Crohn's Disease falls under Inflammatory bowel disease (IBD). IBD is at least two, separate disorders that cause inflammation (redness and swelling) and ulceration (sores) of the small and large intestines. These two disorders are called ulcerative colitis and Crohn's disease.
Inflammatory bowel disease (IBD) is at least two, separate disorders that cause inflammation (redness and swelling) and ulceration (sores) of the small and large intestines. These two disorders are called ulcerative colitis and Crohn's disease.
Crohn's disease can occur anywhere in the digestive tract but is common in the lower small bowel (ileum) or large bowel.
Malnutrition and blood disorders are common conditions in Crohn's Disease patients found to be caused by avoiding food items either because of existing symptoms or concern that they may bring on symptoms. Almost half of Crohn's Disease patients have additional health issues affecting their joints, skin, eyes, and biliary tract that may be more debilitating than the bowel symptoms.
Canada has one of the highest incidence and prevalence rates of IBD in the world with more than 200,000 Canadians living with the disease. These disorders are expensive and can be debilitating. The total direct and indirect costs of IBD are $1.8 billion with the main indirect cost being related to long-term work loss. The average age for people developing IBD often coincides with the most important socioeconomic period of life. The severity of symptoms may prevent those with IBD from realizing their career potential or family creation.
BC Biosimilars Initiative: Phase Two – Information
CDHF is Canada’s trusted source for timely information on the BC Biosimilars Initiative: Phase Two
What is Changing?
BC PharmaCare coverage is changing for people who take Remicade® (infliximab) for the treatment of Crohn’s disease or ulcerative colitis.
Patients currently receiving the biologic drug infliximab, marketed as Remicade®, will see this coverage discontinued, with new coverage provided for the biosimilar versions of infliximab: Inflectra® and Renflexis™.
If you are currently receiving Remicade® to treat your Crohn’s disease or ulcerative colitis and you depend on BC PharmaCare coverage, you need to make an appointment with your gastroenterologist (GI) to discuss this policy change.
Between September 5, 2019 and March 5, 2020 anyone with existing Special Authority coverage for Remicade® will be required to switch to either Inflectra® or Renflexis™. This provides a six-month time frame to switch to the new biosimilar.
As of March 6th, 2020, BC PharmaCare will only cover the biosimilar versions of infliximab: Inflectra® and Renflexis™, for patients living with Crohn’s disease or ulcerative colitis.
BC Pharmacare will consider requests from physicians for patients with exceptional medical requirements that may prevent them from switching to a biosimilar.
What is a Biosimilar?
A biosimilar is a drug proven to be highly similar to a biologic drug that has been authorized for sale in Canada (known as the reference or originator biologic drug).
Biosimilars have been approved by Health Canada based on a thorough comparison to a reference biologic drug and may enter the market after the reference biologic drugs’ patents and data protection has expired.
Biosimilar products first entered the Canadian market in 2009. Health Canada has already approved 15 biosimilars including 3 anti-TNF therapies: INFLECTRA® (inflixmab), RENFLEXIS® (infliximab) and HADLIMA® (adalimumab).
Quality and Safety Around Biosimilars
To be approved in Canada, a biosimilar must be proven to have no clinically meaningful differences to the reference biologic. This means, studies of the biosimilar MUST show that there are no differences in outcomes for patients taking a biosimilar, compared to those taking a reference biologic drug.
Rigorous standards for authorization by Health Canada mean that patients and health care providers can have the same confidence in the quality, safety and efficacy of a biosimilar.
Transitioning to a Biosimilar is Safe and Effective
Health Canada supports switching from a biologic to a biosimilar and considers that a one-time switch from a reference biologic drug to a biosimilar to be acceptable. Health Canada also recommends that the decision to switch be made by the physician/prescriber and patient, taking into account any policies of the relevant jurisdiction.
Have you already been switched/transitioned to a biosimilar version of Remicade® (infliximab)?
Biologic (reference) drugs are medications made by using living organisms (such as yeast or animal cells) to produce complex proteins that are purified then administered to affect certain processes in the human body.
2. What is a Biosimilar?
A biosimilar is a drug demonstrated to be highly similar to a biologic (reference) drug, that has been authorized for sale in Canada.
