New Century Health Policy Changes May 2021

Home , Duvelisib, Niraparib

Policy # Policy Name Type of Change Brief Description of Policy Change Reason for Changes NEW Abecma (idecabtagene vicleucel) N/A N/A N/A N/A‐ Add addendum for Fidelis Care state specific UM ONC_1041 LHRH agonists and antagonist N/A N/A criteria Add inclusion criteria: 3. Breast cancer‐ Abraxane (nab‐paclitaxel) may be used in combination with Tecentriq (atezolizumab) in the first line setting OR in the second line/subsequent line setting if the member has not received the above regimen previously and there is no history of progression on another Immune Checkpoint Inhibitor ( e.g. Keytruda) 5.Non ‐Small Cell Lung Cancer (NSCLC) a.In the rst line se�ng for metasta�c, squamous, Non‐Small Cell Lung Cancer, Taxol (paclitaxel) is preferred over Abraxane (nab‐paclitaxel). The above recommendation is based on results of KEYNOTE‐407 trial which showed no difference in outcomes between the use of Taxol (paclitaxel) UM ONC_1179 Abraxane (nab‐paclitaxel) Negative change and Abraxane (nab‐paclitaxel). Per Clinical Trial Analysis/Criteria

Remove exclusion criteria: UM ONC_1179 Abraxane (nab‐paclitaxel) Positive change 1.O ﬀ‐label indica�ons for Abraxane (nab‐paclitaxel) in ovarian cancer, metasta�c melanoma, urothelial carcinoma, and endometrial carcinoma. Per Clinical Trial Analysis/Criteria Remove inclusion criteria: Advanced/Metastatic Renal Cell Carcinoma c.NOTE: Votrient (pazopanib) is PREFERRED in subsequent se�ng for any IMDC risk clear cell RCC per NCH pathway & NCH Policy (if not used in UM ONC_1195 Votrient (pazopanib) Positive change first line). Per NCH L1 Pathway Remove inclusion criteria: 2.Chronic Myeloid Leukemia (CML)‐ b. UM ONC_1196 Sprycel (dasatinib) Positive change c.As ini�al or subsequent therapy for members with CML with any of the following muta�ons: Y253H or E255K/V. Per Compendia Listing Add exclusion criteria: 2.Sprycel (dasa�nib) is being used on Ph or BCR‐ABL nega�ve CML or in members with the following mutations of BCR‐ABL1: T315I/A, F317L/V/I/C UM ONC_1196 Sprycel (dasatinib) Negative change or V299L. . Per Compendia Listing Add inclusion criteria: 2.Renal Cell Carcinoma (RCC) a.NOTE: Per NCH Policy & NCH Pathway, Torisel is only recommended as monotherapy for metasta�c clear cell renal cell carcinoma, in members UM ONC_1200 Torisel (temsrolimus) Negative change who have failed two oral TKIs and one or more Immune Checkpoint Inhibitor.. Step Therapy Criteria Remove inclusion criteria: b.Torisel (temsirolimus) may be used as a single agent for ini�al/subsequent therapy in members with metasta�c/advanced non‐clear cell Renal UM ONC_1200 Torisel (temsrolimus) Positive change Cell Carcinoma‐RCC. More Cost Effective Alternative(s)

Add inclusion criteria: B.Malignant Melanoma 2.NOTE: Per NCH Policy & NCH Pathway, Zelboraf (vemurafenib) in combina�on with a MEK inhibitor ( e.g. cobime�nib) is a non‐preferred regimen/combination for use as adjuvant therapy in resected stage III melanoma; Opdivo (nivolumab) or Keytruda(pembrolizumab) for 1 year is the preferred option in this clinical setting. This recommendation is based on the lack of Level 1 evidence ( randomized trials and/or meta‐analyses) supporting superior outcomes with anti‐BRAF targeted therapy vs Immune Checkpoint Inhibitor therapy. 3.NOTE: Per NCH Pathway & NCH Policy, Zelboraf (vemurafenib) in combina�on with Cotellic (cobime�nib) + Tecentriq (atezolizumab) is non‐ preferred for the treatment of metastatic/recurrent/unresectable BRAF V600 mutation positive malignant melanoma.This recommendation is based on the lack of Level 1 evidence (randomized trials and or meta‐analyses) supporting superior outcomes with the above regimen in UM ONC_1207 Zelboraf (vemurafenib) Negative change comparison to [Yervoy(ipilimumab) + Opdivo(nivolumab)] the recommended regimen per NCH policy. Per Clinical Trial Analysis/Criteria Add exclusion criteria: B.Use of Zelboraf (vemurafenib) as a single agent or in combination with Cotellic (cobimetinib) + Tecentriq (atezolizumab) in metastatic/recurrent/unresectable BRAF V600 mutation positive malignant melanoma. UM ONC_1207 Zelboraf (vemurafenib) Positive change D.Treatment exceeds the maximum limit of 240 (240 mg) capsules tablets a month. per FDA Labeling Add inclusion criteria: UM ONC_1226 Zaltrap (ziv‐aflibercept) Negative change Zaltrap use is not recommended for metastatic colorectal cancer. More Cost Effective Alternative(s) Add inclusion criteria: 2.Chronic Myelogenous Leukemia i.The member has experienced disease progression / intolerance to three or more of the following tyrosine kinase inhibitors: Gleevec (ima�nib), Tasigna (nilotinib), or Bosulif (bosutinib), or Sprycel(dasatinib) OR UM ONC_1240 Synribo (omacetaxine) Negative change ii.The member has a T315I muta�on and has failed Iclusig (ponatinib) to treat CML with this mutation. Step Therapy Criteria Add inclusion criteria: 2.BRAF V600E or V600K muta�on posi�ve Melanoma a.NOTE: For adjuvant therapy of BRAF V600 E or V600K muta�on posi�ve, stage III melanoma, the preferred agents per NCH Policies & NCH Pathway, for adjuvant therapy are Opdivo (nivolumab OR Keytruda (pembrolizumab). Tafinlar (dabrafenib) + Mekinist (trametinib) is non‐preferred for use in the adjuvant setting based on a lack of Level 1 evidence that nivolumab or pembrolizumab monotherapy is inferior to the above UM ONC_1250 Tafinlar (dabrafenib) Negative change combination. Per NCH L1 Pathway Add inclusion criteria: b.NOTE: For systemic therapy of metasta�c BRAF V600E or V600K mutation positive melanoma the preferred oral combination, per NCH Policies and NCH Pathway, is cobimetinib + vemurafenib. c.Ta nlar (dabrafenib) may be used as a single agent or in combination with Mekinist (trametinib) in members who have intolerance UMPolicy ONC_1250 # TafinlarPolicy Name (dabrafenib) PositiveType of Changechange to/contraindicationBrief Description of Policyto the Changeuse of [Cobimetinib + Vemurafenib]. PerReason Compendia for Changes Listing NEW Abecma (idecabtagene vicleucel) N/A RemoveN/A inclusion criteria: N/A 3.Non ‐Small Cell Lung Cancer (NSCLC) N/A‐ Add addendum for Fidelis Care state specific UM ONC_1041 LHRH agonists and antagonist N/A a.TaN/A  nlar (dabrafenib) may be used as a single agent or in combination with Mekinist (trametinib) as first line or subsequent line therapy for criteria recurrentAdd inclusion or metastatic criteria: BRAF V600E mutation‐positive NSCLC. 4.Thyroid3. Breast Cancercancer‐ Abraxane (nab‐paclitaxel) may be used in combination with Tecentriq (atezolizumab) in the first line setting OR in the second a.Theline/subsequent member has line anaplas setting� c,if papillary,the member follicular, has not and received Hürthle the Cell above thyroid regimen carcinoma previously and Ta andnlar there (dabrafenib) is no history may of be progression used as a single on another agent/ in combinationImmune Checkpoint with Mekinist Inhibitor (trametinib) ( e.g. Keytruda) for radioactive iodine‐refractory ( if radioactive iodine therapy is appropriate) BRAF V600E mutation‐ positive5.Non ‐Small unresectable/recurrent/metastatic Cell Lung Cancer (NSCLC) disease. UM ONC_1250 Tafinlar (dabrafenib) Negative change a.In the rst line se�ng for metasta�c, squamous, Non‐Small Cell Lung Cancer, Taxol (paclitaxel) is preferred over Abraxane (nab‐paclitaxel). The Per Compendia Listing Addabove inclusion recommendation criteria: is based on results of KEYNOTE‐407 trial which showed no difference in outcomes between the use of Taxol (paclitaxel) UM ONC_1179 Abraxane (nab‐paclitaxel) Negative change 4.Thyroidand Abraxane Cancer (nab‐paclitaxel). Per Clinical Trial Analysis/Criteria a.The member has anaplastic, papillary, follicular, and Hürthle Cell thyroid carcinoma and Tafinlar (dabrafenib) may be used as a single agent/in combinationRemove exclusion with Mekinistcriteria: (trametinib) for radioactive iodine‐refractory ( if radioactive iodine therapy is appropriate) BRAF V600E mutation‐ UM ONC_1250ONC_1179 TafinlarAbraxane (dabrafenib) (nab‐paclitaxel) Positive change positive1.O ﬀ‐label unresectable/recurrent/metastatic indica�ons for Abraxane (nab‐paclitaxel) disease. in ovarian cancer, metasta�c melanoma, urothelial carcinoma, and endometrial carcinoma. Per CompendiaClinical Trial Listing Analysis/Criteria AddRemove inclusion inclusion criteria: criteria: 2.MulAdvanced/Metastatic �ple Myeloma Renal Cell Carcinoma NOTE:c.NOTE: PANOBINOSTAT Votrient (pazopanib) containing is PREFERRED regimens in are subsequent NON‐PREFERRED se�ng for for any use IMDC in relapsed/refractory risk clear cell RCC multiple per NCH myeloma. pathway & NCH Policy (if not used in UM ONC_1195 Votrient (pazopanib) Positive change a.Farydak(panabinostat)first line). is not recommended for use in relapsed/refractory mul�ple myeloma. Alterna�ve op�ons are available, please refer to Per NCH L1 Pathway UM ONC_1271 Farydak (panobinostat) Negative change NCHRemove L1 pathway inclusion for criteria: multiple myeloma. More Cost Effective Alternative(s) Remove2.Chronic inclusion Myeloid criteria: