Cancer Drug Reimbursement within the Context of Clinical Trials. (Draft for consultation purposes) Version 8.0

Save this PDF as:
 WORD  PNG  TXT  JPG

Size: px
Start display at page:

Download "Cancer Drug Reimbursement within the Context of Clinical Trials. (Draft for consultation purposes) Version 8.0"

Transcription

1 Cancer Drug Reimbursement within the Context of Clinical Trials (Draft for consultation purposes) Version 8.0 May 17, 2013

2

3 Introduction Clinical and cost-effectiveness factors have led most public payers to align cancer drug funding criteria with clinical trials supporting its use. Thus, funding criteria for most drugs tend to be highly specific, requiring use of the drug as part of a certain regimen, for a certain line of therapy, or for use after disease progression from a certain sequence of therapies or pathway. Increasingly, public payers are being asked to reimburse publicly funded drugs when used as a component of clinical trials research, or after the patient has participated in a clinical trial, even when the patient is no longer eligible under the existing funding criteria. This raises questions about how to balance the competing demands of fiscal responsibility and evidence-based coverage versus support for clinical research activity and patient access to what are expected to be beneficial treatments. The Ministry of Health and Long-Term Care (MOHLTC) and Cancer Care Ontario (CCO) recognize the central role that clinical trials research has in improving patient care and health system performance: They provide the evidence to support better care. This has led to the development of a draft policy document that outlines the principles, policy, and processes for public funding consideration of cancer drugs when used within the context of clinical trials research. Background Clinical trials research offer many health system and societal benefits. Trial participation allows for early access to new therapies and promotes adoption of new standards of care. i Clinical trials may be initiated and sponsored by either the academic community including clinical trial groups (e.g., cooperative groups), or the pharmaceutical industry. Four types of clinical trials exist: phase I trials evaluate the safety and dose of a drug; phase II trials are directed towards a larger group of people to determine effectiveness and toxicities; phase III trials are randomized controlled trials in which alternative interventions are compared in randomly assigned populations; and phase IV trials are typically post-marketing/ postadoption surveys that provide additional information on a drug s safety and clinical benefit. ii In general, the evidence needed to obtain new drug licensing approval by Health Canada and funding approval by the Ontario Ministry of Health and Long-Term Care requires the demonstration of efficacy and/or effectiveness from testing within a phase III trial. 3

4 Other Jurisdictions A survey of Canadian provinces conducted by the Ministry and by CCO in 2012 indicates that with the exception of two provinces, few policies exist on the public funding of a cancer drug within the context of clinical trials. iiiiv Data in other countries is also limited, based on written correspondence and a review completed by OPDP and CCO. In the United States, some federal programs (e.g., Medicare, Veterans Affairs) and privately managed care organizations (e.g., Kaizer Permanente) have public policies in place. v,vi,vii These programs fund routine care costs in cancer clinical trials provided that certain trial criteria are met. vvi,vii However, the funding of drugs subsequent to clinical trial participation does not appear to have been addressed. In the United Kingdom, the National Health Service (NHS) covers both treatment and support costs (treatment costs are patient care costs that would continue to be incurred if patient care is continued after the trial has stopped). v Finland requires that public funding criteria be met; while New Zealand s PHARMAC allows its District Health Boards to make discretionary rulings on the use of publicly funded drugs within the context of trials, even if the drug is not used within the established funding criteria, provided the drug is being used as part of a bona fide clinical trial which has Ethics Committee approval. viiiix The same rule may also be applied on occasion for patients who require access to publicly funded drugs subsequent to trial participation. ix Activities to Date A policy that addresses the public funding of drugs when used within the context of clinical trials has been under consideration by CCO and the MOHLTC for some time. An interprovincial survey across Canada and internationally on the management of publicly funded drugs in this setting has been completed. An environmental scan has also been conducted, in addition to interviews with stakeholders from the medical and research community. This work is ongoing and has supported the development of the draft policy document. The Consultation Process The draft clinical trial policy framework has been developed for consultation with trial investigators, members of the research community (Ontario Institute of Cancer Research, NCIC Clinical Trials Group, Ontario Cancer Research Ethics Board), clinicians, and pharmacists. In 4

5 addition, the draft policy will also be shared with administrators, patient representatives, and the pharmaceutical industry for comment Principles The Overriding Principles of this policy are: 1. Ensure that patients have equitable and timely access to treatments that are safe, offer maximum clinical benefits, and align with best practices; 2. Ensure that coverage decisions are evidence-based, are fiscally responsible, and are consistent with the policies of the Ontario Public Drug Programs; 3. Support clinical trial research provided that it is consistent with the above two principles; and 4. Have a fair, transparent, and accountable process. The Specific Principles associated with this policy are: 1. Ensure Ontario citizens participating in a clinical trial have access to publicly funded cancer drugs provided that: a. Existing criteria for access to the funded drug are satisfied; b. The cancer drug is to be prescribed in a manner that aligns with the funding intent and will not be associated with incremental cancer drug costs to the public programs; and c. The clinical trial complies with standard regulatory and ethical requirements. Scope 2. Ensure Ontario citizens participating in a clinical trial, when applicable, have subsequent access to publicly funded cancer drugs provided that: a. This treatment aligns with the principles associated with the funding for the drug; and b. The subsequent use of the drug will not be associated with any incremental costs to the public programs. This policy applies to oral and injectable drugs currently funded by both CCO and OPDP for the active treatment of cancer, and for supportive care drugs (e.g., colony stimulating factors) that are part of cancer care regimens. 5

