Pharmacy Pearl 20 january 2000

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An intern sees a 26 y/o male patient who has the signs and symptoms of mild gastroesophageal reflux disease (GERD). He states the symptoms do not affect his activities of daily living and do not wake him up at night.  He does not smoke and only drinks alcohol occasionally. He is not overweight, his labs are WNL, and he has no other concurrent medical conditions.

The intern wants to start the patient on a proton pump inhibitor (PPI) because "it's the most effective therapy" for GERD. He says with the new DoD contract price for omeprazole it's 'not that expensive anymore'.  Do you agree or not? Why or why not? 

SELECT  here for discussion 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

DISCUSSION 20 JANUARY 2000

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Proud that you have avoided the urge to beat this person with a blunt object, you should discuss the following with him: 

1) Lifestyle changes - Life style modifications to include elevation of the head of the bed, weight loss, smoking cessation, loose fitting clothes, decreased dietary fat intake, avoidance of certain foods, and avoiding recumbency for 3 hours postprandially are somewhat effective in the treatment of GERD. Although not specifically tested in controlled trials, a 20-30% placebo response rate is assumed to be due to lifestyle modifications. Lifestyle modifications should be continued even if the patient requires pharmacotherapy.

2) Antacids are effective for symptom relief when compared to placebo.  Their onset is relatively rapid (within minutes) and their duration can be as long as 2-3 hours when given in close proximity of a meal. A couple of long term trials suggest that symptom relief in as many as 20% of patients.  Antacids have little effect on healing of severe esophagitis but may be as effective as standard dose H2RAs in mild disease.

3) Promotility agents (metoclopramide, cisapride) are equally effective when compared to H2RAs in the treatment of mild to moderate GERD but are more expensive and have a risk, albeit small, of fatal ventricular arrhythmias (cisapride). Promotility agents may be used in combination with
H2RAs or PPIs if motility problems are documented. 

4) H2RAs (standard dose and high dose) are mainstays of GERD treatment.  Although not as effective as the proton pump inhibitors (PPI) for treatment or prophylaxis, H2RAs can heal a significant number of patients with mild to moderate disease at a fraction of the cost of PPI therapy. Depending on the dose and frequency of the H2RA, as many as 80% of the cases can be healed with a H2RA. 

5) PPIs are the most effective agents for the treatment and maintenance of severe GERD. Depending of the dose, up to 93% of GERD patients will be healed. Although their healing rate is better, the cost per regimen is significantly higher. PPIs should only be used when 1) the patient presents with warning symptoms of severe GERD [dysphagia, choking, weight loss, bleeding, chest pain] or 2) they have failed other less expensive treatment regimens including high dose H2RAs 

6) In a small incremental cost-efficacy analysis comparing omeprazole (20mg QD) and 'double dose' (one study of 150mg QID) ranitidine, estimated that each additional cure using omeprazole instead of ranitidine would cost the facility an additional $532. 

Cost efficacy analysis of GERD 

Drug Dose/ duration Aver Heal rate Cost/ Regimen Cost efficacy
Incremental cost efficacy Vs. RAN 150
Ranitidine 150mg po QID 56 days 68% $ 6.05 $ 8.89 N/A
Omeprazole 20mg po QD 56 days 82% $ 78.40 $ 96.08 $ 532.00

The above cost efficacy comparison table shows the respective drug costs as well as the cost efficacy of the various regimens, based on the averaged efficacy (healing) rates from published studies. Cost efficacy is calculated by dividing the drug cost by the % efficacy. For example, the cost efficacy of ranitidine 150mg po QID is the drug cost ($6.05) divided by the cure rate or efficacy (0.68) to yield the cost efficacy for this drug at this dose ($8.89). When comparing different regimens and/or different drugs, the use of an incremental cost efficacy analysis may be useful. An incremental cost efficacy is done by dividing the difference in drug costs between 2 regimens by the difference in efficacy between the 2 regimens. For example, when comparing ranitidine 150mg po QID and omeprazole 20mg po QD, you divide the difference between the drug costs ($78.40-$6.05 = $72.35) by the difference in the efficacy rates of the 2 drug regimens (0.82 - 0.68 = 0.14). This yields an incremental cost of ~ $532.00. The translation of this number into clinical terms is an MTF would have to spend an additional $532 on omeprazole in order to get one more cure when compared to the ranitidine 150mg po QID (see following illustration).

Illustration

Ranitidine 150mg po QID Omeprazole 20mg po QD 
# of patients 100 patients 100 patients 
Cost/regimen $6.05 $78.40 
Efficacy rate 0.68 (68%) 0.82 (81.6%) 
Cost to treat 100 pts $ 605.00 $ 7,840.00

From chart, difference in cost between 100 omeprazole patients and 100 ranitidine patients = $ 7,840.00 - $ 605.00 = $ 7,235.00 

$ 7,235.00 for 14 additional cures (82-68) = $ 7,235.00 / 14 = ~$ 532.00 per additional cure with omeprazole

Proton pump inhibitors are very effective drugs in the treatment of GERD.  They are probably the best agents for severe GERD and chronic prophylaxis of moderate to severe GERD. Patients with mild GERD who require are still symptomatic with lifestyle changes and require pharmacotherapy should be tried on single dose (and then double dose) H2 blockers before switching to a PPI. The incremental cost-efficacy above supports this for mild GERD. More severe cases may be more appropriately treated with a PPI as initial therapy.

This Pearl is meant for academic and educational purposes only. This Pearl is meant to raise important points regarding the safe and cost-effective pharmacotherapy of patients. It is not meant to be the definitive reference for the treatment or prophylaxis of various diseases. Although every effort is taken to ensure this Pearl is correct and factual, errors may occur. The Pharmacoeconomic Center assumes no liability for incorrect information or harm that may occur from the use of the information included in this Pearl.

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