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Reason for Use code 290 For patients with urinary frequency, urgency or urge incontinence who have: Failed to respond to behavioral techniques AND an adequate trial of oxybutynin with gradual dose escalation has shown to be either ineffective or resulted in unacceptable side effects. NOTE: If after a trial of 2 weeks patients continue to experience similar side effects and no greater efficacy than oxybutynin, continued therapy with this more costly agent should be reassessed. Antimuscarinic agents should be used with caution in the elderly due to potentially serious adverse effects (e.g. confusion, psychosis, acute urinary retention, constipation). Antimuscarinic agents should be avoided in older adults with pre-existing cognitive impairment (e.g. dementia) and those who are already using other drugs with significant anticholinergic effects (e.g. tricyclic antidepressants) in order to avoid a high overall anticholinergic drug burden. 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 ↗)

Ach-Fesoterodine · DIN 02535998 Manufacturer: Accord Healthcare Inc.; listing date 2026-07-31 Health Canada: Marketed since 2026-05-21 · brand ACH-FESOTERODINE · ATC G04BD11 FESOTERODINE · form Tablet (extended-release) · route Oral · ingredients FESOTERODINE FUMARATE 4 MG · company Accord healthcare inc · schedule Prescription

DIN 02535998: Ach-Fesoterodine Raw flags: sec12=Y, sec3=Y Item: 860000072; group id 875; item number 2113; lccId 00233; manufacturer id ACH Source form: Tab; strength: 4mg Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $0.7500; ministry $0.7500 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02535998 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=102481

Interchangeable products

Sandoz Fesoterodine Fumarate · DIN 02521768 · $0.7500 Toviaz · DIN 02380021 · $0.7500

Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02535998

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

Reason for Use code 290 For patients with urinary frequency, urgency or urge incontinence who have: Failed to respond to behavioral techniques AND an adequate trial of oxybutynin with gradual dose escalation has shown to be either ineffective or resulted in unacceptable side effects. NOTE: If after a trial of 2 weeks patients continue to experience similar side effects and no greater efficacy than oxybutynin, continued therapy with this more costly agent should be reassessed. Antimuscarinic agents should be used with caution in the elderly due to potentially serious adverse effects (e.g. confusion, psychosis, acute urinary retention, constipation). Antimuscarinic agents should be avoided in older adults with pre-existing cognitive impairment (e.g. dementia) and those who are already using other drugs with significant anticholinergic effects (e.g. tricyclic antidepressants) in order to avoid a high overall anticholinergic drug burden. 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 Fesoterodine Fumarate · DIN 02521768 Manufacturer: Sandoz Canada Inc.; listing date 2022-06-30 Health Canada: Marketed since 2022-05-02 · brand SANDOZ FESOTERODINE FUMARATE · ATC G04BD11 FESOTERODINE · form Tablet (extended-release) · route Oral · ingredients FESOTERODINE FUMARATE 4 MG · company Sandoz canada incorporated · schedule Prescription

DIN 02521768: Sandoz Fesoterodine Fumarate Raw flags: sec12=Y, sec3=Y Item: 860000072; group id 875; item number 2113; lccId 00233; manufacturer id SDZ Source form: Tab; strength: 4mg Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $0.7500; ministry $0.7500 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02521768 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=101095

Interchangeable products

Ach-Fesoterodine · DIN 02535998 · $0.7500 Toviaz · DIN 02380021 · $0.7500

Shortage status: resolved shortage (ended 2025-10-31); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02521768

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

Reason for Use code 290 For patients with urinary frequency, urgency or urge incontinence who have: Failed to respond to behavioral techniques AND an adequate trial of oxybutynin with gradual dose escalation has shown to be either ineffective or resulted in unacceptable side effects. NOTE: If after a trial of 2 weeks patients continue to experience similar side effects and no greater efficacy than oxybutynin, continued therapy with this more costly agent should be reassessed. Antimuscarinic agents should be used with caution in the elderly due to potentially serious adverse effects (e.g. confusion, psychosis, acute urinary retention, constipation). Antimuscarinic agents should be avoided in older adults with pre-existing cognitive impairment (e.g. dementia) and those who are already using other drugs with significant anticholinergic effects (e.g. tricyclic antidepressants) in order to avoid a high overall anticholinergic drug burden. Coverage limit: LU Authorization Period: Indefinite

Toviaz · DIN 02380021 Manufacturer: Pfizer Canada Inc.; listing date 2013-04-30 Health Canada: Marketed since 2012-04-19 · brand TOVIAZ · ATC G04BD11 FESOTERODINE · form Tablet (extended-release) · route Oral · ingredients FESOTERODINE FUMARATE 4 MG · company Pfizer canada ulc · schedule Prescription

DIN 02380021: Toviaz Raw flags: sec12=Y, sec3=Y Item: 860000072; group id 875; item number 2113; lccId 00233; manufacturer id PFI Source form: Tab; strength: 4mg Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $1.5794; ministry $0.7500 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02380021 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=86587

Interchangeable products

Ach-Fesoterodine · DIN 02535998 · $0.7500 Sandoz Fesoterodine Fumarate · DIN 02521768 · $0.7500

Shortage status: resolved shortage (ended 2022-06-15); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02380021

