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InnomarLive 2023: Part One

By Innomar Strategies

Emerging Trends in the oncology ecosystem. Turning today’s challenges into opportunities for patient care and access

On February 16, 2023, InnomarConsulting™ implemented the 11th annual InnomarLive Speaker Series, entitled “Emerging trends in the oncology ecosystem: Turning today’s challenges into opportunities for patient care and access.” The full day, in person event included presentations and panel discussions from key Canadian thought leaders from Health Canada, CADTH, INESSS, pCPA, a private payer, the pharma industry, an oncologist, and a patient advocate.
Woman and child smiling

Over the course of the day, participants heard about the collaborative efforts launched by various stakeholders to address the increasing volume of new oncology treatments, the challenges this brings to payers in the evaluation of new therapies and the importance of RWE in their evaluations. 

The audience heard compelling discussions from the oncologist’s perspective in delivering quality care in a resource-constrained environment, and from the patient’s perspective in seeking diagnosis, treatment, care, and support. The series of topics were rounded out with the promise of new cell and gene therapies, the need for drug plan sustainability and the important role played by Patient Support Programs (PSPs) in enhancing the oncology patient’s journey.

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Health Canada: Regulatory approaches to oncology reviews in a rapidly changing landscape

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Melissa Hunt, Director, Bureau of Metabolism, Oncology and Reproductive Sciences, Pharmaceutical Drugs Directorate, Health Canada

Melissa described the Health Canada (HC) structure for oncology product reviews within the Pharmaceutical Drugs Directorate (PDD) and the Biologic and Radiopharmaceutical Drugs Directorate (BRDD). Oncology has been an area of innovation within Health Canada where approximately 77% of products with an NOC/c are in oncology and over the last 3 years, 41-54% of New Active Substance (NAS) submissions were part of an expedited pathway, many of these in oncology.
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Health Canada has implemented several strategies to address the increasing number of oncology therapies, including: Conditional Market Authorization, Priority Review, HTA alignment and the expanding use of RWE.  Broader collaborative initiatives like ACCESS and ORBIS have enabled an increased number of approved NDSs and SNDSs by the PDD and BRDD. HC participates in Innovative Medicines Initiative’s SISAQOL-IMI: Setting International Standards of PROs and QoL Endpoints in Cancer Clinical Trials, providing Canadian regulatory expertise on investigating the feasibility of developing recommendations for non-RCTs, and international recommendations for the terminology and definitions of clinical meaningful change in cancer trials.
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CADTH: Update on oncology HTA

Business team working together

Brent Fraser, Vice President, Pharmaceutical Reviews, CADTH

Brent spoke about the oncology HTA submission volumes received by CADTH, their collaborative work and future opportunities. In 2023, 41% (41/100) of Total Completed and In Progress Reimbursement reviews were in Oncology. CADTH has overall ~60 ongoing, active reviews at any time in 2023. With international collaborations across similar HTA organizations (PBAC, NICE, SMC, Wales), they can build on the success of regulator collaborative initiatives (Project ORBIS and Access Consortium) as well as learn from other HTAs like NICE’s proportionate approach. Looking forward, CADTH is developing RWE guidance (presented later) to support inclusion of data in submissions, implementing time limited recommendations and incorporating the GRADE (Grading Recommendations, Assessment, Development, and Evaluation) approach to drug reviews. CADTH completed the transition of Systematic Reviews to the manufacturers, and they expect improvements over time as manufacturers get used to this.


Business team working together

INESSS: The Quebec HTA perspective

Sylvie Bouchard, Director, Drug Evaluation and Technologies for Reimbursement Directorate, INESSS

Sylvie provided an update on Quebec’s Strategic Plan for the Life Sciences Strategy (updated May 2022) and Policy for Rare Diseases (published June 6, 2022). Communication activities and implementation of methodological work by INESSS will make it possible to assess the relevance of innovation and specify the information to collect to demonstrate the clinical, societal, and economic value of Quebec innovations in medical technology. 

