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Drug Category: Gastrointestinal

Medication Class/Individual Agents: Antiemetics/5-HT3 Receptor Antagonists, Appetite Stimulants, and Anabolics

I. Prior-Authorization Requirements

 Antiemetics, Appetite Stimulants, and Anabolics – 5-HT3 Receptor Antagonists

Clinical Notes

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

dolasetron injection Anzemet test  
dolasetron tablet Anzemet PA  
granisetron extended-release injection Sustol PA   - > 2 units/28 days
granisetron injection test  
granisetron tablet PA  
granisetron transdermal system Sancuso PA  
ondansetron 24 mg tablet PA  
ondansetron 4 mg, 8 mg tablet Zofran # test  
ondansetron film Zuplenz PA  
ondansetron injection Zofran # test  
ondansetron orally disintegrating tablet Zofran ODT # test  
ondansetron solution Zofran PA  
palonosetron 0.25 mg/2 mL injection PA   - > 2 units/28 days
palonosetron 0.25 mg/5 mL injection Aloxi # PA   - > 2 units/28 days

Please note: In the case where the prior authorization (PA) status column indicates PA, both the brand and generic (if available) require PA. Typically, the generic is preferred when available unless the brand-name drug appears on the MassHealth Brand Name Preferred Over Generic Drug List. In general, when requesting the non-preferred version, whether the brand or generic, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the preferred version, in addition to satisfying the criteria for the drug itself.

  • Granisetron oral formulations and ondansetron are FDA approved for the prevention/treatment of postoperative, chemotherapy-induced, and radiation-induced nausea and vomiting.
  • Dolasetron is associated with more drug interactions than ondansetron or granisetron injection.
  • Dolasetron is FDA approved for prevention/treatment of postoperative and chemotherapy-induced nausea and vomiting.
  • 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 antiarrhythmic drugs or other drugs that lead to QT prolongation, and cumulative high-dose anthracycline therapy.
  • Netupitant/palonosetron is FDA approved for prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV).
  • Rolapitant is FDA approved in combination with other antiemetic agents for prevention of delayed CINV.
  • Dronabinol and nabilone are orally active cannabinoids that are FDA approved for the treatment of cancer chemotherapy induced nausea and vomiting in patients with an inadequate response to conventional antiemetic treatments.
  • Dronabinol is also FDA approved for the management of anorexia associated with weight loss in patients with acquired immune deficiency syndrome (AIDS).
  • Orally active cannabinoids are recommended by the National Comprehensive Cancer Network (NCCN) as an option for the treatment of breakthrough nausea and vomiting as an addition to the appropriate prophylactic regimen of conventional antiemetics that is based upon emetogenicity of the chemotherapy regimen. The NCCN recommends that consideration can be given to the use of a cannabinoid in palliative care patients; however, the NCCN recognizes that the use of cannabinoids in patients with cancer-related anorexia has limited data to support this use.
  • Oxandrolone is FDA approved for adjunctive therapy to promote weight gain after weight loss following extensive surgery, chronic infections, or severe trauma, and in some patients who, without definite pathophysiologic reasons, fail to gain or to maintain normal weight; to offset protein catabolism with prolonged corticosteroid administration; relief of bone pain associated with osteoporosis.
 

 Antiemetics, Appetite Stimulants, and Anabolics – Not Otherwise Classified

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

aprepitant 125 mg powder for oral suspension Emend PA   - > 6 units/28 days
aprepitant 40 mg and 125 mg capsule Emend # PA   - > 2 capsules/28 days
aprepitant 80 mg Emend # PA   - > 4 capsules/28 days
aprepitant injectable emulsion Cinvanti test  
aprepitant trifold pack Emend BP PA   - > 2 packs/28 days
doxylamine / pyridoxine delayed-release Diclegis BP PA  
doxylamine / pyridoxine extended-release Bonjesta PA  
dronabinol capsule Marinol PA  
dronabinol solution Syndros PA  
fosaprepitant injection Emend test  
fosnetupitant / palonosetron injection Akynzeo PA   - > 2 vials/28 days
megestrol 40 mg/mL suspension Megace # test  
megestrol 625 mg/5 mL suspension Megace ES PA  
nabilone Cesamet PA  
netupitant / palonosetron capsule Akynzeo PA   - > 2 capsules/28 days
oxandrolone PA  
rolapitant injection Varubi PA   - > 2 vials/28 days
rolapitant tablet Varubi PA   - > 2 tablets/28 days
scopolamine transdermal patch Transderm-Scop BP PA  
Table Footnotes
# This designates a brand-name drug with FDA “A”-rated generic equivalents. Prior authorization is required for the brand, unless a particular form of that drug (for example, tablet, capsule, or liquid) does not have an FDA “A”-rated generic equivalent.
 
