Limited Use — Reason for Use code 330 requiredMarketed · checked 2026-09-02
Write on scriptLU code 330 (patient must meet the criteria below)
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ontario Limited Use criteria — code 330
Reason for Use code 330
For the treatment of asthma in patients who are using optimum anti-inflammatory treatment and are still experiencing breakthrough symptoms.
Coverage limit:
LU Authorization Period: Indefinite
No interchangeable product listed in the Ontario extract
Advair 125 · DIN 02245126
Manufacturer: GlaxoSmithKline Inc., GlaxoSmithKline Consumer Health Care; listing date 2003-01-30
Health Canada: Marketed since 2001-12-21 · brand ADVAIR · ATC R03AK06 SALMETEROL AND FLUTICASONE, R03AK06 SALMETEROL AND FLUTICASONE, R03AK06 SALMETEROL AND FLUTICASONE · form Aerosol (metered-dose) · route Inhalation · ingredients SALMETEROL (SALMETEROL XINAFOATE) 25 MCG/ACT, FLUTICASONE PROPIONATE 125 MCG/ACT · company Glaxosmithkline inc · schedule Prescription
Advair 125: Formulary list price $138.4500/unit (unit not stated in source; not the patient's cost)
Ministry pays: $138.4500 per source unit.
Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.
Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=69136 · Verify on the e-Formulary ↗ (DIN 02245126)
Source record
DIN 02245126: Advair 125
Raw flags: sec12=Y, sec3=Y
Item: 121200085; group id 237; item number 0419; lccId 00044; manufacturer id GSK
Source form: Inh-120 Dose Pk; strength: 25/125mcg/Metered Dose
Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below
Source prices (unrounded): $138.4500; ministry $138.4500
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02245126
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=69136
Shortage status: resolved shortage (ended 2024-07-25); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02245126
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Limited Use — Reason for Use code 330 requiredMarketed · checked 2026-09-02
Write on scriptLU code 330 (patient must meet the criteria below)
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ontario Limited Use criteria — code 330
Reason for Use code 330
For the treatment of asthma in patients who are using optimum anti-inflammatory treatment and are still experiencing breakthrough symptoms.
Coverage limit:
LU Authorization Period: Indefinite
No interchangeable product listed in the Ontario extract
Advair 250 · DIN 02245127
Manufacturer: GlaxoSmithKline Inc., GlaxoSmithKline Consumer Health Care; listing date 2003-01-30
Health Canada: Marketed since 2001-12-21 · brand ADVAIR · ATC R03AK06 SALMETEROL AND FLUTICASONE, R03AK06 SALMETEROL AND FLUTICASONE · form Aerosol (metered-dose) · route Inhalation · ingredients FLUTICASONE PROPIONATE 250 MCG/ACT, SALMETEROL (SALMETEROL XINAFOATE) 25 MCG/ACT · company Glaxosmithkline inc · schedule Prescription
Advair 250: Formulary list price $196.5400/unit (unit not stated in source; not the patient's cost)
Ministry pays: $196.5400 per source unit.
Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.
Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=69137 · Verify on the e-Formulary ↗ (DIN 02245127)
Source record
DIN 02245127: Advair 250
Raw flags: sec12=Y, sec3=Y
Item: 121200086; group id 237; item number 0420; lccId 00044; manufacturer id GSK
Source form: Inh-120 Dose Pk; strength: 25/250mcg/Metered Dose
Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below
Source prices (unrounded): $196.5400; ministry $196.5400
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02245127
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=69137
Shortage status: resolved shortage (ended 2025-09-02); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02245127
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Limited Use — Reason for Use code 330 requiredMarketed · checked 2026-09-02
Write on scriptLU code 330 (patient must meet the criteria below)
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ontario Limited Use criteria — code 330
Reason for Use code 330
For the treatment of asthma in patients who are using optimum anti-inflammatory treatment and are still experiencing breakthrough symptoms.