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

Reason for Use code 290 For patients with urinary frequency, urgency or urge incontinence who have: Failed to respond to behavioral techniques AND an adequate trial of oxybutynin with gradual dose escalation has shown to be either ineffective or resulted in unacceptable side effects. NOTE: If after a trial of 2 weeks patients continue to experience similar side effects and no greater efficacy than oxybutynin, continued therapy with this more costly agent should be reassessed. Antimuscarinic agents should be used with caution in the elderly due to potentially serious adverse effects (e.g. confusion, psychosis, acute urinary retention, constipation). Antimuscarinic agents should be avoided in older adults with pre-existing cognitive impairment (e.g. dementia) and those who are already using other drugs with significant anticholinergic effects (e.g. tricyclic antidepressants) in order to avoid a high overall anticholinergic drug burden. 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 ↗)

Ach-Fesoterodine · DIN 02536005 Manufacturer: Accord Healthcare Inc.; listing date 2026-07-31 Health Canada: Marketed since 2026-05-21 · brand ACH-FESOTERODINE · ATC G04BD11 FESOTERODINE · form Tablet (extended-release) · route Oral · ingredients FESOTERODINE FUMARATE 8 MG · company Accord healthcare inc · schedule Prescription

DIN 02536005: Ach-Fesoterodine Raw flags: sec12=Y, sec3=Y Item: 860000073; group id 875; item number 2114; lccId 00233; manufacturer id ACH Source form: Tab; strength: 8mg Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $0.7500; ministry $0.7500 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02536005 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=102482

Interchangeable products

Sandoz Fesoterodine Fumarate · DIN 02521776 · $0.7500 Toviaz · DIN 02380048 · $0.7500

Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02536005

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

Reason for Use code 290 For patients with urinary frequency, urgency or urge incontinence who have: Failed to respond to behavioral techniques AND an adequate trial of oxybutynin with gradual dose escalation has shown to be either ineffective or resulted in unacceptable side effects. NOTE: If after a trial of 2 weeks patients continue to experience similar side effects and no greater efficacy than oxybutynin, continued therapy with this more costly agent should be reassessed. Antimuscarinic agents should be used with caution in the elderly due to potentially serious adverse effects (e.g. confusion, psychosis, acute urinary retention, constipation). Antimuscarinic agents should be avoided in older adults with pre-existing cognitive impairment (e.g. dementia) and those who are already using other drugs with significant anticholinergic effects (e.g. tricyclic antidepressants) in order to avoid a high overall anticholinergic drug burden. 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 Fesoterodine Fumarate · DIN 02521776 Manufacturer: Sandoz Canada Inc.; listing date 2022-06-30 Health Canada: Marketed since 2022-05-02 · brand SANDOZ FESOTERODINE FUMARATE · ATC G04BD11 FESOTERODINE · form Tablet (extended-release) · route Oral · ingredients FESOTERODINE FUMARATE 8 MG · company Sandoz canada incorporated · schedule Prescription

DIN 02521776: Sandoz Fesoterodine Fumarate Raw flags: sec12=Y, sec3=Y Item: 860000073; group id 875; item number 2114; lccId 00233; manufacturer id SDZ Source form: Tab; strength: 8mg Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $0.7500; ministry $0.7500 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02521776 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=101096

Interchangeable products

Ach-Fesoterodine · DIN 02536005 · $0.7500 Toviaz · DIN 02380048 · $0.7500

Shortage status: shortage reported ended 2026-09-08 (report last updated 2026-09-08); 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=02521776

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

Reason for Use code 290 For patients with urinary frequency, urgency or urge incontinence who have: Failed to respond to behavioral techniques AND an adequate trial of oxybutynin with gradual dose escalation has shown to be either ineffective or resulted in unacceptable side effects. NOTE: If after a trial of 2 weeks patients continue to experience similar side effects and no greater efficacy than oxybutynin, continued therapy with this more costly agent should be reassessed. Antimuscarinic agents should be used with caution in the elderly due to potentially serious adverse effects (e.g. confusion, psychosis, acute urinary retention, constipation). Antimuscarinic agents should be avoided in older adults with pre-existing cognitive impairment (e.g. dementia) and those who are already using other drugs with significant anticholinergic effects (e.g. tricyclic antidepressants) in order to avoid a high overall anticholinergic drug burden. Coverage limit: LU Authorization Period: Indefinite

Toviaz · DIN 02380048 Manufacturer: Pfizer Canada Inc.; listing date 2013-04-30 Health Canada: Marketed since 2012-04-19 · brand TOVIAZ · ATC G04BD11 FESOTERODINE · form Tablet (extended-release) · route Oral · ingredients FESOTERODINE FUMARATE 8 MG · company Pfizer canada ulc · schedule Prescription

DIN 02380048: Toviaz Raw flags: sec12=Y, sec3=Y Item: 860000073; group id 875; item number 2114; lccId 00233; manufacturer id PFI Source form: Tab; strength: 8mg Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $1.5794; ministry $0.7500 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02380048 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=86588

Interchangeable products

Ach-Fesoterodine · DIN 02536005 · $0.7500 Sandoz Fesoterodine Fumarate · DIN 02521776 · $0.7500

Shortage status: resolved shortage (ended 2022-09-30); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02380048

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