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 Program Summary

 

This program does not have the preferred product option.

 

This program applies to Blue Partner, Commercial, GenPlus, NetResults A series, SourceRx, and Health Insurance Marketplace formularies.

 

TARGET AGENTS

Afinitor® (everolimus)

Afinitor® Disperz (everolimus)

Alecensa® (alectinib)

Alunbrig™ (brigatinib)

Balversa (erdafitinib)

Bosulif® (bosutinib)

Braftovi™ (encorafenib)

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)

Iclusig™ (ponatinib)

Idhifa® (enasidenib)

Inlyta® (axitinib)

Imbruvica™ (ibrutinib)

Iressa® (gefitinib)

Jakafi™ (ruxolitinib)

Kisqali® (ribociclib)

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

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)

Piqray® (alpelisib)

Pomalyst® (pomalidomide)

Revlimid® (lenalidomide)

Rubraca™ (rucaparib)

Rydapt® (midostaurin)

Sprycel® (dasatinib)

Stivarga® (regorafenib)

Sutent® (sunitinib)

Sylatron® (peginterferon alfa-2b)

TagrissoTM (osimertinib)

Tafinlar® (dabrafenib)

Talzenna™ (talazoparib)

aTarceva® (erlotinib)

aTargretin® (bexarotene)

Tasigna® (nilotinib)

aTemodar® (temozolomide)

Thalomid® (thalidomide)

Tibsovo® (ivosidenib)

Tretinoin® (oral)

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)

Zytiga™ (abiraterone)

a-generic available

 

QUANTITY LIMIT TARGET AGENTS - RECOMMENDED LIMITS±

Brand (generic)

GPI

Quantity Per Day Limit

Afinitor (everolimus) oral tablet

 

2.5 mg tablet

21532530000310

1 tablet

5 mg tablet

21532530000320

1 tablet

7.5 mg tablet

21532530000325

1 tablet

10 mg tablet

21532530000330

1 tablet

Afinitor DISPERZ (everolimus) oral tablet

2 mg tablet for oral suspension

21532530007310

2 tablets^

3 mg tablet for oral suspension

21532530007320

3 tablets^

5 mg tablet for oral suspension

21532530007340

2 tablets^

Alecensa (alectinib) oral capsule

150 mg capsule

21534007100120

8 capsules

Alunbrig (brigatinib) tablet

30 mg tablet

21534010000330

6 tablets

90 mg tablet

21534010000350

1 tablet

180 mg tablet

21534010000365

1 tablet

Starter PAK

2153401000B720

1 pak/180 days

Balversa (erdafitinib) tablet

3 mg tablet

21532225000320

3 tablets

4 mg tablet

21532225000325

2 tablets

5 mg tablet

21532225000330

1 tablet

Bosulif (bosutinib) oral tablet

100 mg tablet

21534012000320

4 tablets

400 mg tablet

21534012000327

1 tablet

500 mg tablet

21534012000340

1 tablet

Braftovi (encorafenib) oral capsules

50 mg capsules

21532040000120

6 capsules

75 mg capsules

21532040000130

6 capsules

Cabometyx (cabozantinib) oral tablet

20 mg tablet

21534013100320

1 tablet

40 mg tablet

21534013100330

1 tablet

60 mg tablet

21534013100340

1 tablet

Calquence (acalabrutinib) oral capsules

100 mg capsule

21534003000120

2 capsules

Caprelsa (vandetanib) oral tablet

 

100 mg tablet

21534085000320

2 tablets

300 mg tablet

21534085000340

1 tablet

Cometriq (cabozantinib) oral capsule

 

140 mg daily dose carton

21534013106480

1 carton/28 days

100 mg daily dose carton

21534013106470

1 carton/28 days

60 mg daily dose carton

21534013106460

1 carton/28 days

Copiktra (duvelisib) oral capsule

15 mg capsule

21538030000120

56 capsules/28 days

25 mg capsule

21538030000130

56 capsules/28 days

Cotellic (cobimetinib) oral tablet

20 mg tablet

21533530200320

63 tablets/28 days

Daurismo (glasdegib) oral tablet

25 mg tablet

21370030300320

2 tablets

100 mg tablet

21370030300335

1 tablet

Erivedge (vismodegib) oral capsule

150 mg capsule

21370070000120

1 capsule

Erleada (apalutamide) oral tablet

60 mg tablet

21402410000320

4 tablets

Farydak (panobinostat) oral capsule

10 mg capsule

21531550100120

6 capsules/21 days

15 mg capsule

21531550100130

6 capsules/21 days

20 mg capsule

21531550100140

6 capsules/21 days

Gilotrif (afatinib) oral tablet

 

