InnomarLive 2023: Part Three

Dr. Gerald Batist, Director, Dept. of Oncology, Sir Mortimer B. Davis-Jewish General Hospital; Director, McGill University Centre for Translational Research in Cancer; Professor, Department of Oncology, McGill University

Following the lively interactive panel discussion, Dr. Gerald Batist took to the stage to deliver insights on the physician’s perspective on delivering quality care to oncology patients. Covid-19 has certainly been a disruptor in the treatment approach for cancer patients. While many challenges arose during the pandemic, what we face today may be more alarming wherein there are larger numbers of patients presenting with more advanced disease than before, thwarted by a shortage of healthcare professionals – what Dr. Batist referred to as the “post-covid cancer tsunami.” However, today’s technological advances and innovations are bringing real promise in managing cancer care with precision medicine. More effective and targeted treatments can lower overall treatment costs by optimizing patient-treatment matching, thereby avoiding predictably ineffective, toxic, and costly treatments while improving overall clinical outcomes. In just the past few years, there has been a surge of New Active Substance approvals in oncology, most of which are targeted therapies. In oncology, innovative approaches like Exactis Innovation and the Oncology Interactive Navigator can improve personalized treatments and successful person-centered care. 

Gaining access to diagnosis, treatment, and care – the patient’s perspective

Claire Edmonds, Registered Psychotherapist, affiliated with Wellspring 

In her own compelling patient narrative, entitled ‘Blind Sided’, Claire portrayed the deep anguish, thoughts, feelings, and determination she experienced dealing with ocular melanoma as she walked us through her journey of challenges and successes as a cancer patient, and an allied health care professional. 

In her research, Claire has looked at a lot of Kaplan-Meier Curves assessing survival of patients or groups, trying to understand good prognostic indicators. Now, she sees these curves with the data points as people, people trying hard to survive, trying hard to live…some of them will make it, some of them won’t. And so, in your work, when you look at these datapoints, know that each datapoint is a patient, and that each patient has a story, and there are possibilities for skillful interactions and possibilities for unskillful interactions.

With this ‘tsunami’ of patients entering hospitals and cancer care, there has been tremendous stress on hospitals, staff, and psycho-social services. To relieve this stress, hospitals are looking to download the psycho-social needs onto community cancer centers, such as Wellspring and other resources. 
  
Wellspring is a cancer support organization that provides a variety of programs and services to people affected by cancer, including patients, survivors, and caregivers. Patient expression through medical narratives (such as Claire’s ‘Blind Sided’ narrative) is one of Wellspring’s support offerings. They offer emotional, psychological, and practical support, such as counseling, educational workshops, and fitness classes.

Hope and Challenges for Cell and Gene Therapies, Turning today’s challenges into opportunities for patient care and access

Dale Hanna, Director, Cell and Gene Therapy Solutions, AmerisourceBergen

Cell and Gene Therapy Solutions is a new and unique group within the AmerisourceBergen organization. They sit at the enterprise level looking globally across all business units to understand the needs of all stakeholders. This enables them to help solve the hurdles they face related to the complexities of cell and gene therapies.

Dale highlighted three hopeful promises from the patient’s perspective: 1) Scientific innovations are leading to greater health outcomes for the sickest patients; 2) inclusion of patient and caregiver voices is coming to the forefront of development and commercialization efforts; 3) Biopharma is pushing the health industry into the 21st century across many different workstreams and perspectives.

There are many challenges within “the reality of the cell and gene complexity experience.” From a manufacturer’s perspective, the key challenges are that in an increasingly competitive and complex environment, unlocking commercial success requires speed to market. They face a war on talent, complexity of process, and miscues during clinical operations for commercial handoff. To successfully scale up volume, an integrated strategy involving service providers is essential. Providers also face challenges when it comes to securing access to treatments for their patients, and not to mention the funding and reimbursement struggles from a financial perspective.

RWE continues to be significant, as it holds the promise of representing real-world practice and behaviors of patients throughout their treatment experience. A patient-driven outcome that is aligned with their daily lives should be included.
Patient support services are often in place to address unmet needs beyond the clinical setting. Designing services around the patient and caregiver to address pre- and post - treatment needs will improve both health and commercial outcomes.

Get ahead of many unknowns and design flexibility in your access pathways when coming to market. You can never partner early enough with industry, regulators, patients, caregivers, and providers to ensure your product has optimal reach and success.

Real-World Evidence: Moving from Engagement to Implementation

Brent Fraser, on behalf of Nicole Mittman, Vice-President, Scientific Evidence, Methodologies, and Resources 

Brent provided an update on the Real-World Evidence Guidance initiative and its next steps. Stakeholder consultations for the guidance were completed on January 6, 2023. Based on the HTAi’s Global Policy Forum after 3 rounds, key principles that surfaced were Transparency, Impartiality, and Inclusivity, with Transparency being at the top of all three rounds. 

The goal is to develop, in collaboration with Health Canada, a guidance document for reporting RWE as a supplement to submissions. This will improve reporting standards, the quality of submitted data and better inform decision making. Fifty-four different stakeholders provided comments, constructing some general themes and learnings. CADTH and Health Canada will respond to the comments by organizing the themes, providing a response to the comments and then determine whether the Guidance Document will be updated. The RWE Guidance Document will be launched at the CADTH Symposium on May 16th to 18th, 2023.

It is particularly important to look at the evidence, and the quality of the evidence. RWE will not lead to automatic approvals but will help fill the gaps of uncertainty. It is necessary to determine what are the appropriate outcomes that need to be measured before we can discuss Outcomes Based Agreements (OBAs). Pharmaceutical manufacturers can prepare by consulting with CADTH and the right stakeholders, patient groups, to understand what the right outcomes are, to ensure the best data comes forward.