ph-1069
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Self Administered Oncology Agents Prior Authorization with Quantity Limit Program Summary

Policy Number: PH-1069

Self-Administered Oncology Agents Prior Authorization with Quantity Limit – through Preferred (optional)

TARGET AGENTS

aAfinitor® (everolimus)

Afinitor® Disperz (everolimus)

Alecensa® (alectinib)

Alunbrig™ (brigatinib)

Ayvakit (avapritinib)

Balversa (erdafitinib)

Bosulif® (bosutinib)

Braftovi® (encorafenib)

Brukinsa™ (zanubrutinib)

Cabometyx® (cabozantinib)

Calquence® (acalabrutinib)

Caprelsa® (vandetanib)

Cometriq® (cabozantinib)

Copiktra (duvelisib)

Cotellic® (cobimetinib)

Daurismo (glasdegib)

Erivedge® (vismodegib)

Erleada™ (apalutamide)

Farydak® (panobinostat)

Gilotrif® (afatinib)

aGleevec® (imatinib)

Hexalen® (altretamine)

Hycamtin® (topotecan)

Ibrance® (palbociclib) capsules

Ibrance® (palbociclib) tablets

Iclusig® (ponatinib)

Idhifa® (enasidenib)

Imbruvica® (ibrutinib)

Inlyta® (axitinib)

Inrebic® (fedratinib)

Iressa® (gefitinib)

Jakafi® (ruxolitinib)

Kisqali® (ribociclib)

Kisqali® Femara® Pack (ribociclib and letrozole co-packaged)

Koselugo™ (selumetinib)  

Lenvima® (lenvatinib)

Lonsurf (trifluridine/tipiracil)

Lorbrena® (lorlatinib)

Lynparza® (olaparib) capsules

Lynparza® (olaparib) tablets

Lysodren® (mitotane)

Matulane® (procarbazine)

Mekinist® (trametinib)

Mektovi® (binimetinib)

Nerlynx (neratinib)

Nexavar (sorafenib)

Ninlaro® (ixazomib)

Nubeqa® (darolutamide)

Odomzo® (sonidegib)

Pemazyre (pemigatinib)

Piqray® (alpelisib)

Pomalyst® (pomalidomide)

Retevmo™ (selpercatinib)

Revlimid® (lenalidomide)

Rozlytrek™ (entrectinib)

Rubraca® (rucaparib)

Rydapt® (midostaurin)

Sprycel® (dasatinib)

Stivarga® (regorafenib)

Sutent® (sunitinib)

Sylatron™ (peginterferon alfa-2b)

Tabrecta™ (capmatinib)

Tagrisso® (osimertinib)

Tafinlar® (dabrafenib)

Talzenna™ (talazoparib)

aTarceva® (erlotinib)

aTargretin® (bexarotene)

Tasigna® (nilotinib)

Tazverik™ (tazemetostat)

aTemodar® (temozolomide)

Thalomid® (thalidomide)

Tibsovo® (ivosidenib)

Tretinoin (oral)

Tukysa™ (tucatinib)

Turalio™ (pexidartinib)

Tykerb® (lapatinib)

Venclexta® (venetoclax)

Verzenio® (abemaciclib)

Vitrakvi® (larotrectinib)

Vizimpro® (dacomitinib)

Votrient® (pazopanib)

Xalkori® (crizotinib)

aXeloda® (capecitabine)

Xospata® (gilteritinib)

Xpovio™ (selinexor)

Xtandi® (enzalutamide)

Yonsa® (abiraterone acetate)

Zejula® (niraparib)

Zelboraf® (vemurafenib)

Zolinza® (vorinostat)

Zydelig® (idelalisib)

Zykadia® (ceritinib)

aZytiga® (abiraterone)           

a-generic available

Indication

Try/Inadequate response

Preferred Agents

Non-Preferred Agents

Advanced or metastatic breast cancer

Try/inadequate response 1 preferred agent

Ibrance, Verzenio

Kisqali, Kisqali Femara Pack

QUANTITY LIMIT TARGET AGENTS - RECOMMENDED LIMITS±

Brand (generic)

GPI

Multisource Code

Quantity Per Day Limit

Afinitor (everolimus)

2.5 mg tableta

21532530000310

M, N, O, or Y

1 tablet

5 mg tableta

21532530000320

M, N, O, or Y

1 tablet

7.5 mg tableta

21532530000325

M, N, O, or Y

1 tablet

10 mg tablet

21532530000330

M, N, O, or Y

1 tablet

Afinitor DISPERZ (everolimus)

2 mg tablet for oral suspension

21532530007310

M, N, O, or Y

2 tablets^

3 mg tablet for oral suspension

21532530007320

M, N, O, or Y

3 tablets^

5 mg tablet for oral suspension

21532530007340

M, N, O, or Y

2 tablets^

Alecensa (alectinib)

150 mg capsule

21534007100120

M, N, O, or Y

8 capsules

Alunbrig (brigatinib)

30 mg tablet

21534010000330

M, N, O, or Y

6 tablets

90 mg tablet

21534010000350

M, N, O, or Y

1 tablet

180 mg tablet

21534010000365

M, N, O, or Y

1 tablet

Starter PAK

2153401000B720

M, N, O, or Y

1 pak/180 days

Ayvakit (avapritinib)

