Proton Pump Inhibitors (PPIs)

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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)
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
1. 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:
1. The heartburn can be controlled by use of OTC medications AND
2. There is no diagnosis of more complicated acid reflux disease, such as erosive esophagitis AND
3. 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)
  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:
1. 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:
  1. The heartburn can be controlled by use of OTC medications AND
  2. There is no diagnosis of more complicated acid reflux disease, such as erosive esophagitis AND
  3. There are no symptoms of a more complicated GI condition.*
  OR
2. Uncomplicated heartburn with a frequency of < 1 episode/week that can be controlled by use of OTC medications
  OR
3. 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:
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:

Outpatient

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.
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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