FDA-approved, for example:

• GERD
• healing of erosive esophagitis, ulcerative GERD, DUs, GUs
• pathological hypersecretory syndromes (e.g., Zollinger-Ellison)
• non-ulcer or functional dyspepsia

 Note: The above list may not include all 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. 
• 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 the member’s condition and requested medication (see below).

bismuth subsalicylate/metronidazole/tetracycline, lansoprazole/amoxicillin/clarithromycin, and Omeclamox-Pak

• Documentation of the following is required:
  • an appropriate diagnosis; and
  • compelling clinical rationale why the requested medication provides a significant or unique therapeutic advantage over the conventionally packaged formulation. 

cimetidine powder 

• Documentation of the following is required:
  • an appropriate diagnosis; and
  • clinical rationale why other commercially available alternatives cannot be used.

famotidine suspension 

• Documentation of the following is required:
  • an appropriate diagnosis; and
  • medical necessity for suspension formulation over tablet formulation.

metoclopramide orally disintegrating tablet (ODT)

• Documentation of the following is required for a diagnosis of GERD:
  • an appropriate diagnosis; and
  • an inadequate response, adverse reaction, or contraindication to omeprazole at a dose of 40 mg daily for two weeks; and
  • an inadequate response, adverse reaction, or contraindication to pantoprazole at a dose of 40 mg daily for two weeks; and
  • one of the following:
    • an inadequate response, adverse reaction, or contraindication to esomeprazole magnesium capsules at a dose of 40 mg daily for two weeks; or
    • an inadequate response, adverse reaction, or contraindication to lansoprazole capsules at a dose of 30 mg daily for two weeks; or
    • an inadequate response, adverse reaction, or contraindication to rabeprazole tablets at a dose of 20 mg daily for two weeks; and
  • medical records documenting an inadequate response, adverse reaction, or contraindication to metoclopramide tablets or solution.
• Documentation of the following is required for a diagnosis of gastroparesis:
  • an appropriate diagnosis; and
  • medical records documenting an inadequate response, adverse reaction, or contraindication to metoclopramide tablets or solution.

nizatidine 

• Documentation of the following is required:
  • an appropriate diagnosis; and
  • an inadequate response (defined as ≥ 14 days of therapy) or adverse reaction to two H₂-antagonists that do not require PA. 

ranitidine capsule

• Documentation of the following is required:
  • an appropriate diagnosis; and
  • medical necessity for capsule formulation over tablets (tablets are available without PA).

Talicia

• Documentation of the following is required:
  • an appropriate diagnosis; and
  • clinical rationale for use over other multi-drug regimens for the treatment of H. pylori. 

Note: All PPIs have a quantity limit of one unit/day for members ≥ 13 years of age (with the exception of omeprazole 20 mg capsules and pantoprazole tablets where the quantity limit is four units/day, and omeprazole 40 mg capsules where the quantity limit is two units/day).

Aciphex Sprinkle, esomeprazole suspension, lansoprazole ODT (two years of age or older), pantoprazole suspension, and Prilosec powder for suspension

• Documentation of the following is required:
  • an appropriate diagnosis; and
  • quantity ≤ one unit/day; and
  • one of the following:
    • the request is for esomeprazole suspension and the member is < one year of age; or
    • all of the following:
      • an inadequate response, adverse reaction, or contraindication to omeprazole at a dose of 40 mg daily for two weeks; and
      • one of the following:
        • an inadequate response, adverse reaction, or contraindication to pantoprazole at a dose of 40 mg daily for two weeks; or
        • member has a g-tube/swallowing disorder; and
      • one of the following:
        • an inadequate response, adverse reaction, or contraindication to esomeprazole magnesium capsules at a dose of 40 mg daily for two weeks; or
        • an inadequate response, adverse reaction, or contraindication to lansoprazole capsules at a dose of 30 mg daily for two weeks; or
        • an inadequate response, adverse reaction, or contraindication to rabeprazole tablets at a dose of 20 mg daily for two weeks.

