® (gefitinib) Ukoniq™ (umbralisib) Jakafi® (ruxolitinib) Venclexta® (venetoclax) Kisqali® (ribociclib) Verzenio® (abemaciclib) Kisqali® Femara® Pack (ribociclib and Vitrakvi® (larotrectinib) letrozole co-packaged) Vizimpro® (dacomitinib) Koselugo™ (selumetinib) Votrient® (pazopanib) Lenvima® (lenvatinib) Welireg™ (belzutifan) Lonsurf (trifluridine/tipiracil) Xalkori® (crizotinib) Lorbrena® (lorlatinib) Xeloda® (capecitabine)a Lumakras™ (sotorasib) Xospata® (gilteritinib) Lynparza® (olaparib) Xpovio® (selinexor) Lysodren® (mitotane) Xtandi® (enzalutamide) Matulane® (procarbazine) Yonsa® (abiraterone acetate) Mekinist® (trametinib) Zejula® (niraparib) Mektovi® (binimetinib) Zelboraf® (vemurafenib) Nerlynx (neratinib) Zolinza® (vorinostat) Nexavar (sorafenib) Zydelig® (idelalisib) Ninlaro® (ixazomib) Zykadia® (ceritinib) Nubeqa® (darolutamide) Zytiga® (abiraterone)a Odomzo® (sonidegib) a-generic available

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Brand (generic) GPI Multisource Code Afinitor (everolimus) 2.5 mg tableta 21532530000310 M, N, O, or Y 5 mg tableta 21532530000320 M, N, O, or Y 7.5 mg tableta 21532530000325 M, N, O or Y 10 mg tablet 21532530000330 M, N, O, or Y Afinitor DISPERZ (everolimus) 2 mg tablet for oral suspension 21532530007310 M, N, O, or Y 3 mg tablet for oral suspension 21532530007320 M, N, O, or Y 5 mg tablet for oral suspension 21532530007340 M, N, O, or Y Alecensa (alectinib) 150 mg capsule 21530507100120 M, N, O, or Y Alunbrig (brigatinib) 30 mg tablet 21530510000330 M, N, O, or Y 90 mg tablet 21530510000350 M, N. O, or Y 180 mg tablet 21530510000365 M, N, O, or Y Starter PAK 2153051000B720 M, N, O, or Y Ayvakit (avapritinib) 25 mg tablet 21490009000310 M, N, O, or Y 50 mg tablet 21490009000315 M, N, O, or Y 100 mg tablet 21490009000320 M, N, O, or Y 200 mg tablet 21490009000330 M, N, O, or Y 300 mg tablet 21490009000340 M, N, O, or Y Balversa (erdafitinib) 3 mg tablet 21532225000320 M, N, O, or Y 4 mg tablet 21532225000325 M, N, O, or Y 5 mg tablet 21532225000330 M, N, O, or Y Bosulif (bosutinib) 100 mg tablet 21531812000320 M, N, O, or Y 400 mg tablet 21531812000327 M, N, O, or Y 500 mg tablet 21531812000340 M, N, O, or Y Braftovi (encorafenib) 50 mg capsule 21532040000120 M, N, O, or Y 75 mg capsule 21532040000130 M, N, O, or Y Brukinsa (zanubrutinib) 80 mg capsule 21532195000120 M, N, O, or Y Cabometyx (cabozantinib) 20 mg tablet 21533010100320 M, N, O, or Y 40 mg tablet 21533010100330 M, N, O, or Y 60 mg tablet 21533010100340 M, N, O, or Y Calquence (acalabrutinib) 100 mg capsule 21532103000120 M, N, O, or Y Caprelsa (vandetanib) 100 mg tablet 21533085000320 M, N, O, or Y 300 mg tablet 21533085000340 M, N, O, or Y Cometriq (cabozantinib) 60 mg daily dose carton 21533010106460 M, N, O, or Y 100 mg daily dose carton 21533010106470 M, N, O, or Y 140 mg daily dose carton 21533010106480 M, N, O, or Y Copiktra (duvelisib) 15 mg capsule 21538030000120 M, N, O, or Y