3. What do experts say about the safety and efficacy of biosimilars?
Health Canada is responsible for ensuring the safety, efficacy, and quality of all new drugs including biologics and biosimilars. For a biosimilar drug to be approved in Canada, Health Canada must find no meaningful differences in safety and effectiveness compared to the biologic. The biosimilars involved in BC PharmaCare’s Biosimilars Initiative have been approved by Health Canada and are already in widespread use.
4. Do I have to switch to a biosimilar?
If you receive coverage through BC PharmaCare and you currently take Remicade® for the treatment of Crohn’s disease or ulcerative colitis, you must switch to the biosimilar version before the end of the transition period (March 5, 2020) to avoid any disruption to your coverage.
There may be medical reasons why some patients cannot switch to a biosimilar. Your gastroenterologist can help you determine if it is medically necessary to remain on a biologic (originator) drug. Your gastroenterologist can submit a Special Authority Request to ask BC PharmaCare to consider continued coverage of the reference biologic drug.
5. What are the benefits of biosimilars?
Biosimilars are developed and approved based in part on data generated during the research and development of the reference biologic drug. Extensive structural and functional studies demonstrate a high degree of similarity between the biosimilar and reference biologic drug, with clinical trials in humans confirming no clinically meaningful difference in efficacy. The difference in development processes allow for biosimilars to be launched at lower prices than the reference biologics representing the potential for major cost savings that can be reinvested into the healthcare system.
Due to the cost savings provided by biosimilars, the launch of infliximab biosimilars in Canada allowed Ulcerative Colitis patients in BC, QC, NB, NS, and NL to have access to infliximab for the first time. The reference biologic (Remicade®) was not covered for Ulcerative Colitis in these provinces.
A healthy and competitive drug market can support more manufacturers to produce new and affordable drugs. Biosimilars will enable patients to have access to many other life-saving treatments. Phase 1 of BC Biosimilar Initiatives allowed BC Pharmacare to cover 2 new innovative medicines for patients with diabetes and psoriatic arthritis (Taltz and Jardiance). Phase 1 also provided Accelerated Access to biologics for Rheumatology patients.
6. Why is coverage changing in BC?
As new treatments are developed, BC PharmaCare must review which drugs are covered and carefully consider how to best meet the needs of B.C. residents. Since the introduction of biologic drugs in the 1980s, these treatments have become the biggest drug expense in Canada. As patents on biologic drugs begin to expire, other manufacturers can start producing highly similar versions of the medication with no differences, at a much lower cost. These versions are called biosimilars. Remicade is B.C.’s second largest biologic expense. By switching to a biosimilar version, you are helping save millions of dollars every year. This is an opportunity to maximize resources, expand coverage for new treatments, and improve patient access to more medications.
7. How do I maintain my Infliximab® coverage?
To maintain your coverage:
Make an appointment to speak with your GI who prescribes your Remicade® to discuss switching from Remicade® to Inflectra® or Renflexis®
Your GI can explain the switch process, answer any questions you may have, register you with the new patient support program, have your new prescription into place.
Make sure you have spoken with your GI and initiated your biosimilar switch by March 5th, 2020.
8. Are there patient support programs?
Yes. Biosimilar manufacturers are providing patient support programs (PSP) and services, and access to infusion centres similar to that of the reference biologic drug . Your prescriber can initiate the enrolment process into a PSP for you, if applicable.
The prevalence of Crohn’s disase in Canada is reported to be 319 per 100,000 individuals. (Ng et al. 2018)
In 2012, approximately 129,000 people lived with Crohn’s disease in Canada, with an estimated 5,700 new cases annually. (Crohn’s and Colitis Foundation of Canada 2012)
People with Crohn’s disease have an elevated risk of premature death (47% higher) and colorectal cancer than the general population. (Crohn’s and Colitis Foundation of Canada 2012)
In 2008, physician visits were estimated to cost the Canadian health care system $80 million/year for Crohn’s disease. (Fedorak et al. 2010)
In 2012, total indirect costs for Crohn’s disease were estimated to be $869 million. (Crohn’s and Colitis Foundation of Canada 2012)
For more information, see Inflammatory Bowel Disease.