Leukemia (CML)‐ b. UM ONC_1196 Sprycel (dasatinib) Positive change b.Thec.As ini member�al or subsequent has relapsed/refractory therapy for members mul�ple with myeloma CML withand Farydakany of the (panobinostat) following muta may�ons: be usedY253H as or the E255K/V. following: Per Compendia Listing i.InAdd combina exclusion�on criteria: with bortezomib and dexamethasone AND ii.The2.Sprycel member (dasa �receivednib) is being at least used 1‐3 on prior Ph ortherapies BCR‐ABL including nega�ve bortezomib CML or in andmembers an immunodulatory with the following agent mutations (i.e. thalidomide, of BCR‐ABL1: lenalidomide, T315I/A, orF317L/V/I/C UM ONC_1271ONC_1196 FarydakSprycel (dasatinib)(panobinostat) Negative change pomalidomide).or V299L. . MorePer Compendia Cost Effective Listing Alternative(s) RemoveAdd inclusion exclusion criteria: criteria: A2.Renal Cell Carcinoma (RCC) 1.Diseasea.NOTE: Per progression NCH Policy while & NCH taking Pathway, Farydak Torisel (panobinostat). is only recommended as monotherapy for metasta�c clear cell renal cell carcinoma, in members UM ONC_1200 Torisel (temsrolimus) Negative change 2.Dosingwho have exceeds failed two single oral dose TKIs limit and oneof Farydak or more (panobinostat) Immune Checkpoint 20 mg. Inhibitor.. Step Therapy Criteria 3.TreatmentRemove inclusion exceeds criteria: the maximum dura�on limit of 16 treatment cycles. UM ONC_1271 Farydak (panobinostat) Positive change 4.Treatmentb.Torisel (temsirolimus) exceeds the may maximum be used limit as a of single 6 (20mg) agent capsules/month, for ini�al/subsequent 12 (10 therapymg) capsules/month, in members with or 6 metasta (15 mg)� capsules/month.c/advanced non‐clear cell Renal More Cost Effective Alternative(s) UM ONC_1200 Torisel (temsrolimus) Positive change AddCell Carcinomaexclusion criteria:‐RCC. More Cost Effective Alternative(s) UM ONC_1271 Farydak (panobinostat) Negative change Farydak(panabinostat) is not recommended for use in myeloma. More Cost Effective Alternative(s) Add inclusion criteria: IbranceAdd inclusion (Palbociclib) criteria: may be used in members with ER/PR positive and HER2 negative recurrent or metastatic breast cancer and the member has UM ONC_1272 Ibrance (palbociclib) Negative change intolerance/contraindicationB.Malignant Melanoma to Kisqali (ribociclib). Per Compendia Listing Add2.NOTE: inclusion Per NCH criteria: Policy & NCH Pathway, Zelboraf (vemurafenib) in combina�on with a MEK inhibitor ( e.g. cobime�nib) is a non‐preferred 2.regimen/combination Ovarian Cancer for use as adjuvant therapy in resected stage III melanoma; Opdivo (nivolumab) or Keytruda(pembrolizumab) for 1 year is NOTE:the preferred The Preferred option PARPin this inhibitor, clinical setting. per NCH This Policies recommendation and NCH Pathways, is based foron maintenancethe lack of Level therapy 1 evidence‐either ( first randomized line or after trials a platinumand/or meta‐sensitive‐analyses) relapsesupporting‐in ovarian superior cancer outcomes is Zejula with (niraparib). anti‐BRAF targetedThis recommendation therapy vs Immune is based Checkpoint on a lack ofInhibitor level 1 therapy.evidence ( randomized trials and/or meta‐ UM ONC_1273 Lynparza (olaparib) Negative change analyses)3.NOTE: Per demonstrating NCH Pathway superiority & NCH Policy, of Lynparza Zelboraf (olaparib) (vemurafenib) over Zejulain combina (niraparib).�on with Cotellic (cobime�nib) + Tecentriq (atezolizumab) is non‐ Per NCH L1 Pathway Addpreferred inclusion for thecriteria: treatment of metastatic/recurrent/unresectable BRAF V600 mutation positive malignant melanoma.This recommendation is 5.Prostatebased on the Cancer lack of Level 1 evidence (randomized trials and or meta‐analyses) supporting superior outcomes with the above regimen in UM ONC_1207 Zelboraf (vemurafenib) Negative change NOTE:comparison Lynparza to [Yervoy(ipilimumab) (Olaparib) is only recommended + Opdivo(nivolumab)] in metastatic the recommendedcastration‐resistant regimen prostate per NCH cancer policy. with mutations in DNA repair genes including Per Clinical Trial Analysis/Criteria butAdd not exclusion limited criteria: to germline/somatic BRCA1 or BRCA2 deleterious/suspected deleterious mutations. a.TheB.Use memberof Zelboraf has (vemurafenib) metasta�c castra as� aon single‐resistant agent prostate or in combination Cancer AND with Cotellic (cobimetinib) + Tecentriq (atezolizumab) in b.Tumormetastatic/recurrent/unresectable is posi�ve for germline or soma BRAF� cV600 BRCA mutation 1/2 or otherpositive DNA malignant Repair gene melanoma. mutation/genomic aberration, as confirmed on a CLIA approved UM ONC_1273ONC_1207 LynparzaZelboraf (vemurafenib)(olaparib) Positive change diagnosticD.Treatment tes exceedst (e.g. Foundation the maximum One limit CDx ofor BRAC240 (240 Analysis mg) CDx)capsules tablets a month. Perper CompendiaFDA Labeling Listing RemoveAdd inclusion exclusion criteria: criteria: UM ONC_1226 Zaltrap (ziv‐aflibercept) Negative change 3.Dosing Zaltrap use exceeds is not single recommended dose limit for of Lynparzametastatic (olaparib) colorectal 400 cancer. mg (capsule) or 300 mg (tablet). More Cost Effective Alternative(s) UM ONC_1273 Lynparza (olaparib) Negative change 4.TreatmentAdd inclusion exceeds criteria: the maximum limit of 480 (50 mg) capsules/18060 (100 mg) and 120 (150 mg) tablets per month. Per FDA Labeling 2.Chronic Myelogenous Leukemia i.The member has experienced disease progression / intolerance to three or more of the following tyrosine kinase inhibitors: Gleevec (ima�nib), Tasigna (nilotinib), or Bosulif (bosutinib), or Sprycel(dasatinib) OR UM ONC_1240 Synribo (omacetaxine) Negative change Addii.The inclusion member criteria: has a T315I muta�on and has failed Iclusig (ponatinib) to treat CML with this mutation. Step Therapy Criteria D.RenalAdd inclusion Cell Carcinoma criteria: c.NOTE:2.BRAF V600E [Opdivo or (nivolumab)+V600K muta� Cabometyxon posi�ve Melanoma(cabozan�nib)] is a non‐preferred regimen per NCH Policy. This ra�onale for this posi�on is as follows : i.Thisa.NOTE: regimen For adjuvant has not therapy been shown of BRAF to beV600 superior E or V600K to the muta NCH� preferredon posi� ve,regimen stage IIIof melanoma,[Yervoy (ipilimumab) the preferred + Opdivo agents (nivolumab) per NCH Policies in a randomized & NCH trial.Pathway, for adjuvant therapy are Opdivo (nivolumab OR Keytruda (pembrolizumab). Tafinlar (dabrafenib) + Mekinist (trametinib) is non‐preferred ii.Thisfor use regimen in the adjuvant did not showsetting an based OS bene on at lack vs Sutent of Level (suni 1 evidence�nib) in the that IMDC nivolumab Favorable or pembrolizumab Risk category in monotherapythe CheckMate is 9ERinferior trial. to the above UM ONC_1250 Tafinlar (dabrafenib) Negative change E.Hodgkin’scombination. Lymphoma Per NCH L1 Pathway NOTE: Add inclusion The preferred criteria: Immune Checkpoint Inhibitor, for members with relapsed/refractory Hodgkin’s Lymphoma (including members who failed or areb.NOTE: not candidates For systemic for therapy autologous of metasta stem cell�c BRAFtransplant) V600E isor Keytruda V600K mutation(pembrolizumab). positive melanoma the preferred oral combination, per NCH Policies 1.Opdivoand NCH Pathway,may be used is cobimetinib in a member + vemurafenib.with The member has classical Hodgkin's Lymphoma that has relapsed or progressed a�er autologous hematopoieticc.Ta nlar (dabrafenib) stem cell may transplantation be used as a (HSCT) single ANDagent post or i‐ntransplantation combination with +/‐ AdcetrisMekinist (brentuximab(trametinib) in vedotin) members OR who has haveprogressed intolerance after 3 or more UM ONC_1250 Tafinlar (dabrafenib) Positive change priorto/contraindication lines of systemic to therapy,the use of and [Cobimetinib the member + hasVemurafenib]. not received prior therapy with an Immune Checkpoint Inhibitor AND Per Compendia Listing 2.NOTE:Remove Opdivoinclusion (nivolumab) criteria: given in combina�on with Adcetris (brentuximab vedo�n) is a Non‐Preferred regimen per NCH Policy. This recommendation3.Non ‐Small Cell Lung is based Cancer on the(NSCLC) lack of Level 1 evidence (randomized clinical trial and/or meta‐analyses) to support superior outcomes with the abovea.Ta nlar combination (dabrafenib) compared may be usedto either as singlea single agent agent Opdivo or in combination (nivolumab) orwith single Mekinist agent (trametinib) Adcetris (brentuximab). as first line or subsequent line therapy for H.Colorectalrecurrent or Cancermetastatic BRAF V600E mutation‐positive NSCLC. UM ONC_1274 Opdivo (nivolumab) Negative change NOTE:4.Thyroid For Cancer metastatic MSI‐High colorectal cancer, the preferred Checkpoint Inhibitor is Keytruda (pembrolizumab). Per Clinical Trial Analysis/Criteria Removea.The member inclusion has criteria: anaplas�c, papillary, follicular, and Hürthle Cell thyroid carcinoma and Tanlar (dabrafenib) may be used as a single agent/in 2.combination Chronic Lymphocy with Mekinist�c Leukemia (trametinib) (CLL)/Small for radioactive Lymphocy iodine�c Lymphoma‐refractory (SLL) ( if radioactive iodine therapy is appropriate) BRAF V600E mutation‐ a.NOTEpositive #1:unresectable/recurrent/metastatic Please refer to the NCH Pathway disease.document for the latest recommended regimens for CLL. UM ONC_1250 Tafinlar (dabrafenib) Negative change 3. AML ‐ Remission induction therapy & post‐remission therapy for members with unfavorable‐risk cytogenetics/members unsuitable for intensive Per Compendia Listing remission induction therapy/members who decline intensive therapy. 4.Mantle Cell Lymphoma UM ONC_1297 Venclexta (venetoclax) Positive change a.NOTE: Please refer to the NCH Pathway document for the latest recommended treatment op�ons for Mantle Cell Lymphoma. Per Clinical Trial Analysis/Criteria

