Patient Groups in British Columbia Criticize Mandatory Switch to Biosimilars in IBD

Patient Groups in British Columbia Criticize Mandatory Switch to Biosimilars in IBD

A collaboration of Canadian patient organizations said British Columbia’s (BC) decision to switch those with inflammatory bowel disease (IBD) to biosimilar drugs is short-sighted and a breach of conventional patient-physician boundaries.

The Biosimilars Working Group advises the 1,700 Crohn’s disease and ulcerative colitis patients affected by the change to consult with their physicians before changing from Remicade (infliximab) to Inflectra (infliximab-dyyb) or Renflexis (infliximab-abda).

Under the province’s Biosimilars Initiative, patients have about six months to transition to the new drugs. After March 5, the publicly funded coverage program PharmaCare will cease coverage for Remicade, except for patients whose physicians determine they are medically unable to switch. BC is the first Canadian province to undertake such actions.

“The sweeping change in coverage is driven by the government’s decision to generate significant healthcare savings from switching patients’ medication rather than negotiating with the makers of the originator biologic to lower their prices,” said the group’s response to the initiative in a press release.

PharmaCare launched the initiative’s first phase in May, aiming to replace Remicade, Enbrel, and Lantus for conditions including diabetes, plaque psoriasis, and rheumatoid arthritis with biosimilar versions by Nov. 25. The second phase, which began Sept. 5, involves Remicade for IBD patients.

Biosimilars are therapies developed to function similarly to biologic medicines costing between 25 percent and 50 percent more, and are increasingly used globally. At around 8 percent, Canada has a relatively low biosimilar use rate.

“The three biologic drugs affected are among the largest drug expenditures in the province, totaling $125 million in 2018,” a BC Biosimilars Initiative webpage states. “Meanwhile, approved biosimilar versions that are more cost-effective and just as safe and effective are underused.”

For its part, the Biosimilars Working Group said that, unlike generic medications, biosimilars are not interchangeable with the original biologic medication. And because biosimilars can only be produced when the original product’s patent expires, product owners are willing to negotiate lower prices, it said. “Unfortunately, public drug plans prefer to support a biosimilar market,” the news release said.

The group also said that adjusting to another care location and staff for intravenous infusions could add more stress to patients.

The nearly $97 million in savings over three years is expected to be reinvested into more resources for complex IBD patients, including more nursing support funding and full coverage of a non-invasive diagnostic tool called the fecal calprotectin test, which assesses intestinal inflammation, and which the Biosimilars Working Group said it welcomes. In addition, other drugs will be added to PharmaCare, and coverage of some existing medications will be enhanced.

“However, the cost-driven objective of the forced-switch policy is worrisome as it fails to put physician wisdom, patient choice, appropriateness of care, accessibility, and affordability at the forefront of health policy,” according to the news release.

Gail Attara, president and CEO of the Gastrointestinal Society, and a group member, said: “Every disease area is unique and each needs to be treated differently. Patients with limited therapeutic options should not be lumped together with those who have a broader range of options available to them. Many people depend on public coverage and only a select few have private plans that do better.”

Overall, the group contends that treatment decisions should remain between the patient and physician. Michael Reilly, executive director of the Alliance for Safe Biologic Medicines, said that’s the way it usually is.

“European countries, for example, enjoy robust biosimilar markets and higher uptake rates, yet the vast majority leave the decision on what biologic medicine to use with the treating physician, in consultation with their patient,” he said.