6 The Policy for Cancer Drugs within the Context of Clinical Trials Ontario Public Drug Programs and Cancer Care Ontario will consider requests for the reimbursement of publicly funded cancer drugs within the context of clinical trials where the drug is being used within the approved funding indication. No consideration will be given for a drug or indication that is currently under review, or where the Executive Officer has decided not to fund. Policy criteria All of the following criteria must be met for funding consideration: 1. Technical Requirements: a. The trial must be approved by a Research Ethics Board; b. The trial must be registered in a recognized and accessible clinical trials registry, such as clinicaltrials.gov, and any evolving Health Canada standards for clinical trials registration; c. Where the drug is combined with an experimental agent, the trial is associated with a No Objections letter from Health Canada in response to a Clinical Trials Application. 2. Cost of Requested Drug a. There are no incremental costs, or otherwise anticipated costs to the public program have been deferred as a result of a patient s participation in a clinical trial that has met the technical requirements listed above. Process 1. Application and assessment a. Prior approval must be obtained. An application must be filed to Cancer Care Ontario s Provincial Drug Reimbursement Programs that includes the link to the clinical trials registration site, along with evidence that the trial requirements have been met and an assessment of the public funding implications for patients participating in the trial or subsequent to trial participation. b. CCO will accept, track, and assess each request for its congruence to this policy and will evaluate the funding policy implications as a result of trial participation, both with respect to the trial in question and the subsequent patient treatment. 6

7 c. Where necessary, clinician experts including the Provincial Disease Site Team Heads, may be consulted for advice on safety and clinical effectiveness, and to ensure that all funding issues have been addressed. 2. Funding Decision and Follow-up a. CCO, in consultation with OPDP will review all requests made under this policy. b. The Executive Officer will make all final funding decisions. c. When a decision is made to approve a request, CCO will inform the Applicant, in writing, of the final funding decision. CCO will also disseminate the funding decision to the hospitals and regional cancer centres. Sites who participate in the clinical trial may be required to submit data for adjudication purposes, consistent with existing drug funding policies. d. When a decision is made not to approve a request, CCO will inform the Applicant, in writing, of the rationale for rejection. e. Where applicable, CCO will provide trial site investigators with information on the potential funding implications so that there may be appropriate communication with patients about the implications of trial participation and options for current and potential future therapy. Expected Application of the Policy Table 1 addresses possible funding situations that may occur during, or subsequent, to a patient s participation in a clinical trial along with the recommendations for management. The management outlined describes the expected decision, based on an interpretation of the draft policy. 7

8 Table 1: Use of a publicly funded drug within the conduct of a clinical trial Scenario Management Principle The drug will be funded. No special actions are required* Clinical trial use of drug is identical to the current funding policy (e.g., control arm therapy in a Phase III trial) Clinical trial use of drug is for same population as a drug that is funded; drug prescription may be altered (e.g., dose, schedule) or may be combined with another agent (e.g., experimental arm therapy in a Phase III trial) Clinical trial use of drug is for an indication that is not currently funded (e.g., drug is tested in clinical trial for line of therapy that does not meet funding criteria) Clinical trial involves re-treatment with a previously funded drug. The current funding criteria for that drug do not include retreatment. Clinical trial includes use of drug within a Health Canada licensed indication but funding for the drug has not been implemented because additional real-world evidence is required The drug will be funded provided that the parameters for conduct of clinical trial must be satisfied**. Provision of drug cannot be associated with incremental cost to the publiclyfunded system.*** Drug will not be publicy funded Drug will not be publicly funded Decision process will be guided by content expertise and provision of the drug through the Evidence Building Program may be considered. research research and is consistent with evidence-based and fiscally responsible decision-making principle that coverage decisions are evidence-based and with policies of the Ontario Public Drug Programs. principle that coverage decisions are evidencebased. research and is consistent with evidence-based and fiscally responsible decision-making The drug is in the process of being considered for an indication represented by an arm of the trial. Drug will not be funded, as a formal funding decision regarding that drug has not been made. the policies of the Ontario Public Drug Programs. 8

9 Use of a publicly funded drug subsequent to patient participation in a clinical trial Scenario Management Principle The clinical trial drug has the same pharmacologic class as the publicly funded drug The clinical trial drug has a different pharmacologic class as the publicly funded drug Drug tested in clinical trial is associated with funding criteria that permit retreatment; circumstance associated with subsequent use of drug meets criteria for provision for retreatment Decision process is to be informed with content expertise. Anticipated outcomes are that drug will not be provided if cross-resistance is expected and a refractory state to the clinical trials agent exists. Drug may be provided if clinical trials drug is associated with beneficial effect and a period off of treatment has passed (i.e., retreatment with same class of agent). Decision process is to be informed with content expertise. Due consideration for cross-resistance and expected benefit will be applied. Drug will be funded. No special actions are required research and is consistent with evidence-based and fiscally responsible decision-making research and is consistent with evidence-based and fiscally responsible decision-making research * While control arm therapy would not require registration with CCO, the experimental arm may have line of therapy or other implications on subsequent access to a publicly funded drug. Thus, trial registration with CCO s Provincial Drug Reimbursement Programs may thus be appropriate. ** Requires Research Ethics Board approval and clinical trial registration (e.g., ClinicalTrials.gov); trial may require Health Canada No Objections Letter associated with Clinical Trials Application *** A negative funding recommendation does not exist for the combination. i CCRA Report Card on Clinical Trials ii iii Roll Up: Public Funding and Clinical Trials (summer 2012 survey conducted by the Ministry s Intergovernmental Unit) iv Excel survey conducted July/August 2012 by CCO PDRP. v 271. A preliminary literature review on policies on public funding of clinical trials v1.0 9

10 vi vii viii CCO correspondence with Finland KELA. ix CCO correspondence with New Zealand Pharmac. 10

Ontario Public Drug Programs / Cancer Care Ontario Policy: Reimbursement of Publicly Funded Cancer Drugs within the Context of Clinical Trials

Ontario Public Drug Programs / Cancer Care Ontario Policy: Reimbursement of Publicly Funded Cancer Drugs within the Context of Clinical Trials Ontario Public Drug Programs / Cancer Care Ontario Policy: Reimbursement of Publicly Funded Cancer Drugs within the Context of Clinical Trials Version: 2.0 Effective Date: January 29, 2016 Replaces Policy:

More information

CADTH Annual Business Plan

CADTH Annual Business Plan CADTH 2016-2017 Annual Business Plan 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

More information

POSITION DESCRIPTION Ministry of Health

POSITION DESCRIPTION Ministry of Health POSITION DESCRIPTION Ministry of Health POSITION TITLE: DIVISION: (e.g., Division, Region, Department) UNIT: (e.g., Branch, Area, District) SUPERVISOR S TITLE: SUPERVISOR S CLASSIFICATION: Pharmacist,

More information

Formulary Management

Formulary Management Formulary Management Formulary management is an integrated patient care process which enables physicians, pharmacists and other health care professionals to work together to promote clinically sound, cost-effective

More information

CLOSING THE COVERAGE GAP. Pan-Canadian Pharmacare

CLOSING THE COVERAGE GAP. Pan-Canadian Pharmacare CLOSING THE COVERAGE GAP Pan-Canadian Pharmacare Prescription drug coverage for all Canadians While the vast majority of Canadians have access to prescription drugs, some Canadians can t afford their medications.

