Newfoundland and Labrador Prescription Drug Program

Newfoundland and Labrador Prescription Drug Program

Guidelines for the Coverage of Proton Pump Inhibitors

Updated December, 2004

Approval for the coverage of Pariet 10mg EC tablets(rabeprazole) and Apo-Omeprazole 20mg (omeprazole) will be considered for patients who meet one of the following criteria:

1) For the treatment of GERD, confirmed by UGI investigation (radiography or endoscopy), following failure of an adequate trial (4 - 8 weeks minimum, at therapeutic dosing) of a H2 antagonist. Approval in this case will be for a 1 year period and is subject to an annual review with request for renewal needed if the medication is to be continued.

2) For the treatment of GERD, based on clinical diagnosis and in the absence of UGI confirmation, for an 8 week period only, and following failure of an adequate trial (4 - 8 weeks minimum, at therapeutic dosing) of a H2 antagonist.

3) For H. Pylori eradication, in conjunction with clarithromycin and metronidazole/amoxicillin, at BID dosing for a 7 day period. Requests for a second eradication treatment will be honored however additional treatments will require diagnostic confirmation of the continued presence of H. pylori.

4) For cytoprotection against nsaid-induced gastropathy in high risk patients (defined as patients requiring chronic nsaid treatment AND who are over 60 years of age, have a previous history of peptic ulcer disease, or have concomitant oral steroid use) who have failed or been intolerant to a trial of misoprostol.

5) For the treatment of active gastritis, duodenal or gastric ulceration, confirmed by UGI investigation (radiography or endoscopy), following failure of a H2 antagonist. Approval will be for 4 weeks for a duodenal ulcer, and 12 weeks for gastritis or gastric ulceration.

Approval for omeprazole (Losec Brand), lansoprazole (Prevacid), and pantoprazole (Pantoloc) will be considered for patients who meet one of the above 5 criteria AND have failed to respond to an 8 week trial of Pariet 10mg EC (rabeprazole) AND Apo-Omeprazole 20mg (omeprazole).*

* when used in H. pylori regimens (as per criteria 3) failure of a Pariet 10mg EC and Apo-Omeprazole 20mg based regimen is not required

1)	For the treatment of GERD, confirmed by UGI investigation (radiography or endoscopy), following failure of an adequate trial (4 - 8 weeks minimum, at therapeutic dosing) of a H2 antagonist. Approval in this case will be for a 1 year period and is subject to an annual review with request for renewal needed if the medication is to be continued.
2)	For the treatment of GERD, based on clinical diagnosis and in the absence of UGI confirmation, for an 8 week period only, and following failure of an adequate trial (4 - 8 weeks minimum, at therapeutic dosing) of a H2 antagonist.
3)	For H. Pylori eradication, in conjunction with clarithromycin and metronidazole/amoxicillin, at BID dosing for a 7 day period. Requests for a second eradication treatment will be honored however additional treatments will require diagnostic confirmation of the continued presence of H. pylori.
4)	For cytoprotection against nsaid-induced gastropathy in high risk patients (defined as patients requiring chronic nsaid treatment AND who are over 60 years of age, have a previous history of peptic ulcer disease, or have concomitant oral steroid use) who have failed or been intolerant to a trial of misoprostol.
5)	For the treatment of active gastritis, duodenal or gastric ulceration, confirmed by UGI investigation (radiography or endoscopy), following failure of a H2 antagonist. Approval will be for 4 weeks for a duodenal ulcer, and 12 weeks for gastritis or gastric ulceration.