Policy Drug(s) Type of Change Brief Description of Policy Change

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Policy Drug(s) Type of Change Brief Description of Policy Change

Transcript Of Policy Drug(s) Type of Change Brief Description of Policy Change

Policy UM ONC_1038
UM ONC_1038
UM ONC_1042
UM ONC_1042 UM ONC_1042 UM ONC_1072

Drug(s) Emend (Aprepitant oral or Fosaprepitant), Cinvanti (aprepitant injection) and Varubi (rolapitant oral/injection)

Type of Change Negative change

Emend (Aprepitant oral or Fosaprepitant), Cinvanti (aprepitant injection) and Varubi (rolapitant oral/injection)

Positive change

Somatostatin Analog: Sandostatin Negative change (octreotide) and Somatuline (lanreotide)

Somatostatin Analog: Sandostatin (octreotide) and Somatuline (lanreotide) Somatostatin Analog: Sandostatin (octreotide) and Somatuline (lanreotide) Myeloid Growth Factors

Positive change Positive change Positive change

Brief Description of Policy Change Add inclusion criteria: a.Note: Per NCH policy, intravenous Emend (fosaprepitant) is preferred over oral Emend (aprepitant).
Remove exclusion criteria: - Varubi (rolapitant oral/injection) is being used in patients with severe hepatic impairment (Child-Pugh class C) or with CYP2D6 substrates with a narrow therapeutic index such as thioridazine and pimozide. - Emend or Cinvanti is being used concomitantly with pimozide, thioridiazine, terfenadine, astemizole, or cisapride.
Add inclusion criteria: 3.NETS: Neuro Endocrine a.Somatosta n Analog is being used in member with metasta c/unresectable neuroendocrine tumors origina ng in the gastrointes nal tract/pancreas/lung/adrenal glands/other organs ( except small cell lung cancer) as a single or in combination with other therapies. 4.Thymomas and Thymic Carcinomas a.The member has unresectable/metasta c thymomas or thymic carcinomas AND b.The tumor/disease is posi ve on an Octreoscan (or similar imaging confirming that the tumor is somatosta n receptor posi ve) Remove inclusion criteria: 4.Thymomas and Thymic Carcinomas Sandostatin SQ or LAR depot (octreotide) is being used as second line therapy for locally advanced/metastatic disease with or without prednisone
Remove exclusion criteria: 1.Dosing exceeds single dose limit from 40 to 60 mg Sandosta n LAR depot
Add inclusion critiera: 3.MGF use is supported as Secondary Prophylaxis for members with solid tumors or non-myeloid malignancies who experienced any of the following: a.A prior episode of febrile neutropenia with the current chemotherapy OR b.A neutropenic event leading to chemotherapy dose delay or dose decrease in the cura ve intent se ng. E.Use of MGF in members receiving concurrent chemoradia on 1.For members on concurrent chemoradia on, the use of long ac ng MGF (e.g. pegfilgras m and biosimilars) is not recommended per NCH policy. 2.For members on concurrent chemoradia on, the use of short ac ng MGF (e.g. filgras m and biosimilars) will be reviewed on a case by case basis.

UM ONC_1133 Erbitux (Cetuximab) UM ONC_1133 Erbitux (Cetuximab)
UM ONC_1133 Erbitux (Cetuximab)