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Brand (generic) GPI Multisource Code 25 mg capsule 21538030000130 M, N, O, or Y Cotellic (cobimetinib) 20 mg tablet 21533530200320 M, N, O, or Y Daurismo (glasdegib) 25 mg tablet 21370030300320 M, N, O, or Y 100 mg tablet 21370030300335 M, N, O, or Y Erivedge (vismodegib) 150 mg capsule 21370070000120 M, N, O, or Y Erleada (apalutamide) 60 mg tablet 21402410000320 M, N, O, or Y Farydak (panobinostat) 10 mg capsule 21531550100120 M, N, O, or Y 15 mg capsule 21531550100130 M, N, O, or Y 20 mg capsule 21531550100140 M, N, O, or Y Fotivda (tivozanib) 0.89 mg (890 mcg) capsule 21533076250120 M, N, O, or Y 1.34 mg (1340 mcg) capsule 21533076250130 M, N, O, or Y Gavreto (pralsetinib) 100 mg capsule 21535750000120 M, N, O, or Y Gilotrif (afatinib) 20 mg tablet 21360006100320 M, N, O, or Y 30 mg tablet 21360006100330 M, N, O, or Y 40 mg tablet 21360006100340 M, N, O, or Y Gleevec (imatinib)a 100 mg tablet 21531835100320 M, N, O, or Y 400 mg tablet 21531835100340 M, N, O, or Y Hycamtin (topotecan) 0.25 mg capsule 21550080100120 M, N, O, or Y 1 mg capsule 21550080100140 M, N, O, or Y Ibrance (palbociclib) 75 mg capsule 21531060000120 M, N, O, or Y 100 mg capsule 21531060000130 M, N, O, or Y 125 mg capsule 21531060000140 M, N, O, or Y 75 mg tablet 21531060000320 M, N, O, or Y 100 mg tablet 21531060000330 M, N, O, or Y 125 mg tablet 21531060000340 M, N, O, or Y Iclusig (ponatinib) 10 mg tablet 21531875100315 M, N, O, or Y 15 mg tablet 21531875100320 M, N, O, or Y 30 mg tablet 21531875100330 M, N, O, or Y 45 mg tablet 21531875100340 M, N, O, or Y Idhifa® (enasidenib) 50 mg tablet 21535030200320 M, N, O, or Y 100 mg tablet 21535030200340 M, N, O, or Y Imbruvica (ibrutinib) 70 mg capsule 21532133000110 M, N, O, or Y 140 mg capsule 21532133000120 M, N, O, or Y 140 mg tablet 21532133000320 M, N, O, or Y 280 mg tablet 21532133000330 M, N, O, or Y 420 mg tablet 21532133000340 M, N, O, or Y 560 mg tablet 21532133000350 M, N, O, or Y Inlyta (axitinib)