BP Brand Preferred over generic equivalents. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing the non-preferred drug generic equivalent.
 

II. Therapeutic Uses

FDA-approved, for example:

  • AIDS-associated anorexia, cachexia, or weight loss
  • CINV
  • Nausea and vomiting of pregnancy (NVP)
  • Osteoporosis-related bone pain
  • Postoperative nausea and vomiting (PONV)
  • Prevent weight loss/promote weight gain
  • Prevention of nausea and vomiting due to motion sickness
  • Radiation-induced nausea and vomiting (RINV) 

Note: The above list may not include all FDA-approved indications.

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III.  Evaluation Criteria for Approval

Please note: In the case where the prior authorization (PA) status column indicates PA, both the brand and generic (if available) require PA. Typically, the generic is preferred when available unless the brand-name drug appears on the MassHealth Brand Name Preferred Over Generic Drug List. In general, when requesting the non-preferred version, whether the brand or generic, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the preferred version, in addition to satisfying the criteria for the drug itself.

  • All PA requests must include clinical diagnosis, drug name, dose, and frequency.
  • A preferred drug may be designated for this therapeutic class. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing a non-preferred drug within a therapeutic class. Additional information about these agents, including PA requirements and preferred products, can be found within the MassHealth Drug List at www.mass.gov/druglist.
  • For recertification requests, approval may require submission of additional documentation including, but not limited to, documentation of: some or all criteria for the original approval; response to therapy; clinical rationale for continuation of use; status of member’s condition; appropriate diagnosis; appropriate age; appropriate dose, frequency, and duration of use for requested medication; complete treatment plan; current laboratory values; and member’s current weight.
  • Additional criteria may apply depending upon diagnosis (see below).

  

Akynzeo, palonosetron, Sustol, and Varubi > 2 units/28 days

  • Documentation of all of the following is required: 
    • appropriate diagnosis; and
    • medical necessity for exceeding the quantity limit.

Anzemet tablet and granisetron tablet

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • inadequate response, adverse reaction, or contraindication to ondansetron.

aprepitant 40 mg capsule, 125 mg capsule, and trifold pack > 2 units/28 days

  • Documentation of one of the following is required:
    • diagnosis of CINV; or
    • diagnosis of PONV and medical necessity for exceeding the quantity of > 2 units/28 days.

aprepitant 80 mg capsule > 4 capsules/28 days

  • Documentation of one of the following is required:
    • diagnosis of CINV; or
    • diagnosis of PONV and medical necessity for exceeding quantities > 4 capsules/28 days.

SmartPA: Claims for aprepitant (40 mg, 80 mg, 125 mg, trifold pack) above the established quantity limits will usually process at the pharmacy without a PA request if the member has a history of paid MassHealth pharmacy claims history of an antineoplastic medication in the last 60 days or has MassHealth medical claims for a CPT code for chemotherapy administration in the last 60 days.

Bonjesta and doxylamine/pyridoxine delayed-release

  • Documentation of all of the following is required: 
    • appropriate diagnosis; and
    • inadequate response to combination therapy with pyridoxine and doxylamine.

Cesamet

  • Documentation of all of the following is required: 
    • appropriate diagnosis; and
    • inadequate response, adverse reaction, or contraindication to two conventional antiemetics at least one of which must be a 5-HT3 receptor antagonist; and
    • request is within the quantity limit of six capsules/day. 

dronabinol capsule and Syndros

  • Documentation of all of the following is required for a diagnosis of AIDS-associated anorexia:
    • appropriate diagnosis; and
    • inadequate response, adverse reaction, or contraindication to megestrol; and
    • for Syndros, one of the following:
      • inadequate response or adverse reaction to dronabinol capsule or nabilone capsule; or
      • medical necessity for the use of a solution formulation. 

 

  • Documentation of all of the following is required for a diagnosis of CINV:
    • appropriate diagnosis; and
    • inadequate response, adverse reaction, or contraindication to two conventional antiemetics at least one of which must be a 5-HT3 receptor antagonist; and
    • for Syndros, one of the following:
      • inadequate response or adverse reaction to dronabinol capsule or nabilone capsule; or
      • medical necessity for the use of a solution formulation. 