Negative change Positive change
Positive change

Add inclusion criteria: 2.Head and Neck Cancers a.Note: Randomized data have shown that Erbitux (cetuximab) + radia on therapy is inferior to cispla n + radia on therapy. Therefore, the use of Erbitux (cetuximab) + radia on therapy for cura ve intent is only recommended for members who have a contraindication to cisplatin use. 3.Colorectal Cancer a.The member has stage IV, KRAS/NRAS Wild-Type metasta c colorectal cancer and Erbitux (cetuximab) is being used as a single agent or in combina on with FOLFIRI, or FOLFOX, or irinotecan in the ini al or subsequent line setting, except for members who have experienced disease progression on prior therapy with Erbitux( cetuximab) or Vectibix (panitumumab) Remove inclusion criteria: 2.Head and Neck Cancers ii.Sequen al chemoradia on (Erbitux + Radia on) following induc on chemotherapy 3.Colorectal Cancer i.Ini al therapy: A.In combina on with FOLFOX (fluorouracil, leucovorin, and oxalipla n) or FOLFIRI (fluorouracil, leucovorin, and irinotecan) regimen OR B.As a single agent. ii.Recurrent therapy [not previously treated with Erbitux (cetuximab) or Vec bix (panitumumab)] A.For disease previously treated with oxalipla n based chemotherapy without irinotecan (i.e. FOLFOX OR CAPEOX/XELOX): used in combina on with FOLFIRI (fluorouracil, leucovorin, and irinotecan), irinotecan. or as a single agent OR B.For disease previously treated with irinotecan- based chemotherapy without oxalipla n (i.e. FOLFIRI): used in combina on with irinotecan, FOLFOX (fluorouracil, leucovorin, and oxalipla n) regimen, or as Remove exclusion criteria Off-label indications for Erbitux (cetuximab) in NSCLC.

UM ONC_1192
UM ONC_1192 UM ONC_1201 UM ONC_1205 UM ONC_1205 UM ONC_1205 UM ONC_1205 UM ONC_1206 UM ONC_1220
UM ONC_1220 UM ONC_1245 UM ONC_1245 UM ONC_1245 UM ONC_1245 UM ONC_1248

Afinitor (everolimus)

Positive change

Afinitor (everolimus) Yervoy (ipilimumab) Halaven (eribulin) Halaven (eribulin)

Positive change Negative change Positive change Negative change

Halaven (eribulin)
Halaven (eribulin) Xalkori (crizotinib)

Positive change
Positive change Negative change

Arzerra (ofatumumab)

Positive change

Arzerra (ofatumumab)

Negative change

Xofigo (radium Ra 223 dichloride) Positive change

Xofigo (radium Ra 223 dichloride) Positive change

Xofigo (radium Ra 223 dichloride) Negative change

Xofigo (radium Ra 223 dichloride) Positive change

Ixempra(ixabepilone)