More information

Ontario Steering Committee for Cancer Drug Programs, an ad hoc committee of the Committee to Evaluate Drugs. Terms of Reference

Ontario Steering Committee for Cancer Drug Programs, an ad hoc committee of the Committee to Evaluate Drugs. Terms of Reference Ontario Steering Committee for Cancer Drug Programs, an ad hoc committee of the Committee to Evaluate Drugs Terms of Reference 1. Authority The Ontario Steering Committee for Cancer Drug Programs is established

More information

Is it time for a new drug development paradigm?

Is it time for a new drug development paradigm? Is it time for a new drug development paradigm? Robert McDonough, M.D. Senior Director, Clinical Policy Research and Development 1 The Aetna Way Our Cause To make quality health care more affordable and

More information

Inquiry into Improving New Zealand s Environment to Support Innovation though Clinical Trials

Inquiry into Improving New Zealand s Environment to Support Innovation though Clinical Trials 1 Inquiry into Improving New Zealand s Environment to Support Innovation though Clinical Trials Response to Health Committee request for information: PHARMAC s policies and processes for funding newly

More information

EXTERNAL REVIEW OF THE ONTARIO HEALTH INSURANCE PLAN S OUT-OF-COUNTRY PROGRAM ` Recommendation Ministry Response Implementation Status

EXTERNAL REVIEW OF THE ONTARIO HEALTH INSURANCE PLAN S OUT-OF-COUNTRY PROGRAM ` Recommendation Ministry Response Implementation Status ` Increasing Awareness and Access to Information for Patients and Providers 1. Develop an icon for the Program on the Ministry website with a direct link to the Program to improve access to information

More information

Prior Authorization, Pharmacy and Health Case Management Information. Prior Authorization. Pharmacy Information. Health Case Management

Prior Authorization, Pharmacy and Health Case Management Information. Prior Authorization. Pharmacy Information. Health Case Management Prior Authorization, Pharmacy and Health Case Management Information The purpose of this information sheet is to provide you with details on how Great-West Life will be assessing and managing your claim

More information

CMS Proposes New Standards and Processes for Medicare Coverage of Investigational Devices and Related Clinical Studies and Trials

CMS Proposes New Standards and Processes for Medicare Coverage of Investigational Devices and Related Clinical Studies and Trials July 25, 2013 CMS Proposes New Standards and Processes for Medicare Coverage of Investigational Devices and Related Clinical Studies and Trials For more information, contact: Seth H. Lundy +1 202 626 2924

More information

4.1 Objectives of Clinical Trial Assessment

4.1 Objectives of Clinical Trial Assessment L1 4.1 Objectives of Clinical Trial Assessment Presentation to APEC Preliminary Workshop on Review of Drug Development in Clinical Trials Celia Lourenco, PhD, Manager, Clinical Group I Office of Clinical

More information

Prior Authorization, Pharmacy and Health Case Management Information. Prior Authorization. Pharmacy Information. Health Case Management

Prior Authorization, Pharmacy and Health Case Management Information. Prior Authorization. Pharmacy Information. Health Case Management Prior Authorization, Pharmacy and Health Case Management Information The purpose of this information sheet is to provide you with details on how Great-West Life will be assessing and managing your claim

More information

Prior Authorization, Pharmacy and Health Case Management Information. Prior Authorization. Pharmacy Information. Health Case Management

Prior Authorization, Pharmacy and Health Case Management Information. Prior Authorization. Pharmacy Information. Health Case Management Prior Authorization, Pharmacy and Health Case Management Information The purpose of this information sheet is to provide you with details on how Great-West Life will be assessing and managing your claim

More information

The fourth hurdle system. International HTA agencies. Australian PBAC. Difference between health technology regulatory body and HTA body

The fourth hurdle system. International HTA agencies. Australian PBAC. Difference between health technology regulatory body and HTA body * This presentation is prepared by the author in one s personal capacity for the purpose of academic exchange and does not represent the views of his/her organisations on the topic discussed. Local Application

More information

Risk Management Plan (RMP) Guidance (Draft)

Risk Management Plan (RMP) Guidance (Draft) Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare Translated by Pharmaceuticals and Medical Devices Agency Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour

More information

NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE CENTRE FOR HEALTH TECHNOLOGY EVALUATION. Technology Appraisals Programme

NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE CENTRE FOR HEALTH TECHNOLOGY EVALUATION. Technology Appraisals Programme Page 1 of 14 NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE CENTRE FOR HEALTH TECHNOLOGY EVALUATION Technology Appraisals Programme Specification for Cancer Drugs Fund data collection arrangements 1

More information

The College of Family Physicians of Canada. Position Statement Prescribing Rights for Health Professionals

The College of Family Physicians of Canada. Position Statement Prescribing Rights for Health Professionals The College of Family Physicians of Canada Position Statement Prescribing Rights for Health Professionals Introduction The College of Family Physicians of Canada (CFPC) supports models of practice that

More information

Chander Sehgal, MD, MBA Director, Common Drug Review (CDR) Taipei, Taiwan July 23 26, 2012

Chander Sehgal, MD, MBA Director, Common Drug Review (CDR) Taipei, Taiwan July 23 26, 2012 Chander Sehgal, MD, MBA Director, Common Drug Review (CDR) Taipei, Taiwan July 23 26, 2012 CANADIAN PERSPECTIVE Common Drug review: A *pan-canadian process CANADA: 33 M people; area 10 M km 2 DIVERSITY!

More information

Can an administrative drug claims database be used to understand claimant drug utilization?

