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Pharmacy Clinical Policy Bulletins
Subject: Proton Pump Inhibitors (PPIs)
Class Edit Summary*
 |
 |
Status |
 |
Drug |
 |
PR |
 |
PR-QL |
 |
PR-AL |
 |
ST |
 |
M EX‡ |
 |
 |
 |
 |
P |
 |
AcipHex® (rabeprazole) |
 |
X |
 |
X |
 |
|
 |
|
 |
|
 |
 |
 |
 |
P |
 |
omeprazole |
 |
X |
 |
X |
 |
|
 |
|
 |
|
 |
 |
 |
 |
P |
 |
Prevacid® (lansoprazole) |
 |
X |
 |
X |
 |
|
 |
|
 |
|
 |
 |
 |
 |
FE |
 |
Nexium® (esomeprazole) |
 |
X |
 |
X |
 |
|
 |
X |
 |
X |
 |
 |
 |
 |
FE |
 |
Prilosec® (omeprazole) |
 |
X |
 |
X |
 |
|
 |
X |
 |
X |
 |
 |
 |
 |
FE |
 |
Protonix® (pantoprazole) |
 |
X |
 |
X |
 |
|
 |
X |
 |
X |
 |
 |
 |
 |
FE |
 |
Zegerid® (omeprazole IR) |
 |
X |
 |
X |
 |
|
 |
X |
 |
X |
 |
 |
*P = Preferred; FE = Formulary Excluded; NP = Nonpreferred
PR = Precertification; QL = Quantity Limits; AL = Age Limits; ST = Step-Therapy
‡M EX = Medical Exception – This means the physician or health care professional
must obtain a medical exception from Aetna, in order for the medication to be
eligible for coverage. Medical Exception criteria apply to Formulary Excluded
drugs for members enrolled in or covered by closed benefits plans, and also
apply to Step-Therapy drugs in cases where a member’s physician believes it
is medically necessary for the member to use a step-therapy drug in the first
instance without a trial of the prerequisite alternative drug(s).
Important Note
This Pharmacy Clinical Policy Bulletin expresses Aetna's determination of whether certain services or supplies are medically necessary. Aetna has reached these conclusions based upon a review of currently available clinical information (including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the technology, evidence-based guidelines of public health and health research agencies, evidence-based guidelines and positions of leading national health professional organizations, views of physicians practicing in relevant clinical areas, and other relevant factors). Aetna expressly reserves the right to revise these conclusions as clinical information changes, and welcomes further relevant information. Each benefits plan defines which services are covered, which are excluded, and which are subject to dollar caps or other limits. Members and their health care providers will need to consult the member's benefits plan to determine if there are any exclusions or other benefit limitations applicable to this service or supply. The conclusion that a particular service or supply is medically necessary does not constitute a representation or warranty that this service or supply is covered (that is, will be paid for by Aetna) for a particular member. The member's benefits plan determines coverage. Some plans exclude coverage for services or supplies that Aetna considers medically necessary. If there is a discrepancy between this policy and a member's plan of benefits, the benefits plan will govern. In addition, coverage may be mandated by applicable legal requirements of a state, the federal government or CMS for Medicare and Medicaid members. CMS's Coverage Database can be found on the following website: http://www.cms.hhs.gov/center/coverage.asp.
Policy
- Precertification Criteria – (A OR B OR C) AND D
20 mg prescription Prilosec and omeprazole capsules
are excluded from coverage for most members. For plans where these drugs
are a covered benefit, the criteria below apply.
Under some plans, including plans that use an open or closed formulary,
AcipHex, Nexium, omeprazole, Prevacid, Prilosec and Zegerid
are subject to precertification. If precertification requirements apply
Aetna considers AcipHex, Nexium, omeprazole, Prevacid, Prilosec and
Zegerid to be medically necessary for those members who meet the following
precertification criteria:
- Member is < 6 years of age – FOR omeprazole,
Prevacid, or Prilosec ONLY
OR
- Documented diagnosis listed below (no requirement for nonprescription
Prilosec OTC)
Duodenal ulcer - active ulcer OR maintenance of healed ulcer (Aetna considers drug therapy to be medically necessary for a period of up to 12 months.)
