Regulation - LGIC
Proposed Amendments to Ontario Regulation 201/96 made under the Ontario Drug Benefit Act and Regulation 935 made under the Drug Interchangeability and Dispensing Fee Act
Regulation Number(s):
O. Reg. 201/96; Regulation 935
Instrument Type:
Regulation - LGIC
Bill or Act:
Ontario Drug Benefit Act and Drug Interchangeability and Dispensing Fee Act
Summary of Decision:
A notice was posted on the ministry's website on July 23, 2015 that provided stakeholders with information on the proposed amendments to the ODBA Regulation. Stakeholders were given a 30-day period to comment on the proposed regulatory amendments. As a result of the comments we received, the draft ODBA regulations were revised to:
• Exempt extemporaneous preparations and drugs supplied to patients on complex medical regimens from the 5 dispensing fees per 365-day period rule to reflect that more frequent dispensing is required in these cases; and
• Grandparent patients who are entitled to have brand products reimbursed as "no substitution" claims under existing program rules.
• Exempt extemporaneous preparations and drugs supplied to patients on complex medical regimens from the 5 dispensing fees per 365-day period rule to reflect that more frequent dispensing is required in these cases; and
• Grandparent patients who are entitled to have brand products reimbursed as "no substitution" claims under existing program rules.
Further Information:
ODBA regulation for consultation
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DIDFA regulation for consultation
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Ontario regulation 285/15
Ontario regulation 284/15
Proposal Number:
15-HLTC021
Posting Date:
July 23, 2015
Summary of Proposal:
Patients First: Ontario's Action Plan for Health Care reflects a commitment on the part of the ministry to build a health-care system that is patient-centered. A sustainable drug system, working together with our partners, puts Ontario in the best position to ensure access for patients to drug products that they require.
The Ministry of Health and Long-Term Care (the "ministry") is proposing to implement a number of changes to reflect best evidence, increased value for money, and achieve better outcomes.
Proposed amendments to Ontario Regulation 201/96 made under the Ontario Drug Benefit Act are required to implement the proposed initiatives as follows:
- Reduce the mark-up percentage fee from 8% to 6% for high cost drugs equal to or in excess of $1000 per claim.
- In the long-term care sector, reduce dispensing fees and enhance medication management to support appropriate prescribing, resulting in lower LTC pharmacy costs. Dispensing fees paid to pharmacies for supplying listed drug products to long-term care home residents would be reduced by $1.26 across all categories of pharmacies.
- Optimize the quantity of medication dispensed for certain chronic care medications where patients have been on the same medication for years, in order to minimize unnecessary trips by patients to the pharmacy for the same prescription and reduce co-payment costs to patients. A limit on the number of dispensing fees would be applied to allow for a maximum of 5 dispensing fees billed per year per patient per chronic therapy drug.
- Require patients to try two or more generics before the brand product is reimbursed by the ministry as a "no substitution" claim.
Housekeeping changes to Ontario Regulation 201/96 are included to clarify existing language relating to the current conditions for charging co-payments.
The ministry is also proposing to amend section 6 of Regulation 935 made under the Drug Interchangeability and Dispensing Fee Act to further streamline interchangeability designations for a small number of generic products. The proposed amendments to section 6(1)(h) would do the following:
- With respect to aqueous solutions that are currently exempt from the in vivo bioequivalence study requirement, remove the requirement that the aqueous solutions must be the "same volume" as the original product, and replace it with a requirement that the aqueous solution be the "same strength" as the original product.
- Exempt dermatological products from the in vivo bioequivalence study requirement. To qualify for the exemption the product would have to contain one or more glucocorticoids as the only active ingredient(s), and have a declaration of equivalence from Health Canada with the original product or another listed interchangeable product with which it would be designated as interchangeable.
- Exempt products with a transdermal route of administration for systemic effect from the in vivo bioequivalence study requirement. To qualify for the exemption the product would have to have a declaration of equivalence from Health Canada with the original product or another listed interchangeable product with which it would be designated as interchangeable.
The Ministry of Health and Long-Term Care (the "ministry") is proposing to implement a number of changes to reflect best evidence, increased value for money, and achieve better outcomes.
Proposed amendments to Ontario Regulation 201/96 made under the Ontario Drug Benefit Act are required to implement the proposed initiatives as follows:
- Reduce the mark-up percentage fee from 8% to 6% for high cost drugs equal to or in excess of $1000 per claim.
- In the long-term care sector, reduce dispensing fees and enhance medication management to support appropriate prescribing, resulting in lower LTC pharmacy costs. Dispensing fees paid to pharmacies for supplying listed drug products to long-term care home residents would be reduced by $1.26 across all categories of pharmacies.
- Optimize the quantity of medication dispensed for certain chronic care medications where patients have been on the same medication for years, in order to minimize unnecessary trips by patients to the pharmacy for the same prescription and reduce co-payment costs to patients. A limit on the number of dispensing fees would be applied to allow for a maximum of 5 dispensing fees billed per year per patient per chronic therapy drug.
- Require patients to try two or more generics before the brand product is reimbursed by the ministry as a "no substitution" claim.
Housekeeping changes to Ontario Regulation 201/96 are included to clarify existing language relating to the current conditions for charging co-payments.
The ministry is also proposing to amend section 6 of Regulation 935 made under the Drug Interchangeability and Dispensing Fee Act to further streamline interchangeability designations for a small number of generic products. The proposed amendments to section 6(1)(h) would do the following:
- With respect to aqueous solutions that are currently exempt from the in vivo bioequivalence study requirement, remove the requirement that the aqueous solutions must be the "same volume" as the original product, and replace it with a requirement that the aqueous solution be the "same strength" as the original product.
- Exempt dermatological products from the in vivo bioequivalence study requirement. To qualify for the exemption the product would have to contain one or more glucocorticoids as the only active ingredient(s), and have a declaration of equivalence from Health Canada with the original product or another listed interchangeable product with which it would be designated as interchangeable.
- Exempt products with a transdermal route of administration for systemic effect from the in vivo bioequivalence study requirement. To qualify for the exemption the product would have to have a declaration of equivalence from Health Canada with the original product or another listed interchangeable product with which it would be designated as interchangeable.
Contact Address:
Executive Officer of Ontario Public Drug Programs
Ministry of Health and Long-Term Care
80 Grosvenor Street, 9th Floor
Hepburn Block, Queen's Park
Toronto ON M7A 1R3
Fax: 416-325-6647
Ministry of Health and Long-Term Care
80 Grosvenor Street, 9th Floor
Hepburn Block, Queen's Park
Toronto ON M7A 1R3
Fax: 416-325-6647
Effective Date:
October 1, 2015
Decision:
Approved