Can an administrative drug claims database be used to understand claimant drug utilization? Can an administrative drug claims database be used to understand claimant drug utilization? By Elaine McKenzie, BSP, MBA, Consultant, TELUS Health Analytics Elaine McKenzie is a consultant who works with

More information

Programmes publics de médicaments de l Ontario. Bureau de l administratrice en chef et sous-ministre adjointe

Programmes publics de médicaments de l Ontario. Bureau de l administratrice en chef et sous-ministre adjointe Ministry of Health and Long-Term Care Ontario Public Drug Programs Office of the Executive Officer and Assistant Deputy Minister Hepburn Block, 9 th Floor 80 Grosvenor Street Queen s Park Toronto ON M7A

More information

4.07 Provincial Personal Income Tax Revenue and Related Credits and Reductions

4.07 Provincial Personal Income Tax Revenue and Related Credits and Reductions MINISTRY OF FINANCE 4.07 Provincial Personal Income Tax Revenue and Related Credits and Reductions (Follow-up to VFM Section 3.07, 1999 Annual Report) BACKGROUND With the exception of Quebec, all Canadian

More information

Clinical Trials: Questions and Answers

Clinical Trials: Questions and Answers Clinical Trials: Questions and Answers Key Points Clinical trials are research studies that test how well new medical approaches work in people (see Question 1). Every clinical trial has a protocol, which

More information

2003 FIRST MINISTERS ACCORD

2003 FIRST MINISTERS ACCORD 2003 FIRST MINISTERS ACCORD ON HEALTH CARE RENEWAL 1 In September 2000, First Ministers agreed on a vision, principles and action plan for health system renewal. Building from this agreement, all governments

More information

Public Policy Statement: Clinical Trial Ethics

Public Policy Statement: Clinical Trial Ethics Public Policy Statement: Clinical Trial Ethics Purpose As a global healthcare company, Merck's role is first and foremost to discover, develop and provide innovative products and services that save and

More information

OCULAR THERAPEUTICS PROTOCOL - OPTOMETRISTS

OCULAR THERAPEUTICS PROTOCOL - OPTOMETRISTS Ocular Therapeutic Protocol (Pages 1 7, includes one attachment) OCULAR THERAPEUTICS PROTOCOL - OPTOMETRISTS I, Michael Reid, Chief Executive of Queensland Health, under the provisions of section 170 and

More information

PET SCAN PRIMER. A Guide to the Implementation of Positron Emission Tomography Imaging in Ontario. Executive Summary

PET SCAN PRIMER. A Guide to the Implementation of Positron Emission Tomography Imaging in Ontario. Executive Summary Brought to you in partnership with: PET SCAN PRIMER A Guide to the Implementation of Positron Emission Tomography Imaging in Ontario Executive Summary Prepared by the Members of the Ontario PET Steering

More information

Global Policy on Interactions with Healthcare Professionals

Global Policy on Interactions with Healthcare Professionals Global Policy on Interactions with Healthcare Professionals Global Policy on Interactions with Healthcare Professionals Pfizer is committed to collaborating with physicians and other healthcare professionals,

More information

Targeting Cancer: Innovation in the Treatment of Chronic Myelogenous Leukemia EXECUTIVE SUMMARY. New England Healthcare Institute

Targeting Cancer: Innovation in the Treatment of Chronic Myelogenous Leukemia EXECUTIVE SUMMARY. New England Healthcare Institute Targeting Cancer: Innovation in the Treatment of Chronic Myelogenous Leukemia New England Healthcare Institute NEHI Innovation Series March 2004 Executive Summary From drugs and medical devices, to information

More information

Will a pan-canadian approach to drug purchasing save the provinces money?

Will a pan-canadian approach to drug purchasing save the provinces money? Will a pan-canadian approach to drug purchasing save the provinces money? combining the purchasing power of the public drug programs would help provinces and territories achieve economies of scale and

More information

97TH GENERAL ASSEMBLY State of Illinois 2011 and 2012 SB3197

97TH GENERAL ASSEMBLY State of Illinois 2011 and 2012 SB3197 *LRB0KTG0b* TH GENERAL ASSEMBLY State of Illinois 0 and 0 SB Introduced //0, by Sen. Iris Y. Martinez SYNOPSIS AS New Act INTRODUCED: Creates the Electronic Prescribing Act. Provides that beginning August,

More information

Amgen GLOBAL CORPORATE COMPLIANCE POLICY

Amgen GLOBAL CORPORATE COMPLIANCE POLICY 1. Scope Applicable to all Amgen Inc. and subsidiary or affiliated company staff members, consultants, contract workers and temporary staff worldwide ( Covered Persons ). Consultants, contract workers,

More information

[Section 7] CLINICAL TRIALS. A. Clinical Equipoise. B. Phases of Pharmaceutical Research [ 7.1 ]

[Section 7] CLINICAL TRIALS. A. Clinical Equipoise. B. Phases of Pharmaceutical Research [ 7.1 ] [Section 7] CLINICAL TRIALS Clinical trials are most frequently undertaken in biomedical or health research, although other clinically related disciplines, such as psychology, also conduct research that

More information

EVIDENCE IN BRIEF OVERALL CLINICAL BENEFIT

EVIDENCE IN BRIEF OVERALL CLINICAL BENEFIT perc also deliberated on the alignment of bendamustine with patient values. perc noted that bendamustine has a progression-free survival advantage, may be less toxic than currently available therapies

More information

PRINCIPLES ON RESPONSIBLE SHARING OF TRUTHFUL AND NON-MISLEADING INFORMATION ABOUT MEDICINES WITH HEALTH CARE PROFESSIONALS AND PAYERS

PRINCIPLES ON RESPONSIBLE SHARING OF TRUTHFUL AND NON-MISLEADING INFORMATION ABOUT MEDICINES WITH HEALTH CARE PROFESSIONALS AND PAYERS PRINCIPLES ON RESPONSIBLE SHARING OF TRUTHFUL AND NON-MISLEADING INFORMATION ABOUT MEDICINES WITH HEALTH CARE PROFESSIONALS AND PAYERS INTRODUCTION In the era of data-driven medicine, where all parties

