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Reason for Use code 293 Gastroesophageal Reflux Disease (GERD) For the treatment of erosive GERD or upper GI malignancy; OR For the treatment of non-erosive GERD after failure of H2-receptor antagonist therapy. Patients with GERD should be reassessed within 6 months after initial treatment with a PPI. The reassessment could include confirmation of need for PPI with endoscopy, a trial of PPI withdrawal, or step-down therapy to H2-receptor antagonist therapy. Note: There is a lack of published evidence to support double-dose PPI therapy in this setting. Coverage limit: LU Authorization Period: 1 year Reason for Use code 295 H. pylori-positive Peptic Ulcers For the treatment of H. pylori-positive peptic ulcers where H. pylori is documented, by serology, urea breath test or endoscopy, for a course of up to 14 days in combination with antimicrobial therapy. Retreatment of H. pylori-positive peptic ulcers must be documented by persistent H. pylori infection on urea breath test or endoscopy. Maximum duration: 14 days (for retreatment, a four-week period must elapse since the end of the previous treatment). Coverage limit: LU Authorization Period: 1 year Reason for Use code 297 Confirmed Peptic Ulcers or NSAID-induced Ulcer Prophylaxis: For the treatment of confirmed peptic ulcers and NSAID-induced ulcers; OR For the prophylaxis of NSAID-induced ulcers for patients at increased risk of GI bleeding. Note: There is a lack of published evidence to support double-dose PPI therapy in this setting. Coverage limit: LU Authorization Period: 1 year Reason for Use code 401 Other Gastrointestinal Disorders: For the treatment of gastroduodenal Crohns disease, short-gut syndrome, scleroderma, or pancreatitis. Note: There is a lack of published evidence to support double-dose PPI therapy in these settings. Coverage limit: LU Authorization Period: 1 year Reason for Use code 402 Severe Conditions: For the treatment of severe esophagitis, Zollinger-Ellison syndrome, esophageal stricture, persistent symptoms of GERD or persistent erosive esophagitis, or upon hospital discharge following a gastrointestinal bleed. For patients receiving double-dose therapy, the need to continue treatment at higher doses should be reassessed after eight weeks. For re-treatment at higher doses, a four-week period should have elapsed from the end of the previous treatment. Reassessment could include a procedural assessment of the condition or step-down therapy to lower-dose proton pump inhibitor (PPI) therapy. Coverage limit: LU Authorization Period: 1 year

Lowest DBP recovery rule under medically necessary no-substitution claims: 6.2 Medically Necessary "No Substitution" Claims The Side Effect Reporting Form will not have to be renewed. However, the pharmacy must maintain a copy of the prescription that contains a direction that there be no substitution and the required Health Canada Side Effect Reporting Form (completed and signed by the prescriber). The prescriber must write “No Substitution” or “No Sub” on renewal or subsequent new written prescriptions, and indicate “No Substitution” on subsequent new oral prescriptions. The dispenser will be reimbursed the DBP plus a mark-up and the lesser of the posted usual and customary fee or the ODB dispensing fee minus the applicable ODB co-payment amount. Where a completed Side Effect Reporting Form is not available at the pharmacy during an inspection, the difference between the cost of the higher-cost product and the lowest DBP listed for the interchangeable category will be recovered. (ontario.ca, Revision #17; 2026-08-03 ↗) 6.2 Medically Necessary "No Substitution" Claims The Ministry will provide reimbursement of a higher-cost interchangeable product in medically necessary circumstances where a patient has experienced a significant adverse reaction with two (2) lower-cost interchangeable drug products, where available. When a prescriber identifies a patient for which it is medically necessary that a higher cost interchangeable product be provided, the prescriber must: • Complete, sign and forward to the pharmacist a copy of the Health Canada side effect reporting form for each lower-cost interchangeable drug product trialed (Side Effect Reporting Form[s]); and • Write “No Substitution” or “No Sub” on a written prescription or indicate “No Substitution” to the pharmacist in the case of a verbal prescription. The prescriber should keep a copy of the completed form in the patient’s record for future use and reference. In the case of a written prescription, when the pharmacist or dispensing physician receives a prescription with the written notation “No Substitution” or “No Sub”, reimbursement will be provided for the higher-cost interchangeable product only if the prescription is accompanied by a completed Health Canada Side Effect Reporting Form for each of the lower-cost interchangeable drug products trialed. This form must be completely filled out noting the details of the adverse reaction and signed by the prescriber. In the case of a verbal prescription, the prescriber must satisfy the operator of the pharmacy or dispensing physician that a completed Health Canada Side Effect Reporting Form for each of the lower-cost interchangeable drug products trialed has been completed and signed by the prescriber. A written record of this verbal prescription and the completed Health Canada Side Effect Reporting Form must be received by the pharmacy prior to claim submission. Upon receipt, the pharmacist must: • Fax, submit online or mail the completed and signed form to Health Canada’s Canada Vigilance Program; and • Retain his or her copy of the completed and signed Side Effect Reporting Form. (ontario.ca, Revision #17; 2026-08-03 ↗)

Mylan-Lansoprazole · DIN 02353849 Manufacturer: Mylan Pharmaceuticals ULC; listing date 2010-09-09 Health Canada: Marketed since 2010-06-18 · brand MYLAN-LANSOPRAZOLE · ATC A02BC03 LANSOPRAZOLE · form Capsule (delayed-release) · route Oral · ingredients LANSOPRAZOLE 30 MG · company Mylan pharmaceuticals ulc · schedule Prescription

DIN 02353849: Mylan-Lansoprazole Raw flags: chronicUseMed=Y, sec12=Y, sec3=Y Item: 564000073; group id 680; item number 1697; lccId 00103; manufacturer id MYL Source form: DR Cap; strength: 30mg Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below; chronic-use medication (100-day supply rule, dispensing-fee limit) Source prices (unrounded): $0.5000; ministry $0.5000 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02353849 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=83905

Interchangeable products

Apo-Lansoprazole · DIN 02293838 · $0.5000 Lansoprazole · DIN 02357690 · $0.5000 Lansoprazole · DIN 02410389 · $0.5000 Prevacid · DIN 02165511 · $0.5000 Sandoz Lansoprazole · DIN 02385651 · $0.5000 Taro-Lansoprazole · DIN 02402629 · $0.5000 Teva-Lansoprazole · DIN 02280523 · $0.5000

Shortage status: active shortage (reported 2026-06-11, estimated to end 2027-03-09, last updated 2026-09-03); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02353849

Shortage record checked 2026-09-13T08:10:21.292534+00:00