Coverage limit:
LU Authorization Period: Indefinite
Savings card: innoviCares lists Advair Diskus (Ontario list dated 2026-09-10) — pays part of the brand-versus-generic difference after other coverage; free sign-up. (innovicares.ca ↗)
1 brand, same coverage
Advair Diskus · DIN 02240835
Manufacturer: GlaxoSmithKline Inc., GlaxoSmithKline Consumer Health Care; listing date 2001-10-11
Health Canada: Marketed since 2002-03-12 · brand ADVAIR 100 DISKUS · ATC R03AK06 SALMETEROL AND FLUTICASONE · form Powder · route Inhalation · ingredients SALMETEROL (SALMETEROL XINAFOATE) 50 MCG/ACT, FLUTICASONE PROPIONATE 100 MCG/ACT · company Glaxosmithkline inc · schedule Prescription
Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.
Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=64426 · Verify on the e-Formulary ↗ (DIN 02240835)
Source record
DIN 02240835: Advair Diskus
Raw flags: sec12=Y, sec3=Y
Item: 121200083; group id 237; item number 0421; lccId 00044; manufacturer id GSK
Source form: Inh-60 Dose Pk; strength: 50/100mcg
Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below
Source prices (unrounded): $115.6500; ministry $42.4050
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02240835
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=64426Interchangeable products
PMS-FluticasonePropionateSalmeterol DPI · DIN 02494507 · $42.4050
Wixela Inhub · DIN 02495597 · $42.4050
Shortage status: resolved shortage (ended 2024-11-04); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02240835
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Limited Use — Reason for Use code 330 requiredMarketed · checked 2026-09-02
Write on scriptLU code 330 (patient must meet the criteria below)
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ontario Limited Use criteria — code 330
Reason for Use code 330
For the treatment of asthma in patients who are using optimum anti-inflammatory treatment and are still experiencing breakthrough symptoms.
Coverage limit:
LU Authorization Period: Indefinite
Savings card: innoviCares lists Advair Diskus (Ontario list dated 2026-09-10) — pays part of the brand-versus-generic difference after other coverage; free sign-up. (innovicares.ca ↗)
1 brand, same coverage
Advair Diskus · DIN 02240836
Manufacturer: GlaxoSmithKline Inc., GlaxoSmithKline Consumer Health Care; listing date 2000-07-17
Health Canada: Marketed since 2002-04-03 · brand ADVAIR 250 DISKUS · ATC R03AK06 SALMETEROL AND FLUTICASONE · form Powder · route Inhalation · ingredients FLUTICASONE PROPIONATE 250 MCG/ACT, SALMETEROL (SALMETEROL XINAFOATE) 50 MCG/ACT · company Glaxosmithkline inc · schedule Prescription
Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.
Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=64427 · Verify on the e-Formulary ↗ (DIN 02240836)
Source record
DIN 02240836: Advair Diskus
Raw flags: sec12=Y, sec3=Y
Item: 121200080; group id 237; item number 0422; lccId 00044; manufacturer id GSK
Source form: Inh-60 Dose Pk; strength: 50/250mcg
Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below
Source prices (unrounded): $138.4500; ministry $50.7600
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02240836
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=64427Interchangeable products
PMS-FluticasonePropionateSalmeterol DPI · DIN 02494515 · $50.7600
Wixela Inhub · DIN 02495600 · $50.7600
Shortage status: resolved shortage (ended 2025-05-21); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02240836
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Limited Use — Reason for Use code 330 requiredMarketed · checked 2026-09-02
Write on scriptLU code 330 (patient must meet the criteria below)
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ontario Limited Use criteria — code 330
Reason for Use code 330
For the treatment of asthma in patients who are using optimum anti-inflammatory treatment and are still experiencing breakthrough symptoms.
