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  • In this presentation, I examine the contribution that health economics can make (and is making) to genetics and genomic issues in health care.
  • OK, so my 3 main objectives this morning are: First - to highlight the areas where health economics can contribute towards issues in genetics and genomics. Second - to summarise the current publicly funded health economics and genetics research in the UK. Finally - to describe some ongoing studies: to illustrate the types of genetic areas colleagues and I are working in and the different economic methods that are being used. The 3 studies I have chosen cover: - Pharmacogenetics - DNA versus clinical diagnosis - Novel genomic technologies
  • In terms of the areas where health economics can make a contribution in genetics, these 4 are probably the main ones: Health care financing (e.g insurance) – Here economics has been used to e examine policy issues such as whether, and what circumstances, insurance companies should be given access to genetic test results. 2. Service organisation – addresses questions such as should genetic counselling be undertaken in primary or secondary care, or which labs should undertake genetic testing. 3. Economic evaluation compares costs and benefits of alternative interventions, often using cost-effectiveness analysis) For instance addressing questions such as whether a particular drug, genomic technology or screening programme is cost-effective and represents good value for money for the NHS. 4. Patient decision making – Value of genetic information – addressing questions such as do patients (and health care providers) value the information provided by a genetic test. I focus on the second two areas, as these are the main areas where we can see how health economics can be used to assess the benefits and impact on interventions and clinical practice. Examine policy issue such as whether, and if so under what circumstances, insurance companies should be given access to genetic test results. The insurance industry argues for mandatory disclosure in order to avoid problems of adverse selection; genetic interest groups argue for a moratorium or legislation preventing such disclosure; a third option would be a voluntary consent law. The purpose of this paper is to investigate the impact of alternative policies on individuals’ incentives to both acquire genetic information and to disclose it to insurers. The theoretical framework used to inform this analysis is provided by the ‘games of persuasion’ literature, in which one agent tries to influence another agent’s decision by selectively withholding her private information regarding quality. The application of the theoretical framework to this policy context yields surprising results. Individuals have the incentive to acquire genetic information and to disclose the test results if disclosure is voluntary. If, however, they are obliged to disclose the results of any genetic tests they have taken, their incentive may be not to acquire such information. I discuss the policy implications of these findings both from the point of view of the insurance industry and from a public health perspective.
  • So in terms of the ongoing economics research in the UK, I estimate that there are around 31 publicly funded students being undertaken at the moment. Obviously there are economists working in industry, but I thought it was more useful to summarise research studies and difficult to access info on what industry economists are working on. Of these 31, the universities of Oxford and Manchester, are each doing 10. Both locations are linked to Genetics Knowledge Parks, Depts Health and Trade and Industry. Although, some of the studies are funded by other sources, this does illustrate that the Knowledge Parks have been pivotal in increasing the level of health economics and genetics research. Types of questions being addressed - Largely economic impact of new genetic interventions upon NHS Health economic techniques Many economic decision models, due to lack of RCTs in some areas Main funding bodies: Dept Health and European Commission What can we deduce from this? - Small, but growing level of research.
  • In terms of pharmacogenetics, the earliest commercial development are in pharmaceutical companies. They often have in-house health economists (often not doing full evaluations though, more focussed on pricing issues). There’s then a push from companies to force NHS to provide their interventions. At this stage the products are put through the normal Health Technology Assessment Process in the NHS and obviously NICE is an important part of this. So for NICE its important to examine the economic impact upon NHS of targetting a drug. Because once targetting is agreed possible there are issues around cost-effectiveness of genetic testing and the drug itself. A recent and high profile example of a pharmacogenetics technology is obviously HERCEPTIN and health economics added a lot to the debate (summarise findings). In terms of ongoing Px studies in the UK, an interesting example is a study being undertaken in Manchester at the North West Genetics Knowledge Park, which is exploring the Measurement of TPMT activity is encouraged prior to commencing azathioprine or 6-mercaptopurine, as patients with low activity (10% prevalence) or especially absent activity (prevalence 0.3%) are at a heightened risk of drug-induced bone marrow toxicity due to accumulation of the unmetabolised drug. Reuther et al found that about 5% of all thiopurine therapies will fail due to toxicity. This intolerant group could be anticipated by routine measurement of TPMT activity. cost effectiveness of thiopurine methyltransferase (TPMT) genotyping to reduce ADRs associated with prescribing azathioprine. Azathioprine is used in the treatment of several different types of rheumatic disease, including rheumatoid arthritis and systemic lupus erythematosus (SLE). Azathioprine has effects on the immune system (the body's own defence system). One of its actions is to reduce the activity of the immune system, so it is always used with care. Doctors may prescribe it for people on steroid treatment so their steroid dose can be smaller. Azathioprine is a type of medicine called an immunosuppressant. It is used to dampen down the activity of cells in the immune system. Research has suggested that pharmacogenetic tests may help to predict those patients who will experience serious side effects, known as adverse drug reactions (ADRs)2. ADRs have a massive impact on the National Health Service (NHS) in the UK. One in ten of all NHS bed days in England can be attributed to ADRs, at a cost of £380m a year. The results of a pharmacogenetic test can help clinicians to decide: firstly, if the drug is the right drug to use; secondly, the correct dose to maximise benefits and; thirdly, the potential for ADR. Azathioprine is an immunosuppressive drug used in the management of inflammatory conditions, such as rheumatoid arthritis or Crohn’s disease. Clinical evidence suggests that a pharmacogenetic test that looks for changes in a specific gene called thiopurine s-methyl transferase (TPMT) can be used to identify the risk of developing profound neutropaenia (low number of white blood cells) in individuals prescribed azathioprine. No other side effects are identified by the test. Despite theoretical advances in personalised medicine, the use of pharmacogenetics tests, including the TPMT test, has not yet been widely integrated into clinical practice.
