Oncology Drug Approval Process in Canada

Ryan ClarkeWednesday, April 17, 2013

Overview

• Process

• Drug approvals

• Pricing

• pan-Canadian Oncology Drug Review

• Listings (ON)

Process

• Public drug formularies are impacted by federal, provincial and national policies

• Manufacturer submits to Health Canada for approval

• Patented Medicine Prices Review Board (PMPRB) regulates prices

• pan-Canadian Oncology Drug Review (pCODR) reviews new oncology drugs and makes reimbursement recommendations

• Provinces also review new oncology drugs and make reimbursement decisions

Final decision made by Executive Officer

Drug Approval Process in ON

Health CanadaIssues NOC & DIN

Interim decision made by Executive Officer

Non-CDR products /non-pCODR products

Manufacturer submitsNOC= Notice of Compliance – indicating drug is safe and effectiveDIN= Drug Identification NumberCDR =Common Drug ReviewCDEC = Canadian Drug Expert CommitteepCODR = pan-Canadian Oncology Drug ReviewpERC = pCODR Expert Review CommitteeNCE = New Chemical Entity

Ontario’s CED reviews Health Canada status, CDR recommendation, pCODR recommendation and conducts Ontario-specific review.

CED provides recommendation to Executive Officer to reimburse (or not) through publicly funded program

Common Drug Review products(NCE / new combination product / new indication)CDEC recommendation to drug plans

Manufacturer submits

pCODR Products(NCE / new combination product / new indication)pERC recommendation to drug plansspecific to oncology drugs

Up to 2 yearsNon-transparent

Up to 1 yearTransparent

Negotiations

Up to 2 mthsTransparent

~ 1 month

Open ended

Drug Approvals

• Submissions for approval are to the Therapeutic Products Directorate of Health Canada

• Reviewed and assessed for safety, efficacy and quality

• Issued a Notice of Compliance (NOC) or Notice of Compliance with Conditions (NOCc)

• Average approval time from New Drug Submission to NOC – 18 months

Pricing

• In Canada, we have regulated prices for patented or brand name drugs by the Patented Medicine Prices Review Board

• Mission – contribute to Canadian health care by ensuring that prices of patented medicines are not excessive

• Also report on price trends of all medicines and R&D conducted by patentees

• Annual Report 2011 – Canadian prices were the fourth highest among the seven comparator countries, lower than prices in Switzerland, Germany and the US.

pan-Canadian Oncology Drug Review

• The pan-Canadian Oncology Drug Review (pCODR) assesses cancer drugs and makes recommendations to the provinces and territories to guide their drug funding decisions

• Established in 2010 by the provincial and territorial Ministries of Health, pCODR is designed to bring consistency and clarity to the assessment of new cancer drugs by looking at both clinical evidence and cost-effectiveness

pCODR Organizational Structure

9

pCODR Patient Evidence Submissions

• As of April, 2011 there is a Submit & Contribute section at www.pcodr.ca

• It allows registered patient advocacy groups to submit and contribute drug review information and input into the review process and initial recommendation

• Groups must be registered with pCODR, but first you must be eligible to register

• The registration process can take up to five business days and is done by way of an Online Registration Request

pCODR Patient Evidence Submissions

• Within two business days of submitting their request, patient advocacy groups will receive an e-mail from pCODR with instructions on the final steps to complete their registration

• As part of completing their registration, patient advocacy groups will create a username and password allowing them to login to pCODR’s ‘secure Submit & Contribute page’

• Submissions are available at www.pcodr.ca by tracking a review

• There are conditions for registration i.e. the mandate of the group must exist prior to registration

pCODR Patient Evidence Submissions

• Areas for input include:– Information about the group including

declaration of COI– How was information gathered for submission– Experiences of patients with type of cancer

(symptoms, limitations, quality of life, financial) with current treatment, impact on caregivers

– Patient experiences with the new drug (medical, psychosocial) including risks and benefits, examples of better symptom management, ease of use

Listings

• Provinces and territories have (and will continue to have) the final word on whether a medication is publicly funded

• Federal government does the same with their six public formularies (i.e. Non-Insured Health Benefit Program for Canadian First Nations and Inuit people, veterans, Canadian Forces members, designated migrants, RCMP and Correctional Service Canada)

• 19 different public formularies, each with their own review and decision-making processes

Oncology Listings - Ontario

• Manufacturer or Disease Site Groups can make a submission to the province

• From there it will be initially reviewed by the Steering Committee for Cancer Drug Programs (just being established now)

• The Steering Committee will then make a recommendation to the Committee to Evaluate Drugs (CED)

• CED - 10 physician/pharmacist members, plus 2 patient representatives, appointed by the government

• CED mandated to make recommendations to the Executive Officer (EO) on which drugs should be reimbursed through the various Ontario Public Drug Programs

• EO makes the final decision

Patient Evidence Submissions - Ontario

• New patient input process in place as of April 1, 2010

• Patient evidence submissions will be accepted from registered advocacy groups directly to the CED

• There had never before been a process to allow this kind of direct engagement between the members of the CED and the public

• Having said that, the process and guidelines around submissions are very narrow

Patient Evidence Submissions - Ontario

• Impact of the disease/condition

• Treatment outcomes that matter most to patients

• Information from patients who have used this drug

• Does not ask how information was gathered to address these issues (still allows for surveys and patient interviews)

• Information provided is collated by the ministry and reviewed and presented by a patient member of the CED, during the CED discussions of societal values and patient perspective of the drug product

Advocacy Solutions®

Contact Information:

Ryan Clarke, LL.B.t. 905.891.0311f. 905.891.0366

ryan@advocacysolutions.cawww.advocacysolutions.ca