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Table 3: Gastrointestinal Drugs - Histamine H2 Antagonists, Proton Pump Inhibitors, and Miscellaneous Gastroesophageal Reflux Agents


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Drug Category: Gastrointestinal Drugs

Medication Class/Individual Agents: Histamine H2 Antagonists, Proton Pump Inhibitors, Miscellaneous Gastroesophageal Reflux Agents

I. Prior-Authorization Requirements

 Gastrointestinal Drugs – Combination H. Pylori Medication

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

bismuth subcitrate / metronidazole / tetracycline Pylera test  

The separate ingredients of the combination products do not require prior authorization (PA). Please note: lansoprazole, omeprazole, and pantoprazole do not require PA (within quantity limits).

 
bismuth subsalicylate / metronidazole / tetracycline PA   A90
lansoprazole / amoxicillin / clarithromycin PA   A90
omeprazole / amoxicillin / rifabutin Talicia PA  
omeprazole / clarithromycin / amoxicillin Omeclamox-Pak PA  

 Gastrointestinal Drugs – Histamine H2 Antagonists

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

cimetidine test   *, M90

Optimize Dosing Regimen:

  • For duodenal ulcer (DU) or gastric ulcer (GU) treatment, administer total daily dose between evening meal and bedtime; ulcer healing is directly proportional to degree of nocturnal acid reduction.

Duration of Therapy:

  • DU – four weeks
  • GU – eight weeks
 
cimetidine powder PA  
famotidine injection test  
famotidine suspension PA   A90
famotidine tablet Pepcid test   # , *, M90
nizatidine 150 mg capsule PA   - > 2 units/day M90
nizatidine 300 mg capsule PA   - > 1 unit/day M90
nizatidine solution PA   A90
ranitidine injection Zantac test   #
ranitidine syrup test   A90
ranitidine tablet test   *, M90

 Gastrointestinal Drugs – Miscellaneous Gastroesophageal Reflux Agents

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

metoclopramide nasal spray Gimoti PA  
metoclopramide orally disintegrating tablet PA   A90

 Gastrointestinal Drugs – Proton Pump Inhibitors (PPIs)

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

Clinical Notes

dexlansoprazole Dexilant test   BP, M90

Optimize Dosing Regimen:

  • For maximum efficacy, a PPI must be taken in a fasting state, just before or with breakfast. In general for patients on PPIs, it is not necessary to prescribe other antisecretory agents (e.g., H2 antagonists, prostaglandins). If an antisecretory agent is prescribed with a PPI, the PPI should not be taken within six hours of the H2 antagonist or prostaglandin.

Once Daily (QD) Dosing versus Twice Daily (BID) Dosing:

  • QD dosing is adequate for most individuals except for H. pylori treatment (PPI is BID for the first two weeks of therapy). For pathological hypersecretory conditions, such as Zollinger-Ellison syndrome, a BID PPI regimen may be needed for high total daily doses. When/if a second dose is prescribed, it should be taken just before the evening meal.

Apparent PPI Non-responder:

  • Careful history should be obtained to ensure appropriate timing of drug administration and no significant drug interactions before prescribing a second dose or switching to another PPI.

Duration of Therapy:

  • DU – four weeks (QD dosing)
  • GU – eight weeks (QD dosing)
  • H. pylori – two weeks (BID dosing) + two more weeks if DU using QD dosing and six more weeks if GU using QD dosing
  • acute symptomatic gastroesophageal reflux disease (GERD) – four to eight weeks (QD dosing)

Nasogastric (NG) Tube Administration:

Omeprazole capsules, lansoprazole capsules, and esomeprazole capsules may be opened and mixed in a small amount of liquid (see specific product information for further information on liquids compatible with capsule contents and the recommended techniques for NG tube administration).

Tablet/Capsule Administration:

PPI tablets or the contents of PPI capsules should not be chewed, split, or crushed. For patients who have difficulty swallowing PPI capsules, the capsule can be opened and the intact granules can be sprinkled on applesauce. See specific product information for further information on liquids and foods compatible with capsule contents.

 
esomeprazole magnesium 10 mg, 20 mg, 40 mg suspension Nexium test   BP, M90
esomeprazole magnesium 2.5 mg, 5 mg suspension Nexium PA   M90
esomeprazole magnesium capsule Nexium PA   - > 1 unit/day # , M90
esomeprazole sodium IV Nexium  IV PA  
lansoprazole capsule Prevacid PA   - > 1 unit/day # , M90
lansoprazole orally disintegrating tablet Prevacid Solutab PA   - ≥ 2 years BP, M90
omeprazole / sodium bicarbonate capsule Zegerid test   # , M90
omeprazole / sodium bicarbonate suspension Zegerid PA   M90
omeprazole 10 mg PA   - > 1 unit/day M90
omeprazole 20 mg capsule PA   - > 4 units/day M90
omeprazole 40 mg PA   - > 2 units/day M90
omeprazole suspension Prilosec PA  
pantoprazole 40 mg suspension Protonix PA   BP, M90
pantoprazole IV Protonix IV test   #
pantoprazole tablet Protonix PA   - > 4 units/day # , M90
rabeprazole delayed-release capsule Aciphex Sprinkle PA  
rabeprazole delayed-release tablet Aciphex PA   - > 1 unit/day # , M90
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.
 
* The generic OTC and, if any, generic prescription versions of the drug are payable under MassHealth without prior authorization.
 
A90 Allowable 90-day supply. Dispensing in up to a 90-day supply is allowed. May not include all strengths or formulations. Quantity limits and other restrictions may apply.
 
M90 Effective 12/19/22, mandatory 90-day supply. After dispensing up to a 30-day supply initial fill, dispensing in a 90-day supply is required. May not include all strengths or formulations. Quantity limits and other restrictions may also apply. Prior to 12/19/22, allowable 90-day supply and dispensing in up to a 90-day supply is allowed.
 

II. Therapeutic Uses

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.

 

 

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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. 
  • 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 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 instead of 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 instead of tablet formulation.

 

Gimoti

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • medical records documenting an inadequate response, adverse reaction, or contraindication to metoclopramide orally disintegrating tablet, and metoclopramide tablets or solution.

   

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 150 mg capsule > two units/day, nizatidine 300 mg capsule > one unit/day

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • prescriber is a gastrointestinal (GI) specialist or a GI consult is provided; and
    • medical records documenting inadequate response to the requested agent dosed at 300 mg daily for four weeks with dates provided. 

  

nizatidine solution

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • an inadequate response, adverse reaction, or contraindication to famotidine; and
    • medical necessity for solution formulation instead of the capsule. 

  

Talicia

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • clinical rationale for use instead of 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 2.5 mg, 5 mg 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 2.5 mg, 5 mg 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.

      

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 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 without a PA request if the member is < 13 years of age.

  

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 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 without a PA request 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.

 

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 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 without a PA request 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 instead of 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 instead of 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.


Original Effective Date: 01/2002

Last Revised Date: 10/2022


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Last updated 10/31/22

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