FDA-approved, for example:

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

Non-FDA-approved, for example:

• Anorexia of non-AIDS-related etiology or require appetite stimulation
• Appetite stimulation or relief from nausea/vomiting associated with a comorbid cancer diagnosis
• Nausea/vomiting of any etiology (not associated with chemotherapy or cyclic vomitting)
• PONV
• RINV
• Severe thermal burns

Note: The above lists may not include all FDA-approved and non-FDA-approved indications.

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.
• Dispensing in a 90-day supply of medication may be mandated or allowable for agents in this therapeutic class (designated by M90 or A90, respectively, in the Drug Notes section above). Applicable quantity limits are described below as units per day, per month, per 28 days, or as clinically appropriate, and may be extrapolated for fills of longer day supply. 
• 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 and/or requested medication (see below). Other factors, including rebate and FDA-approval status, may change independently of scheduled MassHealth updates, which may result in additional restrictions.

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

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

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

• Documentation of the following is required:
  • diagnosis of one of the following:
    • CINV; or
    • PONV. 

aprepitant 80 mg capsule > 4 capsules/28 days

• Documentation of the following is required:
  • diagnosis of one of the following:
    • CINV; or
    • PONV. 

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 doxylamine and pyridoxine; and
  • for Bonjesta, inadequate response or adverse reaction to doxylamine/pyridoxine delayed-release.

Cinvanti

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

dronabinol capsule

• 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 acetate. 
• Documentation of all of the following is required for a diagnosis of CINV:
  • appropriate diagnosis; and
  • inadequate response, adverse reaction, or contraindication to at least two conventional antiemetics at least one of which must be a 5HT3 receptor antagonist.
• Documentation of all of the following is required for a diagnosis of anorexia of non-AIDS-related etiology or require appetite stimulation:
  • appropriate diagnosis; and
  • inadequate response, adverse reaction, or contraindication to megestrol acetate. 
• Documentation of all of the following is required for a diagnosis of nausea/vomiting of any etiology (not associated with chemotherapy or cyclic vomitting):
  • appropriate diagnosis; and
  • inadequate response, adverse reaction, or contraindication to at least two conventional antiemetics at least one of which must be a 5HT3 receptor antagonist.
• Documentation of the following is required for a diagnosis of appetite stimulation or relief from nausea/vomiting associated with a comorbid cancer diagnosis:
  • appropriate diagnosis.

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

• Documentation of the following is required:
  • diagnosis of one of the following:
    • CINV; or
    • PONV.

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.^†

granisetron tablet

• Documentation of all of the following is required: 
  • diagnosis of one of the following:
    • CINV; or
    • PONV; or
    • RINV; and
  • medical necessity for exceeding the quantity limit.

megestrol 625 mg/5 mL suspension

• Documentation of all of the following is required:
  • appropriate diagnosis; and
  • medical records documenting an inadequate response or adverse reaction to one, or contraindication to both of the following: megestrol 40 mg/mL suspension, megestrol tablet. 
• For recertification, documentation of the following is required:
  • positive response to therapy including weight gain or no net weight loss from baseline; or
  • clinical rationale for continued therapy despite weight loss.

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
  • medical necessity for the use of the solution formulation as noted by one of the following:
    • member has a swallowing disorder or condition affecting ability to swallow; or
    • member is < 13 years of age; or
    • clinical rationale why conventional formulations cannot be used; or
    • provider notes the appropriate dose cannot be achieved without splitting a tablet.

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 or adverse reaction to two or contraindication to all of the following: acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), calcitonin.
• Documentation of the following is required for a diagnosis of severe thermal burns:
  • appropriate diagnosis.

Sancuso

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

IV.  Pediatric Members

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

^†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.