20 mg tablet

21534006100320

1 tablet

30 mg tablet

21534006100330

1 tablet

40 mg tablet

21534006100340

1 tablet

Gleevec (imatinib) oral tablet

 

100 mg tablet

21534035100320

3 tablets

400 mg tablet

21534035100340

2 tablets

Hexalen (altretamine) oral capsule

50 mg capsule

21100005000110

No Quantity Limit

Hycamtin (topotecan) oral capsule

0.25 mg capsule

21550080100120

No Quantity Limit

1 mg capsule

21550080100140

No Quantity Limit

Ibrance (palbociclib) oral capsule

75 mg capsule

21531060000120

21 capsules/28 days

100 mg capsule

21531060000130

21 capsules/ 28 days

125 mg capsule

21531060000140

21 capsules/28 days

Iclusig (ponatinib) oral tablet

 

15 mg tablet

21534075100320

2 tablets

45 mg tablet

21534075100340

1 tablet

Idhifa® (enasidenib) oral tablet

50 mg tablet

21535030200320

1 tablet

100 mg tablet

21535030200340

1 tablet

Imbruvica (ibrutinib) oral capsule

 

70 mg capsule

21534033000110

1 capsule

140 mg capsule

21534033000120

4 capsules

140 mg tablet

21534033000320

1 tablet

280 mg tablet

21534033000330

1 tablet

420 mg tablet

21534033000340

1 tablet

560 mg tablet

21534033000350

1 tablet

Inlyta (axitinib) oral tablet

 

1 mg tablet

21534008000320

6 tablets

5 mg tablet

21534008000340

4 tablets

Iressa (gefitinib) oral tablet

250 mg tablet

21534030000320

1 tablet

Jakafi (ruxolitinib) oral tablet

 

5 mg tablet

21537560200310

2 tablets

10 mg tablet

21537560200320

2 tablets

15 mg tablet

21537560200325

2 tablets

20 mg tablet

21537560200330

2 tablets

25 mg tablet

21537560200335

2 tablets

Kisqali (ribociclib) oral tablet

200 mg tablet

21531070500320

63 tablets/28 days

200 mg daily dose pack (200 mg tablets)

2153107050B720

21 tablets/28 days

400 mg daily dose pack (200 mg tablets)

2153107050B740

42 tablets/28 days

600 mg daily dose pack (200 mg tablets)

2153107050B760

63 tablets/28 days

Kisqali Femara Pack (ribociclib and letrozole co-packaged) oral tablet

200 mg ribociclib tablets and 2.5 mg letrozole tablets

2199000260B720

91 tablets/28 days¥

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

2199000260B730

49 tablets/28 days¥

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

2199000260B740

70 tablets/28 days¥

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

2199000260B760

91 tablets/28 days¥

Lenvima (lenvatinib) oral capsule

4 mg capsule therapy pack

2153405420B210

30 capsules/30 days

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

2153405420B215

60 capsules/30 days

10 mg capsule therapy pack

2153405420B220

30 capsules/30 days

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

2153405420B223

90 capsules/30 days

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

2153405420B240

60 capsules/30 days

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

2153405420B244

90 capsules/30 days

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

2153405420B230

60 capsules/30 days

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

2153405420B250

90 capsules/30 days

Lonsurf (trifluridine/tipiracil) oral tablet

15 mg/6.14 mg tablet

21990002750320

100 tablets/28 days

20 mg/8.19 mg tablet

21990002750330

80 tablets/28 days

Lorbrena (lorlatinib) oral tablet

25 mg tablet

21534056000320

3 tablets

100 mg tablet

21534056000330

1 tablet

Lynparza (olaparib) oral capsule

50 mg capsule

21535560000120

16 capsules

Lynparza (olaparib) oral tablet

100 mg tablet

21535560000330

4 tablets

150 mg tablet

21535560000340

4 tablets

Lysodren (mitotane) oral tablet

500 mg tablet

21402250000320

No Quantity Limit

Matulane (procarbazine) oral capsule

50mg capsule

21700050100105

No Quantity Limit

Mekinist (trametinib) oral tablet

 

