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Reason for Use code 367 For the treatment of patients with Parkinson's disease with 25% of the waking day in the off state despite maximally tolerated doses of levodopa. Coverage limit: LU Authorization Period: Indefinite

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 ↗)

Mint-Entacapone · DIN 02535939 Manufacturer: Mint Pharmaceuticals Inc.; listing date 2024-03-28 Health Canada: Marketed since 2024-02-21 · brand MINT-ENTACAPONE · ATC N04BX02 ENTACAPONE · form Tablet · route Oral · ingredients ENTACAPONE 200 MG · company Mint pharmaceuticals inc · schedule Prescription

DIN 02535939: Mint-Entacapone Raw flags: sec12=Y, sec3=Y Item: 289200014; group id 538; item number 1456; lccId 00142; manufacturer id MIN Source form: Tab; strength: 200mg Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $0.4010; ministry $0.4010 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02535939 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=102475

Interchangeable products

Comtan · DIN 02243763 · $0.4010 Sandoz Entacapone · DIN 02380005 · $0.4010 Teva-Entacapone · DIN 02375559 · $0.4010

Shortage status: anticipated shortage (last updated 2026-07-28); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02535939

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

Reason for Use code 367 For the treatment of patients with Parkinson's disease with 25% of the waking day in the off state despite maximally tolerated doses of levodopa. Coverage limit: LU Authorization Period: Indefinite

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 ↗)

Sandoz Entacapone · DIN 02380005 Manufacturer: Sandoz Canada Inc.; listing date 2012-05-29 Health Canada: Marketed since 2012-03-30 · brand SANDOZ ENTACAPONE · ATC N04BX02 ENTACAPONE · form Tablet · route Oral · ingredients ENTACAPONE 200 MG · company Sandoz canada incorporated · schedule Prescription

DIN 02380005: Sandoz Entacapone Raw flags: sec12=Y, sec3=Y Item: 289200014; group id 538; item number 1456; lccId 00142; manufacturer id SDZ Source form: Tab; strength: 200mg Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $0.4010; ministry $0.4010 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02380005 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=86585

Interchangeable products

Comtan · DIN 02243763 · $0.4010 Mint-Entacapone · DIN 02535939 · $0.4010 Teva-Entacapone · DIN 02375559 · $0.4010

Shortage status: resolved shortage (ended 2026-06-01); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02380005

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

Reason for Use code 367 For the treatment of patients with Parkinson's disease with 25% of the waking day in the off state despite maximally tolerated doses of levodopa. Coverage limit: LU Authorization Period: Indefinite

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-Entacapone · DIN 02375559 Manufacturer: Teva Canada Limited; listing date 2012-05-29 Health Canada: Marketed since 2012-03-29 · brand TEVA-ENTACAPONE · ATC N04BX02 ENTACAPONE · form Tablet · route Oral · ingredients ENTACAPONE 200 MG · company Teva canada limited · schedule Prescription

DIN 02375559: Teva-Entacapone Raw flags: sec12=Y, sec3=Y Item: 289200014; group id 538; item number 1456; lccId 00142; manufacturer id TEV Source form: Tab; strength: 200mg Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $0.4010; ministry $0.4010 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02375559 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=86097

Interchangeable products

Comtan · DIN 02243763 · $0.4010 Mint-Entacapone · DIN 02535939 · $0.4010 Sandoz Entacapone · DIN 02380005 · $0.4010

Shortage status: shortage reported ended 2026-07-31 (report last updated 2026-07-31); confirm supply with the pharmacy; reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02375559

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

Reason for Use code 367 For the treatment of patients with Parkinson's disease with 25% of the waking day in the off state despite maximally tolerated doses of levodopa. Coverage limit: LU Authorization Period: Indefinite

Stalevo · DIN 02305933 Manufacturer: Sandoz Canada Inc.; listing date 2009-03-02 Health Canada: Marketed since 2020-07-24 · brand STALEVO · ATC N04BA03 LEVODOPA,DECARBOXYLASE INHIBITOR, AND COMT INHIBITOR, N04BA03 LEVODOPA,DECARBOXYLASE INHIBITOR, AND COMT INHIBITOR · form Tablet · route Oral · ingredients ENTACAPONE 200 MG, LEVODOPA 50 MG, CARBIDOPA 12.5 MG · company Sandoz canada incorporated · schedule Prescription

DIN 02305933: Stalevo Raw flags: sec12=Y, sec3=Y Item: 920000588; group id 932; item number 2224; lccId 00199; manufacturer id SDZ Source form: Tab; strength: 50 & 12.5 & 200mg Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $1.7471; ministry $1.7471 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02305933 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=79150

Shortage status: resolved shortage (ended 2021-03-12); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02305933