Positive change

Remove inclusion criteria: 3.Renal Cell Carcinoma (RCC) a.Subsequent therapy as a single agent OR in combina on with Lenvima lenva nib(lenva nib) or /Avas n (bevacizumab) for relapsed or medically unresectable stage IV disease in members who have progressed on prior tyrosine kinase inhibitor, including Sutent (sunitinib), Nexavar (sorafenib), or Votrient (pazopanib) therapy. 5.Lung Neuroendocrine tumor a.Used as treatment for stage IIIb-IV or unresectable low- or intermediate-grade neuroendocrine carcinoma. 6.Waldenström's macroglobulinemia/Lymphoplasmacy c lymphoma a.Single-agent salvage therapy for disease that does not respond to primary therapy or for progressive or relapsed disease. 7.Hodgkin Lymphoma a.Used subsequent therapy as a single agent for refractory or relapsed disease. 9.So Tissue Sarcoma – PEComa/Recurrent Angiomyolipoma/Lymphangioleiomyomatosis a.Used in combina on with either Gleevec ( ima nib), Sutent (suni nib), or S varga (regorafenib) for disease progression a er single-agent therapy with Gleevec (ima nib), Sutent (suni nib), and S varga (regorafenib). 10.Thymomas and Thymic Carcinomas Remove exclusion criteria: 1.The member has stage I-III RCC OR has not progressed on a TKI, including Nexavar (sorafenib), Sutent (suni nib), or Votrient (pazopanib). 2.The member has neuroendocrine pancrea c tumor which is resectable. Remove inclusion criteria: 4.Small Cell Lung Cancer a.The member has SCLC and Yervoy (ipilimumab) will be used in combina on with Opdivo (nivolumab) as subsequent therapy and the member has not experienced disease progression on other PD-1/PDLAdd inclusion critiera: 2.Breast Cancer a.The member has recurrent or metasta c breast cancer, and Halaven (eribulin) is being used a s a single agent Add inclusion criteria: 3.So Tissue Sarcoma Members with metastatic/unresectable liposarcoma with disease progression on anthracycline based therapy and A randomized phase III trial showed improved OS in metastatic liposarcoma compared to dacarbazine. There was no benefit in leiomyosarcoma and other sarcoma subtypes were not studied. for palliative therapy in the member with disease progression on an anthracycline-containing regimen. Remove inclusion criteria: 2.Breast Cancer c.The member has failed both an anthracycline and a taxane in either the metasta c or adjuvant se ng. Remove exclusion criteria: 1.The member did not receive prior treatment with an anthracycline AND taxane based chemotherapy for breast cancer or prior anthracycline containing regimen for liposarcomaso ssue sarcoma. Add inclusion criteria: NSCLC NOTE#2: For ROS1 + metastatic Non Small Cell Lung Cancer, crizotinib is the preferred agent for patients without brain metastases, and Entrectinib is preferred for patients with brain metastases because of improved brain penetration i.ROS1 rearrangement-posi ve tumors without brain metastases as first line or subsequent therapy OR Remove Inclusion criteria: 2. CLL a. The member has CLL which in the clinician’s judgment requires therapy AND Arzerra (ofatumumab) is being used for the following: i. In combination with bendamustine as first line therapy OR ii. As a single agent or in combination with FC (fludarabine, cyclophosphamide) for members with relapsed or refractory disease OR iii. Maintenance therapy as second-line extended dosing following complete or partial response to treatment for relapsed or refractory disease. 3.Waldenstrom’s Macroglobulemia a.The member has Waldenström Macroglobulinemia and Arzerra (ofatumumab) is being as a single agent or combina on therapy for Rituximab – intolerant members who don’t respond to primary therapy. Add inclusion criteria: 2.Chronic Lymphocy c Leukemia (CLL) NOTE: Per NCH Policy and NCH Pathways, Arzerra ( ofatumumab) is not recommended for use in CLL. Several alternative/superior options are available. Please refer to the NCH Pathway document for details. Add inclusion critiera: 2.Prostate Cancer NOTE: Xofigo is a non-preferred drug per NCH Policy & NCH Pathways. Xofigo may be used in members with metastatic castrate-resistant prostate cancer who have symptomatic bone metastases ( e.g. bone pain) and do not have visceral metastases a.Xofigo must not be combined with abiraterone as detrimental outcomes have been noted in studies Remove inclusion criteria: The member has hormone refractory disease and bone metastases AND The member has symptomatic disease (i.e. cancer related bone pain on analgesic medication or treatment with external beam radiation therapy for bone pain) AND The member has no known visceral Add exclusion criteria: 2.Use with Zy ga (abiraterone) is contraindicated with Xofigo (radium Ra 223 dichloride).
Remove exclusion criteria: 3.The presence of visceral metasta c disease or malignant lymphadenopathy.
Remove exclusion criteria: 3.AST or ALT greater than 2.5 mes the upper limit of normal (ULN) or bilirubin greater than one mes ULN due to increased risk of toxicity and neutropenia-related death.

