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Drug Category: Gastrointestinal Drugs

Medication Class/Individual Agents: Histamine H2 Antagonists/Proton Pump Inhibitors

I. Prior-Authorization Requirements

 Gastrointestinal Drugs-Histamine H2 Antagonists/Proton Pump Inhibitors - Combination H. Pylori Medication

Drug Generic Name

Drug Brand Name

PA
Status

Average cost per claim ($)

Clinical Notes

bismuth subcitrate / metronidazole / tetracycline Pylera PA  $642.87  

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

$  This value represents the average cost per claim of the most commonly prescribed quantities as of 2/2015. Where applicable, cost represents that of an “A”- rated generic equivalent (#).

 
bismuth subsalicylate / tetracycline / metronidazole Helidac PA  $818.59  
lansoprazole / amoxicillin / clarithromycin Prevpac PA  $744.89  
omeprazole / clarithromycin / amoxicillin Omeclamox-Pak PA  $599.40  

 Gastrointestinal Drugs-Histamine H2 Antagonists/Proton Pump Inhibitors - Histamine H2 Antagonists

Drug Generic Name

Drug Brand Name

PA
Status

Average cost per claim ($)

Clinical Notes

cimetidine Tagamet # *   $11.64 (#)  

Optimize Dosing Regimen:

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

Duration of Therapy:

  • duodenal ulcer (DU) – four weeks
  • gastric ulcer (GU) – eight week

$   This value represents the average cost per claim of the most commonly prescribed quantities as of 2/2015. Where applicable, cost represents that of an “A”- rated generic equivalent (#).

 
famotidine Pepcid # *   $5.80 (#)  
nizatidine Axid PA  $69.12 (#)  
ranitidine capsules PA  $41.31  
ranitidine injection   $14.92  
ranitidine syrup   $12.30  
ranitidine tablet Zantac # *   $5.95 (#)  
ranitidine, effervescent tablet Zantac EFFERdose PA  $307.45  

 Gastrointestinal Drugs-Histamine H2 Antagonists/Proton Pump Inhibitors - Proton Pump Inhibitors (PPIs)

Drug Generic Name

Drug Brand Name

PA
Status

Average cost per claim ($)

Clinical Notes

dexlansoprazole Dexilant PA  $206.59  

Please note: omeprazole and pantoprazole do not require PA (within quantity limits).

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 1st two weeks of therapy). For pathological hypersecretory conditions, such as ZE 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:

  • duodenal ulcer (DU) – four weeks (QD dosing)
  • gastric ulcer (GU) – eight weeks (QD dosing)
  • H. pylori – two weeks (BID dosing) + two more weeks if DU using QD dosing and 6 more weeks if GU using QD dosing
  • acute symptomatic GERD – four to eight weeks (QD dosing)

Nasogastric (NG) Tube Administration:

Omeprazole capsules, lansoprazole capsules, and esomeprazole magnesium 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.

$   This value represents the average cost per claim of the most commonly prescribed quantities as of 2/2015. Where applicable, cost represents that of an “A”- rated generic equivalent (#).

 
esomeprazole magnesium Nexium PA  $323.50 (#)  
esomeprazole sodium IV Nexium  IV PA  $112.94 (#)  
esomeprazole strontium PA  $66.00 - $424.68  
lansoprazole capsule Prevacid # PA  - ≥ 2 years and PA > 30 units/month $31.28 (#)  
lansoprazole orally disintegrating tablet Prevacid Solutab PA  - ≥ 2 years and PA > 30 units/month $313.98  
omeprazole / sodium bicarbonate Zegerid PA  $345.14 (#)  
omeprazole 10 mg Prilosec # PA  - > 30 units/month $13.67 (#)  
omeprazole 20 mg Prilosec # PA  - > 120 units/month $5.77 (#)  
omeprazole 40 mg PA  $8.98 - $14.97  
omeprazole suspension Prilosec PA  $611.74  
pantoprazole 20 mg tablet Protonix # PA  - > 30 units/month $5.72 (#)  
pantoprazole 40 mg suspension Protonix PA  $265.71 - $528.42  
pantoprazole 40 mg tablet Protonix # PA  - > 60 units/month $8.57 (#)  
pantoprazole IV Protonix IV #   $51.24 (#)  
rabeprazole delayed-release capsule Aciphex Sprinkle PA  $370.39  
rabeprazole delayed-release tablet Aciphex PA  $53.53 (#)  
# 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.
 
