Committee Approval Date: December 12, 2014 Next Review Date: July 2015

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1 Medication Policy Manual Policy No: dru378 Topic: Akynzeo, netupitant/palonosetron Date of Origin: December 12, 2014 Committee Approval Date: December 12, 2014 Next Review Date: July 2015 Effective Date: January 1, 2015 IMPORTANT REMINDER This Medical Policy has been developed through consideration of medical necessity, generally accepted standards of medical practice, and review of medical literature and government approval status. Benefit determinations should be based in all cases on the applicable contract language. To the extent there are any conflicts between these guidelines and the contract language, the contract language will control. The purpose of medical policy is to provide a guide to coverage. Medical Policy is not intended to dictate to providers how to practice medicine. Providers are expected to exercise their medical judgment in providing the most appropriate care. Description Netupitant/palonosetron (Akynzeo) is an oral capsule containing a fixed combination of netupitant, a P/neurokinin 1 (NK 1 ) receptor antagonist, and palonosetron, a serotonin-3 (5HT 3 ) receptor antagonist. Netupitant/palonosetron is indicated for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly-emetogenic chemotherapy. dru378.0 Page 1 of 8

2 Policy/Criteria I. Most contracts require prior authorization approval of netupitant/palonosetron prior to coverage. Netupitant/palonosetron may be considered medically necessary when used for the prevention of chemotherapy-induced nausea/vomiting (CINV) associated with highly-emetogenic chemotherapy (HEC) (as defined in Appendix 1). II. Administration, Quantity Limitations, and Authorization Period A. RegenceRx considers netupitant/palonosetron to be a self-administered medication. B. When prior authorization is approved, netupitant/palonosetron may be authorized in quantities of one capsule per chemotherapy cycle. C. Authorization may be reviewed at least every 6 months to confirm that current medical necessity criteria are met and that the medication is effective. III. Netupitant/palonosetron is considered not medically necessary when used for the following conditions: A. Prevention and/or treatment of postoperative nausea and vomiting (PONV) B. Prevention and/or treatment of CINV associated with moderate, low or minimal-emetogenic chemotherapy (Appendix 1) IV. Netupitant/palonosetron is considered investigational when used for all other conditions, including but not limited to: A. Hyperemis gravidarum B. Nausea and vomiting of pregnancy (NVP) Position Statement - The combination of netupitant/palonosetron has low value in the upfront prevention of CINV because there are less costly alternatives available. - Antiemetic regimens should be chosen based on the drug with the highest emetic risk (see Appendix 1) as well as patient specific risk factors. - Add-on NK1s are superior for preventing nausea and vomiting and sequelae of CINV with HEC as part of a three-drug regimen compared to a two-drug regimen (5HT3/corticosteroid). [1,3-4] - Chemotherapy-induced nausea and vomiting (CINV) due to moderate and highlyemetogenic chemotherapy is difficult to control. Netupitant/palonosetron is effective for prevention of CINV due to highly-emetogenic chemotherapy. dru378.0 Page 2 of 8