Fedorak RN et al. Canadian Digestive Health Foundation Public Impact Series 4: Inflammatory bowel disease in Canada. Incidence, prevalence, and direct and indirect economic impact. Can J Gastroenterol. 2010 Nov;24(11):651-5.
Ng SC et al. Worldwide incidence and prevalence of inflammatory bowel disease in the 21st century: A systematic review of population-based studies. Lancet. 2018 Dec 23;390(10114):2769-78.
Signs and Symptoms
Many of the symptoms of Crohn's Disease are similar. Symptoms outside the gut may include aching, sore joints, skin and mouth sores and red, inflamed eyes.
The most common symptoms of Crohn's disease are abdominal pain (often in the right, lower area of the abdomen) and diarrhea. There may also be rectal bleeding, weight loss and fever. Children may suffer poor growth.
What risks are associated with Crohn's Disease?
Too many people skip potentially life-saving procedures because of misunderstandings and misconceptions about the bowel prep. However, most people who have had colonoscopies, will tell you it isn't nearly as bad as you think and that the benefits far outweigh the risks.
Tests and Treatment
Treating Crohn's Disease
Although several drugs are useful in controlling these conditions, as yet a cure has not been found. Since the disease is not curable, long-term treatment is often required.
Medications
These include anti-inflammatory drugs (sulfasalazine/5-ASA), corticosteroids (prednisone and budesonide),immunosuppressives (methotrexate and azathioprine) and immunomodulatory agents (infliximab). Some of these may be given by different methods including oral, rectal and intravenously. Antibiotics may be useful in certain circumstances for Crohn's disease.
Benefits and Risk Assessment Tool
Click through our online e-learning tool below to explore the different medications and treatment options for IBD. Remember, no treatment is NOT an option!
Sometimes, additional action may be required to achieve remission. Below are some auxiliary treatment options that may be suggested by your doctor.
Symptomatic treatment
Specific medications are used to treat diarrhea and abdominal cramps. Anti-diarrheal drugs slow the muscles of the intestine which in turn slow the passage of stool through the body and help with diarrhea. While abdominal pain often occurs with IBD, it is important to note that the pain is a consequence of the disease and, if treated appropriately, the pain should subside. People with IBD should be careful to avoid taking an excess of pain killers and anti-diarrheal drugs since this may lead to complications.
Dietary treatment
Diet alone is not effective in treating Crohn's disease or ulcerative colitis. However, it is important that patients with IBD have a well-balanced diet. Calcium is important to protect bones. Fibre may not be tolerated during flare ups. Certain vitamins (for example, B12) may be required. Selected patients may sometimes be helped by a registered dietitian.
Surgery
People with both Crohn's disease and ulcerative colitis may need surgery at some point in their lives. Surgery is less common in ulcerative colitis than in Crohn's disease and is often performed when ulcerative colitis is no longer responding to medical treatment. Unlike Crohn's disease, surgery will cure ulcerative colitis by removing all diseased bowel. With the colon being completely removed the patient may require an ileostomy (bag outside the body to collect waste) or a second operation to form a new rectum (called a pouch procedure). Despite all of the advances in medical research over the last several decades, we still do not know the cause of IBD and much further research is required.
Testing for Crohn's Disease
Tests are needed to determine whether the patient has ulcerative colitis or Crohn's disease and to rule out other causes. To diagnose these disorders the doctor will take a complete history and perform a physical examination. In addition, blood tests are used to find out if you are anemic (low blood count) as a result of blood loss, or if there is an increased number of white blood cells in your body, suggesting an inflammatory process
Stool samples can tell your doctor if there is blood loss or if an infection by a parasite or bacteria is causing some of your symptoms.
The doctor may also look inside your rectum and large bowel through a long, flexible video camera called an endoscope. During this safe procedure, samples of the lining of the intestine (biopsies) may be taken to be looked at under the microscope.
On some occasions an X-ray exam may be required. This is done by putting barium (a white chalky solution) into the upper intestine (swallowing barium) or by putting the barium into the bowel by inserting a tube into the anus
Living Positively
Crohn's is a chronic (long-term) condition with symptoms that can disappear and then flare up again throughout your life. Living with the unpredictable nature of Crohn's can pose physical and emotional challenges that may seem overwhelming at times. However, there are several things that you can do to contribute to your health and well-being.