Add inclusion criteria: b.NOTE #2: Please note that per NCH Policy & NCH Pathway, the combina�on of Venclexta (venetoclax) and Gazyva (obinutuzumab) for rst line therapy of CLL/SLL is a Non‐Preferred Regimen. This recommendation is based on the lack of Level 1 evidence (randomized trials and/or meta‐ analyses) to show superior outcomes with the above combination when compared with Venclexta (venetoclax) and Rituximab biosimilars. 3.Acute Myeloid Leukemia (AML) a. Venclexta (venetoclax) may be used in combination with either decitabine or azacitidine for members with AML who have unfavorable‐risk cytogenetics or are unsuitable for intensive remission induction therapy or decline intensive therapy; either of the above combinations may be UM ONC_1297 Venclexta (venetoclax) Negative change used. Per Clinical Trial Analysis/Criteria Remove exclusion criteria: UM ONC_1297 Venclexta (venetoclax) Positive change 4.Treatment exceeds the maximum limit of 120180 (100 mg) or 240 (50 mg) tablets per month. Per FDA Labeling Add inclusion criteria: 4.Thyroid Cancer a.The member has anaplastic, papillary, follicular, and Hürthle Cell thyroid carcinoma and Tafinlar (dabrafenib) may be used as a single agent/in combination with Mekinist (trametinib) for radioactive iodine‐refractory ( if radioactive iodine therapy is appropriate) BRAF V600E mutation‐ UM ONC_1250 Tafinlar (dabrafenib) Positive change positive unresectable/recurrent/metastatic disease. Per Compendia Listing Add inclusion criteria: 2.Mul �ple Myeloma NOTE: PANOBINOSTAT containing regimens are NON‐PREFERRED for use in relapsed/refractory multiple myeloma. a.Farydak(panabinostat) is not recommended for use in relapsed/refractory mul�ple myeloma. Alterna�ve op�ons are available, please refer to UM ONC_1271 Farydak (panobinostat) Negative change NCH L1 pathway for multiple myeloma. More Cost Effective Alternative(s) Remove inclusion criteria: b.The member has relapsed/refractory mul�ple myeloma and Farydak (panobinostat) may be used as the following: i.In combina�on with bortezomib and dexamethasone AND ii.The member received at least 1‐3 prior therapies including bortezomib and an immunodulatory agent (i.e. thalidomide, lenalidomide, or UM ONC_1271 Farydak (panobinostat) Negative change pomalidomide). More Cost Effective Alternative(s) Remove exclusion criteria: A 1.Disease progression while taking Farydak (panobinostat). 2.Dosing exceeds single dose limit of Farydak (panobinostat) 20 mg. 3.Treatment exceeds the maximum dura�on limit of 16 treatment cycles. UM ONC_1271 Farydak (panobinostat) Positive change 4.Treatment exceeds the maximum limit of 6 (20mg) capsules/month, 12 (10 mg) capsules/month, or 6 (15 mg) capsules/month. More Cost Effective Alternative(s) Add exclusion criteria: UM ONC_1271 Farydak (panobinostat) Negative change Farydak(panabinostat) is not recommended for use in myeloma. More Cost Effective Alternative(s) Add inclusion criteria: Ibrance (Palbociclib) may be used in members with ER/PR positive and HER2 negative recurrent or metastatic breast cancer and the member has UM ONC_1272 Ibrance (palbociclib) Negative change intolerance/contraindication to Kisqali (ribociclib). Per Compendia Listing Add inclusion criteria: 2. Ovarian Cancer NOTE: The Preferred PARP inhibitor, per NCH Policies and NCH Pathways, for maintenance therapy‐either first line or after a platinum‐sensitive relapse‐in ovarian cancer is Zejula (niraparib). This recommendation is based on a lack of level 1 evidence ( randomized trials and/or meta‐ UM ONC_1273 Lynparza (olaparib) Negative change analyses) demonstrating superiority of Lynparza (olaparib) over Zejula (niraparib). Per NCH L1 Pathway Add inclusion criteria: 5.Prostate Cancer NOTE: Lynparza (Olaparib) is only recommended in metastatic castration‐resistant prostate cancer with mutations in DNA repair genes including but not limited to germline/somatic BRCA1 or BRCA2 deleterious/suspected deleterious mutations. a.The member has metasta�c castra�on‐resistant prostate Cancer AND b.Tumor is posi�ve for germline or soma�c BRCA 1/2 or other DNA Repair gene mutation/genomic aberration, as confirmed on a CLIA approved UM ONC_1273 Lynparza (olaparib) Positive change diagnostic test (e.g. Foundation One CDx or BRAC Analysis CDx) Per Compendia Listing Remove exclusion criteria: 3.Dosing exceeds single dose limit of Lynparza (olaparib) 400 mg (capsule) or 300 mg (tablet). PolicyUM ONC_1273 # PolicyLynparza Name (olaparib) TypeNegative of Change change 4.TreatmentBrief Description exceeds of Policy the maximum Change limit of 480 (50 mg) capsules/18060 (100 mg) and 120 (150 mg) tablets per month. PerReason FDA forLabeling Changes NEW Abecma (idecabtagene vicleucel) N/A N/A N/A N/A‐ Add addendum for Fidelis Care state specific UM ONC_1041 LHRH agonists and antagonist N/A N/A criteria Add inclusioninclusion criteria:criteria: D.Renal3. Breast Cell cancer Carcinoma‐ Abraxane (nab‐paclitaxel) may be used in combination with Tecentriq (atezolizumab) in the first line setting OR in the second c.NOTE:line/subsequent [Opdivo (nivolumab)+line setting if theCabometyx member (cabozan has not �receivednib)] is a the non above‐preferred regimen regimen previously per NCH and Policy. there Thisis no ra history�onale of for progression this posi�on on is another as follows : i.ThisImmune regimen Checkpoint has not Inhibitor been shown ( e.g. toKeytruda) be superior to the NCH preferred regimen of [Yervoy (ipilimumab) + Opdivo (nivolumab) in a randomized trial.5.Non ‐Small Cell Lung Cancer (NSCLC) ii.Thisa.In the regimen rst line did se not�ng show for metasta an OS bene�c, squamous,t vs Sutent Non (suni‐Small�nib) Cell in theLung IMDC Cancer, Favorable Taxol (paclitaxel) Risk category is preferred in the CheckMate over Abraxane 9ER trial. (nab‐paclitaxel). The E.Hodgkin’sabove recommendation Lymphoma is based on results of KEYNOTE‐407 trial which showed no difference in outcomes between the use of Taxol (paclitaxel) UM ONC_1179 Abraxane (nab‐paclitaxel) Negative change NOTE: and Abraxane The preferred (nab‐paclitaxel). Immune Checkpoint Inhibitor, for members with relapsed/refractory Hodgkin’s Lymphoma (including members who failed or Per Clinical Trial Analysis/Criteria are not candidates for autologous stem cell transplant) is Keytruda (pembrolizumab). 1.OpdivoRemove exclusion may be used criteria: in a member with The member has classical Hodgkin's Lymphoma that has relapsed or progressed a�er autologous UM ONC_1179 Abraxane (nab‐paclitaxel) Positive change hematopoietic1.O ﬀ‐label indica stem�ons cell for transplantation Abraxane (nab ‐(HSCT)paclitaxel) AND in post ovarian‐transplantation cancer, metasta +/‐ Adcetris�c melanoma, (brentuximab urothelial vedotin) carcinoma, OR has and progressed endometrial after carcinoma. 3 or more Per Clinical Trial Analysis/Criteria priorRemove lines inclusion of systemic criteria: therapy, and the member has not received prior therapy with an Immune Checkpoint Inhibitor AND 2.NOTE:Advanced/Metastatic Opdivo (nivolumab) Renal Cellgiven Carcinoma in combina�on with Adcetris (brentuximab vedo�n) is a Non‐Preferred regimen per NCH Policy. This recommendationc.NOTE: Votrient (pazopanib)is based on theis PREFERRED lack of Level in 1subsequent evidence (randomized se�ng for any clinical IMDC trial risk and/or clear cell meta RCC‐analyses) per NCH topathway support & superior NCH Policy outcomes (if not usedwith inthe UM ONC_1195 Votrient (pazopanib) Positive change abovefirst line). combination compared to either single agent Opdivo (nivolumab) or single agent Adcetris (brentuximab). Per NCH L1 Pathway H.ColorectalRemove inclusion Cancer criteria: UM ONC_1274 Opdivo (nivolumab) Negative change NOTE:2.Chronic For Myeloidmetastatic Leukemia MSI‐High (CML) colorectal‐ b. cancer, the preferred Checkpoint Inhibitor is Keytruda (pembrolizumab). Per Clinical Trial Analysis/Criteria UM ONC_1196 Sprycel (dasatinib) Positive change Removec.As ini� alinclusion or subsequent criteria: therapy for members with CML with any of the following muta�ons: Y253H or E255K/V. Per Compendia Listing 2.Add Chronic exclusion Lymphocy criteria:�c Leukemia (CLL)/Small Lymphocy�c Lymphoma (SLL) a.NOTE2.Sprycel #1: (dasa Please�nib) refer is being to the used NCH on Pathway Ph or BCR document‐ABL nega for� theve CML latest orrecommended in members withregimens the following for CLL. mutations of BCR‐ABL1: T315I/A, F317L/V/I/C UM ONC_1196 Sprycel (dasatinib) Negative change 3.or V299L.AML ‐ Remission . induction therapy & post‐remission therapy for members with unfavorable‐risk cytogenetics/members unsuitable for intensive Per Compendia Listing remissionAdd inclusion induction criteria: therapy/members who decline intensive therapy. 