Coverage limit:
LU Authorization Period: Indefinite
Savings card: innoviCares lists Advair Diskus (Ontario list dated 2026-09-10) — pays part of the brand-versus-generic difference after other coverage; free sign-up. (innovicares.ca ↗)
1 brand, same coverage
Advair Diskus · DIN 02240837
Manufacturer: GlaxoSmithKline Inc., GlaxoSmithKline Consumer Health Care; listing date 2000-07-17
Health Canada: Marketed since 2002-03-08 · brand ADVAIR 500 DISKUS · ATC R03AK06 SALMETEROL AND FLUTICASONE · form Powder · route Inhalation · ingredients FLUTICASONE PROPIONATE 500 MCG/ACT, SALMETEROL (SALMETEROL XINAFOATE) 50 MCG/ACT · company Glaxosmithkline inc · schedule Prescription
Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.
Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=64428 · Verify on the e-Formulary ↗ (DIN 02240837)
Source record
DIN 02240837: Advair Diskus
Raw flags: sec12=Y, sec3=Y
Item: 121200081; group id 237; item number 0423; lccId 00044; manufacturer id GSK
Source form: Inh-60 Dose Pk; strength: 50/500mcg
Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below
Source prices (unrounded): $196.5400; ministry $72.0600
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02240837
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=64428Interchangeable products
PMS-FluticasonePropionateSalmeterol DPI · DIN 02494523 · $72.0600
Wixela Inhub · DIN 02495619 · $72.0600
Shortage status: resolved shortage (ended 2023-04-18); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02240837
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Limited Use — Reason for Use code 330 requiredMarketed · checked 2026-09-02
Write on scriptLU code 330 (patient must meet the criteria below)
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ontario Limited Use criteria — code 330
Reason for Use code 330
For the treatment of asthma in patients who are using optimum anti-inflammatory treatment and are still experiencing breakthrough symptoms.
Coverage limit:
LU Authorization Period: Indefinite
Brand vs generic price
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 ↗)
1 brand, same coverage
PMS-FluticasonePropionateSalmeterol DPI · DIN 02494507
Manufacturer: Pharmascience Inc.; listing date 2020-04-30
Health Canada: Marketed since 2020-03-05 · brand PMS-FLUTICASONE PROPIONATE/SALMETEROL DPI · ATC R03AK06 SALMETEROL AND FLUTICASONE, R03AK06 SALMETEROL AND FLUTICASONE · form Powder · route Inhalation · ingredients SALMETEROL (SALMETEROL XINAFOATE) 50 MCG/ACT, FLUTICASONE PROPIONATE 100 MCG/ACT · company Pharmascience inc · schedule Prescription
PMS-FluticasonePropionateSalmeterol DPI: Formulary list price $42.4050/unit (unit not stated in source; not the patient's cost)
Ministry pays: $42.4050 per source unit.
Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.
Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=98451 · Verify on the e-Formulary ↗ (DIN 02494507)
Source record
DIN 02494507: PMS-FluticasonePropionateSalmeterol DPI
Raw flags: sec12=Y, sec3=Y
Item: 121200083; group id 237; item number 0421; lccId 00044; manufacturer id PMS
Source form: Inh-60 Dose Pk; strength: 50/100mcg
Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below
Source prices (unrounded): $42.4050; ministry $42.4050
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02494507
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=98451Interchangeable products
Advair Diskus · DIN 02240835 · $42.4050
Wixela Inhub · DIN 02495597 · $42.4050
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=02494507
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Limited Use — Reason for Use code 330 requiredMarketed · checked 2026-09-02
Write on scriptLU code 330 (patient must meet the criteria below)
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ontario Limited Use criteria — code 330
Reason for Use code 330
For the treatment of asthma in patients who are using optimum anti-inflammatory treatment and are still experiencing breakthrough symptoms.