  • modelling stroke and heart failure: No cascade screening vs Cascade genetic screening: Cascade clinical surveillance every 5 years if negative result is dominated by genetic screening Cascade clinical screening is extendly dominated by a combination of No cascade screening and Cascade genetic screening Without stroke and heart failure: 1st degree relative of proband No cascade screening vs Cascade genetic screening: ICER £11,595 per life year saved Screening for different family sizes No cascade screening vs Cascade genetic screening: ICER £11,368 per life year saved We simulated cascade screening the sons/daughters of a HCM proband detected clinically between age 40-60. We obtained the probability of having 1, 2 or 3 children given this age range from the ONS data and estimated individually the benefits and costs of cascade screening in children aged 18, 20 and 22 years old. These costs and benefits were added according to family size and multiplied by the probability of the proband having a family of that size.
  • Microarrays have received considerable attention in the scientific research community. An array (microarray or chip) is a solid surface, often a microscope slide, onto which control DNA, cDNA ( complementary DNA ) or short single stranded sequences (oligonucleotides) are spotted (Aitman, 2001). In aCGH, arrays are used to compare a control versus a test genome searching for differences in the test genome (Figure 1). When the test genome is a patient DNA sample, such differences signpost DNA sequences that might be implicated in the patient’s phenotype. aCGH has application in many genetics areas, proving particularly useful in diagnosing ILD. Indeed, research indicates that at least 10-15% more diagnoses are made compared with standard cytogenetic analysis (Knight et al. , 2006).
  • Table 6. Cost comparison of aCGH and karyotyping per sample Cost Category aCGH - £442 Karyotyping - £117 Difference - £442£117£325
  • We would like to find out what you think is important in testing for inherited heart diseases . This testing can diagnose or rule-out inherited diseases such as hypertrophic cardiomyopathy (HCM), dilated cardiomyopathy (DCM) or Long QT syndrome (LQTS). As you know, all of these conditions may predispose people to serious cardiac events. Testing can be done through clinical exams (for instance ECG and ECHO) or through genetic testing from a blood sample.
  • With a discrete choice experiment, respondents are presented with a series of scenarios, which have information on different attributes of a service and corresponding levels for these attributes. This example is taken from the
  • The costs and effects (number of additional diagnoses) of an aCGH test versus standard cytogenetic analysis using karyotyping, were compared. A cost per diagnosis detected was used rather than a cost per life year gained or quality adjusted life year (QALY), as testing is unlikely to save lives and evaluating QALY’s is problematic in children, especially those with LD.

Power point 243KB Power point 243KB Presentation Transcript

    • HGC Information Gathering: Strategic priorities in genetics research
    • Health Economics
    • Sarah Wordsworth, PhD
    • Health Economics Research Centre
    • University of Oxford
    Human Genetics Commission February 7 th 2007, London
  • What Can Health Economics Add?
    • Health economics contribution to genetics/genomics
    • Current publicly funded health economics and genetics research in the UK
    • Examples
      • Pharmacogenetics
      • DNA versus clinical diagnosis
      • Novel genomic technologies
  • Health economics – Contribution to Genetics/Genomics
    • Health Care Financing
      • (e.g. insurance)
    • Service Organisation
      • (e.g. primary versus secondary care counselling; which laboratories should undertake genetic testing)
    • Economic Evaluation
      • (compares costs and benefits of alternative interventions, often using cost-effectiveness analysis)
    • Patient (and Clinician) Decision Making
      • (e.g. value of genetic information, benefits and dis-benefits of genetic information)
  • Current Publicly Funded Health Economics Research in Genetics
    • 36 Studies *
      • Most in Oxford and Manchester (Universities with GKPs)
    • Types of Questions Being Addressed:
      • Largely economic impact of new genetic interventions upon NHS
    • Health Economic Techniques:
      • Many economic decision models, due to lack of RCTs in some areas
    • Main Funding Bodies:
      • Dept Health and European Commission
    • What can we deduce from this?
