This is a reminder to all patentees of their filing requirements to the PMPRB respecting revenues and research and development expenditures. All patentees must submit their Form 3 information for 2016 by March 1, 2017.
These filing requirements are contained in section 5 of the Patented Medicines Regulations.
As part of their ... Read More
17
Feb2017
06
Feb2017
Kaitlyn Proulx appointed Managing Director / Directrice Générale
Neil Palmer, Founder and Principal Consultant of PDCI Market Access Inc is pleased to announce the appointment of Kaitlyn Proulx as Managing Director. As Managing Director, Kaitlyn manages PDCI’s operations and leads the firm’s pricing and market access consulting teams from PDCI’s headquarters ... Read More
06
Dec2016
On December 2, 2016, Health Canada released its updated guidelines for biosimilar biologic drug submissions. The document will provide guidance to sponsors to enable them to satisfy the information and regulatory requirements for the authorization of biosimilars in Canada.
The following criteria determine the scope if products that are eligible to ... Read More
02
Dec2016
As a first step to framework modernization, the Patented Medicines Prices Review Board (PMPRB) is undertaking major consultations regarding possible reform of its Compendium of Policies, Guidelines and Procedures, commonly referred to as “the Guidelines.”
During Phase 1 of this consultation initiative, the PMPRB asked for input on how to rethink ... Read More
01
Dec2016
Effective December 1, 2016, all new Special Authorization requests for the treatment of Moderately to Severely Active Crohn's Disease and Fistulizing Crohn's Disease or Ulcerative Colitis for infliximab naive patients will be assessed for coverage with Inflectra. Remicade will not be approved for new infliximab starts for patients with the ... Read More
28
Nov2016
Effective November 30, 2016, the Ontario Public Drug Programs will begin funding INFLECTRA™ (infliximab) as a limited use benefit for the following new indications:
LU Code 477 - For the treatment of ulcerative colitis in patients who meet clinical criteria.
LU Code 478 - For the treatment of moderate to severe Crohn’s ... Read More
23
Nov2016
The Patented Medicine Prices Review Board (PMPRB) announced the reappointment of Dr. Mitchell Levine of Hamilton, Ontario as Vice-chairperson of the Board for a second five-year term. Dr. Levine is a Professor in the departments of Medicine and Clinical Epidemiology and Biostatistics in the Faculty of Health Sciences at McMaster ... Read More
31
Oct2016
The Canadian Association for Healthcare Reimbursement (CAHR) is holding a one-day event to explore a national approach to pharma policy considering international and Canadian perspectives. The entire day gives attendees excellent opportunities to hear from payers, pharma, patient-led organizations and providers, including PDCI’s own Courtney Abunassar.
Related to this topic, the ... Read More
20
Oct2016
INESSS Upcoming Meetings with Manufacturers – June 2017 “Liste des médicaments”
INESSS is offering an opportunity for in-person meetings to manufacturers who have filed a submission by the November 25, 2016 deadline for drugs to be listed on the June 2017 “Liste des médicaments". These meetings will be held between December ... Read More
13
Oct2016
The pan-Canadian Pharmaceutical Alliance (pCPA) updated the status of negotiations on brand name drugs as of September 30, 2016:
37 negotiations are currently underway with no new files added since the last update of August 31, 2016.
118 joint negotiations have been completed with 4 files successfully negotiated ... Read More