Topic: The Labrynth of the drug approval processes in Canada; what you should know. The presentation was created by Ryan Clarke of Advocacy Solutions for CCSN's webinar series. Please see www.survivornet.ca for a recording of the presentation.
3. 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
4. Final decision made by Executive Officer
Drug Approval Process in ON
Health Canada
Issues NOC & DIN
Interim decision made by Executive Officer
Non-CDR products /
non-pCODR products
Manufacturer submits
NOC= Notice of Compliance – indicating drug
is safe and effective
DIN= Drug Identification Number
CDR =Common Drug Review
CDEC = Canadian Drug Expert Committee
pCODR = pan-Canadian Oncology Drug
Review
pERC = pCODR Expert Review Committee
NCE = 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 plans
specific to oncology drugs
Up to 2 years
Non-transparent
Up to 1 year
Transparent
Negotiations
Up to 2 mths
Transparent
~ 1 month
Open ended
5. 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
6. 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.
7. 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
9. Confidential – Do Not Distribute
pCODRReview Process
Updated March 31, 2011
1. Conduct
Pre-
Submission
Planning
activities
including
getting
input from
PAG and
notifying
Patient
Advocacy
Groups
2. Prepare
& submit
Request
for Drug
Review
4.2.
Conduct
Economic
Review
5.
Summarize
& Review
with pERC
6. Prepare &
Publicly
Post Initial
Recomm,
Post
Reviews
8. Summarize
& Review with
pERC
3.1 Screen
Submission
and Initiate
Review
Process
End‡
Industry/TumourGrouppCODR*
Variable 5 business days 70-90 business days 12 business days 10 business days 20 business days
7.1 Get
Feedback
from
Submitter
(and impacted
manufacturer)
7.3 Get
Feedback
from Patient
Advocacy
Group
7.2 Get
Feedback
from PAG
PatientAdvocacy
Groups
9. Prepare &
Publicly Post
Final
Recomm &
Post Input
12 business days
*Includes pCODR Secretariat, Clinical
Guidance Panel, Economic Guidance Panel,
pCODR Expert Review Committee (pERC)
and Provincial Advisory Group (PAG)
4.1.1/4.2.2
Clarify info
with
Submitter
during
review
4.1.
Conduct
Clinical
Review
3.2 Collect
Patient
Advocacy
Group
Input
Estimated
99 – 149
business days
7.4
Eligible for
Early
Conversion?
No Yes
‡Next steps could include
Recommendation implementation,
Procedural Review or Resubmission
9
10. 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
11. 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
12. 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
13. 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
14. 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
15. 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
16. 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