Gastric ulcer - active benign (Aetna considers drug therapy to be medically necessary for a period of up to 12 months.); maintenance
Gastrojejunal ulcer - active; maintenance
NSAID-induced gastric ulcer - healing (Aetna considers drug therapy to be medically necessary for a period of up to 12 months.); risk reduction for recurrence
Peptic ulcer disease (Aetna considers drug therapy to be medically necessary for a period of up to 12 months.)
Stress ulcer/surgical prophylaxis
Barrett's esophagus
Crohn's disease
Erosive esophagitis - active, maintenance, healed
Gastric residual reduction
Gastrointestinal bleed
GERD - moderate to severe with symptoms (treatment, maintenance, screening)
H. pylori, treatment
Hypersecretory conditions, including Zollinger-Ellison Syndrome
Laryngopharyngeal reflux
Member is Post transplant and/or MD is a transplant specialist
OR
- Documented diagnosis of other GI condition for which Prilosec OTC is
indicated (heartburn, chronic reflux), the use of a PPI is required, AND
one of the below:
- Intolerance to the nonprescription Prilosec OTC 20mg OR
- Failure of an adequate trial of two weeks of the nonprescription
Prilosec OTC 20mg
AND
| D. |
Quantity limits: |
According to the manufacturer,
the proton pump inhibitors can be dosed up to a maximum daily dose at
the interval(s) as indicated in the table below. A quantity of each
drug will be considered medically necessary as indicated in the table
below if member fulfills criteria A or B or C above. |
 |
Drug |
 |
Maximum Daily Dose/ Dosing
Interval |
 |
Dosage Strength |
 |
Quantity Limits |
 |
 |
AcipHex |
 |
20 mg/ Once daily |
 |
20mg |
 |
Up to 30 tablets in 30 days |
 |
 |
Nexium |
 |
40 mg/ Once daily |
 |
20mg, 40mg |
 |
Up to 30 capsules in 30 days |
 |
 |
omeprazole |
 |
40 mg/ Once daily |
 |
10mg, 20mg |
 |
Up to 30 capsules in 30 days |
 |
 |
Prevacid |
 |
30 mg/ Once daily |
 |
15mg, 30mg |
 |
Up to 30 capsules, tablets, or
packets in 30 days |
 |
 |
Prilosec |
 |
40 mg/ Once daily |
 |
10mg, 20mg, 40mg |
 |
Up to 30 capsules in 30 days |
 |
 |
Protonix |
 |
40 mg/ Once daily |
 |
20mg, 40mg |
 |
Up to 30 tablets in 30 days |
 |
 |
Zegerid |
 |
40 mg/ Once daily |
 |
20 mg,
40 mg
|
 |
Up to 30 packets in 30 days |
 |
 |
Zegerid |
 |
40mg/ Once daily |
 |
20 mg,
40 mg
|
 |
Up to 30 capsules in 30 days |
 |
For coverage of additional quantities, a member's treating physician must
request prior authorization through the Pharmacy Management Precertification
Unit. Additional quantities of proton pump inhibitors will be considered
medically necessary for those members who meet ANY of the following criteria:
- Member has a diagnosis of a pathological hypersecretory condition OR
- Member is being treated for Barrett's esophagus OR
- Member is being treated for laryngopharyngeal reflux OR
- Member is being treated for a GI bleed (3-month duration) OR
- Member is being treated for eradication of H. pylori (triple therapy
only; 30 day duration) OR
- Member is a child < 11 years of age who is being treated for gastroesophageal reflux disease (GERD) or erosive esophagitis and remains symptomatic after 2 or more weeks of once-daily proton pump inhibitor Prevacid and Prilosec only OR
- Member has gastroesophageal reflux disease (GERD) and meets ALL the
following criteria:
- Member has nocturnal acid breakthrough on once-daily proton pump
inhibitor
AND
- Member has tried and failed an adequate trial of two weeks of a H2 receptor antagonist (cimetidine, famotidine, nizatadine, ranitidine; prescription or non-prescription) given as an evening dose.