Aciphex Sprinkle > one unit/day, esomeprazole suspension > one unit/day, lansoprazole ODT (2 years of age or older) > one unit/day, pantoprazole 40 mg suspension > one unit/day, and Prilosec powder for suspension > one unit/day

• Documentation of the following is required:
  • an appropriate diagnosis; and
  • one of the following:
    • diagnosis of abnormal secretion of gastrin/Zollinger-Ellison, Barrett's Esophagus, or esophagitis; or
    • medical records documenting an inadequate response to the requested agent after once daily dosing for two weeks; and
  • one of the following:
    • the request is for esomeprazole suspension and the member is < one year of age; or
    • all of the following:
      • an inadequate response, adverse reaction, or contraindication to omeprazole at a dose of 40 mg daily for two weeks; and
      • one of the following:
        • an inadequate response, adverse reaction, or contraindication to pantoprazole at a dose of 40 mg daily for two weeks; or
        • member has a g-tube/swallowing disorder; and
      • one of the following:
        • an inadequate response, adverse reaction, or contraindication to esomeprazole magnesium capsules at a dose of 40 mg daily for two weeks; or
        • an inadequate response, adverse reaction, or contraindication to lansoprazole capsules at a dose of 30 mg daily for two weeks; or
        • an inadequate response, adverse reaction, or contraindication to rabeprazole tablets at a dose of 20 mg daily for two weeks.

Dexilant > one unit/day, esomeprazole magnesium capsule > one unit/day, lansoprazole capsule > one unit/day, and rabeprazole delayed-release tablet > one unit/day for uncomplicated GERD, extraesophageal symptoms/conditions secondary to gastric reflux, healing/maintenance of healed duodenal ulcers, H. pylori eradication, non-ulcer or functional dyspepsia, risk reduction/healing of drug-induced gastric ulcer

• Documentation of the following is required:        
  • an appropriate diagnosis; and
  • an inadequate response, adverse reaction, or contraindication to omeprazole at a dose of 40 mg daily for two weeks; and
  • an inadequate response, adverse reaction, or contraindication to pantoprazole at a dose of 40 mg daily for two weeks; and
  • medical records documenting an inadequate response to the requested agent after once daily dosing for two weeks.

SmartPA: Claims for Dexilant > one unit/day, esomeprazole magnesium capsule > one unit/day, lansoprazole capsule > one unit/day, and rabeprazole delayed-release tablet > one unit/day will usually process at the pharmacy if the member is < 13 years of age.^†

Dexilant > one unit/day, esomeprazole magnesium capsule > one unit/day, lansoprazole capsule > one unit/day, omeprazole 20 mg capsule > four units/day, omeprazole 40 mg > two units/day, pantoprazole tablet > four units/day, and rabeprazole delayed-release tablet > one unit/day for abnormal secretion of gastrin/Zollinger-Ellison, Barrett's Esophagus, esophagitis

• Documentation of the diagnosis is required for approval.

SmartPA: Claims for Dexilant > one unit/day, esomeprazole magnesium capsule > one unit/day, lansoprazole capsule > one unit/day, omeprazole 20 mg capsule > four units/day, omeprazole 40 mg > two units/day, pantoprazole tablet > four units/day, and rabeprazole delayed-release tablet > one unit/day will usually process at the pharmacy if the member is < 13 years of age or there is a history of MassHealth medical claims for abnormal secretion of gastrin/Zollinger-Ellison, Barrett's esophagus, or erosive esophagitis.^†

esomeprazole sodium IV

• Documentation of the following is required: 
  • an appropriate diagnosis; and
  • medical necessity for intravenous route of administration; and
  • an inadequate response, adverse reaction, or contraindication to pantoprazole IV.

esomeprazole strontium and omeprazole/sodium bicarbonate capsule

• Documentation of the following is required:
  • an appropriate diagnosis; and
  • an inadequate response, adverse reaction, or contraindication to omeprazole at a dose of 40 mg daily for two weeks; and
  • an inadequate response, adverse reaction, or contraindication to pantoprazole at a dose of 40 mg daily for two weeks; and
  • one of the following:
    • an inadequate response, adverse reaction, or contraindication to esomeprazole magnesium capsules at a dose of 40 mg daily for two weeks; or
    • an inadequate response, adverse reaction, or contraindication to lansoprazole capsules at a dose of 30 mg daily for two weeks; or
    • an inadequate response, adverse reaction, or contraindication to rabeprazole tablets at a dose of 20 mg daily for two weeks; and
  • quantity ≤ one unit/day.

esomeprazole strontium > one unit/day and omeprazole/sodium bicarbonate capsule > one unit/day

• Documentation of the following is required:
  • an appropriate diagnosis; and
  • an inadequate response, adverse reaction, or contraindication to omeprazole at a dose of 40 mg daily for two weeks; and
  • an inadequate response, adverse reaction, or contraindication to pantoprazole at a dose of 40 mg daily for two weeks; and
  • one of the following:
    • an inadequate response, adverse reaction, or contraindication to esomeprazole magnesium capsules at a dose of 40 mg daily for two weeks; or
    • an inadequate response, adverse reaction, or contraindication to lansoprazole capsules at a dose of 30 mg daily for two weeks; or
    • an inadequate response, adverse reaction, or contraindication to rabeprazole tablets at a dose of 20 mg daily for two weeks; and
  • one of the following:
    • diagnosis of abnormal secretion of gastrin/Zollinger-Ellison, Barrett's Esophagus, or esophagitis; or
    • medical records documenting an inadequate response to the requested agent after once daily dosing for two weeks.