100 mg tablet

21534009000320

M, N, O, or Y

1 tablet

200 mg tablet

21534009000330

M, N, O, or Y

1 tablet

300 mg tablet

21534009000340

M, N, O, or Y

1 tablet

Balversa (erdafitinib)

3 mg tablet

21532225000320

M, N, O, or Y

3 tablets

4 mg tablet

21532225000325

M, N, O, or Y

2 tablets

5 mg tablet

21532225000330

M, N, O, or Y

1 tablet

Bosulif (bosutinib)

100 mg tablet

21534012000320

M, N, O, or Y

4 tablets

400 mg tablet

21534012000327

M, N, O, or Y

1 tablet

500 mg tablet

21534012000340

M, N, O, or Y

1 tablet

Braftovi (encorafenib)

50 mg capsule

21532040000120

M, N, O, or Y

6 capsules

75 mg capsule

21532040000130

M, N, O, or Y

6 capsules

Brukinsa (zanubrutinib)

80 mg capsule

21534095000120

M, N, O, or Y

4 capsules

Cabometyx (cabozantinib)

20 mg tablet

21534013100320

M, N, O, or Y

1 tablet

40 mg tablet

21534013100330

M, N, O, or Y

1 tablet

60 mg tablet

21534013100340

M, N, O, or Y

1 tablet

Calquence (acalabrutinib)

100 mg capsule

21534003000120

M, N, O, or Y

2 capsules

Caprelsa (vandetanib)

100 mg tablet

21534085000320

M, N, O, or Y

2 tablets

300 mg tablet

21534085000340

M, N, O, or Y

1 tablet

Cometriq (cabozantinib)

140 mg daily dose carton

21534013106480

M, N, O, or Y

1 carton/28 days

100 mg daily dose carton

21534013106470

M, N, O, or Y

1 carton/28 days

60 mg daily dose carton

21534013106460

M, N, O, or Y

1 carton/28 days

Copiktra (duvelisib)

15 mg capsule

21538030000120

M, N, O, or Y

56 capsules/28 days

25 mg capsule

21538030000130

M, N, O, or Y

56 capsules/28 days

Cotellic (cobimetinib)

20 mg tablet

21533530200320

M, N, O, or Y

63 tablets/28 days

Daurismo (glasdegib)

25 mg tablet

21370030300320

M, N, O, or Y

2 tablets

100 mg tablet

21370030300335

M, N, O, or Y

1 tablet

Erivedge (vismodegib)

150 mg capsule

21370070000120

M, N, O, or Y

1 capsule

Erleada (apalutamide)

60 mg tablet

21402410000320

M, N, O, or Y

4 tablets

Farydak (panobinostat)

10 mg capsule

21531550100120

M, N, O, or Y

6 capsules/21 days

15 mg capsule

21531550100130

M, N, O, or Y

6 capsules/21 days

20 mg capsule

21531550100140

M, N, O, or Y

6 capsules/21 days

Gilotrif (afatinib)

20 mg tablet

21534006100320

M, N, O, or Y

1 tablet

30 mg tablet

21534006100330

M, N, O, or Y

1 tablet

40 mg tablet

21534006100340

M, N, O, or Y

1 tablet

Gleevec (imatinib)a

100 mg tablet

21534035100320

M, N, O, or Y

3 tablets

400 mg tablet

21534035100340

M, N, O, or Y

2 tablets

Hexalen (altretamine)

50 mg capsule

21100005000110

M, N, O, or Y

No Quantity Limit

Hycamtin (topotecan)

0.25 mg capsule

21550080100120

M, N, O, or Y

No Quantity Limit

1 mg capsule

21550080100140

M, N, O, or Y

No Quantity Limit

Ibrance (palbociclib)

75 mg capsule

21531060000120

M, N, O, or Y

21 capsules/28 days

100 mg capsule

21531060000130

M, N, O, or Y

21 capsules/28 days

125 mg capsule

21531060000140

M, N, O, or Y

21 capsules/28 days

75 mg tablet

21531060000320

M, N, O, or Y

21 tablets/28 days

100 mg tablet

21531060000330

M, N, O, or Y

21 tablets/28 days

125 mg tablet

21531060000340

M, N, O, or Y

21 tablets/28 days

Iclusig (ponatinib)

15 mg tablet

21534075100320

M, N, O, or Y

2 tablets

45 mg tablet

21534075100340

M, N, O, or Y

1 tablet

Idhifa (enasidenib)

50 mg tablet

21535030200320

M, N, O, or Y

1 tablet

100 mg tablet

21535030200340

M, N, O, or Y

1 tablet

Imbruvica (ibrutinib)

70 mg capsule

21534033000110

M, N, O, or Y

1 capsule

140 mg capsule

21534033000120

M, N, O, or Y

2 capsules

140 mg tablet

21534033000320

M, N, O, or Y

1 tablet

280 mg tablet

21534033000330

M, N, O, or Y

1 tablet

420 mg tablet

21534033000340

M, N, O, or Y

1 tablet

560 mg tablet

21534033000350

M, N, O, or Y

1 tablet

Inlyta (axitinib)

1 mg tablet

21534008000320

M, N, O, or Y

6 tablets

5 mg tablet

21534008000340

M, N, O, or Y

4 tablets

Inrebic (fedratinib)