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

Reason for Use code 367 For the treatment of patients with Parkinson's disease with 25% of the waking day in the off state despite maximally tolerated doses of levodopa. Coverage limit: LU Authorization Period: Indefinite

Stalevo · DIN 02337827 Manufacturer: Sandoz Canada Inc.; listing date 2010-10-28 Health Canada: Marketed since 2020-07-24 · brand STALEVO · ATC N04BA03 LEVODOPA,DECARBOXYLASE INHIBITOR, AND COMT INHIBITOR, N04BA03 LEVODOPA,DECARBOXYLASE INHIBITOR, AND COMT INHIBITOR · form Tablet · route Oral · ingredients CARBIDOPA 18.75 MG, ENTACAPONE 200 MG, LEVODOPA 75 MG · company Sandoz canada incorporated · schedule Prescription

DIN 02337827: Stalevo Raw flags: sec12=Y, sec3=Y Item: 920000615; group id 932; item number 2222; lccId 00199; manufacturer id SDZ Source form: Tab; strength: 75 & 18.75 & 200mg Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $1.7471; ministry $1.7471 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02337827 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=82347

Shortage status: resolved shortage (ended 2021-04-16); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02337827

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

Reason for Use code 367 For the treatment of patients with Parkinson's disease with 25% of the waking day in the off state despite maximally tolerated doses of levodopa. Coverage limit: LU Authorization Period: Indefinite

Stalevo · DIN 02305941 Manufacturer: Sandoz Canada Inc.; listing date 2009-03-02 Health Canada: Marketed since 2020-07-24 · brand STALEVO · ATC N04BA03 LEVODOPA,DECARBOXYLASE INHIBITOR, AND COMT INHIBITOR, N04BA03 LEVODOPA,DECARBOXYLASE INHIBITOR, AND COMT INHIBITOR · form Tablet · route Oral · ingredients CARBIDOPA 25 MG, LEVODOPA 100 MG, ENTACAPONE 200 MG · company Sandoz canada incorporated · schedule Prescription

DIN 02305941: Stalevo Raw flags: sec12=Y, sec3=Y Item: 920000589; group id 932; item number 2225; lccId 00199; manufacturer id SDZ Source form: Tab; strength: 100 & 25 & 200mg Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $1.7471; ministry $1.7471 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02305941 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=79151

Shortage status: resolved shortage (ended 2024-07-08); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02305941

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

Reason for Use code 367 For the treatment of patients with Parkinson's disease with 25% of the waking day in the off state despite maximally tolerated doses of levodopa. Coverage limit: LU Authorization Period: Indefinite

Stalevo · DIN 02337835 Manufacturer: Sandoz Canada Inc.; listing date 2010-10-28 Health Canada: Marketed since 2020-07-24 · brand STALEVO · ATC N04BA03 LEVODOPA,DECARBOXYLASE INHIBITOR, AND COMT INHIBITOR, N04BA03 LEVODOPA,DECARBOXYLASE INHIBITOR, AND COMT INHIBITOR · form Tablet · route Oral · ingredients ENTACAPONE 200 MG, LEVODOPA 125 MG, CARBIDOPA 31.25 MG · company Sandoz canada incorporated · schedule Prescription

DIN 02337835: Stalevo Raw flags: sec12=Y, sec3=Y Item: 920000616; group id 932; item number 2223; lccId 00199; manufacturer id SDZ Source form: Tab; strength: 125 & 31.25 & 200mg Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $1.7471; ministry $1.7471 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02337835 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=82348

Shortage status: resolved shortage (ended 2021-03-12); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02337835

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

Reason for Use code 367 For the treatment of patients with Parkinson's disease with 25% of the waking day in the off state despite maximally tolerated doses of levodopa. Coverage limit: LU Authorization Period: Indefinite

Stalevo · DIN 02305968 Manufacturer: Sandoz Canada Inc.; listing date 2009-03-02 Health Canada: Marketed since 2020-07-24 · brand STALEVO · ATC N04BA03 LEVODOPA,DECARBOXYLASE INHIBITOR, AND COMT INHIBITOR, N04BA03 LEVODOPA,DECARBOXYLASE INHIBITOR, AND COMT INHIBITOR · form Tablet · route Oral · ingredients CARBIDOPA 37.5 MG, ENTACAPONE 200 MG, LEVODOPA 150 MG · company Sandoz canada incorporated · schedule Prescription

DIN 02305968: Stalevo Raw flags: sec12=Y, sec3=Y Item: 920000590; group id 932; item number 2226; lccId 00199; manufacturer id SDZ Source form: Tab; strength: 150 & 37.5 & 200mg Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $1.7471; ministry $1.7471 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02305968 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=79152

Shortage status: resolved shortage (ended 2024-07-29); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02305968

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