CADTH Report | Genome-Wide Sequencing: Ethical Considerations

Copied from: https://cadth.ca/genome-wide-sequencing-ethical-considerations

Direct link to reports

Project Protocol, Ethics, Patients’ Perspectives, and Experiences Section | https://cadth.ca/sites/default/files/hta-he/he0020-genonme-wide-sequencing-protocol.pdf

Genome Wide Sequencing: Ethical Considerations | https://cadth.ca/sites/default/files/hta-he/he0020-genome-wide-sequencing-ethical-considerations.pdf

Last updated: November 12, 2019Project Number: HE0020-000Product Line: Technology Review Result type: Report

This Genome-Wide Sequencing: Ethical Considerations Technology Review was conducted by CADTH in collaboration with Health Quality Ontario (HQO), together with a supporting rapid review of the qualitative evidence of patient preferences. Read the full HQO Health Technology Assessment project for more information.

Unexplained developmental disabilities and multiple congenital anomalies describes a set of overlapping symptoms attributed to several conditions, including global developmental delay and intellectual disability. Early detection in children is critical to ensure timely access to appropriate care. However, due to complex presentation and multifactorial etiology, diagnostic challenges are common. Genome-wide sequencing (whole exome and genome sequencing) involves broad evaluation and detection of genetic variants. This technology may play a role when conditions with potential underlying genetic causes are difficult to diagnose with traditional approaches.

CADTH, in collaboration with Health Quality Ontario, conducted a Health Technology Assessment project on the use of genome-wide sequencing for patients with unexplained developmental disabilities and multiple congenital anomalies. Health Quality Ontario completed a systematic review of clinical evidence, an economic evaluation, and direct patient engagement for patient preferences and values. CADTH conducted a review of qualitative literature on patient perspectives and experiences, and a review of ethical issues.

CADTH Report | Dosing and Timing of Immuno-Oncology Drugs

Copied from: https://cadth.ca/dosing-and-timing-immuno-oncology-drugs

Direct Link to PDF of report: https://cadth.ca/sites/default/files/ou-tr/ho0008-dosing-timing-immuno-oncology-drugs.pdf

Last updated: November 21, 2019Project Number: HO0008-000Product Line: Optimal Use, Technology ReviewResult type: Report

Immuno-oncology (IO) drugs (also called immune checkpoint inhibitors or immunotherapy drugs) have transformed the field of cancer. These drugs have elicited unprecedented therapeutic responses, allowing significant regression and sometimes resolution of several cancer types. Dosing of IO therapies investigated in clinical trials is inconsistent across studies. Decision-makers are looking for evidence that would help improve the consistency of dosing schedules across tumour types. In addition, they are asking about the feasibility and timing of re-treatment with IO drugs after progression on IO-based adjuvant therapy. This review explores the clinical and pharmacological literature addressing these questions.

Submit your abstract to the CADTH Symposium by Oct-25. Decision-Making in an Age of Uncertainty (Apr 19-21, Toronto) — the “must attend” event for anyone interested in the assessment, uptake, and management of drugs and medical devices in Canada.

Additional information, presentation formats and application information available at: https://symposium.cadth.ca/call-for-abstract/

Note: Travel awards available for patient representatives, undergraduate students and graduate students.

The 2020 CADTH Symposium will be held at the Sheraton Centre Toronto Hotel in Toronto, Ontario from April 19 to 21, 2020. The theme is Decision-Making in an Age of Uncertainty. Topics relevant to this theme include, but are not limited to:

• methods to address uncertainty
• disinvestment
• innovative payment schemes
• decision-making by patients, clinicians, and policy-makers
• implementation issues
• managing uncertainty.

The CADTH Symposium is widely considered a “must attend” event for anyone with an interest in the assessment, uptake, and management of drugs and medical devices in Canada. The CADTH Symposium typically attracts 750 to 900 delegates from across Canada and beyond, including health researchers; health economists; senior leaders from government, regional health authorities, hospitals, and other facilities; clinicians and patients; students; and industry representatives. With the Symposium in 2020 being held in Toronto for the very first time, we are anticipating 1,000 to 1,200 delegates. As one of the major health technology assessment conferences in the world, the CADTH Symposium offers a unique opportunity for delegates to learn from local, national, and international experts, and to share expertise and knowledge.

Who Should Submit an Abstract?

Presentations from all interested parties are welcome. These include:

• federal, provincial, and territorial health care policy-makers and decision-makers, economists, and regulators
• health care executives and managers from health regions, alliances, hospitals, and long-term care facilities
• researchers (from non-profit organizations, universities, regional health authorities, hospitals, and other settings)
• health economists
• knowledge transfer and exchange professionals
• clinicians
• representatives from the pharmaceutical and medical devices industries, and consultants
• health care associations and patient groups
• professional associations
• graduate and undergraduate students studying in a health- or health technology assessment-related field.

