CADTH Common Drug Review CDR INFORMATION SESSION TORONTO, ON OCTOBER 8, 2014
CADTH Participants • Brian O’Rourke – President and CEO • Peter Chinneck – Special Assistant to the President and CEO • Chander Sehgal – Director, CDR and Optimal Use of Drugs • Karen Lee – Director, Health Economics • Julie Blouin – Manager, Health Economics • Lili Loorand-Stiver – CDR Submissions and Procedures Officer • Jessica Birrell – Formulary Review Submissions Coordinator • Sanja Milanovic – Formulary Review Submissions Coordinator • Shireen Ghanbari – Administrative Coordinator • Dale Calder – Events Planning Officer • Glenna Gosewich - Events Planning Officer
Please note: • CDR statistics presented in these slides are preliminary in nature, providing only a snapshot in time • For complete context on any CDR procedure or submission guidelines-related slides, please consult the following documents as appropriate: Procedure for the CADTH Common Drug Review (http://www.cadth.ca/media/cdr/process/CDR_Procedure.pdf) Submission Guidelines for the CADTH Common Drug Review ( http://www.cadth.ca/media/cdr/process/CDR_Submission_Guidelines.pdf Guidelines for the Economic Evaluation of Health Technologies: Canada (http://www.cadth.ca/media/pdf/186_EconomicGuidelines_e.pdf )
Overview • Clearing the backlog of CDR submissions • CADTH’s plan to eliminate the backlog • Status update • CDR industry application fees • Performance metrics • CDR revised priority review procedure – update • CDR submitted price – update • Highlights of 2014 versions: • Procedure for the CADTH Common Drug Review • Submission Guidelines for the CADTH Common Drug Review • Pharmacoeconomic update • Q&A • Open Forum
CLEARING THE BACKLOG OF CDR SUBMISSIONS CDR INDUSTRY APPLICATION FEES CDR REVISED PRIORITY REVIEW PROCEDURE – UPDATE CDR SUBMITTED PRICE – UPDATE
Reason for the CDR Backlog • Fixed Budget: CDR has a fixed budget (30-35 reviews/year) • High Volume: the number of reviews has exceeded targets Number of Submissions Received Annually Red = years where submissions ≥30; Blue = years with <30 submissions
CADTH’s Plan to Eliminate the Backlog • Special transfer of money from CADTH reserves • Increasing the number of drug reviews initiated each month and reviewed at each CDEC meeting • Scheduling an extra meeting of CDEC in December 2014 • Assigning experienced staff from other CADTH programs to CDR on an interim basis • Recruiting additional staff and contractors
Backlog of CDR Submissions Backlog numbers reflect aggregate numbers at the end of each month
Mandatory Advanced Notification 7 6 5 4 3 2 1 0 Jul-14 Aug-14 Sep-14 Oct-14 Nov-14 Dec-14 Jan-15 Feb-15 Mar-15 Notifications Submissions received
CDR Industry Application Fees a Application types under schedules A and B would typically undergo a standard CDR review. Application types under schedule C would typically undergo a tailored CDR review. The various application fee schedules reflect the relative difference in estimated effort for the review of the various application types. b When application is filed for the review of multiple indications at the same time and CADTH decides to conduct a standard CDR review for each indication, an application fee of $72,000 will apply to only one of these indications and an application fee of $57,600 (20% discount) will apply to each of the other indication(s) to be reviewed. In addition, for each subsequent indication for a drug filed sequentially at a later date, an application fee of $57,600 will apply.
Performance Metrics CDR review Embargoed CDEC Accepted for Initiation of report(s) to recommendation review review applicant issued Performance metric of 180 calendar days
Performance Metrics Milestones for Payment of CADTH Common Drug Review Application Fees Schedule Milestone 1 Milestone 2 Total Fee Description Per Cent Amount Due Description Per Cent Amount Due Due Due A Initiation 70% $50,400 Sending 30% $21,600 $72,000 of review reports to B 70% $40,320 30% $17,280 $57,600 applicant 70% $25,200 30% $10,800 $36,000 C D Request 100% $7,000 NA 0% $0 $7,000 accepted
Compliance with Performance Metrics Performance Compliance Refund for Submissions Metric Target Non-Compliance Screening of submission 10 business 100% NA or resubmission and days “Acceptance for Review” Date of “Acceptance for 180 calendar 95% 25% of the application Review” to date of days fee payable back to the issuance of embargoed manufacturer CDEC recommendation
Revised Priority Review Criteria Clinical criteria: All of the following criteria must be demonstrated: • The drug is indicated or anticipated to be indicated for an immediately life-threatening or other serious disease. • The drug addresses an unmet medical need. • The drug offers substantial improvement in clinically important outcome measures of efficacy and effectiveness, when compared with other appropriate comparators. Economic criterion: • For the drug under review, the projected combined cost savings for the participating drug plans is an average of at least $7.5 million per year for the first three years the product is marketed in Canada, when compared with appropriate comparators.
