The challenges of bringing rare disease therapies to Canada
Covid-19 has underlined the issues, says Bob McLay of Sobi Canada (890 words, 7 min)
NPC Healthbiz Weekly is presented to you in cooperation with Peak Pharma Solutions
The Canadian government’s recent scramble to procure Covid-19 vaccines has highlighted the need for better collaboration and cooperation between the government and the Pharma industry—an issue Bob McLay sees all too often in the rare disease space.
McLay is the Vice President and General Manager of Swedish Orphan Biovitrum (Sobi) Canada. Sobi is a biotech company based in Sweden focusing on developing and manufacturing innovative therapies for rare disease patients.
“The vaccine situation with Covid-19 has highlighted the challenge,” said McLay. “I think we as Canadians saw a bit of a mad scramble, ‘Are we getting the vaccine or not getting the vaccine?’ Every day in the newspaper, you read something different. I think we’re coming around better now, but at the beginning, it didn’t look very good. From an insider’s standpoint, I just thought, ‘Does the government even have any relationships with anyone in the industry? Are they scrambling now to try to make friends?’
“I think [the vaccine procurement] really highlighted the need for public health policy that is cooperative, collaborative and partners with industry—I don't care if it's pharmaceuticals, or tech or what, but you really need to know people and have those relationships, to be able to make decisions quickly and get things done.”
McLay (photo below) discussed the challenges Sobi Canada faces in bringing rare disease therapies to Canadian patients in need on a recent episode of the NPC Podcast, a program for Pharma executives hosted by Peter Brenders. Brenders is the General Manager of BeiGene Canada (Listen to the episode here.)
While the evolution of technology has significantly advanced therapies in the rare disease space in recent years, McLay said there is a lack of an effective funding model to bring the expensive therapies into Canada.
“It’s expensive to get these therapies; it’s difficult to [conduct] the science,” he said. “These are all highly educated people who get involved in this, and we have to pay them.”
McLay said that part of the problem with bringing rare disease therapies to Canada is how the regulator looks at the treatments. He notes that regulators such as Health Canada and the health technology assessment groups look at treatments using the lens of the common drug review.
“Even the common drug review—it's called the common drug review,” he remarked. “So how are they supposed to look at a rare disease drug? The metrics they use, the measurements they use, really doesn’t lend itself to being very successful at getting innovation here for Canadians with rare diseases.
“I think Canadians would be mortified if they really knew how rare disease patients and families were treated in this country.”
Additionally, the Patented Medicine Prices Review Board (PMPRB) also makes it difficult for those in the rare disease space to bring treatments to Canada, McLay noted. He added the PMPRB regulations make it unpredictable for Pharma to run a business in Canada successfully.
“When I go to [my colleagues] in Boston, my bosses or the people in Sweden and they’re trying to understand how much product do we need to make? What kind of inventory do we need? What kind of price are we going to get in Canada? How much revenue? How many patients? It's completely unpredictable,” said McLay. “The timelines are long; you never know what the answer [from the regulator] is going to be. So it’s a rats’ nest to get through all the rigour and regulation here.”
The situation becomes even more difficult for rare diseases because fewer patients and the questions surrounding coverage make it further challenging.
“I remember in the old days, Canada would be a tier-one or tier-two country to bring products in,” McLay recalled. “I think we’re being relegated to the tier three or tier four countries such as Russia or Slovenia—areas like that. We take great pride in our healthcare system, and I don’t think we want to be relegated to playing in the same field as those countries that maybe we should be ahead of.”
The takeaway: With the Canadian government promising a billion dollars for rare disease treatments, McLay would like to see the funding go toward patient care and the procurement of innovative treatments to address the large unmet need.
He notes other countries don’t see near the delays and gaps in treatment Canadian patients do. Further, patients in other countries often receive treatments months or years ahead of their Canadian counterparts.
“Our system is not really patient-centric,” McLay explained. “In Germany, as an example, when a new product comes out, it’s instantly approved, instantly paid for by the government. Then what they do is, a year later, they say, ‘Ok, let’s look at what that price was, let’s look at what the real-world outcome was, and we can decide on was their value for money there, was there a reasonable price. So let’s renegotiate at that time.
“That’s really putting that patient first, especially in a rare disease situation. [In Canada] we’re relying on samples, maybe having to come in under a special authorization program. It’s not that easy.”
Further reading: An article at Pharmaceutical-technology.com, a website dedicated to issues relevant to pharmaceutical professionals, notes that low awareness for rare diseases among patients, physicians and members of the general public can lead to an increase in morbidity and potential mortality. Story here.
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YOUR HEALTHBIZ WEEK 06/08/21
Bristol Myers Squibb is being sued for US$6.4 billion for allegedly delaying its Breyanzi cancer treatment to avoid paying shareholders of the Celgene Corp., which BMS purchased in 2019. According to Reuters, the complaint alleges BMS failed to use contractually required effort to win U.S. FDA approval for the non-Hodgkin lymphoma drug by the Dec. 31, 2020 deadline. Missing the deadline meant BMS was exempt from an additional US$9 to Celgene shareholders for each share they held. The payment exemption helped Bristol Myers Squibb to acquire Celgene at a discount, the complaint notes.