Coverage limit:
LU Authorization Period: Indefinite
Brand vs generic price
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 ↗)
1 brand, same coverage
PMS-FluticasonePropionateSalmeterol DPI · DIN 02494515
Manufacturer: Pharmascience Inc.; listing date 2020-04-30
Health Canada: Marketed since 2020-03-05 · brand PMS-FLUTICASONE PROPIONATE/SALMETEROL DPI · ATC R03AK06 SALMETEROL AND FLUTICASONE, R03AK06 SALMETEROL AND FLUTICASONE · form Powder · route Inhalation · ingredients SALMETEROL (SALMETEROL XINAFOATE) 50 MCG/ACT, FLUTICASONE PROPIONATE 250 MCG/ACT · company Pharmascience inc · schedule Prescription
PMS-FluticasonePropionateSalmeterol DPI: Formulary list price $50.7600/unit (unit not stated in source; not the patient's cost)
Ministry pays: $50.7600 per source unit.
Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.
Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=98452 · Verify on the e-Formulary ↗ (DIN 02494515)
Source record
DIN 02494515: PMS-FluticasonePropionateSalmeterol DPI
Raw flags: sec12=Y, sec3=Y
Item: 121200080; group id 237; item number 0422; lccId 00044; manufacturer id PMS
Source form: Inh-60 Dose Pk; strength: 50/250mcg
Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below
Source prices (unrounded): $50.7600; ministry $50.7600
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02494515
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=98452Interchangeable products
Advair Diskus · DIN 02240836 · $50.7600
Wixela Inhub · DIN 02495600 · $50.7600
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=02494515
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Limited Use — Reason for Use code 330 requiredMarketed · checked 2026-09-02
Write on scriptLU code 330 (patient must meet the criteria below)
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ontario Limited Use criteria — code 330
Reason for Use code 330
For the treatment of asthma in patients who are using optimum anti-inflammatory treatment and are still experiencing breakthrough symptoms.
Coverage limit:
LU Authorization Period: Indefinite
Brand vs generic price
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 ↗)
1 brand, same coverage
PMS-FluticasonePropionateSalmeterol DPI · DIN 02494523
Manufacturer: Pharmascience Inc.; listing date 2020-04-30
Health Canada: Marketed since 2020-03-05 · brand PMS-FLUTICASONE PROPIONATE/SALMETEROL DPI · ATC R03AK06 SALMETEROL AND FLUTICASONE, R03AK06 SALMETEROL AND FLUTICASONE · form Powder · route Inhalation · ingredients SALMETEROL (SALMETEROL XINAFOATE) 50 MCG/ACT, FLUTICASONE PROPIONATE 500 MCG/ACT · company Pharmascience inc · schedule Prescription
PMS-FluticasonePropionateSalmeterol DPI: Formulary list price $72.0600/unit (unit not stated in source; not the patient's cost)
Ministry pays: $72.0600 per source unit.
Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.
Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=98453 · Verify on the e-Formulary ↗ (DIN 02494523)
Source record
DIN 02494523: PMS-FluticasonePropionateSalmeterol DPI
Raw flags: sec12=Y, sec3=Y
Item: 121200081; group id 237; item number 0423; lccId 00044; manufacturer id PMS
Source form: Inh-60 Dose Pk; strength: 50/500mcg
Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below
Source prices (unrounded): $72.0600; ministry $72.0600
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02494523
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=98453Interchangeable products
Advair Diskus · DIN 02240837 · $72.0600
Wixela Inhub · DIN 02495619 · $72.0600
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=02494523
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Limited Use — Reason for Use code 330 requiredMarketed · checked 2026-09-02
Write on scriptLU code 330 (patient must meet the criteria below)
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ontario Limited Use criteria — code 330
Reason for Use code 330
For the treatment of asthma in patients who are using optimum anti-inflammatory treatment and are still experiencing breakthrough symptoms.