Be informed, proactive, and involved in your care. By establishing a solid partnership with your health care team, developing coping skills, and maintaining a positive outlook, it is possible to stay healthy and happy, despite living with ulcerative colitis.
Diet and lifestyle changes
Although diet and stress do not cause ulcerative colitis, there may be times when changes in your lifestyle may help control your symptoms and lengthen the time between flare-ups. The following changes may help to ease your symptoms:
Limit milk/dairy products. If you are lactose intolerant (cannot digest the sugar in milk), milk and dairy products can produce symptoms of excess gas and diarrhea.
Restrict intake of certain high-fibre foods: such as nuts, seeds, and raw vegetables.
Limit intake of caffeine, alcohol, carbonated drinks and fatty foods. .
Eat small, frequent meals, rather than large meals..
Exercise regularly to promote movement of the colon and reduce stress..
Minimize stress. Yoga, meditation and slow, relaxed breathing techniques can help people with ulcerative colitis manage stress..
Ask your doctor or pharmacist if one of these formulations may be right for you. It is important to take the probiotic in the dose and duration recommended by the manufacturer to achieve the best results.
FAQs
Am I going to get cancer because I have Crohn's Disease?
People with Crohn's Disease are at an increased risk of developing colon cancer. Having regular endoscopies will help identify polyps that could potentially develop into cancer.
Does diet affect Crohn's Disease?
Diet alone is not effective in treating Crohn's disease. However, it is important that patients with Crohn's Disease have a well-balanced diet. Calcium is important to protect bones. Fibre may not be tolerated during flare ups. Certain vitamins (for example, B12) may be required. Selected patients may sometimes be helped by a registered dietitian.
How is IBD different than IBS?
Although both illnesses can be seriously debilitating, there are several primary differences between Inflammatory Bowel Disease (IBD) and Irritable Bowel Syndrome (IBS). IBD is an autoimmune disorder that causes swelling and ulcerations (sores) in the bowel. IBS involves problems with motility (how the bowel moves contents through our intestines) and sensitivity (how the brain interprets sensations in the bowel). Symptoms of IBS may wax and wane and possibly disappear altogether whereas IBD is a chronic condition.
Benefit and Risk Assessment Tool for IBD Treatments
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Making informed decisions is imperative to your good health but understanding the benefits and risks associated with IBD therapy options can be challenging. CDHF developed the IBD e-BRAT – a tool to help you learn more about common risks as well as important benefits around the therapy options. Explore your options on the tool now!
This e-learning tool was made possible due to an unrestricted educational grant from Pfizer Canada
What’s Health Canada Saying about Biosimilars? Infographic
IBD Treatments and Pregnancy
https://www.youtube.com/watch?v=UnhyzoKCjck
At the 2016 CDHF Healthy Gut Summit, Dr. Vivian Huang gave an interesting presentation on what Inflammatory Bowel Disease (IBD) is, the treatments available, and specifically how IBD affects pregnancy.
Living with Crohn’s Disease Infographic
Fecal Calprotectin: The Inside Story On Inflammation
If you have IBD, you know the painful symptoms you suffer from during a flare are caused by inflammation. Wouldn’t it be great to know -- in advance -- if a flare was on its way, so that you could prevent it from happening! Well, a safe, simple, non-invasive test could help you do just that! Watch the CDHF's latest animation on the Fecal CalProtectin -- or fCal -- test now.
Uncovering Biologics: Your IBD BodyGuard!
https://www.youtube.com/watch?v=wUdtfvOkF0s
If you have Inflammatory Bowel Disease (IBD), you know that taking medication to manage your symptoms and prevent flares is imperative. Your doctor may prescribe a biologic if you have moderate to severe Crohn's Disease or Ulceractive Colitis. Watch the CDHF’s latest animation on biologics and learn how they can protect you from the painful and debilitating symptoms of IBD.