0.5 mg tablet

21533570100310

3 tablets

2 mg tablet

21533570100330

1 tablet

Mektovi (binimetinib) oral tablet

15 mg tablet

21533520000320

6 tablets

Nerlynx (neratinib) oral tablet

40 mg tablet

21534058100320

6 tablets

Nexavar (sorafenib) oral tablet

 

200 mg tablet

21533060400320

4 tablets

Ninlaro (ixazomib) oral capsule

2.3 mg capsule

21536045100120

3 capsules/28 days

3 mg capsule

21536045100130

3 capsules/28 days

4 mg capsule

21536045100140

3 capsules/28 days

Nubeqa (darolutamide) oral tablet

300 mg tablet

21402425000320

4 tablets

Odomzo (sonidegib) oral capsule

200 mg capsule

21370060200120

30 capsules/30 days

Piqray (alpelisib)

 

200 mg daily dose pack (200 mg tablets)

2153801000B720

1 pack (28 tablets)/28 days

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

2153801000B725

1 pack (56 tablets)/28 days

300 mg daily dose pack (150 mg tablets)

2153801000B730

1 pack (56 tablets)/28 days

Pomalyst (pomalidomide) oral capsule

 

1 mg capsule

21450080000110

21 capsules/28 days

2 mg capsule

21450080000115

21 capsules/28 days

3 mg capsule

21450080000120

21 capsules/28 days

4 mg capsule

21450080000125

21 capsules/28 days

Revlimid (lenalidomide) oral capsule

 

2.5 mg capsule

99394050000110

1 capsule

5 mg capsule

99394050000120

1 capsule

10 mg capsule

99394050000130

1 capsule

15 mg capsule

99394050000140

21 capsules/28 days

20 mg capsule

99394050000145

21 capsules/28 days

25 mg capsule

99394050000150

21 capsules/28 days

Rubraca (rucaparib) oral tablet

200 mg tablet

21535570200320

4 tablets

250 mg tablet

21535570200325

4 tablets

300 mg tablet

21535570200330

4 tablets

Rydapt (midostaurin) oral capsule

25 mg capsule

21533030000130

8 capsules

Sprycel (dasatinib) oral tablet

 

20 mg tablet

21534020000320

3 tablets

50 mg tablet

21534020000340

1 tablet

70 mg tablet

21534020000350

1 tablet

80 mg tablet

21534020000354

1 tablet

100 mg tablet

21534020000360

1 tablet

140 mg tablet

21534020000380

1 tablet

Stivarga (regorafenib) oral tablet

 

40 mg tablet

21533050000320

84 tablets/28 days

Sutent (sunitinib) oral capsule

 

12.5 mg capsule

21533070300120

3 capsules

25 mg capsule

21533070300130

1 capsule

37.5 mg capsule

21533070300135

1 capsule

50 mg capsule

21533070300140

1 capsule

Sylatron (peginterferon alfa-2b) injection

200 mcg

21700075206410

21700075206450

No Quantity Limit

300 mcg

21700075206420

21700075206460

No Quantity Limit

600 mcg

21700075206430

No Quantity Limit

Tafinlar (dabrafenib) oral capsule

 

50 mg capsule

21532025100120

4 capsules

75 mg capsule

21532025100130

4 capsules

Talzenna (talazoparib) oral capsule

0.25 mg capsule

21535580400110

3 capsules

1 mg capsule

21535580400120

1 capsule

Tagrisso (osimertinib) oral tablet

40 mg tablet

21534065200320

1 tablet

80 mg tablet

21534065200330

1 tablet

Tarceva (erlotinib)a oral tablet

 