4.Mantle2.Renal Cell Cell Carcinoma Lymphoma (RCC) UM ONC_1297 Venclexta (venetoclax) Positive change a.NOTE: PleasePer NCH refer Policy to the& NCH NCH Pathway, Pathway Torisel document is only for recommended the latest recommended as monotherapy treatment for metastaop�ons �forc clear Mantle cell Cell renal Lymphoma. cell carcinoma, in members Per Clinical Trial Analysis/Criteria UM ONC_1200 Torisel (temsrolimus) Negative change who have failed two oral TKIs and one or more Immune Checkpoint Inhibitor.. Step Therapy Criteria AddRemove inclusion inclusion criteria: criteria: b.NOTEb.Torisel #2: (temsirolimus) Please note thatmay perbe used NCH asPolicy a single & NCH agent Pathway, for ini �theal/subsequent combina�on therapy of Venclexta in members (venetoclax) with metasta and Gazyva�c/advanced (obinutuzumab) non‐clear for cell rst Renal line UM ONC_1200 Torisel (temsrolimus) Positive change therapyCell Carcinoma of CLL/SLL‐RCC. is a Non‐Preferred Regimen. This recommendation is based on the lack of Level 1 evidence (randomized trials and/or meta‐ More Cost Effective Alternative(s) analyses) to show superior outcomes with the above combination when compared with Venclexta (venetoclax) and Rituximab biosimilars. 3.Acute Myeloid Leukemia (AML) a.Add Venclexta inclusion (venetoclax) criteria: may be used in combination with either decitabine or azacitidine for members with AML who have unfavorable‐risk cytogeneticsB.Malignant Melanomaor are unsuitable for intensive remission induction therapy or decline intensive therapy; either of the above combinations may be UM ONC_1297 Venclexta (venetoclax) Negative change used.2.NOTE: Per NCH Policy & NCH Pathway, Zelboraf (vemurafenib) in combina�on with a MEK inhibitor ( e.g. cobime�nib) is a non‐preferred Per Clinical Trial Analysis/Criteria Removeregimen/combination exclusion criteria: for use as adjuvant therapy in resected stage III melanoma; Opdivo (nivolumab) or Keytruda(pembrolizumab) for 1 year is UM ONC_1297 Venclexta (venetoclax) Positive change 4.Treatmentthe preferred exceeds option thein this maximum clinical setting.limit of This120 recommendation180 (100 mg) or 240 is based (50 mg) on thetablets lack perof Level month. 1 evidence ( randomized trials and/or meta‐analyses) Per FDA Labeling Addsupporting inclusion superior criteria: outcomes with anti‐BRAF targeted therapy vs Immune Checkpoint Inhibitor therapy. 2.Ovarian3.NOTE: Per Cancer NCH Pathway & NCH Policy, Zelboraf (vemurafenib) in combina�on with Cotellic (cobime�nib) + Tecentriq (atezolizumab) is non‐ UM ONC_1301 Rubraca (rucaparib) Negative change a.NOTE:preferred Rucaparib for the treatment is a non‐preferred of metastatic/recurrent/unresectable PARP‐inhibitor per NCH Policy BRAF for ovarian V600 mutation cancer. The positive preferred malignant PARP inhibitor melanoma. is Niraparib.This recommendation is More Cost Effective Alternative(s) Addbased exclusion on the lack criteria: of Level 1 evidence (randomized trials and or meta‐analyses) supporting superior outcomes with the above regimen in UM ONC_1207ONC_1301 ZelborafRubraca (rucaparib)(vemurafenib) Negative change 5.Treatmentcomparison toexceeds [Yervoy(ipilimumab) the maximum limit+ Opdivo(nivolumab)] of 120 (300 mg), the120 recommended (250 mg), tablets/month regimen per or NCH 180 policy.(200 mg) tablets/month. perPer FDAClinical Labeling Trial Analysis/Criteria Add inclusionexclusion criteria:criteria: 2.OvarianB.Use of Zelboraf Cancer (vemurafenib) as a single agent or in combination with Cotellic (cobimetinib) + Tecentriq (atezolizumab) in a.Niraparibmetastatic/recurrent/unresectable monotherapy may be used BRAF in V600 ANY onemutation of the positive following: malignant melanoma. UM ONC_1207 Zelboraf (vemurafenib) Positive change i.TheD.Treatment member exceeds has newly the diagnosedmaximum stagelimit of III/IV 240 ovarian (240 mg) carcinoma capsules and tablets has undergone a month. surgery (with or without op�mal debulking) and has per FDA Labeling completedAdd inclusion first criteria: line platinum‐based chemotherapy AND Niraparib is being used as a single agent for maintenance therapy (regardless of BRCA UM ONC_1226 Zaltrap (ziv‐aflibercept) Negative change mutation Zaltrap use test is results).not recommended NOTE: Niraparib for metastatic is the Preferred colorectal agent cancer. per NCH Policy & NCH Pathway in this setting. This recommendation is based on the More Cost Effective Alternative(s) lackAdd ofinclusion Level 1 criteria:evidence (randomized clinical trial and or meta‐analyses) to support the superiority of other maintenance regimens, specifically UM ONC_1307 Zejula (niraparib) Negative change olaparib2.Chronic and Myelogenous [olaparib+bevacizumab] Leukemia over niraparib alone. Per Clinical Trial Analysis/Criteria Addi.The exclusion member criteria:has experienced disease progression / intolerance to three or more of the following tyrosine kinase inhibitors: Gleevec (ima�nib), UM ONC_1307 Zejula (niraparib) Negative change 2.ConcurrentTasigna (nilotinib), use with or Bosulif other an (bosutinib),�‐cancer therapy or Sprycel(dasatinib) including bevacizumab. OR Per Clinical Trial Analysis/Criteria UM ONC_1240 Synribo (omacetaxine) Negative change ii.The member has a T315I muta�on and has failed Iclusig (ponatinib) to treat CML with this mutation. Step Therapy Criteria Add inclusion criteria: UM ONC_1324 Kymriah (tisagenlecleucel) Negative change B2.BRAF‐ Cell Lymphomas V600E or V600K ‐ 2.Members muta�on must posi have�ve Melanoma previously received at least two lines of therapy, including rituximab and an anthracycline (for DBCL) Per Clinical Trial Analysis/Criteria Adda.NOTE: exclusion For adjuvant criteria: therapy of BRAF V600 E or V600K muta�on posi�ve, stage III melanoma, the preferred agents per NCH Policies & NCH MemberPathway, does for adjuvant not have therapy adequate are bone Opdivo marrow (nivolumab reserve OR defined Keytruda by ALL(pembrolizumab). of the following: Tafinlar (dabrafenib) + Mekinist (trametinib) is non‐preferred 1.Absolutefor use in the neutrophil adjuvant count setting (ANC) based ≥ 1000/uL;on a lack andof Level 1 evidence that nivolumab or pembrolizumab monotherapy is inferior to the above UM ONC_1250 Tafinlar (dabrafenib) Negative change 2.Absolutecombination. lymphocyte count (ALC) > 300/uL; and Per NCH L1 Pathway 3.PlateletAdd inclusion Count criteria: ≥ 50,000/uL C.Memberb.NOTE: For does systemic not have therapy adequate of metasta renal,� hepac BRAF�c, V600E cardiac or and V600K pulmonary mutation func positive�on de ned melanoma as: the preferred oral combination, per NCH Policies 1.Creaand NCH�nine Pathway, clearance is cobimetinib ≥ 60 mL/min + vemurafenib. 2.Serumc.Ta nlar ALT (dabrafenib) ≤5 times the may upper be used limit asof anormal single agent or in combination with Mekinist (trametinib) in members who have intolerance UM ONC_1250 Tafinlar (dabrafenib) Positive change 3.Cardiacto/contraindication ejec�on frac to� theon ≥ use45%, of [Cobimetinibno evidence of+ Vemurafenib].pericardial effusion as determined by an echocardiogram (ECHO), and no clinically significant Per Compendia Listing pleuralRemove effusion inclusion criteria: 4.Baseline3.Non ‐Small oxygen Cell Lung satura Cancer�on > (NSCLC) 91% on room air. D.a.Ta Historynlar (dabrafenib)of seizures or may other be CNSused disorder as a single agent or in combination with Mekinist (trametinib) as first line or subsequent line therapy for E.recurrent History ofor autoimmunemetastatic BRAF disease V600E mutation‐positive NSCLC. UM ONC_1324 Kymriah (tisagenlecleucel) Negative change B.F.Ac4.Thyroid �ve Cancerserious infec�on. Per Clinical Trial Analysis/Criteria Adda.The inclusion member criteria: has anaplas�c, papillary, follicular, and Hürthle Cell thyroid carcinoma and Tanlar (dabrafenib) may be used as a single agent/in B.Indolentcombination B Cellwith NHL Mekinist ( Follicular (trametinib) B Cell Lymphomafor radioactive grades iodine 1‐3a,‐refractory Marginal ( Zoneif radioactive Lymphoma, iodine Small therapy Lymphocytic is appropriate) Lymphoma BRAF with V600E an absolutemutation ‐ lymphocytepositive unresectable/recurrent/metastatic count < 5 x 109, lymphoplasmacytic disease. lymphoma/Waldenstrom’s Macroglobulinemia[with IgM paraprotein or >10% of UM ONC_1250 Tafinlar (dabrafenib) Negative change lymphoplasmacytic cells in the bone marrow] Per Compendia Listing 1. NOTE: Per NCH Pathway & NCH Policy Aliqopa (copanlisib) is a Non‐Preferred agent in any setting for the treatment of Follicular B‐cell lymphoma, Marginal Zone Lymphoma & SLL. This recommendation is based on the fact that the ONLY endpoint for the CHRONOS‐1 trial ‐that led UM ONC_1327 Aliqopa (copanlisib) Negative change to the FDA approval of this drug‐ was ORR‐ Overall