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Brand (generic) GPI Multisource Code 1 mg tablet 21335013000320 M, N, O, or Y 5 mg tablet 21335013000340 M, N, O, or Y Inqovi (decitabine/cedazuridine) 35 mg/100 mg tablet 21990002250320 M, N, O, or Y Inrebic (fedratinib) 100 mg capsule 21537520200120 M, N, O, or Y Iressa (gefitinib) 250 mg tablet 21360030000320 M, N, O, or Y Jakafi (ruxolitinib) 5 mg tablet 21537560200310 M, N, O, or Y 10 mg tablet 21537560200320 M, N, O, or Y 15 mg tablet 21537560200325 M, N, O, or Y 20 mg tablet 21537560200330 M, N, O, or Y 25 mg tablet 21537560200335 M, N, O, or Y Kisqali® (ribociclib) 200 mg daily dose pack (200 M, N, O, or Y mg tablets) 2153107050B720 400 mg daily dose pack (200 M, N, O, or Y mg tablets) 2153107050B740 600 mg daily dose pack (200 M, N, O, or Y mg tablets) 2153107050B760 Kisqali Femara Pack (ribociclib and letrozole co-packaged) 200 mg daily dose co-pack (200 mg ribociclib tablets and 2.5 mg 2199000260B730 M, N, O, or Y letrozole tablets) 400 mg daily dose co-pack (200 mg ribociclib tablets and 2.5 mg 2199000260B740 M, N, O, or Y letrozole tablets) 600 mg daily dose co-pack (200 mg ribociclib tablets and 2.5 mg 2199000260B760 M, N, O, or Y letrozole tablets) Koselugo (selumetinib) 10 mg capsule 21533565500110 M, N, O, or Y 25 mg capsule 21533565500125 M, N, O, or Y Lenvima (lenvatinib) 4 mg capsule therapy pack 2133505420B210 M, N, O, or Y 8 mg (2 x 4 mg capsules daily) 2133505420B215 M, N, O, or Y therapy pack 10 mg capsule therapy pack 2133505420B220 M, N, O, or Y 12 mg (3 x 4 mg capsules 2133505420B223 M, N, O, or Y daily) therapy pack 14 mg (10 mg and 4 mg 2133505420B240 M, N, O, or Y capsule daily) therapy pack 18 mg (10 mg and 2 x 4 mg 2133505420B244 M, N, O, or Y capsules daily) therapy pack 20 mg (2 x 10mg capsules 2133505420B230 M, N, O, or Y daily) therapy pack 24 mg (2 x 10mg and 1 x 4 mg 2133505420B250 M, N, O, or Y capsules daily) Lonsurf (trifluridine/tipiracil) 15 mg/6.14 mg tablet 21990002750320 M, N, O, or Y 20 mg/ 8.19 mg tablet 21990002750330 M, N, O, or Y Lorbrena (lorlatinib)

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Brand (generic) GPI Multisource Code 25 mg tablet 21530556000320 M, N, O, or Y 100 mg tablet 21530556000330 M, N, O, or Y Lumakras (sotorasib) 120 mg tablet 21532480000320 M, N, O, or Y Lynparza (olaparib) 50 mg capsule 21535560000120 M, N, O, or Y Lynparza (olaparib) 100 mg tablet 21535560000330 M, N, O, or Y 150 mg tablet 21535560000340 M, N, O, or Y Lysodren (mitotane) 500 mg tablet 21402250000320 M, N, O, or Y Matulane (procarbazine) 50mg capsule 21700050100105 M, N, O, or Y Mekinist (trametinib) 0.5 mg tablet 21533570100310 M, N, O, or Y 2 mg tablet 21533570100330 M, N, O, or Y Mektovi (binimetinib) 15 mg tablet 21533520000320 M, N, O, or Y Nerlynx (neratinib) 4 mg tablet 21533035100320 M, N, O, or Y Nexavar (sorafenib) 200 mg tablet 21533060400320 M, N, O, or Y Ninlaro (ixazomib) 2.3 mg capsule 21536045100120 M, N, O, or Y 3 mg capsule 21536045100130 M, N, O, or Y 4 mg capsule 21536045100140 M, N, O, or Y Nubeqa (darolutamide) 300 mg tablet 21402425000320 M, N, O, or Y Odomzo (sonidegib) 200 mg capsule 21370060200120 M, N, O, or Y Onureg (azacitidine) 200 mg tablet 21300003000320 M, N, O, or Y 300 mg tablet 21300003000330 M, N, O, or Y Orgovyx (relugolix) 120 mg tablet 21405570000320 M, N, O, or Y Pemazyre (pemigatinib) 4.5 mg tablet 21532260000320 M, N, O, or Y 9 mg tablet 21532260000330 M, N, O, or Y 13.5 mg tablet 21532260000340 M, N, O, or Y Piqray (alpelisib) 200 mg daily dose pack (200 M, N, O, or Y 2153801000B720 mg tablets) 250 mg daily dose pack (200 M, N, O, or Y 2153801000B725 mg tablets and 50 mg tablets) 300 mg daily dose pack (150 M, N, O, or Y 2153801000B730 mg tablets) Pomalyst (pomalidomide) 1 mg capsule 21450080000110 M, N, O, or Y 2 mg capsule 21450080000115 M, N, O, or Y 3 mg capsule 21450080000120 M, N, O, or Y 4 mg capsule 21450080000125 M, N, O, or Y Qinlock (ripretinib)

