Keeping evidence current during Covid-19
Suzanne McGurn of CADTH discusses how the pandemic has changed the organization's processes (550 words, 3 mins.)
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While the Covid-19 pandemic has created many challenges for the Pharma industry, the Canadian Agency for Drugs and Technologies in Health (CADTH) has adapted and generated new efficiencies to continue its evidence review processes according to Suzanne McGurn.
She is the President and CEO of CADTH, an independent, not-for-profit organization responsible for providing healthcare decision-makers with objective evidence to make informed decisions about the optimal use of health technologies.
A timely pivot, and the ability to take advantage of virtual technologies, has allowed CADTH to continue with its reviews of pharmaceutical products, said McGurn. She noted part of the organization’s success has been due to its ability to reallocate resources from programs such as the Scientific Evidence Advice Program and redirect them to Covid-related issues.
“I think at our heart we have learned that there are ways that we can do things differently,” said McGurn (photo below) on a recent episode of the NPC Podcast, a program for Pharma executives hosted by Peter Brenders. Brenders is CEO of the New Brunswick Health Research Foundation. (Listen to the episode here.)
“Every one of us hates to comment about the positives of experiencing a pandemic. [As a result of the pandemic], we are in a moment where disruption, innovation, new technologies, devices and therapeutics are rapidly emerging. I think everyone—industry and businesses—have suddenly had this door open to things that people never thought were possible,” McGurn continued.
“Healthcare may never be the same. I remain optimistic that it won't be the same in a way. [I am] interested to see how we at CADTH can support those changes and the explosion of innovation while supporting jurisdictions make really difficult decisions that are going to have to be made as we come out of a pandemic.”
She added that at CADTH, the organization has been able to find a balance between quality, completeness and timeliness while at the same time shortening some processes. McGurn noted that Covid-19 has resulted in the organization being unable to complete a full Health Technology Assessment or get patient perspective. Still, CADTH has been able to provide clinicians with the same amount of time to weigh in on the review process.
While the pandemic has created a need for an expedited review process, McGurn cautioned of the potential risks involved.
“Whenever I hear the speed equation in the evidence [review], I think we have to be careful as we think forward about how that fits in a risk environment,” she said. “In a pandemic, when thousands of people are dying, there are so many unknowns and the timelines for us to make decisions are so small, I think there's a different risk equation. I think what that will look like for many of us is perhaps more segmented ways in which we do our reviews and [prioritizing] what comes first.”
The takeaway: The pandemic has taught McGurn the need for evidence reviews to remain a living document.
“They are not point-in-time,” she explained. “They are things that we need to keep alive and continue to go back to as evidence emerges, particularly in places of importance [such as Covid-19] where the evidence is being generated almost weekly.”
Further, McGurn said she has learned during Covid-19 that relationships matter.
“I think that the more opportunity that we have to have exchange [information] and understand one another's perspective, the better off we will all be and being able to find our way to new and improved futures,” she said.
Further reading: Covid-19 has also had an impact on scholarly publications and peer-review practices. In a study published in the journal Research Evaluation, the authors note journal editors are using different quality criteria to assess Covid-19 related manuscripts. Link here.
YOUR HEALTHBIZ WEEK 03/23/21
Eli Lilly said its experimental treatment for moderate to severe ulcerative colitis succeeded in a late-stage trial, Reuters reports. The 12-week study was testing the efficacy and safety of mirikizumab in patients with inflammatory bowel disease. Mirikizumab met the main goal of reducing colon inflammation and frequency of stools in patients compared to placebo. Additionally, the treatment demonstrated rapid improvement in patient symptoms as early as four weeks after initiating treatment.
Takeda Canada announced that Health Canada has issued ALUNBRIG® (brigatinib tablets) marketing authorization without conditions as monotherapy for the first-line treatment of adult patients with anaplastic lymphoma kinase positive (ALK+) locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC). The approval is based on results from the phase 3 ALTA-1L trial, which evaluated 275 patients and showed that once-daily treatment with brigatinib tablets was superior to crizotinib on efficacy and tolerability measures, making it a promising first-line treatment option.
One year after AbbVie purchased Allergan for US$63 billion, the company is reportedly looking to sell its portfolio of women’s treatments and healthcare products valued at US$5 billion. According to Reuters, the Illinois-based company plans to sell off the assets gained from the Allergan acquisition, including the Lo Loestrin Fe birth control pill.
