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.