• The NCCN and ASCO guidelines recommend a day combination of aprepitant fosaprepitant, or rolapitant PO AND dexamethasone, AND 5-HT3 antagonist for prevention of CINV with high emeotgenic risk and 3 day combinations of aprepitant or fosaprepitant or rolapitant PO AND dexamethasone and 5-HT3 antagonists for moderate emetogenic risk.
• For prevention of nausea and vomiting with low risk intravenous chemotherapy, treatment with either dexamethasone, metoclopramide, or prochlorperazine is recommended.
• For agents with minimal emetic risk potential, NCCN guidelines do not recommend routine prophylaxis.
• NCCN lists the following parenteral chemotherapy agents as high, moderate, low and minimal emetic risk:

  High emetic risk (>90 % frequency of emesis)	AC combination defined as any chemotherapy regimen that contains an anthracycline and cyclophosphamide Carboplatin AUC ≥4 Carmustine > 250 mg/m2 Cisplatin Doxorubicin ≥60mg/m2 Ifosfamide ≥2 g/m2 per dose Streptozocin	Cyclophosphamide > 1,500 mg/m2 Dacarbazine Mechlorethamine Epirubicin > 90mg/m2
  Moderate emetic risk (30-90 % frequency of emesis)	Aldesleukin > 12-15 million IU/m2 Amifostine > 300 mg/m2 Azacitidine Bendamustine Busulfan Carboplatin AUC <4d Carmustine < 250 mg/m2 Clofarabine Cyclophosphamide < 1,500 mg/m2 Cytarabine > 200 mg/m2 Trabectedin	Dactinomycin Daunorubicin Dinutuximab Doxorubicin < 60mg/m2 Dual-drug liposomal encapsulation of cytarabine and danorubicin Enfortumab vedotin-eifv Epirubicin ≤90 mg/m2 Fam-trastuzumab deruxtecan Idarubicin Ifosfamide <2g/m2 per dose Interferon alfa >10 million IU/m2 Irinotecan Melphalan Methotrexate > 250 mg/m2 Oxaliplatin Temozolomide
  Low emetic risk (10-30 % frequency of emesis)	Ado-trastuzumab emtansine Amifostine < 300 mg/m2 Aldesleukin < 2 million IU/m2 Arsenic trioxide Axicabtagene ciloleucel Benlinostat Blinatumomab Brentuzimab vedotin Cabazitaxel Carfilzomib Copanlisib Cytarabine (low dose) 100-200 mg/m2 Docetaxel Doxorubicin (liposomal) Eribulin Etoposide 5-Fluorouracil Floxuridine Gemcitabine Gemcitabine ozogamicin	Inotuzumab ozogamicin Ixabepilone Methotrexate > 50 mg/m2 < 250 mg/m2 Mitomycin Mitoxantrone Mogamulizumab Moxetumomab Necitumumab Olaratumab Omacetaxine Paclitaxel Paclitaxel-albumin Pemetrexed Pentostatin Polatuzumab vedotin Pralatrexate Romidepsin Tagraxofusp Talimogene laherparepvec Thiotepa Topotecan Ziv-aflibercept
  Minimal emetic risk (< 10 % frequency of emesis)	Alemtuzumab Atezolizumab Avelumab Asparaginase Bevacizumab Bleomycin Blinatumomab Bortezomib Cemiplimab Cetuximab Cladribine (2-chlorodeoxyadenosine) Cytarabine < 100 mg/m2 Daratumumab Decitabine Denileukin diftitox Dexrazoxane Durvalumab Elotuzumab Fludarabine	Ipilimumab Methotrexate < 50 mg/m2 Nelarabine Nivolumab Obinutuzumab Ofatumumab Panitumumab Pegaspargase Peginterferon Pembrolizumab Pertuzumab Ramucirumab Rituximab Rituximab and hyaluronidase Siltuximab Temsirolimus Trastuzumab Trastuzumab and hyaluronidase Valrubicin Vinblastine Vincristine Vincristine (liposomal) Vinorelbine

The requirements of the Horizon BCBSNJ Granisetron extended- release (Sustol), Palonosetron (Aloxi), Aprepitant (Cinvanti), Fonetupitant/Palonosetron (Akynzeo), and Rolapitant (Varubi) Program may require a precertification/prior authorization via MagellanRx Management. These requirements are member-specific: please verify member eligibility and requirements through the Horizon Provider Portal (www.horizonblue.com/provider). Ordering clinicians should request pre-certification from MagellanRx Management at ih.magellanrx.com or call 1-800-424-4508 (when applicable).]

