IBD: Crohn’s Disease

IBD: Crohn’s Disease

Alberta Health Biosimilars Initiative

CDHF is Canada’s trusted source for timely information on the Alberta Health Biosimilars Initative

What is Changing?

As of July 1, 2020 Alberta Health will only cover the biosimilar versions of infliximab: Inflectra and Renflexis, for patients living with Crohn’s disease or ulcerative colitis. Those who wish to maintain their Alberta Health coverage for the drug molecule will be required to switch from a biologic drug to the biosimilar by July 1, 2020, to avoid any disruption to coverage.

This initiative will apply to adult members enrolled in one of these government sponsored drug plans provided through Alberta Blue Cross:

Non-Group Coverage (Group 1)
Coverage for Seniors (Group 66)
Palliative Coverage (Group 20514)
Child and Family Services (Group 20403)
Alberta Child Health Benefit (Group 20400)
Children and Youth Services (Group 19824)
Income Support (Group 19823)
Learners Program (Group 22128)
Assured Income for the Severely Handicapped (Group 19823)
Alberta Adult Health Benefit (Group 23609)
If you are currently receiving Remicade® to treat your Crohn’s disease or ulcerative colitis and you depend on Alberta Health coverage, you need to contact with your health care professional to discuss this policy change. An exceptions process will be in place should your prescriber believe there is a medical reason why a patient cannot switch to a biosimilar. For individuals starting a biologic or changing their biologic drug, a tiered framework will apply, requiring patients to try a number of first-line therapeutic options prior to being able to access a second-line agent. Patients and health providers will still have numerous treatment options, including other biologics, covered through the government sponsored drug plans.
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), and RENFLEXIS® (infliximab) with HADLIMA® (adalimumab), which is not commercially available in Canada.

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

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. Once you have switched to a biosimilar version of Remicade® (infliximab) please take our patient survey.

CDHF Resource Links

Learn More

Other Resources

Frequently Asked Questions

1. What is a Biologic?

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.

4. Do I have to switch to a biosimilar?

If you receive coverage through Alberta Health 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 (July 1,  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. An exception process will be in place should a prescriber believe there is a medical reason why their patient cannot switch to a biosimilar.

5. Why is the change happening?

Alberta spent more than $238 million in the 2018 to 2019 fiscal year on biologic drugs, and these costs are increasing every year. Costs per patient for originator biologics can be more than $25,000 per patient per year, with biosimilar versions costing up to 50% less than originator biologics.

Alberta is implementing the Biosimilar Initiative which will save approximately $30 million annually that can be invested into other health care services for Albertans.

6. 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 July 1st, 2020.

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What is 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.

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), and RENFLEXIS® (infliximab) with HADLIMA® (adalimumab), which is not commercially available in Canada.

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

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)?

CDHF Resource Links

Learn More

Other Resource Links


Frequently Asked Questions

1. What is a Biologic?

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.

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Statistics

  • 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.

Citations:

Crohn’s and Colitis Foundation of Canada. 2012. The impact of inflammatory bowel disease in Canada - 2012 Final report and recommendations.http://crohnsandcolitis.ca/Crohns_and_Colitis/documents/reports/ccfc-ibd-impact-report-2012.pdf?ext=.pdf [accessed 3 September 2018]

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.

COVID-19 Helpful Links

Not showing symptoms for COVID-19? You should still be taking care to practice social distancing!

The fact of the matter is, even if you’re not showing any symptoms, you can pass this virus on to people who ARE at risk. This not only means the elderly in our community, but people who are have compromised immune systems. Many IBD patients, for example, are on medications that suppress the immune system, and it’s times like these that we need to band together and think of our neighbours. People who suffer from a chronic underlying conditions chronic respiratory illnesses, diabetes, cancer, etc are also at risk. We must be proactive now and get in front of this pandemic.

Practicing social distancing is the best way possible to keep this virus from spreading and potentially harming more people in our community. If you are not taking immunosuppressive medications and your condition is currently in remission, you are at the same level of risk as the general public, according to Crohn’s and Colitis Canada. However, if you are taking an immunosuppressive medication, make sure to continue taking your medications and prioritize social distancing as soon as you can. 

If you are not showing any symptoms, please refrain from any in person visits with a doctor. Healthcare professionals will be working day and night to help the infected, and they must prioritize at risk patients. If we all take care and do our best to protect one another by following the advice of the Public Health Agency of Canada, we have to potential to save countless lives while we wait for a viable vaccine.

