Biosimilar starts and switches

Chances are if you have rheumatoid arthritis (RA) you have been on a class of drugs called disease-modifying anti-rheumatic drugs, or DMARDS, aimed at controlling disease activity. DMARDS are effective for most patients with RA, however, one in three will require a “biologic” - a medication created using living organisms that target specific processes in the immune system.

Biologics are effective, but costly. In 2018-19, Alberta Blue Cross, Alberta’s provincial drug plan, reported biologic drugs cost more than $238 million, with Remicade®, Humira®, and Enbrel® being three of the top four drivers of drug spending in Alberta.

In December 2019, the Government of Alberta mandated that patients with RA* on a provincial drug plan, who have been taking Remicade® and Enbrel®, must switch to a biosimilar by July 1, 2020, unless there are exceptional medical circumstances as determined by their physician that prevent them from switching. As the name implies, biosimilars are similar, but not identical, to biologics, and have been approved for use by Health Canada. They also cost up to fifty percent less than biologics.

The Government of Alberta estimates switching from all biologics (not just for RA, but for other conditions as well) to biosimilars will save the province between $227 million and $380 million over the next four years, however, the consequences of the switch in terms of actual cost savings, patient outcomes, and health services impacts need more investigation.

A McCaig Institute research team, led by Drs. Deborah Marshall and Dianne Mosher, aims to provide real-world information on the switch to biosimilars using standardized measurements of disease activity and health-related quality of life information to determine the budget and personal impacts of these starts and switches. This work will inform health policy for the use of biosimilars for RA patients.

The actual budget impact

Marshall’s team is working on a study estimating the impact to the provincial drug budget of the switch from biologics to biosimilars for RA patients. The study, which began before Alberta announced their estimated cost savings, looks at data as far back as 1995 and considers physician prescribing practices in Calgary and patterns of starts and stops, adherence and retention for biologic therapy.

“We looked at when biologics were introduced to patients, which biologic they were taking, how long they stayed on it, if they were switched to another biologic, or if they stopped using biologics altogether,” says Marshall. “We found there were patterns. People don’t stay on the same drugs consistently over time – sometimes they stop and sometimes they switch to other drugs - there are times when they are not taking their drug because they are experiencing side effects, or because they are in remission, and there are times when they’ve switched to other drugs.”

Taking these patterns into account, Marshall’s team estimates the actual cost reductions associated with the switch from biologics to biosimilars may not be as large as projected, but still represent significant savings for the healthcare system. The team expects to publish their findings later this year.

The impact on patients

While completing the budget impact analysis, Marshall’s team realized the need to follow patient experiences in the switch from biologics to biosimilars. “Biosimilars have been shown to be safe and effective. However, for patients who have been well controlled on a medication asking them to switch can be scary,” says co-investigator and rheumatologist Dr. Paul MacMullan, MD. “It’s important that patient experiences are heard and taken into account.”

So Marshall’s and Mosher’s team are embarking on a new study to look at patient experiences with the switch. They are asking approximately 1500 Alberta patients with RA who are making the switch to complete a survey asking about how they felt about making the switch to biosimilars, with a follow-up questionnaire in six months to see how the transition went.

“The beauty of this study is that we can look at what’s happening with patients who are switched, and hear what’s happening from their perspective – not just the healthcare system’s perspective,” says Dr. Gillian Currie, PhD, another co-investigator on this project. “It would be interesting to do another study looking at the healthcare professional’s experiences – the doctors and the nurses and pharmacists who are managing this whole switch,” she says. “The impact of this is much bigger than just a dollar figure.”

 

Deborah A Marshall, PhD, is a professor in the Department of Community Health Sciences at the University of Calgary’s Cumming School of Medicine. She is also the Arthur J.E. Child Chair of Rheumatology Outcomes Research and former Canada Research Chair, Health Services and Systems Research, a member of the O’Brien Institute of Public Health and the McCaig Institute of Bone and Joint Health.

Dianne Mosher, MD, is a rheumatologist, a professor in the Department of Medicine, and the Associate Dean, Strategic Partnerships and Community Engagement for the University of Calgary’s Cumming School of Medicine. She is a member of the McCaig Institute for Bone and Joint Health and the Alberta Health Services’ Bone and Joint Strategic Clinical Network.

Paul MacMullan, MD, is Chief of the Division of Rheumatology, a member of the McCaig Institute for Bone and Joint Health, and a clinical associate professor in the Department of Medicine, Cumming School of Medicine at the University of Calgary.

Gillian Currie, PhD, is an adjunct associate professor in the Departments of Community Health Sciences (CHS) and Pediatrics in the University of Calgary’s Cumming School of Medicine, as well as the Associate Director of Health Economics Research in CHS. She is a member of the O’Brien Institute of Public Health and the Alberta Children’s Hospital Research Institute.

Other investigators/organizations involved in these projects: Dr. Susa Benseler, Dr. Marinka Twilt, Dr. Claire Barber, Andrea Brose, Bryanne Kennedy, Raymond Lee, Arthritis Society.

 

* The specific indications are:

• Remicade (all indications)
• Enbrel (all indications except plaque psoriasis and pediatric juvenile idiopathic arthritis)