Emend 125 mg powder for oral suspension > 6 units/28 days

  • Documentation of one of the following is required:
    • diagnosis of CINV; or
    • diagnosis of PONV and medical necessity for exceeding quantities > 6 units/28 days.

SmartPA: Claims for Emend 125 mg powder for oral suspension above the established quantity limits will usually process at the pharmacy without a PA request if the member has a history of paid MassHealth pharmacy claims history of an antineoplastic medication in the last 60 days or has MassHealth medical claims for a CPT code for chemotherapy administration in the last 60 days.

megestrol 625 mg/5 mL suspension

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • medical records documenting an inadequate response, adverse reaction, or contraindication to megestrol 40 mg/mL suspension or tablet. 

ondansetron 24 mg tablet

  • Documentation of all of the following is required: 
    • appropriate diagnosis; and
    • clinical rationale why ondansetron 8 mg tablet or ondansetron 8 mg ODT (three units) cannot be utilized.

 ondansetron solution

  • Documentation of all of the following is required: 
    • appropriate diagnosis; and
    • one of the following:
      • medical condition in which member is not able to swallow oral dosage formulations; or
      • clinical rationale why conventional dosage formulations cannot be utilized.

oxandrolone

  • Documentation of all of the following is required for a diagnosis of promoting weight gain/preventing weight loss in adult members: 
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • significant weight loss as defined by one of the following:
      • body mass index (BMI) ≤ 20 kg/m2; or
      • involuntary loss of ≥ 10% of premorbid body weight; or
      • involuntary loss of ≥ 5% of body weight within six months; and
    • inadequate response (defined by at least four weeks of therapy), adverse reaction, or contraindication to megestrol. 
  • Documentation of all of the following is required for a diagnosis of promoting weight gain/preventing weight loss in pediatric members:
    • appropriate diagnosis; and
    • member is < 18 years of age.
  • Documentation of all of the following is required for a diagnosis of osteoporosis-related bone pain:
    • appropriate diagnosis; and
    • medical records documenting an inadequate response, adverse reaction, or contraindication to two of the following agents: acetaminophen or nonsteroidal anti-inflammatory drugs (NSAIDs), opioids, calcitonin.

Sancuso

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • inadequate response, adverse reaction, or contraindication to ondansetron ODT.

scopolamine transdermal patch

  • Documentation of all of the following is required for a diagnosis of nausea and vomiting associated with recovery from surgery/anesthesia and CINV:
    • appropriate diagnosis; and
    • one of the following:
      • inadequate response, adverse reaction, or contraindication to ondansetron; or 
      • medical necessity for transdermal patch (ondansetron ODT trial required if documenting medical necessity for transdermal patch without trial of ondansetron tablets).

 

  • Documentation of all of the following is required for a diagnosis of preventing nausea and vomiting due to motion sickness:
    • appropriate diagnosis; and
    • one of the following:
      • inadequate response, adverse reaction, or contraindication to meclizine (for prevention of motion sickness); or
      • medical necessity for transdermal patch.

Zuplenz

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • one of the following:
      • medical condition in which member is not able to swallow oral dosage formulations; or
      • clinical rationale why conventional dosage formulations cannot be utilized; and
    • medical records documenting an inadequate response or adverse reaction to ondansetron ODT; and
    • clinical rationale as to why ondansetron film would be more efficacious than ODT.

 

IV.  Pediatric Patients

  • ondansetron (Zofran) is FDA-approved for chemotherapy-associated nausea and vomiting in children ≥ four years old; however weight based dosing (I.V. product) is available for children ≥ six months old.
  • promethazine and prochlorperazine are FDA-approved for use in children ≥ two years old. 

 

Conventional Antiemetics (not all inclusive)

Antihistamines

Prokinetic

Phenothiazines

Anticholinergics

dimenhydrinate

diphenhydramine

hydroxyzine

meclizine

metoclopramide

prochlorperazine

promethazine

scopolamine

trimethobenzamide

Note: The decision on whether PA is required is based upon information available in the MassHealth medical claim and pharmacy claim databases. The MassHealth database contains member information exclusive to MassHealth, and no other health plans.


Original Effective Date: 12/2003

Last Revised Date: 08/2019


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Last updated 08/29/19