Section 1 General Information
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1 Section 1 General Information Name of the drug CDR is reviewing and indication(s) of interest Name of patient group Name of primary contact for this submission Name of author (if different) Position or title with patient group Patient group s contact information: Telephone number(s) Telephone Address Website Actemera Rheumatoid Arthritis The Arthritis Society Lynn Moore Director, Public Affairs lmoore@arthritis.ca X347 As above As above 393 University Ave, Ste Toronto ON M5G 1E Submitting Organization The Arthritis Society is Canada s principal health charity providing vital information and programs to the millions of Canadians with arthritis. Since 1948, The Society has invested more than $170 million towards innovative research projects that are searching for the causes of, and better treatments for, arthritis. This investment is also used to train rheumatologists, ensuring Canadians can receive the specialized care they need. Annually, The Arthritis Society touches more than 80,000 Canadians with arthritis through the education and services it offers. 1.2 Conflict of Interest Declarations The Society receives funding support from Hoffmann La Roche Limited in the form of sponsorships and unrestricted educational grants. The Society receives similar support from a number of other pharmaceutical organizations, but the vast majority of its funding comes from donors. Hoffmann La Roche Limited played no role whatsoever in compiling this submission. Section 2 Condition and Current Therapy Related Information 2.1 Information Gathering The information was obtained through a variety of means including: A call to individual patients for input mediated by The Society s National Advocacy Committee and selected Society Divisional staff and volunteers Consultation with Society stakeholders as part of the process of identifying The Society s approach to advocacy relating to drugs Consolidation of existing input on access to drugs from The Society s divisional consultations Anecdotes obtained via the day to day business of The Society, including face to face educational programs run by The Society across Canada, The Society s chat rooms, engagement with Society volunteers who live with various forms of arthritis including Rheumatoid, etc.
2 In many instances the comments are provided exactly as received from people living with arthritis. 2.2 Experience Patients Have with Their Condition Rheumatoid Arthritis affects nearly 1% of Canadian adults, nearly all are women and almost 2/3rds of people with arthritis are of working age. When you have arthritis you live every day with pain and disability. Arthritis is among the top two causes of long term disability. People over 55 who live with arthritis are twice as likely to report a long term disability than Canadians living with another chronic condition, including the big three cancer, cardiovascular disease and diabetes. If you have arthritis you are three times as likely to report living with moderate to severe pain than if you were living with any of the other chronic conditions. Arthritis is reported to be among the most costly of the chronic diseases, and it is generally accepted that the costing available for arthritis is understated. (Arthritis in Canada, 2005) At the present time, there is no known cure for arthritis, but appropriate treatment and management (pharmacological and non pharmacological) have been shown to prevent disability, maintain function and reduce pain. Early diagnosis and timely and right treatment are essential to prevent the irreversible joint damage that all too often results from the inflammation that is the hallmark of Rheumatoid Arthritis. What aspects of this condition are more important to control than others? Joint destruction, pain, fatigue, reduction in range of motion and stiffness. Fatigue and pain are the most debilitating aspects of RA. They impact all aspects of life (physical, social, emotional, and economic) and ultimately independence. How does this condition affect day-to-day life? What people living with Rheumatoid Arthritis tell us: Fatigue that sleep does not satisfy. Chronic pain Can sleep for 14 hours and wake up exhausted One of the most frustrating aspects is the fatigue, complete exhaustion when you have done nothing. So it affects your day to day life because you are unable to get even the smallest things done Swollen, stiff joints that restrict range of motion and impact basic hygiene, grooming, and dressing; Before I was well managed on (biologic), I was unable to brush my hair and teeth or bathe myself. I had to move back home to my parents Joint destruction Depression Decreased libido Inability to participate in activities that make life interesting and meaningful, like family gatherings, hobbies, social events, cultural activities, even a nice dinner out Once I was in the bathtub and realized I could not get out. I had to bang on the wall until a neighbour came to help me Are there activities that the patients are not able to do as a result of the condition? I am no longer able to do the job that I worked so hard to get which is very frustrating Cannot look after my family and be the parent I had hoped to be
3 Shopping and preparing meals Cleaning my home Inability to continue participation in the work force Withdrawal from planning and participating in social activities overwhelmed and unreliable Limits inflicted on ability to continue hobbies and to exercise to full potential Work disability Travel, enjoy retirement Walk for any distance When my arthritis is bad, personal care is very difficult but so is loss of independence Go up and down stairs During a flare, I can t pick up my child, hold a pen, open a jar, or chop vegetables for dinner I was accepted to university on a sports scholarship, and now I m not able to play to the level I need to. I ll be going to school part time next year 2.3 Patients Experience with Current Therapy Essential to have access to a range of Disease Modifying Anti Rheumatic Drugs (DMARDS), including biologics and Methotrexate, so that there are options to allow for individualized approaches to disease management Existing therapies also include Celebrex, Tramacet for acute pain. How effective is the current therapy in controlling the common aspects of this condition? Where they work, current treatments are extremely effective. For others, current treatments are not at all effective, or not effective enough Many patients are not managing their condition as well as they and their physician