Income-based coverage of two additional oral diabetic drugs, Actos and Avandia, and two cancer medications, Gleevec and Xeloda, will be provided through the exceptional drug request process. This investment is in addition to the $23 million in public drug programs currently provided by the Department of Social Services and Seniors. Coverage of three additional medications, Amaryl, Diamicron and Prandase, will be provided through the Diabetes Control Program, effective May 1, 2006.

“The additions of these drugs will be of significant medical benefit to cancer patients and people diagnosed with diabetes on PEI,” said Minister Gillan.

Coverage of Actos and Avandia will be available effective July 1, 2006 to patients diagnosed with Type II diabetes who are not adequately treated with other diabetes drugs. Coverage of Gleevec and Xeloda will be available effective May 1, 2006 to Islanders diagnosed with cancer when oncologists feel such medications are best suited to fight their particular type of cancer.

“Thanks to advancing research, new drugs are being introduced to the marketplace at a steady pace,“ noted Minister Gillan. “However, with these advances has come the challenge of accessing and paying for these drugs, most of which are catastrophically expensive. I want to assure Islanders that PEI is an active participant in work of the National Pharmaceutical Strategy to develop options for catastrophic drug coverage for all Canadians. We expect the national task force to present options to the First Ministers this June,” he added.

The Prince Edward Island Drug Programs Formulary is a listing of therapeutically effective medications approved for coverage and those considered therapeutically interchangeable under the Provincial Drug Programs. It is compiled by the Minister of Social Services and Seniors with the advice of the Atlantic and Canadian Expert Drug Advisory Committees.

QUESTIONS AND ANSWERS

PEI Drug Programs – April 11, 2006

1. What is the process to add drugs to the PEI Drug Programs formulary?

The coverage of all new medications for PEI programs must be approved by the Minister of Social Services and Seniors based upon recommendations received from one of two expert advisory committees - the Atlantic Expert Advisory Committee (AEAC) and the Canadian Expert Drug Advisory Committee (CEDAC).

Both committees are made up of physicians, pharmacists, pharmacologists, health economists, and other drug review experts. They have been mandated by the respective federal, provincial, and territorial governments to review new drugs and provide evidence-based drug listing recommendations to the participating government drug programs.

The CEDAC currently reviews all new pharmaceutical products that are completely new to Canada or new products made up of a combination of new or existing medications. The AEAC reviews new products that are not reviewed by the CEDAC (e.g. new dosage forms of existing medications) and new uses for existing medications, and also does retrospective reviews of entire classes of medications. Over time, the CEDAC will expand the types of products that it reviews until eventually it will completely replace the AEAC.

The AEAC and CEDAC base their reviews upon a combination of published and unpublished clinical trials information submitted by the manufacturer, the available medical literature, the clinical experience of committee members, and input from recognized medical specialists in the use of the medication being reviewed. Criteria that are considered include: Clinical studies, demonstrating the safety and efficacy of the drug in appropriate patient populations; therapeutic advantages and disadvantages relative to accepted alternative therapies; and cost-effectiveness relative to accepted alternative therapies.

The committees can make the following recommendations regarding the coverage of new products:

Coverage be provided to anyone eligible for coverage by an appropriate drug program;

Coverage be provided under an appropriate drug program, but only to people meeting specific medical criteria (e.g. have a specific medical condition or have failed another therapy);

Coverage not be provided to anyone

More information on the CEDAC can be found at www.cadth.ca/index.php/en/cdr. More information on the AEAC can be found at www.gov.ns.ca/health/pharmacare/acdr.htm.

Participating jurisdictions make their own decisions regarding the coverage of medications that have been reviewed by either process. However, in most jurisdictions, including PEI, coverage of new products is limited to where either committee has recommended that coverage be provided. Coverage is not provided for products where either committee has recommended that coverage not be provided.

Once a new drug has been approved by the Minister, it takes a minimum of one month for coverage to become effective. This time is needed to notify pharmacies and prescribers and make any needed changes to the computerized adjudication system used by pharmacies. A minimum of three months may be needed where a new program or processes have to be introduced.

