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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 ↗)

Auro-Abacavir/Lamivudine · DIN 02454513 Manufacturer: Auro Pharma Inc.; listing date 2016-12-22 Health Canada: Marketed since 2016-08-31 · brand AURO-ABACAVIR/LAMIVUDINE · ATC J05AR02 LAMIVUDINE AND ABACAVIR · form Tablet · route Oral · ingredients ABACAVIR (ABACAVIR SULFATE) 600 MG, LAMIVUDINE 300 MG · company Auro pharma inc · schedule Prescription

DIN 02454513: Auro-Abacavir/Lamivudine Raw flags: sec3=Y Item: 081800094; group id 61; item number 0121; lccId None; manufacturer id AUR Source form: Tab; strength: 600mg & 300mg Recorded listing: General benefit Source prices (unrounded): $5.9875; ministry $5.9875 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02454513 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=94109

Interchangeable products

Apo-Abacavir-Lamivudine · DIN 02399539 · $5.9875 Jamp Abacavir/Lamivudine · DIN 02497654 · $5.9875 Kivexa · DIN 02269341 · $5.9875 Mylan-Abacavir-Lamivudine · DIN 02450682 · $5.9875 PMS-Abacavir-Lamivudine · DIN 02458381 · $5.9875 Teva-Abacavir-Lamivudine · DIN 02416662 · $5.9875

Shortage status: resolved shortage (ended 2020-04-14); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02454513

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

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 ↗)

Jamp Abacavir/Lamivudine · DIN 02497654 Manufacturer: Jamp Pharma Corporation; listing date 2022-03-31 Health Canada: Marketed since 2022-02-22 · brand JAMP ABACAVIR / LAMIVUDINE · ATC J05AR02 LAMIVUDINE AND ABACAVIR · form Tablet · route Oral · ingredients LAMIVUDINE 300 MG, ABACAVIR (ABACAVIR SULFATE) 600 MG · company Jamp pharma corporation · schedule Prescription

DIN 02497654: Jamp Abacavir/Lamivudine Raw flags: sec3=Y Item: 081800094; group id 61; item number 0121; lccId None; manufacturer id JPC Source form: Tab; strength: 600mg & 300mg Recorded listing: General benefit Source prices (unrounded): $5.9875; ministry $5.9875 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02497654 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=98745

Interchangeable products

Apo-Abacavir-Lamivudine · DIN 02399539 · $5.9875 Auro-Abacavir/Lamivudine · DIN 02454513 · $5.9875 Kivexa · DIN 02269341 · $5.9875 Mylan-Abacavir-Lamivudine · DIN 02450682 · $5.9875 PMS-Abacavir-Lamivudine · DIN 02458381 · $5.9875 Teva-Abacavir-Lamivudine · DIN 02416662 · $5.9875

Shortage status: resolved shortage (ended 2026-04-17); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02497654

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

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-Abacavir-Lamivudine · DIN 02450682 Manufacturer: Mylan Pharmaceuticals ULC; listing date 2016-05-31 Health Canada: Marketed since 2016-03-29 · brand MYLAN-ABACAVIR/LAMIVUDINE · ATC J05AR02 LAMIVUDINE AND ABACAVIR · form Tablet · route Oral · ingredients ABACAVIR (ABACAVIR SULFATE) 600 MG, LAMIVUDINE 300 MG · company Mylan pharmaceuticals ulc · schedule Prescription

DIN 02450682: Mylan-Abacavir-Lamivudine Raw flags: sec3=Y Item: 081800094; group id 61; item number 0121; lccId None; manufacturer id MYL Source form: Tab; strength: 600mg & 300mg Recorded listing: General benefit Source prices (unrounded): $5.9875; ministry $5.9875 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02450682 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=93683

Interchangeable products

Apo-Abacavir-Lamivudine · DIN 02399539 · $5.9875 Auro-Abacavir/Lamivudine · DIN 02454513 · $5.9875 Jamp Abacavir/Lamivudine · DIN 02497654 · $5.9875 Kivexa · DIN 02269341 · $5.9875 PMS-Abacavir-Lamivudine · DIN 02458381 · $5.9875 Teva-Abacavir-Lamivudine · DIN 02416662 · $5.9875

Shortage status: resolved shortage (ended 2019-06-18); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02450682

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

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 ↗)

Teva-Abacavir-Lamivudine · DIN 02416662 Manufacturer: Teva Canada Limited; listing date 2016-05-31 Health Canada: Marketed since 2016-03-14 · brand TEVA-ABACAVIR/LAMIVUDINE · ATC J05AR02 LAMIVUDINE AND ABACAVIR · form Tablet · route Oral · ingredients LAMIVUDINE 300 MG, ABACAVIR (ABACAVIR SULFATE) 600 MG · company Teva canada limited · schedule Prescription

DIN 02416662: Teva-Abacavir-Lamivudine Raw flags: sec3=Y Item: 081800094; group id 61; item number 0121; lccId None; manufacturer id TEV Source form: Tab; strength: 600mg & 300mg Recorded listing: General benefit Source prices (unrounded): $5.9875; ministry $5.9875 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02416662 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=90124

Interchangeable products

Apo-Abacavir-Lamivudine · DIN 02399539 · $5.9875 Auro-Abacavir/Lamivudine · DIN 02454513 · $5.9875 Jamp Abacavir/Lamivudine · DIN 02497654 · $5.9875 Kivexa · DIN 02269341 · $5.9875 Mylan-Abacavir-Lamivudine · DIN 02450682 · $5.9875 PMS-Abacavir-Lamivudine · DIN 02458381 · $5.9875

Shortage status: active shortage (reported 2025-01-29, last updated 2025-01-30); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02416662

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