100 mg capsule

21537520200120

M, N, O, or Y

4 capsules

Iressa (gefitinib)

250 mg tablet

21534030000320

M, N, O, or Y

1 tablet

Jakafi (ruxolitinib)

5 mg tablet

21537560200310

M, N, O, or Y

2 tablets

10 mg tablet

21537560200320

M, N, O, or Y

2 tablets

15 mg tablet

21537560200325

M, N, O, or Y

2 tablets

20 mg tablet

21537560200330

M, N, O, or Y

2 tablets

25 mg tablet

21537560200335

M, N, O, or Y

2 tablets

Kisqali (ribociclib)

200 mg tablet

21531070500320

M, N, O, or Y

63 tablets/28 days

200 mg daily dose pack (200 mg tablets)

2153107050B720

M, N, O, or Y

21 tablets/28 days

400 mg daily dose pack (200 mg tablets)

2153107050B740

M, N, O, or Y

42 tablets/28 days

600 mg daily dose pack (200 mg tablets)

2153107050B760

M, N, O, or Y

63 tablets/28 days

Kisqali Femara Pack (ribociclib and letrozole co-packaged)

200 mg ribociclib tablets and 2.5 mg letrozole tablets

2199000260B720

M, N, O, or Y

91 tablets/28 days¥

200 mg daily dose co-pack (200 mg ribociclib tablets and 2.5 mg letrozole tablets)

2199000260B730

M, N, O, or Y

49 tablets/28 days¥

400 mg daily dose co-pack (200 mg ribociclib tablets and 2.5 mg letrozole tablets)

2199000260B740

M, N, O, or Y

70 tablets/28 days¥

600 mg daily dose co-pack (200 mg ribociclib tablets and 2.5 mg letrozole tablets)

2199000260B760

M, N, O, or Y

91 tablets/28 days¥

Koselugo (selumetinib)

10 mg capsule

21533565500110

M, N, O, or Y

8 capsules

25 mg capsule

21533565500125

M, N, O, or Y

4 capsules

Lenvima (lenvatinib)

4 mg capsule therapy pack

2153405420B210

M, N, O, or Y

30 capsules/30 days

8 mg (2 x 4 mg capsules daily) therapy pack

2153405420B215

M, N, O, or Y

60 capsules/30 days

10 mg capsule therapy pack

2153405420B220

M, N, O, or Y

30 capsules/30 days

12 mg (3 x 4 mg capsules daily) therapy pack

2153405420B223

M, N, O, or Y

90 capsules/30 days

14 mg (10 mg and 4 mg capsule daily) therapy pack

2153405420B240

M, N, O, or Y

60 capsules/30 days

18 mg (10 mg and 2 x 4 mg capsules daily) therapy pack

2153405420B244

M, N, O, or Y

90 capsules/30 days

20 mg (2 x 10mg capsules daily) therapy pack

2153405420B230

M, N, O, or Y

60 capsules/30 days

24 mg (2 x 10mg and 1 x 4 mg capsules daily)

2153405420B250

M, N, O, or Y

90 capsules/30 days

Lonsurf (trifluridine/tipiracil)

15 mg/6.14 mg tablet

21990002750320

M, N, O, or Y

100 tablets/28 days

20 mg/8.19 mg tablet

21990002750330

M, N, O, or Y

80 tablets/28 days

Lorbrena (lorlatinib)

25 mg tablet

21534056000320

M, N, O, or Y

3 tablets

100 mg tablet

21534056000330

M, N, O, or Y

1 tablet

Lynparza (olaparib)

50 mg capsule

21535560000120

M, N, O, or Y

16 capsules

Lynparza (olaparib)

100 mg tablet

21535560000330

M, N, O, or Y

4 tablets

150 mg tablet

21535560000340

M, N, O, or Y

4 tablets

Lysodren (mitotane)

500 mg tablet

21402250000320

M, N, O, or Y

No Quantity Limit

Matulane (procarbazine)

50mg capsule

21700050100105

M, N, O, or Y

No Quantity Limit

Mekinist (trametinib)

0.5 mg tablet

21533570100310

M, N, O, or Y

3 tablets

2 mg tablet

21533570100330

M, N, O, or Y

1 tablet

Mektovi (binimetinib)

15 mg tablet

21533520000320

M, N, O, or Y

6 tablets

Nerlynx (neratinib)

40 mg tablet

21534058100320

M, N, O, or Y

6 tablets

Nexavar (sorafenib)

 200 mg tablet

21533060400320

M, N, O, or Y

4 tablets

Ninlaro (ixazomib)

2.3 mg capsule

21536045100120

M, N, O, or Y

3 capsules/28 days

3 mg capsule

21536045100130

M, N, O, or Y

3 capsules/28 days

4 mg capsule

21536045100140

M, N, O, or Y

3 capsules/28 days

Nubeqa (darolutamide)

300 mg tablet

21402425000320

M, N, O, or Y

4 tablets

Odomzo (sonidegib)

200 mg capsule

21370060200120

M, N, O, or Y

30 capsules/30 days

Pemazyre (pemigatinib)

4.5 mg tablet

21532260000320

M, N, O, or Y

14 tablets/21 days

9 mg tablet

21532260000330

M, N, O, or Y

14 tablets/21 days

13.5 mg tablet

21532260000340

M, N, O, or Y

14 tablets/21 days

Piqray (alpelisib)