25 mg tablet

21534025100320

2 tablets

100 mg tablet

21534025100330

1 tablet

150 mg tablet

21534025100360

1 tablet

Targretin (bexarotene)a oral capsule

75 mg capsule

21708220000120

No Quantity Limit

Tasigna (nilotinib) oral capsule

 

50 mg capsule

21534060200110

4 capsules

150 mg capsule

21534060200115

4 capsules

200 mg capsule

21534060200125

4 capsules

Temodar (temozolomide)a oral capsule

5 mg capsule

21104070000110

No Quantity Limit

20 mg capsule

21104070000120

No Quantity Limit

100 mg capsule

21104070000140

No Quantity Limit

140 mg capsule

21104070000143

No Quantity Limit

180 mg capsule

21104070000147

No Quantity Limit

250 mg capsule

21104070000150

No Quantity Limit

Thalomid (thalidomide) oral capsule

 

50 mg capsule

99392070000120

1 capsule

100 mg capsule

99392070000130

1 capsule

150 mg capsule

99392070000135

2 capsules

200 mg capsule

99392070000140

2 capsules

Tibsovo (ivosidenib) oral tablet

250 mg tablet

21534940000320

2 tablets

Tretinoin oral capsule

10 mg capsule

21708080000110

No Quantity Limit

Turalio (pexidartinib)

200 mg capsule

21534073010120

4 capsules

Tykerb (lapatinib) oral tablet

 

250 mg tablet

21534050100320

6 tablets

Venclexta (venetoclax) oral tablet

10 mg tablet

21470080000320

2 tablets

50 mg tablet

21470080000340

1 tablet

100 mg tablet

21470080000360

6 tablets

Starter pack

2147008000B720

1 pack (42 tablets)/180 days

Verzenio (abemaciclib) oral tablet

50 mg tablet

21531010000305

2 tablets

100 mg tablet

21531010000310

2 tablets

150 mg tablet

21531010000315

2 tablets

200 mg tablet

21531010000320

2 tablets

Vitrakvi (larotrectinib) oral capsule

25 mg capsule

21533835200120

6 capsules

100 mg capsule

21533835200150

2 capsules

Vitrakvi (larotrectinib) oral solution

20 mg/mL solution

21533835202020

10 mLs

Vizimpro (dacomitinib) oral tablet

15 mg tablet

21534019000320

1 tablet

30 mg tablet

21534019000330

1 tablet

45 mg tablet

21534019000340

1 tablet

Votrient (pazopanib) oral tablet

 

200 mg tablet

21534070100320

4 tablets

Xalkori (crizotinib) oral capsule

 

200 mg capsules

21534015000120

2 capsules

250 mg capsules

21534015000125

2 capsules

Xeloda (capecitabine)a oral tablet

150 mg tablet

21300005000320

No Quantity Limit

500 mg tablet

21300005000350

No Quantity Limit

Xospata (gilteritinib) oral tablet

40 mg tablet

21534031200320

3 tablets

Xpovio (selinexor)

60 mg once weekly therapy pack (20 mg tablets)

2156006000B750

12 tablets (1 box)/28 days

80 mg once weekly therapy pack (20 mg tablets)

2156006000B740

16 tablets (1 box)/28 days

80 mg twice weekly therapy pack (20 mg tablets)

2156006000B720

32 tablets (1 box)/28 days

100 mg once weekly therapy pack (20 mg tablets)

2156006000B730

20 tablets (1 box)/28 days

Xtandi (enzalutamide) oral capsule

40 mg capsules

21402430000120

4 capsules

Yonsa (abiraterone acetate) oral tablet

125 mg tablet

21406010200310

4 tablets

Zejula (niraparib) oral capsule

100 mg capsules

21535550200120

3 capsules

Zelboraf (vemurafenib) oral tablet

 

240 mg tablets

21532080000320

8 tablets

Zolinza (vorinostat) oral capsule

 

100 mg capsules

21531575000120

4 capsules

Zydelig (idelalisib) oral tablet

 

100 mg tablets

21538040000320

 

2 tablets

150 mg tablets

21538040000330

 

2 tablets

Zykadia (ceritinib)

 

150 mg capsules

21534014000130

3 capsules

150 mg tablet

21534014000330

3 tablets

Zytiga (abiraterone) oral tablet

 