I. Dolasetron (Anzemet):
A. Dolasetron (Anzemet) injection is medically necessary for the following FDA-approved indication:

• Prevention and treatment of post-operative nausea and vomiting (PONV) in adults 18 years of age and older and pediatric patients over the age of 2 years.

[INFORMATIONAL NOTE: As per the FDA approved package insert:
• This medication can only be taken at a fixed dose of 100 mg orally within 1 hour before chemotherapy. Use of intravenous dolasetron is contraindicated for the prevention of chemotherapy induced nausea and vomiting.
• For prevention of cancer chemotherapy-induced nausea and vomiting, the recommended dose for pediatric patients 2-16 years of age is 1.8 mg/kg given as a single dose approximately 30 minutes before chemotherapy, up to a maximum of 100 mg.
• For prevention or treatment of post-operative nausea and/or vomiting, the recommended adult dose is 12.5 mg given as a single dose approximately 15 minutes before the cessation of anesthesia (prevention) or as soon as nausea or vomiting presents (treatment).
• For prevention or treatment of post-operative nausea and/or vomiting in pediatric patients 2-16 years of age, the recommended intravenous dose is 0.35 mg/kg, with a maximum dose of 12.5 mg given as a single dose approximately 15 minutes before the cessation of anesthesia or as soon as nausea or vomiting presents.
• Dolasetron injection mixed in apple or apple-grape juice may be used for oral dosing in pediatric patients 2-16 years of age. For CINV, the recommended dosage is 1.8 mg/kg up to a maximum of 100 mg given within 1 hour before chemotherapy. For PONV, the recommended dosage is 1.2 mg/kg up to a maximum of 100 mg given within 2 hours before surgery.
• Safety and effectiveness in pediatric patients under 2 years of age have not been established.
• Dolasetron should be administered with caution in patients who have or may develop prolongation of cardiac conduction intervals, particularly QTc. These include patients with hypokalemia or hypomagnesemia, patients taking diuretics with potential for inducing electrolyte abnormalities, patients with congenital QT syndrome, patients taking anti-arrhythmic drugs or other drugs which lead to QT prolongation, and cumulative high dose anthracycline therapy. This warning is extended to pediatric patients since rare cases of arrhythmial, cardiac arrest leading to death, and myocardial infarction have been reported in children and adolescents taking dolasetron.]

B. Dolasetron (Anzemet) injection is considered investigational in other conditions including, but not limited to the prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy (CINV), including high dose cisplatin.

[INFORMATIONAL NOTE: A December 2010 FDA Safety Alert FDA notified healthcare professionals that a contraindication is being added to the prescribing information advising that the injection form of dolasetron mesylate should no longer be used to prevent nausea and vomiting associated with cancer chemotherapy in pediatric and adult patients due to the risk of developing tosade de pointes.

In 2011, the FDA approved package insert was updated to state: "Anzemet injection solution administered intravenously is contraindicated in adult and pediatric patients for the prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy due to the dose dependent QT prolongation." Furthermore, this indication was removed from the FDA approved indication section of the package insert. ].

