The fourth hurdle system. International HTA agencies. Australian PBAC. Difference between health technology regulatory body and HTA body

Transcription

1 * This presentation is prepared by the author in one s personal capacity for the purpose of academic exchange and does not represent the views of his/her organisations on the topic discussed. Local Application of HTA in the management of New Drugs International experience from 3 rd Annual Meeting HTAi Adelaide, Australia Jul 2006 Eileen Ma Pharmacist, CPO Difference between health technology regulatory body and HTA body HT regulatory body is a legal system, mandated by govt, for the licensing of drugs and other health technologies within a particular jurisdiction, conducted primarily to ensure safety. HTA body does not address whether a technology CAN be used, but whether it SHOULD be used and for whom and under what circumstances. Who pays can be a significant factor in the uptake and diffusion of a technology. Ms Eileen Ma 1 Ms Eileen Ma 2 The fourth hurdle system The requirement to justify the reimbursement of pharmaceuticals by health care systems with costeffectiveness data Is it just the reimbursement decision based on only cost-effectiveness analyses (pharmacoeconomics)? Is it the entirety of process and decision in between licensure and final utilisation of publicly funded technologies? (incl. data, endpoint, implementation) International HTA agencies Australia PBAC (Pharmaceutical Benefits Advisory Committee) NZ PHARMAC (Pharmaceutical Management Agency of New Zealand) UK NICE (National Institute of Clinical Excellence) Canada CDR (Common Drug Review) under CADTH (Canadian Agency for Drugs and Technologies in Health) Scotland SMC (Scottish Medicines Consortium) Ms Eileen Ma 3 Ms Eileen Ma 4 Centralised assessment process for drug coverage differ substantially for different countries Australia [PBAC] and NZ [Pharmac] assessment connected to centralised drug funding mechanisms UK NICE assesses only a minority of prescription drugs, based on potential cost, health system impact, or controversy Canada assessment is a coordinated effort of the federal and provincial drug benefit programs Australian PBAC Since 1993 Timeline 18 weeks Submission by drug manufacturers (sponsors) Price negotiation with drug manufacturers after listing approval on the Pharmaceutical Benefits Scheme (PBS) Final listing on PBS up to 5 months post-meeting 50% of submission are cost minimisation vs. comparator PBAC does not apply a set of simple decision rules, but rather weighs up several relevant factors for consideration What is an acceptable ICER? (ICER<$52,000/ QALY usually list) Ms Eileen Ma 5 Ms Eileen Ma 6 1

2 Problems with ICERs - Australian experience Lack of budget constraint Assumptions:- Constant return no diminishing marginal utility for individuals or for society Small gains (often imprecise) may add up to a few large gains Heterogeneity in preferences ignored Risk of potential loss ignored (adverse effects) Relevant factors for PBAC Less readily quantifiable Severity of condition treated Presence of effective alternatives Ability to target therapy to those who would benefit most Uncertainty Equity Development of resistance Govt health priorities and other relevant factors Ms Eileen Ma 7 Ms Eileen Ma 8 Scottish Medicines Consortium (SMC) Advises Scottish NHS Boards & Area Drug & Therapeutics Committees on all new medicines, new formulations of existing medicines, and major new indications for established products (since Jan 2002) excludes the assessment of vaccines, branded generics, non-prescription-only medicines, blood products and diagnostic drugs Scottish Medicines Consortium (SMC) Timeline 18 weeks Submission by drug manufacturers (sponsors) Political & societal pressure to make products available Examples: cancer medicines may be licensed with little phase 3 data complex regimens and the use of many different regimen may make it difficult to identify suitable comparators Higher median cost/qaly, yet acceptance rate same as other drugs (66%) Ms Eileen Ma 9 Ms Eileen Ma 10 Canadian CDR Compared to Canada s Common Drug Review (CDR) Since Sep 2003 Time line weeks CDR supports CEDAC (Canadian Expert Drug Advisory Committee) Submission by drug manufacturers (sponsors) Invite manufacturer for comments Economic models by manufacturers CDR critique If me-too, cost minimisation Centralised drug review agencies CDR PBAC (Aus) Pharmac (NZ) SMC (Scot) NICE (UK) Total # of same drugs reviewed # of similar decisions - 19 (86%) 10 (77%) 15 (65%) 2 (40%) 46 (73%) # of different decisions - 3 (14%) 3 (23%) 8 (35%) 3 (60%) 17 (27%) Ms Eileen Ma 11 Ms Eileen Ma 12 2