Symposium Objectives

The objectives of the 2020 CADTH Symposium are to:

• provide a forum for productive discussion between parties committed to the use of evidence-based information and advice to inform policy, influence practice, and improve health
• provide education and training that will build the capacity to produce and use evidence-based information on drugs and other health technologies
• foster a better understanding about the perspectives of different health care system sectors and the challenges they face, and to jointly look for solutions and new approaches that will enhance the quality and sustainability of health care in Canada.

Deadline

Abstracts must be received by 5 p.m. EDT on Friday, October 25, 2019.
Questions may be sent by email to symposium@cadth.ca

Travel awards for patient group representatives, undergrads and grad students to attend the CADTH Symposium in Toronto. Apply by Dec 10.

Application information available at https://symposium.cadth.ca/travel-awards-program/

Since 2007, CADTH has provided financial support toward conference-related costs for more than 395 students and patient group representatives as part of our commitment to making this important event accessible to all health care stakeholders.

This year, eligible students and patient group representatives can receive up to $2,000 to offset registration, travel, food, accommodation, and other conference-related expenses.

For Students

The 2020 CADTH Symposium offers an excellent opportunity to share your research, learn about the latest advancements in health technology assessment, and interact with peers from across the country (as well as leading Canadian and international experts). If you’re a full-time undergraduate or graduate student attending a degree-granting institution in Canada and taking courses in a field relevant to CADTH’s work, we invite you to apply for a travel award.

For Patient Group Representatives

It’s important that your voice is heard. If you work for a not-for-profit, patient-related organization, or a citizen’s organization interested in health policy, we invite you to apply for a travel award.

How to Apply

Step 1: Review the 2020 CADTH Symposium Travel Award Program Criteria.

Step 2: Complete and submit the 2020 Travel Awards Application form to CADTH by December 10, 2019.

Travel award decisions will be made by the end of January 2020, and awards will be issued to successful applicants by the end of March 2020.

Reminder: The Abstract Submission Deadline for the 2020 CADTH Symposium is October 25, 2019. Priority will be given to travel award applicants who have submitted an abstract for the 2020 CADTH Symposium.

If you have questions about the 2020 CADTH Symposium, or the Travel Award Program, please contact us at symposium@cadth.ca. We’re looking forward to seeing you in Toronto in 2020.

The CADTH pan-Canadian Oncology Drug Review Invites Patient Advocacy Group and Registered Clinician Input on Nelarabine (Atriance) for Acute Lymphoblastic Leukemia

Patient groups and clinicians that have not yet registered with pCODR and would like to provide input are invited to visit pCODR Registration for details on registration.

The CADTH pan-Canadian Oncology Drug Review (pCODR) is anticipating that a submission will be made for nelarabine (Atriance) for acute lymphoblastic leukemia (ALL).

The manufacturer has indicated that it will seek funding for nelarabine (Atriance) for individuals, aged 1–30 years, newly diagnosed with intermediate- or high-risk (CNS1 or CNS 2) T-ALL, stages II-IV, during upfront therapy.

The targeted deadline for receiving patient group input and registered clinician input on nelarabine (Atriance) for ALL is June 28, 2019 by 5:00 p.m. Eastern Time. This date is tentative and will be confirmed on the CADTH website once the submission has been filed by the manufacturer.

Patient group submissions can be made through the CADTH website once the submission has been filed by the manufacturer using the Patient Input Template for CADTH CDR and pCODR Programs.

Registered clinician submissions can be made through the CADTH website once the submission has been filed by the manufacturer by using the designated Clinician Input Template for nelarabine (Atriance) for ALL.

About CADTH: CADTH is an independent, not-for-profit organization responsible for providing Canada’s health care decision-makers with objective evidence to help make informed decisions about the optimal use of drugs and medical devices in our health care system. CADTH receives funding from Canada’s federal, provincial, and territorial governments, with the exception of Quebec. Learn more at: www.cadth.ca.

CADTH Invites Patient Advocacy Group and Registered Clinician Input on: Axicabtagene Ciloleucel (TBD) for Diffuse large B-cell lymphoma (DLBCL)[Due 23-Nov-2018]

This is to notify stakeholders that CADTH is anticipating that a submission will be made for Axicabtagene Ciloleucel (TBD) for diffuse large B-cell lymphoma (DLBCL).

Patient groups that have registered with CADTH are invited to provide input by using the Patient Input Template for CADTH CAR T-Cell Therapy Reviews.