A. Granisetron hydrochloride (Kytril) injection is medically necessary for the following FDA-approved indications:
• Prevention of nausea and/or vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy (CINV), including high dose cisplatin, in adults 18 years of age and older and pediatric patients over the age of 2 years;
• Prevention and treatment of postoperative nausea and vomiting (PONV) in adults 18 years of age and older and pediatric patients over the age of 2 years.
[INFORMATIONAL NOTE: As per the FDA approved package insert:
• For prevention of CINV, the recommended dose is 10 mcg/kg administered intravenously within 30 minutes before initiation of chemotherapy, and only on the day(s) chemotherapy is given.
• The recommended dose for prevention of CINV in pediatric patients 2 to 16 years of age is 10 mcg/kg.
• For prevention of PONV, the recommended adult dose is 1 mg administered intravenously over 30 seconds, before induction of anesthesia or immediately before reversal of anesthesia.
• The recommended dosage for the treatment of nausea and/or vomiting after surgery is 1 mg administered intravenously over 30 seconds.
• Safety and effectiveness of granisetron injection have not been established in patients less than 2 years of age.
• As with other antiemetics, routine prophylaxis is not recommended in patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and/or vomiting must be avoided during the postoperative period, granisetron injection is recommended even where the incidence of postoperative nausea and/or vomiting is low.]

• Use in combination with or without lorazepam, histamine-2 blockers, or proton pump inhibitors after moderate emetic risk chemotherapy

A. Granisetron (Sustol) extended-release injection, for subcutaneous use, is medically necessary for the following FDA-approved indications:
• Prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens, in combination with other antiemetics in adult patients 18 years of age and older who have previously tried and failed or have a contraindication to palonosetron injection (Aloxi) (failure is defined as 2 or more documented episodes of vomiting attributed to the current chemotherapy regimen)
B. Granisetron (Sustol) injection is medically necessary for the following off-label indication:
· Prevention of acute and delayed nausea and vomiting associated with high emetogenic chemotherapy (HEC) in adult patients 18 years of age and older who have previously tried and failed or have a contraindication to palonosetron injection (Aloxi) (failure is defined as 2 or more documented episodes of vomiting attributed to the current chemotherapy regimen)

[INFORMATIONAL NOTE: As per the FDA approved package insert:
• For subcutaneous injection only.
• The recommended dosage is 10 mg administered subcutaneously.
• Administer in combination with dexamethasone at least 30 minutes before initiation of MEC or AC combination chemotherapy.
  o For patients receiving MEC, the recommended dexamethasone dosage is 8 mg IV on Day 1.
  o For patient receiving AC combination chemotherapy regimens, the recommended dexamethasone dosage is 20 mg IV on Day 1, followed by 8 mg orally, twice a day, on Days 2, 3, and 4.
  o If administered with a neurokinin 1 (NK1) receptor antagonist, see the prescribing information of the NK1 receptor antagonist for the recommended dexamethasone dosage.
• Administer on Day 1 of chemotherapy and not more frequently than once every 7 days because of the extended-release properties of the formulation.
• In patients with moderate renal impairment (creatinine clearance of 30 to 59 mL/min), administer on Day 1 of chemotherapy and not more frequently than once every 14 days.
• In patients with severe renal impairment (creatinine clearance of less than 30 mL/min), avoid use.
• The safety and effectiveness of Sustol in pediatric patients under 18 years of age have not been established.]

B. Granisetron (Sustol) extended-release injection, for subcutaneous use, is considered investigational in other conditions.

A. Ondansetron hydrochloride (Zofran) injection is medically necessary for the following FDA-approved indications:
• Prevention of nausea and/or vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy (CINV), including high dose cisplatin in adults 18 years of age and older and pediatric patients 6 months or older;
• Prevention of postoperative nausea and/or vomiting (PONV) in adults 18 years of age and older and pediatric patients 1 month or older.

[INFORMATIONAL NOTE: As per the FDA approved package insert:
• For prevention of CINV, the recommended IV dosing is: 1) a single 32-mg dose infused over 15 minutes beginning 30 minutes before the start of chemotherapy (adults only) or 2) three 0.15-mg/kg doses, the first dose infused over 15 minutes beginning 30 minutes before the start of chemotherapy, then subsequent doses (0.15 mg/kg) administered 4 and 8 hours after the first dose (adults and pediatric patients 6 months-18 years of age).
• Limited information is available about dosage in pediatric cancer patients younger than 6 months of age.
• For prevention of PONV, the recommended dose for adults is 4 mg administered intravenously over 2 to 5 minutes or intramuscularly as a single injection, immediately before induction of anesthesia, or postoperatively needed.
• While recommended as a fixed dose for patients weighing more than 40 kg, few patients above 80 kg have been studied. In patients who do not achieve adequate control of postoperative nausea and vomiting following a single, prophylactic, preinduction, I.V. dose of ondansetron 4 mg, administration of a second I.V. dose of 4 mg ondansetron postoperatively does not provide additional control of nausea and vomiting.
• For prevention of PONV in pediatric surgical patients (1 month to 12 years of age), dosing is a single 0.1-mg/kg dose for patients weighing 40 kg or less, or a single 4-mg dose for patients weighing more than 40 kg over 2 to 5 minutes immediately prior to or following anesthesia induction, or postoperatively needed.
• For patients who do not receive prophylactic ondansetron injection and experience nausea and/or vomiting postoperatively, ondanseteron injection may be given to prevent further episodes.]

