CADTH - Why it is important, and what now?
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The CADTH symposium focused on the importance of health technology assessment (HTA) in informing decision-making for various stakeholders, including technology developers, patients, and clinicians. It emphasized the need for a more inclusive approach that incorporates real-world evidence and qualitative data to address patient experiences and unmet needs. The discussions highlighted a gap in patient participation and the requirement for more collaborative, transparent processes in HTA to improve outcomes and access to treatments.
CADTH - Why it is important, and what now?
- 1. CADTH: Why is it important, & what now? May 5th, 2016
- 2. CADTH Symposium Theme Evidence for Everyone: Expanding the Reach of Health Technology Assessment April 10-12 in Ottawa
- 3. Who Pays for Pharmaceuticals in Canada? Total 2013 Rx Meds Expenditure $29.3 B*; 100% Private Sector Share $17.1 B; 58.4% of total Public Sector Share $12.2 B; 41.6% of total Other Publicly Funded Drug Expenditure; 1.1 B; 3.8% of total; 9.0% of public share Federal Drug Benefit Plan; 0.6 B; 2.0% of total; 4.9% of public share Provincial Drug Benefit Plan; 10.5 B; 35.8% of total; 86.1% of public share Out-of-Pocket Contributions; 7.0 B; 23.9% of total; 40.9% of private share Private Insurers; 10.1 B; 34.5% of total; 59.1% of private share * Not including medicines dispensed in hospitals Source: Prescribed Drug Spending in Canada 2012 Report, CIHI
- 4. Complex Pathway to Patient Access Drug Development Health Canada Review Patented Medicine Prices Review Board Health Technology Assessment Hospitals Patient Access Private Drug Plans Provincial Drug Plans 1.
- 5. Health Canada • Considers clinical evidence from clinical trials to decide if a drug/ biologic is safe and effective for sale • If so, the manufacturer can sell • Monitors therapies post approval for ongoing safety and effectiveness
- 6. Canadian Agency For Drugs and Technologies in Health ( CADTH) • Federal/provincial/ territorial health technology assessment body with two reimbursement recommendation programs for provinces/ territories: Common Drug Review ( CDR) program for non-cancer drugs • Considers clinical, economic evidence and finally patient input pan-Canadian Oncology Review ( pCODR) program for oncology drugs • Considers clinical, economic, patient input and ease of implementation “equally” as its deliberative framework • • Each decides the “value” of the drug relative to others available and relative to opportunity costs of funding this drug versus other drugs • Recommends a yes , a yes with conditions usually a pricing reduction or no to provincial funding bodies in health ministries INESSSS in Quebec
- 7. Provincial drug budgets • Silos with at least one silo for drugs • Oncology budgets are generally managed through the cancer agencies in the province • In Ontario and Atlantic Canada take home oncology drugs are not paid for by the provinces but other provinces do cover them • Ontario has just announced an amalgamation of its Ontario Pharmaceutical Drug Plans but no details are available yet
- 8. WHAT THE HTA PROCESS VALUES Elizabeth Lye Lymphoma Canada
- 9. “Better Evidence for Everyone” Clinical Econo mic Patient Experience
- 10. Ethical Considerations • Identifying values - Canada Health Act : Public Administration; Comprehensiveness; Universality; Portability; Accessibility • Developing framework to support identification and analysis of ethical data to support better-informed, value-sensitive decisions • Training, engagement of ethicists in HTA process • Scarcity of ethical evidence; limited resources and expertise
- 11. “More” Evidence • Incorporation of real-world evidence; patient values • Quality of life data; lived experience of the disease • Tools to facilitate indirect comparisons of new and/or existing therapies • Network meta-analysis adoption, cross-trial comparisons • New methods for generating evidence
- 12. Engagement and Collaboration • “Patient and public engagement” • PAG input: Update to the CADTH Guidelines for Economic Evaluation of Health Technologies • Clinician input: pCODR – pilot project 1.