NOTE: Aetna does NOT consider prescription PPIs to be medically necessary
for members with the following indications:
- Uncomplicated heartburn of greater than 1-month duration, with a frequency
of at least 2 heartburn episodes per week when all of the following criteria
are met:
- The heartburn can be controlled by use of OTC medications AND
- There is no diagnosis of more complicated acid reflux disease, such
as erosive esophagitis AND
- There are no symptoms of a more complicated GI condition.*
OR
- Uncomplicated heartburn with a frequency of <
1 episode/week that can be controlled by use of OTC medications
OR
- Any of the following diagnoses when NOT in combination with a diagnosis
listed under B above:
Dyspepsia
Gastritis or duodenitis
Gastroparesis
Gastric bypass surgery
Hiatal hernia
Schatzki's ring (esophagogastric ring)
* Symptoms of a more complicated GI condition may include any of the following:
trouble or pain swallowing food
vomiting with blood
bloody or black stools
heartburn of > 3 months duration
heartburn with lightheadedness, sweating, dizziness
chest pain or shoulder pain with shortness of breath, sweating, pain spreading
to arms, neck, shoulders
frequent chest pain
frequent wheezing, particularly with heartburn
unexplained weight loss
nausea or vomiting
stomach pain
- Step-Therapy Criteria
20 mg prescription Prilosec capsules are excluded from coverage
for most members. For plans where these drugs are a covered benefit, the
criteria below apply. Under some plans, including plans that use an open
or closed formulary, Nexium, Prilosec, Protonix and Zegerid
are subject to step-therapy. Aetna considers Nexium, Prilosec, Protonix
and Zegerid to be medically necessary for those members who meet the following
step-therapy criterion:
A documented trial of one month each of both lansoprazole (Prevacid) AND
rabeprazole (AcipHex) - alternatives on the Preferred Drug List.
If it is medically necessary for a member to be treated initially with
a medication subject to step-therapy, the member's treating physician may
contact the Aetna Pharmacy Management Precertification Unit to request coverage
as a medical exception at 1-800-414-2386. (See criteria under section III
below.)
- Medical Exception Criteria - A OR [(B OR C) AND D]
20 mg prescription Prilosec capsules are excluded from coverage
for most members. For plans where these drugs are a covered benefit, the
criteria below apply.
Nexium, Prilosec, Protonix, and Zegerid currently are listed
on the Aetna Formulary Exclusions List.* Therefore, they are excluded from
coverage for members enrolled in prescription drug benefits plans that use
a closed formulary, unless a medical exception is granted. Aetna considers
Nexium, Prilosec, Protonix, and Zegerid to be medically necessary for those
members who meet the following criteria:
- Member is < 6 years of age AND is intolerant to OR has failed an adequate trial of two (2) weeks of the formulary alternative Prevacid - FOR Prilosec ONLY
OR
- Documented diagnosis listed below (no requirement for nonprescription
Prilosec OTC)
Duodenal ulcer - active ulcer OR maintenance of healed ulcer (Aetna considers drug therapy to be medically necessary for a period of up to 12 months.)
Gastric ulcer - active benign (Aetna considers drug therapy to be medically necessary for a period of up to 12 months.); maintenance
Gastrojejunal ulcer - active; maintenance
NSAID-induced gastric ulcer - healing (Aetna considers drug therapy to be medically necessary for a period of up to 12 months.); risk reduction for recurrence
Peptic ulcer disease (Aetna considers drug therapy to be medically necessary for a period of up to 12 months.)