B. Ondansetron hydrochloride (Zofran) injection is also medically necessary for the following off-label indications:
• Short-term treatment of nausea/vomiting associated with acute gastroenteritis in adults 18 years of age and older and children above 1 month of age
• If not previously given, add to previous agents as breakthrough treatment for chemotherapy-induced nausea/vomiting
• Use in combination with dexamethasone with or without lorazepam, histamine-2 blockers, or proton pump inhibitors
• Before intravenous high or moderate emetic risk chemotherapy in combination with or without aprepitant, rolapitant or fosaprepitant
• Use in combination with or without lorazepam, histamine-2 blockers, or proton pump inhibitors after intravenous moderate emetic risk chemotherapy
• Hyperemesis gravidarum unresponsive to other anti-emetics.

A. Palonosetron hydrochloride (Aloxi) injection is medically necessary for the following indications:
• Prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (CINV) in adults 18 years of age and older who have previously tried and failed or have a contraindication to another intravenous selective serotonin (5-HT₃) receptor antagonist at FDA recommended dose (i.e., Kytril, Zofran) (failure is defined as 2 or more documented episodes of vomiting attributed to the current chemotherapy regimen);
• Prevention of acute nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy in adults 18 years of age and older;
• Prevention of postoperative nausea and vomiting (PONV) for up to 24 hours following surgery in adults 18 years of age and older;
• Prevention of acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including highly emetogenic cancer chemotherapy in pediatric patients aged 1 month to less than 17 years

• Before high emetic risk chemotherapy in combination with dexamethasone; AND
  • In combination with aprepitant (PO or IV), rolapitant (PO or IV), olanzapine, or fosaprepitant; OR
  • In combination with olanzapine AND aprepitant (PO or IV), rolapitant (PO or IV) or fosaprepitant
• Before moderate emetic risk chemotherapy if patient has previously tried and failed or has a contraindication to another intravenous selective serotonin (5-HT₃) receptor antagonist at FDA recommended dose (i.e., Kytril, Zofran) (failure is defined as 2 or more documented episodes of vomiting attributed to the current chemotherapy regimen); AND
  • In combination with dexamethasone; OR
  • In combination with aprepitant (PO or IV), rolapitant (PO or IV), olanzapine, or fosaprepitant for select patients with additional risk factors or previous treatment failure with a steroid + 5HT3 receptor-antagonist alone

• Prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (CINV) including high-dose cisplatin in adults and pediatric patients 6 months of age and older;
• Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy in adults and pediatric patients 6 months of age and older.

[INFORMATIONAL NOTE: As per the FDA approved package insert:
• For prevention of CINV, aprepitant capsules are given for 3 days as part of a regimen that includes a corticosteroid and a 5-HT3 antagonist. The recommended dose of aprepitant is 125 mg orally 1 hour prior to chemotherapy treatment (Day 1) and 80 mg orally once daily in the morning on Days 2 and 3.
• For prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, fosaprepitant dimeglumine for injection may be administered in a single dose regimen over 20-30 minutes and initiated 30 minutes prior to chemotherapy as an intravenous infusion either as:
  • 150 mg on Day 1 of the CINV regimen (Single Dose Regimen)
  • No capsules of EMEND are administered on Days 2 and 3
• Emend injection should be administered in conjunction with a corticosteroid (such as dexamethasone) and a 5-HT3 antagonist (such as ondansetron).
• For prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, fosaprepitant dimeglumine for injection may be administered in a 3-day dosing regimen over 15 minutes and initiated 30 minutes prior to chemotherapy as an intravenous infusion
• For prevention of nausea and vomiting associated with MEC, fosaprepitant should be administered in a 3-day regimen over 15 minutes and initiated 30 minutes prior to chemotherapy as in intravenous infusion
• Fosaprepitant has not been studied for the treatment of established nausea and vomiting.
• Chronic continuous administration is not recommended
• Emend is contraindicated in members taking pimozide concomitantly.]
  

