Access to Provincial Drug Cost Reimbursement for MS Therapies

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Once a new therapy is approved by the Health Products and Food Branch of Health Canada and assessed by the Common Drug Review, the Ontario government's own team of clinical experts and two lay citizens, the Committee to Evaluate Drugs (CED), determines whether it should be listed as a benefit under Ontario's drug plans. Usually drugs have to be listed on the provincial formulary to be covered, however, a special process — called Exceptional Access or “Section 16” — provides coverage for drugs that have not been listed as a benefit on the provincial formulary, but have been approved by Health Canada and reviewed by the CED.

The disease modifying therapies for multiple sclerosis fall into the Exceptional Access program. Avonex™ (interferon beta-1a), Betaseron® (interferon beta-1b), Copaxone™ (glatiramer acetate) and Rebif® (interferon beta-1a) may be accessed by people who need assistance with the cost of the drugs through Exceptional Access. These individuals must apply and be approved before they are eligible to receive assistance through Ontario's drug cost reimbursement programs. Approval is granted on an individual’s ability to meet certain clinical criteria established by the CED.

In addition to the disease modifying therapies, some symptom management therapies may be obtained through the Exceptional Access program, while others – often older therapies – are listed on the provincial drug formulary. In some instances, these older drugs have remained as first line therapies. The symptom management drugs that may be obtained through the Exceptional Access program include, but may not be limited to:

The following information provides additional details about the criteria for access and reimbursement process in Ontario for the MS therapies. Individuals who need assistance with the request process can contact the MS Society for support.

Common questions and answers

When can I apply for reimbursement?

You will be eligible for reimbursement under Ontario's drug programs once your Exceptional Access request is approved.

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How do I apply for Exceptional Access?

Your doctor must submit a standard Exceptional Access request form on your behalf, describing your medication requirements to the Ministry of Health and Long-Term Care 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.

The Exceptional Access request form can also be accessed on the Ontario Public Drug Program’s website.

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What can I do if my Exceptional Access request is denied?

Your doctor can appeal the rejection by writing the Ministry of Health and Long-Term Care Drug Programs Branch. Most rejections occur because the physician initially provided inadequate information. You may want to review the eligibility criteria outlined below with your physician.

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What are the Exceptional Access criteria?

Generally, to be approved, people starting treatment must meet the criteria that were used in the clinical trials:

• Patient can be assessed by GP or specialist

• Prescription must be approved by Ministry of Health and Long-Term Care panel (Exceptional Access)

• Approval is given for up to one year

For disease modifying therapies, people must also meet the following requirements:

• Patient must have clinically definite MS (at least 2 attacks in past 2 years) and ambulatory with or without mobility aids:
  Avonex® (EDSS 3.5 or less)
  Betaseron® (EDSS 6.0 or less)
  Copaxone® (EDSS 5.0 or less)
  and Rebif® (EDSS 6.0 or less)

• The Ontario Drug Benefit Program will approve an initial treatment period of 6 months for patients requiring the administration of Tysabri® for the treatment of Rapidly Evolving Severe Relapsing-Remitting Multiple Sclerosis (RES-RRMS) who meet specific criteria. For more information on these criteria please contact your physician or the Exceptional Access Program at Ontario Public Drug Programs 1-866-598-6530 or 416-327-8109.

• For people who have a high risk of developing MS (Clinically Isolated Syndrome or CIS), two therapies - Avonex® and Betaseron® - may be approved under the Exceptional Access program. To gain Exceptional Access, individuals must have one acute attack and brain lesions typical of MS.

Criteria for symptom management treatments vary. Some information regarding criteria is provided above. Please consult your physician for additional information.

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What are the criteria for people already on treatment?

People who are on active treatment probably will have had fewer attacks and may be concerned about meeting the above criteria when applying to continue on therapy. In this case, your physician should explicitly state that the request is for continuation of therapy. He or she should provide detailed information about your diagnosis, disability score and frequency of attacks before you started on therapy on the standard Exceptional Access request form. This form can also be accessed on the Ontario Public Drug Program’s website.