3 Why recommendations may differ Agencies mandates, priorities & resources Unique provisions & capacities Timing of evidence Studies considered, external influences Interpretation of evidence Values & perspectives (societal/individual/ public/expert) Uncertainties & risk-tolerance levels Benefits/harms, post-market safety, costeffectiveness data Drug cost Orphan & catastrophic drug policies Transparency available on websites NZ Pharmac minutes of PTAC (Pharmacology & Therapeutics Advisory Committee) & subcommittees, economic analyses AUS PBAC meeting outcomes in the form of Public Summary Documents; include both +ve/- ve outcomes, reasons and recommendations, but reserves the right to withhold any elements on ground of commercial confidentiality SCOT SMC minutes of SMC meetings, summary documents CAN CDR Brief recommendations and reasons; submission status report UK NICE full evaluation reports Ms Eileen Ma 13 Ms Eileen Ma 14 Rapid review Conducted by some area D&TCs (e.g. Australia) or in some countries (e.g. Argentina) or as part of more timely service within the HTA agency (e.g. HTIS (Health Technology Inquiry Service) of CADTH) Length of time required depends on organisational methodology/framework and topics being assessed Restriction on no. of databases used; including only RCTs, exclude use of quality tools, shorter time frame reflected in less details (usual timeline 6-12weeks) HA Drug Advisory Committee (DAC) Formed in Aug 1996 with the following objectives: To advise hospitals on costeffectiveness of new pharmaceuticals based on scientific medical evidence To provide guidelines for use of new pharmaceuticals where appropriate Ms Eileen Ma 15 Ms Eileen Ma 16 New role since HADF Operation of the DAC All new drugs must go through DAC before lising on HADF Classify drugs as G, S or SFI or reject submission Criteria for SFI: New drugs with preliminary data Drugs with marginal benefit Life style drugs Recommend SFI for safety net consideration- currently refer to the HA Privately Financed Medical Technologies (PFMT) Committee Ms Eileen Ma members from various medical disciplines (including chief pharmacist and pharmacologists) quarterly meetings: Jan, Apr, Jul, Oct requests for new drugs come from hospital/ cluster Drug & Therapeutics Committees evaluation prepared by the Chief Pharmacist s Office based on currently available evidence Evaluation time line: 6 weeks Ms Eileen Ma 18 3

4 New drugs with major clinical and financial impact Hospital Drug & Therapeutics Committee CPO Recommendation DAC Expert group New drugs that affect a significantly large patient population or those that are very expensive must be considered within local context local expert groups are often formed in response to the request from DAC to evaluate currently available evidence against the background of patient risk categories and the burden of treatment to HA Examples: COX-II inhibitors, immunosuppressive agents, glycoprotein IIb/IIIa inhibitors, drugs for Alzheimer s disease, bdmards Recommendations from these expert groups will then be considered by DAC Ms Eileen Ma 19 Ms Eileen Ma 20 DAC statistics From Oct 1996 till Jul 2006: evaluated 182 new drugs (some with more than one indication) 119 (65%) approved for formulary use plus 21 SFI (77% including SFI) (Canadian CEDAC 45% as of Dec 05; Australian PBAC 37% ) Cancer drugs 15/16 drugs approved (SFI); 24/26 indications (SMC 66% approval rate) Some recommended as SFI with safety net, e.g. imatinib (Glivec) for CML & GIST Ms Eileen Ma 21 Ms Eileen Ma 22 Ms Eileen Ma 23 Ms Eileen Ma 24 4

5 Ms Eileen Ma 25 Ms Eileen Ma 26 Ms Eileen Ma 27 Ms Eileen Ma 28 Summary International HTA experience show some congruence in the recommendations for new pharmaceuticals but differ in underlying political and health-system context Full evaluation (including costeffectiveness analyses) are time consuming Difficult to rely decision on ICERs alone Sharing of information? Concerns of transparency? Thank You! Ms Eileen Ma 29 Ms Eileen Ma 30 5