On December 1, 2017, Manitoba Health, Seniors and Active Living released a notice announcing a number of updates to their product submission criteria (last updated in 2007) to consider requirements introduced since 2007 including:
- requirement to complete pan-Canadian Pharmaceutical Alliance (pCPA) negotiations for brand products;
- the pCPA Centralized Price Confirmation Process for generic drug products;
- regulatory requirements to report drug shortages;
- removal of the requirement to execute of a written agreement (commonly known as a Drug Utilization Management Agreement) between the company and the Government of Manitoba for multisource and Self-Monitoring of Blood Glucose (SMBG) strips, lancets, and needles;
- need to increase transparency for components, such as price increases and company-sponsored Patient Access Programs (PAPs), also known as Compassionate Programs.
Provincial Drug Programs (PDP) will transition to the new submission criteria in the following manner:
- New or amended submissions are not required for products that are currently in queue with PDP;
- Companies can send submissions under the old or new submissions until January 2, 2018; and
- Companies must follow the new submission criteria after January 2, 2018.
The “Ongoing Listing Requirements” will replace “SECTION 8.00 – MANITOBA PRODUCT PRICE” and “SECTION 3.00 – COMMUNICATION PLANS AND LEARNING PROGRAMS, PRESCRIPTION ASSISTANCE PROGRAMS” in all Drug Utilization Management Agreements effective immediately.
The PDP will not be amending existing Drug Utilization Management Agreements.
For more information, please consult the Manitoba Health, Seniors and Active Living website. If you have any questions, please send an e-mail to PDPInfoAudit@gov.mb.ca.