August 11, 2016
EAP Update: Unacceptable Approval Timelines
In the ORA’s regular calls with Rob Campbell, Director of the Drug Program Delivery Branch (DPDB), it was agreed that EAP turnaround times can be improved. The impact that delays can have on patients was also acknowledged. Over the past year, the DPDB has launched many initiatives to improve turnaround times. Last Fall they conducted multiple education sessions for reimbursement coordinators and brand manufacturers to explain the process and highlight the importance of complete and legible applications. At that time, 20% of applications were incomplete or illegible – impacting the approval process. Despite this effort, it has only made a minor improvement on the quality of submissions. In the Spring of 2016, EAP experienced four months of slow response time from its application management system. As of June 2016, the system is operating efficiently. EAP also experienced a high turnover in staff at the start of the year. Seven pharmacists have now been hired and are in various stages of training. Two more begin next week. With a commitment to the ORA, EAP focused on the 700 biologic renewal backlog which has now been cleared. New application approval time is currently at 10 weeks. EAP expects to be close to the 10 days approval time by the end of September.
DPDB is in the process of developing a new web-based application system, Special Authorization Digital Information Exchange system (SADIE), (formerly known as EARMS). Extensive work will begin in early September to develop this 24/7/365 application system that will provide real-time approvals for many drugs and speed up the review time for other drugs. DPDB will be consulting throughout the Fall on this new system including taking advantage of the OntarioMD Fall conference. It is important to note that EAP receives almost 70,000 unique funding requests annually and about 80% of requests are approved. As a result, the ministry has been looking at a number of ways to move drugs off of EAP. The ministry has made some changes (e.g. Keppra) with recent ODB Formulary updates. Proposed regulatory amendments were posted for consultation on the Regulatory Registry between June 1, 2016 and July 18, 2016. If these regulatory amendments are approved, it would allow some additional products to be transitioned to the ODB Formulary which will improve patient access and reduce administrative burden to physicians and the program area.
It is worth noting that everyday, a pharmacist is dedicated to biologics. As well, a couple of the new pharmacists are being trained to deal with biologic approvals.
Henry Averns personally discussed the situation with Rob Campbell (who is moving on in a few weeks). Rob was reluctant to accept that LU codes would be the best solution here and cited a historical increase in use with many drugs converted to LU code, with a tendency for physicians to lower their threshold to apply. Having said that, Rob also paradoxically acknowledged that new biosimilars may not be added to the EAP burden. So interpret that how you will. What is clear is that the EAP are now at least not trying to deny that the current situation is unacceptable and potentially harmful to our patients, and they are promising meaningful improvements within 6 weeks. Our duty is to respect the current criteria and complete forms properly – a 16% rate of incomplete forms, and requests in patients who clearly do not fulfill criteria, is undermining our own requests for improvement.