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Brand (generic) GPI Multisource Code 50 mg tablet 21533053000320 M, N, O, or Y Retevmo (selpercatinib) 40 mg capsule 21535779000120 M, N, O, or Y 80 mg capsule 21535779000140 M, N, O, or Y Revlimid (lenalidomide) 2.5 mg capsule 99394050000110 M, N, O, or Y 5 mg capsule 99394050000120 M, N, O, or Y 10 mg capsule 99394050000130 M, N, O, or Y 15 mg capsule 99394050000140 M, N, O, or Y 20 mg capsule 99394050000145 M, N, O, or Y 25 mg capsule 99394050000150 M, N, O, or Y Rozlytrek (entrectinib) 100 mg capsule 21533820000120 M, N, O, or Y 200 mg capsule 21533820000130 M, N, O, or Y Rubraca (rucaparib) 200 mg tablet 21535570200320 M, N, O, or Y 250 mg tablet 21535570200325 M, N, O, or Y 300 mg tablet 21535570200330 M, N, O, or Y Rydapt (midostaurin) 25 mg capsule 21533030000130 M, N, O, or Y Sprycel (dasatinib) 20 mg tablet 21531820000320 M, N, O, or Y 50 mg tablet 21531820000340 M, N, O, or Y 70 mg tablet 21531820000350 M, N, O, or Y 80 mg tablet 21531820000354 M, N, O, or Y 100 mg tablet 21531820000360 M, N, O, or Y 140 mg tablet 21531820000380 M, N, O, or Y Stivarga (regorafenib) 40 mg tablet 21533050000320 M, N, O, or Y Sutent (sunitinib)a 12.5 mg capsule 21533070300120 M, N, O, or Y 25 mg capsule 21533070300130 M, N, O, or Y 37.5 mg capsule 21533070300135 M, N, O, or Y 50 mg capsule 21533070300140 M, N, O, or Y Sylatron (peginterferon alfa-2b) injection 200 mcg vial 21700075206410 M, N, O, or Y 300 mcg vial 21700075206420 M, N, O, or Y 600 mcg vial 21700075206430 M, N, O, or Y Tabrecta (capmatinib) 150 mg tablet 21533716200320 M, N, O, or Y 200 mg tablet 21533716200330 M, N, O, or Y Tafinlar (dabrafenib) 50 mg capsule 21532025100120 M, N, O, or Y 75 mg capsule 21532025100130 M, N, O, or Y Tagrisso (osimertinib) 40 mg tablet 21360068200320 M, N, O, or Y 80 mg tablet 21360068200330 M, N, O, or Y Talzenna (talazoparib) 0.25 mg capsule 21535580400110 M, N, O, or Y 1 mg capsule 21535580400120 M, N, O, or Y Tarceva (erlotinib)a 25 mg tablet 21360025100320 M, N, O, or Y