Data from Janssen’s Phase III DISCOVER-2a trial showed that guselkumab, a selective IL-23 inhibitor, leads to skin clearance and joint symptom relief for up to two years in patients with active psoriatic arthritis (PsA). Findings from the new trial show that 56 per cent and 55 per cent of patients treated with guselkumab every four and every eight weeks, respectively, experienced at least a 50 per cent improvement in the ACR score through 100 weeks. Approximately 62 per cent of patients who received guselkumab every four weeks and 55 per cent of patients who received guselkumab every eight weeks with clinically meaningful baseline PsO also achieved complete skin clearance by follow-up.
According to Reuters, the U.S. FDA has extended the review period for the expanded use of AbbVie’s rheumatoid arthritis treatment upadacitinib by three months, citing the need for more time to assess the treatment’s benefit-risk profile. The U.S. health agency is reviewing the application for the use of upadacitinib in patients with active psoriatic arthritis, a type of inflammatory arthritis, the drugmaker said.
UPCOMING NATIONAL PHARMA CONGRESS WEBINARS
The National Pharma Congress Spring Webinar is scheduled for Wednesday, May 12, 2021, and the Summer Webinar is scheduled for Tuesday, June 22, 2021. Be sure to watch the NPC HealthBiz Weekly for updates on the event.
CANADIAN HEALTHCARE MARKETING HALL OF FAME
The Canadian Healthcare Marketing Hall of Fame awards were established in 2002 to honour healthcare marketers who have contributed to our avocation and are an inspiration to others.
More than 100 honourees have been selected during the past 18 years. In the selection committee's view, they stand for a representative cross-section of the qualities that make our business unique and fulfilling. Each week, NPC Healthbiz Weekly will acknowledge one past Hall of Fame Honouree.
2012 Inductee
Dr. Richard Gladstone
Association of Community Neurologists
Toronto
Editor’s note: Dr. Gladstone is a consultant in the Division of Neurology at the North York General Hospital in Toronto.
Even before his medicine career started, Dr. Richard Gladstone found himself thrown into the deep end while he was visiting his parents in the hospital. “I’m going into the operating room, and I need an assistant, and you look like you can help me,” a surgeon told Dr. Gladstone, then a University of Toronto undergrad studying political science and economics in anticipation of a career in law.
“And I went,” said Dr. Gladstone.
That was in 1957, and Dr. Gladstone was visiting the hospital often to see his parents. They had been injured aboard the SS Andrea Doria when it was struck by the icebreaker MS Stockholm.
This experience convinced Dr. Gladstone to change his area of study, from law to medicine. His intention in both career paths was to make a difference in people’s lives.
“I thought I could do that in the justice system,” said Dr. Gladstone, “but I like this better.”
Though he is a neurologist, Dr. Gladstone said he “externed” at the Toronto Psychiatric Hospital for four months between his third and fourth year of medical school.
“I thoroughly enjoyed it. My job was to give insulin sub-coma therapy and electric shock therapy to my patients with the guidance of my staff member.”
He said that these therapies are now much safer but that “back then, it was pretty challenging.”
Years later, Dr. Gladstone highlights his career as a community neurologist. “One of the things I’m proud of is that I started the Association of Community Neurologists in Toronto 30 years ago,” he said. It’s an organization that has provided educational opportunities for neurologists after graduation.
“We’d have four or six meetings a year. We’d bring in distinguished speakers from all over the world, and we’d have dinner meetings, conferences, one or two-day conferences, lunch meetings, seminars, and so on and that way, we’d keep up-to-date with new advances. I’ve planned almost 130 of these meetings over the years, and they have been very successful.”
He also helped create the Community Psychiatry Association of Toronto along with Dr. Mostafa Showraki, a psychiatrist.
“I encouraged him to start a similar program for psychiatrists, which is now very popular among the psychiatrists in the city.”
Dr. Gladstone is the Founding Editor (Neurology) of The Chronicle of Neurology & Psychiatry, a publication for Canadian neurologists, psychiatrists, and GPs interested in those specialties. The publication was established in 1996.
In 2011, Dr. Gladstone received a Long Service Award for teaching at the University of Toronto. Now, he says, he is phasing out teaching “because there are younger, more capable people around, and I’m basically a community neurologist now.”
His practice in Toronto has been at the same location since 1970. For 10 years, he was the head of neurology at North York General Hospital. He’s now part-time courtesy staff at Sunnybrook and Humber River Hospital.
NEXT WEEK
The 03/30 edition of NPC Healthbiz Weekly will feature Lindsay Williams, Vice President and Managing Director at Stryker Canada, on the role of MedTech during the pandemic. It’s easy to get your no-charge subscription and have the issue sent to your phone or inbox each Tuesday at 6:00 a.m. sharp.
Stay safe, stay sure, and stay on your game. We’ll see you again next Tuesday.