UM ONC_1249 Mekinist (trametinib) UM ONC_1249 Mekinist (trametinib)

UM ONC_1249 Mekinist (trametinib)

UM ONC_1249 UM ONC_1265

Mekinist (trametinib) Zykadia (ceritinib)

UM ONC_1265 Zykadia (ceritinib)

UM ONC_1274 Opdivo (nivolumab)

UM ONC_1276

Onivyde (irinotecan liposome injection)

UM ONC_1276

Onivyde (irinotecan liposome injection)

UM ONC_1276 UM ONC_1277

Onivyde (irinotecan liposome injection) Alecensa (Alectinib)

UM ONC_1282

Imlygic (Talimogene Laherparepvec)

UM ONC_1282

Imlygic (Talimogene Laherparepvec)

UM ONC_1282

Imlygic (Talimogene Laherparepvec)

Negative change
Negative change
Positive change Negative change Negative change Positive change Negative change Negative change
Positive change Positive change Positive change Negative change Positive change Positive change

Add inclusion critiera: 2. Malignant Melanoma NOTE #1: The preferred combination for targeted therapy of metastatic/unresectable/recurrent BRAF V600E malignant melanoma, per NCH Policy & NCH Pathway is [vemurafenib + cobimetinib] NOTE#2: Mekinist ( trametinib) may be used in combination with dabrafenib, as first line, second-line, or subsequent treatment for metastatic or unresectable disease, if member is intolerant to/has a contraindication to the preferred combination [ Vemurafenib+ Cobimetinib] NOTE# 3: Mekinist(trametinib) + dabrafenib may be used an a member with The member has BRAF V600E mutation positive malignant melanoma as adjuvant treatment after complete resection of the Remove inclusion criteria: Melanoma Mekinist (trametinib) is being used in combination with Tafinlar (dabrafenib) as any of the following: i.As adjuvant treatment a er complete resec on of the primary lesion and comple on of a regional lymph node dissec on OR ii.As ini al treatment for recurrent/metasta c disease, including satellite/in-transit recurrence or metastases OR iii.As first line, second-line, or subsequent treatment for metasta c or unresectable disease, if targeted therapy not previously used. 5.Colorectal Cancer a.The member has unresectable, advanced, or metasta c BRAF V600E muta on posi ve colorectal cancer and Mekinist (trame nib) is being used in combina on with dabrafenib and cetuximab/panitumumab as any of the following: i.Primary treatment OR ii.Subsequent therapy if targeted therapy not previously used. 6.Ovarian Cancer a.Mekinist (trame nib) is being used as recurrent therapy for low grade serous carcinoma. Remove exclusion criteria: 1.The member has BRAF wild-type melanoma, NSCLC, or anaplas c thyroid cancer, or colorectal cancer. 