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Brand (generic) GPI Multisource Code 100 mg tablet 21360025100330 M, N, O, or Y 150 mg tablet 21360025100360 M, N, O, or Y Targretin (bexarotene) 75 mg capsulea 21708220000120 M, N, O, or Y 1% gel (60 gm tube) 90376220004020 M, N, O, or Y Tasigna (nilotinib) 50 mg capsule 21531860200110 M, N, O. or Y 150 mg capsule 21531860200115 M, N, O, or Y 200 mg capsule 21531860200125 M, N, O, or Y Tazverik (tazemetostat) 200 mg tablet 21533675200320 M, N, O, or Y Temodar (temozolomide)a 5 mg capsule 21104070000110 M, N, O, or Y 20 mg capsule 21104070000120 M, N, O, or Y 100 mg capsule 21104070000140 M, N, O, or Y 140 mg capsule 21104070000143 M, N, O, or Y 180 mg capsule 21104070000147 M, N, O, or Y 250 mg capsule 21104070000150 M, N, O, or Y Tepmetko (tepotinib) 225 mg tablet 21533773100320 M, N, O, or Y Thalomid (thalidomide) 50 mg capsule 99392070000120 M, N, O, or Y 100 mg capsule 99392070000130 M, N, O, or Y 150 mg capsule 99392070000135 M, N, O, or Y 200 mg capsule 99392070000140 M, N, O, or Y Tibsovo (ivosidenib) 250 mg tablet 21534940000320 M, N, O, or Y Tretinoin 10 mg capsule 21708080000110 M, N, O, or Y Truseltiq (infigratinib) 50 mg daily dose (2x25 mg 2153223540B220 M, N, O, or Y capsules) 75 mg daily dose (3x25 mg 2153223540B225 M, N, O, or Y capsules) 100 mg daily dose (100 mg 2153223540B230 M, N, O, or Y capsules) 125 mg daily dose (100 mg 2153223540B235 M, N, O, or Y capsules and 25 mg capsules) Tukysa (tucatinib) 50 mg tablet 21170080000320 M, N, O, or Y 150 mg tablet 21170080000340 M, N, O, or Y Turalio (pexidartinib) 200 mg capsule 21533045010120 M, N, O, or Y Tykerb (lapatinib)a 250 mg tablet 21533026100320 M, N, O, or Y Ukoniq (umbralisib) 200 mg tablet 21533080400320 M, N, O, or Y Venclexta (venetoclax) 10 mg tablet 21470080000320 M, N, O, or Y 50 mg tablet 21470080000340 M, N, O, or Y 100 mg tablet 21470080000360 M, N, O, or Y Starter pack 2147008000B720 M, N, O, or Y

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Brand (generic) GPI Multisource Code Verzenio (abemaciclib) 50 mg tablet 21531010000305 M, N, O, or Y 100 mg tablet 21531010000310 M, N, O, or Y 150 mg tablet 21531010000315 M, N, O, or Y 200 mg tablet 21531010000320 M, N, O, or Y Vitrakvi (larotrectinib) 25 mg capsule 21533835200120 M, N, O, or Y 100 mg capsule 21533835200150 M, N, O, or Y 20 mg/mL solution 21533835202020 M, N, O, or Y Vizimpro (dacomitinib) 15 mg tablet 21360019000320 M, N, O, or Y 30 mg tablet 21360019000330 M, N, O, or Y 45 mg tablet 21360019000340 M, N, O, or Y Votrient (pazopanib) 200 mg tablet 21533042100320 M, N, O, or Y Xalkori (crizotinib) 200 mg tablet 21530517000120 M, N, O, or Y 250 mg tablet 21530517000125 M, N, O, or Y Welireg (belzutifan) 40 mg tablet 21421020000320 M, N, O, or Y Xeloda (capecitabine)a 150 mg tablet 21300005000320 M, N, O, or Y 500 mg tablet 21300005000350 M, N, O, or Y

Xospata (gilteritinib) 40 mg tablet 21533020200320 M, N, O, or Y Xpovio (selinexor) 40 mg once weekly therapy 2156006000B712 M, N, O, or Y pack (20 mg tablets) 40 mg once weekly therapy 2156006000B760 M, N, O, or Y pack (40 mg tablets) 40 mg twice weekly therapy 2156006000B715 M, N, O, or Y pack (20 mg tablets) 40 mg twice weekly therapy 2156006000B765 M, N, O, or Y pack (40 mg tablets) 60 mg once weekly therapy 2156006000B750 M, N, O, or Y pack (20 mg tablets) 60 mg once weekly therapy 2156006000B780 M, N, O, or Y pack (60 mg tablets) 60 mg twice weekly therapy 2156006000B755 M, N, O, or Y pack (20 mg tablets) 80 mg once weekly therapy 2156006000B740 M, N, O, or Y pack (20 mg tablets) 80 mg once weekly therapy 2156006000B770 M, N, O, or Y pack (40 mg tablets) 80 mg twice weekly therapy 2156006000B720 M, N, O, or Y pack (20 mg tablets) 100 mg once weekly therapy 2156006000B730 M, N, O, or Y pack (20 mg tablets) 100 mg once weekly therapy 2156006000B775 M, N, O, or Y pack (50 mg tablets) Xtandi (enzalutamide) 40 mg capsule 21402430000120 M, N, O, or Y