- 13. CADTH Symposium Report Back Need for change in HTA??? Sabrina Hanna Save Your Skin Foundation
- 14. Evidence for Everyone Expanding the reach of Health Technology Assessment (HTA) What does this mean and who is everyone?
- 15. Evidence for everyone Initially established as a tool for policy-makers, health technology assessment (HTA) now supports a much broader range of decision-makers. Everyone — whether technology developers in academic settings and industry, patients, clinicians, regional health authority and hospital administrators, or private sector insurers — can benefit from the evidence produced by HTA bodies. Because HTA wasn’t originally designed with these stakeholders in mind, do its processes and outputs need to change to make it easier for clinicians, patients, and other key stakeholders to integrate evidence into their decision- making?
- 16. Is there a need for change? YES!
- 17. Numbers versus Words • Quantitative data versus qualitative date • Qualitative data gives a voice to the science • Qualitative data answers the questions 1. what are the unmet needs 2. what are the experiences of the current treatment 3. what is it like to live with the medical condition.
- 18. Need for Change • Quantify qualitative data • Create a template or guide that will help patient groups provide input that is meaningful and relevant • Scientific Literacy • Educate patient groups
- 19. Better decisions versus Different Decisions • Patient submissions help expert committees make better decisions not different decisions • Gap between theory and practice
- 20. Need for Change • Formula/Value system for Quality of Life (QoL) data • Educate experts on the role of the Patient groups • Provide resources for patient groups to develop submissions that are professional and relevant to the patient experience
- 22. Patient Centricity • Patients Included • Patients included charter – Patients or caregivers actively participate in the design and planning – Patients and caregivers attend and participate – Travel accommodation expenses are paid in full, in advance. Scholarships are provided – The disability requirement of participants are accommodated – Access for virtual participants is facilitated
- 23. Efficient HTA in real time Health technology assessment (HTA) refers to the systematic evaluation of properties, effects, and/or impacts of health technology. It is a multidisciplinary process to evaluate the social, economic, organizational and ethical issues of a health intervention or health technology. • Interface of science and policy
- 24. Need for Change • Join the digital age • Share everything. hide nothing. Adapt Often • Improvement of transparency and communication • Take HTA already delivered and adapt to our setting • Consult with people who benefit from and use the work of HTA professionals • Establish patient/citizen councils
- 25. Bigger Picture • See the bigger picture instead of the smaller picture
- 27. CADTH AND PATIENT PARTICIPATION The evidence isn’t in Mona Forrest
- 28. CADTH’s Symposium in April was “certified” Patients Included The evidence: This is a self-certification which any organization can use, providing they meet criteria listed on the www.patientsincluded.org website. What was missing: Very few patients were involved in panels, and few were given scholarships to attend; what financial support was available had to be divided between students, preferably those presenting, and patients. The process was unclear for patients and/or patient groups to participate in planning the Symposium, including themes, topics and speakers, and in presenting. There was no recognition or thanks in the program for any participation by patients.
- 29. CADTH obsessions • Strong belief that patient groups are in conflict of interest if they receive pharmaceutical company funding • Disdainful for patients/patient groups that use Survey Monkey or similar free or economical web-based tools to survey patients • Believe that patient participation is a risk: patients will be uninformed, will belabour their own experience, will disrupt professional decision-making • Belief that patient input for drug reviews is suspect because not seen as professional; lived experience is not seen as valid • Patient groups are questioned about their representivity and who they report to
- 32. What is missing • Transparency about how CADTH is funded - amounts and sources, so patients may form their own opinions about possible bias • Genuine understanding and respect for patient participation • Patient pathways on CADTH website: very difficult to find out who the patient representatives are (where they exist); how they are picked, and for how long a term (danger of being co-opted) • Train researchers and academic experts on value of patient input and lived experience • Need for critical mass: more patients, perhaps a panel of patient-experts to be called upon in turn • Do away with literature searches as a source of patient experiences and work with real patients CADTH Symposium • Dedicated patient tables at meals and adjacent spaces so patients can share experiences • Serious funding to allow more patients to attend
- 33. The Future: best practices internationally Martine Elias - Myeloma Canada Slides presented by Louise Binder
- 34. Our challenges are Global: • Are regulatory decision makers able to change their decision making paradigm? • HTA agencies provide information and recommendations, but then 3rd parties make the reimbursement decisions • What flexibility do HTA agencies have to navigate the reimbursement environment. Will a new model be required? • Industry needs to address regulators, HTAs, Clinicians and patients. Can they satisfy all? • Bottom line: Can we manage the continuum from bench to access in a smooth and efficient way? 1.