Priority Review Status Brand Name Non-proprietary Indication Priority Review Granted Ultibro Breezhaler indacaterol/glycopyrronium COPD Kalydeco ivacaftor CFTR gating mutations Firazyr icatibant Hereditary angioedema Remsima infliximab RA, AS, PA, psoriasis Inflectra infliximab RA, AS, PA, psoriasis Vimizim elosulfase alfa Mucopolysaccharidosis IVA Zaxine rifaximin Hepatic encephalopathy Esbriet pirfenidone idiopathic pulmonary fibrosis TBC Sofosbuvir/Ledipasvir Hepatitis C infection Priority Review NOT Granted Invokana canagliflozin Type 2 diabetes Signifor pasireotide Cushing’s disease Afinitor everolimus SEGA-TSC Xeljanz tofacitinib RA Juxtapid lomitapide Familial hypercholesterolemia Pending and Ongoing assessments Xolair omalizumab Chronic idiopathic urticaria AS = ankylosing spondylitis, COPD = chronic obstructive pulmonary disease; PA = psoriatic arthritis, RA = Rheumatoid arthritis; SEGA = subependymal giant cell astrocytoma; TBC = to be confirmed; TSC = tuberous sclerosis complex
CDR - Price considerations • Confidential price permitted through the CDR process Revised Definitions (September 2014 version) Submitted The price per unit that is submitted to CDR and that must not be price exceeded for any of the drug plans following release of a CDEC Final Recommendation, irrespective of the type of recommendation made and whether or not the Canadian Drug Expert Committee criteria for listing are the same as the criteria requested by the manufacturer. Confidential A price per unit that is submitted in confidence, as part of the Price CDR submission requirements and to which the provisions of the CADTH Common Drug Review Confidentiality Guidelines apply. Key Issue: should the confidential price become public if a drug plan decides to list the drug for the indication reviewed through the CDR process
Confidential versus Non-confidential Prices 22 37% Confidential price submitted 37 Non-confidential price submitted 63% • 59 CDEC recommendations were issued from November 2012 to August 2014. • Approximately 1/3 of submissions/resubmissions were filed with a confidential submitted price.
CDEC Recommendation Options Options Description and Considerations • Drug demonstrates comparable or added clinical benefit and acceptable List cost/cost-effectiveness relative to one or more appropriate comparators. • Drug demonstrates comparable or added clinical benefit and acceptable List with clinical cost/cost-effectiveness relative to one or more appropriate comparators in a criteria subgroup of patients within the approved indication. • Drug demonstrates added clinical benefit, but the cost/cost-effectiveness and/or conditions relative to one or more appropriate comparators is unacceptable. In such cases, a condition may include a reduced price. • Drug demonstrates comparable clinical benefit and acceptable cost/cost- effectiveness relative to one or more appropriate comparators. • Drug demonstrates no added clinical benefit and the cost/cost-effectiveness Do not list at the relative to one or more appropriate comparators is unacceptable. • Drug demonstrates added clinical benefit, but the cost/incremental cost- submitted price effectiveness ratio far exceeds that of existing treatment options and precludes a recommendation to list with clinical criteria and/or conditions. Do not list • Drug does not demonstrate comparable clinical benefit relative to one or more appropriate comparators.
CDEC Recommendations Since November 2012 40 58% 35 30 25 20 27% 15 10 14% 5 2% 0 List with clinical criteria Do not list Do not list at the List and/or conditions submitted price
Conditions Involving Price or Cost 40 34 35 30 25 20 53% 47% 15 10 5 0 All List with clinical criteria Condition involving cost No conditions involving cost and/or conditions
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