200 mg daily dose pack (200 mg tablets)

2153801000B720

M, N, O, or Y

1 pack (28 tablets)/28 days

250 mg daily dose pack (200 mg tablets and 50 mg tablets)

2153801000B725

M, N, O, or Y

1 pack (56 tablets)/28 days

300 mg daily dose pack (150 mg tablets)

2153801000B730

M, N, O, or Y

1 pack (56 tablets)/28 days

Pomalyst (pomalidomide)

1 mg capsule

21450080000110

M, N, O, or Y

21 capsules/28 days

2 mg capsule

21450080000115

M, N, O, or Y

21 capsules/28 days

3 mg capsule

21450080000120

M, N, O, or Y

21 capsules/28 days

4 mg capsule

21450080000125

M, N, O, or Y

21 capsules/28 days

Retevmo (selpercatinib)

40 mg capsule

21534079000120 

M, N, O, or Y

6 capsules

80 mg capsule

21534079000140 

M, N, O, or Y

4 capsules

Revlimid (lenalidomide)

2.5 mg capsule

99394050000110

M, N, O, or Y

1 capsule

5 mg capsule

99394050000120

M, N, O, or Y

1 capsule

10 mg capsule

99394050000130

M, N, O, or Y

1 capsule

15 mg capsule

99394050000140

M, N, O, or Y

21 capsules/28 days

20 mg capsule

99394050000145

M, N, O, or Y

21 capsules/28 days

25 mg capsule

99394050000150

M, N, O, or Y

21 capsules/28 days

Rozlytrek (entrectinib)

100 mg capsule

21533820000120

M, N, O, or Y

1 capsule

200 mg capsule

21533820000130

M, N, O, or Y

3 capsules

Rubraca (rucaparib)

200 mg tablet

21535570200320

M, N, O, or Y

4 tablets

250 mg tablet

21535570200325

M, N, O, or Y

4 tablets

300 mg tablet

21535570200330

M, N, O, or Y

4 tablets

Rydapt (midostaurin)

25 mg capsule

21533030000130

M, N, O, or Y

8 capsules

Sprycel (dasatinib)

20 mg tablet

21534020000320

M, N, O, or Y

3 tablets

50 mg tablet

21534020000340

M, N, O, or Y

1 tablet

70 mg tablet

21534020000350

M, N, O, or Y

1 tablet

80 mg tablet

21534020000354

M, N, O, or Y

1 tablet

100 mg tablet

21534020000360

M, N, O, or Y

1 tablet

140 mg tablet

21534020000380

M, N, O, or Y

1 tablet

Stivarga (regorafenib)

40 mg tablet

21533050000320

M, N, O, or Y

84 tablets/28 days

Sutent (sunitinib)

12.5 mg capsule

21533070300120

M, N, O, or Y

3 capsules

25 mg capsule

21533070300130

M, N, O, or Y

1 capsule

37.5 mg capsule

21533070300135

M, N, O, or Y

1 capsule

50 mg capsule

21533070300140

M, N, O, or Y

1 capsule

Sylatron (peginterferon alfa-2b)

200 mcg vial

21700075206410

21700075206450

M, N, O, or Y

No Quantity Limit

300 mcg vial

21700075206420

21700075206460

M, N, O, or Y

No Quantity Limit

600 mcg vial

21700075206430

M, N, O, or Y

No Quantity Limit

Tabrecta (capmatinib)

150 mg tablet

21534016200320

M, N, O, or Y

4 tablets

200 mg tablet

21534016200330

M, N, O, or Y

4 tablets

Tafinlar (dabrafenib)

50 mg capsule

21532025100120

M, N, O, or Y

4 capsules

75 mg capsule

21532025100130

M, N, O, or Y

4 capsules

Tagrisso (osimertinib)

40 mg tablet

21534065200320

M, N, O, or Y

1 tablet

80 mg tablet

21534065200330

M, N, O, or Y

1 tablet

Talzenna (talazoparib)

0.25 mg capsule

21535580400110

M, N, O, or Y

3 capsules

1 mg capsule

21535580400120

M, N, O, or Y

1 capsule

Tarceva (erlotinib)a

25 mg tablet

21534025100320

M, N, O, or Y

2 tablets

100 mg tablet

21534025100330

M, N, O, or Y

1 tablet

150 mg tablet

21534025100360

M, N, O, or Y

1 tablet

Targretin (bexarotene)a

75 mg capsule

21708220000120

M, N, O, or Y

No Quantity Limit

Tasigna (nilotinib)

50 mg capsule

21534060200110

M, N, O, or Y

4 capsules

150 mg capsule

21534060200115

M, N, O, or Y

4 capsules

200 mg capsule

21534060200125

M, N, O, or Y

4 capsules

Tazverik (tazemetostat)

200 mg tablet

21533675200320

M, N, O, or Y

8 tablets

Temodar (temozolomide)a

5 mg capsule

21104070000110

M, N, O, or Y

No Quantity Limit

20 mg capsule

21104070000120

M, N, O, or Y

No Quantity Limit

100 mg capsule

21104070000140

M, N, O, or Y

No Quantity Limit

140 mg capsule

21104070000143

M, N, O, or Y

No Quantity Limit

180 mg capsule

21104070000147

M, N, O, or Y

No Quantity Limit

250 mg capsule

21104070000150

M, N, O, or Y

No Quantity Limit

Thalomid (thalidomide)