IBD Treatment Options: Understanding Your Benefits and Risks Animation
https://www.youtube.com/watch?v=evV_Dngm-IQ
Making informed decisions is imperative to your good health but understanding the benefits and risks associated with IBD therapy options can be challenging. CDHF developed the IBD BRAT - a tool to help you learn more about common risks as well as important benefits around the therapy options. Watch this animation for an overview now.
Inflammatory Bowel Disease with Dr. Mike Evans
https://www.youtube.com/watch?v=Keqzt83KMVA
Helping you understand the details of IBD. Dr. Mike Evans is founder of the Health Design Lab at the Li Ka Shing Knowledge Institute, an Associate Professor of Family Medicine and Public Health at the University of Toronto, and a staff physician at St. Michael's Hospital.
A biosimilar biologic drug, or biosimilar, is a drug demonstrated to be highly similar to a biologic drug that was already authorized for sale (known as the reference biologic drug). Biosimilars are approved based on a thorough comparison to a reference drug and may enter the market after the expiry of reference drug patents and data protection. Watch this video to get more insight into what Health Canada is saying about biosimilars!
Pediatric Inflammatory Bowel Disease – Dr. Thomas Walters
https://www.youtube.com/watch?v=CoKuPsG01vo
Dr. Walters presentation on pediatric inflammatory bowel disease at CDHF's Digestive Health in Children and Adolescents Public Forum.
Webseminar: Understanding the Benefits and Risks of IBD Therapies
https://www.youtube.com/watch?v=gPoES4-eisA
This empowering session reviewed the basics of IBD, outlined the benefits and risks of medications used to treat ulcerative colitis and Crohn’s disease and answered the many questions of attendees. Special thanks to Dr. Talat Bessissow for sharing his insights and expertise and to AbbVie Inc. for sponsoring our IBD Treatment Options Webseminar.
Biosimilars for IBD: Making the Transition Webinar
[embed]https://www.youtube.com/watch?v=XG3F9LyMS5g&feature=youtu.be[/embed]
On May 28th, Dr. McCurdy answered the following questions in a very informative webinar presentation on Biosimilars:
What’s the difference between a reference biologic drug and a biosimilar?
Biosimilars: What’s Health Canada saying?
What is the clinical evidence to date?
How do doctors go about transitioning their patients from a reference biologic drug to a biosimilar?
Watch this webinar now!
Hot off the Presses: The Latest IBD Information from Scientific Meetings with Dr. Silverberg Webinar
[embed]https://www.youtube.com/watch?v=HAG6qYhkyv4[/embed]
In this educational webinar, Dr. Silverberg reviewed the most recent scientific findings in Inflammatory Bowel Disease (IBD) and discussed the role of diet and gut bacteria in IBD. Watch the recording of this webinar now.
Transition Pathway Brochure for IBD Patients
Helping inflammatory bowel disease (IBD) patients best understand transitioning/switching from a reference biologic to a biosimilar.
BC Biosimilars Initiative: Phase Two – Infographics
IBD: Switching from a Biologic to a Biosimilar
Having to change any kind of medication can be very stressful. While CDHF believes in patient-physician choice, we acknowledge political policy decisions and our organization is committed to providing clear and unbiased information and resources for patients. Both biologics and biosimilars have gone through rigorous standards for authorization by Health Canada, to which both have been found safe and effective for use in Inflammatory Bowel Disease (IBD). Watch this video to learn more about switching from a biologic to a biosimilar.
Have you been switched/transitioned to a biosimilar version of Remicade® (infliximab)?
Patient Survey
BC PharmaCare coverage is changing for people who take Remicade® (infliximab) for the treatment of Crohn's disease or ulcerative colitis.
In light of this, CDHF wants to understand the recent experiences of people living in Canada who have switched/transitioned from Remicade® (infliximab) to the biosimilar versions of infliximab: Inflectra® and Renflexis™.
If you haven't been asked to switch/transition yet, please note that we will keep this survey open for a few months so you can come back to it and complete it.This survey is only for people living in the Canada, aged 18+ who have switched/transitioned from the biologic Remicade to the biosimilar Inflectra® or Renflexis™.
The final anonymous results will be shared with health care professionals, and the public.
If you have any questions, please email Kelsey@CDHF.ca
To find out more about the BC Biosimilars Initative: Phase Two, visit our information page here.