* 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:

  • gastroesophageal reflux disease (GERD)
  • healing of erosive esophagitis, ulcerative GERD, duodenal ulcers, gastric ulcers
  • 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 for an FDA “A”-rated generic equivalent of a brand name drug, both brand and generic require PA.  PA requests submitted for a brand name drug must meet the criteria for the drug itself and the prescriber must provide medical records documenting an inadequate response or adverse reaction to the respective generic equivalent.

 

  • All PA requests must include clinical diagnosis, drug name, dose, and frequency. 
  • Additional criteria may apply, depending upon the member’s condition and requested medication (see below).

 

Helidac, Omeclamox-Pak, Pylera, Prevpac

  • Prescriber provides documentation of the following:
    • an appropriate diagnosis; and
    • requested medication provides a significant or unique therapeutic advantage over the conventionally packaged formulation 

 

Nizatadine 

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

 

Ranitidine capsules 

  • Documentation of the following is required:
    • supporting medical necessity for capsule formulation over tablets (tablets are available without PA).

 

Zantac Efferdose

  • Documentation of the following is required:  
    • an inadequate response (defined as ≥ 14 days of therapy), or adverse reaction to ranitidine oral solution.

 

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

 

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

  • Documentation of the following is required:
    • appropriate clinical indication; and
    • quantity ≤ 30 units/30 days; and
    • one of the following:
      • if 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 40 mg daily for two weeks; and
        • one of the following:
          • an inadequate response, adverse reaction, or contraindication to pantoprazole 40 mg daily for two weeks; or
          • documentation of a g-tube/swallowing disorder; and
        • one of the following:
          • 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, Nexium suspension > 30 units/month, lansoprazole ODT (2 years of age or older) > 30 units/month, Prilosec powder for suspension > 30 units/month, Protonix 40 mg suspension > 30 units/month, and Zegerid powder for suspension > 30 units/month

  • Documentation of the following is required:
    • appropriate clinical indication; and
    • an inadequate response, adverse reaction, or contraindication to omeprazole 40 mg daily for two weeks; and
    • one of the following:
      • an inadequate response, adverse reaction, or contraindication to pantoprazole 40 mg daily for two weeks; or
      • documentation of a g-tube/swallowing disorder; and
    • one of the following:
      • 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 inadequate response to the requested agent after once daily dosing for two weeks.

  

Dexilant capsules, esomeprazole magnesium, esomeprazole strontium, and omeprazole/sodium bicarbonate capsules

  • Documentation of the following is required:
    • appropriate clinical indication; and
    • an inadequate response, adverse reaction, or contraindication to omeprazole 40 mg daily for two weeks; and
    • an inadequate response, adverse reaction, or contraindication to pantoprazole 40 mg daily for two weeks; and
    • one of the following:
      • 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.

 

Dexilant capsules > 30 units/month, esomeprazole magnesium > 30 units/month, esomeprazole strontium > 30 units/month, and omeprazole/sodium bicarbonate capsules > 30 units/month

  • Documentation of the following is required:
    • appropriate clinical indication; and
    • an inadequate response, adverse reaction, or contraindication to omeprazole 40 mg daily for two weeks; and
    • an inadequate response, adverse reaction, or contraindication to pantoprazole 40 mg daily for two weeks; and
    • one of the following:
      • 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 inadequate response to the requested agent after once daily dosing for two weeks.