We know there’s a lot of information being shared online, so we have decided to make a list of relevant links to help you easily find the best resources for you:

CDHF Links:

You can learn more about health and safety recommendations for patients by going to the Crohn’s and Colitis web page here: https://crohnsandcolitis.ca/Living-with-Crohn-s-Colitis/COVID-19-and-IBD

Health Canada also has information and recommendations for the general public on how to safely navigate this pandemic.https://www.canada.ca/en/public-health/services/diseases/coronavirus-disease-covid-19.html

For additional information about COVID-19 in your area, please visit the links below:

Federal COVID-19 information
Travel Advice and Advisories
Ontario COVID-19 information
British Columbia COVID-19 information
Quebec COVID-19 information
Alberta COVID-19 information
New Brunswick COVID-19 information
Newfoundland and Labrador COVID-19 information
Nova Scotia COVID-19 information
Prince Edward Island COVID-19 information
Manitoba COVID-19 information
Saskatchewan COVID-19 information
Yukon COVID-19 information
Northwest Territories COVID-19 information
Nunavut COVID-19 information

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

[iframe_loader type='iframe' width='100%' height='600' frameborder='0' scrolling='no' src='/wp-content/uploads/articulate_uploads/IBD-Benefits-and-Risk-Assesment-Tool/story.html'] 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

[embed]https://www.youtube.com/watch?v=uS0PFfuwMY8[/embed]
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.

What’s Health Canada Saying about Biosimilars?

[embed]https://www.youtube.com/watch?v=1OeDtXWn3_8[/embed]
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.

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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.

IBD Treatment Options: Understanding Your Benefits and Risks (Crohn’s Disease)

Making informed decisions is imperative to your good health but understanding the benefits and risks associated with Crohn's Disease treatment 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. Check out our detailed online version by clicking here, or download the coles notes version below!