Amgen’s treatment for lung cancer patients with a specific mutation in the gene KRAS whose disease has worsened after treatment with chemotherapy or other medicines has received U.S. FDA approval, according to Reuters. About 36% of patients who received sotorasib treatment in clinical trials saw their tumours with the KRAS mutation shrink. Sotorasib is designed to target the gene mutation known as KRAS G12C, which occurs in roughly 13% of non-small cell lung cancers.
According to a Reuters report, Novartis has signed a collaboration agreement and an option to acquire Zurich-based start-up Cellerys. Cellerys is researching a therapy to fight multiple sclerosis (MS). The agreement would see the Swiss drugmaker support Cellerys’ development of the CLS12311 therapy currently in a Phase 2 study. As part of the deal, Novartis would also have the option to acquire Cellerys following the Phase 2 trial.
Health Canada has granted conditional approval to Bristol Myers Squibb Canada for idecabtagene vicleucel (ide-cel), a B-cell maturation antigen-directed chimeric antigen receptor T cell immunotherapy for adults with multiple myeloma (MM). The treatment is for MM patients who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody. They are refractory to their last treatment. The conditional approval is based on the pivotal Phase II KarMMa study results, which demonstrated ide-cel’s ability to deliver rapid, deep and durable responses with a single infusion.
NATIONAL PHARMA CONGRESS SUMMER WEBINAR
“Post-Covid Countdown” is the theme of the National Pharma Congress Summer Webinar, scheduled for Tuesday, June 22, 2021. The event follows the recent NPC Spring Webinar, attended by 400 registrants. Faculty for the Summer 2021 event are Ronnie Miller (Roche Canada), Patrick Forsythe (Eisai Canada), and Brian Canestraro (Intercept Pharma). Your hosts are: Ben Parry (Pangaea Consultants) and Mitch Shannon (Chronicle Companies.) 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 inspire 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 Honourees.
2011 Inductee
James Cran
ANTIBODY Healthcare Communications
Toronto
Editor’s note: James co-founded ANTIBODY HealthCare Communications in 2003. In April 2020, he decided to return to his entrepreneurial roots and took on the role of President of Pharma Consultants Inc.
For many, being a casualty of restructuring or downsizing in the corporate world can be a shock, not easily absorbed. But, for James Cran, that shock presented the opportunity of a lifetime. “It was the best thing that happened to me,” says Cran, who co-founded ANTIBODY Healthcare Communications Inc. with Michael Paul, his Creative Director who passed away in 2010.
Having been a pharmaceutical sales representative, sales manager, and marketing director at various companies in the industry, Cran was well-equipped to be on the supply side of the equation and respond to the needs of pharmaceutical marketers by heading a healthcare communications agency.
“Our motto is that we get it,” says Cran, whose company has a client list that is a nice balance of Montreal and Toronto business. “We understand what needs to be done to be successful. You don’t have to hold our hands. We are built to be an extension of [a pharmaceutical company’s] marketing department.”
His life in pharma provided Cran with experience managing small products, big products, and people. Cran started his career as a sales representative for Astra and was named Rookie of the Year in 1991, receiving a promotion to Product Manager in 1993 after being in the field for a couple of years. As Product Manager, he managed several products in the company’s hospital division.
By 1996, Cran found himself at SmithKline Beecham, where he worked on a pre-launch of an angiotensin II receptor blocker, which was sold to another company. Cran was then asked to take on Paxil. He took the product to blockbuster status with $200 million in sales in a matter of years.
“We launched multiple indications, and it became one of the top brands in Canada,” says Cran.
He received a promotion to Group Product Manager, Respiratory, Anti-Infectives, and New Product Planning before SmithKlineBeecham’s merger with Glaxo. After the merger, he found himself in familiar territory, responsible for psychiatry products such as Paxil and Wellbutrin.
After spending 18 months at GlaxoSmithKline and running their largest portfolio, Cran headed in a new career direction with ANTIBODY Healthcare Communications. Since its birth, the agency has launched over 40 brands and has grown from two to a staff of 50 in eight years. It managed to land its first client two short months after opening its doors. Pharma marketers named ANTIBODY agency of the year in 2008.
“Once we start working with our clients, they start to see the difference between us and some of our competitors,” says Cran.
In today’s extremely competitive environment, Cran looks to his Product Services and Medical divisions to discover the exceptional aspects of a product and develop effective messaging and tactics to support the product.
“It is about finding a point of differentiation,” says Cran. “It is about finding something unique that is a hook and building a market around it.”
For the future, Cran plans to maintain ANTIBODY’s partnerships and innovate, developing new avenues for patient adoption of branded products. Even during leisure, while golfing or fishing, Cran is never far from his Blackberry, ready to respond to his clients’ needs.
A NEW PODCAST
“NPC Podcast Presents: Next in Pharma” is coming tomorrow to a podcast download site near you. The first episode, “AI-Powered Analytics,” is hosted by Michael Cloutier. Mike’s guests are Martin Booth, Director of Analytics and Data Excellence at AstraZeneca; Omer Ariburnu, Affiliate Head of Customer Excellence and Operations at Biogen; and Shawna Boynton, Omnichannel Marketing Manager at Novo Nordisk. “NPC Podcast Presents: Next in Pharma” is presented in co-operation with our friends at ODAIA.ai
NEXT WEEK
The 06/15 edition of NPC Healthbiz Weekly will feature Brigitte Sonier-Ferguson, the acting CEO of the Atlantic Cancer Research Institute, on the industry, academic partnerships, and sharing expertise to help develop diagnostics in healthcare systems the impact of research on clinical care. 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.