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Brand (generic) GPI Multisource Code 40 mg tablet 21402430000320 M, N, O, or Y 80 mg tablet 21402430000340 M, N, O, or Y Yonsa (abiraterone acetate) 125 mg tablet 21406010200310 M, N, O, or Y Zejula (niraparib) 100 mg capsule 21535550200120 M, N, O, or Y Zelboraf (vemurafenib) 240 mg tablet 21532080000320 M, N, O, or Y Zolinza (vorinostat) 100 mg capsule 21531575000120 M, N, O, or Y Zydelig (idelalisib) 100 mg tablet 21538040000320 M, N, O, or Y 150 mg tablet 21538040000330 M, N, O, or Y Zykadia (ceritinib) 150 mg capsule 21530514000130 M, N, O, or Y 150 mg tablet 21530514000330 M, N, O, or Y Zytiga (abiraterone)a 250 mg tablet 21406010200320 M, N, O, or Y 500 mg tablet 21406010200330 M, N, O, or Y a-generic available

PRIOR AUTHORIZATION CRITERIA FOR APPROVAL Initial Evaluation Target Agent(s) will be approved when ONE of the following is met: 1. ONE of the following: A. Information has been provided that indicates the patient is currently being treated with the requested agent within the past 180 days OR B. The prescriber states the patient is currently being treated with the requested agent within the past 180 days AND is at risk if therapy is changed OR C. ALL of the following: 1. ONE of the following: A. The patient’s age is within FDA labeling for the requested indication for the requested agent OR B. The prescriber has provided information in support of using the requested agent for the patient’s age AND ii. ONE of the following: a. The patient has an FDA approved indication for the requested agent OR b. The patient has an indication that is supported by NCCN 1 or 2A recommended use, AHFS, or DrugDex level of evidence of 1 or 2A [i.e., this indication must be supported by ALL requirements in the compendia (e.g., performance status, disease severity, previous failures, monotherapy vs combination therapy, etc.)] for the requested agent AND iii. ONE of the following: a. ALL of the following:

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1. The requested indication requires genetic/specific diagnostic testing per FDA labeling or compendia (NCCN 1 or 2A recommended use, AHFS, DrugDex level of evidence of 1 or 2A) for the requested agent AND 2. Genetic/specific diagnostic testing has been completed AND 3. The results of the genetic/specific diagnostic testing indicate therapy with the requested agent is appropriate OR b. The requested indication does NOT require specific genetic/diagnostic testing per FDA labeling or compendia (NCCN 1 or 2A recommended use, AHFS, DrugDex level of evidence of 1 or 2A) for the requested agent AND iv. ONE of the following: a. The requested agent being used as monotherapy AND is approved for use as monotherapy in the FDA labeling or compendia (NCCN 1 or 2A recommended use, AHFS, DrugDex level of evidence of 1 or 2A) for the requested indication OR b. The requested agent will be used as combination therapy with all agent(s) and/or treatments (e.g., radiation) listed for concomitant use in the FDA labeling or compendia (NCCN 1 or 2A recommended use, AHFS, DrugDex level of evidence of 1 or 2A) for the requested indication AND v. ONE of the following: a. The requested agent is FDA labeled or supported by compendia (NCCN 1 or 2A recommended use, AHFS, DrugDex level of evidence of 1 or 2A) as a first-line agent for the requested indication OR b. The patient has tried and had an inadequate response to the appropriate number and type(s) of prerequisite agent(s) listed in the FDA labeling or compendia (NCCN 1 or 2A recommended use, AHFS, DrugDex level of evidence of 1 or 2A) for the requested indication OR c. The patient has an intolerance, FDA labeled contraindication, or hypersensitivity to the first-line agent(s) for the requested indication AND vi. If the client has preferred products* for the requested indication (*Preferred agents are determined by the client and may include both brand and generic agents), then ONE of the following: a. The requested agent is a preferred agent for the requested indication OR b. The requested agent is a non-preferred agent for the requested indication (as determined by the client), AND ONE of the following: a. The patient’s history indicates use of a preferred agent for the requested indication OR b. The patient has an intolerance or hypersensitivity to a preferred agent(s) for the requested indication