- 35. But what does Cancer Care Ontario want…. • CCO is interested in supporting RWE that addresses payer needs with the potential to inform or validate funding decisions • CCO is committed to expanding its efforts to use RWE to inform decision making and is management for cancer funding programs by collaborating with their cancer partners • They welcome input on who this could involve. • WHERE IS THE PATIENT VOICE… 1.
- 36. What is being done elsewhere to bring patient value through RWE into the decision process – EU Example (1) • GetReal aims to collect RWE data for early adoption in the pharmaceutical R&D and the healthcare decision making process by: – Bringing together healthcare decision makers, academics, pharmaceutical companies, clinicians, and patient stakeholders; – Proposing innovative trial designs and assessing the value of information; – Proposing and testing innovative analytical and predictive modelling approaches; – Creating new decision making support, and building tools to allow for the evaluation of development programs and use in the assessment of the value of introducing new treatments; – Sharing and discussing deliverables with healthcare decision makers, academics, pharmaceutical companies, clinicians, and patient stakeholders; 1.
- 37. What is being done elsewhere to bring patient value through RWE into the decision process – EU Example (2) is an enabling platform for the coordination of Medicines Adaptive Pathways to Patients (MAPPs) activities. MAPPs seeks to foster access to beneficial treatments for the right patient groups at the earliest appropriate time in the product life-span in a sustainable fashion. 1.
- 38. Our problems will be solved when countries can find ways to deliver access, and manage their uncertainty- right drug at the right time for the right patient… Innovative schemes to provide reimbursement Health outcome based: Rebate for early non-responders or pay for results Finance disease management programs, education Response schemes based on RWE data collection eg. Coverage with evidence development Provide additional data when available Non-Outcomes based: Population level cap Initiation period costs Capped duration of treatment Volume discountIF THERE IS A WILL THERE IS A WAY>>>>>
- 39. Collaboration required.. • Widespread collaboration of efforts, including on an international scale, is ideal and would support evidence generation • Incorporation of RWE more formally into the R&D continuum – opportunity for every stakeholder to cooperate (pharma, regulators, HTA, patients and clinicians) • Need for streamlined approach to when and how real world evidence is considered in decision making process • Perhaps the development of collaborative networks and incentivize problem solving were proposed solutions…. Worth exploring 1.
- 40. A picture is worth a 1000 words… HTA Producers HTA evaluators Patient
- 41. Recommendations from the Symposium Find it on the front page of the CCSN website, or the following link: http://survivornet.ca/en/news/what_is_cadth_a nd_why_does_it_matter 1.
- 42. Questions? Please type questions in the “questions” box in your GoToWebinar toolbox – right hand side of the screen!
- 43. Canadian Cancer Survivor Network Contact Info Canadian Cancer Survivor Network 1750 Courtwood Crescent, Suite 210 Ottawa, ON K2C 2B5 Telephone / Téléphone : 613-898-1871 E-mail jmanthorne@survivornet.ca or mforrest@survivornet.ca Web site www.survivornet.ca Blog: http://jackiemanthornescancerblog.blogspot.com/ Twitter: @survivornetca Facebook: www.facebook.com/CanadianSurvivorNet Pinterest: http://pinterest.com/survivornetwork/