Biosimilars

pan-Canadian Pharmaceutical Alliance (pCPA): November 2019 Trends and Insights   The pan-Canadian Pharmaceutical Alliance (pCPA) has issued the November 30, 2019 status of brand negotiations.  Highlights since the last update include: 6 products completed CADTH review, for a total of 9 files under consideration; 4 products initiated pCPA negotiations, for a total of 34 active negotiations; 12 negotiations completed for a total of 294 completed negotiations; No negotiations closed, for…

Summary of CADTH Drug Portfolio Information Session   Date: Monday, November 25, 2019 Time: 1:30 pm to 4:00 pm On November 25, 2019, CADTH hosted two information sessions in Toronto, Ontario for their Medical Device and Drug Portfolios. These annual sessions are an opportunity for stakeholders to get the latest information about priority initiatives and process changes. The summary below is separated into the following sections: Welcome and Strategic Overview…

pan-Canadian Pharmaceutical Alliance (pCPA): October 2019 Trends and Insights   The pan-Canadian Pharmaceutical Alliance (pCPA) has issued the October 31, 2019 status of brand negotiations.  Highlights since the last update include: 4 products completed CADTH review, for a total of 7 files under consideration; 2 products initiated pCPA negotiations, for a total of 42 active negotiations; 6 negotiations completed for a total of 282 completed negotiations; 2 negotiation closed, for…

pan-Canadian Pharmaceutical Alliance (pCPA): September 2019 Trends and Insights   The pan-Canadian Pharmaceutical Alliance (pCPA) has issued the September 30, 2019 status of brand negotiations.  Highlights since the last update include: 4 products completed CADTH review, for a total of 6 files under consideration; 8 products initiated pCPA negotiations, for a total of 48 active negotiations; 6 negotiations completed for a total of 276 completed negotiations; 1 negotiation closed, for…

pan-Canadian Pharmaceutical Alliance (pCPA): August 2019 Trends and Insights   The pan-Canadian Pharmaceutical Alliance (pCPA) has issued the August 31, 2019 status of brand negotiations.  Highlights since the last update include: 5 products completed CADTH review, for a total of 13 files under consideration; 8 products initiated pCPA negotiations, for a total of 47 active negotiations; 7 negotiations completed for a total of 270 completed negotiations; 1 negotiation closed, for…

pan-Canadian Pharmaceutical Alliance (pCPA): July 2019 Trends and Insights   The pan-Canadian Pharmaceutical Alliance (pCPA) has issued the status of brand negotiations as of July 31, 2019. Highlights since the last update include: 5 products completed CADTH review, for a total of 12 files under consideration; 7 products initiated pCPA negotiations, for a total of 47 active negotiations; 6 negotiations completed for a total of 263 completed negotiations; 3 negotiations…

pan-Canadian Pharmaceutical Alliance (pCPA): May 2019 Trends and Insights   The pan-Canadian Pharmaceutical Alliance (pCPA) has issued the status of brand negotiations as of May 31, 2019. Highlights since the last update include: 2 negotiations completed for a total of 253 completed negotiations; 2 negotiations closed, for a total of 37 closed negotiations; 1 file closed without negotiations, for a total of 65 declined negotiations; 10 products completed CADTH review,…

MORSE Consulting has prepared a summary of the key highlights from the Patented Medicines Prices Review Board’s (PMPRB) recent webinar on the release of their Meds Entry Watch 2017 report (third edition). Date: February 20th 2019 Time: 1pm-2pm Presented by: Elena Lungu (Manager NPDUIS, PMPRB), Jared Berger (Policy Analyst, Policy and Economic Analysis Branch, PMPRB) Objective: To present the Meds Entry Watch, 2017 report to interested stakeholders and allow an…

On November 27, 2018 the BC Ministry of Health changed coverage of glatiramer products, GLATECT™ and COPAXONE®, which demonstrates a shift from previous public drug plan approaches for funding of subsequent entry products (biosimilars) for chronic diseases.   Background   GLATECT™ is the first subsequent entry glatiramer-based treatment available for reimbursement for RRMS in Canada – i.e. a follow on product to Copaxone®. It is classifed as a non-biological complex…

pCPA Biosimilars/Biologics Policy Directions Webinar   On Tuesday September 25, 2018 the pan-Canadian Pharmaceutical Alliance Office (pCPAO) hosted a one-hour webinar for industry to introduce the Biologics Policy Directions and pCPA Negotiations document. The objectives of the webinar were to: Present the pCPA Biologics Policy Directions & pCPA Negotiations document; and Invite and address industry feedback. This edition of MORSE Signals provides an overview of the webinar and provides key…

A Comparison of Proposed INESSS and Current CADTH Evaluation Fees   On February 21, 2018, the Quebec government released draft regulations (Gazette Officielle du Québec) that outline fees payable to Institut national d'excellence en santé et en services sociaux (INESSS) for the scientific evaluation of a drug or stable blood product. The fees are expected to vary based on the type of dossier submitted for scientific review with INESSS determining…

The MORSE KEY: Upcoming Events and Conferences   There are a number of conferences/events/deadlines that individuals in market access may be interested in for the upcoming month of September. For more details, please visit the MORSE Key Market Access Events page. Government/Agencies September 15 – CADTH Deadline for Comments on Therapeutic Review Framework September 18 – PMPRB HDAP Meeting September 20 –CDEC Meeting Associations September 11 – 2017 CAPDM MEMBER…

INESSS Introduces New Pre-NOC and Biosimilar Guidance   The Institut national d'excellence en santé et en services sociaux (INESSS) released its new submission guidelines on June 2nd, 2017. The guidelines, which are now effective, include revised and new Form applications and letter templates for drug submissions. The two major highlights relate to pre-NOC review and the introduction of new guidelines for biosimilar submissions. Pre-NOC Review Unlike the CADTH pre-NOC guidelines…