Pharmacy Prior Authorization Criteria

Antiemetics Quantity Limit Overrides

Indications for Prior Authorization

Akynzeo (netupitant/palonosetron)

• For diagnosis of Chemotherapy-induced nausea and vomiting
  AKYNZEO capsules is indicated in combination with dexamethasone in adults 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. AKYNZEO capsules is a combination of palonosetron and netupitant: palonosetron prevents nausea and vomiting during the acute phase and netupitant prevents nausea and vomiting during both the acute and delayed phase after cancer chemotherapy. AKYNZEO for injection and AKYNZEO injection are indicated in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy. AKYNZEO for injection is a combination of palonosetron and fosnetupitant, a prodrug of netupitant: palonosetron prevents nausea and vomiting during the acute phase and fosnetupitant prevents nausea and vomiting during both the acute and delayed phase after cancer chemotherapy.

  Limitations of Use: AKYNZEO for injection and AKYNZEO injection have not been studied for the prevention of nausea and vomiting associated with anthracycline plus cyclophosphamide chemotherapy.

Anzemet (dolasetron)

• For diagnosis of Chemotherapy-induced nausea and vomiting
  Indicated for the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy, including initial and repeat courses in adults and children 2 years and older.

• For diagnosis of Radiotherapy-induced nausea and vomiting
  Used for the prevention and treatment of nausea and vomiting induced by radiation therapy. [11, 12]

• For diagnosis of Postoperative nausea and vomiting
  Used orally for the prevention of postoperative nausea and vomiting. [13]

Emend (aprepitant)

• For diagnosis of Chemotherapy-induced nausea and vomiting
  Indicated, in combination with other antiemetic agents, in patients 6 months of age and older for oral suspension, or 12 years of age and older for the capsules, for the prevention of: (1) acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin; (2) nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC).

  Limitations of Use: (1) Emend has not been studied for the treatment of established nausea and vomiting; (2) Chronic continuous administration of Emend is not recommended because it has not been studied, and because the drug interaction profile may change during chronic continuous use.

• For diagnosis of Postoperative Nausea and Vomiting - capsules only
  Indicated in adults for the prevention of postoperative nausea and vomiting. Limitations of Use: (1) Emend has not been studied for the treatment of established nausea and vomiting; (2) Chronic continuous administration of Emend is not recommended because it has not been studied, and because the drug interaction profile may change during chronic continuous use.

Granisetron

• For diagnosis of Chemotherapy-induced nausea vomiting
  Indicated for the prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin.

• For diagnosis of Radiation-induced nausea and vomiting
  Indicated for the prevention of nausea and vomiting associated with radiation, including total body irradiation and fractionated abdominal radiation.

• For diagnosis of Postoperative nausea and vomiting
  Used for the prevention of postoperative nausea and vomiting. [14, 15]

Marinol (dronabinol)

• For diagnosis of Chemotherapy-induced nausea and vomiting
  Indicated in adults for the treatment of nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments.

• For diagnosis of Anorexia in patients with AIDS
  Indicated in adults for the treatment of anorexia associated with weight loss in patients with AIDS.

Sancuso (granisetron transdermal system)

• For diagnosis of Chemotherapy-induced nausea and vomiting
  Indicated for the prevention of nausea and vomiting in adults receiving moderately and/or highly emetogenic chemotherapy regimens of up to 5 consecutive days duration.

Sustol (granisetron injection)

• For diagnosis of Chemotherapy-induced nausea and vomiting
  Indicated in combination with other antiemetics in adults for the 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.

Varubi (rolapitant)

• For diagnosis of Chemotherapy-induced nausea and vomiting
  Indicated in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy.

Zofran (ondansetron)

• For diagnosis of Chemotherapy-induced nausea and vomiting
  Indicated for the prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2. Also indicated for the prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.

• For diagnosis of Radiotherapy-induced nausea and vomiting
  Indicated for the prevention of nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen.

• For diagnosis of Postoperative nausea and vomiting
  Indicated for the prevention of postoperative nausea and/or vomiting. As with other antiemetics, routine prophylaxis is not recommended for 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 postoperatively, Zofran Tablets, Zofran ODT Orally Disintegrating Tablets, Zofran Oral Solution, and Zuplenz are recommended even where the incidence of postoperative nausea and/or vomiting is low.

• For diagnosis of Hyperemesis gravidarum
  Used in the management of hyperemesis gravidarum. [10, 16]

Criteria

Akynzeo, Anzemet, eneric dronabinol, Brand Emend, Generic aprepitant, granisetron, Brand Marinol, Generic ondansetron 24 mg tablet, Generic ondansetron oral solution, Generic ondansetron ODT, Sancuso, Sustol, or Varubi

Quantity Limit

Length of Approval: 12 Month(s)
For diagnosis of Chemotherapy-induced nausea and vomiting

• Diagnosis of chemotherapy-induced nausea and vomiting
AND
• Patient is receiving moderately to highly emetogenic chemotherapy
AND
• Provider attests that a higher quantity is needed due to the number of chemotherapy sessions

Anzemet, granisetron, Generic ondansetron 24 mg tablet, Generic ondansetron oral solution, or Generic ondansetron ODT

Quantity Limit

Length of Approval: 12 Month(s)
For diagnosis of Radiotherapy-induced nausea and vomiting

• Diagnosis of radiotherapy-induced nausea and vomiting
AND
• Patient is receiving radiotherapy consisting of total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen
AND
• Provider attests that a higher quantity is needed due to the number of radiation sessions