50 mg capsule

99392070000120

M, N, O, or Y

1 capsule

100 mg capsule

99392070000130

M, N, O, or Y

1 capsule

150 mg capsule

99392070000135

M, N, O, or Y

2 capsules

200 mg capsule

99392070000140

M, N, O, or Y

2 capsules

Tibsovo (ivosidenib)

250 mg tablet

21534940000320

M, N, O, or Y

2 tablets

Tretinoin

10 mg capsule

21708080000110

M, N, O, or Y

No Quantity Limit

Tukysa (tucatinib)

50 mg tablet

21534080000320

M, N, O, or Y

10 tablets

150 mg tablet

21534080000340

M, N, O, or Y

4 tablets

Turalio (pexidartinib)

200 mg capsule

21534073010120

M, N, O, or Y

4 capsules

Tykerb (lapatinib)

 250 mg tablet

21534050100320

M, N, O, or Y

6 tablets

Venclexta (venetoclax)

10 mg tablet

21470080000320

M, N, O, or Y

2 tablets

50 mg tablet

21470080000340

M, N, O, or Y

1 tablet

100 mg tablet

21470080000360

M, N, O, or Y

6 tablets

Starter pack

2147008000B720

M, N, O, or Y

1 pack (42 tablets)/180 days

Verzenio (abemaciclib)

50 mg tablet

21531010000305

M, N, O, or Y

2 tablets

100 mg tablet

21531010000310

M, N, O, or Y

2 tablets

150 mg tablet

21531010000315

M, N, O, or Y

2 tablets

200 mg tablet

21531010000320

M, N, O, or Y

2 tablets

Vitrakvi (larotrectinib)

25 mg capsule

21533835200120

M, N, O, or Y

6 capsules

100 mg capsule

21533835200150

M, N, O, or Y

2 capsules

20 mg/mL oral solution

21533835202020

M, N, O, or Y

10 mLs

Vizimpro (dacomitinib)

15 mg tablet

21534019000320

M, N, O, or Y

1 tablet

30 mg tablet

21534019000330

M, N, O, or Y

1 tablet

45 mg tablet

21534019000340

M, N, O, or Y

1 tablet

Votrient (pazopanib)

 200 mg tablet

21534070100320

M, N, O, or Y

4 tablets

Xalkori (crizotinib)

200 mg capsule

21534015000120

M, N, O, or Y

2 capsules

250 mg capsule

21534015000125

M, N, O, or Y

2 capsules

Xeloda (capecitabine)a

150 mg tablet

21300005000320

M, N, O, or Y

No Quantity Limit

500 mg tablet

21300005000350

M, N, O, or Y

No Quantity Limit

Xospata (gilteritinib)

40 mg tablet

21534031200320

M, N, O, or Y

3 tablets

Xpovio (selinexor)

60 mg once weekly therapy pack (20 mg tablets)

2156006000B750

M, N, O, or Y

12 tablets (1 box)/28 days

80 mg once weekly therapy pack (20 mg tablets)

2156006000B740

M, N, O, or Y

16 tablets (1 box)/28 days

80 mg twice weekly therapy pack (20 mg tablets)

2156006000B720

M, N, O, or Y

32 tablets (1 box)/28 days

100 mg once weekly therapy pack (20 mg tablets)

2156006000B730

M, N, O, or Y

20 tablets (1 box)/28 days

Xtandi (enzalutamide)

40 mg capsule

21402430000120

M, N, O, or Y

4 capsules

Yonsa (abiraterone acetate)

125 mg tablet

21406010200310

M, N, O, or Y

4 tablets

Zejula (niraparib)

100 mg capsule

21535550200120

M, N, O, or Y

3 capsules

Zelboraf (vemurafenib)

240 mg tablet

21532080000320

M, N, O, or Y

8 tablets

Zolinza (vorinostat)

100 mg capsule

21531575000120

M, N, O, or Y

4 capsules

Zydelig (idelalisib)

100 mg tablet

21538040000320

M, N, O, or Y

2 tablets

150 mg tablet

21538040000330

M, N, O, or Y

2 tablets

Zykadia (ceritinib)

150 mg capsule

21534014000130

M, N, O, or Y

3 capsules

150 mg tablet

21534014000330

M, N, O, or Y

3 tablets

Zytiga (abiraterone)

 250 mg tableta

21406010200320

M, N, O, or Y

4 tablets

 500 mg tablet

21406010200330

M, N, O, or Y

2 tablets

a-generic available

±Agents with variable dosing based on the patient’s weight, body surface area, blood concentration etc are not subject to quantity limit

^Calculation is based on 4.5 mg/m2 with a standard BSA of 2.0 and rounding up to nearest full dose.1,2

¥ Quantity limit of 91 tablets per 28 days includes 63 tablets of ribociclib and 28 tablets of letrozole

 

PRIOR AUTHORIZATION WITH QUANTITY LIMIT CRITERIA FOR APPROVAL – through Preferred (optional)

Initial Evaluation

Target Agent(s) will be approved when ALL of the following are met:

1.  ONE of the following:

  1. Information has been provided that indicates the patient is currently being treated with the requested agent

OR

B.  The prescriber states the patient is being treated with the requested agent AND is at risk if therapy is changed

OR

C.  ALL of the following:

i.   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 

ii.   ONE of the following:

  1. ALL of the following:
    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

  1. Genetic/specific diagnostic testing has been completed

AND

  1. The results of the genetic/specific diagnostic testing indicate therapy with the requested agent is appropriate

                                        OR

  1. The requested indication does NOT require specific genetic/diagnostic testing per FDA labeling or supported by compendia (NCCN 1 or 2A recommended use, AHFS, DrugDex level of evidence of 1 or 2A) for the requested agent

AND

  1. ONE of the following:
      1. The requested agent 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

      1. The requested agent will be used 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

  1. ONE of the following:
  1. 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

  1. 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

  1. The patient has an intolerance, FDA labeled contraindication, or hypersensitivity 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 

AND

  1. ONE of the following:
      1. The requested agent is a preferred agent

OR

      1. The requested agent is a non-preferred agent AND ONE of the following:
        1. The patient’s medication history indicates use of a preferred agent for the requested indication

OR

        1. The patient has an intolerance, FDA labeled contraindication, or hypersensitivity to ALL preferred agent(s) for the requested indication

OR

        1. BOTH of the following:
          1. NCCN does NOT specify the plan preferred agent(s) as a preferred regimen for the requested indication

AND

            1. NCCN specifies the requested agent as a preferred regimen for the requested indication

OR

        1. The prescriber has provided information in support of use of the non-preferred agent over the preferred agent(s) for the requested indication

Indication

Try/Inadequate response

Preferred Agents

Non-Preferred Agents

Advanced or metastatic breast cancer

Try/inadequate response 1 preferred agent

Ibrance, Verzenio

Kisqali, Kisqali Femara Pack

AND

  1. If the requested agent is Imbruvica 140 mg or 280 mg tablets, ONE of the following:
    1. The patient has tried and had an inadequate response to Imbruvica 140 mg capsules

OR

  1. The patient has an intolerance, FDA labeled contraindication, or hypersensitivity to Imbruvica capsules that is not expected to occur with Imbruvica tablets

AND

  1. If the requested agent is a brand product with a generic equivalent, ONE of the following:
    1. The patient has tried and had an inadequate response to the generic equivalent

OR

  1. The patient has an intolerance, FDA labeled contraindication, or hypersensitivity to the generic equivalent that is not expected to occur with the requested brand agent

AND

          1. The patient does not have any FDA labeled contraindications to the requested agent

AND

          1. The patient does not have any FDA labeled limitation(s) of use that is otherwise not supported in NCCN to the requested agent

AND

          1. ONE of the following:
  1. Quantity limit does NOT apply to the requested agent

OR

  1. The requested quantity (dose) does NOT exceed the program quantity limit

OR

  1. ALL of the following:
  1. The requested quantity (dose) is greater than the program quantity limit

AND

  1. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication

AND

  1. The requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does not exceed the program quantity limit

OR

  1. ALL of the following:
  1. The requested quantity (dose) is greater than the program quantity limit

AND

  1. The requested quantity (dose) is greater than the maximum FDA labeled dose for the requested indication

AND

  1. 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 dose titration requests over the program quantity limit and Vitrakvi

   Up to 12 months for all other requests

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

  1. ONE of the following:
    1. 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

  1. The requested agent is NOT Vitrakvi

AND

  1. The patient does not have any FDA labeled contraindications to the requested agent

AND

  1. The patient does not have any FDA labeled limitation(s) of use that is otherwise not supported in NCCN to the requested agent

AND

  1. ONE of the following:
  1. Quantity limit does NOT apply to the requested agent

OR

  1. The requested quantity (dose) does NOT exceed the program quantity limit

OR

  1. ALL of the following:
  1. The requested quantity (dose) is greater than the program quantity limit

AND

  1. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication

AND

  1. The requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does not exceed the program quantity limit

OR

  1. ALL of the following:
  1. The requested quantity (dose) is greater than the program quantity limit

AND

  1. The requested quantity (dose) is greater than the maximum FDA labeled dose for the requested indication

AND

  1. The prescriber has provided information in support of therapy with a higher dose for the requested indication

Length of Approval:  Up to 12 months

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

FDA Labeled Contraindication(s)

Agent

Contraindications

Afinitor/Afinitor Disperz (everolimus)

Hypersensitivity to everolimus, to other rapamycin derivatives

Alecensa (alectinib)

None

Alunbrig (brigatinib)

None

Ayvakit (avapritinib)

None

Balversa (erdafitinib)

None

Bosulif (bosutinib)

Hypersensitivity to bosutinib

Braftovi (encorafenib)

None

Brukinsa (zanubrutinib)

None

Cabometyx (cabozantinib)

None

Calquence (acalabrutinib)

None

Caprelsa

(vandetanib)

Congenital long QT syndrome

Cometriq (cabozantinib)

None

Copiktra (duvelisib)

None

Cotellic (cobimetinib)

None

Daurismo (glasdegib)

None

Erivedge (vismodegib)

None

Erleada (apalutamide)

Pregnancy

Farydak (panobinostat)

None

Gilotrif (afatinib)