Clinicians and clinician groups that have registered with CADTH are invited to provide input using the Clinician Input Template for Axicabtagene Ciloleucel for Diffuse large B-cell lymphoma (DLBCL).

The targeted deadline for receiving stakeholder input on Axicabtagene Ciloleucel (TBD) for diffuse large B-cell lymphoma (DLBCL) is November 23, 2018 by 5:00 p.m. Eastern Time. This submission is now open for input and patient group and clinician submissions can be made through the CADTH website.

Patient groups and clinicians who have not yet registered with CADTH and would like to provide input are invited to visit CADTH Registration for details on registration.

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About CADTH

CADTH is an independent, not-for-profit organization responsible for providing Canada’s health care decision-makers with objective evidence to help make informed decisions about the optimal use of drugs and medical devices in our health care system. CADTH receives funding from Canada’s federal, provincial, and territorial governments, with the exception of Quebec.
Learn more at: www.cadth.ca.

DUE OCT 15: CADTH pan-Canadian Oncology Drug Review (pCODR): invitation to patient groups and registered clinicians to provide input on Dinutuximab (Unituxin) for neuroblastoma – submit using templates by Oct 15

The CADTH pan-Canadian Oncology Drug Review (pCODR) is anticipating that a submission will be made for Dinutuximab (Unituxin) for Neuroblastoma.  The manufacturer has indicated that it will seek funding for dinutuximab (Unituxin) to be used in combination with GM-CSF, IL-2 and Retinoic acid (RA) for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multi-agent, multimodality therapy.

The targeted deadline for receiving patient group input and registered clinician input on crizotinib (Xalkori)for ROS1-positive advanced NSCLC, dinutuximab (Unituxin) for neuroblastoma and palbociclib (Ibrance) in combination with fulvestrant for MBC is October 15, 2018  by 5:00 p.m. Eastern Time. This date is tentative and will be confirmed on the CADTH website once the submission has been filed by the manufacturer.

Templates to Complete

Patient group submissions can be made through the CADTH website once the submission has been filed by the manufacturer using the Patient Input Template for CADTH CDR and pCODR Programs.

Registered clinician submissions can be made through the CADTH website once the submission has been filed by the manufacturer by using the designated:

• Clinician Input Template for Crizotinib (Xalkori) for ROS1-positive advanced NSCLC,
• Clinician Input Template for Dinutuximab (Unituxin) for Neuroblastoma
• Clinician Input Template for  Palbociclib (Ibrance) in combination with fulvestrant for MBC.

Patient groups and clinicians that have not yet registered with pCODR and would like to provide input are invited to visit pCODR Registration for details on registration.

About CADTH

CADTH is an independent, not-for-profit organization responsible for providing Canada’s health care decision-makers with objective evidence to help make informed decisions about the optimal use of drugs and medical devices in our health care system. CADTH receives funding from Canada’s federal, provincial, and territorial governments, with the exception of Quebec.

Learn more at: www.cadth.ca.

CADTH Symposium Travel Award Program for Students and Patient Group Representatives – apply by 10-Dec-2018

CADTH is pleased to announce the 2019 CADTH Symposium Travel Award Program for students and patient group representatives.

Since 2007, CADTH has provided financial support toward conference-related costs for more than 335 student and patient group representatives as part of our commitment to making this important event accessible to all health care stakeholders.

This year, eligible students and patient group representatives can receive up to $2,000 to offset registration, travel, food, accommodation, and other conference-related expenses.

For Students

The 2019 CADTH Symposium offers an excellent opportunity to share your research, learn about the latest advancements in health technology assessment, and interact with peers from across the country as well as leading Canadian and international experts. If you’re a full-time undergraduate or graduate student attending a degree-granting institution in Canada, and taking courses in a field relevant to CADTH’s work, we invite you to apply for a travel award.

For Patient Group Representatives

It’s important that your voice is heard. If you work for a not-for-profit, patient-related organization, or a citizen’s organization interested in health policy, we invite you to apply for a travel award.

How to Apply

Step 1: Review the 2019 CADTH Symposium Travel Award Program Criteria.
Step 2: Complete and submit the 2019 Travel Awards Application form to CADTH by December 10, 2018.

Travel award decisions will be made by the end of January 2019, and awards will be issued to successful applicants by the end of March 2019.

Reminder: The Abstract Submission Deadline for the 2019 CADTH Symposium is October 26, 2018. Priority will be given to Travel Award applicants who have submitted an abstract for the 2019 CADTH Symposium.

If you have questions about the 2019 CADTH Symposium, or the Travel Award Program, please contact us at symposium@cadth.ca. We’re looking forward to seeing you in Edmonton in 2019.