• Use in combination with dexamethasone and a serotonin antagonist with or without lorazepam, histamine-2 blockers, or proton pump inhibitors
  • before high emetic risk chemotherapy
  • before moderate emetic risk chemotherapy for select patients

A. Rolapitant (Varubi) injection is medically necessary for the following FDA approved indications
· Prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including, but not limited to highly emetogenic chemotherapy, in combination with other antiemetic agents, in adults 18 years of age and older

B. Rolapitant (Varubi) injections is considered investigational in other conditions.

A. Aprepitnat (Cinvanti) injection is medically necessary for the following FDA-approved indications:
· Prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (CINV) including high-dose cisplatin, as a single-dose regimen in combination with other antiemetic agents, in adults 18 years of age and older;
· Prevention of delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy, as a single-dose regimen, in combination with other antiemetic agents, in adults 18 years of age and older
· Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy as a 3-day regimen, in combination with other antiemetic agents, in adults 18 years of age and older
· Will NOT be used for treatment of established nausea and vomiting

[INFORMATIONAL NOTE: As per the FDA approved package insert:
• For prevention of CINV with highly emetogenic chemotherapy (HEC): Aprepitant should be given as a 130 mg IV infusion over 30 minutes 30 minutes prior to chemotherapy in addition to:
  • Dexamethasone 12 mg orally and a 5HT₃ antagonist (such as ondansetron)
  • On day 2 patients should receive dexamethasone 8 mg orally
  • On day 3-4 patients should receive dexamethasone 8 mg given twice daily
• For prevention of CINV with moderately emetogenic chemotherapy (MEC): Aprepitant should be given as a 100 mg IV infusion over 30 minutes approximately 30 minutes prior to chemotherapy in addition to:
  • Dexamethasone 12 mg orally and a 5HT₃ antagonist (such as ondansetron)
  • On day 2-3 give aprepitant 80 mg orally once daily
  • For prevention of CINV, aprepitant capsules are given for 3 days as part of a regimen that includes a corticosteroid and a 5-HT3 antagonist. The recommended dose of aprepitant is 125 mg orally 1 hour prior to chemotherapy treatment (Day 1) and 80 mg orally once daily in the morning on Days 2 and 3.
  • The safety and effectiveness of Cinvanti has not been established in pediatric patients.
  • Cinvanti is contraindicated in members with concurrent use of pimozide.]

B. Cinvanti (aprepitant) injection is considered investigational in other conditions.

A. Fosnetupitant/Palonosetron (Akynzeo) injection is medically necessary for the following FDA-approved indications:
· Prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (CINV) in combination with dexamethasone in adults 18 years of age and older who have tried and failed or have a contraindication to generic palonosetron injection (Aloxi) OR any other generically available IV selective serotonin 5-HT3 receptor antagonist (i.e. ondansetron, granisetron) and generically available NK-1 receptor antagonist (i.e. aprepitant, fosaprepitant or rolapitant) (failure is defined as 2 or more documented episodes of vomiting attributed to the current chemotherapy regimen)
· Will NOT be used for prevention of nausea and vomiting associated with anthracycline plus cyclophosphamide chemotherapy

· For the prevention of CINV with highly emetogenic chemotherapy (HEC): Fosnetupitant/palonosetron should be given as a 235mg/0.25mg infusion over 30 minutes 30 minutes prior to chemotherapy in addition to:
o Dexamethasone 12 mg orally
o On day 2-4 give dexamethasone 8 mg once a day.
· The safety and effectiveness of Akynzeo has not been established in pediatric patients below the age of 18 years.
· Avoid in patients with severe hepatic impairment.
· Avoid in patients with severe renal impairment or end-stage renal disease.]