None

Gleevec

(imatinib)

None

Hexalen

(altretamine)

Hypersensitivity to altretamine, preexisting severe bone marrow depression, severe neurological toxicity

Hycamtin

(topotecan)

Severe hypersensitivity to topotecan

Ibrance (palbociclib)

None

Iclusig (ponatinib)

None

Idhifa (enasidenib)

None

Imbruvica (ibrutinib)

None

Inlyta (axitinib)

None

Inrebic (fedratinib)

None

Iressa (gefitinib)

None

Jakafi

(ruxolitinib)

None

Kisqali (ribociclib)

None

Kisqali Femara Pack (ribociclib and letrozole co-packaged)

Hypersensitivity to letrozole, or any excipients of Femara

Koselugo (selumetinib)

None

Lenvima (lenvatinib)

None

Lonsurf (trifluridine/tipiracil)

None

Lorbrena (lorlatinib)

Concomitant use with a strong CYP3A inducer, due to potential for serious hepatotoxicity 

Lynparza (olaparib) capsules

None

Lynparza (olaparib) tablets

None

Lysodren

(mitotane)

None

Matulane

(procarbazine)

Known hypersensitivity to procarbazine, inadequate marrow reserve

Mekinist (trametinib)

None

Mektovi (binimetinib)

None

Nerlynx (neratinib)

None

Nexavar (sorafenib)

Known severe hypersensitivity to sorafenib or its components, use in combination with carboplatin and paclitaxel in patients with squamous cell lung cancer

Ninlaro (ixazomib)

None

Nubeqa (darolutamide)

None

Odomzo (sonidegib)

None

Pemazyre (pemigatinib)

None

Piqray (alpelisib)

Severe hypersensitivity to Piqray or to any of its components

Pomalyst (pomalidomide)

Pregnancy

Retevmo (selpercatinib)

None

Revlimid (lenalidomide)

Pregnancy, severe hypersensitivity to lenalidomide

Rozlytrek (entrectinib)

None

Rubraca (rucaparib)

None

Rydapt (midostaurin)

Hypersensitivity to midostaurin or any of the excipients

Sprycel (dasatinib)

None

Stivarga (regorafenib)

None

Sutent

(sunitinib)

None

Sylatron (peginterferon alfa-2b)

Autoimmune hepatitis, hepatic decompensation (Child-Pugh score >6, Class B and C), hypersensitivity to peginterferon alfa-2b or interferon alfa-2b

Tabrecta (capmatinib)

None

Tafinlar (dabrafenib)

None

Tagrisso (osimertinib)

None

Talzenna (talazoparib)

None

Tarceva

(erlotinib)

None

Targretin (bexarotene)

Pregnancy; known serious hypersensitivity to bexarotene or other components of the product

Tasigna

(nilotinib)

Hypokalemia, hypomagnesemia, long QT syndrome

Tazverik (tazemetostat)

None

Temodar (temozolomide)

Hypersensitivity to dacarbazine (DTIC) or Temodar components

Thalomid (thalidomide)

Pregnancy, hypersensitivity to thalidomide or its components

Tibsovo (ivosidenib)

None

Tretinoin (oral)

known hypersensitivity to tretinoin, any of its components, or other retinoids; sensitivity to parabens

Tukysa (tucatinib)

None

Turalio (pexidartinib)

None

Tykerb

(lapatinib)

Known hypersensitivity to lapatinib or its components

Venclexta (venetoclax)

Concomitant use with strong CYP3A inhibitors at initiation and during ramp-up phase in patients with CLL/SLL

Verzenio (abemaciclib)

None

Vitrakvi (larotrectinib)

None

Vizimpro (dacomitinib)

None

Votrient (pazopanib)

None

Xalkori (crizotinib)

None

Xeloda (capecitabine)

Severe renal failure, hypersensitivity to capecitabine or any of its components, hypersensitivity to 5-fluorouracil

 Xospata (gilteritinib)

Hypersensitivity to gilteritinib or any of the excipients

Xpovio (selinexor)

None

Xtandi (enzalutamide)

Pregnancy

Yonsa (abiraterone acetate)

Pregnancy

Zejula (niraparib)

None

Zelboraf (vemurafenib)

None

Zolinza (vorinostat)

None

Zydelig (idelalisib)

History of serious allergic reactions including anaphylaxis and toxic epidermal necrolysis

Zykadia (ceritinib)

None

Zytiga (abiraterone)

None

 

FDA APPROVED INDICATIONS3-93

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.

SAFETY3-93

Agent

Contraindications

Afinitor/Afinitor Disperz (everolimus)

Hypersensitivity to everolimus, to other rapamycin derivatives

Alecensa (alectinib)

None

Alunbrig (brigatinib)

None

Ayvakit (avapritinib)

None

Balversa (erdafitinib)

None

Bosulif (bosutinib)

Hypersensitivity to bosutinib

Braftovi (encorafenib)

None

Brukinsa (zanubrutinib)

None

Cabometyx (cabozantinib)

None

Calquence (acalabrutinib)

None

Caprelsa

(vandetanib)

Congenital long QT syndrome

Cometriq (cabozantinib)

None

Copiktra (duvelisib)

None

Cotellic (cobimetinib)

None

Daurismo (glasdegib)

None

Erivedge (vismodegib)

