Albertans living with Crohn’s disease or ulcerative colitis, which are the main forms of inflammatory bowel disease (IBD), could have their biologic treatments changed due to a non-medical switch through the Biosimilar Initiative Policy.
Crohn’s disease and ulcerative colitis are chronic inflammatory disorders of the gastrointestinal tract. The symptoms can vary but include chronic abdominal pain, diarrhea, rectal bleeding, and can result in surgery.
“Our ability to treat Crohn’s and colitis with medical therapy has been dramatically revolutionized by the introduction of medications called biologics,” said Gastroenterologist and Assistant Professor at the University of Calgary Dr. Christopher Ma.
“Biologics very complex molecules, large protein-based molecules, and they are the most effective and in the majority of cases also the safest treatment for patients with moderate to severe Crohn’s disease or colitis,” Ma said.
A biologic medication, infused intravenously, called Remicade, or infliximab, was the first biologic medication available for patients with Crohn’s disease or ulcerative colitis.
However, drugs called biosimilars that are similar to but not identical to the original biologics have recently been introduced.
“Biologic medications have such a complex structure that it’s almost impossible to exactly replicate them,” Ma said.
“The makers of Remicade, have said publicly, that they will match the price of a biosimilar, so we question why governments would enact a switch policy when the savings are questionable,” said the President and CEO of Crohn’s and Colitis Canada Mina Mawani.
“This is not about biosimilars. These are effective treatments for patients with Crohn’s and colitis. This is about the act of switching a patient who is stable on a biologic to a biosimilar for non-medical reasons,” she said.
Under the Biosimilar Initiative Policy, Crohn’s disease and colitis patients and their doctors will be limited in finding the best treatment plan.
If patients are switched from a biologic medication to a biosimilar medication, their disease could potentially worsen.
“There have been studies looking at switching patients from a biologic to a biosimilar,” Ma said.
“However, we don’t have enough information to say that this is for sure a safe policy,” he added.
The Canadian Association of Gastroenterology researched switching patients’ biologic medications to a biosimilar medication and found a non-medical switch could increase the lack of response or disease flares by 33 per cent, Mawani said.
The consequences of losing response in patients with Crohn’s disease or ulcerative colitis may be severe, including the risk of needing to go back into the hospital or have surgery.
“We presented this data and evidence to the government, and they are not listening,” Mawani said.
The Joint Canadian Association of Gastroenterology and Crohn’s and Colitis Canada position statement on biosimilars for the treatment of IBD, recommends a biosimilar may be started in patients with active Crohn’s disease who have never been on a biologic therapy. However, switching, especially after patients have responded well to a biologic is not recommend.
“We recommend against non-medical switching from originator infliximab to a biosimilar in patients who have stable IBD and are doing well on the original product. Data suggests that switching in this setting leads to an increased risk of worsening of the disease, dose-escalation, and/or switching to an alternative therapy,” the position statement said.
Adding, “We do not recommend automatic substitution of a biologic with a biosimilar in IBD patients given the paucity of evidence for the efficacy and safety of this approach.”
Although the cost associated with researching, developing, manufacturing, and administering the biologics is expensive, there are cost savings associated with patients being on effective treatments, Ma said.
“If Crohn’s or colitis is not well controlled, patients end up in the hospital, they go to the emergency room, or they need surgery,” he said.
Adding, “For a large portion of our patients, they are debilitated by their symptoms. Not only is it associated with direct cost, but it carries this huge burden of the indirect cost when the disease is not well controlled.”
If the non-medical switch is passed, the care and treatment of patients will remain the top priority for Ma.
If patients are switched to a biosimilar medication and do not respond well, they cannot be changed back to a biologic medication, complicating treatment plans, Mawani said.
“If you fail on the biosimilar for Remicade, the next step is likely another course of treatment, and the options are very limited,” she added.
“No matter what the policy is, all of the physicians I work with are all committed to making sure patients care is not compromised and we will do everything possible to make sure they get their medication and a switch happens as safely as possible. For all patients, we will do our best to support them through any decision,” Ma said.
Ma and his colleagues are acutely aware that cost savings and being cost-effective is important. However, the long-term ramifications of the non-medical switch need to be considered.
“We finally have therapies that have made patients’ lives much better, many of these patients have struggled for a long time, and these drugs have finally given them a sense of normalcy. I implore the government to not take that away,” Ma said.
Any Albertans who will be affected by the non-medical switch are encouraged to write a letter to the provincial government, call their local MLA, and share their story.
“Over 20,000 letters have been written,” Mawani said.
“Patients are very concerned about being forced off of a treatment that is working for them. This is not about supporting one product over another, this is about ensuring that patients’ health is not put at risk,” she said.
To write a letter, please visit the Crohn’s and Colitis Canada website at,
http://action.crohnsandcolitis.ca/choice?fbclid=IwAR07k_hKkLXY1Ai8YKCyiF8nx6n31g-PRYafDdps_xB1pz13g-zjk0fJSic, or for more information regarding the non-medical switch, visit the website at https://crohnsandcolitis.ca/?gclid=EAIaIQobChMI2tm21cT-5QIVyB6tBh3f6QYDEAAYASAAEgLuKvD_BwE.