Demystifying PMPRB and Canada's regulatory process
Mike Cloutier of Accelera Canada discusses the challenges of the new PMPRB guidelines
NPC Healthbiz Weekly is presented to you in cooperation with Peak Pharma Solutions
With the Patented Medicine Prices Review Board’s (PMPRB) new guidelines set to take effect in July, there is a growing concern over how the new regulations will impact Pharma’s ability to bring new treatment options to Canada.
Mike Cloutier, a founding partner of Accelera Canada, works with international Pharma companies looking to bring Canadians treatments. His main task is demystifying the Canadian market opportunity and striking down misconceptions about the industry.
“There are concerns that are evolving as we speak. Our goal is to have a calm and professional conversation about the realities of what is going on in Canada and sit on the same side of the table with [international companies] and start to work towards solutions,” Cloutier (photo below) explained on a recent episode of the NPC Podcast, a podcast for life sciences managers, hosted by Peter Brenders. Brenders is the CEO of the New Brunswick Health Research Foundation (Listen to the episode here).
In the wake of new PMPRB guidelines, Cloutier, who has international experience in the U.S., Europe and Latin America, has spent time promoting Canada as a critical market for Pharma.
Part of his pitch to international Pharma companies is Canada’s competitive and accessible regulatory process.
“There is a dated perception that we are a second-tier country in terms of our regulatory process,” he said. “But that is no longer the case. We have very competitive review times; we collaborate with other international jurisdictions to leverage work done elsewhere. We offer both priority reviews and conditional approvals to accelerate access, as well as very expeditious review times for devices.”
Cloutier added that there are opportunities for hybrid market access in Canada that is not very well understood.
“The private market allows early access for some patients while we navigate the public access process. Advocacy still works in Canada—if there is a compelling unmet need, we can take advantage of that. Getting astute advice early on about how Canadians set pricing, how it works in our system, and how that lines up with international pricing is key,” said Cloutier.
While he believes Canada is a good market and Rx prices are not out of line with other major markets, Cloutier believes the forthcoming regulations will deter some companies from bringing treatments to Canada.
“I would say that there are going to be circumstances where companies outside of Canada are going to choose not to come to Canada,” Cloutier admitted. “I’m hoping that those would be relatively small in number, and I hope they are unique, only because it would be disastrous and unfortunate for Canadian patients, for caregivers and for healthcare professionals to not have access to these medications.”
The takeaway: Though some companies may be discouraged by the new PMPRB regulations, Cloutier says it is crucial to promote the Canadian pharma ’s positivesindustry's positives to international companies.
“We have to all do our part to strike down the myths, eliminate the misconceptions, provide logical solutions and provide guidance and ensure that people understand that there are [positives] and that there’s a balanced view that needs to occur,” said Cloutier.
Additionally, he said it is important for the Canadian pharma industry to continue challenging the PMPRB changes.
“We need to continue to work to develop better policy and to ensure that affordable access exists for all Canadians,” Cloutier said. “The price concerns are real, and they’re justified. Not everything is affordable and prices are rising. It is really important to remind Canadians that the pharmaceutical and biotech product innovations that are made available are amongst the most economical if not the most economical and efficient care options available—we can never lose sight of that.”
Further reading: The new PMPRB guidelines aren’t the only regulations set to take effect this year. There are several provincial and federal regulations that were set to come into effect in 2021. Story here.
YOUR HEALTHBIZ WEEK 01/12/21
According to Reuters' report, treating critically ill Covid-19 patients with Roche’s tocilizumab (Actemra) or Sanofi’s sarilumab (Kevzara) arthritis drugs significantly improves survival rates and reduces the length of time patients require intensive care. The findings, which have not been peer-reviewed, showed that the immunosuppressive drugs tocilizumab and sarilumab reduced death rates by 8.5 percentage points among patients hospitalized and severely ill with the virus.
Results from two Phase III induction studies, ADVANCE and MOTIVATE, showed both doses of risankizumab (600 mg and 1200 mg) met both primary endpoints of clinical remission and endoscopic response at week 12 in adult patients with moderate to severe Crohn’s disease, according to an announcement made by AbbVie. The ADVANCE study enrolled patients who had an inadequate response or were intolerant to conventional and/or biologic therapy. The MOTIVATE study evaluated patients who had responded inadequately or were intolerant to biologic therapy.
