2014 CLINICAL POLICY UNIT. Dr Vesna Kupresan

Transcription

1 2014 CLINICAL POLICY UNIT Dr Vesna Kupresan

2 Healthcare Industry Challenges Medical inflation Cost drivers Aging population Increased utilization of healthcare Growing chronic disease burden Rapid evolution of medical technology

3 The rising costs of new technology Sufficient evidence to show new technologies are responsible for a large part of increases in health care expenditure. However, are all new technologies value for money? How do we make decision on which technology to reimburse? The private insurer has to manage resources (fund high quality healthcare that is safe, clinically appropriate and cost-effective) and attempt to achieve affordable premiums, be sustainable (long-term) and offer financial protection for members. So, decisions about which medical devices and drugs to fund are crucial to ensure quality and sustainability of health care. Clinical policies are one of the tools used to control the cost drivers and should be developed in a credible, transparent and consistent manner using principles of evidence-based medicine

4 What is EBM? More than 20 years since EBM became a new paradigm for teaching and practicing clinical medicine Tradition, anecdote and theory was replaced by evidence from high quality RCTs and observational studies in combination with clinical expertise Evidence based medicine is the conscientious, explicit and judicious use of current best evidence in making decision about the care of individual patients. The practice of evidence based medicine means integrating individual clinical expertise with the best available external clinical evidence from systematic research. Many new concepts were introduced Cochrane Collaboration international research review groups (collate and summarize evidence from clinical trials) Methodological and publication standards Infrastructures for developing and updating clinical practice guidelines Courses for teaching critical appraisal Sackett et al. Evidence based medicine: what it is and what it isn t. BMJ 312(7023): Greenhalgh et al. Evidence based medicine: a movement in crisis? BMJ 2014;348:g3725 doi: /bmj.g3725

5 Practicing EBM Health Technology Assessment A form of policy research that systematically examines the short and long term consequences, in terms of health and resource use, of the application of a health technology, a set of related technologies or a technology related issue. (Henshall et al. 1997) Its primary purpose is to provide objective information to support health care decisions and policy making It includes assessments of drugs, medical and surgical procedures, devices and diagnostics and pathology tests used in health care

6 Practicing EBM Health Technology Assessment Select specific clinical questions to answer (technology under review) Search the literature or databases for relevant clinical information Appraise the evidence for validity and usefulness to the patient and practice Implement useful findings in everyday practice Adapted from: Rosenberg W, Donald A. Evidence-based medicine: an approach to clinical problem-solving. BMJ 1995;310:

7 Practicing EBM Levels of clinical trials Usually described as a pyramid Highest level of evidence top of the pyramid Lowest level of evidence bottom of the pyramid When a literature evaluation is carried out, the most desirable evidence is from information at the top of the evidence ladder Meta-analysis (Synthesis of data from RCTs and other trials) Randomized, controlled, double-blinded (RCTs) Cohort studies (Large numbers, Prospective) Observational Studies Cross-over studies Case-control studies Case series and Case Reports Expert Opinion and Anecdotal Evidence Animal studies In vitro studies Miot J. (May 2012)

8 Practicing EBM Clinical trials Systematic Reviews and Meta Analysis Strongest form of evidence (preferably include only high quality RCTs) Systematic and comprehensive review of the literature Critical appraisal of all relevant studies Use robust methodology to minimize bias Methodology is described and followed Provide statistical analysis of results Not all reviews are systematic reviews Many are simply descriptive Inherent biases Cherry pick the literature Lack of sound methodology Miot J. (May 2012)

9 Practicing EBM Clinical trials Randomized Controlled Trials Considered Gold Standard of trials Patients are randomly allocated to a group Strict inclusion and exclusion criteria Both groups have similar base characteristics (only difference is the treatment intervention) Patients are followed-up to the end of trial Outcome measure are defined before the trial Controlled trials allow the researcher to determine whether there is a difference in the outcome of each group. Cohort studies Observational Very large sample size A cohort trial is used to compare the outcome of a group of patients who have been exposed to a certain medicine or intervention with a control group who have not been exposed, but are otherwise similar Often prospective Take many years to complete e.g. incidence of breast cancer in women taking HRT e.g. does smoking cause lung cancer Miot J. (May 2012)