In addition, your physician should provide information about your clinical status while on treatment including details about any attacks or side effects you have experienced while on the therapy as well as your current Expanded Disability Status Scale (EDSS) score.

Will my Exceptional Access need to be renewed periodically?

Yes. Exceptional Access is given on a case-by-case basis for periods of time usually ranging from six to 12 months. In 2008, Ontario Public Drug Programs introduced a Telephone Request System (TRS) through which renewals of Avonex®, Betaseron®, Copaxone® and Rebif® may be granted. It is recommended that you discuss this renewal option with your physician six to eight weeks before the expiry of your Exceptional Access approval.

For medications not eligible for renewal through the Telephone Request System, six weeks before the expiry of the approval, your physician must re-submit a standard Exceptional Access request form to Ontario Public Drug Programs. You should remind your physician to do this. See above for information about the criteria for people already on treatment.

The Exceptional Access request form can also be accessed on the Ontario Public Drug Program’s website.

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What are the criteria for renewals?

To have your Exceptional Access renewed, you must:

• Be ambulatory, in the case of disease modifying therapies (see above);

• Have experienced no deterioration in your medical condition while on treatment.

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Where can I get help to pay for the drug?

Once Exceptional Access is granted, individuals can access either the Ontario Drug Benefits Plan or the Trillium Drug Program to help cover the cost of the drug.

Ontario Drug Benefits Plan
Social assistance (Ontario Works) 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 or who have no drug program can apply to the Trillium Drug Program (TDP) to help pay for a large portion of the cost of the drug. Requests forms and guides are available from your local pharmacy.

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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 some drugs and what your private benefits cover. Remember you will need Exceptional Access approval to be reimbursed under the Trillium program for those drugs not listed on the Ontario Public Drug Programs Formulary.

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Should I wait to purchase the drug until my Exceptional Access request is approved?

Yes, because you will not be reimbursed for the cost until your Exceptional Access request is approved. However, individuals applying to the Trillium Drug Program (TDP) for the first time should be aware that requests can take up to two weeks to process. It is advisable to submit your request to the TDP at the same time as the Exceptional Access request.

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How will I know my Exceptional Access request has been approved?

Check with your physician because Ontario Public Drug Programs will notify him or her about whether coverage has been approved for you. Most decisions are made within two to six weeks.

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How will I know my request to Trillium Drug Program has been processed?

Once your request is processed, you will receive a letter from Trillium Drug Program advising that you are enrolled in the program. You may also check with your pharmacist or contact the Trillium Drug Program directly about the status of your request (please see the end of this section for contact information). It will take approximately two weeks for the Trillium Drug Program to process your request.

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Do I have to pay a portion of the cost myself?

Under the Trillium program you must pay a certain amount on prescription drugs (deductible) each year. Usually it is about 4% of net family income.

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Do I have to pay my deductible all at once?

No. The deductible can be paid in quarterly installments over the Trillium Drug 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.

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Do I have to pay the full deductible if I apply later in the year?

No. Your deductible will be based only on the number of months left in the Trillium Drug 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.

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Do I have to reapply every year?

Yes. Once registered with the Trillium program, you will be sent a pre-completed 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

Exceptional Access Program

Ontario Public Drug Programs at 1-866-598-6530 or 416-327-8109 or discuss with your physician. You may also visit www.health.gov.on.ca/english/providers/program/
drugs/funded_drug/fund_odbp.html.

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Trillium Drug Program

Ministry of Health at 1-800-575-5386 or 416-642-3038 or contact your local pharmacy. Information about the Trillium Drug Program, including forms and guides, is available at www.health.gov.on.ca/english/providers/program/
drugs/funded_drug/fund_trillium.html.

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Ontario Drug Benefits Plan

Ministry of Health and Long-Term Care Drug Programs Branch at 1-866-598-6530 or 416-327-8109. Additional information on the Ontario Drug Benefits Plan can be found at www.health.gov.on.ca/english/providers/program/
drugs/funded_drug/fund_odbp.html.

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Assistance with the request process

The Client Information & Referral Coordinator can help clients with general information about these application processes. Contact 1-800-268-7582 ext. 3133.

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