About CADTH

CADTH is an independent, not-for-profit organization responsible for providing Canada’s health care decision-makers with objective evidence to help make informed decisions about the optimal use of drugs and medical devices in our health care system. CADTH receives funding from Canada’s federal, provincial, and territorial governments, with the exception of Quebec.

Learn more at: www.cadth.ca.

pCODR invites the input of clinicians and patient groups on Blinatumomab (Blincyto) for Ph+ B-cell precursor Acute Lymphoblastic Leukemia (tentative target date: September 17, 2018 by 5:00 p.m. Eastern Time)

See below the information on how to submit feedback to CADTH pCODR on Blinatumomab for Ph+ B-cell precursor ALL. CADTH is an independent, not-for-profit organization responsible for providing Canada’s health care decision-makers with objective evidence to help make informed decisions about the optimal use of drugs and medical devices in our health care system. Please remember that clinicians, tumour groups and patient groups need to be registered with pCODR to submit input directly.  After a registration is submitted, the process can take two business days.  In addition, both C17 and N2 are registered and can submit input.

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The CADTH pan-Canadian Oncology Drug Review (pCODR) is anticipating that a submission will be made for blinatumomab (Blincyto) for Philadelphia chromosome positive (Ph+) B-cell precursor (BCP) acute lymphoblastic leukemia (ALL).

The manufacturer has indicated that it will seek funding for blinatumomab (Blincyto) for the treatment of patients with relapsed or refractory Philadelphia chromosome positive (Ph+) B-cell precursor (BCP) ALL.

Patient groups and clinicians that have registered with pCODR are invited to provide input by using the applicable templates: Patient Input Template for CADTH CDR and pCODR Programs or the pCODR Registered Clinician Input on a Drug Review template, which are available at Process in Brief (www.cadth.ca/pcodr/process-in-brief).

The targeted deadline for receiving patient group and registered clinician input on blinatumomab (Blincyto) for ALL is September 17, 2018 by 5:00 p.m. Eastern Time. This date is tentative and will be confirmed on the CADTH website once the submission has been filed by the manufacturer. Patient group and registered clinician submissions can be made through the CADTH website once the submission has been filed.

Patient groups and clinicians that have not yet registered with pCODR and would like to provide input are invited to visit pCODR Registration for details on registration.

STAY TUNED: CADTH to Evaluate CAR T-Cell Therapies. Information on review process below – stakeholders, patient groups and clinicians will have an opportunity to provide their insight at a future date

As published on: April 17, 2018 at https://cadth.ca/news/cadth-evaluate-car-t-cell-therapies-0

Since the FDA approved the first gene therapy in 2017, Canadian patients, health care providers, and decision-makers have been anticipating the arrival of chimeric antigen receptor (CAR) T-cell therapies in Canada. During this time, CADTH has been considering how to effectively and rigorously assess the clinical effectiveness and value that these therapies may bring to patients and the health care system.

Today, we are pleased to provide further details about how our reviews of CAR T-cell therapies will proceed.

Review Process

CAR T-cell therapies are ushering in a new approach to treating cancer and other serious conditions. Given the unique aspects of these health technologies, CADTH will review CAR T-cell therapies through its health technology assessment process for medical devices and clinical interventions, and not through its pan-Canadian Oncology Drug Review (pCODR) or Common Drug Review (CDR).

This approach is being implemented in direct response to feedback from federal, provincial, and territorial Ministries of Health and the Canadian Association of Provincial Cancer Agencies (CAPCA), and is consistent with that being taken by several other health technology assessment bodies, including the Institut national d’excellence en santé et en services sociaux (INESSS) in Quebec.

Assessments will be led by CADTH, with recommendations, advice, and guidance from the Health Technology Expert Review Panel (HTERP). HTERP’s current member composition will be supplemented with individuals who have the applicable clinical expertise and who are leading the implementation of CAR T-cell program planning provincially.

Transparency, collaboration, and stakeholder engagement are central to each assessment that CADTH undertakes, and our appraisals of CAR T-cell therapies will be no different. Stakeholders, including patient groups and registered clinicians, will have the opportunity to provide their insight and perspective on these new treatments. For indications specific to cancer, we will also work closely with the Canadian Association of Provincial Cancer Agencies to ensure that any operational and implementation issues are effectively addressed.

Our assessments of CAR T-cell therapies will include a clinical and health economics review, patient and clinician input, manufacturer input, and a comprehensive review of implementation considerations. Reports for each component of the review will be released publicly on the CADTH website. There will be opportunities for feedback on interim versions of these reports.