Infographic that explains: What is IBD? Inflammatory bowel disease (IBD) is a chronic disease for which there is currently no cure. It is a group of disorders that involve chronic inflammation of all or part of the digestive tract. Like many chronic diseases, IBD can alternate between severe episodes (flare-ups) and stretches of time with milder symptoms or no symptoms at all (disease remission). It can be painful, affect growth in children, and sometimes lead to serious complications. The disease has two main forms: ulcerative colitis (UC) and Crohn’s disease (CD)
Infographic that explains: Understanding the benefits and risks of IBD treatment options Ongoing treatment of any chronic disease is imperative. IBD is typically treated with a series of medications. Your treatment plan will likely revolve around medications designed to reduce intestinal inflammation, control your symptoms and even prevent long-term damage from inflammation. When you have the proper treatment, you can expect to enjoy improved physical health, greater quality of life, less abdominal pain, less fatigue and significantly less depression. There is no clear roadmap of how your IBD will progress over time. Everyone is different. You will experience peaks and valleys of symptoms over the years. To make the right decision about your IBD treatment, you need to balance the benefits and risks of treatment against the risks of no treatment. All medications have benefits, risks, and side effects. However, it is vital for you to understand that not treating the disease can be even more dangerous. When you get the right treatment for your stage of disease, situation and lifestyle, the benefits of treatment far outweigh the risks. Most people living with IBD go on to lead fulfilling lives despite the challenges of the illness. Treatment can help you maximize your health. With the proper treatment, you can: • Reduce complications • Reduce the number and frequency of flares • Minimize hospital stays and surgery • Improve healing • Enjoy longer periods of remission • Experience a better quality of life IBD can be frustrating and debilitating. Finding the best medicine and consistently following the recommended treatment can help you control your disease. When you achieve your best health, you multiply your opportunities to develop physically, intellectually, emotionally and socially. A standard of health that allows you to enjoy and fully participate in work, school and social situations should be your goal.
Infographic that explains: 5-amino salicylic acid (5-ASAs), also known as mesalamine, reduces inflammation in the intestine, controls diarrhea and helps maintain remission (freedom from symptoms). 5-ASAs can be used at the same time as other medications, such as immunosuppressants and steroids. The goal of 5-ASA therapy is to help you achieve and maintain remission if you have mild to moderate ulcerative colitis and colonic Crohn’s disease. Some formulations also help induce and maintain remission of mild, small intestinal Crohn’s disease. Also: Steroids Steroids rapidly reduce inflammation by suppressing the activity of immune cells. The most common steroids used to treat IBD (prednisone, methyprednisone, and hydrocortisone) circulate throughout the whole body. Some newer steroids (e.g., budesonide) target specific areas of the intestine, and tend to have fewer side effects and less toxicity. Steroids are a short-term therapy to control acute flares and achieve remission. They are not used as maintenance therapy. Steroids can be taken with maintenance medications such as 5-ASAs, immunosuppressants, and biologics. This means you can begin treatment with a maintenance drug while still on steroids. symptoms improve, your doctor will carefully and gradually wean you off the steroid. Depending on the severity and location of the disease, steroids can be delivered orally, rectally, or intravenously. Do not stop taking steroids on your own! It is very important to slowly wean your body from these drugs under the direction of your physician.
Infographic that explains: Immunosuppressants Immunosuppressants are drugs that suppress the immune system, thus reducing inflammation and preventing the body from mistakenly attacking its own digestive system (a feature of IBD). Immunosuppressants aims to decrease the use of steroids, bring about remission, and maintain remission for patients with moderate to severe disease. Immunosuppressants have fewer and less severe side effects than steroids, so you can use them for longer periods of time. It can take several months for oral immunosuppressants to achieve their full effect but they can be combined with steroids until that time. You can also use them with other medications – for example, to prevent your disease from flaring while you are tapering off steroids. Commonly used immunosuppressants are azathioprine (Imuran), 6-mercatopurine (Purinethol), and methotrexate. Immunosuppressants can be taken orally and Methotrexate can be taken orally or by injection. Also explains: Biologics Biologics are proteins specifically engineered to block one or more inflammatory pathways in your body and thus reduce the inflammation that causes your IBD. One class of biologics blocks the action of a protein called tumor necrosis factor (TNF-α), which your body makes naturally. If you have IBD, you produce more of this protein than normal, which causes inflammation and damage to healthy tissue. By suppressing TNF-α production, anti-TNF biologics reduce inflammation and damage. Biologic therapy aims to induce and maintain remission for patients with moderate to severe disease. Sometimes, biologics are used in combination with other IBD medicines to achieve a better treatment effect and/ or reduce the risk of developing antibodies against the biologic. Biologics are delivered in one of two ways: • through intravenous (IV) infusion by a healthcare provider at a clinic • by subcutaneous injection which you can do yourself or have done by a trained nurse at home or in a clinic.
Infographic that explains: A biosimilar drug has demonstrated to be highly similar to a biologic drug that has already been authorized for sale (known as the reference biologic drug).Biosimilars were previously known in Canada as Subsequent Entry Biologics (SEBs). Health Canada states that biosimilars are not generic biologics. Health Canada only approves biosimilars for marketing in Canada when the manufacturer demonstrates that their product is of similar quality, safety, and efficacy to the original reference drug. Also explains: JAK Inhibitors, New ORAL treatment for ulcerative colitis can be done at home, XELJANZ® (tofacitinib) is a new oral treatment option for adult patients with moderate to severe ulcerative colitis (UC) that may help achieve and maintain remission. XELJANZ® (tofacitinib) is a janus kinase (JAK) inhibitor. JAK inhibitors are small molecules in a pill form that interfere with a number of key proinflammatory cytokines involved in the origination and development of inflammatory bowel disease. Treatment of UC in the past 10 to 20 years have been through injectables or intravenous agents. Now XELJANZ, the first Janus kinase (JAK) inhibitor approved by Health Canada, provides a new option for individuals with UC and helps promote mucosal healing in the gastrointestinal tract. When you have IBD, the interior layer of tissue lining your intestine (called the mucosa) gets damaged. Mucosal healing is the restoration of a healthy mucosa. JAK Inhibitors help to promote mucosal healing in the gastrointestinal tract. Use of XELJANZ in combination with biological therapies for UC or with potent immunosuppressant’s such as azathioprine and cyclosporine is not recommended.
Infographic that summarizes: While you can expect to have IBD for the rest of your life, current treatment options can help control the disease and minimize symptoms so you can enjoy a healthy, fulfilling life. Understanding your options and their associated benefits and risks can help you make the best decisions about your health. To get the most out of your treatment, follow the plan you and your doctor have discussed and agreed upon as being best for you, your body, situation and lifestyle. It is important that you be involved in decisions about your treatment. If you don’t understand something your doctor tells you, don’t be afraid to ask questions. If you find your drug regimen difficult to follow or wish to try out a different type of treatment, tell your doctor. If cost is a barrier, discuss this with your doctor: there may be a solution you didn’t know about. To get the most out of your treatment, become a partner with your doctor: deciding on a treatment plan together, asking questions or for more information, and letting your doctor know how things are going at every step of the way. Donate: CDHF relies on the generosity of our supporters to run our foundation and achieve our goals. Your gift will support initiatives that help reduce the incidence of digestive disorders, improve quality of life, support those living with digestive diseases and disorders and the professionals who care for them and, enhance education and research. https://cdhf.ca/donation/

Have you been switched/transitioned to a biosimilar version of Remicade® (infliximab)?

Patient Survey

BC PharmaCare and Alberta Health 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.

Alberta Health Initiative: Phase Two – Infographics

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