Ontario - Note to Prescribers
Ministry of Health and Long Term Care
Request For Special Coverage of Non-Listed Drug Products
This note to Prescribers describes a mechanism available to make requests for coverage of drug products that are not listed as benefits under the Ontario Drug Benefit (ODB) program. These are often referred to as "Section 8" requests. This Note also outlines the criteria used in reviewing requests and what information prescribers are required to submit.
Individual Clinical Review (Section 8) Mechanism
The ministry considers requests for coverage of drug products not listed in the ODB Formulary/Comparative Drug Index (Formulary/CDI) for ODB-eligible persons. The ministry is guided by recommendations of the Drug Quality and Therapeutics Committee (DQTC) and other expert medical advisers when reviewing individual requests for coverage of drug programs.
The individual clinical review (Section 8) mechanism is reserved for requests for which there are not Formulary/CDI alternatives to treat conditions or diseases that would otherwise cause severe debilitating effects and there is no suitable product listed in the Formulary/CDI, and the drug is not covered under another government program. It is not intended to be used to request drugs to treat self-limiting conditions/symptoms, or for patient "convenience", or to continue patients previously enrolled in clinical trials of new drugs once these drugs are approved for marketing.
Application Process
To apply for special coverage the physician must send a written request to the Drug Programs Branch. Ministry staff coordinate the review process, which includes obtaining a recommendation from the DQTC. The DQTC requires full details of an individual case in order to make a recommendation. Your attention to the information requirements listed below will ensure a complete and timely review. Requests that contain insufficient information will be returned to the physician.
Requests should be sent to the attention of:
Individual Clinical Review (Section 8) Unit
Drug Programs Branch
3rd floor, 5700 Yonge Street
North York, ON M2M 4K5
Facsimile: (416)327-7526
(Faxed requests are preferred - DO NOT mail in a previously faxed request)
Telephone inquires should be directed to: (416)327-8109
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In order to ensure a timely response to patients and their physicians and an approval process based on therapeutic benefits, fairness and consistency, the criteria for consideration of requests under the Section 8 mechanism are outlined below: Each request should include a concise clinical description and therapeutic plan which must include at a minimum:
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Reimbursement
The ministry's decision on individual coverage in a particular patient’s case will be communicated via letter to the physician making the request. If coverage is approved, the physician may provide a copy of the approval notice for the patient to take to their pharmacy. Pharmacists are not required to keep a copy of the authorization letter on file since the Health Network adjudicates Section 8 claims on-line. Generally, requests may be approved for a period of up to one year. Approval is not retroactive, but begins from the specified coverage date and is valid until the expiration date noted on the authorization letter.
As Section 8 authorizations are DIN specific, in cases where the dose of a prescription changes, requiring the use of a different strength of the drug (i.e. requiring a different DIN) a new Section 8 request is required.
Note that patients must be eligible for ODB in order to receive coverage for the requested product. Patients not currently ODB-eligible may become eligible through the Trillium Drug Program. For more information, call 1-800-575-5386.
Extension of Coverage
It is anticipated that a patient will continue to require the product beyond the approval period, the physician is required to request an extension of coverage at least four weeks prior to its expiration.
Coverage will not be continued automatically between expiration and re-issuance of approval. Requests for extension should include a summary of the patient’s progress on the drug product, any changes in drug therapy, and the rationale for the continued need for the product. Sufficient information is needed to ensure a timely response to requests.
Ontario Drug Benefit Program
January 2001
Access To Provincial Drug Cost Reimbursement Example Province Of Ontario
Once a new therapy is approved by the Health Protection Branch, the Ontario Government’s own team of clinical experts determines whether it should be listed as a benefit under it’s drug plans. Usually drugs have to be listed on the provincial formulary to be covered, however, a special process - called a Section 8 - provides coverage for drugs that have not been listed as a benefit on the provincial formulary, but have been approved by the federal government and reviewed by the Ontario Drug Quality and Therapeutics Committee (DQTC).
The following information provides additional details about the criteria for access and reimbursement process for Neupogen - Neutropenia therapy in Ontario.
Common questions and answers
When can I apply for reimbursement?
You will be eligible for reimbursement under Ontario's drug plans once your Section 8 is approved.
How do I apply for Section 8 coverage?
Your doctor must send a detailed letter, on your behalf, describing your Neutropenia to the Drug Programs Branch. Medical experts will review your doctor’s request and will advise him or her, within two to three weeks, whether coverage has been approved. Make sure your doctor knows that he or she must sign the letter.
What can I do if my Section 8 is denied?
Your doctor can appeal the rejection in writing the Drug Programs Branch. Most rejections occur because the physician initially provided inadequate information.
Where can I get help to pay for the drug?
Once Section 8 coverage is granted, individuals can access either the Ontario Drug Benefits Plan or the Trillium Drug Programs to help cover the cost of the drug.
Ontario Drug Benefits Plan
Social assistance and Ontario Disability Support Plan recipients are covered under this plan and pay only $2 per prescription.
Trillium Drug Program
People who are not 100% covered by a private or employer paid drug plan can apply to the Trillium Drug Program (TDP) to help pay for a large portion of the cost of the drug. Application forms are available from your local pharmacy.
Can I apply to Trillium if I have private drug coverage?
Yes. You can use the Trillium Drug Program (TDP) to help pay the difference between the cost of the drug and what your private benefits cover. Remember you will need Section 8 coverage to be reimbursed under the Trillium program to do this.
How will I know my Section 8 has been approved?
Check with your physician because the Drug Programs Branch will notify him or her about whether coverage has been approved for you. Most decisions re made within three weeks.
Do I have to pay a portion of the cost myself?
Under the Trilium program you must pay a certain amount on prescription drugs (deductible) each year. Usually it is about 4% of net family income.
Do I have to pay my deductible all at once?
No. Starting August 1, 1999, the deductible can be paid in quarterly installments over the Trillium program year (August 1 to July 31). Once the deductible has been paid in each quarter, your family will receive full drug benefits for that quarter.
Do I have to pay the full deductible if I apply later in the year?
No. Starting August 1, 1999, your deductible will be based only on the number of months left in the Trillium program year. Your enrollment date will be used to calculate your prorated quarterly deductible. Your family will receive full drug benefits, once the deductible is paid in each quarter.
Do I have to reapply each year?
Yes. Once registered with the Trillium program, you will be sent a precompleted form at the end of each fiscal year. If the information contained in the form is correct, you should simply sign and return the form to the program. However, if your income and/or family status have changed, you must notify the program at this time, as this will affect your deductible.
Useful contact information
Section 8 process Ministry of Health Drug Programs Branch at (416)327-8109 (collect calls are accepted) or discuss it with your physician.
Trillium Drug Program Ministry of Health at 1-800-575-5386 or (416)326-1558 or contact your local pharmacy.
Ontario Drug Benefits Plan Ministry of Health Drug Programs Branch at
(416)327-8109 (collect calls are accepted).
Assistance with Application Process Please call a Regional Manager, Individual and Family Services at 1-800-268-7582 (for central and southwestern Ontario) or 1-800-268-9666 (for eastern Ontario) or 1-800-267-9885 (for northern Ontario).