3.Previous treatment with BRAF or MEK inhibitor (i.e. vemurafenib, dabrafenib, cobime nib, binime nib, or trame nib). Add exclusion criteria: 2.Disease progression while taking taking any MEK inhibitors + BRAF inhibitor combina on. Add inclusion criteria: Zykadia (ceritinib) may be used for first line therapy of ALK+ metastatic NSCLC if the member is intolerant /has a contraindication to Alcensa (alectinib). Zykadia (ceritinib) may be used for second line or subsequent therapy for ALK+ metastatic NSCLC if the member has experienced disease progression on Alcensa (alectinib), or Xallakori (crizotinib). Remove inclusion criteria: NSCLC The member has locally advanced, recurrent, or metastatic NSCLC and Zykadia (ceritinib) is being used as a single agent for ALL of the following conditions: i.The member has anaplas c lymphoma kinase (ALK)-posi ve NSCLC AND ii.Zykadia (ceri nib) is being used for subsequent therapy following disease progression on first-line therapy with another ALK inhibitor, e.g. Alcensa (alec nib) or Xalkori (crizo nib). Remove inclusion criteria: I.Small Cell Lung Cancer (SCLC) 1.The member has recurrent/relapsed SCLC and Opdivo (nivolumab) is being used as a single agent o r in combination with Yervoy (ipilimumab) as subsequent therapy beyond second line AND Add inclusion criteria: 2.Metasta c adenocarcinoma of the pancreas NOTE: Onyvide (liposomal irinotecan) is a non-preferred drug per NCH Policy and NCH Pathways Onyvide (liposomal irinotecan) may be used for members with metastatic pancreas cancer who have progressed on prior therapy with both a gemcitabine-based regimen ( e.g. gemcitabine + nab-paclitaxel) and FOLFIRINOX( except when patient was felt to be unfit for this regimen). 2.Onyvide must be used with 5 Fu and leucovorin Remove inclusion criteria: a.Onivyde (irinotecan liposome) must be used in combina on with fluorouracil and leucovorin AND b.Member must have progressed on prior treatment of a fluoropyrimidine or gemcitabine-based therapy AND c.Member must NOT have failed prior therapy with irinotecan HCL (non-liposomal formula on). Remove exclusion criteria: 2.Disease progression while taking irinotecan HCL (non-liposomal formula on). Remove inclusion criteria: NSCLC iii.As subsequent therapy following disease progression on first-line therapy OR iv.Con nua on of therapy if used first line. Add inclusion criteria: 2.Melanoma NOTE#1: Imlygic is indicated ONLY for use as intra-lesional injections for visible/metastatic malignant melanoma skin lesions NOTE#2: Imlygic is not recommended per NCH Policy or NCH Pathway for combination therapy with Checkpoint Inhibitors, e.g. ipilimumab, nivolumab, and pembrolizumab. There are no randomized trials supporting the superiority of Checkpoint Inhibitors + Imlygic over either therapy given alone. i.The member has stage IIIB, IIIC, or IV melanoma and Imylgic is being used as a single agent as an intra-lesional injec on for unresectable, in-transit/distant/locally recurrent skin metastases from Remove inclusion criteria: In melanoma for: i.Unresectable stage III in-transit metastases ii.Local/satellite and/or in-transit unresectable recurrence iii.Unresectable or distant metasta c disease. Remove exclusion criteria: 3.Member is immunocompromised or has any immune-mediated events. 4.Member has a Herpe c infec on and on an -herpe c treatment.