Pfizer CEO Mace Rothenberg says he is leaving the company after two years. Rothenber led the company’s pharma operations. His successor will be Dr. Aida Habtezion, a physician-scientist and associate dean for academic affairs at Stanford University. Rothenberg will spend the next few months assisting Dr. Habtezion’s transition into her new role at Pfizer.
Haven, the joint healthcare venture of Amazon, Berkshire Hathaway and JPMorgan Chase will cease to exist at the end of February, according to CNN. Created in 2018, the venture was formed to help provide better health care services and insurance at a lower cost to workers and families at these three leading American firms—and potentially to other U.S. companies as well.
NATIONAL PHARMA CONGRESS WINTER WEBINAR
The National Pharmaceutical Congress Winter Webinar is scheduled for Wednesday, February 10, 2021. As a reader of the NPC HealthBiz Weekly you are invited to attend the webinar at no charge. Register now at pharmacongress.info
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.
2018 Inductee
Manny Kapur
Croma Canada
Toronto
Editor’s note: Manny Kapur founded Xthetica in July 2019, where he currently serves as its president.
Manny Kapur ventured into the pharmaceutical industry as a way to earn money to further his academic studies. “I got a job at 3M Pharmaceuticals quite quickly, right out of university after my exams. At the time, I needed money since I had been accepted into an MHSc in Sports Medicine in the U.S., looking into biomechanical design,” said Kapur. “It was a great job. It was a small and struggling pharmaceutical company, but they trained us really well. I liked it so much I stayed.”
As the years went by, Kapur transformed his initial position as a sales representative at 3M Pharmaceuticals into a successful pharmaceutical industry career, specializing in cardiovascular specialty sales. After five years at 3M, he worked as regional manager of Fournier Pharma Canada, where he managed partnerships with Roche, Solvay, and Bayer Pharma. He ventured into aesthetics in 2001 when he was approached by Rob Seguin, the skincare director at Allergan, mentor, and great friend.
“They were trying to launch Botox. Initially I laughed. I said, ‘Who would ever inject a product like that into their face?’ The more research I did, I realized that it was an excellent product with numerous medical indications. I took it on and that’s how I got into the aesthetics industry,” said Kapur.
He created a new Skin Care Business unit that launched Botox in Canada and the global market. His campaign led to the U.S. and global approvals of the product for cosmetic use and is now one of the world's more recognized brands.
“We took a more commercial approach to the marketing strategy. We did the same thing for dermal fillers with Medicis Pharma. After two years of launching in Canada we launched dermal fillers in the U.S. and we made $150 million in the first year in the U.S., using the launch model we used in Canada,” added Kapur.
Kapur is now the managing director of Croma-Pharma’s Canadian division. He was influential in building the Croma Division in Canada and launching dermal fillers, Universkin bespoke skincare, and Arthrex PRP for aesthetics use. He is currently designing the first introduction of polydioxanone (PDO) threads to the Canadian market.
“The pharmaceutical business, when I left it was changing quite a bit. It was highly regulated,” said Kapur. “Aesthetics allowed me to be more creative. I feel like an entrepreneur, and as an entrepreneur, I always wanted to create and try new ways of doing business. In aesthetics, I have been able to build out many new companies, multiple product introductions, and launch a lot of new and exciting novel modalities.”
In recent years, Kapur has been actively mentoring young marketing and sales professionals and has built a very strong team, most of whom have been together for 10 to 15 years through all the companies.
“I always remind them to build relationships and approach HCPs and partners with a lot of integrity and appreciation and teamwork being a hallmark. Having really good customer service is the foundation,” he said. “Then, in terms of marketing, just always try to do different things and bring value to your customers. For example, there are some really great ideas on social media. Be creative, and remind yourself always of the privilege of doing something you love doing.”
NEXT WEEK
The 01/19 edition of NPC Healthbiz Weekly will feature Jim Hall, Senior Vice President and General Manager of Covid Pharma Canada, on career advice for a post-Covid world. 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.