More information

1. Comparative effectiveness of alemtuzumab

1. Comparative effectiveness of alemtuzumab Cost-effectiveness of alemtuzumab (Lemtrada ) for the treatment of adult patients with relapsing remitting multiple sclerosis with active disease defined by clinical or imaging features The NCPE has issued

More information

CANADIAN PHARMACISTS ASSOCIATION. Election Brief

CANADIAN PHARMACISTS ASSOCIATION. Election Brief CANADIAN PHARMACISTS ASSOCIATION Election Brief Pharmacists The Most Accessible Health Provider in Canada Health care in Canada is undergoing significant changes and challenges. The impact of new technologies,

More information

The Academy of Managed Care Pharmacy s Concepts in Managed Care Pharmacy. Outcomes Research

The Academy of Managed Care Pharmacy s Concepts in Managed Care Pharmacy. Outcomes Research The Academy of Managed Care Pharmacy s Concepts in Managed Care Pharmacy Outcomes Research What Is Outcomes Research? Outcomes research is a facet of research that measures results of various medical treatments

More information

Ontario Smoking Cessation Program

Ontario Smoking Cessation Program Ontario Smoking Cessation Program Contents Eligibility... 1 Pharmacist Education... 1 Pharmacist Payment and Program Evaluation... 2 Readiness Assessment... 2 Primary Follow-Up Session... 3 Secondary Follow-Up...

More information

Clinical Trials: The Crux of Cancer Innovation

Clinical Trials: The Crux of Cancer Innovation Clinical Trials: The Crux of Cancer Innovation Even as medical science is transforming cancer care, major deficiencies in the way cancer clinical trials are designed, carried out, regulated and funded

More information

Regulation of Pharmacy Technicians in Prince Edward Island. January 12, 2012 Michelle Wyand Assistant Registrar PEI Pharmacy Board

Regulation of Pharmacy Technicians in Prince Edward Island. January 12, 2012 Michelle Wyand Assistant Registrar PEI Pharmacy Board Regulation of Pharmacy Technicians in Prince Edward Island January 12, 2012 Michelle Wyand Assistant Registrar PEI Pharmacy Board mwyand@gmail.com PEI Pharmacy Board The Regulatory Body for the Practice

More information

2. Background This was the fourth submission for everolimus requesting listing for clear cell renal carcinoma.

2. Background This was the fourth submission for everolimus requesting listing for clear cell renal carcinoma. PUBLIC SUMMARY DOCUMENT Product: Everolimus, tablets, 5 mg and 10 mg, Afinitor Sponsor: Novartis Pharmaceuticals Australia Pty Ltd Date of PBAC Consideration: November 2011 1. Purpose of Application To

More information

NURSE PRACTITIONER STANDARDS FOR PRACTICE

NURSE PRACTITIONER STANDARDS FOR PRACTICE NURSE PRACTITIONER STANDARDS FOR PRACTICE February 2012 Acknowledgement The Association of Registered Nurses of Prince Edward Island gratefully acknowledges permission granted by the Nurses Association

More information

Use of Guidelines for Treatment of Stage 3 Colon Cancer

Use of Guidelines for Treatment of Stage 3 Colon Cancer Use of Guidelines for Treatment of Stage 3 Colon Cancer Most stage 3 colon cancer patients receiving chemotherapy at a cancer centre after surgery are treated according to the provincial guideline. Some

More information

Equitable Choice. Ensuring affordability and accessibility to drug therapies

Equitable Choice. Ensuring affordability and accessibility to drug therapies Equitable Choice Ensuring affordability and accessibility to drug therapies Equitable Choice - Ensuring affordability & accessibility to drug therapies Equitable Choice: Ensuring affordability and accessibility

More information

Methadone Maintenance Treatment Program

Methadone Maintenance Treatment Program Methadone Maintenance Treatment Program Answers to Frequently Asked Questions Why is the College involved in the MMT program? The methadone maintenance treatment (MMT) program of the College of Physicians

More information

ODB Expanded Services Billing

ODB Expanded Services Billing ODB Expanded Services Billing Contents Description of Services... 1 Reasons for a Clinical Intervention... 1 Outcomes... 2 Documentation Requirements... 2 Running the Update to Add Expanded Services PINs...

More information

Food and Drug Regulations Project Number 1623 Schedule F

Food and Drug Regulations Project Number 1623 Schedule F Graham Spry Building 250 Lanark Avenue Address Locator: 2005D Ottawa, Ontario K1A 0K9 09-118361-538 Provincial and Territorial Deputy Ministers of Health Provincial and Territorial Drug Program Managers

More information

NSW Cancer Trials Network Network Portfolio Policy October 2012

NSW Cancer Trials Network Network Portfolio Policy October 2012 NSW Cancer Trials Network Network Portfolio Policy October 2012 E12/18446 Cancer Institute NSW Page 1 of 7 Contents BACKGROUND... 3 NSW CANCER TRIALS NETWORK PORTFOLIO KEY PRINCIPLES... 3 PORTFOLIO COMPLIANCE

More information

Cancer Treatments Subcommittee of PTAC Meeting held 18 September 2015. (minutes for web publishing)

Cancer Treatments Subcommittee of PTAC Meeting held 18 September 2015. (minutes for web publishing) Cancer Treatments Subcommittee of PTAC Meeting held 18 September 2015 (minutes for web publishing) Cancer Treatments Subcommittee minutes are published in accordance with the Terms of Reference for the

More information

Care Definition, Practice Foundations, and Ability-Based Outcomes Updated May 23, 2013

Care Definition, Practice Foundations, and Ability-Based Outcomes Updated May 23, 2013 University of Washington School of Pharmacy Care Definition, Practice Foundations, and Ability-Based Outcomes The pharmacist graduating from the University of Washington School of Pharmacy promotes the

More information

executive summary Scope Aim and targeted readership

executive summary Scope Aim and targeted readership executive summary Scope The development, evaluation and introduction of medical innovations and technologies in general and innovative medical devices in particular are considered an increasingly important

More information

Methods for the comparative evaluation of pharmaceuticals

Methods for the comparative evaluation of pharmaceuticals HTA REPORT EXECUTIVE SUMMARY Methods for the comparative evaluation of pharmaceuticals Zentner A, Velasco-Garrido M, Busse R Political Background The German Institute for Quality and Efficiency in Health

