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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   BP, A90

The separate ingredients of the combination products are available without prior authorization (PA). Please note: lansoprazole, omeprazole, and pantoprazole are available without PA (within quantity limits).

 
lansoprazole / amoxicillin / clarithromycin PA   A90
omeprazole / amoxicillin / rifabutin Talicia PA  
omeprazole / clarithromycin / amoxicillin Omeclamox-Pak PA  
vonoprazan / amoxicillin Voquezna Dual Pak PA  
vonoprazan / amoxicillin / clarithromycin Voquezna Triple 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
 
famotidine injection test  
famotidine suspension test   A90
famotidine tablet Pepcid test   # , *, M90
nizatidine 150 mg capsule PA   - > 2 units/day M90
nizatidine 300 mg capsule PA   - > 1 unit/day M90

 Gastrointestinal Drugs – Miscellaneous Gastroesophageal Reflux Agents

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

metoclopramide nasal spray Gimoti PA  

 Gastrointestinal Drugs – Potassium-Competitive Acid Blockers (PCABs)

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

vonoprazan Voquezna PA  

 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 members 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 members 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 powder for oral suspension Zegerid PA   M90
omeprazole / sodium bicarbonate suspension Konvomep PA  
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  
omeprazole suspension compounding kit First-Omeprazole 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. PA 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 PA.
 
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 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.
 

II. Therapeutic Uses

FDA-approved, for example:

  • active benign gastric ulcer
  • diabetic gastroparesis
  • extraesophageal symptoms/conditions secondary to gastric reflux (e.g., asthma, non-cardiac chest pain, etc.)
  • GERD
  • healing of erosive esophagitis, ulcerative GERD, DUs, GUs
  • H. pylori eradication
  • non-ulcer or functional dyspepsia
  • pathological hypersecretory syndromes (e.g., Zollinger-Ellison, Barrett's esophagus)
  • reduction of risk of upper GI bleeding in critically ill patients

 

Non-FDA-approved, for example:

  • extraesophageal symptoms/conditions secondary to gastric reflux (e.g., asthma, non-cardiac chest pain, etc.)
  • GERD
  • healing of erosive esophagitis, ulcerative GERD, DUs, GUs
  • H. pylori eradication
  • pathological hypersecretory syndromes (e.g., Zollinger-Ellison)
  • non-ulcer or functional dyspepsia

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

 

 

Gimoti

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • inadequate response, adverse reaction, or contraindication to both of the following:
      • metoclopramide tablets; and
      • metoclopramide solution.

 

lansoprazole/amoxicillin/clarithromycin, and Omeclamox-Pak

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • medical necessity for the combination product instead of the conventionally packaged formulation. 

 

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

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • prescriber is a gastrointestinal (GI) specialist or a GI consult is provided; and
    • medical records documenting inadequate response (defined as ≥ 14 days of therapy) to the requested agent dosed at 300 mg daily. 

    

Talicia

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • one of the following:
      • clinical rationale for use instead of other multi-drug regimens for the treatment of H. pylori; or
      • inadequate response or adverse reaction to one or contraindication to all of the following:
        • bismuth quadruple therapy; or
        • concomitant therapy consisting of a PPI, clarithromycin, amoxicillin, and metronidazole; or
        • clarithromycin triple therapy.

    

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:
    • appropriate diagnosis; and
    • requested quantity is ≤ one unit/day; and
    • one of the following:
      • request is for esomeprazole suspension and the member is < one year of age; or
      • inadequate response (defined as ≥ 28 days of therapy) or adverse reaction to one or contraindication to all of the following: esomeprazole magnesium capsule 40 mg daily, lansoprazole capsule 30 mg daily, omeprazole 40 mg daily, pantoprazole 40 mg daily, rabeprazole tablet 20 mg daily; or
      • both of the following:
        • member has a g-tube/swallowing disorder; and
        • inadequate response (defined as ≥ 28 days of therapy), or adverse reaction to one, or contraindication to all of the following: esomeprazole magnesium capsule 40 mg daily, lansoprazole capsule 30 mg daily, omeprazole 40 mg daily.

 

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:
    • 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 once daily dosing of the requested agent (defined as ≥ 14 days of therapy); and
    • one of the following:
      • request is for esomeprazole suspension and the member is < one year of age; or
      • inadequate response (defined as ≥ 28 days of therapy) or adverse reaction to one or contraindication to all of the following: esomeprazole magnesium capsule 40 mg daily, lansoprazole capsule 30 mg daily, omeprazole 40 mg daily, pantoprazole 40 mg daily, rabeprazole tablet 20 mg daily; or
      • both of the following: 
        • member has a g-tube/swallowing disorder; and
        • inadequate response (defined as ≥ 28 days of therapy), or adverse reaction to one, or contraindication to all of the following: esomeprazole magnesium capsule 40 mg daily, lansoprazole capsule 30 mg daily, omeprazole 40 mg daily.

      

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:        
    • appropriate diagnosis; and
    • inadequate response (defined as ≥ 14 days of therapy), adverse reaction, or contraindication to both of the following:
      • omeprazole 40 mg daily; and
      • pantoprazole 40 mg daily; and
    • medical records documenting an inadequate response (defined as ≥ 14 days of therapy) to once daily dosing of the requested agent.