To accelerate access to innovative medicines, INESSS encourages manufacturers to adhere to Health Canada’s aligned review process. INESSS supports the competitiveness of listings by supporting efforts by the MSSS to reduce registration delays and their contribution to the management of increased LOI negotiations, employing new methods. 

They published the Policy for Rare Diseases on June 6, 2022. However, the Action Plan detailing its deployment measures, as well as funding, are not yet available. Topics covered by the policy include: training for HCPs, access to preconception screening and prenatal diagnostics, genomic medicine, telehealth and tele pharmacy, pharmaceutical access, an enhanced food program, Quebec registry, research, and accelerating therapeutic innovations. 

Since 2020, the increased number of oncology treatments and HTA reviews, as well as other challenges, have created a backlog within INESSS. Their goals in 2023 are to get back in line with CADTH, to allow Quebec to join the pCPA negotiations and rollback the backlog to zero. They have implemented the necessary actions to achieve these goals. 

Precision Medicine has been an evolving area in oncology. INESSS’s goal is to implement Companion Diagnostic Tests evaluation processes and inform the MSSS in a timely fashion that a medical biology analysis is associated with drugs evaluated. INESSS describes how to ensure Quebec cancer patients receive timely access to innovative technologies in two important published documents.1,2

Approaches to conditional implementation for innovative technologies include: coverage with evidence development and performance-linked reimbursement to manage the use of technology to control its cost-effectiveness in real-world conditions. It is important that INESSS receives the Ministry’s commitment and openness to receiving these kinds of recommendations. 



Team discussing together

pCPA: Update on oncology drug negotiations

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Daniel Sperber, Senior Economist, pan-Canadian Pharmaceutical Alliance (pCPA) 

Daniel gave an overview of the pCPA’s role in the Canadian drug review process and its transition to a stand-alone organization, as well as other changes anchored by the new pCPA Strategic Plan that they released in April 2022. Since then, a process has been underway to identify and incorporate a new organizational structure and put other resources in place. 

In oncology, pCPA participants differ across payer and organizations across Canada (MOH drug plans, Cancer agencies, Health Authorities) and there is an extensive overlap between CADTH Provincial Advisory Group (PAG) and pCPA negotiation participants, giving a higher level of clinical familiarity with new drug submissions prior to pCPA negotiations.
Team discussing together
In the CAR-T space, pCPA conducts CAR-T negotiations on an ongoing basis with unique payers and decision makers for CAR-T drugs. Although oncology negotiation activities during COVID-19 were impacted, they now exceed pre-pandemic levels, with overall file timelines and LOI rates similar to the pre-pandemic period. 

Advice given to manufacturers included: 1) building internal acceptance of HTA clinical recommendations and criteria, 2) being ready to negotiate when an engagement letter is received, 3) preparing to offer cost effective/cost saving pricing, and 4) be mindful about proposals involving patient level tracking.

Private Payers: Assessing the value of oncology drugs

Daria O’Reilly, Lead Health Economist, Pharmacy Consulting Health Benefits and Payment Solutions, TELUS Health

Private payers consider an enhanced evaluation of budgets, populations, costs, values and philosophical beliefs. At TELUS Health, cancer treatments are in the top 10 (ranked #7) of drug classes by eligible amount, with 4.2% eligible costs from only 1.6% of claimants. 

With many cancer subtypes defined as rare diseases, and over one-third of DRDs are oncology, there are evidence gaps in clinical trial data, productivity, disability, and difficulty in determining cost-effectiveness. Yet, it is imperative to reduce uncertainties and mitigate risk, given the lack of evidence available. 

Payers/HTAs need to find ways to evolve their decision-making processes. One approach is to consider generating evidence from RWD. Potential sources of RWD include: EMR, registries, insurer databases, PSPs, preferred pharmacy networks, and other technologies, like mobile and wearable devices. 

Potential uses of RWE includes initial drug review and post-listing evaluation, ongoing formulary management, adherence, market share (to assess financial risk) and outcomes-based agreements (OBAs). 

In summary, it has been challenging to balance innovation with rising prices, under great uncertainty. Insurers are becoming more sophisticated in health technology assessments, and although public and private payers serve different populations, collaboration is necessary to find RWD and generate RWE for listing decision-making and OBAs.