More information

Patient Assistance Program Primer

Patient Assistance Program Primer Patient Assistance Program Primer Suzanne Lepage Private Health Plan Strategist Suzanne Lepage Consulting Inc. Kitchener, Ontario The opinions expressed in this presentation are those of the speaker. The

More information

EARLY ECONOMIC MODELS PAY OFF IN PRODUCT DEVELOPMENT

EARLY ECONOMIC MODELS PAY OFF IN PRODUCT DEVELOPMENT AN ARTICLE FROM PAREXEL ACCESS EARLY ECONOMIC MODELS PAY OFF IN PRODUCT DEVELOPMENT Once drug developers have achieved regulatory approval with data from trials against the standard of care, they must

More information

COMMISSION ON ACCREDITATION FOR DIETETICS EDUCATION 2008 FOUNDATION KNOWLEDGE AND COMPETENCIES DIETITIAN EDUCATION

COMMISSION ON ACCREDITATION FOR DIETETICS EDUCATION 2008 FOUNDATION KNOWLEDGE AND COMPETENCIES DIETITIAN EDUCATION Individuals interested in becoming Registered Dietitians should expect to study a wide variety of topics focusing on food, nutrition and management. These areas are supported by the sciences: biological,

More information

NEW RESPIRATORY HEALTH PROGRAM

NEW RESPIRATORY HEALTH PROGRAM NEW RESPIRATORY HEALTH PROGRAM Introducing the Medavie Blue Cross Managing Chronic Disease Program Medavie Blue Cross is proud to announce our innovative new approach to managing chronic disease- the first

More information

pan-canadian Oncology Drug Review Patient Engagement Guide October 2015

pan-canadian Oncology Drug Review Patient Engagement Guide October 2015 pan-canadian Oncology Drug Review Patient Engagement Guide October 2015 RECORD OF UPDATES Update Version Reported on pcodr Website Original April 2011 April 27, 2011 Revised June 2012 June 4, 2012 Revised

More information

CORE AND COMPREHENSIVE HEALTH CARE SERVICES (UPDATE 2008)

CORE AND COMPREHENSIVE HEALTH CARE SERVICES (UPDATE 2008) CMA POLICY CORE AND COMPREHENSIVE HEALTH CARE SERVICES (UPDATE 2008) CMA believes that physicians must be actively involved in the decision-making process on core and comprehensive services. It developed

More information

MEDICAL SERVICES COMMISSION OUT OF PROVINCE AND OUT OF COUNTRY MEDICAL CARE GUIDELINES

MEDICAL SERVICES COMMISSION OUT OF PROVINCE AND OUT OF COUNTRY MEDICAL CARE GUIDELINES MEDICAL SERVICES COMMISSION OUT OF PROVINCE AND OUT OF COUNTRY MEDICAL CARE GUIDELINES A. PREAMBLE The primary purpose of the Medicare Protection Act is "to preserve a publicly managed and fiscally sustainable

More information

3.09 Drug Programs Activity

3.09 Drug Programs Activity MINISTRY OF HEALTH AND LONG-TERM CARE 3.09 Drug Programs Activity BACKGROUND Ontario s drug programs are administered by the Drug Programs Branch (Branch) of the Ministry of Health and Long-Term Care.

More information

Introduction of a Standard Drug Formulary in Hospital Authority

Introduction of a Standard Drug Formulary in Hospital Authority Introduction of a Standard Drug Formulary in Hospital Authority PURPOSE This paper seeks Members views on the introduction of a Standard Hospital Authority Drug Formulary ( ) ( Standard Drug Formulary

More information

Draft Pan-Canadian Primary Health Care Electronic Medical Record Content Standard, Version 2.0 (PHC EMR CS) Frequently Asked Questions

Draft Pan-Canadian Primary Health Care Electronic Medical Record Content Standard, Version 2.0 (PHC EMR CS) Frequently Asked Questions December 2011 Draft Pan-Canadian Primary Health Care Electronic Medical Record Content Standard, Version 2.0 (PHC EMR CS) Frequently Asked Questions Background and History What is primary health care?

More information

10/31/2014. Medication Adherence: Development of an EMR tool to monitor oral medication compliance. Conflict of Interest Disclosures.

10/31/2014. Medication Adherence: Development of an EMR tool to monitor oral medication compliance. Conflict of Interest Disclosures. Medication Adherence: Development of an EMR tool to monitor oral medication compliance Donna Williams, RN PHN Carol Bell, NP MSN Andrea Linder, RN MS CCRC Clinical Research Nurses Stanford University SOM

More information

Aspiring to a new standard of healthcare for Canada

Aspiring to a new standard of healthcare for Canada Aspiring to a new standard of healthcare for Canada Introduction Information technology (IT) has a fundamental role to play in transforming Canada s healthcare system. Over the past decade, large investments

More information

TOWARD A FRAMEWORK FOR. Assisted Dying in Canada

TOWARD A FRAMEWORK FOR. Assisted Dying in Canada TOWARD A FRAMEWORK FOR Assisted Dying in Canada Introduction In February 2015, the Supreme Court of Canada struck down the ban on physician-assisted dying, ruling that it could be permissible for a competent

More information

UNIVERSITY OF WISCONSIN HOSPITAL AND CLINICS DEPARTMENT OF PHARMACY SCOPE OF PATIENT CARE SERVICES FY 2014 October 1 st, 2014

UNIVERSITY OF WISCONSIN HOSPITAL AND CLINICS DEPARTMENT OF PHARMACY SCOPE OF PATIENT CARE SERVICES FY 2014 October 1 st, 2014 UNIVERSITY OF WISCONSIN HOSPITAL AND CLINICS DEPARTMENT OF PHARMACY SCOPE OF PATIENT CARE SERVICES FY 2014 October 1 st, 2014 Department Name: Department of Pharmacy Department Director: Steve Rough, MS,

More information

Using Clinical Registries to Create Evidence-based Health Care Policy : Experiences from Ontario, Canada

Using Clinical Registries to Create Evidence-based Health Care Policy : Experiences from Ontario, Canada Using Clinical Registries to Create Evidence-based Health Care Policy : Experiences from Ontario, Canada April 2009 Jack V. Tu, MD PhD FRCPC CANADA RESEARCH CHAIR IN HEALTH SERVICES RESEARCH Institute

More information

The Role and Importance of Clinical Trial Registries & Results Databases. Deborah A. Zarin, M.D. Director, ClinicalTrials.gov.