Stress ulcer/surgical prophylaxis
Barrett's esophagus
Crohn's disease
Erosive esophagitis - active, maintenance, healed
Gastric residual reduction
Gastrointestinal bleed
GERD - moderate to severe with symptoms (treatment, maintenance, screening)
H. pylori, treatment
Hypersecretory conditions, including Zollinger-Ellison Syndrome
Laryngopharyngeal reflux
Member is Post transplant and/or MD is a transplant specialist
OR
- Documented diagnosis of other GI condition for which Prilosec OTC is
indicated (heartburn, chronic reflux), the use of a PPI is required, AND
one of the below:
- Intolerance to the nonprescription Prilosec OTC 20mg OR
- Failure of an adequate trial of two weeks of the nonprescription
Prilosec OTC 20mg
AND
- A documented
- Contraindication to the preferred alternatives lansoprazole (Prevacid)
AND rabeprazole (AcipHex) OR,
- Intolerance to the preferred alternatives lansoprazole (Prevacid)
AND rabeprazole (AcipHex) OR
- Allergy to the preferred alternatives lansoprazole (Prevacid) AND
rabeprazole (AcipHex) OR
- Failure of an adequate trial of one month each of the preferred alternatives lansoprazole (Prevacid) AND rabeprazole (AcipHex)
NOTE: Aetna does NOT consider prescription PPIs to be medically necessary
for members with the following indications:
- Uncomplicated heartburn of greater than 1-month duration, with a frequency
of at least 2 heartburn episodes per week when all of the following criteria
are met:
- The heartburn can be controlled by use of OTC medications AND
- There is no diagnosis of more complicated acid reflux disease, such
as erosive esophagitis AND
- There are no symptoms of a more complicated GI condition.*
OR
- Uncomplicated heartburn with a frequency of <
1 episode/week that can be controlled by use of OTC medications
OR
- Any of the following diagnoses when NOT in combination with a diagnosis
listed under B above:
Dyspepsia
Gastritis or duodenitis
Gastroparesis
Gastric bypass surgery
Hiatal hernia
Schatzki's ring (esophagogastric ring)
* Symptoms of a more complicated GI condition may include any of the following:
trouble or pain swallowing food
vomiting with blood
bloody or black stools
heartburn of > 3 months duration
heartburn with lightheadedness, sweating, dizziness
chest pain or shoulder pain with shortness of breath, sweating, pain spreading
to arms, neck, shoulders
frequent chest pain
frequent wheezing, particularly with heartburn
unexplained weight loss
nausea or vomiting
stomach pain
Special Notes
Prilosec OTC is used to treat frequent heartburn, defined as heartburn
that occurs two or more days per week. Prilosec OTC is not for people who
have heartburn infrequently, defined as one episode of heartburn a
week or less, or those that want immediate relief of heartburn. Other nonprescription
heartburn treatments, antacids and acid reducers, are indicated for infrequent
heartburn.
Both prescription Prilosec and Prilosec OTC contain the same active ingredient,
omeprazole, which effectively stops acid production. Prescription Prilosec
treats diseases that require diagnosis and supervision by a doctor. Prilosec
OTC treats only symptoms of frequent heartburn. Used as directed, Prilosec
OTC will not treat the conditions that prescription Prilosec treats.
Prilosec OTC is a delayed-release 20mg tablet, taken once a day (every
24 hours) for 14 days before eating. It should not be taken for more than
14 days or a 14-day course repeated more often than every 4 months unless
directed by a physician. The FDA based its approval of Prilosec OTC on the
results of various studies. Two clinical studies demonstrated that it was
effective in increasing the proportion of patients with no heartburn over
24 hours; the effectiveness of Prilosec OTC increases from day 1 to day
14.
*Information regarding Aetna's Preferred Drug List, Formulary Exclusions list, Precertification and Step-Therapy lists is available on our website. In addition, members should refer to their plan documents and may call the toll-free telephone number on their ID card for information regarding their benefits. Health care professionals also may obtain information by calling the Pharmacy Management Precertification Unit at 1-800-414-2386, or they can register to use our password-protected provider website. Visit www.aetna.com, select "Doctors & Hospitals" and choose "Physician Self-Service." Once registration is completed, health care professionals may use our online Precertification/medical exception email request form.
The lists above are subject to change. Not all programs - for example step-therapy, precertification, and quantity limits - are available in all service areas (for example, step-therapy does not apply to fully insured New Jersey members).