Coverage limit:
LU Authorization Period: Indefinite
Brand vs generic price
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 ↗)
1 brand, same coverage
Wixela Inhub · DIN 02495597
Manufacturer: Mylan Pharmaceuticals ULC; listing date 2020-04-30
Health Canada: Marketed since 2020-02-13 · brand WIXELA INHUB · ATC R03AK06 SALMETEROL AND FLUTICASONE, R03AK06 SALMETEROL AND FLUTICASONE · form Powder · route Inhalation · ingredients FLUTICASONE PROPIONATE 100 MCG/ACT, SALMETEROL (SALMETEROL XINAFOATE) 50 MCG/ACT · company Mylan pharmaceuticals ulc · schedule Prescription
Wixela Inhub: Formulary list price $42.4050/unit (unit not stated in source; not the patient's cost)
Ministry pays: $42.4050 per source unit.
Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.
Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=98549 · Verify on the e-Formulary ↗ (DIN 02495597)
Source record
DIN 02495597: Wixela Inhub
Raw flags: sec12=Y, sec3=Y
Item: 121200083; group id 237; item number 0421; lccId 00044; manufacturer id MYL
Source form: Inh-60 Dose Pk; strength: 50/100mcg
Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below
Source prices (unrounded): $42.4050; ministry $42.4050
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02495597
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=98549Interchangeable products
Advair Diskus · DIN 02240835 · $42.4050
PMS-FluticasonePropionateSalmeterol DPI · DIN 02494507 · $42.4050
Shortage status: resolved shortage (ended 2025-01-24); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02495597
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Limited Use — Reason for Use code 330 requiredMarketed · checked 2026-09-02
Write on scriptLU code 330 (patient must meet the criteria below)
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ontario Limited Use criteria — code 330
Reason for Use code 330
For the treatment of asthma in patients who are using optimum anti-inflammatory treatment and are still experiencing breakthrough symptoms.
Coverage limit:
LU Authorization Period: Indefinite
Brand vs generic price
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 ↗)
1 brand, same coverage
Wixela Inhub · DIN 02495600
Manufacturer: Mylan Pharmaceuticals ULC; listing date 2020-03-31
Health Canada: Marketed since 2020-02-13 · brand WIXELA INHUB · ATC R03AK06 SALMETEROL AND FLUTICASONE, R03AK06 SALMETEROL AND FLUTICASONE · form Powder · route Inhalation · ingredients SALMETEROL (SALMETEROL XINAFOATE) 50 MCG/ACT, FLUTICASONE PROPIONATE 250 MCG/ACT · company Mylan pharmaceuticals ulc · schedule Prescription
Wixela Inhub: Formulary list price $50.7600/unit (unit not stated in source; not the patient's cost)
Ministry pays: $50.7600 per source unit.
Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.
Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=98550 · Verify on the e-Formulary ↗ (DIN 02495600)
Source record
DIN 02495600: Wixela Inhub
Raw flags: sec12=Y, sec3=Y
Item: 121200080; group id 237; item number 0422; lccId 00044; manufacturer id MYL
Source form: Inh-60 Dose Pk; strength: 50/250mcg
Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below
Source prices (unrounded): $50.7600; ministry $50.7600
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02495600
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=98550Interchangeable products
Advair Diskus · DIN 02240836 · $50.7600
PMS-FluticasonePropionateSalmeterol DPI · DIN 02494515 · $50.7600
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=02495600
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Limited Use — Reason for Use code 330 requiredMarketed · checked 2026-09-02
Write on scriptLU code 330 (patient must meet the criteria below)
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ontario Limited Use criteria — code 330
Reason for Use code 330
For the treatment of asthma in patients who are using optimum anti-inflammatory treatment and are still experiencing breakthrough symptoms.
