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JointHealth™ insight   September/October 2007


This special edition of JointHealth monthly is full of important medication information. In this issue, we are pleased to include the JointHealth Arthritis Medications Guide, an easy to read guide to medications currently used to treat arthritis. Also included are a report card on provincial medication reimbursement plans, as well as information about the levels of medication review in Canada, and helpful tips about making your own medication decisions.


Advocacy

JointHealth™ Arthritis Medication Guide

Arthritis medications in Canada


In a recent survey conducted by Arthritis Consumer Experts and other arthritis consumer organizations, people living with arthritis overwhelmingly reported that medications are their most important weapon in their fight against arthritis.

New advances, along with a better understanding of combination medication therapy, are allowing people with arthritis to live healthier, more productive lives. Advances in the area of disease-modifying anti-rheumatic medications (or "DMARDs") and more specifically biologic response modifiers (or "biologics") have made an incredible difference in the lives of thousands of people living with inflammatory forms of arthritis. While there are no cures for the over 100 types of arthritis, scientific advances and vastly improved treatments are making a difference for many living with the disease today.

Tragically, thousands of Canadians who depend on financial assistance from provincial medication benefit plans do not have access to new or improved medications. Through lengthy bureaucratic reviews or "do not list" decisions, provincial and territorial governments are denying reimbursement for arthritis medications proved safe, effective and cost-effective to people who need them the most.

Across the country, provincial medication benefit plan coverage for arthritis medications varies widely. For example, people living with ankylosing spondylitis in British Columbia have no provincial coverage for any biologic response modifier (or "biologic"). People living in Ontario have case-by-case coverage for two biologics, and those living in Quebec are covered for three.

In many provinces, review times are another critical issue. In some cases, provinces are taking years to review new medications after they have been reviewed and approved by Health Canada. This means that while people with arthritis are living with crippling pain and joint damage, the provinces are undertaking unreasonably long reviews of medications which have already been reviewed at least twice at the federal level. Unlike in cancer and HIV and AIDS where medications are reviewed in a timely fashion, arthritis medication reviews are among the slowest, a possible sign of discrimination given that many forms of arthritis also have devastating health consequences. For more information about the levels of prescription medication review in Canada, please see the article entitled "the medication review process in Canada: A long and winding road" in this guide.

The bottom line is this: medications are a critically important tool for treating crippling, debilitating forms of arthritis and across the country and people with arthritis who depend on financial assistance from their provincial medication benefit plan are being routinely denied the medications arthritis specialists say they need. It is for these reasons that ACE has created the JointHealth™ Arthritis Medications Guide.

In this 10-page JointHealth™ Arthritis Medications Guide, you will find a chart listing important information about the medications used to treat arthritis in Canada. Click here to view the arthritis medications chart. As well, the guide includes a "Report Card" on provincial formulary reimbursement listings for biologic response modifiers for each of the provinces and territories in Canada. The Report Card, is an easy reference guide informing you about how your province compares to others in terms of review times and listing decisions (both the medications chart and Report Card are located on an easy-to-read pull-out sheet). We have also included an in-depth article on what to consider when making decisions about medications, and an article about the various steps involved in reviewing medications in Canada.


Advocacy

Report Card on provincial formulary reimbursement listings for biologic response modifiers

Arthritis Consumer Experts believes that you, the arthritis consumer and patient, play a vitally important role in developing and implementing your own treatment plan. Biologic response modifiers (or "biologics") are the newest and most effective class of treatments available to fight potentially devastating forms of inflammatory arthritis, like rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis.

Despite the critical need for provincial medication reimbursement plan coverage for biologics to treat moderate to severe rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis, listings vary widely from province to province. In many provinces, biologics are not covered for treatment of psoriatic arthritis or ankylosing spondylitis.

There is strong scientific proof that biologics deliver incredible value, medically and socially. Given their importance to patients in need, ACE is urging provincial ministries of health across Canada to list all Health Canada-approved biologics on their provincial medication plan or expand their listing criteria when it does not meet the "best practice" guidelines recommended by the Canadian Rheumatology Association. Please note that information provided on biologic response modifiers listed is for rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis only. Biologic response modifiers are also being successfully used to treat other forms of arthritis including juvenile idiopathic arthritis, Still's disease and lupus, to name a few.

To view the report card, click here.

Tips for reading the report card

Here are a few definitions that will be helpful to you when reading the Report Card.
  • NOC stands for "notice of compliance". This notice is issued by Health Canada under the Food and Drug Regulations. The issuance of an NOC indicates that a medication meets the required Health Canada standards for safety and efficacy, and approved for sale in Canada. For more information please click here.

  • Under review means that this medication has been approved by Health Canada and the province is currently deciding whether or not to reimburse for this medication.

  • In clinical trials means that this medication is undergoing testing for use in treating this disease type.

  • Listing status unknown means there is no public information available

  • Declined listing means that the formulary has decided not to reimburse patients being prescribed this medication.

  • Case by case (or CBC): Each province and territory has a process by which medications that are not normally included in the provincial, territorial or federal drug benefit lists are covered (or reimbursed). For the purposes of this report card, we have referred to these as case by case (or CBC) approvals. These differ from province to province; in all, there are three categories across the country:
    • SA stands for "special authority" (applicable in British Columbia, Alberta, New Brunswick)
    • EDS stands for "exceptional drug status" (applicable in Saskatchewan, Manitoba, Quebec, Newfoundland, Nova Scotia, Prince Edward Island, Yukon, Northwest Territories, Nunavut)
    • ICR stands for "individual clinical review" (applicable in Ontario)
    In general, the provinces will reimburse for medications in these categories only when a patient's rheumatologist provides details of the patient's condition and reasons for needing this medication. In some cases, special requirements must be met before approval is granted.

