Pharmacy Prior Authorization Criteria

Proton Pump Inhibitors

Indications for Prior Authorization

Aciphex (rabeprazole)

For diagnosis of Healing of Erosive or Ulcerative GERD in Adults
Indicated for short-term (4 to 8 weeks) treatment in the healing and symptomatic relief of erosive or ulcerative GERD. For those patients who have not healed after 8 weeks of treatment, an additional 8-week course of Aciphex may be considered.
For diagnosis of Maintenance of Healing of Erosive or Ulcerative GERD in Adults
Indicated for maintaining healing and reduction in relapse rates of heartburn symptoms in patients with erosive or ulcerative gastroesophageal reflux disease (GERD Maintenance). Controlled studies do not extend beyond 12 months.
For diagnosis of Treatment of Symptomatic Gastroesophageal Reflux Disease (GERD) in Adults
Indicated for the treatment of daytime and nighttime heartburn and other symptoms associated with GERD in adults for up to 4 weeks.
For diagnosis of Healing of Duodenal Ulcers in Adults
Indicated for short-term (up to 4 weeks) treatment in the healing and symptomatic relief of duodenal ulcers. Most patients heal within 4 weeks.
For diagnosis of Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence in Adults
In combination with amoxicillin and clarithromycin as a three drug regimen, indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or history within the past 5 years) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. In patients who fail therapy, susceptibility testing should be done. If resistance to clarithromycin is demonstrated or susceptibility testing is not possible, alternative antimicrobial therapy should be instituted.
For diagnosis of Pathological Hypersecretory Conditions including Zollinger-Ellison Syndrome in Adults
Indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.
For diagnosis of Short-term Treatment of Symptomatic GERD in Adolescent Patients 12 years of Age and Older
Indicated for the treatment of symptomatic GERD in adolescents 12 years of age and above for up to 8 weeks.

Aciphex Sprinkle (rabeprazole)

For diagnosis of Patients 1 to 11 Years of Age
Indicated for treatment of GERD in pediatric patients 1 to 11 years of age for up to 12 weeks.

Dexilant (dexlansoprazole)

For diagnosis of Healing of Erosive Esophagitis
Indicated in patients 12 years of age and older for healing of all grades of erosive esophagitis for up to 8 weeks.
For diagnosis of Maintenance of Healed Erosive Esophagitis
Indicated in patients 12 years of age and older to maintain healing of erosive esophagitis and relief of heartburn for up to six months in adults and 16 weeks in patients 12 to 17 years of age.
For diagnosis of Symptomatic Non-Erosive GERD
Indicated in patients 12 years of age and older for the treatment of heartburn associated with symptomatic non-erosive GERD for 4 weeks.

Konvomep (omeprazole and sodium bicarbonate)

For diagnosis of Gastric Ulcer
Indicated for the short-term treatment (4 to 8 weeks) of active benign gastric ulcer in adults.
For diagnosis of Reduction of Risk of Upper Gastrointestinal Bleeding in Critically Ill Patients
Indicated for the reduction of risk of upper gastrointestinal (GI) bleeding in critically ill adult patients.

Nexium (esomeprazole)

For diagnosis of Healing of Erosive Esophagitis
Nexium delayed-release capsules and Nexium delayed-release oral suspension are indicated for the short-term treatment (4 to 8 weeks) in the healing and symptomatic resolution of diagnostically confirmed erosive esophagitis in adults. For those patients who have not healed after 4 to 8 weeks of treatment, an additional 4 to 8 week course of Nexium may be considered.
In pediatric patients 1 month to less than 1 year of age, Nexium delayed-release oral suspension is indicated for short-term treatment (up to 6 weeks) of erosive esophagitis due to acid-medicated GERD.
In pediatric patients 1 year to 11 years of age, Nexium delayed-release oral suspension is indicated for the short-term treatment (8 weeks) for the healing of EE.
In pediatric patients 12 years to 17 years of age, Nexium delayed-release capsules and Nexium delayed-release oral suspension are indicated for for the short-term treatment (4 to 8 weeks) for the healing of EE.
For diagnosis of Maintenance of Healing of Erosive Esophagitis
NEXIUM delayed-release capsules and NEXIUM for delayed-release oral suspension are indicated for the maintenance of healing of erosive esophagitis in adults. Controlled studies do not extend beyond 6 months.
For diagnosis of Symptomatic GERD
NEXIUM delayed-release capsules and NEXIUM for delayed-release oral suspension are indicated for short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with GERD in adults.
NEXIUM delayed-release capsules and NEXIUM for delayed-release oral suspension are indicated for short-term treatment (4 weeks) of heartburn and other symptoms associated with GERD in pediatric patients 12 years to 17 years of age.
NEXIUM for delayed-release oral suspension is indicated for short-term treatment (up to 8 weeks) of heartburn and other symptoms associated with GERD in pediatric patients 1 year to 11 years of age.
For diagnosis of Risk Reduction of NSAID-Associated Gastric Ulcer
NEXIUM delayed-release capsules and NEXIUM for delayed-release oral suspension are indicated for the reduction in the occurrence of gastric ulcers associated with continuous NSAID therapy in adult patients at risk for developing gastric ulcers. Patients are considered to be at risk due to their age (60 years and older) and/or documented history of gastric ulcers. Controlled studies do not extend beyond 6 months.
For diagnosis of Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence
Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.
Triple therapy: NEXIUM delayed-release capsules or NEXIUM for delayed-release oral suspension in combination with amoxicillin and clarithromycin is indicated for the treatment of adult patients with H. pylori infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate H. pylori.
In patients who fail therapy, susceptibility testing should be done. If resistance to clarithromycin is demonstrated or susceptibility testing is not possible, alternative antimicrobial therapy should be instituted.
For diagnosis of Pathological Hypersecretory Conditions including Zollinger-Ellison Syndrome
NEXIUM delayed-release capsules and NEXIUM for delayed-release oral suspension are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome, in adults.