None

Erleada (apalutamide)

Pregnancy

Farydak (panobinostat)

None

Gilotrif (afatinib)

None

Gleevec

(imatinib)

None

Hexalen

(altretamine)

Hypersensitivity to altretamine, preexisting severe bone marrow depression, severe neurological toxicity

Hycamtin

(topotecan)

Severe hypersensitivity to topotecan

Ibrance (palbociclib)

None

Iclusig (ponatinib)

None

Idhifa (enasidenib)

None

Imbruvica (ibrutinib)

None

Inlyta (axitinib)

None

Inrebic (fedratinib)

None

Iressa (gefitinib)

None

Jakafi

(ruxolitinib)

None

Kisqali (ribociclib)

None

Kisqali Femara Pack (ribociclib and letrozole co-packaged)

Hypersensitivity to letrozole, or any excipients of Femara

Koselugo (selumetinib)

None

Lenvima (lenvatinib)

None

Lonsurf (trifluridine/tipiracil)

None

Lorbrena (lorlatinib)

Concomitant use with a strong CYP3A inducer, due to potential for serious hepatotoxicity 

Lynparza (olaparib) capsules

None

Lynparza (olaparib) tablets

None

Lysodren

(mitotane)

None

Matulane

(procarbazine)

Known hypersensitivity to procarbazine, inadequate marrow reserve

Mekinist (trametinib)

None

Mektovi (binimetinib)

None

Nerlynx (neratinib)

None

Nexavar (sorafenib)

Known severe hypersensitivity to sorafenib or its components, use in combination with carboplatin and paclitaxel in patients with squamous cell lung cancer

Ninlaro (ixazomib)

None

Nubeqa (darolutamide)

None

Odomzo (sonidegib)

None

Pemazyre (pemigatinib)

None

Piqray (alpelisib)

Severe hypersensitivity to Piqray or to any of its components

Pomalyst (pomalidomide)

Pregnancy

Retevmo (selpercatinib)

None

Revlimid (lenalidomide)

Pregnancy, severe hypersensitivity to lenalidomide

Rozlytrek (entrectinib)

None

Rubraca (rucaparib)

None

Rydapt (midostaurin)

Hypersensitivity to midostaurin or any of the excipients

Sprycel (dasatinib)

None

Stivarga (regorafenib)

None

Sutent

(sunitinib)

None

Sylatron (peginterferon alfa-2b)

Autoimmune hepatitis, hepatic decompensation (Child-Pugh score >6, Class B and C), hypersensitivity to peginterferon alfa-2b or interferon alfa-2b

Tabrecta (capmatinib)

None

Tafinlar (dabrafenib)

None

Tagrisso (osimertinib)

None

Talzenna (talazoparib)

None

Tarceva

(erlotinib)

None

Targretin (bexarotene)

Pregnancy; known serious hypersensitivity to bexarotene or other components of the product

Tasigna

(nilotinib)

Hypokalemia, hypomagnesemia, long QT syndrome

Tazverik (tazemetostat)

None

Temodar (temozolomide)

Hypersensitivity to dacarbazine (DTIC) or Temodar components

Thalomid (thalidomide)

Pregnancy, hypersensitivity to thalidomide or its components

Tibsovo (ivosidenib)

None

Tretinoin (oral)

known hypersensitivity to tretinoin, any of its components, or other retinoids; sensitivity to parabens

Tukysa (tucatinib)

None

Turalio (pexidartinib)

None

Tykerb

(lapatinib)

Known hypersensitivity to lapatinib or its components

Venclexta (venetoclax)

Concomitant use with strong CYP3A inhibitors at initiation and during ramp-up phase in patients with CLL/SLL

Verzenio (abemaciclib)

None

Vitrakvi (larotrectinib)

None

Vizimpro (dacomitinib)

None

Votrient (pazopanib)

None

Xalkori (crizotinib)

None

Xeloda (capecitabine)

Severe renal failure, hypersensitivity to capecitabine or any of its components, hypersensitivity to 5-fluorouracil

 Xospata (gilteritinib)

Hypersensitivity to gilteritinib or any of the excipients

Xpovio (selinexor)

None

Xtandi (enzalutamide)

Pregnancy

Yonsa (abiraterone acetate)

Pregnancy

Zejula (niraparib)

None

Zelboraf (vemurafenib)

None

Zolinza (vorinostat)

None

Zydelig (idelalisib)

History of serious allergic reactions including anaphylaxis and toxic epidermal necrolysis

Zykadia (ceritinib)

None

Zytiga (abiraterone)

None

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  92. Tabrecta prescribing information. Novartis Pharmaceuticals Corp. May 2020.
  93. Retevmo prescribing information. Lilly USA, LLC. May 2020.

This pharmacy policy is not an authorization, certification, explanation of benefits or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All pharmacy policies are based on (i) information in FDA approved package inserts (and black box warning, alerts, or other information disseminated by the FDA as applicable); (ii) research of current medical and pharmacy literature; and/or (iii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.
 
The purpose of pharmacy policies are to provide a guide to coverage. Pharmacy policies are not intended to dictate to physicians how to practice medicine. Physicians should exercise their medical judgment in providing the care they feel is most appropriate for their patients.
 
Neither this policy, nor the successful adjudication of a pharmacy claim, is guarantee of payment.

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