Many medications on the Preferred Drug List are subject to manufacturer rebate arrangements between Aetna and the manufacturer of those medications. If the member's prescription benefits plan has a deductible or copay levels based on a percentage of Aetna's contracted rate with the participating pharmacy, the contracted rate does not include or reflect any manufacturer rebate arrangements between Aetna and the medication manufacturer. In prescription plans with a deductible or copayment or coinsurance tiers, use of drugs from the Preferred Drug List generally will result in lower costs to members. However, where the prescription plan utilizes a deductible or copayments or coinsurance calculated on a percentage basis, there could be some circumstances in which a preferred drug would cost the member more than a nonpreferred drug because (1) the negotiated pharmacy payment rate for the preferred drug may be more than the negotiated pharmacy payment rate for the nonpreferred drug, and (2) rebates received by Aetna from drug manufacturers are not reflected in the cost of a prescription drug obtained by a member. The Preferred Drug List is subject to change.
In evaluating clinically and therapeutically similar drugs for selection for the Preferred Drug List, Aetna reviews the costs of drugs and takes into account rebates negotiated between Aetna and drug manufacturers. Consequently, a drug may be included on the Preferred Drug list that is more expensive than a nonpreferred alternative before any rebates Aetna may receive from a drug manufacturer are taken into account. In addition, certain drugs may be chosen for "preferred" status because of their clinical or therapeutic advantages or level of acceptance among physicians even though they cost more than nonpreferred alternatives. The net cost to a self-funded plan sponsor for covered prescriptions will vary based on (1) the terms of Aetna's arrangements with participating pharmacies; (2) the amount of the member's copayment, coinsurance or deductible obligation under the terms of the plan; and (3) the percentage, if any, of rebates to which the plan sponsor is entitled under its agreement with Aetna. As a result, a self-funded plan sponsor's actual claim expense per prescription for a particular preferred drug may in some circumstances be higher than for a nonpreferred alternative.
For members in Texas, additions to the 2006 Preferred Drug List will be effective no later than January 1, 2006. In accordance with state law, fully insured members in Texas who are receiving coverage for medications that are removed from the Preferred Drug List during the plan year will continue to have those medications covered at the same benefit level until their plan's renewal date.
This definition of precertification is not the same as the definition used by Texas law. Our use of the term "precertification" relates to the prior authorization of your services by Aetna, based on our decision of whether the service is medically necessary. Precertification is not a guarantee of payment or "verification" as defined by Texas law.
California HMO members enrolled in a closed formulary benefits plan who are receiving coverage for medications that are moved to the Formulary Exclusions List, and California HMO members who are receiving coverage for medications added to the Precertification or Step-Therapy lists, will continue to have those medications covered, for as long as the treating physician continues prescribing them. This coverage, in accordance with state law, is only provided when the drug is appropriately prescribed and is considered safe and effective for treating the member's medical condition.
Nothing in this section shall preclude the prescribing health care professional from prescribing another drug covered by the plan that is medically appropriate for the enrollee, nor shall anything in this section be construed to prohibit generic drug substitutions.
Place of Service:
The above policy is based on the following references:
- DeVault KR, Castell DO. Updated guidelines for the diagnosis and treatment
of gastroesophageal reflux disease. Am J Gastroenterology 1999; 94(6):
1434-1442.
- Castell DO, Brunton SA, Earnest DL, et al. GERD: Management Algorithms for
the Primary Care Physician and the Specialist. Practical Gastroenterology
Feb 1999:20-44.
- Fennerty MB, Castell DO, Fendrick AM, et al. The diagnosis and treatment
of gastroesophageal reflux disease in a managed care environment. Arch Int
Med. 1996;156:477-84.
- Kahrilas PF. Gastroesophageal reflux disease. JAMA. 1996;276:983-88.
- Singh G, et al. Gastrointestinal tract complications of nonsteroidal anti-inflammatory
drug treatment in rheumatoid arthritis. Arch Int Med. 1996;156:1530-36.
- Bjorkman DJ. Nonsteroidal Anti-inflammatory drug induced gastrointestinal
injury. Am J Med. 1996;101(supp 1A):25-32.
- Graham DY, et al. Duodenal and gastric ulcer prevention with misoprostol
in arthritis patients taking NSAIDs. Ann Intern Med. 1993;119:257-62.
- Silverstein F, et al. Reduction by misoprostol of clinically detected serious
gastrointestinal complications associated with nonsteroidal anti-inflammatory
drug use in older patients with rheumatoid arthritis. Ann Intern Med.