Coverage limit:
LU Authorization Period: Indefinite
Brand vs generic price
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 ↗)
1 brand, same coverage
Wixela Inhub · DIN 02495619
Manufacturer: Mylan Pharmaceuticals ULC; listing date 2020-03-31
Health Canada: Marketed since 2020-02-13 · brand WIXELA INHUB · ATC R03AK06 SALMETEROL AND FLUTICASONE, R03AK06 SALMETEROL AND FLUTICASONE · form Powder · route Inhalation · ingredients SALMETEROL (SALMETEROL XINAFOATE) 50 MCG/ACT, FLUTICASONE PROPIONATE 500 MCG/ACT · company Mylan pharmaceuticals ulc · schedule Prescription
Wixela Inhub: Formulary list price $72.0600/unit (unit not stated in source; not the patient's cost)
Ministry pays: $72.0600 per source unit.
Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.
Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=98551 · Verify on the e-Formulary ↗ (DIN 02495619)
Source record
DIN 02495619: Wixela Inhub
Raw flags: sec12=Y, sec3=Y
Item: 121200081; group id 237; item number 0423; lccId 00044; manufacturer id MYL
Source form: Inh-60 Dose Pk; strength: 50/500mcg
Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below
Source prices (unrounded): $72.0600; ministry $72.0600
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02495619
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=98551Interchangeable products
Advair Diskus · DIN 02240837 · $72.0600
PMS-FluticasonePropionateSalmeterol DPI · DIN 02494523 · $72.0600
Shortage status: resolved shortage (ended 2026-08-12); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02495619
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Other drugs in the same formulary class (12:12 Sympathomimetic (Adrenergic) Agents) and how they are covered
Drug-class inventory only. Lists recorded Ontario formulary products, not every Canadian medication; does not recommend treatment.
Covered without a code on the Ontario formulary: EPINEPHRINE HCL, TERBUTALINE SULFATE
Some products covered without a code (check the product listing): ORCIPRENALINE SULFATE, SALBUTAMOL
12:12 Sympathomimetic (Adrenergic) Agents
From Health Canada product monographs; label wording only, not a treatment recommendation.
Matching is lexical and uses one held product label per generic; formulations and qualifying criteria may differ.
No displayed matched alternative is a general benefit.
FLUTICASONE FUROATE & VILANTEROL · Limited Use, codes 330, 456 (1), Limited Use, codes 330 (1)
BREO ELLIPTA 100/25 mcg once daily is the only strength indicated for the treatment of
COPD.
PM: https://pdf.hres.ca/dpd_pm/00049111.PDF; date January 7, 2019; DIN 02408872; fetched 2026-09-10
Product monograph
Coverage source: ON formulary extract 2026-08-26
What the Health Canada label says it is for
INDICATIONS AND CLINICAL USE
Asthma
ADVAIR/ADVAIR DISKUS (fluticasone propionate/salmeterol) is a combination of an
inhaled corticosteroid (ICS) and a long-acting beta2-adrenergic agonist (LABA) indicated
for the maintenance treatment of asthma, in patients with reversible obstructive airways
disease.
ADVAIR/ADVAIR DISKUS should be prescribed for patients not adequately controlled
on a long-term asthma control medication, such as an ICS, or whose disease severity
clearly warrants treatment with both an ICS and a LABA.
ADVAIR/ADVAIR DISKUS is not indicated for patients whose asthma can be managed
by occasional use of a rapid onset, short duration, inhaled beta2-agonist, or for patients
whose asthma can be successfully managed by inhaled corticosteroids along with
occasional use of a rapid onset, short duration, inhaled beta2-agonist.
Page 3 of 70
ADVAIR/ADVAIR DISKUS should not be used as a rescue medication. To relieve
acute asthmatic symptoms, a rapid onset, short duration inhaled bronchodilator (e.g.
salbutamol) should be used.
Chronic Obstructive Pulmonary Disease (COPD)
ADVAIR DISKUS 250 a…
https://pdf.hres.ca/dpd_pm/00056976.PDF
PM date: June 17, 2020
Source product: ADVAIR 100 DISKUS; DIN 02240835; fetched 2026-09-10
Product monograph posted by Health Canada; excerpt for lookup only.