2. What is the 2006/07 budget of the PEI Drug Programs?

Program -- 2006/07 expenditure -- 2000/01 expenditure

Seniors Program -- $10,976,000 -- $ 6,381,400

MS Program -- $ 684,100 -- $ 600,000

Family Health Benefit Program -- $ 246,700 -- $ 55,000

Financial Assistance Program -- $ 5,857,000 -- $ 3,400,000

Diabetes Control Program -- $ 1,079,000 -- $ 892,000

Private Nursing Home Program -- $ 528,400 -- n/a***

High Cost Drugs -- $ 669,000 -- n/a

Other Programs* -- $ 3,163,800 -- $ 2,377,900

Total -- $ 22,535,000** -- $14,380,400

* Includes HIV/AIDS, Cystic Fibrosis, Hepatitis, Addictions, Corrections, etc.

** Excludes costs of administration, materials, salaries, etc.

*** N/A programs not available in 2002/01

3. What new drugs are included in the $669,000 for High Cost Drugs?

The $669,000 represents additional funding for the coverage of five diabetes drugs, Actos, Amaryl, Avandia, Diamicron, and Prandase, and two cancer drugs, Gleevec and Xeloda.

4. How will coverage for these new medications be provided?

Amaryl, Diamicron, and Prandase: Amaryl, Diamicron, and Prandase will be added to the oral diabetes medications covered by the Diabetes Control Program, effective May 1, 2006. Patients approved for coverage through the Diabetes Control Program will be able to obtain up to a 90-day supply of these medications from any PEI community retail pharmacy upon payment of an $11.00 per prescription co-pay.

Actos and Avandia: Income-based coverage of Actos and Avandia will be added to the Diabetes Control Program, effective July 1, 2006.

Physicians must apply for coverage for their patients through the Exceptional Drug Request (EDR) process. Coverage will be limited to patients diagnosed with Type II diabetes and whose blood sugars are not controlled by other oral diabetes medications or are unable to take other oral diabetes medications.

Approved patients will be able to obtain up to a 30-day supply of these medications from any PEI community retail pharmacy upon payment of an income-based co-pay plus the pharmacy fee for each prescription obtained. The co-pay is based upon total net family income, similar to that currently paid by Islanders using the Multiple Sclerosis Medications Program. Depending upon family income, the co-pay will range from $2.00 per prescription, to the full cost of the prescription.

Patients will be required to apply to the Drug Programs and provide copies of recent Canada Revenue Agency Notices of Assessment or Re-Assessment for each person in the household completing an income tax return in the previous year.

Gleevec and Xeloda: Effective May 1, 2006, income-based coverage of Gleevec and Xeloda will be available to PEI residents diagnosed with certain types of cancer and who meet medical criteria currently being developed in consultation with oncologists at the PEI Cancer Treatment Centre.

Oncologists must apply for coverage for their patients through the Exceptional Drug Request (EDR) process.

Approved patients will be able to obtain up to a 30-day supply of these medications from any PEI community retail pharmacy upon payment of an income-based copay plus the pharmacy fee for each prescription obtained. The co-pay is based upon total net family income, similar to that currently paid by Islanders using the Multiple Sclerosis Medications Program. Depending upon family income, the co-pay will range from $2.00 per prescription, to the full cost of the prescription.

Patients will be required to apply to the Drug Programs and provide copies of recent Canada Revenue Agency Notices of Assessment or Re-Assessment for each person in the household completing an income tax return in the previous year.

More information will be made available as the details of coverage are developed.

5. What is the Exceptional Drug Request Process?

Most government drug programs across Canada have similar special authorization processes in place. In PEI, the Exceptional Drug Request (EDR) process allows for coverage of drugs where:

• Specific medical criteria for coverage must be met before coverage will be provided.

• Alternative medications listed in the Drug Programs Formulary are ineffective or are contraindicated.

• There are no alternative medications listed in the Drug Programs Formulary.

Physicians, dentists, and nurse practitioners must apply for coverage by sending a completed Exceptional Drug Request Form to the Drug Programs Office.

All EDRs are reviewed by pharmacists and physicians associated with the drug programs. Outside experts are consulted as needed.

Coverage under the EDR process may be approved for up to two years. A new EDR is required to renew coverage.

EDRs will only considered under the AIDS/HIV, Family Health Benefit, Financial Assistance, Nursing Home, and Seniors Programs.

EDRs will not be considered for:

• Drugs that have not yet been reviewed by either the AEAC or CEDAC.

• Drugs where either the AEAC or CEDAC have recommended that coverage not be provided.

• Uses that have not been approved by Health Canada.

• Drugs that are specifically excluded from coverage by the drug programs.