General News Update

Denis Morrice

Denis Morrice, Executive Director of the ORA, is very skilled in sharing “tidbits” of relevant industry news! A few highlights of interesting and trending topics:

• Special Authorization Digital Information Exchange (SADIE) is on target for 2018. Rheumatologists will be able to send files to the Biologic and Biosimilar Patient Support Program reps (PSP) to initiate a request for them in SADIE. The Doctor must do the actual submission. The PSP may handle the follow up at the discretion of the Doctor. More details forthcoming in 2018

• EAP approval times are still under the 10 working day target

• The panCanadian Pharmaceutical Alliance (pCPA) is well behind in their approval process of new drugs o Delays in picking up the file (2 – 3 months) o Getting to the Letter of Intent (6 – 12 months)  The reasons are varied: perceived value; willingness to negotiate; then listing with provinces – again variables – provincial resources, policies, budget cycles

• The pCPA is willing to consider Standardized criteria of arthritis medications starting with Biologics for Rheumatoid arthritis. CRA/ORA preparing for coordinated response

• Just a reminder – the new Drug Shortage website: drugshortagescanada.ca. You can get listed to be notified of certain areas of shortages. A lot more attention is being given by international groups

• Word on the street – Private Payers becoming more restrictive re: high cost drugs with plans to introduce MLF DrugWatch type programs

• Private Payers now leaning toward waiting for CADTH, CDR recommendations before listing the new drugs approved by Health Canada

• There seems to be agreement that 1 in 5 Canadians can’t afford their medications – if not a National Pharmacare Program, should there at least be an Essential list of medications covered as promoted by WHO?

• ORA and CUS (Canadian Uveitis Society) reps are meeting to discuss the value of a shared care model between rheumatologists and ophthalmologists to support patients with uveitis via standardized criteria of therapeutics and a registry to report outcomes

• Ontario Best Practices Research Initiative (OBRI) has submitted a proposal to Ontario Public Drug Program/pCPA simply requesting that part of listing agreements support by pharma be given to OBRI for RWD data collection and reporting outcomes to all stakeholders – patients, doctors, payers, pharma

• CADTH: if you are having trouble getting to sleep try reading: Updated Guidelines for the Economic Evaluation of Health Technologies – 4th Edition March 28, 2017 – Online at: Guidelines for the Economic Evaluation of Health Technologies: Canada

Dennis Morrice
Executive Director, ORA