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Delivering on Canada’s promise of value-based access to drugs for rare diseases

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Durhane Wong-Rieger, President and CEO, CORD 

Durhane presented what they have been working on at CORD over the past 3 years, during which time they have involved key stakeholders, including Health Canada. CORD will present their activities more fulsomely with workshops at their conference on March 28th and 29th in Ottawa. 

Current timelines from NOC to listing are too long. On average, it takes a total of 18.9 months from NOC to pCPA agreement (best case scenario). Only three out of five DRDs approved by the FDA/EMA are submitted to Canada. Of those, 7/10 approved DRDs receive a recommendation for reimbursement in public drug plans, yet only 25% of eligible patients receive treatment, up to 5 years later. The longer we wait, the more we harm patients. 
Person looking through files
Some oncology drugs, although expedited, can take longer as they get hung up every step of the way due to data uncertainty, high prices, negotiations, and other challenges. At the end of the day, 30% will receive a ‘Do Not List’. So, we are having a tough time getting innovative technologies into Canada, and when we do, we have a tough time getting them to patients.

CORD’s proposed strategy involves three pillars: 1) Centers of Expertise for precise diagnoses, testing and treatment algorithms that make sense, 2) Managed Drug Access Plans, even with high levels of uncertainty 3) Research to support development of new drugs and on-going assessments in real-life. We can maximize the return on the $1B drug strategy investment by providing the right drug to the right patient at the right time for the right price. Alternative pathways are also being proposed, looking at RWE-based decision options/managed access pathways that are already in place in the big 5 EU countries.



Commercializing new oncology treatments: the manufacturer’s perspective

Carlene Todd, Vice President, Access, Hoffmann-La Roche Limited 

Carlene presented the challenges and opportunities from a manufacturer’s perspective in commercializing new oncology treatments. Approval to access to health technologies in Canada requires many sequential steps, with each step introducing opportunities for delay that have been increasing over the past 10 years. 

In 2020, the time from HC approval to its first provincial formulary listing (all drugs) was 21 months, which has almost doubled since the 2013-2015 period (11.5 months).  Although Canada is one country, it feels more like thirteen countries, with each province having its own infrastructure and complexities. Upon first provincial listing, the time to 80% formulary listings for oncology drugs was significantly less than for non-oncology drugs (172 days vs 436 days). 
Precision oncology is rapidly evolving, with up to 46 key biomarkers and ~84 targeted therapies expected in the US by 2025, increasing the opportunities to ensure the right care is delivered for the right patient at the right time. Canada is well positioned in creating a stronger, more resilient healthcare system, which starts with a recognition of industry’s value to Canada and a commitment to building a long-lasting partnership between all healthcare system stakeholders. The private sector brings unique capabilities to the ecosystem, including expertise in innovative therapies, biomanufacturing and information technology in key areas of 1) health data and RWE, 2) partnerships and collaboration and 3) the value of innovation. Initiatives like PREDiCT (Personal Response Determinants in Cancer Therapy) at the BC Cancer Agency, deliver an RWE generation framework for innovative health technologies, providing learnings with sustainable, scalable data and testing infrastructure, enabling more timely personalized cancer care with less waste in the system. 

For the value of innovation to be realized in cancer care, current processes, regulations, and approaches will have to change with 1) a broad concept of value applied across the entire access continuum, 2) early diagnosis and the right targeted therapy to reduce waste in the system, 3) Alternate formulations that help relieve hospital capacity issues and 4) Outcomes Based Agreements (OBAs) to address uncertainty. 

Looking ahead, RWE informs streamlined reimbursement and funding pathways to enable timely access. We need to collaborate to solve the complexity of our healthcare challenges, and to capture and recognize holistic value propositions.

InnomarLive 2023: Part Two 
Panel Discussion Summary: “How can we turn these challenges into opportunities which will benefit patient care and access?” 
Read more

InnomarLive 2023: Part Three
Caring for Canadian oncology patients – the physician’s perspective 
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