1995;123:241-9.
- Chiba N et al. Speed of healing and symptom relief in grade II to IV gastroesophageal
reflux disease: A meta-analysis. Gastroenterology 1997; 112(6): 1798-1810.
- Florent C et al. Efficacy and safety of lansoprazole in the treatment of
gastric ulcer: A multicenter study. Eur J Gastroenterol Hepatol 1994;
6: 1135-1139.
- Yeomans ND et al. A comparison of omeprazole with ranitidine for ulcers
associated with non-steroidal anti-inflammatory drugs. The ASTRONAUT study.
N Engl J Med 1998; 338: 719-726.
- Vivian E et al. Efficacy and cost effectiveness of lansoprazole versus omeprazole
in maintenance treatment of symptomatic gastroesophageal reflux disease. Am J Manag Care 1999; 5: 881-886.
- Welage, LS, Berardi, RR, Evaluation of Omeprazole, Lansoprazole, Pantoprazole,
and Rabeprazole in the Treatment of Acid-Related Disease. J Am Pharm Assoc
40(1):52,2000.
- American Pharmaceutical Association, New Product Bulletin-AcipHex (rabeprazole
sodium), 1999:1-13.
- Rehner M et al. Comparison of pantoprazole versus omeprazole in the treatment
of acute duodenal ulceration -- A multicenter study. Aliment Pharmacol Ther
1995; 9: 411-416.
- Dekkers CPM, Beker JA, et al. Comparison of rabeprazole 20 mg versus omeprazole
20 mg in the treatment of active duodenal ulcer: a European mulitcentre study.
Alimental Pharmacol Ther 1999;179-186.
- Cloud ML, Enas N, et al. Rabeprazole in the treatment of acid related diseases:
Results of three placebo-controlled dose-response clinical trials in duodenal
ulcer, gastric ulcer, and gastroesophageal reflux disease (GERD). Digestive
Disease and Sciences 1998;43(5):993-1000.
- Richardson P, Hawkey CJ, Stack WA. Proton pump inhibitors: Pharmacology and
rationale for use in gastrointestinal disorders. Drugs 1998;56(3):307-335.
- Jaspersen, D et al. A comparison of omeprazole, lansoprazole, and pantoprazole
in the maintenance treatment of severe reflux oesophagitis. Aliment Pharmacol
Ther 12:49-52, 1998.
- Supplement-Acid Secretory Disorders: Burning Issues and Hot Topics. Am
J Gastroenterology 94(11):S1-S25, November 1999.
- Vivian E, et al. Efficacy and cost effectiveness of lansoprazole versus
omeprazole in maintenance treatment of symptomatic gastroesophageal reflux disease.
Am J Manag Care 1999;5:881-886.
- Johnston BT, Gastroesophageal reflux disease and a HAPPI quality of life.
Am J Gastroenterology 94(7):1723-1724, July 1999.
- Saltiel E, Proton Pump Inhibitors: A comparative review. US Pharmacist,
December 1997, HS-21-30.
- Corinaldesi, R et al. Pantoprazole and omeprazole in the treatment of reflux
oesophagitis: a European multicenter study. Aliment Pharmacol Ther 9:667-671,
1995.
- Holtz, J et al. Pantoprazole is superior to ranitidine in the treatment of
acute gastric ulcer. Scand J Gastroenterol 30(2):111-115, 1995.
- Armbrecht, U et al. Treatment of reflux esophagitis of moderate and severe
grade with ranitidine or pantoprazole-Comparison of 24-hour intragastric an
oesophageal pH. Aliment Pharmacol Ther 11(5):959-965, 1997.
- Koop, H et al. Comparative trial of pantoprazole and ranitidine in the treatment
of reflux esophagitis. J Clin Gastroenterol 20(3):192-195, 1995.
- van Rensburg, CJ et al. Improved duodenal ulcer healing with pantoprazole
compared with ranitidine: A multicentre study. Eur J Gastroenterol Hepatol
6(8):739-743, 1994.
- Cremer, M et al. A double-blind study of pantoprazole and ranitidine in
the treatment of acute duodenal ulcer. Dig Dis Sci 40(6):1360-1364,
1995.