UM ONC_1284 Ninlaro (ixazomib) UM ONC_1284 Ninlaro (ixazomib)

UM ONC_1284 Ninlaro (ixazomib) UM ONC_1287 Tagrisso (osimertinib)

UM ONC_1287 Tagrisso (osimertinib) UM ONC_1287 Tagrisso (osimertinib) UM ONC_1288 Fusilev (levoleucovorin)

UM ONC_1290 Yondelis (trabectedin)

UM ONC_1290 Yondelis (trabectedin)

UM ONC_1290 UM ONC_1377

Yondelis (trabectedin) Brukinsa (zanubrutinib)

UM ONC_1377 UM ONC_1377

Brukinsa (zanubrutinib) Brukinsa (zanubrutinib)

UM ONC_1396 Koselugo (selumetinib)

Negative change Negative change
Positive change Negative change
Negative change Positive change Positive change
Positive change Negative change Positive change Negative change Positive change Positive change Negative change

Add inclusion criteria: 2.Mul ple Myeloma NOTE#1: Ninlaro (ixazomib) containing regimens are Non-Preferred regimens per NCH Policy and NCH Pathway for both initial therapy and for relapsed/refractory multiple myeloma NOTE#2: Ninlaro( ixazomib) is Non-Preferred for any maintenance therapy, including maintenance after HSCT Remove inclusion criteria: i.Primary chemotherapy or for disease relapse a er 6 months following primary chemotherapy with the same regimen: 1.In combina on with lenalidomide and dexamethasone OR 2.In combina on with cyclophosphamide and dexamethasone for transplant candidates OR ii.Maintenance: as a single agent for transplant candidates. iii.Relapse, progressive, or refractory disease 3.In combina on with dexamethasone and pomalidomide for members who have received at least two prior therapies including an immunomodulatory agent and a proteasome inhibitor and who have demonstrated disease progression on or within 60 days of completion of the last therapy. Remove exclusion criteria: 1.History of refractory disease on Ninlaro (ixazomib), proteasome inhibitor (i.e. bortezomib or carfilzomib), or immunodulatory agent (i.e. lenalidomide or pomalidomide). Refractory disease is defined as disease progression on treatment or progression within 60 days after the last dose of a given therapy. 2.Members have not received/experienced disease progression on regimens containing all of the following: bortezomib, lenalidomide and daratumumab ( all 3 drugs don’t have to be present in the same Add inclusion criteria: 2.Non-Small Cell Lung Cancer (NSCLC) Per NCH Policy & NCH Pathways Tagrisso(osimertinib) is the PREFERRED Drug in the following clinical scenarios for: a First line therapy of recurrent/metasta c, EGFR muta on posi ve Non-Small Cell Lung Cancer. Ra onale: FLAURA trial including long term follow up of this trial b.The member has recurrent or metasta c, EGFR + (Exon 19 deletion or Exon 21 L858R point mutation) c.The member has EGFR + (Exon 19 dele on or Exon 21 L858R point muta on), stage II-IIIA, Non Small Cell Lung Cancer, that has been surgically resected, and Tagrisso(osimer nib) is being used as adjuvant therapy (with or without adjuvant chemotherapy). Maximum duration of such adjuvant therapy with Tagrisso (Osimertinib) is up to 3 years. Add exclusion criteria: 1.Concurrent use with cytotoxic chemotherapy. Prior adjuvant chemotherapy for stage II-IIIA resected, EGFR+ NSCLC is allowed. 3.Member has an uncommon EGFR muta on, especially and Exon 20 muta on Remove exclusion criteria: 1.Symptoma c conges ve heart failure or life-threatening arrhythmias. 2.Inters al lung disease/pneumoni s, that is caused by or is related to Tagrisso therapy Remove inclusion critiera: a.The member has advanced colorectal cancer and Fusilev/Khapzory (if there are contraindications/intolerance/failure to Fusilev) is being used only when Leucovorin is not available at the office and the shortage is reported on FDA drug shortage website1 AND b.Fusilev/Khapzory (if there are contraindications/intolerance/failure to Fusilev) is being used in combination with fluorouracil-based regimens in ONE of the following conditions: i.For poten a on of fluorouracil therapy in the treatment of colorectal cancer Add inclusion critiera: 2.So Tissue Sarcoma a.The member has unresectable or metasta c so ssue sarcoma ( Leiomyosarcoma, liposarcoma, and transloca on-related sarcomas) b.Yondelis (trabectedin) is being used as a single agent palliative therapy Add exclusion criteria: 2.Yondelis use in sarcomas other than leiomyosarcoma, liposarcoma and transloca on-associated sarcomas. 3.[In the phase III TSAR trial, pa ents with non-liposarcoma/LMS histotypes, trabectedin had no objec ve tumor responses rela ve to the liposarcoma/LMS group (0 versus 19 percent) and had similar PFS to those receiving best supportive care (median 1.8 versus 1.5 months). In contrast, for those with liposarcoma/LMS, trabectedin demonstrated improved PFS relative to best supportive care (median 5.1 Remove exclusion criteria: 4.Significant chronic liver disease, such as cirrhosis or ac ve hepa s requiring an viral therapy. Add inclusion criteria: f.Mantle Cell Lymphoma i.Note: Per NCH L1 pathway and NCH policies, Imbruvica (ibru nib) is the preferred Bruton's tyrosine kinase (BTK) inhibitor over Brukinsa (zanubru nib). Remove inclusion criteria: ii.Member is intolerant to or has a contraindica on to Ibru nib- the preferred BTK inhibitor per NCH Pathway and Policies Remove exclusion criteria: 2.Clinically significant ac ve cardiovascular disease. 3.Uncontrolled systemic infec on or infec on requiring an -microbial therapy. Add inclusion criteria: 2.Plexiform Neurofibromas (PN) ii.Posi ve gene c tes ng for neurofibromatosis type 1 (NF1) muta on
ChangeTherapyInclusion CriteriaExclusion CriteriaAgent