On April 1, 2016, the pan-Canadian Pharmaceutical Alliance (pCPA) issued manufacturers a notification of first principles for subsequent entry biologics (SEBs) to guide negotiations and inform expectations. This information has not yet been posted on the pCPA website but is being shared with their permission.
Please see below for a copy ... Read More
11
Apr2016
30
Mar2016
Due to a high workload volume and ensuring submissions are reviewed in a timely manner, CADTH is deferring the effective date of the following two CDR procedural revisions:
The timing of CDR review team’s responses being provided to the manufacturer, and
The revised CDR voluntary withdrawal procedure
The revised date for these two ... Read More
30
Mar2016
Recommendation Framework for CADTH Common Drug Review (CDR) and pan-Canadian Oncology Drug Review (pCODR) Programs
In collaboration with the participating jurisdictions and with input from stakeholders, CADTH has established a single recommendation framework to support the drug expert committees (the CADTH Canadian Drug Expert Committee [CDEC] and the CADTH pCODR Expert ... Read More
24
Mar2016
In December 2015, the Patented Medicine Prices Review Board (PMPRB) posted a Notice and Comment seeking stakeholder comments on the following proposed changes:
Reasonable Relationship Test (Schedule 4) Amendment
List Price relative to Maximum Average Potential Price (MAPP) Verification (Section C.11) Amendment
Subsequent to stakeholder feedback received during the public comment period, ... Read More
24
Mar2016
Effective April 1, 2016, all drug products reviewed by the Common Drug Review (CDR) and the pan-Canadian Oncology Drug Review (pCODR) will no longer require a routine review by the Committee to Evaluate Drugs (CED), the Ontario Ministry of Health and Long-Term Care’s expert drug advisory committee. This change also ... Read More
15
Mar2016
The Ontario Public Drug Programs (OPDP) began funding INFLECTRA™ (infliximab) as a Limited Use (LU) benefit for eligible ODB recipients, effective February 25, 2016, for the following indications:
Rheumatoid Arthritis
Ankylosing Spondylitis
Psoriatic Arthritis
Plaque Psoriasis
The LU criteria are posted in the eFormulary which can found on the ministry’s website at:
http://www.health.gov.on.ca/en/pro/programs/drugs/odbf_eformulary.aspx
The funding of ... Read More
15
Mar2016
The Canadian Agency for Drugs and Technologies in Health (CADTH) posted a call for patient input on March 11, 2016 for Hospira HealthCare Corporation’s subsequent entry biologic (SEB), INFLECTRA™ (infliximab).
According to the CADTH website, Hospira is seeking public reimbursement for Crohn’s disease and Ulcerative Colitis.
For those interested in providing ... Read More
10
Mar2016
The Canadian Agency for Drugs and Technologies in Health (CADTH) posted a call for patient input on March 9, 2016 for etanercept - the subsequent entry biologic (SEB) version of Amgen’s ENBREL™. For those interested in providing patient input, please complete the CDR Patient Input Submission.
According to the ... Read More
10
Mar2016
The Ontario Ministry of Health and Long-Term Care (the ‘ministry’) is proposing to update recipient cost-sharing arrangements for non-low income seniors as well as expand eligibility for the Seniors Co-Payment Program under the Ontario Drug Benefit (ODB) program.
Proposed amendments to Ontario Regulation 201/96 made under the Ontario Drug Benefit Act ... Read More
26
Feb2016
Revised Procedures for CDR and pCODR
For all drug applications filed for review through either the Common Drug Review (CDR) or pan-Canadian Oncology Drug Review (pCODR) process on or after April 1, 2016, CADTH will no longer accept confidential submitted prices. The submitted price will be disclosed in all applicable CDR ... Read More