- Katz PO, Anderson C, Khoury R, & Castell DO. Gastro-aesophageal reflux
associated with nocturnal gastric acid breakthrough on proton pump inhibitors.
Aliment Pharmacol Ther 1998: 12: 1231-1234.
- Robinson, M. Clinical Relevance and Management of 'Occasional Acid Breakthrough'
on Proton Pump Inhibitor Therapy. Pract Gastroenterol November 1999:
55 - 57.
- Peghini P, Castell DO, Decktor D. Understanding Nocturnal Acid Breakthrough
on Proton Pump Inhibitors. Pract Gastroenterol May 2000: 60 - 67.
- Earnest D. Symptomatic Occasional Acid Breakthrough During Proton Pump Inhibitor
Therapy is Common. Ask Your Patients. Pract Gastroenterol February
2000: 51 - 54.
- Peghini PL, Katz, PO, Bracy NA, & Castell DO. Nocturnal Recovery of
Gastric Acid Secretion with Twice-Daily Dosing of Proton Pump Inhibitors. Am
J Gastroenterol 1998: 93: (5) 763 - 767.
- Beck IT, Champion MC, Lemire S, et al. The Second Canadian Consensus Conference
of the Management of Patients with Gastroesophageal Reflux Disease. Can
J Gastroentrerol 1997: 11 (Suppl B) 7B - 20B.
- Moss SF, Arnold R, Tytgat GNJ, et al. Consensus Statement for Management
of Gastroesophageal Reflux Disease. J Clin Gastroenterol 1998: 27 (1):
6-12.
- Zimmermann, AE, Esomeprazole, A Novel Proton Pump Inhibitor for the Treatment
of Acid Related Disorders, Formulary 2000;35:882-93.
- Kahrilas et al., Esomeprazole Improves Healing Symptoms Resolution as Compared
with Omeprazole in Reflux Oesophagitis Patients: a Randomized Controlled Trial.
The Esomperazole Study Investigator, Aliment Pharmacol Ther 2000;14(10):1249-1258.
- Richter et al., abstract - Esomerprazole is Superior to Omeprazole for the
Healing of Erosive Esophagitis in GERD Patients, Gastroenterology, 2000;118:A20.
- Vakil et al., abstract - Esomeprazole is Effective as Maintenance Therapy
in GERD Patients with Healed Erosive Esophagitis (EE), Gastroenterology,
2000;118:A22.
- Johnson, et al., abstract - Efficacy and Safety of Esomeprazole as Maintenance
Therapy in GERD Patients with Healed Erosive Esophagitis (EE), Gastroenterology
2000;118:A17.
- Lind et al., Esomeprazole Provides Improved Acid Control vs. Omeprazole In
Patients with Symptoms of Gastro-esophageal Reflux Disease, Aliment Pharmacol
Ther., 2000;14:861-867.
- Food and Drug Administration, Prilosec OTC (omeprazole) information page;
June 20, 2003. http://www.fda.gov/cder/drug/infopage/prilosecOTC/default.htm
- Olin BR, editor. Drugs Facts and Comparisons (electronic online version).
St. Louis: J.B. Lippincott Company, 2005.
- USPDI Drug Information for the HealthCare Professional (online through
Stat!Ref). Thomson MICROMEDEX, Greenwood Village, Colorado; 2005.
- McEvoy GK, editor. AHFS Drug Information (online through Stat!Ref).
American Society of Health-Systems Pharmacists, Bethesda, Maryland; 2005.
- Prevacid Product Information. TAP Pharmaceuticals, Chicago, IL. October
2002.
- AcipHex Product Information. Eisai, Inc. Teaneck, NJ. November 2002.
- Protonix Product Information, Wyeth Laboratories, Philadelphia, PA. July
2002.
- Prilosec Product Information. AstraZeneca, Wayne PA. July 2002.
- Nexium Product Information, AstraZeneca, Wilmington, DE, 2002.
- Medical Economics, Inc., PDR Electronic Library. Thomson Medical Economics,
Montvale, NJ; 2003.
Property of Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
March 1, 2006
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