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OR c. The patient has an FDA labeled contraindication to ALL preferred agent(s) for the requested indication OR d. BOTH of the following: 1. NCCN does NOT specify the plan preferred agent(s) as a preferred regimen for the requested indication AND 2. NCCN specifies the requested agent as a preferred regimen for the requested indication OR e. The prescriber has provided information in support of use of the non-preferred agent over the preferred agent(s) for the requested indication OR f. If the requested agent is Bosulif or Tasigna for CML, the patient has been previously treated with either Bosulif OR Tasigna for the requested indication

Indication Preferred Agents Non-Preferred Agents Advanced or Ibrance, Verzenio Kisqali, Kisqali Femara metastatic breast Pack cancer Newly diagnosed Imatinib (generic), Bosulif, Tasigna adult and pediatric Sprycel patients with positive chronic myeloid in chronic phase

AND vii. If the requested agent is Imbruvica 140 mg or 280 mg tablets, ONE of the following: a. The patient has tried and had an inadequate response to Imbruvica 140 mg capsules OR b. The patient has an intolerance or hypersensitivity to Imbruvica capsules that is not expected to occur with Imbruvica tablets OR c. The patient has an FDA labeled contraindication to Imbruvica capsules that is not expected to occur with Imbruvica tablets AND viii. If the requested agent is Zytiga/abiraterone 500 mg, ONE of the following: a. The patient has tried and had an inadequate response to generic abiraterone 250 mg tablets OR b. The patient has an intolerance or hypersensitivity to generic abiraterone 250 mg tablets that is not expected to occur with the requested agent OR

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c. The patient has an FDA labeled contraindication to generic abiraterone 250 mg tablets that is not expected to occur with the requested agent AND ix. If the requested agent is a brand product with a generic equivalent, ONE of the following: a. The patient has an intolerance or hypersensitivity to the generic equivalent that is not expected to occur with the requested brand agent OR b. The patient has an FDA labeled contraindication to the generic equivalent that is not expected to occur with the requested brand agent OR c. The prescriber has provided information to support the use of the requested brand agent over the generic equivalent AND 2. The patient does not have any FDA labeled contraindications to the requested agent AND 3. The patient does not have any FDA labeled limitation(s) of use for the requested agent that is otherwise not supported in NCCN to the requested agent AND 4. ONE of the following: a. The requested quantity (dose) is within FDA labeled dosing for the requested indication OR b. The dose is not within FDA approved labeling AND the prescriber has provided information in support of therapy with a higher dose for the requested indication

Length of Approval: Up to 3 months for Vitrakvi Up to 12 months for all other agents

Renewal Evaluation Target Agent(s) will be approved when ALL of the following are met: 1. The patient has been previously approved for the requested agent through the plan’s Prior Authorization process AND 2. ONE of the following: A. The requested agent is Vitrakvi AND the patient has experienced clinical benefit (i.e., partial response, complete response, or stable disease) with the requested agent OR B. The requested agent is NOT Vitrakvi AND 3. The patient does not have any FDA labeled contraindications to the requested agent AND 4. The patient does not have any FDA labeled limitation(s) of use that is otherwise not supported in NCCN to the requested agent AND 5. ONE of the following: a. The requested quantity (dose) is within FDA labeled dosing for the requested indication OR b. The dose is not within FDA approved labeling AND the prescriber has provided information in support of therapy with a higher dose for the requested indication

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Length of Approval: Up to 12 months

FDA Approved Genetic Tests FDA Companion Diagnostics: https://www.fda.gov/medical-devices/vitro-diagnostics/list- cleared-or-approved-companion-diagnostic-devices-vitro-and-imaging-tools

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