Prevacid (lansoprazole)

For diagnosis of Treatment of Active Duodenal Ulcer
Indicated for short-term treatment (for 4 weeks) for healing and symptom relief of active duodenal ulcer in adults.
For diagnosis of Eradication of H. pylori to Reduce the Risk of Duodenal Ulcer Recurrence
In combination with amoxicillin plus clarithromycin as triple therapy, indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one-year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.
In combination with amoxicillin as dual therapy, indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.
For diagnosis of Maintenance of Healed Duodenal Ulcers
Indicated to maintain healing of duodenal ulcers in adults. Controlled studies do not extend beyond 12 months.
For diagnosis of Treatment of Active Benign Gastric Ulcer
Indicated for short-term treatment (up to 8 weeks) for healing and symptom relief of active benign gastric ulcer in adults.
For diagnosis of Healing of NSAID-Associated Gastric Ulcer
Indicated in adults for the treatment of NSAID-associated gastric ulcer in patients who continue NSAID use. Controlled studies did not extend beyond 8 weeks.
For diagnosis of Risk Reduction of NSAID-Associated Gastric Ulcer
Indicated in adults for reducing the risk of NSAID-associated gastric ulcers in patients with a history of a documented gastric ulcer who require the use of an NSAID. Controlled studies did not extend beyond 12 weeks.
For diagnosis of Treatment of Symptomatic GERD
Indicated for short-term treatment in adults and pediatric patients 12 to 17 years of age (up to eight weeks) and pediatric patients one to 11 years of age (up to 12 weeks) for the treatment of heartburn and other symptoms associated with GERD.
For diagnosis of Treatment of Erosive Esophagitis
Indicated for short-term treatment in adults and pediatric patients 12 to 17 years of age (up to eight weeks) and pediatric patients one to 11 years of age (up to 12 weeks) for healing and symptom relief of all grades of erosive esophagitis. For adults who do not heal with Prevacid for 8 weeks (5 to 10%), it may be helpful to give an additional 8 weeks of treatment. If there is a recurrence of erosive esophagitis, an additional 8-week course of Prevacid may be considered.
For diagnosis of Maintenance of Healing of Erosive Esophagitis
Indicated in adults to maintain healing of EE. Controlled studies did not extend beyond 12 months.
For diagnosis of Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
Indicated in adults for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.

Prilosec (omeprazole)

For diagnosis of Treatment of Active Duodenal Ulcer
Indicated for short-term treatment of active duodenal ulcer in adults. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.
For diagnosis of Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence
In combination with clarithromycin and amoxicillin, indicated for treatment of patients with H. pylori infection and duodenal ulcer disease (active or up to 1-year history) to eradicate H. pylori in adults.
In combination with clarithromycin, indicated for treatment of patients with H. pylori infection and duodenal ulcer disease to eradicate H. pylori in adults.
Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.
Among patients who fail therapy, Prilosec with clarithromycin is more likely to be associated with the development of clarithromycin resistance as compared with triple therapy. In patients who fail therapy, susceptibility testing should be done. If resistance to clarithromycin is demonstrated or susceptibility testing is not possible, alternative antimicrobial therapy should be instituted.
For diagnosis of Treatment of Active Benign Gastric Ulcer
Indicated for short-term treatment (4 to 8 weeks) of active benign gastric ulcer in adults.
For diagnosis of Treatment of Symptomatic GERD
Indicated for the treatment of heartburn and other symptoms associated with GERD for up to 4 weeks in patients 1 year of age and older.
For diagnosis of Treatment of Erosive Esophagitis (EE) Due to Acid-Mediated GERD
Indicated for the short-term treatment (4 to 8 weeks) of erosive esophagitis due to acid-mediated GERD that has been diagnosed by endoscopy in patients 1 year of age and older.
The efficacy of Prilosec used for longer than 8 weeks in these patients has not been established. If a patient does not respond to 8 weeks of treatment, an additional 4 weeks of treatment may be given. If there is recurrence of erosive esophagitis or GERD symptoms, additional 4 to 8 week courses of omeprazole may be considered.
Also indicated for the short-term treatment (up to 6 weeks) of erosive esophagitis due to acid-mediated GERD in pediatric patients 1 month to less than 1 year of age.
For diagnosis of Maintenance of Healing of Erosive Esophagitis Due to Acid-Mediated GERD
Indicated for the maintenance healing of EE due to acid-mediated GERD in patients 1 year of age and older. Controlled studies do not extend beyond 12 months.
For diagnosis of Pathological Hypersecretory Conditions
Indicated for the long-term treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine adenomas and systemic mastocytosis) in adults.