10 Practicing EBM Clinical trials Case controlled studies Observational Similar to cohort studies Used to gather information about the cause or prognosis of a disease rather than its treatment Small sample size Generally retrospective rather than prospective Data is collected from medical history of the patients and Compared to information collected from controls (other patients, general population) generally matched for age, gender, disease Usually within a single practice, centre, region Miot J. (May 2012)

11 Practicing EBM Clinical trials Case series and case reports Case series - series of patient reports Case report - describe the medical history of a single patient Not controlled Huge potential for bias Weak source of evidence Expert Opinion and Anecdotal Evidence May guide direction of research and indicate possible problems Useful for understanding clinical practice but generally worthless unless supported by evidence-based medicine In-vitro and Animal studies Describe mechanism of action and early indication of efficacy Useful for preliminary research (safety and toxicity) Miot J. (May 2012)

12 How Discovery makes clinical policy and funding decisions? Supporting best practice management The Process Discovery Health has developed a thorough and rigorous process that involves a clinical and financial evaluation based on the principles of evidence-based medicine and cost-effectiveness. Published in SAMJ

13 Who is responsible for the process at Discovery Clinical Policy Unit The unit strives to ensure access to the best quality healthcare that is clinically robust and cost-effective. The unit consists of highly qualified health professionals including medical doctors, pharmacists, nurses and other professionals. Responsibility: clinical research, policy development and funding recommendations for Discovery Health and the medical schemes under its management. The funding policies are developed in a credible, transparent and consistent manner using principles of evidence-based medicine and health economic analyses.

14 How does this process work The process involves assessment of new technology (pharmaceuticals, devices, procedures) or new indications for existing technology. The requests for health technology assessment may be submitted by external parties such as providers, manufacturers /suppliers and hospitals as well as internal parties. The new technology assessment includes a clinical and financial filters and the application of health economics where relevant.

15 How Discovery makes clinical policy and funding decisions Clinical filter First step in Health Technology Assessment Thorough process to identify and summarise clinical evidence of a technology Is new technology ethical, safe and clinically effective? Health Technology Assessment steps Define objectives of review (specific clinical question to answer) Search of the literature and databases for relevant clinical information Critical Appraisal of peer-reviewed scientific literature Recommendation regarding level of evidence Implementation of findings

16 How Discovery makes clinical policy and funding decisions Clinical filter: Health Technology Assessment 1. Select specific clinical question to answer (technology under review) PICO is an acronym standing for: Patient or type of person related to the problem in question (patient selection) Intervention (medicine, procedure, device, pathology test) Comparison (alternative) Outcome (difference obtained between findings of the intervention and the comparison) e.g. Clinical evaluation of Bone morphogenic protein (RhBMP-2) used to promote bone growth after fusion surgery in degenerative disc disease in the lower spine, as an alternative to autogenous bone graft.

17 How Discovery makes clinical policy and funding decisions Clinical filter: Health Technology Assessment 2. Search the literature and databases for relevant clinical information Systematic literature review approach: Product registration (national and international) Leading national and international medical journals (published clinical trials) What type of study was done (level of clinical trials) How was the study carried out (randomization, bias, follow-up) Is the study applicable to our patients (population, inclusion/exclusion criteria, outcome measures, comparators) Knowledge databases (Hayes, Cochrane library, Micromedex, UpToDate) National and international guidelines Consultation with local opinion leaders and professional societies International Health Technology Assessment decisions and reports (NICE, CADTH) International private and public funding decisions (AETNA, CIGNA, BCBS, Medicare, NHS)

18 How Discovery makes clinical policy and funding decisions Clinical filter: Health Technology Assessment 3. Critical Appraisal of peer-reviewed scientific literature for validity and usefulness to the patient and practice SORT level of evidence Study quality Level 1: good quality patient-oriented evidence Level 2: limited quality patient-oriented evidence Level 3: other evidence Strength of recommendation A: Recommendation based on consistent and good quality patient-oriented evidence B: Recommendation based on inconsistent or limited quality patient-oriented evidence C: Recommendation based on consensus, usual practice, opinion, disease-oriented evidence and case series for studies of diagnosis, treatment prevention or screening Consistency across studies Consistent: Most studies found similar or at least coherent conclusions (means that differences are explainable) If high quality and up-to-date systematic reviews or meta-analysis exist, they support the recommendation Inconsistent: Considerable variation among study findings and lack of coherence If high quality and up-to-date systematic reviews or meta-analysis exist, they do not find consistent evidence in favor of the recommendation