B. Fosnetupitant/Palonosetron (Akynzeo) injection is considered investigational in other conditions.

A. Amisulpride (Barhemsys) injection is medically necessary in adults for the following FDA-approved indications:
• Prevention of postoperative nausea and vomiting (PONV), either alone or in combination with an antiemetic of a different class, when ALL of the following criteria are met:
  • Member is ≥ 18 years of age
  • Member is undergoing elective surgery under general anesthesia
    • Member is not undergoing intra-thoracic, transplant, or central nervous system surgery
    • Member is not scheduled for an outpatient/day case surgery
  • Member must have high risk of nausea and vomiting, including 3 risk factors (e.g. post-operative opioids, non-smoker, female gender, history of PONV/motion sickness)
  • Member does not have documented, clinically significant cardiac arrhythmia or congenital long QT syndrome, and member is not receiving any medication in the post-operative period (prior to receiving the requested drug) that is known to prolong the QT interval
  • Member has tried and failed prior prophylaxis of PONV using current standard of care therapies
• Treatment of PONV in patients who have received antiemetic prophylaxis with an agent of a different class or have not received prophylaxis, when ALL of the following criteria are met:
  • Member is ≥ 18 years of age
  • Member is undergoing elective surgery under general anesthesia
    • Member is not undergoing transplant surgery
  • Member has moderate or high risk of experiencing PONV (risk factors include post-operative opioids, non-smoker, female gender, history of PONV/motion sickness)
  • Member must have experienced first episode of PONV ≤ 24 hours after the end of their surgery and prior to discharge from the hospital
  • Member does not have documented, clinically significant cardiac arrhythmia or congenital long QT syndrome, and member is not receiving any medication in the post-operative period (prior to receiving the requested drug) any drug that is known to prolong the QT interval
  • Member has not received prior treatment with a dopamine-2 (D₂) antagonist antiemetic
  • Member has tried and failed prior treatment of PONV using standard of care therapies

[INFORMATIONAL NOTE: As per the FDA labeled PI, warnings and precautions: BARHEMSYS causes dose- and concentration-dependent prolongation of the QT interval. Avoid BARHEMSYS in patients with congenital long QT syndrome and in patients taking droperidol. Electrocardiogram (ECG) monitoring is recommended in patients with pre-existing arrhythmias/cardiac conduction disorders; electrolyte abnormalities (e.g., hypokalemia or hypomagnesemia); congestive heart failure; and in patients taking other medicinal products (e.g., ondansetron) or with other medical conditions known to prolong the QT interval.]