250 mg tableta

21406010200320

4 tablets

500 mg tablet

21406010200330

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.70,71

¥ 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

Initial Evaluation

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

1. ONE of the following:

A. There is documentation that the patient is currently being treated with the requested agent

           OR

  1. 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:

  1. 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

  1. 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:

a. 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

b. 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 a documented 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:

a. The requested agent is a preferred agent* (*Preferred agents are determined by the client and may include both brand and generic agents)

OR

  1. The requested agent is a non-preferred agent (as determined by the client) 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 a documented intolerance, FDA labeled contraindication, or hypersensitivity to ALL preferred agent(s) for the requested indication                                                    OR
  2. The prescriber has provided documentation in support of use of the non-preferred agent over the preferred agent(s) for the requested indication

          AND

  1. 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

    1. The patient has a documented 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:

a. The patient has tried and had an inadequate response to the generic equivalent

         OR

    1. The patient has a documented 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

4. 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 submitted documentation 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 Prime Therapeutics 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 submitted documentation in support of therapy with a higher dose for the requested indication

 

Length of Approval: Up to 12 months

FDA Companion Diagnostics: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/ucm301431.htm

 

FDA APPROVED INDICATIONS1-69,72-83

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.

SAFETY1-69,72-83

Agent

Contraindications

Afinitor/Afinitor Disperz (everolimus)

Hypersensitivity to everolimus, to other rapamycin derivatives

Alecensa (alectinib)

None

Alunbrig (brigatinib)

None

Balversa (erdafitinib)

None

Bosulif (bosutinib)

Hypersensitivity to bosutinib

Braftovi (encorafenib)

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

Iressa (gefitinib)

None

Jakafi

(ruxolitinib)

None

Kisqali (ribociclib)

None

Kisqali Femara Pack (ribociclib and letrozole co-packaged)

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

Piqray (alpelisib)

Severe hypersensitivity to Piqray or to any of its components

Pomalyst (pomalidomide)

Pregnancy

Revlimid (lenalidomide)

Pregnancy, severe hypersensitivity to lenalidomide

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

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

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

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

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)

Pregnancy

 