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 magnesium OTC

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • inadequate response (defined as ≥ 14 days of therapy), adverse reaction, or contraindication to both of the following:
      • omeprazole 40 mg daily; and
      • pantoprazole 40 mg daily; and
    • inadequate response (defined as ≥ 14 days of therapy) or adverse reaction to one, or contraindication to both of the following: lansoprazole 30 mg capsule daily, rabeprazole 20 mg tablet daily; and
    • medical records documenting an inadequate response, adverse reaction, or contraindication to prescription esomeprazole capsules to an equivalent dose to the requested dose.

 

esomeprazole sodium IV

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

 

First-Omeprazole

  • Documentation of the following is required: 
    • appropriate diagnosis; and
    • medical necessity for the requested formulation as noted by one of the following:
      • member is < 13 years of age; or
      • member utilizes tube feeding (G-tube/J-tube); or
      • member has a swallowing disorder or condition affecting ability to swallow.

 

Konvomep, omprazole/sodium bicarbonate powder for oral suspension

  • Documentation of the following is required: 
    • appropriate diagnosis; and
    • member is ≥ 18 years of age; and
    • medical necessity for the requested formulation as noted by one of the following:
      • member utilizes tube feeding (G-tube/J-tube); or
      • member has a swallowing disorder or condition affecting ability to swallow; and
    • inadequate response (defined as ≥ 14 days of therapy) or adverse reaction to three or contraindication to all of the following: esomeprazole suspension, lansoprazole orally disintegrating tablet, omeprazole capsule, pantoprazole suspension.

 

lansoprazole OTC

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • inadequate response (defined as ≥ 14 days of therapy), adverse reaction, or contraindication to both of the following:
      • omeprazole 40 mg daily; and
      • pantoprazole 40 mg daily; and
    • medical records documenting an inadequate response, adverse reaction, or contraindication to prescription lansoprazole capsules to an equivalent dose to the requested dose.

 

omeprazole 10 mg > one unit/day

  • Documentation of the following is required:
    • 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:  
    • appropriate diagnosis; and
    • medical records documenting an inadequate response (defined as ≥ 14 days of therapy) to the agent dosed at 80 mg daily; 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 OTC

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • inadequate response (defined as ≥ 14 days of therapy), adverse reaction, or contraindication to pantoprazole 40 mg daily; and
    • inadequate response (defined as ≥ 14 days of therapy), adverse reaction, or contraindication to one of the following: esomeprazole magnesium 40 mg capsule daily, lansoprazole 30 mg capsule daily, rabeprazole 20 mg tablet daily; and
    • medical records documenting an inadequate response, adverse reaction, or contraindication to prescription omeprazole to an equivalent dose to the requested dose.

  

omeprazole/sodium bicarbonate OTC

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • inadequate response (defined as ≥ 14 days of therapy), adverse reaction, or contraindication to both of the following:
      • omeprazole 40 mg daily; and
      • pantoprazole 40 mg daily; and
    • inadequate response (defined as ≥ 14 days of therapy) or adverse reaction to one, or contraindication to all of the following:
      • esomeprazole magnesium 40 mg capsule daily; or
      • lansoprazole 30 mg capsule daily; or
      • rabeprazole 20 mg tablet daily; and
    • medical records documenting an inadequate response, adverse reaction, or contraindication to prescription omeprazole to an equivalent dose to the requested dose.

  

Brand-name Protonix

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • requested quantity is ≤ four units/day; and
    • inadequate response (defined as ≥ 14 days of therapy), adverse reaction, or contraindication to omeprazole 40 mg daily; and
    • inadequate response (defined as ≥ 14 days of therapy), adverse reaction, or contraindication to one of the following:
      • esomeprazole magnesium 40 mg capsule daily; or
      • lansoprazole 30 mg capsule daily; or
      • rabeprazole 20 mg tablet daily; and
    • medical records documenting an adverse reaction or inadequate response to a generic equivalent of the requested product.
  • For requested quantity > 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.

 

Voquezna

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • member is ≥ 18 years of age: and
    • prescriber is a gastroenterologist, or consult notes from a gastroenterologist are provided; and
    • requested quantity is ≤ one tablet/day; and 
    • one of the following:
      • both of the following:
        • diagnosis of LA grade C or D erosive esophagitis; and 
        • inadequate response (defined as ≥ 28 days of therapy) or adverse reaction to one or contraindication to all of the following: dexlansoprazole, esomeprazole, lansoprazole, omeprazole, pantoprazole or rabeprazole; or
      • inadequate response (defined as ≥ 28 days of therapy) or adverse reaction to three or contraindication to all of the following: dexlansoprazole, esomeprazole, lansoprazole, omeprazole, pantoprazole or rabeprazole.

   

Voquezna Dualpak and Voquezna Triplepak

  • Documentation of the following is required:
    • appropriate diagnosis; and
    • member is ≥ 18 years of age: and
    • requested quantity is ≤ eight tablet/day; and
    • medical necessity for the requested agent instead of other multi-drug regimens available without PA; and 
    • one of the following:
      • for Voquezna Dualpak, member has not utilized an amoxicillin-containing regimen for the current infection; or 
      • for Voquezna Triplepak, member has not utilized an amoxicillin or a clarithromycin containing regimen for the current infection.


Original Effective Date: 01/2002

Last Revised Date: 05/2024


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Last updated 05/16/24

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