B. Amisulpride (Barhemsys) injection is considered investigational in other conditions.

• Palonesetron hydrochloride (Aloxi)
  • CINV:
    • Adults: 0.25 mg single dose prior to chemotherapy on day 1 of the chemotherapy cycle.
    • Pediatrics (1 month to less than 17 years): 20 mcg/kg (max 1.5mg) single dose prior to chemotherapy on day 1 of the chemotherapy cycle.
  • PONV: 0.075 mg given immediately before anesthesia (adults only)
  • Max billable units (per dose and over time): 1 billable unit = 25 mcg (0.025 mg)
    • Chemo-induced N/V: 10 billable units per 7 days
    • Post-Op N/V: 3 billable units as one time only
• Dolasestron (Anzemet)
  • PONV:
    • Adults: 12.5 mg single dose
    • Pediatrics (2 years and older): 0.35 mg/kg (not to exceed 12.5 mg) single dose
• Ondansetron (Zofran)
  • CINV:
    • Adults and pediatric patients 6 months and older: 0.15 mg/kg per dose for 3 doses (up to 16mg per dose)
  • PONV:
    • Adults and pediatric patients older than 12 years of age: 4 mg single dose
    • Pediatric patients 1 month to 12 years and more than 40 kg: 4 mg single dose
    • Pediatric patients 1 month to 12 years and less than 40 kg: 0.1 mg/kg single dose
• Granisetron (Kytril)
  • CINV:
    • Adults and pediatrics (2 years and older): 10 mcg/kg prior to chemotherapy
  • PONV:
    • Adults: 1 mg fixed dose
• Granisetron extended-release (Sustol)
  • CINV:
    • Adults: 10 mg single subcutaneous injection at least 30 minutes before the start of emetogenic chemotherapy on day 1
  • Max billable units (per dose and over time): 1 billable unit = 0.1 mg
    • 100 billable units per 7 days
• Fosaprepitant (Emend)
  • CINV
    • Adults: 150 mg single dose prior to chemotherapy (highly emetogenic chemotherapy single dose regimen)
    • Pediatrics
      • (6 months to less than 2 years): 5 mg/kg (max 150 mg) prior to chemotherapy
      • (2 years to less than 12 years): 4 mg/kg (max 150 mg) prior to chemotherapy
      • (12 years to 17 years): 150 mg single dose prior to chemotherapy
  • Max billable units (per dose and over time): 1 billable unit = 1mg
    • 150 billable units per 7 days
• Rolapitant (Varubi) – CINV: 166.5 mg single dose within 2 hours prior to the initiation of chemotherapy (adults only)
• Aprepitant (Cinvanti) – CINV:
  · Single-dose regimen: Administer 130 mg for highly emetogenic chemotherapy or for moderately emetogenic chemotherapy given as a single dose on day 1 of the chemotherapy cycle (adults only)
  · 3-day regiment: Administer 100 mg for moderately emetogenic chemotherapy given on Day 1 of the chemotherapy cycle, with oral aprepitant on Days 2 and 3
• Fosnetupitant/Palonosetron (Akzynzeo) – CINV: 235 mg/0.25 mg (1 vial) single dose vial infused over 30 minutes starting 30 minutes before start of highly emetogenic chemotherapy on day 1 (adults only)
• Amisulpride (Barhemsys)
  • Prevention of PONV: 5 mg as a single IV infusion over 1-2 minutes at time of induction of anesthesia (adults only)
  • Treatment of PONV: 10 mg as a single IV infusion over 1-2 minutes in the event of nausea and/or vomiting after a surgical procedure (adults only)

• Member continues to meet initial review criteria; AND
• Member has response to therapy; AND
• Absence of unacceptable toxicity from the drug (e.g.: QT prolongation)

Medicaid Coverage

For Horizon NJ Health members, please follow this link for the corresponding HNJH drug policy https://services3.horizon-bcbsnj.com/ddn/NJhealthWeb.nsf

________________________________________________________________________________________

Horizon BCBSNJ Medical Policy Development Process:

This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.

___________________________________________________________________________________________________________________________

Index:
Injectable Antiemetic Agents [Dolasetron (Anzemet), Granisetron (Kytril), Ondansetron (Zofran), Palonosetron (Aloxi), and Fosaprepitant (Emend)]
Anti-emetics
Anti-emetic Agents
5-HT3 Antagonists
Dolasetron (Anzemet)
Anzemet (Dolasetron)
Granisetron (Kytril)
Kytril (Granisetron)
Ondansetron (Zofran)
Zofran (Ondansetron)
Palonosetron (Aloxi)
Aloxi (Palonosetron)
Fosaprepitant (Emend)
Emend (Fosaprepitant)
Granisetron (Sustol)
Sustol (Granisetron)
Rolapitant (Varubi)
Varubi (Rolapitant)
Aprepitant (Cinvanti)
Cinvanti (Aprepitant)
Fosnetupitant/Palonosetron (Akzyneo)
Akynzeo (Fosnetupitant/Palonosetron)
Amisulpride (Barhemsys)
Barhemsys (Amisulpride)

References:

1. Scorza K, Williams A, Phillips JD, et al. Evaluation of Nausea and Vomiting. American Family Physician. 2007;76(1): 76-84. Available at: www.aafp.org/afp.