know is possible. Some have had to leave the workforce and others are finding it difficult to self manage their disease and their overall health using prescribed therapies such as strengthening and cardiovascular exercises and experience muscle weakening thus unstable joints Current treatment is effective, to a point. I will never be able to run across the street or live in a house with stairs, and I m not yet 40 Flares remain unpredictable My treatment is very effective, for now. I m scared it will fail me eventually and I will never be able to find another that works I can feel my (biologic) working immediately during the infusion. It has made a huge difference for me Not enough. I m still not able to walk for more than about a minute at a time Without my current treatment regimen, I feel sure I would not be able to work Are there adverse effects that are more difficult to tolerate than others? Nausea and diarrhea If I try to take a higher dose I have stomach issues Nausea not able to plan to do anything on the day I take methotrexate, so lose a whole day every week to vomiting Huge site reactions from injections Need to go off methotrexate at least three months before starting to try to conceive a child, but going off it makes my disease flare badly (relevant for both men and women)
4 Are there hardships in accessing current therapy? Difficulty in finding or rejection by General Practitioners who do not want to manage a disease that is not controlled and/or time consuming to manage Huge waiting lists for rheumatologists in my area Special authority program in BC means delays in accessing treatment Are there needs, experienced by some or many patients that are not being met by current therapy? What are these needs? For people diagnosed with RA in their 20s and 30s, treatment will be needed over the entire remainder of their lifespan, which could be 50 years or more. As the body may develop a resistance to a medication after several years, it is important that biologics with a variety of targets be made available to people with RA so that their doctors can continue to treat them with the full arsenal of medications available to them Patients need to use a variety of drugs to control their arthritis, some in combinations NSAIDS, DMARDS, biologics, corticosteroids, and natural health products I am terrified that my biologic medication will fail and I won t be able to access another one that will work for me Many patients have tried the other biologic medications and have failed on these medications The new biologic medication may fill the needs of patients who have not responded well or have experienced no significant change in their disease condition / outcome with drugs currently available. The drug will allow physicians and patients another option to stem the devastating effects of RA. It may also slow or induce remission Daily/weekly needles are really difficult if you need to travel for work or for pleasure. They need to be kept chilled and it can be really difficult to take them on airplanes (through security). Getting approval from PharmaCare for enough supply to go on an extended trip is almost impossible 2.4 Impact on Caregivers Caregivers may have to help with needles, which can be tricky and often scary; especially when a needle causes pain to the person you are giving it to. It is awful to hurt the person you are trying to help It s hard on your caregiver when you are vomiting for an entire day because of a medication. They have to plan their life around losing a day (every week) to look after you, or at the very least not be able t count on you to help with family responsibilities Caregivers give the gift of time. The challenge is to find the time to provide care required among their other responsibilities and commitments Caregivers in today s society are required to fill the role of nurse, social worker, personal care attendant, housekeeper, religious adviser, chauffer and the list goes on Caregivers also suffer emotionally when they see the patient suffer knowing that there is little they can do about it because the current treatment regime is not providing the outcomes hoped for. Dose, frequency, and ease of application are concerns for Health Care Providers working within a busy practice, and for caregivers Health Care Provider s knowledge and comfort level in administering the drug and monitoring outcomes will be a factor
5 Section 3 Related Information about the Drug Being Reviewed 3.1 Information Gathering See section 2.1 for this information 3.2 What Are the Expectations for the New Drug or What Experiences Have Patients Had To Date with the New Drug? Rheumatoid Arthritis is a life long condition and often requires complex management, including a regime of powerful drugs that can have multiple affects and interactions. Too many Canadians live with the fear that a drug which has been effective in managing their symptoms can suddenly stop working, requiring a substantial increase in dosage or a change to a new medication. Every day The Arthritis Society sees the difference made by availability of effective medications on Rheumatoid Arthritis. People with Rheumatoid Arthritis who developed the disease before the availability of many of the newer Disease Modifying Anti Rheumatic Drugs (DMARDs) or who have not found a drug or drug combination that works for them have severe and disabling joint damage and can experience episodes of incapacity due to the consequences of their disease. Regularly, we hear these people, who are mostly women as Rheumatoid Arthritis is far more prevalent in women, tell their stories of how they have lost their jobs and struggle to fulfill their family roles or engage in social activities. The Society benefits from their commitment to helping others through volunteering. However, we always have to have a backup plan, as frequently their disease prevents these volunteers from honouring their commitments, or their joint damage does not allow them to complete simple tasks like posting a flip chart page on a wall. A new treatment option can make a profound difference in the lives of these people. Canadians and their physicians must be able to select the approved therapy that is best for the management of arthritis. If a drug is approved by Health Canada to be marketed in Canada ability to pay must not be a barrier to access. b) Based on patients experience with the new drug as part of a clinical trial or through a manufacturer s compassionate supply: No comment Section 4 Additional Information No comment
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