Patient organizations for those with inflammatory bowel disease (IBD) are upset with the government of British Columbia for a plan to shift patients to biosimilars over the next 6 months.
Patient organizations for those with inflammatory bowel disease (IBD) are upset with the government of British Columbia for a plan to shift patients to biosimilars over the next 6 months.
As announced by the province last week, patients with Crohn disease (CD) and ulcerative colitis (UC) will have 6 months to move from reference infliximab (Remicade) to either of the infliximab biosimilars, Inflectra and Renflexis. After March 5, 2020, PharmaCare, a publicly funded drug coverage program, will stop coverage for Remicade for these indications, except in certain circumstances.
Earlier this year, British Columbia became the first Canadian province to mandate that patients currently taking reference biologics for rheumatology indications and for diabetes must be switched to biosimilars over a 6-month period.
Patients are opposed to the conceit of nonmedical switching, or moving patients off the reference product purely for financial or for formulary reasons.
“We believe the onus is on payers (government or private) to negotiate with manufacturers of innovative biologics and their biosimilars to protect options for patient care,” wrote Gail Attara, president and chief executive officer of the Gastrointestinal Society and president of the Canadian Society of Intestinal Research. “It is reasonable to expect that manufacturers should lower prices when drugs are no longer on patent.”
She also said IBD is a difficult condition to manage and switching someone without knowing the consequence could stir mental and emotional risk, including the nocebo effect. Attara also said that Canada has a different healthcare system than Europe, where different countries may have different payment systems and models that could influence biosimilar uptake.
Canada has a significantly lower use rate for biosimilars, at approximately 8%. Other European Union countries have upwards of 50% to 95%; Attara said the actual percentages vary based on the age of the biosimilar.
Separately, Crohn’s and Colitis Canada released an updated position statement on biosimilars; while noting that biosimilars are safe and effective, the organization said the “decision to switch a patient from a biologic drug to its biosimilar should be based on patient/doctor choice.”
It also released a survey of gastroenterologists, nurses, patients, and caregivers that showed just more than 50% of gastroenterologists and IBD nurses agreed that a 1-time switch for patients with IBD from a reference biologic to a biosimilar was acceptable.
Asked about the possibility of a switch, patients said they would need support, including additional and dedicated appointments with their specialists and nurses, education and communication, and financial information and support.
Crohn’s and Colitis Canada also said that if the price difference between the reference product and the originator is ever eliminated, policy makers should stop mandatory nonmedical switches.
Biosimilars Gastroenterology Roundup for November 2024—Podcast Edition
December 1st 2024On this episode of Not So Different, we discuss market changes in the adalimumab space; calls for PBM transparency and biosimilar access reforms grew; new data for biosimilars in gastroenterology conditions; and all the takeaways from this year's Global Biosimilars Week.
Senators Introduce Bipartisan Legislation to Protect Skinny Labeling
January 2nd 2025To close out the year, 4 senators came together to introduce a new bipartisan bill to protect biosimilar and generic drug manufacturers from patent litigation when obtaining “skinny label” approvals for their products.
Biosimilars Policy Roundup for September 2024—Podcast Edition
October 6th 2024On this episode of Not So Different, we discuss the FDA's approval of a new biosimilar for treating retinal conditions, which took place in September 2024 alongside other major industry developments, including ongoing legal disputes and broader trends in market dynamics and regulatory challenges.
The Top 5 Most-Read Policy Articles of 2024
December 28th 2024The top biosimilar policy articles of 2024 highlight advancements that include FDA guidance to simplify biosimilar interchangeability and CMS drug price negotiations under the Inflation Reduction Act, alongside challenges posed by pharmacy benefit manager rebate practices and the need for more active stakeholder engagement.
How Vertical Integration Drives Innovation and Access in Biosimilars
December 27th 2024Elie Bahou, PharmD, highlights how vertical integration in the biosimilar industry streamlines costs, improves supply reliability, accelerates market adoption, and enhances patient access, while emphasizing the value of collaboration, quality control, and value-based contracts for sustainable health care delivery.