 

esomeprazole sodium IV

  • Documentation of the following is required: 
    • appropriate clinical indication; and
    • medical necessity for intravenous route of administration; and
    • an inadequate clinical response or adverse reaction to a trial of pantoprazole IV.

 

lansoprazole capsules (two years of age or older) and rabeprazole tablets

  • Documentation of the following is required:        
    • an appropriate clinical indication; and
    • an inadequate response, adverse reaction, or contraindication to omeprazole 40 mg daily for two weeks; and
    • an inadequate response, adverse reaction, or contraindication to pantoprazole 40 mg daily for two weeks; and
    • quantity ≤ 30 units/30 days.

 

lansoprazole capsules (two years of age or older) and rabeprazole tablets > 30 units/month

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

 

omeprazole 40 mg

  • Documentation of the following is required:
    • appropriate clinical indication; and
    • clinical rationale for 40 mg when 20 mg capsules are available; and
    • an inadequate response, adverse reaction or contraindication to pantoprazole 40 mg daily for two weeks; and
    • one of the following:
      • 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 ≤ units/30 days.

 

omeprazole 10 mg > 30 units/month

  • Documentation of the following is required:
    • appropriate clinical indication; 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 40 mg > 30 units/month

  • Documentation of the following is required:
    • appropriate clinical indication; and
    • clinical rationale for omeprazole 40 mg above quantity limits when omeprazole 20 mg capsules are available up to 4 capsules/day without PA; and
    • an inadequate response, adverse reaction or contraindication to pantoprazole 40 mg daily for two weeks; and
    • one of the following: 
      • 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.

 

omeprazole 20 mg > 120 units/month for GERD, extraesophageal symptoms/conditions secondary to gastric reflux, H. pylori eradication, Non-ulcer or functional dyspepsia

  • Documentation of the following is required:  
    • medical records documenting inadequate response to the agent dosing at 80 mg daily for at least two weeks; and
    • documentation of a consult with a GI (gastrointestinal) specialist.

SmartPA: Claims for omeprazole > 120 units/month will usually process at the pharmacy if the member is ≤ 12 years of age.

  

omeprazole 20 mg > 120 units/month for abnormal secretion of gastrin/Zollinger Ellison, Barrett's Esophagus, esophagitis, ulcerations 

  • Documentation of the diagnosis is required for approval.

SmartPA: Claims for omeprazole > 120 units/month will usually process at the pharmacy if the member is ≤ 12 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.

 

pantoprazole 20 mg > 30 units/month for GERD, extraesophageal symptoms/conditions secondary to gastric reflux, H. pylori eradication, Non-ulcer or functional dyspepsia

  • Documentation of the following is required:
    • appropriate clinical indication; and
    • clinical rationale for pantoprazole 20 mg above quantity limits when 40 mg tablets are available up to 2 tablets/day without PA.

 

pantoprazole 20 mg > 30 units/month for abnormal secretion of gastrin/Zollinger Ellison, Barrett's Esophagus, esophagitis, ulcerations 

  • Documentation of the diagnosis is required for approval.

 

pantoprazole 40 mg tablets > 60 units/month for GERD, extraesophageal symptoms/conditions secondary to gastric reflux, H. pylori eradication, Non-ulcer or functional dyspepsia

  • Documentation of the following is required:  
    • medical records documenting inadequate response to the agent dosing at 80 mg daily for at least two weeks; and
    • documentation of a consult with a GI (gastrointestinal) specialist.

SmartPA: Claims for pantoprazole > 60 units/month will usually process at the pharmacy if the member is ≤ 12 years of age.

 

pantoprazole 40 mg tablets > 60 units/month  for abnormal secretion of gastrin/Zollinger Ellison, Barrett's Esophagus, esophagitis, ulcerations 

  • Documentation of the diagnosis is required for approval.

SmartPA: Claims for pantoprazole > 60 units/month will usually process at the pharmacy if the member is ≤ 12 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.

 

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: 06/2015


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Last updated 06/29/15