Response Rate. Per Clinical Trial Analysis/Criteria UM ONC_1327 Aliqopa (copanlisib) Negative change Add exclusion criteria: Not recommended More Cost Effective Alternative(s) Remove exclusion criteria: A.Aliqopa (copanlisib) is being used a�er disease progression with the same regimen or prior PI3K inhibitors [ e.g. Zydelig (idelalisib) or Copiktra (duvelisib)]. B.Concurrent use with other chemotherapy, immunotherapy, or ongoing systemic cor�costeroid. UM ONC_1327 Aliqopa (copanlisib) Positive change C.Dosing exceeds single dose limit of Aliqopa (copanlisib) 60 mg. More Cost Effective Alternative(s) Add inclusion criteria: 2.The member has chemotherapy‐refractory disease, dened as one or more of a�er the following: a. No response to last line of therapy Two or more lines of systemic chemotherapy OR UM b.For DLBCL, two or more lines of systemic chemotherapy, including rituximab and an anthracycline. ONC_1329 Yescarta (axicabtagene ciloleucel) Positive change Disease progression or relapse less ≤12 months after autologous stem‐cell transplantation (ASCT). Per Clinical Trial Analysis/Criteria Add exclusion criteria: E.The member does not have adequate bone marrow reserve dened by ALL of the following: 1.Absolute neutrophil count (ANC) ≥ 1000/uL 2.Absolute lymphocyte count (ALC) ≥ 100/uL 3.Platelet Count ≥ 75,000/uL. F.The member does not have adequate renal, hepa�c, cardiac and pulmonary func�on dened as: 1.Crea �nine clearance ≥ 60 mL/min 2.Serum ALT/AST <2.5 �mes the upper limit of normal 3.Total bilirubin <1.5 mg/dl, except in subjects with Gilbert’s syndrome 4.Cardiac ejec�on frac�on ≥ 50%, no evidence of pericardial effusion as determined by an echocardiogram (ECHO), and no clinically significant pleural effusion 5.Baseline oxygen satura�on > 92% on room air. G.Primary central nervous system lymphoma H.Ac �ve central nervous system malignancy I.History of seizures or other CNS disorder J.History of autoimmune disease UM K.Prior Allogeneic hematopoie�c stem cell transplant (HSCT) ONC_1329 Yescarta (axicabtagene ciloleucel) Negative change L.Ac �ve serious infec�on Per Clinical Trial Analysis/Criteria Add inclusion criteria: 2.Ovarian Cancer UM ONC_1301 Rubraca (rucaparib) Negative change a.NOTE: Rucaparib is a non‐preferred PARP‐inhibitor per NCH Policy for ovarian cancer. The preferred PARP inhibitor is Niraparib. More Cost Effective Alternative(s) Add exclusion criteria: UM ONC_1301 Rubraca (rucaparib) Negative change 5.Treatment exceeds the maximum limit of 120 (300 mg), 120 (250 mg), tablets/month or 180 (200 mg) tablets/month. per FDA Labeling Add inclusion criteria: 2.Ovarian Cancer a.Niraparib monotherapy may be used in ANY one of the following: i.The member has newly diagnosed stage III/IV ovarian carcinoma and has undergone surgery (with or without op�mal debulking) and has completed first line platinum‐based chemotherapy AND Niraparib is being used as a single agent for maintenance therapy (regardless of BRCA mutation test results). NOTE: Niraparib is the Preferred agent per NCH Policy & NCH Pathway in this setting. This recommendation is based on the lack of Level 1 evidence (randomized clinical trial and or meta‐analyses) to support the superiority of other maintenance regimens, specifically UM ONC_1307 Zejula (niraparib) Negative change olaparib and [olaparib+bevacizumab] over niraparib alone. Per Clinical Trial Analysis/Criteria Add exclusion criteria: UM ONC_1307 Zejula (niraparib) Negative change 2.Concurrent use with other an�‐cancer therapy including bevacizumab. Per Clinical Trial Analysis/Criteria

Add inclusion criteria: UMPolicy ONC_1324 # KymriahPolicy Name (tisagenlecleucel) NegativeType of Change change BBrief‐Cell Description Lymphomas of ‐ Policy2.Members Change must have previously received at least two lines of therapy, including rituximab and an anthracycline (for DBCL) PerReason Clinical for ChangesTrial Analysis/Criteria NEW Abecma (idecabtagene vicleucel) N/A AddN/A exclusion criteria: N/A Member does not have adequate bone marrow reserve defined by ALL of the following: N/A‐ Add addendum for Fidelis Care state specific UM ONC_1041 LHRH agonists and antagonist N/A 1.AbsoluteN/A neutrophil count (ANC) ≥ 1000/uL; and criteria 2.AbsoluteAdd inclusion lymphocyte criteria: count (ALC) > 300/uL; and 3.Platelet3. Breast Countcancer ≥ ‐ 50,000/uLAbraxane (nab‐paclitaxel) may be used in combination with Tecentriq (atezolizumab) in the first line setting OR in the second C.Memberline/subsequent does notline have setting adequate if the member renal, hepa has� notc, cardiac received and the pulmonary above regimen func�on previously dened as:and there is no history of progression on another 1.CreaImmune �nine Checkpoint clearance Inhibitor ≥ 60 mL/min ( e.g. Keytruda) 2.Serum5.Non ‐Small ALT ≤ Cell5 times Lung theCancer upper (NSCLC) limit of normal 3.Cardiaca.In the  rstejec line�on se frac�ng�on for ≥ metasta45%, no� c,evidence squamous, of pericardial Non‐Small effusion Cell Lung as Cancer, determined Taxol by(paclitaxel) an echocardiogram is preferred (ECHO), over Abraxane and no clinically(nab‐paclitaxel). significant The pleuralabove recommendation effusion is based on results of KEYNOTE‐407 trial which showed no difference in outcomes between the use of Taxol (paclitaxel) UM ONC_1179 Abraxane (nab‐paclitaxel) Negative change 4.Baselineand Abraxane oxygen (nab satura‐paclitaxel).�on > 91% on room air. Per Clinical Trial Analysis/Criteria D. History of seizures or other CNS disorder E.Remove History exclusion of autoimmune criteria: disease UM ONC_1324ONC_1179 KymriahAbraxane (tisagenlecleucel) (nab‐paclitaxel) NegativePositive change change B.F.Ac1.O ﬀ‐label�ve serious indica� infecons for�on. Abraxane (nab‐paclitaxel) in ovarian cancer, metasta�c melanoma, urothelial carcinoma, and endometrial carcinoma. Per Clinical Trial Analysis/Criteria AddRemove inclusion inclusion criteria: criteria: B.IndolentAdvanced/Metastatic B Cell NHL Renal ( Follicular Cell Carcinoma B Cell Lymphoma grades 1‐3a, Marginal Zone Lymphoma, Small Lymphocytic Lymphoma with an absolute lymphocytec.NOTE: Votrient count (pazopanib) < 5 x 109, lymphoplasmacytic is PREFERRED in subsequent lymphoma/Waldenstrom’s se�ng for any IMDC Macroglobulinemia[with risk clear cell RCC per NCHIgM paraproteinpathway & NCHor >10% Policy of (if not used in UM ONC_1195 Votrient (pazopanib) Positive change lymphoplasmacyticfirst line). cells in the bone marrow] Per NCH L1 Pathway 1.Remove NOTE: inclusion Per NCH criteria: Pathway & NCH Policy Aliqopa (copanlisib) is a Non‐Preferred agent in any setting for the treatment of Follicular B‐cell lymphoma,2.Chronic Myeloid Marginal Leukemia Zone Lymphoma (CML)‐ b. & SLL. This recommendation is based on the fact that the ONLY endpoint for the CHRONOS‐1 trial ‐that led UM ONC_1327ONC_1196 AliqopaSprycel (dasatinib)(copanlisib) NegativePositive change change toc.As the ini FDA�al orapproval subsequent of this therapy drug‐ was for membersORR‐ Overall with Response CML with Rate. any of the following muta�ons: Y253H or E255K/V. Per ClinicalCompendia Trial ListingAnalysis/Criteria UM ONC_1327 Aliqopa (copanlisib) Negative change Add exclusion criteria: Not recommended More Cost Effective Alternative(s) Remove2.Sprycel exclusion (dasa�nib) criteria: is being used on Ph or BCR‐ABL nega�ve CML or in members with the following mutations of BCR‐ABL1: T315I/A, F317L/V/I/C UM ONC_1196 Sprycel (dasatinib) Negative change A.Aliqopaor V299L. .(copanlisib) is being used a�er disease progression with the same regimen or prior PI3K inhibitors [ e.g. Zydelig (idelalisib) or Copiktra Per Compendia Listing (duvelisib)].Add inclusion criteria: B.Concurrent2.Renal Cell Carcinoma use with other (RCC) chemotherapy, immunotherapy, or ongoing systemic cor�costeroid. UM ONC_1327 Aliqopa (copanlisib) Positive change C.Dosinga.NOTE: Per exceeds NCH Policysingle &dose NCH limit Pathway, of Aliqopa Torisel (copanlisib) is only recommended 60 mg. as monotherapy for metasta�c clear cell renal cell carcinoma, in members More Cost Effective Alternative(s) UM ONC_1200 Torisel (temsrolimus) Negative change Addwho inclusionhave failed criteria: two oral TKIs and one or more Immune Checkpoint Inhibitor.. Step Therapy Criteria 2.TheRemove member inclusion has criteria: chemotherapy‐refractory disease, dened as one or more of a�er the following: a.b.Torisel No response (temsirolimus) to last line may of be therapy used as Two a single or more agent lines for of ini systemic�al/subsequent chemotherapy therapy OR in members with metasta�c/advanced non‐clear cell Renal UM ONC_1200 Torisel (temsrolimus) Positive change b.ForCell Carcinoma DLBCL, two‐RCC. or more lines of systemic chemotherapy, including rituximab and an anthracycline. More Cost Effective Alternative(s) ONC_1329 Yescarta (axicabtagene ciloleucel) Positive change Disease progression or relapse less ≤12 months after autologous stem‐cell transplantation (ASCT). Per Clinical Trial Analysis/Criteria Add exclusion criteria: E.TheAdd inclusion member criteria: does not have adequate bone marrow reserve dened by ALL of the following: 1.AbsoluteB.Malignant neutrophil Melanoma count (ANC) ≥ 1000/uL 2.Absolute2.NOTE: Per lymphocyte NCH Policy count& NCH (ALC) Pathway, ≥ 100/uL Zelboraf (vemurafenib) in combina�on with a MEK inhibitor ( e.g. cobime�nib) is a non‐preferred 3.Plateletregimen/combination Count ≥ 75,000/uL. for use as adjuvant therapy in resected stage III melanoma; Opdivo (nivolumab) or Keytruda(pembrolizumab) for 1 year is F.Thethe preferred member option does not in this have clinical adequate setting. renal, This hepa recommendation�c, cardiac and is pulmonary based on thefunc lack�on of de Levelned 1 as: evidence ( randomized trials and/or meta‐analyses) 1.Creasupporting �nine superior clearance outcomes ≥ 60 mL/min with anti‐BRAF targeted therapy vs Immune Checkpoint Inhibitor therapy. 