2. Anzemet Injection [package insert]. Bridgewater, NJ: Sanofi-aventis, Bridgewater, NJ; 2014.

3. Anzemet Tablet [package insert]. Bridgewater, NJ: Sanofi-aventis, Bridgewater, NJ; 2014.

4. Product Information: Kytril™ (granisetron hydrochloride) Injection. Roche Pharmaceuticals. Nutley, NJ. April 2011.

5. Product Information: Kytril™ (granisetron hydrochloride) Tablets, Oral Solution. Roche Pharmaceuticals. Nutley, NJ. October 2009.

6. Product Information: Granisol™(granisetron HCl) Oral Solution. Hawthorn Pharmaceuticals, Inc. Madison, MS. December 2007.

7. Product Information: Sancuso™ (granisetron Transdermal System). ProStrakan Inc., Bedminster, NJ. August 2008.

8. Product Information: Zofran™ (ondansetron hydrochloride) Injection. GlaxoSmithKline Research Triangle Park, NC. September 2014.

9. Product Information: Zofran™ (ondansetron hydrochloride) Tablets, Zofran ODT (ondansetron) Orally Disintegrating Tablets, Zofran™ (ondansetron hydrochloride) Oral Solution. GlaxoSmithKline Research Triangle Park, NC. September 2014.

10. Product Information: Aloxi™ (palonosetron hydrochloride) Injection for Intravenous Use. Helsinn Healthcare SA, Switzerland. September 2018.

11. Emend for Injection [package insert]. Bridgewater, NJ: Sanofi-aventis, Bridgewater, NJ; November 2019.

12. Emend Capsules [package insert]. Bridgewater, NJ: Sanofi-aventis, Bridgewater, NJ; 2014.

13. Ettinger DS, et al. National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology™; Antiemesis. V.1. 03/15/2016. Available at: http://www.nccn.org

14. Kris MG, Hesketh PJ, Somerfield MR, et al. American Society of Clinical Oncology Guideline for Antiemetics in Oncology: Update 2006. J Clin Oncol. 2006;24:2932-2947.

15. NCCN Drugs & Biologics Compendium™. National Comprehensive Cancer Network. 2017. Available at: http://www.nccn.org/index.asp.

16. Facts and Comparisons™ 4.0. Wolter Kluwers Health. 2009. Available at: http://online.factsandcomparisons.com/index.aspx.

17. MICROMEDEX® Healthcare Series. Thomson Micromedex. Available at: http://www.thomsonhc.com/.

18. FDA Safety Alert. Anzemet (dolasetron mesylate): Drug Safety Communication - Reports of Abnormal Heart Rhythms. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm237341.htm

19. Anzemet. Lexi-Drugs. Lexicomp. Wolters Kluwer Health, Inc. Hudson, OH. Available at: http://online.lexi.com. Accessed March 3, 2015.

20. Sustol extended-release injection [package insert]. Redwood City, CA: Heron Therapeutics, Redwood City, CA; May 2017.

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23. Cinvanti for Injection [package insert]. San Diego, CA: Heron Therapeutics, Inc; October 2019.

24. Akynzeo Injection and Capsules [Package Insert]. Iselin, NJ: Helinn Therapeutics, Inc; June 2020.

25. Barhemsys (amisulpride) Injection [Package Insert]. Indianapolis, IN: Acacia Pharma Inc. February 2020.

26. ClinicalTrials.gov. Study of APD421 as PONV Treatment (no Prior Prophylaxis). NCT02449291. Available at: https://clinicaltrials.gov/ct2/show/NCT02449291

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28. ClinicalTrials.gov. US Phase III Study of APD421 in PONV. NCT01991860. Available at: https://clinicaltrials.gov/ct2/show/NCT01991860

29. ClinicalTrials.gov. Study of APD421 in Combination as PONV prophylaxis. NCT02337062. Available at: https://clinicaltrials.gov/ct2/show/NCT02337062

30. Apfel CC, Laara E, Koivuranta M, et al. (1999). A simplified risk score for predicting postoperative nausea and vomiting. Anesthesiology, 91, 693-700.

31. IPD Analytics. New Drug Review: Barhemsys (amisulpride). March 2020.

Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)

CPT*

HCPCS
J0185

J1260
J1453

J1626

J2405
J2469