DEXILANT, Dexlansoprazole Form

Dexlansoprazole (Dexilant®) is a proton pump inhibitor (PPI). FDA Approved Indication(s) Dexilant is indicated in patients 12 years of age and older for:
• Healing of all grades of erosive esophagitis (EE). • Maintenance of healed EE and relief of heartburn. • Treatment of symptomatic non-erosive gastroesophageal reflux disease (GERD). Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Dexilant is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. All Indications (must meet all):

1. Prescribed for one of the following uses (a, b, c, d, or e):
   a. Symptomatic GERD, including heartburn or laryngopharyngeal reflux; b. Esophageal complications of GERD (e.g., erosive esophagitis, esophageal stricture, Barrett’s esophagus, and Schatzki’s ring); c. Extra-esophageal complications (e.g., laryngopharyngeal reflux, vocal cord damage/nodules, asthma, laryngitis and pharyngitis); d. Peptic ulcer disease (e.g., gastric ulcers, duodenal ulcers, H. pylori and Zollinger- Ellison Syndrome); e. Gastrointestinal bleed prophylaxis for NSAID use and member meets at least one of the following (i, ii, or iii): i. History of peptic ulcer disease; ii. Age ≥ 60 years; iii. Concurrent therapy with anticoagulants (e.g., warfarin, aspirin, clopidogrel) or oral corticosteroids (e.g., prednisone);

2. Age ≥ 12 years;

   3. Failure of lansoprazole, omeprazole, and pantoprazole, at up to maximally indicated doses, unless all are contraindicated or clinically significant adverse effects are experienced; Page 1 of 7

   CLINICAL POLICY Dexlansoprazole

3. Dose does not exceed both of the following (a and b): a. 60 mg per day; b. 1 capsule per day. Approval duration: 12 months B. Other diagnoses/indications (must meet 1 or 2):
4. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: HIM.PA.33 for health insurance marketplace; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: HIM.PA.103 for health insurance marketplace; or
5. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: HIM.PA.154 for health insurance marketplace.
   II. Continued Therapy A. All Indications in Section I (must meet all):
6. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
   2. Member is responding positively to therapy;
   3. If request is for a dose increase, new dose does not exceed both of the following (a and b): a. 60 mg per day; b. 1 capsule per day. Approval duration: 12 months B. Other diagnoses/indications (must meet 1 or 2):

7. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: HIM.PA.33 for health insurance marketplace; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: HIM.PA.103 for health insurance marketplace; or Page 2 of 7

   CLINICAL POLICY Dexlansoprazole

8. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: HIM.PA.154 for health insurance marketplace.
   III. Diagnoses/Indications for which coverage is NOT authorized:
   A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – HIM.PA.154 for health insurance marketplace or evidence of coverage documents. IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key FDA: Food and Drug Administration Appendix B: Therapeutic Alternatives
   This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent for all relevant lines of business and may require prior authorization.
   Dosing Regimen Drug Name Dose Limit/ Maximum Dose 40 mg/day (240 mg/day for pathological hypersecretory conditions) 40 mg/day (360 mg/day for pathological hypersecretory conditions) pantoprazole tablets and suspension (Protonix®) omeprazole capsules (Prilosec®) Short-term treatment of erosive esophagitis associated with GERD Adult and pediatric (age ≥ 5 years and weight ≥ 40 kg): 40 mg PO QD Pediatric (age ≥ 5 years and weight ≥ 15 kg to < 40 kg): 20 mg PO QD Maintenance of healing of erosive esophagitis 40 mg PO QD Pathological hypersecretory conditions, including Zollinger-Ellison Syndrome 40 mg PO BID Duodenal ulcer 20 mg PO QD
   Symptomatic GERD; Erosive esophagitis (treatment and maintenance)
   Adult: 20 mg PO QD Pediatric (age 1 to 16 years): Weight 5 kg to < 10 kg: 5 mg Weight 10 kg to < 20 kg: 10 mg Weight ≥ 20 kg: 20 mg Pediatric (age 1 month to < 1 year): Page 3 of 7

   CLINICAL POLICY Dexlansoprazole Drug Name Dosing Regimen Dose Limit/ Maximum Dose 30 mg/day (180 mg/day for pathological hypersecretory conditions) lansoprazole capsules (Prevacid®) Weight 5 kg to < 10 kg: 5 mg Weight ≥ 10 kg: 10 mg H. pylori Triple therapy: 20 mg PO BID for 10 days, in combination with amoxicillin and clarithromycin Dual therapy: 40 mg PO QD for 14 days, in combination with clarithromycin 40 mg/day Gastric ulcer
   40 mg PO QD
   Pathological hypersecretory conditions, including Zollinger-Ellison Syndrome 60 mg PO QD to 80 mg/day PO in divided doses Duodenal ulcers, risk reduction of NSAID-associated gastric ulcer,
   maintenance of healing of erosive esophagitis 15 mg PO QD Short-term treatment of symptomatic GERD and erosive esophagitis Adult: 15 to 30 mg PO QD Pediatric (age 1 to 11 years): Weight > 30 kg: 30 mg PO QD Weight ≤ 30 kg: 15 mg PO QD Pediatric (age 12 to 17 years): Non-erosive GERD: 15 mg Erosive esophagitis: 30 mg H. pylori Triple therapy: 30 mg PO BID for 10 or 14 days in combination with amoxicillin and clarithromycin Dual therapy: 30 mg PO TID for 14 days in combination with amoxicillin Benign gastric ulcer, healing of NSAID- associated gastric ulcer 30 mg PO QD Page 4 of 7

   CLINICAL POLICY Dexlansoprazole Drug Name Dosing Regimen Dose Limit/ Maximum Dose Pathological hypersecretory conditions, including Zollinger-Ellison Syndrome 60 mg PO QD Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic. Appendix C: Contraindications/Boxed Warnings • Contraindication(s): o Hypersensitivity (e.g., to drug or other PPIs, substituted benzimidazoles, or to any components of the formulation) o Coadministration with rilpivirine-containing products • Boxed warning(s): none reported Appendix D: General Information • Dexilant 60 mg vs. Prevacid 30 mg in EE was evaluated in two studies. Non-inferiority was demonstrated in both studies, but superiority was demonstrated in only one study. • Dexilant 90 mg was studied and did not provide additional clinical benefit over Dexilant 60 mg in EE. • Pediatric patients: The safety and efficacy of Dexilant, Zegerid and Protonix in children have not been established. V. Dosage and Administration
   Indication Healing of erosive esophagitis Maintenance of healed erosive esophagitis and relief of heartburn; Symptomatic non-erosive GERD VI. Product Availability
   Delayed-release capsule: 30 mg, 60 mg Dosing Regimen Maximum Dose 60 mg PO QD 30 mg PO QD 60 mg/day 60 mg/day VII.