19 Practicing EBM Clinical filter: Health Technology Assessment Alternatively, Mulrow et al, 1994 suggested the following level structure: Level I a I b II a II b III IV Type of Evidence Evidence obtained from meta-analysis of randomized controlled trials Evidence obtained from at least one randomized controlled trial Evidence obtained from a least one well designed controlled trial without randomization Evidence obtained from at least on other type of well-designed quasiexperimental study Evidence obtained from well-designed non-experimental descriptive studies, such as comparative studies, correlation studies and case control studies Evidence obtained from expert committee reports or opinions and/or clinical experience of respected authorities These levels of evidence, however, do not include literature such as reference texts, abstracts, package inserts and promotional literature.

20 How Discovery makes clinical policy and funding decisions Clinical filter: Health Technology Assessment Hayes Rating System (reflects the strength of the evidence regarding efficacy and safety of a medical technology, its impact on health outcomes, indications for use, patient selection criteria, medical consensus, and comparison to alternative technologies. The ratings are scaled A through D) A - Established benefit B - Some proven benefit C - Potential but unproven benefit D - No proven benefit and/or not safe Micromedex levels of evidence (strength of recommendation, strength of evidence, and efficacy) 4. Recommendation regarding level of evidence Sufficient limited Insufficient

21 How Discovery makes clinical policy and funding decisions Financial filter The objective of this filter is to ensure the proposed health technology is responsibly funded Incidence and prevalence of the condition Historical and projected costs of the condition and current treatment Cost of the new technology Cost of the comparator Budget impact Cost-effectiveness/Health economics

22 Health Economics Are all new technologies value for money? Is the increased benefit worth the increased cost? Use of health economics models based on the principles of cost effectiveness rather than simply on the cost of the new technology. Health economics is an aid to decision making not a substitute. It provides tools for evaluation, negotiation and implementation. Enables access to medical advances at prices appropriate in relation to the additional clinical benefits they offer. Combines clinical and financial considerations for treatment modality 22

23 Funding mechanisms Finding a funding mechanism for the new technology 23

24 How Discovery makes clinical policy and funding decisions 24

25 CPU Watch List Process The process starts with submission of the following information: New Products Expanded Indications M2 (similar to existing) Clinical evidence-based data to prove that the technology is safe and effective (all relevant highest quality of evidence available for technology under review) Clinical indications for new technology Details of costs associated with the technology as well as costs of comparative technologies, where available Any health economic data to support the cost-effectiveness of the new technology Product Validation Allocation for research Remember PICO methodology Patient Intervention Comparator Outcome 25

26 CPU Watch List Process HTA form The information required should be included in the completed Discovery Technology Evaluation Document and submitted by the applicant to the CPU Both a hardcopy (paper based) and electronic submission must be sent for review These must follow the stipulated format (i.e. per Section) in order to ensure an efficient handling of the submission Section A: Application details Section B: Manufacturer/Applicant s details Section C: Clinical information (overview of disease/condition and the new technology, indications, comparators) Section D: Regulatory Bodies (FDA, CE, MCC) Section E: Coding and costs Section F: Clinical evidence (clinical trials with description of trial design, comparator, sample size, outcome measures, results) Section G: Health Economic and Budget Impact Analysis Section F: For internal use Each Section must be separated by a file divider (hard copy) or new folder (electronic copy) Any submissions that do not comply with the required format will be returned to the manufacturer 26

27 CPU Watch List Process Clinical evaluation duration Communication Letter with recommendation regarding level of evidence Approval letter/m2 letter (sufficient evidence) for isem referral (price negotiations) Decline letter (insufficient or limited evidence) Synopsis of clinical evidence Dormant letter Completed HTA form is not received within 1 month 27

28 In first half of 2014 CPU received more than 90 new technology applications Some interesting stats for 2013 (July to December) Diagnostics and Pathology 12% Medicine 31% Medical and surgical procedures and devices 47% >200 external liaison interactions 73 new technology submissions 10 HE evaluations 720 queries 84 CISs ands QSs 67 protocols new/updates

29 2014 THANK YOU Dr Vesna Kupresan