Generic ondansetron 24 mg tablet, Generic ondansetron oral solution, or Generic ondansetron ODT

Quantity Limit

Length of Approval: 6 Month(s)
For diagnosis of Hyperemesis gravidarum

• Diagnosis of nausea and vomiting due to pregnancy (i.e., hyperemesis gravidarum) [10, 16]
AND
• History of failure, contraindication, or intolerance to at least one of the following: [A]
• doxylamine
• metoclopramide (Reglan)
• prochlorperazine (Compazine)
• promethazine (Phenergan)
• pyridoxine (Vitamin B6)
AND
• Patient has had at least a partial response to therapy at a dose within the quantity limit

P & T Revisions

2024-11-04, 2023-10-02, 2022-08-31, 2021-10-27, 2021-09-28, 2021-05-18, 2020-07-24, 2020-05-04, 2020-04-17

References

1. Akynzeo prescribing information. Helsinn Therapeutics (U.S.), Inc. Iselin, NJ. February 2023.
2. Anzemet prescribing information. Validus Pharmaceuticals LLC. Parsippany, NJ. December 2023.
3. Emend prescribing information. Merck Sharp & Dohme Corp. Whitehouse Station, NJ. May 2022.
4. Granisetron prescribing information. Ascend Laboratories. Montvale, NJ. July 2022.
5. Marinol prescribing information. AbbVie Inc. North Chicago, IL. August 2017.
6. Sancuso prescribing information. Kyowa Kirin, Inc. Bedminster, NJ. July 2024.
7. Varubi prescribing information. TerSera Therapeutics LLC. Deerfield, IL. August 2020.
8. Zofran prescribing information. Novartis Pharmaceuticals Corporation. East Hanover, NJ. June 2020.
9. Zuplenz prescribing information. Fortovia Therapeutics, Inc. Raleigh, NC. May 2020.
10. Micromedex Healthcare Series [database on the Internet]. Greenwood Village (CO): Thomson Reuters (Healthcare) Inc.; Updated periodically. Available by subscription at: http://www.thomsonhc.com/. Accessed September 9, 2021.
11. Fauser AA, Russ W, Bischoff M. Oral dolasetron mesilate (MDL 73,147EF) for the control of emesis during fractionated total-body irradiation and high-dose cyclophosphamide in patients undergoing allogeneic bone marrow transplantation. Support Care Cancer. 1997 May;5(3):219-22.
12. Basch E, Prestrud AA, Hesketh PJ, et al. Antiemetics: American Society of Clinical Oncology Clinical Practice Guideline Update. J Clinic Oncol. 2011;29(31):4189-98.
13. AHFS Drug Information website. Available at: https://online.lexi.com/lco/action/doc/retrieve/docid/250/413041. Accessed September 9, 2021.
14. Fujii Y, Tanaka H, Kawasaki T. Preoperative oral granisetron for the prevention of postoperative nausea and vomiting after breast surgery. Eur J Surg. 2001 Mar;167(3):184-7.
15. Fujii Y, Tanaka H, Kawasaki T. Prophylaxis with oral granisetron for the prevention of nausea and vomiting after laparoscopic cholecystectomy: a prospective randomized study. Arch Surg. 2001 Jan;136(1):101-4.
16. ACOG Practice Bulletin. Nausea and vomiting of pregnancy. American College of Obstetricians and Gynecologists. Obstet Gynecol. 2018; 103(1):15-30.
17. Sustol prescribing information. Heron Therapeutics. San Diego, CA. May 2023.

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End Notes

1. Treatment of nausea and vomiting of pregnancy with vitamin B6 or vitamin B6 plus doxylamine is safe and effective and should be considered first-line pharmacotherapy (Level A Evidence). Treatment of nausea and vomiting of pregnancy with ginger has shown beneficial effects and can be considered as a nonpharmacologic option (Level B Evidence). Several types of dopamine antagonists can be used for the treatment of nausea and vomiting of pregnancy such as promethazine, prochlorperazine, and metoclopramide. Antihistamines (such as dimenhydrinate and diphenhydramine) have been shown to be effective in controlling nausea and vomiting symptoms of pregnancy and are frequently used. Evidence is limited on the safety or efficacy of the 5-HT3 inhibitors (e.g. ondansetron) for nausea and vomiting of pregnancy. The ACOG recommends discussing the available data with patients as well as weighing the risks and benefits in women less than 10 weeks of gestation. Because of their limited data, they should not be advocated for first-line use until agents with established safety and efficacy have been tried and have failed. Treatment of severe nausea and vomiting of pregnancy or hyperemesis gravidarum with methylprednisolone may be efficacious in refractory cases; however, the risk profile of methylprednisolone suggests it should be a treatment of last resort (Level B Evidence). [16]

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Revision History

• 2024-11-04: Annual review: No criteria changes. Removed Zuplenz from guideline as it is obsolete. Updated references.
• 2023-10-02: Annual review: No criteria changes. Removed Brand Zofran oral solution from guideline as it is obsolete. Updated references.
• 2022-08-31: 2022 Annual Review
• 2021-10-27: Removed Cesamet as a target; Background updates.
• 2021-09-28: Addition of EHB formulary to guideline, no changes to criteria
• 2021-05-18: Addition of EHB formulary to guideline, no changes to criteria
• 2020-07-24: Removed GPIs for Brand Zofran ODT products as these are obsolete; Background updates.
• 2020-05-04: Updates to CINV and RINV criteria.
• 2020-04-17: GPI replication update for Varubi tablets (added GPI 5028005020B720, removed GPI 50280050200320).

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