v 2 Background The only national, volunteer-based charity - - PowerPoint PPT Presentation

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▪ The only national, volunteer-based charity focused on finding the cures for Crohn’s disease and ulcerative colitis and improving the lives of children and adults affected by these chronic diseases ▪ IBD causes sections of the gastrointestinal tract to become severely inflamed and ulcerated. An abnormal response of the body’s immune system plays a role in the diseases’ pathology. In the absence of cures, current therapies are directed at inducing and maintaining

• remission. Most people afflicted with IBD require ongoing medication.

When this fails, surgeries are often required. ▪ Transforming the lives of people affected by Crohn’s and colitis (the two main forms of inflammatory bowel disease) through research, patient programs, advocacy, and awareness

Background

▪ The introduction of biologic medications changed the landscape of care for patients living with Crohn’s or colitis ▪ Infliximab’s biosimilars (Inflectra and Renflexis) are approved by Health Canada to treat IBD ▪ In the IBD therapeutic area (Crohn’s disease and ulcerative colitis), there are only 5 biologics, and now, two biosimilars ▪ Relatively low number compared to other immunology diseases (Rheumatology has 10 biologics, and several biosimilars)

Biologics

▪ We support the introduction of safe and effective treatments for IBD ▪ Patients, in consultation with their doctor, must be able to select the treatment option best suited to each patient’s individual circumstances without undue interference from government or private payers ▪ Patients in remission being treated with an innovator biologic should not be forced to switch to a biosimilar by any government or private payer without the informed consent of the patient in consultation with their physician

Our position on biosimilars

▪ Each patient is already stable on originator biologic for 6 months. ▪ Half of all patients are switched, half are not. Study continues for 12 months to monitor patient symptoms (disease worsening) of no switch vs switch.

NOR-SWITCH Trial (2017)

Disease Biologic (n=202) Biosimilar (n=206) Difference in disease worsening in stable vs switch Crohn’s disease 14 worsen (21.2%) 23 worsen (36.5%)

• 14.3%

Ulcerative colitis 3 (9.1%) 5 (11.9%)

• 2.6%

Spondyloarthritis 17 (39.5%) 14 (33.3%) 6.3% (-14.5%–27.2%) Rheumatoid arthritis 11 (36.7%) 9 (30.0%) 4.5% (-20.3%–29.3%) Psoriatic arthritis 7 (53.8%) 8 (61.5%)

• 8.7% (-45.4%–28.1%)

Psoriasis 1 (5.9%) 2 (12.5%)

• 6.7% (-26.7%–13.2%)

Overall 53 (26.2%) 61 (29.6%)

• 4.4% (-12.7%–3.9%)

There weren’t enough IBD participants for gastroenterologists to have full confidence in the data

▪ Need more education on biosimilars (what they are) and the implications of a switch in medication from a biologic to a biosimilar. ▪ In general, the reaction was negative to any efforts that might be undertaken to force a patient to switch to a biosimilar. ▪ Some reported feeling that a change was a setback in their treatment. Any change was reported as being disruptive. A new drug might have side effects. ▪ Many individuals were concerned that treatment options were limited. ▪ Some shared negative stories of the consequences of trying new medication.

*The Arthritis Society. Biosimilar Focus Group Project Report. March 2017.

Patient Biosimilar Focus Group*: IBD patients reactions to biosimilars

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Patient concerns

▪ A forced change in treatment (biologic/biosimilar policy) is a primary concern for IBD patients: ▪ Patients want to be and should be consulted before any policy is implemented which could jeopardize their treatment stability ▪ Crohn’s and Colitis Canada patient survey reveals gaps in patient education ▪ 70+% (N= 1646) of participants reported that they have not received enough information about biosimilars ▪ Less than 25% of patients had heard about biosimilar medication from their physician ▪ Only 1% had heard about biosimilar medication from a government or public health insurer.

Patient Concerns

▪ ‘Nocebo Effect’: Patients believe the treatment won’t be as effective therefore jeopardizing an IBD patient’s treatment stability ▪ Canada is unique ▪ Only country where biologic treatment is done through a drug manufacturer’s third- party patient support program. Other countries do all infusion biologics in a hospital. ▪ This presents a challenge: patient awareness of a switch ▪ If a patient is on a biologic and gets treatment at its company’s clinic, when the patient is switched they have to go to another company’s clinic. ▪ If that patient is switched for non-medical reasons they can doubt the switch is in their best interest. ▪ Mental states such as beliefs and expectations can strongly influence the outcome of disease.

Clinician Concerns

▪ Crohn’s and Colitis Canada’s role is to raise patient’s awareness of the clinical evidence and to represent the patient community’s best interests ▪ Patients, in consultation with their doctor, must be able to select the treatment option best suited to each patient’s individual circumstances without undue interference from government or private payers ▪ Canadian scientific and medical IBD experts are not in consensus that switching a patient from a biologic to a biosimilar poses no risk to treatment stability ▪ Best Medicines Coalition (BMC), a national alliance of over 25 patient organizations, has broad consensus that patient/doctor choice is paramount – including regarding non-medical switching

Conclusion