3 - For postoperative nausea and vomiting (PONV) and CINV with minimal to moderateemetogenic chemotherapy, it is unknown if netupitant/palonosetron is superior to bestvalue generic options. - Netupitant/palonosetron may be covered for up to one dose per chemotherapy cycle, the dosing at which it has been shown to be safe and effective. Clinical Efficacy Chemotherapy Induced Nausea and Vomiting (CINV) - Palonosetron (Aloxi) is the preferred 5HT3 for emetic prophylaxis of both HEC and moderately-emetogenic chemotherapy (MEC) regimens, preferred for its long half-life and single-dose ease of use. [1] - Netupitant/palonosetron (Akynzeo) is a combination product effective for the prevention of acute and delayed emesis. [8] - Based on clinical trial data, netupitant/palonosetron (Akynzeo) demonstrated superior complete response rates relative to oral palonosetron for the prevention of chemotherapy-induced nausea and vomiting associated with HEC based on three low confidence comparative trials. [9-11] - One multi-cycle safety study evaluated the use of netupitant/palonosetron for use with MEC and HEC. However, the FDA medical review designated the efficacy of netupitant/palonosetron to be exploratory in this trial. Therefore, the use of netupitant/palonosetron for the prevention and/or treatment of CINV for chemotherapy regimens that are not labeled as highly-emetogenic chemotherapy (Appendix 1) is [11, 14] considered not medically necessary. - In addition, The National Comprehensive Cancer Network (NCCN) and The American Society of Clinical Oncology (ASCO) have reclassified some of the chemotherapy regimens used to establish efficacy of netupitant/palonosetron in clinical trials to highly-emetogenic chemotherapy. - Although clinical trial data supports the use of netupitant/palonosetron (Akynzeo) for the prevention of chemotherapy-induced nausea and vomiting (CINV) following highly-emetogenic chemotherapy, it is important to note that oral palonosetron, the active comparator, is not commercially available. - There are no trials of netupitant/palonosetron (Akynzeo) for use with low or minimalemetogenic chemotherapy. - The National Comprehensive Cancer Network (NCCN) provides recommendations for antiemetic use during chemotherapy, based on emetogenic potential as follows: [1] o High emetic risk: 5HT3 + dexamethasone + NK1 (Category 1) Use of a NK1 is recommended in combination with a 5HT3 [palonosetron (preferred)] and dexamethasone. dru378.0 Page 3 of 8

4 Oral aprepitant (daily x 3 days) or fosaprepitant IV (one dose) are NK1 options. o Moderate emetic risk: 5HT3 (Category 1) + dexamethasone ± NK1 A 5HT3 [palonosetron (preferred)] + dexamethasone is recommended for most moderate emetic regimens. Palonosetron is preferred, despite a lack of evidence for superiority with steroids, for moderate emetic risk chemotherapy. For select agents in this category (carboplatin, cyclophosphamide, and doxorubicin), addition of NK1 to a 5HT3/dexamethasone is recommended (Category 1). o Low emetic risk: dexamethasone, metoclopramide, prochlorperazine, or 5HT3 antagonist (all Category 2A) - IV antiemetics are preferred when patients are unable to swallow due to emesis. - Clinical guidelines recognize all 5HT3s (except dolasetron IV) and NK1s for the prevention of CINV; however, the guidelines have not been updated to include recommendations for netupitant/palonosetron (Akynzeo). [1] RegenceRx performs independent analyses of oncology medications. The RegenceRx analysis and coverage policy may differ from NCCN clinical practice guidelines. Nausea and Vomiting of Pregnancy (NVP) and Hyperemisis Gravidarum - A systematic review found ondansetron to be effective for the treatment of hyperemesis gravidarum; however, there is no comparative evidence versus other 5HT3s. [4] - There are no FDA-approved 5HT3s or NK1s for the treatment of hyperemesis gravidarum. Clinical practice guidelines recognize the use of ondansetron as a last-line treatment option. [12] - Clinical practice guidelines recognize phenothiazines, antihistamine H1 receptor blockers (diphenhydramine, meclizine, and dimenhydrinate), metoclopramide and ondansetron for refractory cases of NVP in combination with IV fluids for treatment of dehydration. [12] - The combination of netupitant/palonosetron for use in NVP or hyperemesis gravidarum is not supported by clinical practice guidelines or trial data, therefore its use in these medical conditions is considered investigational. Postoperative Nausea and Vomiting (PONV) [4] - A systematic review found ondansetron, dolasetron, and granisetron to be similarly effective for the prevention of PONV in adults. - A systematic review found aprepitant to be non-inferior to ondansetron for the prevention of PONV in adults. dru378.0 Page 4 of 8