2.Serum3.NOTE: PerALT/AST NCH <2.5Pathway �mes & theNCH upper Policy, limit Zelboraf of normal (vemurafenib) in combina�on with Cotellic (cobime�nib) + Tecentriq (atezolizumab) is non‐ 3.Totalpreferred bilirubin for the <1.5 treatment mg/dl, exceptof metastatic/recurrent/unresectable in subjects with Gilbert’s syndrome BRAF V600 mutation positive malignant melanoma.This recommendation is 4.Cardiacbased on ejecthe lack�on offrac Level�on ≥ 1 evidence50%, no evidence (randomized of pericardial trials and effusion or meta ‐asanalyses) determined supporting by an echocardiogram superior outcomes (ECHO), with andthe aboveno clinically regimen significant in UM ONC_1207 Zelboraf (vemurafenib) Negative change pleuralcomparison effusion to [Yervoy(ipilimumab) + Opdivo(nivolumab)] the recommended regimen per NCH policy. Per Clinical Trial Analysis/Criteria 5.BaselineAdd exclusion oxygen criteria: satura�on > 92% on room air. G.PrimaryB.Use of Zelboraf central (vemurafenib)nervous system lymphomaas a single agent or in combination with Cotellic (cobimetinib) + Tecentriq (atezolizumab) in H.Acmetastatic/recurrent/unresectable �ve central nervous system malignancy BRAF V600 mutation positive malignant melanoma. UM ONC_1207 Zelboraf (vemurafenib) Positive change I.HistoryD.Treatment of seizures exceeds or the other maximum CNS disorder limit of 240 (240 mg) capsules tablets a month. per FDA Labeling J.HistoryAdd inclusion of autoimmune criteria: disease UM ONC_1226 Zaltrap (ziv‐aflibercept) Negative change K.Prior Zaltrap Allogeneic use is not hematopoierecommended�c stemfor metastatic cell transplant colorectal (HSCT) cancer. More Cost Effective Alternative(s) ONC_1329 Yescarta (axicabtagene ciloleucel) Negative change L.AcAdd � inclusionve serious criteria: infec�on Per Clinical Trial Analysis/Criteria 2.Chronic Myelogenous Leukemia Addi.The inclusion member criteria: has experienced disease progression / intolerance to three or more of the following tyrosine kinase inhibitors: Gleevec (ima�nib), B.MelanomaTasigna (nilotinib), or Bosulif (bosutinib), or Sprycel(dasatinib) OR UM ONC_1240 Synribo (omacetaxine) Negative change 1.NOTE:ii.The member The preferred has a T315I BRAF muta and� MEKon and inhibitor has failed combina Iclusig�on (ponatinib) regimen, per to NCHtreat policy CML with and pathway,this mutation. for unresectable/metasta�c BRAF muta�on Step Therapy Criteria positiveAdd inclusion melanoma criteria: is the combination of Cotellic (cobimetinib) + Zelboraf (vemurafenib) over Mektovi (binimetinib) + Braftovi (encorafenib). This recommendation2.BRAF V600E or V600Kis based muta on the�on lack posi of�ve Level Melanoma 1 evidence ( randomized trials and or meta‐analyses) showing the superiority of Braftovi (encorafenib)a.NOTE: For adjuvant + Mektovi therapy (binimetinib) of BRAF overV600 the E or preferred V600K muta regimen.�on posi�ve, stage III melanoma, the preferred agents per NCH Policies & NCH 1.BraPathway, �ovi for(encorafenib) adjuvant therapy may be are used Opdivo in BRAFV600E (nivolumab or ORV600K Keytruda mutation (pembrolizumab). positive unresectable/metastatic Tafinlar (dabrafenib) melanoma + Mekinist in (trametinib) members who is non have‐preferred intolerance/contraindicationfor use in the adjuvant setting to based Zelboraf on a(vemurafenib) lack of Level 1 + evidence Cotellic (cobimetinib). that nivolumab or pembrolizumab monotherapy is inferior to the above UM ONC_1250 Tafinlar (dabrafenib) Negative change C.Metastacombination. �c Colorectal Cancer Per NCH L1 Pathway 2.BraAdd inclusion�ovi (encorafenib) criteria: will be used in combina�on with Erbitux (cetuximab) or Vec�bix (panitumumab) after prior therapy with an oxaliplatin UM ONC_1335 Braftovi (encorafenib) Negative change and/orb.NOTE: irinotecan For systemic containing therapy regimen.of metasta �c BRAF V600E or V600K mutation positive melanoma the preferred oral combination, per NCH Policies Per Clinical Trial Analysis/Criteria Addand NCHinclusion Pathway, criteria: is cobimetinib + vemurafenib. B.Indolentc.Ta nlar (dabrafenib) Non Hodgkin’s may Lymphoma be used as(Follicular a single Nonagent‐Hodgkin or in combination Lymphoma with (NHL), Mekinist Marginal (trametinib) Zone Lymphoma) in members who have intolerance UM ONC_1250 Tafinlar (dabrafenib) Positive change 1.Copiktra(duvelisib)to/contraindication to may the be use used of [Cobimetinib as monotherapy + Vemurafenib]. for members with relapsed Indolent NHL who have experienced disease progression on or Per Compendia Listing afterRemove 2 prior inclusion lines of criteria: therapy ( prior therapies must have included any 2 of the following: rituximab monotherapy/rituximab+chemotherapy/RIT‐ Radio3.Non Immuno‐Small Cell Therapy Lung Cancer e.g. Zevalin). (NSCLC) hronica.Ta nlar Lymphocytic (dabrafenib) Leukemia may be (CLL)/Smallused as a Lymphocyticsingle agent orLymphoma in combination (CLL/SLL) with Mekinist (trametinib) as first line or subsequent line therapy for recurrentCLL/SLL or metastatic BRAF V600E mutation‐positive NSCLC. 2.Copiktra4.Thyroid Cancer (duvelisib) will be used as a single agent following disease progression on at least two prior therapies, including bendamus�ne + rituximaba.The member Treanda has (bendamustine)anaplas�c, papillary, + Rituxan follicular, (rituximab) and Hürthle and ibrutinib Cell thyroid (unless carcinoma there is and intolerance/contraindication Tanlar (dabrafenib) may beto ibrutinib).used as a single The latter agent/ in recommendationcombination with isMekinist based on (trametinib) the lack of forLevel radioactive 1 evidence iodine ( randomized‐refractory trials ( if radioactive and/or meta iodine‐analyses) therapy to showis appropriate) the superiority BRAF ofV600E duvelisib mutation over‐ either UM ONC_1346 Copiktra (duvelisib) Negative change BRpositive or ibrutinib. unresectable/recurrent/metastatic disease. Per Clinical Trial Analysis/Criteria UM ONC_1250 Tafinlar (dabrafenib) Negative change Add exclusion criteria: Per Compendia Listing UM ONC_1346 Copiktra (duvelisib) Negative change C.Treatment exceeds the maximum limit of 60 (25 mg) or 60 (15 mg) tablets/month. Per FDA Labeling Add inclusion criteria: Breast cancer iv.Member has experienced disease progression on or a�er therapy with an aromatase inhibitor + a CDK4/6 inhibitor (e.g., abemaciclib, UM ONC_1360 Piqray (alpelisib) Negative change palbociclib, or ribociclib). Step Therapy Criteria Add exclusion criteria: 2.Previous Fulvestrant therapy 3.Previous therapy with an mTOR inhibitor e.g. everolimus UM ONC_1360 Piqray (alpelisib) Negative change 6. Treatment exceeds the maximum limit of 60 (150 mg), 60 (100 mg), or 120 (50 mg) tablets/month. Per Clinical Trial Analysis/Criteria Remove exclusion criteria: Receipt of previous chemotherapy for advanced/metasta�c disease UM ONC_1360 Piqray (alpelisib) Positive change

Add inclusion criteria: B.Mul �ple Myeloma NOTE: Xpovio is a Non‐Preferred drug for use in Multiple Myeloma per the NCH Policy. Several other alternative treatment options are available. 