At the vanguard of innovation: Interview with Sophie Rochon
April 19, 2019
Sophie Rochon’s job as National Director, Health Policy and Patient Access, for Novartis Oncology has her talking to government policymakers—and listening to poignant patient stories. An expert negotiator and nationally respected industry leader known for her solutions-based approach, Rochon works to get government, patient groups, private insurers, and professional associations to improve patient access to treatments vital to their continued health. A board member of Group Entreprises en Santé, Rochon also serves as co-chair of the innovation committee of Montréal Invivo. Here, Rochon gives us a peek at the early days of integration of cell and gene therapies in Canada following the September 2018 approval of the CAR-T cell therapy Kymriah.
Tell us a little about Kymriah. What does the treatment mean to Canadians?
Kymriah is indicated for certain types of lymphoma in adults and leukemia for children. The treatment involves reprogramming a patient’s own T cells so they recognize and attack the cancer cells. It is personalized medicine at its best and offers hope to patients who have run out of other treatment options. The first child treated with Kymriah, Emily Whitehead in the US, is now cancer-free for seven years.
What is your experience to date bringing this historic innovation to market?
Everything about the treatment is new, so we expected the process to look different. For one thing, Health Canada, CADTH and INESSS conducted a parallel regulatory review and health technology assessments. Interestingly, CADTH looked at the treatment through the lens of a device rather than a drug. The assessment process went far beyond efficacy and safety, and looked at hospital implementation, societal impact, and ethical issues.
Tell us about access. Where and how will the therapy be offered?
First and foremost, our objective is to provide appropriate patients with safe access to Kymriah. Kymriah will be offered at centres accredited by FACT [Foundation for the Accreditation of Cellular Therapy]. We will initially roll it out at two centres in Ontario and two in Quebec, and from there we hope to expand to a national network. The treatment centres will need to have affiliated cellular therapy labs and specially trained personnel.
How close are you to offering the treatment in Canada outside of clinical trials?
We’re laying down the infrastructure and the training, as well as discussing with the provinces. In terms of a first treatment date, the best estimate I can give right now is “soon.”
How are the negotiations going?
Cancer Care Ontario is taking the lead on negotiations, not just for Ontario but the other provinces and territories. For new drugs, such negotiations have traditionally gone through the pCPA [pan-Canadian Pharmaceutical Alliance] office, but in this case the discussion goes far beyond pricing, so it made sense for a cancer organization to step in. The pCPA is participating as an observer.
What factors come into play in setting a price for Kymriah?
The patient population Kymriah treats has limited treatment options and historically poor outcomes. The price of Kymriah takes into consideration unmet medical needs, clinical and quality of life measures, the value of Kymriah in consideration of its clinical benefit and its ability to mitigate the economic, healthcare and social burden of disease in the two indications for which it is approved.
We are exploring ways we can support health system stakeholders to introduce Kymriah in a responsible and sustainable manner including innovative pricing models, early access mechanisms, outcomes-based agreements as well as patient and caregiver support.
How might a risk-sharing arrangement work for Kymriah?
In the US, Novartis has entered into outcomes-based agreements (OBAs) with the certified treatment centers that offer Kymriah for the pediatric and young adult leukemia indications. We are exploring similar arrangements in Canada.
What is the role of health outcomes data in the CAR-T space?
There is a global Kymriah registry in place, enabling the collection of shareable clinical data. In Canada, it could be an exciting opportunity to use outcomes data to test OBAs. We still need to figure out how to broaden access to data. Are we comfortable using proxy measures? How can we automate the collection and sharing of data? To give a simple example: when a patient has an outcome, do we have the appropriate infrastructure to collect data on that outcome in a timely manner?
How do expensive therapies such as CAR-T fit in with a sustainable healthcare system?
It bears noting that patented drugs represent only 7% of total healthcare spend. Even if we take all drugs off the table, we’ll still have full hospitals with patients who require procedures, equipment, and staff. If we can get better at measuring these costs, as well as evaluating the cost-effectiveness of different treatments, we’ll be in a position to have balanced discussions about sustainability. For the time being, our role at Novartis is to introduce CAR-T to the health system in a responsible way, and to pave the way for CAR-T therapies that come after us.
Is CAR-T moving us toward a cure for cancer?
It’s too early to say, but long-term remission is now a realistic scenario. Some truly great minds have gone into the development of CAR-T. In this case we can actually say: it is rocket science.