omeprazole 10 mg > one unit/day

• Documentation of the following is required:
  • an appropriate diagnosis; and
  • clinical rationale for omeprazole 10 mg above quantity limits when omeprazole 20 mg capsules are available up to four capsules/day without PA.

omeprazole 20 mg capsule > four units/day, omeprazole 40 mg > two units/day, and pantoprazole tablet > four units/day for uncomplicated GERD, extraesophageal symptoms/conditions secondary to gastric reflux, healing/maintenance of healed duodenal ulcers, H. pylori eradication, non-ulcer or functional dyspepsia, risk reduction/healing of drug-induced gastric ulcer

• Documentation of the following is required:  
  • an appropriate diagnosis; and
  • medical records documenting an inadequate response to the agent dosed at 80 mg daily for two weeks; and
  • prescriber is a gastrointestinal (GI) specialist or a GI consult is provided.

SmartPA: Claims for omeprazole 20 mg capsule > four units/day, omeprazole 40 mg > two units/day, and pantoprazole tablet > four units/day will usually process at the pharmacy if the member is < 13 years of age.^†

omeprazole/sodium bicarbonate powder for suspension

• Documentation of the following is required:
  • an appropriate diagnosis; and
  • quantity ≤ one unit/day; and
  • an inadequate response, adverse reaction, or contraindication to omeprazole at a dose of 40 mg daily for two weeks; and
  • one of the following:
    • an inadequate response, adverse reaction, or contraindication to pantoprazole at a dose of 40 mg daily for two weeks; or
    • member has a g-tube/swallowing disorder; and
  • one of the following:
    • an inadequate response, adverse reaction, or contraindication to esomeprazole magnesium capsules at a dose of 40 mg daily for two weeks; or
    • an inadequate response, adverse reaction, or contraindication to lansoprazole capsules at a dose of 30 mg daily for two weeks; or
    • an inadequate response, adverse reaction, or contraindication to rabeprazole tablets at a dose of 20 mg daily for two weeks; and
  • medical necessity for the requested agent over all proton pump inhibitor dissolving, sprinkled, and suspension/packet formulations.

omeprazole/sodium bicarbonate powder for suspension > one unit/day

• Documentation of the following is required:
  • an appropriate diagnosis; and
  • an inadequate response, adverse reaction, or contraindication to omeprazole at a dose of 40 mg daily for two weeks; and
  • one of the following:
    • an inadequate response, adverse reaction, or contraindication to pantoprazole at a dose of 40 mg daily for two weeks; or
    • member has a g-tube/swallowing disorder; and
  • one of the following:
    • an inadequate response, adverse reaction, or contraindication to esomeprazole magnesium capsules at a dose of 40 mg daily for two weeks; or
    • an inadequate response, adverse reaction, or contraindication to lansoprazole capsules at a dose of 30 mg daily for two weeks; or
    • an inadequate response, adverse reaction, or contraindication to rabeprazole tablets at a dose of 20 mg daily for two weeks; and
  • medical necessity for the requested agent over all proton pump inhibitor dissolving, sprinkled, and suspension/packet formulations; and
  • one of the following:
    • diagnosis of abnormal secretion of gastrin/Zollinger-Ellison, Barrett's Esophagus, or esophagitis; or
    • medical records documenting an inadequate response to the requested agent after once daily dosing for two weeks.    

Brand-name Protonix

• Documentation of the following is required:
  • an appropriate diagnosis; and
  • quantity ≤ four units/day; and
  • an inadequate response, adverse reaction, or contraindication to omeprazole at a dose of 40 mg daily for two weeks; and
  • one of the following:
    • an inadequate response, adverse reaction, or contraindication to esomeprazole magnesium capsules at a dose of 40 mg daily for two weeks; or
    • an inadequate response, adverse reaction, or contraindication to lansoprazole capsules at a dose of 30 mg daily for two weeks; or
    • an inadequate response, adverse reaction, or contraindication to rabeprazole tablets at a dose of 20 mg daily for two weeks; and
  • medical records documenting an adverse reaction or inadequate response to a generic equivalent of the requested product.
• Requests > four units/day will be evaluated on a case-by-case basis taking into account the member's diagnosis, documentation of GI consult, and medical records of prior trials of the requested agent.

^†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.