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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

Clinical Notes

bismuth subcitrate / metronidazole / tetracycline Pylera PA  

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).

 
lansoprazole / amoxicillin / clarithromycin PA  
omeprazole / clarithromycin / amoxicillin Omeclamox-Pak PA  

 Gastrointestinal Drugs – Histamine H2 Antagonists

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Clinical Notes

cimetidine * test  

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 Pepcid PA  
famotidine tablet Pepcid # * test  
nizatidine PA  
ranitidine capsules PA  
ranitidine injection Zantac # test  
ranitidine syrup test  
ranitidine tablet * test  

 Gastrointestinal Drugs – Miscellaneous Gastroesophageal Reflux Agents

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

metoclopramide orally disintegrating tablet PA  

 Gastrointestinal Drugs – Proton Pump Inhibitors (PPIs)

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Clinical Notes

dexlansoprazole Dexilant BP PA   - > 30 units/month

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 capsule Nexium # PA   - > 30 units/month
esomeprazole magnesium suspension Nexium PA  
esomeprazole sodium IV Nexium  IV PA  
esomeprazole strontium PA  
lansoprazole capsule Prevacid # PA   - > 30 units/month
lansoprazole orally disintegrating tablet Prevacid Solutab BP PA   - ≥ 2 years
omeprazole / sodium bicarbonate Zegerid PA  
omeprazole 10 mg PA   - > 30 units/month
omeprazole 20 mg capsule PA   - > 120 units/month
omeprazole 40 mg PA   - > 60 units/month
omeprazole suspension Prilosec PA  
pantoprazole 40 mg suspension Protonix PA  
pantoprazole IV Protonix IV # test  
pantoprazole tablet Protonix # PA   - > 120 units/month
rabeprazole delayed-release capsule Aciphex Sprinkle PA  
rabeprazole delayed-release tablet Aciphex # PA   - > 30 units/month
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.
 

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. 
  • 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).

 

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; and
    • an inadequate response (defined as ≥ 14 days of therapy) or adverse reaction to ranitidine syrup.

 

lansoprazole/amoxicillin/clarithromycin, Omeclamox-Pak, and Pylera

  • 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. 

    

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).

  

Note: All PPIs have a quantity limit of 1 unit/day for members ≥ 13 years of age (with the exception of omeprazole 20 mg capsules and pantoprazole tablets where the quantity limit is 4 units/day, and omeprazole 40 mg capsules where the quantity limit is 2 units/day).

 

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

  • Documentation of the following is required:
    • an appropriate diagnosis; and
    • quantity ≤ 30 units/30 days; and
    • one of the following:
      • the request is for Nexium 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 > 30 units/month, lansoprazole ODT (2 years of age or older) > 30 units/month, Nexium suspension > 30 units/month, Prilosec powder for suspension > 30 units/month, and Protonix 40 mg suspension > 30 units/month

  • 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 Nexium 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 > 30 units/month, esomeprazole magnesium capsule > 30 units/month, lansoprazole capsule > 30 units/month, and rabeprazole delayed-release tablet > 30 units/month 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 > 30 units/month, esomeprazole magnesium capsule > 30 units/month, lansoprazole capsule > 30 units/month, and rabeprazole delayed-release tablet > 30 units/month will usually process at the pharmacy if the member is < 13 years of age.

  

Dexilant > 30 units/month, esomeprazole magnesium capsule > 30 units/month, lansoprazole capsule > 30 units/month, omeprazole 20 mg capsule > 120 units/month, omeprazole 40 mg > 60 units/month, pantoprazole tablet > 120 units/month, and rabeprazole delayed-release tablet > 30 units/month for abnormal secretion of gastrin/Zollinger-Ellison, Barrett's Esophagus, esophagitis

  • Documentation of the diagnosis is required for approval.

SmartPA: Claims for Dexilant > 30 units/month, esomeprazole magnesium capsule > 30 units/month, lansoprazole capsule > 30 units/month, omeprazole 20 mg capsule > 120 units/month, omeprazole 40 mg > 60 units/month, pantoprazole tablet > 120 units/month, and rabeprazole delayed-release tablet > 30 units/month 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 ≤ 30 units/30 days.

 

esomeprazole strontium > 30 units/month and omeprazole/sodium bicarbonate capsule > 30 units/month

  • 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 > 30 units/month

  • 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 4 capsules/day without PA.

 

omeprazole 20 mg capsule > 120 units/month, omeprazole 40 mg > 60 units/month, and pantoprazole tablet > 120 units/month 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 > 120 units/month, omeprazole 40 mg > 60 units/month, and pantoprazole tablet > 120 units/month 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 ≤ 30 units/30 days; 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 > 30 units/month

  • 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 ≤ 120 units/30 days; 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 > 120 units/month 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: 11/2019


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Last updated 11/25/19