REFERENCES

  1. Afinitor/Afinitor Disperz prescribing information. Novartis. April 2018.
  2. Alecensa prescribing information. Genentech. June 2018.
  3. Alunbrig prescribing information. Ariad Pharmaceuticals Inc. April 2017.
  4. Bosulif prescribing information. Pfizer Inc. December 2017.
  5. Braftovi prescribing information. Array BioPharma Inc. June 2018.
  6. Cabometyx prescribing information. Exelixis Inc. December 2017.
  7. Calquence prescribing information. AstraZeneca. November 2017.
  8. Caprelsa prescribing information. AstraZeneca Pharmaceuticals. July 2016.
  9. Cometriq prescribing information. Exelixis, Inc. January 2018.
  10. Cotellic prescribing information. Genentech. January 2018.
  11. Erivedge prescribing information. Genentech. November 2017.
  12. Erleada prescribing information. Janssen Ortho LLC. February 2018.
  13. Farydak prescribing information. Novartis. December 2017.
  14. Gilotrif prescribing information. Boehringer Ingelheim Pharmaceuticals. January 2018.
  15. Gleevec prescribing information. Novartis. September 2017.
  16. Hexalen prescribing Information. MGI PHARMA, INC. June 2018.
  17. Hycamtin prescribing Information. GSK. July 2017.
  18. Ibrance prescribing information. Pfizer. February 2018.
  19. Iclusig prescribing Information. ARIAD Pharmaceuticals. December 2017.
  20. Idhifa prescribing information. Celgene. August 2017.
  21. Imbruvica prescribing information. Pharmacyclics, Inc. June 2018.
  22. Inlyta prescribing information. Pfizer. New York, NY. March 2017.
  23. Iressa prescribing information. AstraZeneca. July 2015.
  24. Jakafi prescribing information. Incyte. December 2017.
  25. Kisqali Femara Pack prescribing information. Novartis. May 2018.
  26. Kisqali prescribing information. Novartis. July 2018.
  27. Lenvima prescribing information. Eisai. June 2018.
  28. Lonsurf prescribing information. Taiho Oncology. July 2017.
  29. Lynparza capsules prescribing information. AstraZeneca. October 2017.
  30. Lynparza tablets prescribing information. AstraZeneca. February 2018.
  31. Lysodren prescribing Information. E.R. Squibb & Sons, L.L.C. July 2018.
  32. Matulane prescribing Information. Sigma-tau. February 2018.
  33. Mekinist prescribing information. GlaxoSmithKline. May 2018.
  34. Mektovi prescribing information. Array BioPharma Inc. June 2018.
  35. Nerlynx prescribing information. Puma Biotech. July 2018.
  36. Nexavar prescribing information. Bayer. December 2017.
  37. Ninlaro prescribing information. Millennium. November 2016.
  38. Odomzo prescribing information. Novartis. September 2017.
  39. Pomalyst prescribing information. Celgene Corporation. June 2018.
  40. Revlimid prescribing information. Celgene Corporation. December 2017.
  41. Rubraca prescribing information. Clovis Oncology. April 2018.
  42. Rydapt prescribing information. Novartis. June 2018.
  43. Sprycel prescribing information. E.R. Squibb & Sons, L.L.C. January 2018.
  44. Stivarga prescribing information. Bayer Healthcare Pharmaceuticals. June 2018.
  45. Sutent prescribing information. Pfizer. November 2017.
  46. Sylatron prescribing information. Schering Corporation. May 2018.
  47. Tafinlar prescribing information. GlaxoSmithKline. May 2018.
  48. Tagrisso prescribing information. AstraZeneca. April 2018.
  49. Tarceva prescribing information. Genentech. October 2016.
  50. Targretin prescribing information. Valeant. August 2015.
  51. Tasigna prescribing information. Novartis. July 2018.
  52. Temodar prescribing Information. Merck Sharp & Dohme Corp. October 2017.
  53. Thalomid prescribing information. Celgene Corporation. December 2017.
  54. Tibsovo prescribing information. Agios Pharmaceuticals, Inc. July 2018.
  55. Tretinoin prescribing information. Barr Laboratories, Inc. January 2018.
  56. Tykerb prescribing information. GSK. April 2017.
  57. Venclexta prescribing information. AbbVie Inc. November 2018.
  58. Verzenio prescribing information. Eli Lilly and Company. February 2018.
  59. Votrient prescribing information. GSK. May 2017.
  60. Xalkori prescribing information. Pfizer. February 2018.
  61. Xeloda prescribing information. Genentech, Inc. April 2018.
  62. Xtandi prescribing information. Astellas Pharma US, Inc. July 2018.
  63. Yonsa prescribing information. Sun Pharmaceuticals Inc. June 2018.
  64. Zejula prescribing information. Tesaro. May 2018.
  65. Zelboraf prescribing information. Genentech, USA. December 2017.
  66. Zolinza prescribing information. Merck Sharp & Dohme Corp. December 2015.
  67. Zydelig prescribing information. Gilead Sciences, Inc. February 2018.
  68. Zykadia prescribing information. Novartis Pharmaceuticals. December 2017.
  69. Zytiga prescribing information. Janssen Biotech, Inc. May 2018.
  70. 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.
  71. 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.
  72. Copiktra prescribing information. Verastem, Inc. September 2018.
  73. Vizimpro prescribing information. Pfizer Inc. September 2018.
  74. Talzenna prescribing information. Pfizer Inc. October 2018.
  75. Lorbrena prescribing information. Pfizer Inc. November 2018.
  76. Daurismo prescribing information. Pfizer Inc. November 2018.
  77. Vitrakvi prescribing information. Loxo Oncology, Inc. November 2018.
  78. Xospata prescribing information. Astellas Pharma Inc. November 2018.
  79. Balversa prescribing information. Janssen Pharmaceutical Companies. April 2019.
  80. Piqray prescribing information. Novartis Pharmaceuticals Corp. May 2019.
  81. Xpovio prescribing information. Karyopharm Therapeutics Inc. July 2019.
  82. Nubeqa prescribing information. Bayer HealthCare Pharmaceuticals Inc. July 2019.
  83. Turalio prescribing information. Daiichi Sankyo, Inc. August 2019.

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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