5 - In one high quality systematic review, 5HT3s and NK1s were consistently effective for clinical outcomes such as prevention of emesis and need for rescue medications. - Ondansetron and dolasetron are similarly effective for the prevention of PONV in children. - Based on direct comparative trials, there is no conclusive evidence that one 5HT3 or NK1 is superior to others for prevention of PONV. - The combination of netupitant/palonosetron for PONV has not been supported by clinical trial data, therefore its use is considered not medically necessary. Safety [10] - Netupitant/palonosetron carries a labeled warning for the risk of anaphylaxis. - The most common adverse reactions in clinical trials include: dyspepsia, fatigue, constipation, erythema, and headache. - In a multi-cycle safety study, the safety profile of netupitant/palonosetron was comparable to aprepitant and palonosetron with no cardiac safety concerns. [11] - The inhibition of CYP3A4 by netupitant can result in increased plasma concentrations of the concomitant drug. dru378.0 Page 5 of 8

6 Appendix 1. Emetic Risk Classification for IV Antineoplastics [1] High AC: cyclophosphamide + anthracycline (doxorubicin, epirubicin) carmustine > 250 mg/m 2 cisplatin cyclophosphamide >1,500 mg/m 2 dacarbazine (DTIC) Moderate aldesleukin (Proleukin) > million IU/m 2 amifostine >300 mg/m 2 arsenic trioxide azacitidine (Vidaza) bendamustine (Treanda) busulfan carboplatin b carmustinev 250 mg/m 2 clofarabine (Clolar) cyclophosphamide (Cytoxan) 1,500 mg/m 2 cytarabine > 200 mg/m 2 dactinomycin b Low Ado-trastuzumab emtansine amifostine 300 mg aldesleukin (Proleukin) 12 million IU/m 2 brentuximab (Adcetris) cabazitaxel (Jevtana) carfilzomib cytarabine mg/m 2 docetaxel (Taxotere) doxorubicin liposomal (Doxil) eribulin (Halaven) etoposide (VP-16) 5 fluorouracil (5-FU) floxuridine gemcitabine (Gemzar) interferon alfa 5-10 million IU/m 2 ixabepilone (Ixempra) Minimal alemtuzumab asparaginase (Elspar) bevacizumab (Avastin) bleomycin bortezomib cetuximab (Erbitux) cladribine (2 chlorodeoxyadenosine) cytarabine < 100 mg/m 2 decitabine denileukin diftitox dexrazoxane fludarabine (Fludara) interferon alpha 5 million IU/m 2 ipilimumab doxorubicin 60 mg/m 2 epirubicin > 90 mg/m 2 ifosfamide 2g/m 2 /dose mechlorethamine streptozocin daunorubicin b doxorubicin 60 mg/m 2 epirubicin 90 mg/ m 2 idarubicin ifosfamide < 2g/m 2 b interferon alfa 10 million IU/m 2 irinotecan b melphalan methotrexate 250 mg/ m 2 b oxaliplatin (Eloxatin) temozolomide IV (Temodar) methotrexate mg/m 2 mitomycin mitoxantrone omacetaxine paclitaxel paclitaxel-albumin bound (Abraxane) panitumumab (Vectibix) pemetrexed (Alimta) pentostatin pralatrexate (Folotyn) romidepsin (Istodax) thiotepa topotecan Ziv-aflibercept methotrexate 50 mg/m 2 nelarabine ofatumumab panitumumab pegaspargase peginterferon pertuzumab rituximab (Rituxan) temsirolimus valrubicin vinblastine vincristine vinorelbine Adapted from NCCN Guidelines a List is not exhaustive. Medications not listed here will be evaluated with the most recent versions of ASCO and NCCN, as well as their prescribing information. b May be designated at a higher emetic risk if at a higher dose or used in certain combinations (e.g. with cyclophosphamide). dru378.0 Page 6 of 8

