A   B   C   D   E   F   G   H   I   J   K   L   M   N   O   P   Q   R   S   T   U   V   W   X   Y   Z


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  $545.63  

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

$  This value represents the average cost per claim of the most commonly prescribed quantities as of 3/2013. Where applicable, cost represents that of an “A”- rated generic equivalent (#).

 
bismuth subsalicylate / tetracycline / metronidazole Helidac PA  $819.24  
lansoprazole / amoxicillin / clarithromycin Prevpac PA  $512.22  
omeprazole / clarithromycin / amoxicillin Omeclamox-Pak PA  $439.36  

 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 # *   $12.27 (#)  

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) – 4 weeks
  • gastric ulcer (GU) – 8 week

$   This value represents the average cost per claim of the most commonly prescribed quantities as of 3/2013. Where applicable, cost represents that of an “A”- rated generic equivalent (#).

 
famotidine Pepcid # *   $5.81 (#)  
nizatidine Axid PA  $169.58  
ranitidine capsules PA  $41.31  
ranitidine injection   $27.32  
ranitidine syrup   $9.62 (#)  
ranitidine tablet Zantac # *   $5.50 (#)  
ranitidine, effervescent tablet Zantac EFFERdose PA  $483.83  

 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  $146.47  

Please note: omeprazole and pantoprazole do not require prior authorization (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.

QD Dosing versus 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) – 4 weeks (QD dosing)
  • gastric ulcer (GU) – 8 weeks (QD dosing)
  • H. pylori – 2 weeks (BID dosing) + 2 more weeks if DU using QD dosing and 6 more weeks if GU using QD dosing
  • acute symptomatic GERD – 4-8 weeks (QD dosing)

NG Tube Administration:

Omeprazole (Rx) capsules, Prevacid (lansoprazole) capsules, and Nexium (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 3/2013. Where applicable, cost represents that of an “A”- rated generic equivalent (#).

 
esomeprazole magnesium Nexium PA  $205.13  
esomeprazole sodium IV Nexium  IV PA  $127.66  
esomeprazole strontium PA  $184.44 - $213.74  
lansoprazole capsule Prevacid # PA  - > or = 2 years and PA > 30 units/month $81.00  
lansoprazole, orally disintegrating tablet Prevacid Solutab PA  - > or = 2 years and PA > 30 units/month $217.71  
omeprazole / sodium bicarbonate PA  $507.04  
omeprazole 10 mg Prilosec # PA  - > 30 units/month $35.79 (#)  
omeprazole 20 mg Prilosec # PA  - > 120 units/month $16.60  
omeprazole 40 mg PA  $579.27  
omeprazole suspension Prilosec PA  $360.49  
pantoprazole 20 mg tablet Protonix # PA  - > 30 units/month $7.33 (#)  
pantoprazole 40 mg suspension Protonix PA  $156.32  
pantoprazole 40 mg tablet Protonix # PA  - > 60 units/month $7.12 (#)  
pantoprazole IV Protonix IV   $43.40  
rabeprazole Aciphex PA  $302.17  
# 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.

Back to top


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.  Prior authorization 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 prior-authorization 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
    • one of the following
      • medical necessity for a combination H. Pylori medication
      • 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 clinical response to two generic H2-antagonists that do not require prior authorization, prescribed at therapeutic doses for an appropriate duration, or an adverse reaction to two generic H2-antagonists that do not require prior authorization.

 

Ranitidine capsules 

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

 

Zantac Efferdose

  • Documentation of the following is required:  
    • an inadequate response, adverse reaction or contraindication to ranitidine oral solution.

 

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

  • 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 lansoprazole capsules at a dose of 30 mg daily for two weeks; and 
    • an inadequate response, adverse reaction, or contraindication to pantoprazole 40 mg daily for two weeks; and
    • quantity < or = 30 units/30 days.

 

Aciphex > 30 units/month, Dexilant capsules > 30 units/month, esomeprazole strontium > 30 units/month, Nexium capsules > 30 units/month, and omperazole/sodium bicarbonate > 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 lansoprazole capsules at a dose of 30 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.

 

Lansoprazole capsules (2 years of age or older) 

  • 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
    • pantoprazole 40 mg daily for two weeks; and
    • quantity < or = 30 units/30 days.

 

Lansoprazole capsules (2 years of age or older) > 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
    • pantoprazole 40 mg daily for two weeks; and
    • medical records documenting inadequate response to the requested agent after once daily dosing for two weeks.

 

Nexium 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 Protonix IV.

 

Nexium suspension, lansoprazole ODT (2 years of age or older), Prilosec powder for suspension, and Protonix suspension

  • Documentation of the following is required:
    • appropriate clinical indication; and
    • quantity < or = 30 units/30 days; and
    • one of the following:
      • if the request is for Nexium packets and the member is < 1 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:
          • documentation of a g-tube/swallowing disorder with 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 lansoprazole capsules at a dose of 30 mg daily for two weeks and pantoprazole 40 mg daily for two weeks.

 

Nexium suspension > 30 units/month, lansoprazole ODT (2 years of age or older) > 30 units/month, Prilosec powder for suspension > 30 units/month, and Protonix 40 mg 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:
      • documentation of a g-tube/swallowing disorder with inadequate response, adverse reaction, or contraindication to lansoprazole capsules at a dose of 30 mg for two weeks; or
      • an inadequate response, adverse reaction, or contraindication to lansoprazole capsules at a dose of 30 mg daily for two weeks and 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 lansoprazole capsules at a dose of 30 mg daily for two weeks; and
    • quantity < or = 30 units/30 days.

 

omeprazole 10 mg > 30 units/month, omeprazole 40 mg > 30 units/month

  • Documentation of the following is required:
    • appropriate clinical indication; and
    • clinical rationale for omeprazole 10 mg or 40 mg above quantity limits when 20 mg capsules are available up to 4 capsules/day without prior authorization; and
    • if the request is for omeprazole 40 mg, the member must have had an inadequate response, adverse reaction or contraindication to pantoprazole 40 mg daily for two weeks and lansoprazole capsules at a dose of 30 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 prior authorization.

 

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: 01/2014


Clinical Criteria Main Page | Back to topPrevious  |  Next

Last updated 03/10/14