1.Xpovio (selinexor) may be used as a single agent for a member with relapsed/refractory mul�ple myeloma who has experienced disease progression on at least 4 prior lines of therapy including two one proteasome inhibitor (e.g. bortezomib, carfilzomib, ixazomib), twoone immunomodulatory agent (e.g. lenalidomide, thalidomide, pomalidomide), and Darzalex (daratumumab). C.Di ffuse Large B‐cell Lymphoma (DLBCL) NOTE: Xpovio is a Non‐Preferred drug per NCH Policy, for relapsed/refractory Diffuse Large B‐Cell Lymphoma (and all related Large B‐Cell UM ONC_1365 Xpovio (selinexor) Negative change Lymphomas) Step Therapy Criteria Add exclusion criteria: UM ONC_1365 Xpovio (selinexor) Negative change D.Treatment exceeds the maximum limit of 8 (40, 60mg, or 80 mg) , 8 (80mg), or 4 (100mg) tablets/month. Per FDA Labeling Add inclusion criteria: B.Mantle Cell Lymphoma, CD‐19 positive Tecartus (brexucabtagene autoleucel) may be used as monotherapy will be used in members 18 years or older with relapsed/refractory Mantle Cell Lymphoma that has progressed that on 2 prior therapieswas either relapsed or refractory to up to 5 prior regimens. Prior therapy should have includedincluding a chemo‐immunotherapy regimen (e.g.e.g., R‐CHOP, or BR, R‐HyperCVAD) and a BTK (Bruton Tyrosine Kinase) inhibitor (e.g. ibrutinib, acalabrutinib, or zanubrutinib). Member should have a confirmed diagnosis of Mantle Cell Lymphoma, either with cyclinD1 overexpression or a positive t(11;14) translocation in UM ONC_1413 Tecartus (brexucabtagene autoleucel) Negative change the lymphoma cells. Per Clinical Trial Analysis/Criteria Add exclusion criteria: B.CD ‐19 posi�vity not conrmed. C.Diagnosis of Mantle Cell Lymphoma not conrmed by either a posi�ve cyclin D1 expression or a posi�ve t(11;14) transloca�on in lymphoma cells. A.D.The member does not have adequate bone marrow reserve dened by ALL the following: 1.Absolute neutrophil count (ANC) ≥ 1000 cells/uL 2.Absolute lymphocyte count (ALC) ≥ 100 cells/uL 3.Platelet Count ≥ 75,000/uL. B.E.The member does not have adequate renal, cardiac, and pulmonary func�on dened as: 1.Crea �nine clearance ≥ 60 mL/min 2.Cardiac ejec�on frac�on ≥ 50% and there is no evidence of pericardial effusion as determined by an echocardiogram (ECHO) 3.EKG has no clinically signicant ndings 4.Baseline oxygen satura�on >92% on room air. C.F.Prior Allogeneic hematopoie�c stem cell transplant (HSCT) D.G.History of CNS lymphoma (including lymphomatous meningi�s), history of brain metastases, or any CNS disorder E.H.Ac �ve serious infec�on UM ONC_1413 Tecartus (brexucabtagene autoleucel) Negative change I.Does not exceed dura�on limit as one �me administra�on. Per Clinical Trial Analysis/Criteria Add inclusion criteria: B.Metasta �c HER‐2 + Breast Cancer NOTE: Margenza(margetuximab) is a Non‐Preferred drug per NCH Policy based on a lack of level 1 evidence demonstrating superiority over UM ONC_1420 Margenza (margetuximab‐cmkb) Negative change trastuzumab containing regimens. More Cost Effective Alternative Add inclusion criteria: B.Melanoma 1.NOTE: The preferred BRAF and MEK inhibitor combina�on regimen, per NCH policy and pathway, for unresectable/metasta�c BRAF muta�on positive melanoma is the combination of Cotellic (cobimetinib) + Zelboraf (vemurafenib) over Mektovi (binimetinib) + Braftovi (encorafenib). This recommendation is based on the lack of Level 1 evidence ( randomized trials and or meta‐analyses) showing the superiority of Braftovi (encorafenib) + Mektovi (binimetinib) over the preferred regimen. 1.Bra �ovi (encorafenib) may be used in BRAFV600E or V600K mutation positive unresectable/metastatic melanoma in members who have intolerance/contraindication to Zelboraf (vemurafenib) + Cotellic (cobimetinib). C.Metasta �c Colorectal Cancer 2.Bra �ovi (encorafenib) will be used in combina�on with Erbitux (cetuximab) or Vec�bix (panitumumab) after prior therapy with an oxaliplatin UMPolicy ONC_1335 # BraftoviPolicy Name (encorafenib) NegativeType of Change change and/orBrief Description irinotecan of containing Policy Change regimen. ReasonPer Clinical for ChangesTrial Analysis/Criteria NEW Abecma (idecabtagene vicleucel) N/A AddN/A inclusion criteria: N/A B.Indolent Non Hodgkin’s Lymphoma (Follicular Non‐Hodgkin Lymphoma (NHL), Marginal Zone Lymphoma) N/A‐ Add addendum for Fidelis Care state specific UM ONC_1041 LHRH agonists and antagonist N/A 1.Copiktra(duvelisib)N/A may be used as monotherapy for members with relapsed Indolent NHL who have experienced disease progression on or criteria afterAdd inclusion 2 prior lines criteria: of therapy ( prior therapies must have included any 2 of the following: rituximab monotherapy/rituximab+chemotherapy/RIT‐ Radio3. Breast Immuno cancer Therapy‐ Abraxane e.g. Zevalin).(nab‐paclitaxel) may be used in combination with Tecentriq (atezolizumab) in the first line setting OR in the second hronicline/subsequent Lymphocytic line Leukemia setting if (CLL)/Smallthe member Lymphocytic has not received Lymphoma the above (CLL/SLL) regimen previously and there is no history of progression on another ImmuneCLL/SLL Checkpoint Inhibitor ( e.g. Keytruda) 2.Copiktra5.Non ‐Small (duvelisib) Cell Lung will Cancer be used (NSCLC) as a single agent following disease progression on at least two prior therapies, including bendamus�ne + rituximaba.In the rst Treanda line se �(bendamustine)ng for metasta �+ c,Rituxan squamous, (rituximab) Non‐Small and ibrutinibCell Lung (unless Cancer, there Taxol is(paclitaxel) intolerance/contraindication is preferred over Abraxane to ibrutinib). (nab‐ paclitaxel).The latter The recommendationabove recommendation is based is onbased the onlack results of Level of KEYNOTE1 evidence‐407 ( randomized trial which trialsshowed and/or no difference meta‐analyses) in outcomes to show between the superiority the use ofof duvelisibTaxol (paclitaxel) over either UM ONC_1346ONC_1179 CopiktraAbraxane (duvelisib) (nab‐paclitaxel) Negative change BRand or Abraxane ibrutinib. (nab ‐paclitaxel). Per Clinical Trial Analysis/Criteria Add exclusion criteria: UM ONC_1346 Copiktra (duvelisib) Negative change C.TreatmentRemove exclusion exceeds criteria: the maximum limit of 60 (25 mg) or 60 (15 mg) tablets/month. Per FDA Labeling UM ONC_1179 Abraxane (nab‐paclitaxel) Positive change Add1.O ff‐ inclusionlabel indica criteria:�ons for Abraxane (nab‐paclitaxel) in ovarian cancer, metasta�c melanoma, urothelial carcinoma, and endometrial carcinoma. Per Clinical Trial Analysis/Criteria BreastRemove cancer inclusion criteria: iv.MemberAdvanced/Metastatic has experienced Renal diseaseCell Carcinoma progression on or a�er therapy with an aromatase inhibitor + a CDK4/6 inhibitor (e.g., abemaciclib, UM ONC_1360 Piqray (alpelisib) Negative change palbociclib,c.NOTE: Votrient or ribociclib). (pazopanib) is PREFERRED in subsequent se�ng for any IMDC risk clear cell RCC per NCH pathway & NCH Policy (if not used in Step Therapy Criteria UM ONC_1195 Votrient (pazopanib) Positive change Addfirst line).exclusion criteria: Per NCH L1 Pathway 2.PreviousRemove inclusion Fulvestrant criteria: therapy 3.Previous2.Chronic Myeloid therapy Leukemiawith an mTOR (CML) inhibitor‐ b. e.g. everolimus UM ONC_1360ONC_1196 PiqraySprycel (alpelisib) (dasatinib) NegativePositive change change 6.c.As Treatment ini�al or subsequent exceeds the therapy maximum for limitmembers of 60 with (150 CML mg), with 60 (100 any mg),of the or following 120 (50 mg)muta tablets/month.�ons: Y253H or E255K/V. Per CompendiaClinical Trial Listing Analysis/Criteria RemoveAdd exclusion exclusion criteria: criteria: Receipt 2.Sprycel of (dasa previous�nib) chemotherapy is being used onfor Ph advanced/metasta or BCR‐ABL nega��cve disease CML or in members with the following mutations of BCR‐ABL1: T315I/A, F317L/V/I/C UM ONC_1360ONC_1196 PiqraySprycel (alpelisib) (dasatinib) PositiveNegative change change or V299L. . Per Compendia Listing Add inclusion criteria: 2.Renal Cell Carcinoma (RCC) Adda.NOTE: inclusion Per NCH criteria: Policy & NCH Pathway, Torisel is only recommended as monotherapy for metasta�c clear cell renal cell carcinoma, in members UM ONC_1200 Torisel (temsrolimus) Negative change B.Mulwho have�ple failed Myeloma two oral TKIs and one or more Immune Checkpoint Inhibitor.. Step Therapy Criteria NOTE:Remove Xpovio inclusion is a Noncriteria:‐Preferred drug for use in Multiple Myeloma per the NCH Policy. Several other alternative treatment options are available. 1.Xpoviob.Torisel (temsirolimus)(selinexor) may may be used be used as a as single a single agent agent for afor member ini�al/subsequent with relapsed/refractory therapy in members mul�ple with myeloma metasta who�c/advanced has experienced non‐clear disease cell Renal UM ONC_1200 Torisel (temsrolimus) Positive change progressionCell Carcinoma on ‐aRCC.t least 4 prior lines of therapy including two one proteasome inhibitor (e.g. bortezomib, carfilzomib, ixazomib), twoone More Cost Effective Alternative(s) immunomodulatory agent (e.g. lenalidomide, thalidomide, pomalidomide), and Darzalex (daratumumab). C.Di ffuse Large B‐cell Lymphoma (DLBCL) NOTE:Add inclusion Xpovio criteria:is a Non‐Preferred drug per NCH Policy, for relapsed/refractory Diffuse Large B‐Cell Lymphoma (and all related Large B‐Cell UM ONC_1365 Xpovio (selinexor) Negative change Lymphomas)B.Malignant Melanoma Step Therapy Criteria Add2.NOTE: exclusion Per NCH criteria: Policy & NCH Pathway, Zelboraf (vemurafenib) in combina�on with a MEK inhibitor ( e.g. cobime�nib) is a non‐preferred UM ONC_1365 Xpovio (selinexor) Negative change D.Treatmentregimen/combination exceeds the for maximum use as adjuvant limit of therapy 8 (40, 60mg, in resected or 80 stagemg) ,III 8 melanoma;(80mg), or 4Opdivo (100mg) (nivolumab) tablets/month. or Keytruda(pembrolizumab) for 1 year is Per FDA Labeling Addthe preferred inclusion criteria:option in this clinical setting. This recommendation is based on the lack of Level 1 evidence ( randomized trials and/or meta‐analyses) B.Mantlesupporting Cell superior Lymphoma, outcomes CD‐ with19 positive anti‐BRAF targeted therapy vs Immune Checkpoint Inhibitor therapy. Tecartus3.NOTE: Per(brexucabtagene NCH Pathway &autoleucel) NCH Policy, may Zelboraf be used (vemurafenib) as monotherapy in combina will be� usedon with in members Cotellic (cobime 18 years� nib)or older + Tecentriq with relapsed/refractory (atezolizumab) is non Mantle‐ Cell Lymphomapreferred for that the has treatment progressed of metastatic/recurrent/unresectable that on 2 prior therapieswas either BRAF relapsed V600 or mutation refractory positive to up to malignant 5 prior regimens. melanoma. PriorThis therapy recommendation should have is includedincludingbased on the lack ofa chemoLevel 1‐ immunotherapyevidence (randomized regimen trials (e.g.e.g., and or R meta‐CHOP,‐analyses) or BR, R supporting‐HyperCVAD superior) and a BTKoutcomes (Bruton with Tyrosine the above Kinase) regimen inhibitor in (e.g. UM ONC_1207 Zelboraf (vemurafenib) Negative change ibrutinib,comparison acalabrutinib, to [Yervoy(ipilimumab) or zanubrutinib). + Opdivo(nivolumab)] the recommended regimen per NCH policy. Per Clinical Trial Analysis/Criteria MemberAdd exclusion should criteria: have a confirmed diagnosis of Mantle Cell Lymphoma, either with cyclinD1 overexpression or a positive t(11;14) translocation in UM ONC_1413 Tecartus (brexucabtagene autoleucel) Negative change theB.Use lymphoma of Zelboraf cells. (vemurafenib) as a single agent or in combination with Cotellic (cobimetinib) + Tecentriq (atezolizumab) in Per Clinical Trial Analysis/Criteria Addmetastatic/recurrent/unresectable exclusion criteria: BRAF V600 mutation positive malignant melanoma. UM ONC_1207 Zelboraf (vemurafenib) Positive change B.CDD.Treatment ‐19 posi �exceedsvity not the con maximumrmed. limit of 240 (240 mg) capsules tablets a month. per FDA Labeling C.DiagnosisAdd inclusion of criteria: Mantle Cell Lymphoma not conrmed by either a posi�ve cyclin D1 expression or a posi�ve t(11;14) transloca�on in lymphoma UM ONC_1226 Zaltrap (ziv‐aflibercept) Negative change cells. Zaltrap use is not recommended for metastatic colorectal cancer. More Cost Effective Alternative(s) A.D.TheAdd inclusion member criteria: does not have adequate bone marrow reserve dened by ALL the following: 1.Absolute2.Chronic Myelogenous neutrophil count Leukemia (ANC) ≥ 1000 cells/uL 2.Absolutei.The member lymphocyte has experienced count (ALC) disease ≥ 100 progression cells/uL / intolerance to three or more of the following tyrosine kinase inhibitors: Gleevec (ima�nib), 3.PlateletTasigna (nilotinib), Count ≥ 75,000/uL. or Bosulif (bosutinib), or Sprycel(dasatinib) OR UM ONC_1240 Synribo (omacetaxine) Negative change B.E.Theii.The member member has does a T315I not have muta adequate�on and has renal, failed cardiac, Iclusig and (ponatinib) pulmonary to func treat�on CML de withned as:this mutation. Step Therapy Criteria 1.CreaAdd inclusion�nine clearance criteria: ≥ 60 mL/min 2.Cardiac2.BRAF V600E ejec� oron V600K frac�on muta ≥ 50%�on and posi there�ve Melanoma is no evidence of pericardial effusion as determined by an echocardiogram (ECHO) 3.EKGa.NOTE: has For no adjuvant clinically therapy signicant of BRAF ndings V600 E or V600K muta�on posi�ve, stage III melanoma, the preferred agents per NCH Policies & NCH 4.BaselinePathway, for oxygen adjuvant satura therapy�on >92% are Opdivoon room (nivolumab air. OR Keytruda (pembrolizumab). Tafinlar (dabrafenib) + Mekinist (trametinib) is non‐preferred C.F.Priorfor use in Allogeneic the adjuvant hematopoie setting based�c stem on cella lack transplant of Level (HSCT)1 evidence that nivolumab or pembrolizumab monotherapy is inferior to the above UM ONC_1250 Tafinlar (dabrafenib) Negative change D.G.Historycombination. of CNS lymphoma (including lymphomatous meningi�s), history of brain metastases, or any CNS disorder Per NCH L1 Pathway E.H.AcAdd inclusion�ve serious criteria: infec�on UM ONC_1413 Tecartus (brexucabtagene autoleucel) Negative change I.Doesb.NOTE: not For exceed systemic dura therapy�on limit of asmetasta one ��mec BRAF administra V600E� oron. V600K mutation positive melanoma the preferred oral combination, per NCH Policies Per Clinical Trial Analysis/Criteria Addand NCHinclusion Pathway, criteria: is cobimetinib + vemurafenib. B.Metastac.Ta nlar (dabrafenib)�c HER‐2 + Breast may be Cancer used as a single agent or in combination with Mekinist (trametinib) in members who have intolerance UM ONC_1250 Tafinlar (dabrafenib) Positive change NOTE:to/contraindication Margenza(margetuximab) to the use of [Cobimetinibis a Non‐Preferred + Vemurafenib]. drug per NCH Policy based on a lack of level 1 evidence demonstrating superiority over Per Compendia Listing UM ONC_1420 Margenza (margetuximab‐cmkb) Negative change trastuzumabRemove inclusion containing criteria: regimens. More Cost Effective Alternative 3.Non ‐Small Cell Lung Cancer (NSCLC) a.Ta nlar (dabrafenib) may be used as a single agent or in combination with Mekinist (trametinib) as first line or subsequent line therapy for recurrent or metastatic BRAF V600E mutation‐positive NSCLC. 4.Thyroid Cancer a.The member has anaplas�c, papillary, follicular, and Hürthle Cell thyroid carcinoma and Tanlar (dabrafenib) may be used as a single agent/in combination with Mekinist (trametinib) for radioactive iodine‐refractory ( if radioactive iodine therapy is appropriate) BRAF V600E mutation‐ positive unresectable/recurrent/metastatic disease. UM ONC_1250 Tafinlar (dabrafenib) Negative change Per Compendia Listing Policy # Policy Name Type of Change Brief Description of Policy Change Reason for Changes NEW Abecma (idecabtagene vicleucel) N/A N/A N/A Add inclusion criteria: N/A‐ Add addendum for Fidelis Care state specific UM ONC_1041 LHRH agonists and antagonist N/A B.DiN/A ffuse Large B‐Cell Lymphoma, conrmed CD‐19 posi�ve criteria 1.BreyanziAdd inclusion (lisocabtagene criteria: maraleucel) may be used, as monotherapy, for the treatment of adult members with relapsed or refractory large B‐cell lymphoma3. Breast cancer (CD‐19‐ Abraxanepositive) after (nab ‐diseasepaclitaxel) progression may be used on/after in combination two or more with lines Tecentriq of systemic (atezolizumab) therapy , including in the first chemoimmunotherapy line setting OR in the containing second UM ONC_1421 Breyanzi (lisocabtagene maraleucel) Negative change antiline/subsequent‐CD20 and anthracycline line setting if(unless the member anthracyclines has not receivedare contraindicated) the above regimen and/or previouslyand/or hematopoietic and there is stemno history cell transplant. of progression on another Per FDA Labeling AddImmune exclusion Checkpoint criteria: Inhibitor ( e.g. Keytruda) C.Does5.Non ‐Small not exceed Cell Lung dura Cancer�on limit (NSCLC) as one �me administra�on. D.Thea.In the member rst line does se� notng for have metasta adequate�c, squamous, bone marrow Non reserve.‐Small Cell Lung Cancer, Taxol (paclitaxel) is preferred over Abraxane (nab‐paclitaxel). The aboveE.The member recommendation does not haveis based adequate on results renal, of hepaKEYNOTE�c, cardiac‐407 trial and which pulmonary showed func no� differenceon dened in as: outcomes between the use of Taxol (paclitaxel) UM ONC_1179 Abraxane (nab‐paclitaxel) Negative change and1.Crea Abraxane�nine clearance (nab‐paclitaxel). > 30 mL/min Per Clinical Trial Analysis/Criteria 2.Serum ALT ≤5 times the upper limit of normal Remove3.Cardiac exclusion ejec�on fraccriteria:�on ≥ 40%, no evidence of pericardial effusion as determined by an echocardiogram (ECHO), and no clinically significant UM ONC_1179 Abraxane (nab‐paclitaxel) Positive change pleural1.O ff‐label effusion indica�ons for Abraxane (nab‐paclitaxel) in ovarian cancer, metasta�c melanoma, urothelial carcinoma, and endometrial carcinoma. Per Clinical Trial Analysis/Criteria Remove4.Baseline inclusion oxygen criteria:satura�on > 91% on room air. Advanced/MetastaticF.Primary central nervous Renal system Cell Carcinoma lymphoma. G.Acc.NOTE: �ve Votrientserious infec(pazopanib)�on. is PREFERRED in subsequent se�ng for any IMDC risk clear cell RCC per NCH pathway & NCH Policy (if not used in UM ONC_1421ONC_1195 BreyanziVotrient (pazopanib)(lisocabtagene maraleucel) NegativePositive change change firstH.In line).ammatory disorders. Per ClinicalNCH L1 TrialPathway Analysis/Criteria Remove inclusion criteria: 2.Chronic Myeloid Leukemia (CML)‐ b. UM ONC_1196 Sprycel (dasatinib) Positive change c.As ini�al or subsequent therapy for members with CML with any of the following muta�ons: Y253H or E255K/V. Per Compendia Listing Add exclusion criteria: 2.Sprycel (dasa�nib) is being used on Ph or BCR‐ABL nega�ve CML or in members with the following mutations of BCR‐ABL1: T315I/A, F317L/V/I/C UM ONC_1196 Sprycel (dasatinib) Negative change or V299L. . Per Compendia Listing Add inclusion criteria: 2.Renal Cell Carcinoma (RCC) a.NOTE: Per NCH Policy & NCH Pathway, Torisel is only recommended as monotherapy for metasta�c clear cell renal cell carcinoma, in members UM ONC_1200 Torisel (temsrolimus) Negative change who have failed two oral TKIs and one or more Immune Checkpoint Inhibitor.. Step Therapy Criteria Remove inclusion criteria: b.Torisel (temsirolimus) may be used as a single agent for ini�al/subsequent therapy in members with metasta�c/advanced non‐clear cell Renal UM ONC_1200 Torisel (temsrolimus) Positive change Cell Carcinoma‐RCC. More Cost Effective Alternative(s)