The Role and Importance of Clinical Trial Registries & Results Databases. Deborah A. Zarin, M.D. Director, ClinicalTrials.gov. The Role and Importance of Clinical Trial Registries & Results Databases Deborah A. Zarin, M.D. Director, ClinicalTrials.gov February 2015 Outline Background Current Policies About ClinicalTrials.gov Registering

More information

CENTERS FOR MEDICARE & MEDICAID SERVICES. Medicare & Clinical Research Studies

CENTERS FOR MEDICARE & MEDICAID SERVICES. Medicare & Clinical Research Studies CENTERS FOR MEDICARE & MEDICAID SERVICES Medicare & Clinical Research Studies You may have the choice to join a clinical research study to diagnose or treat an illness. If you join a covered clinical research

More information

A pharmacist s guide to Pharmacy Services compensation

A pharmacist s guide to Pharmacy Services compensation Alberta Blue Cross Pharmaceutical Services A pharmacist s guide to Pharmacy Services compensation 83443 (2015/12) GENERAL DESCRIPTION... 3 Details... 3 ASSESSMENT CRITERIA... 3 Assessment for a Prescription

More information

ViiV Healthcare s Universal Health Coverage for People Living with HIV (PLHIV), Policy

ViiV Healthcare s Universal Health Coverage for People Living with HIV (PLHIV), Policy ViiV Healthcare s Universal Health Coverage for People Living with HIV (PLHIV), Policy The Issue Universal Health Coverage (UHC) means that all people receive the quality health services they need without

More information

What Lies Ahead? Trends to Watch: Health Care Product Development in North America

What Lies Ahead? Trends to Watch: Health Care Product Development in North America What Lies Ahead? Trends to Watch: Health Care Product Development in North America What Lies Ahead? for 2015 DIA has released its third annual What Lies Ahead? report, providing experts insights into the

More information

Market Access for Medical Technology & Pharmaceutical Companies An Organizational Priority in Times of Economic Austerity and Reform

Market Access for Medical Technology & Pharmaceutical Companies An Organizational Priority in Times of Economic Austerity and Reform Market Access for Medical Technology & Pharmaceutical Companies An Organizational Priority in Times of Economic Austerity and Reform By Joakim Steen Mikkelsen, Managing Healthcare Counselor, Embassy of

More information

Singapore Clinical Trials Register. Foo Yang Tong Director Clinical Trials Branch Health Products Regulation Group HEALTH SCIENCES AUTHORITY

Singapore Clinical Trials Register. Foo Yang Tong Director Clinical Trials Branch Health Products Regulation Group HEALTH SCIENCES AUTHORITY Singapore Clinical Trials Register Foo Yang Tong Director Clinical Trials Branch Health Products Regulation Group HEALTH SCIENCES AUTHORITY Clinical Trial Register Global Trend EMA: EU Clinical Trials

More information

Summary of Patient-Centered Outcomes Research Provisions Prepared by AAMC Government Relations, March 2010

Summary of Patient-Centered Outcomes Research Provisions Prepared by AAMC Government Relations, March 2010 Summary of Patient-Centered Outcomes Research Provisions Prepared by AAMC Government Relations, March 2010 Section 6301 of the Patient Protection and Affordable Care Act (as modified by Section 10602)

More information

Current Topics in the Development and Regulatory Approval of Cancer Therapies

Current Topics in the Development and Regulatory Approval of Cancer Therapies Current Topics in the Development and Regulatory Approval of Cancer Therapies Michelle Ponpipom Associate Director Worldwide Regulatory Affairs Merck & Co., Inc. Oncology Drug Development: Dynamic & Evolving

More information

The Role of the Patient/Consumer in Establishing a Dynamic Clinical Research Continuum:

The Role of the Patient/Consumer in Establishing a Dynamic Clinical Research Continuum: The National Working Group on Evidence-Based Health Care The Role of the Patient/Consumer in Establishing a Dynamic Clinical Research Continuum: Models of Patient/Consumer Inclusion August 2008 The Working

More information

CENTER FOR DRUG EVALUATION AND RESEARCH. 203551Orig1s000

CENTER FOR DRUG EVALUATION AND RESEARCH. 203551Orig1s000 CENTER FOR DRUG EVALUATION AND RESEARCH Approval Package for: APPLICATION NUMBER: Trade Name: Generic Name: Sponsor: 203551Orig1s000 Docetaxel Injection Concentrate, 20 mg/ml, 80 mg/4 ml, 140 mg/7 ml.

More information

DC Ontario Response to Ontario s Seniors Strategy: Living Longer, Living Well

DC Ontario Response to Ontario s Seniors Strategy: Living Longer, Living Well DC Ontario Response to Ontario s Seniors Strategy: Living Longer, Living Well JULY 2013 Dietitians of Canada, the professional association for Registered Dietitians in Ontario, is pleased to provide comment

More information

RECOMMENDED CRITERIA OF A PRE-PRINTED ORDER: ORAL CHEMOTHERAPY TAKE HOME PRESCRIPTIONS

RECOMMENDED CRITERIA OF A PRE-PRINTED ORDER: ORAL CHEMOTHERAPY TAKE HOME PRESCRIPTIONS RECOMMENDED CRITERIA OF A PRE-PRINTED ORDER: ORAL CHEMOTHERAPY TAKE HOME PRESCRIPTIONS INTRODUCTION Over the past two decades the delivery of systemic cancer therapy saw an increase in the use of oral

More information

Specialty Pharmacy? Disclosure. Objectives Technician

Specialty Pharmacy? Disclosure. Objectives Technician Disclosure What s so SPECIAL about? I have no actual or potential conflict of interest in relation to this program/presentation. Michael DeCoske, PharmD, BCPS Associate Chief Pharmacy Officer Duke University

More information

Saskatchewan Provincial Health Information

Saskatchewan Provincial Health Information Saskatchewan Provincial Health Information Skilled, dedicated people are at the heart of the health system, and Saskatchewan Health has targeted improvements in training, workplace safety, ad other human