Protonix (pantoprazole)

For diagnosis of Short-Term Treatment of Erosive Esophagitis Associated With GERD
Indicated in adults and pediatric patients five years of age and older for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis. For those adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of Protonix may be considered. Safety of treatment beyond 8 weeks in pediatric patients has not been established.
For diagnosis of Maintenance of Healing of Erosive Esophagitis
Indicated for maintenance of healing of erosive esophagitis and reduction in relapse rates of daytime and nighttime heartburn symptoms in adult patients with GERD. Controlled studies did not extend beyond 12 months.
For diagnosis of Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
Indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.

Zegerid (omeprazole/sodium bicarbonate)

For diagnosis of Duodenal Ulcer
Indicated for short-term treatment of active duodenal ulcer. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.
For diagnosis of Gastric Ulcer
Indicated for short-term treatment (4-8 weeks) of active benign gastric ulcer.
For diagnosis of Symptomatic GERD
Indicated for the treatment of heartburn and other symptoms associated with GERD for up to 4 weeks.
For diagnosis of Erosive Esophagitis due to acid-mediated GERD
Indicated for the short-term treatment (4 to 8 weeks) of erosive esophagitis due to acid-mediated GERD which has been diagnosed by endoscopy in adults.
The efficacy of ZEGERID used for longer than 8 weeks in patients with EE has not been established. If a patient does not respond to 8 weeks of treatment, an additional 4 weeks of treatment may be given. If there is recurrence of EE or GERD symptoms (e.g., heartburn), additional 4 to 8-week courses of ZEGERID may be considered.
For diagnosis of Maintenance of Healing of Erosive Esophagitis Due to Acid-Mediated GERD
Indicated to maintain healing of erosive esophagitis due to acid-mediated GERD. Controlled studies do not extend beyond 12 months.
For diagnosis of Reduction of Risk of Upper Gastrointestinal Bleeding in Critically Ill Patients (40 mg oral suspension only)
Indicated for the reduction of risk of upper GI bleeding in critically ill patients.

Criteria

Brand Aciphex tablets, Authorized Brand Alternative Rabeprazole Sprinkle, Brand Dexilant capsules, Brand Prevacid capsules, Brand Prevacid Solutab, Prilosec suspension, Brand Protonix tablets, Brand Protonix suspension, Brand Zegerid capsules, Brand Zegerid suspension, First-Lansoprazole suspension, First-Omeprazole suspension, Konvomep suspension, First Pantoprazole

Step Therapy

Length of Approval: 12 Month(s)

Requested drug is being used for a Food and Drug Administration (FDA)-approved indication

AND

Trial and failure or intolerance to at least two of the following:

dexlansoprazole
esomeprazole
omeprazole
lansoprazole (capsule)
pantoprazole
rabeprazole (tablets)

Brand Aciphex tablets, Authorized Brand Alternative Rabeprazole Sprinkle, Generic rabeprazole tablets, Brand Dexilant capsules, Brand Nexium capsules, Generic esomeprazole capsules, Nexium suspension, Brand Prevacid capsules, Generic lansoprazole capsules, Brand Prevacid Solutab, Generic lansoprazole orally disintegrating tablets, Generic omeprazole capsules, Prilosec suspension, Brand Protonix tablets, Generic pantoprazole tablets, Brand Protonix suspension, Generic pantoprazole suspension, Brand Zegerid capsules, Generic omeprazole-sodium bicarbonate capsules, Brand Zegerid suspension*, Generic omeprazole-sodium bicarbonate suspension, Generic dexlansoprazole capsules

Authorization of therapy will be issued for 12 months for all diagnoses, except for H. pylori eradication. For H. pylori eradication, authorization will be issued for 14 days. *These products may require step therapy. **Requests for greater than twice-daily dosing must be reviewed using the Quantity Limit General Administrative Guideline. ^Support found in labeling or compendia should be evaluated regardless of indication.

Quantity Limit

For diagnosis of Twice-daily (BID) PPI Therapy**

One of the following:

Trial and inadequate response to once daily PPI regimen

A once daily PPI regimen is not appropriate to treat the patient’s condition