7 Cross References Aloxi, intravenous (IV) palonosetron, RegenceRx Medication Policy Manual, Policy No. dru315 Codes Number Description HCPCS J1626 Injection, granisetron HCl, 100 mcg HCPCS J2405 Injection, ondansetron HCl, per 1 mg HCPCS J2469 Injection, palonosetron HCl, 25 mcg HCPCS J1453 Injection, fosaprepitant dimeglumine, 150 mg HCPCS J8501 Aprepitant, 5 mg, oral HCPCS Q0162 Ondansetron, 1 mg, oral HCPCS Q0166 Granisetron HCl, 1 mg, oral HCPCS Q0180 Dolasetron mesylate, 100 mg, oral References 1. NCCN Clinical Practice Guidelines in Oncology TM. Antiemesis v [cited 11/3/2014]; Available from: 2. Billio, A, Morello, E, Clarke, MJ. Serotonin receptor antagonists for highly emetogenic chemotherapy in adults. The Cochrane database of systematic reviews. 2010(1):CD PMID: McDonagh M, Peterson K, Thakurta S. Consideration of the evidence on antiemetic drugs for nausea and vomiting associated with chemotherapy or radiation therapy in adults. AHRQ Technology Assessment Report. (Prepared by the Oregeon Evidence-based Practice Center under Project No. CANM0509.) Rockville, MD: Agency for Healthcare Research and Quality. July 22, [cited November 4, 2014]; Available from: 4. Peterson K, McDonagh MS, Carson S, Thakurta S. Drug class review: Newer antiemetics. Update 1.(Search date October 2008). Prepared by the Oregon Evidence-based Practice Center for the Drug Effectiveness Review Project (DERP). Oregon Health & Science University. Portland, OR. January [cited November 4, 2014]; Available from: 5. Popovic, M, Warr, DG, Deangelis, C, et al. Efficacy and safety of palonosetron for the prophylaxis of chemotherapy-induced nausea and vomiting (CINV): a systematic review and meta-analysis of randomized controlled trials. Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer Jun;22(6): PMID: Saito, M, Aogi, K, Sekine, I, et al. Palonosetron plus dexamethasone versus granisetron plus dexamethasone for prevention of nausea and vomiting during chemotherapy: a double-blind, double-dummy, randomised, comparative phase III trial. Lancet Oncol Feb; 10 (2): PMID: dru378.0 Page 7 of 8

8 7. Aapro, MS, Grunberg, SM, Manikhas, GM, et al. A phase III, double-blind, randomized trial of palonosetron compared with ondansetron in preventing chemotherapy-induced nausea and vomiting following highly emetogenic chemotherapy. Ann Oncol Sep;17(9): PMID: Micromedex Healthcare Series; Thomson Reuters. [updated periodically]. 9. Hesketh, PJ, Rossi, G, Rizzi, G, et al. Efficacy and safety of NEPA, an oral combination of netupitant and palonosetron, for prevention of chemotherapy-induced nausea and vomiting following highly emetogenic chemotherapy: a randomized dose-ranging pivotal study. Ann Oncol Jul;25(7): PMID: Aapro, M, Rugo, H, Rossi, G, et al. A randomized phase III study evaluating the efficacy and safety of NEPA, a fixed-dose combination of netupitant and palonosetron, for prevention of chemotherapy-induced nausea and vomiting following moderately emetogenic chemotherapy. Ann Oncol Jul;25(7): PMID: Gralla, RJ, Bosnjak, SM, Hontsa, A, et al. A phase III study evaluating the safety and efficacy of NEPA, a fixed-dose combination of netupitant and palonosetron, for prevention of chemotherapy-induced nausea and vomiting over repeated cycles of chemotherapy. Ann Oncol Jul;25(7): PMID: American College of Obstetricians and Gynecologists (ACOG). Nausea and vomiting of pregnancy. Washington (DC): American College of Obstetricians and Gynecologists (ACOG); 2004 Apr. 13 p. (ACOG practice bulletin; no. 52) [reaffirmed 2009]. 13. Akynzeo [package insert]. Woodcliff Lake, NJ: Eisai Inc.; 10/ Center for Drug Evaluation and Research; U.S. Food and Drug Administration Medical Review NDA ; Akynzeo (neutupitant + palonosetron). [cited 11/23/14]; Available from: dru378.0 Page 8 of 8

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