More information

BUSINESS SECTOR STRATEGY:

BUSINESS SECTOR STRATEGY: BUSINESS SECTOR STRATEGY: MEDICAL TECHNOLOGY Created with: MEDEC - CANADA S MEDICAL TECHNOLOGY COMPANIES February 2011 Open for Business is Ontario s initiative to create faster, smarter and streamlined

More information

for the right question

for the right question Real-World & Late Phase Research The right approach for the right question >625 Real-World & Late Phase Programs with >96,000 sites and >810,000 patients in >100 countries since 2011 >180 patient registries

More information

QUESTIONS & ANSWERS: Educators and

QUESTIONS & ANSWERS: Educators and ENTRY-TO-PRACTICE COMPETENCIES AND STANDARDS FOR CANADIAN DENTAL HYGIENISTS QUESTIONS & ANSWERS: Educators and Administrators Canadian Dental Hygienists Association The ETPCS: Q&A attempts to anticipate

More information

c. determine the factors that will facilitate/limit physician utilization of pharmacists for medication management services.

c. determine the factors that will facilitate/limit physician utilization of pharmacists for medication management services. Consumer, Physician, and Payer Perspectives on Primary Care Medication Management Services with a Shared Resource Pharmacists Network Marie Smith, PharmD and Michlle Breland, PhD University of Connecticut,

More information

Standards of Practice for Primary Health Care Nurse Practitioners

Standards of Practice for Primary Health Care Nurse Practitioners Standards of Practice for Primary Health Care Nurse Practitioners June 2010 (1/14) MANDATE The Nurses Association of New Brunswick is a professional organization that exists to protect the public and to

More information

Expanded Access Programs. Richard Klein Office of Special Health issues Food and Drug Administration

Expanded Access Programs. Richard Klein Office of Special Health issues Food and Drug Administration Expanded Access Programs Richard Klein Office of Special Health issues Food and Drug Administration Expanded Access Programs (EAPs) What is expanded access? History Legislative background General principles

More information

Continuing Education Improving Patient Care and Sales Performance with Electronic Medical Records (EMR)

Continuing Education Improving Patient Care and Sales Performance with Electronic Medical Records (EMR) Continuing Education Improving Patient Care and Sales Performance with Electronic Medical Records (EMR) Edition Code: EMR11o.00 2 About The Author This course has been prepared for the Council for Continuing

More information

Accelerating Development and Approval of Targeted Cancer Therapies

Accelerating Development and Approval of Targeted Cancer Therapies Accelerating Development and Approval of Targeted Cancer Therapies Anna Barker, NCI David Epstein, Novartis Oncology Stephen Friend, Sage Bionetworks Cindy Geoghegan, Patient and Partners David Kessler,

More information

Integration of Pharmacists Clinical Services in the Patient-Centered Primary Care Medical Home. March 2009

Integration of Pharmacists Clinical Services in the Patient-Centered Primary Care Medical Home. March 2009 Integration of Pharmacists Clinical Services in the Patient-Centered Primary Care Medical Home March 2009 Introduction: The potential promise and value of the patient-centered primary care medical home

More information

2019 Healthcare That Works for All

2019 Healthcare That Works for All 2019 Healthcare That Works for All This paper is one of a series describing what a decade of successful change in healthcare could look like in 2019. Each paper focuses on one aspect of healthcare. To

More information

Cost-effectiveness of teriflunomide (Aubagio ) for the treatment of adult patients with relapsing remitting multiple sclerosis

Cost-effectiveness of teriflunomide (Aubagio ) for the treatment of adult patients with relapsing remitting multiple sclerosis Cost-effectiveness of teriflunomide (Aubagio ) for the treatment of adult patients with relapsing remitting multiple sclerosis The NCPE has issued a recommendation regarding the cost-effectiveness of teriflunomide

More information

Prior Authorization, Pharmacy and Health Case Management Information. Prior Authorization. Pharmacy Information. Health Case Management

Prior Authorization, Pharmacy and Health Case Management Information. Prior Authorization. Pharmacy Information. Health Case Management Prior Authorization, Pharmacy and Health Case Management Information The purpose of this information sheet is to provide you with details on how Great-West Life will be assessing and managing your claim

More information

EPF position: Clinical trial results communication of the lay summary

EPF position: Clinical trial results communication of the lay summary EPF position: Clinical trial results communication of the lay summary 02/03/2015 This position paper received funding under an operating grant from the European Union s Health Programme (2014-2020). 1

More information

pcodr Performance Metrics Report

pcodr Performance Metrics Report pcodr Performance Metrics Report April 2015 TABLE OF CONTENTS EXECUTIVE SUMMARY...ii Operations...ii Transparency...ii Stakeholder Engagement... iii Looking Ahead... iii 1. INTRODUCTION... 1 2. PERFORMANCE

More information

NFAHW Forum-2015 Ottawa, Canada Duane Landals B.Sc.Ag, DVM

NFAHW Forum-2015 Ottawa, Canada Duane Landals B.Sc.Ag, DVM NFAHW Forum-2015 Ottawa, Canada Duane Landals B.Sc.Ag, DVM of Antimicrobial Use A Pan-Canadian Framework for Professional Standards for Veterinarians 3 CVMA-Veterinary Pharmaceutical Stewardship Advisory

More information

The Clinical Trial Protocol Guide. BioStrategics Consulting Ltd.

The Clinical Trial Protocol Guide. BioStrategics Consulting Ltd. The Clinical Trial Protocol Guide 2011 BioStrategics Consulting Ltd. BioStrategics Consulting Ltd THE CLINICAL TRIAL PROTOCOL The clinical trial protocol to test one s product, to confirm or reject a specific

More information

ADVANCEMENTS IN THE ECONOMIC

ADVANCEMENTS IN THE ECONOMIC ADVANCEMENTS IN THE ECONOMIC EVALUATION OF MEDICINES IN EUROPE. PRESENT SITUATION AND FUTURE PERSPECTIVES Bengt Jönsson Stockholm School of Economics Page 1 CONTENT Methodology Economic evaluation and

More information