If, while reading this report card, you find that your province's performance is unacceptable, we urge you to write to your provincial minister of health and ask them to list all Health Canada-approved biologics on their provincial medication plan or expand their listing criteria when it does not meet with "best practice" guidelines in place around the world.


Education

Arthritis medications: Getting the facts

Medications are often a critically important part of a successful arthritis treatment plan, and new advancements in medication treatments have expanded the options available to people living with arthritis. That said, decisions around medications can be very difficult to make. Getting all the facts about the medication choices available to you will help you to feel more comfortable and confident in your decision.

Once your doctor has made a medication recommendation, it is up to you to decide what is best for you, your family, and your life. You and your doctor should discuss the pros and cons of using the recommended medication, and you need to get all the information you can.

Here are some facts to get from your physician (along with other credible sources of information) before making a medication decision:
  • The generic and brand name of the medication(s) being recommended
  • The full list of medications in the "class" of the recommended medication
  • An explanation why a particular medication or combination of medications is being recommended over another
  • A full list of the benefits and risks of the recommended medication
  • What the most common and most serious side effects are
  • What to do if you develop side effects
  • How long you will have to take the medication
  • A list of the benefits and risks of the other medications in the "class" of the recommended medication
  • What will happen if you do not take the recommended medication
  • A list of non-medication treatment options to try in addition with the recommended medication
Once you have this information, you will be better able to discuss with your physician the full range of choices available to you and make an informed decision.

It is important to remember that in the end, while it is great to have reliable information, advice and support, a good decision for yourself is one that comes free from pressure from others. Making a decision to start a medication is your personal choice, no one else's.

Your Responsibilities

Once you make an informed decision to start a medication that decision comes with responsibilities. These include:
  • Agreeing to take the medication as prescribed
  • Getting side-effect monitoring tests done as ordered by your physician
  • Keeping track of health improvements while on the medication and reporting them to your physician at each follow-up visit
  • Reporting any uncommon or worrisome side effects you may experience to your physician right away
  • Storing the medication as instructed by your pharmacist, and paying careful attention to keeping the medication out of the reach of infants and children.
Sticking with it

In terms of "sticking with" a medication, the research shows that the single most important step a person can take is to develop a good relationship with their physician. Contrary to popular belief, a person who asks questions of their physician is viewed more positively by that physician, not as someone who is challenging their medical expertise or authority. When you have a strong working relationship with your doctor, you will be more likely to follow the treatment plan you have designed together.

Reaching an agreement with your physician about your diagnosis is another important factor in sticking with a medication. Clearly, if a person does not agree with a physician's diagnosis, then they will not have the confidence they need to take the medication being recommended.

Also, understanding what the risks are of not treating your arthritis provides you with motivation to "follow doctor's orders". For example, in rheumatoid arthritis, the research is clear that the risk of suffering long-term disability as a result of untreated (or under-treated) disease - and even premature death - is substantially greater than the risk of serious side effects from medication therapy. Knowing what the "stakes" are in terms of health outcomes is critical when it comes to medications.

Lastly, clearly understanding what the goals are of the medication therapy will help you to assess whether it is working or not. This knowledge translates into feelings of power and control over your arthritis. In the end, only you - in close consultation with your physician - can make informed decisions about starting, tapering off, or stopping medications.


Advocacy

The medication review process in Canada: A long and winding road

To understand the reasons for inconsistency and delay in reimbursement coverage for medications in Canada, it is helpful to understand the series of reviews a medication must undergo before a provincial medication benefit listing is determined.

It works like this:

First, a drug must be approved by Health Canada for use in a specific disease. For Health Canada to approve a medication, it must be proved safe and effective through extensive clinical trial testing conducted by the manufacturer. If the clinical trial results are positive, Health Canada issues a Notice of Compliance (or "NOC") and the medication can be sold in Canada.

If or when a NOC is issued for a new medication, the manufacturer voluntarily applies to the federal/provincial/territorial governed Common Drug Review (or "CDR") for an assessment of their product's cost effectiveness. The CDR assesses whether the new medication is significantly better than older, less expensive ones. Based on their findings, the CDR makes a "list", "list with conditions", or "do not list recommendation" to provincial and territorial drug benefit plans.

With a CDR recommendation in hand, the manufacturer voluntarily applies to individual provinces or territories to receive a drug benefit plan listing decision. Each province has their own system - some more complicated and time onerous than others - for making these decisions. A number of provinces routinely take years to conduct their review.

It should be noted that the CDR process was developed in 2003, and that a key piece of its mandate was to reduce review times. However, review times have further lengthened from pre-CDR times.


Special section
Report card on provincial formulary reimbursement listings

Arthritis medications chart


Acknowledgement

Over the past 12 months, ACE received unrestricted grants-in-aid from: Abbott Laboratories Ltd., Amgen Canada / Wyeth Pharmaceuticals, Arthritis Research Centre of Canada, AstraZeneca Canada Inc., Bristol-Myers Squibb Canada, GlaxoSmithKline, Hoffman-La Roche Ltd., Merck Frosst Canada, Pfizer Canada, and Schering Canada.

ACE thanks these private and public organizations.