      • Small, but growing level of research
      • * (handout of published studies)
  • Study Areas * (handout of published studies) Learning disability Cancer 3 Genomic technologies Newborn screening Cardiovascular disease Haemochromotosis 17 Clinical vs DNA Genetic counselling Cystic fibrosis 6 Service organisation Depression Cancer Anaemia 10 Pharmacogenetics * Diseases Number Study types
  • Pharmacogenetics
    • Research suggests pharmacogenetic tests may help to predict those patients who will experience serious adverse drug reactions (ADRs).
    • ADRs have a massive impact on the National Health Service (NHS) in the UK. One in ten of all NHS bed days in England can be attributed to ADRs, at a cost of £380m a year.
    • Herceptin: High profile example and health economics was an important part of the decision making for NICE.
  • Establishing Cost-effectiveness of TPMT Genotyping to Reduce ADRs with Azathioprine
    • Azathioprine is an immunosuppressant , used to treatment rheumatoid arthritis and Crohn’s disease.
    • ADRs (bone marrow suppression) limit the effective use of Azathioprine.
    • Clinical evidence suggests that a pharmacogenetic test that looks for changes in a specific gene called Thiopurine s-Methyl Transferase (TPMT) can be used to identify the risk of developing profound Neutropaenia (low number of white blood cells) in individuals prescribed Azathioprine.
    • Prospective RCT of pharmacogenetic testing compared to standard care (Based at Manchester University).
    • Standard care : Currently Azathioprine introduced in a step-wise manner plus blood monitoring (Guidelines)
    • PGx test : 3 genetic variants (95%): TPMT*2, TPMT*3A, TPMT*3C
    • Study aims to examine the clinical and the cost-effectiveness of the two approaches
    • Population
    • Gastroenterological & rheumatological
    • Sample: 1000 patients
    • 80% power, 14% to 8% reduction in neutropaenia
    • Outcomes
    • Neutropaenia (neutrophil count < 1x10 9 /l)
    • Clinical effectiveness (Harvey Bradshaw, CRP, ESR)
    • Non-haematological ADRs
    • Health related quality of life status
    • Costs
    • NHS resources
    • Follow-up (Time Horizon)
    • Clinical: 4-months from 1 st Azathioprine Rx
    • Economic: 12-months from 1 st Azathioprine Rx
    • Data collection started: October 2004 to December 2007
    Study Design: Prospective RCT
  • DNA versus Clinical Diagnosis: Example of Genetic Technology in Cardiology
    • Based on the Oxford study , where DNA testing is being performed on those who potentially have HCM.
    • Methods
        • Economic decision model - Starting point is f irst degree relative of known mutation carrier aged 18, then model a family.
    • Attach costs and benefits ( life years saved ) and compare lifetime cost-effectiveness of alternative strategies .
    • Main strategies compared :
      • Proactive clinical diagnosis (Genetic counselling, ECHO, ECG)
      • Proactive genetic diagnosis (Genetic counselling, DNA testing)
      • Incidental clinical diagnosis
      • Do nothing
      • Treatment for high risk individuals ( implantable cardioverter defibrillators (ICDs).
  • Basis of Markov Model High risk Clinical Tests (cascade) DNA Test ICD/ Drug if high risk HCM Low risk Mutation status Outcome of diagnostic Treatment strategy Do nothing Undetected Detected Surveillance if low risk Discharge/ surveillance Presentation Clinical Tests Diagnostic strategy Risk of SCD Clinical Tests (incidental)
  • Results and Conclusions
    • Incidental clinical diagnosis versus cascade genetic cascade diagnosis:
    • Incremental Cost-Effectiveness Ratio ( ICER) of £12,390 per life year saved
    • In this example, using genetic technology adds the ability to ide ntify asymptomatic but genetically at risk individuals and discharge those without mutation.
    • Genetic approach was more cost-effective than the non-genetic approach. This is because using genetic technology potentially avoids unnecessary deaths, although increases short-term health service costs.
  • Genomic Technologies in the NHS: Example of Microarrays in Idiopathic Learning Disability
    • Microarrays
      • An array (microarray/chip) is a solid surface, often a microscope slide onto which DNA etc is spotted. Considered expensive for NHA labs.
    • Comparative Genomic Hybridisation (aCGH)
      • Arrays are used to compare a control versus a test genome to look for differences in test genome.
    • Idiopathic Learning disability
      • In research proving particularly useful in ILD
    • Standard Testing: Karyotyping
      • In most NHS labs, standard testing for ILD uses Karyotyping.
    • Would aCGH be cost-effective in the NHS?
  • A Cost-effectiveness Analysis of aCGH in Idiopathic Learning Disability
    • Costs and effects (number of additional diagnoses) of an aCGH test versus cytogenetic analysis using Karyotyping compared.
    • 4 laboratories (investigating ILD using aCGH, Karyotyping or both) contributed to detailed data collection:
      • Wellcome Trust Centre for Human Genetics, University of Oxford
      • Oxford Regional Cytogenetics laboratory
      • Birmingham Regional Genetics Laboratory
      • South East Scotland Cytogenetics laboratory
    • Array costs were based on Agilent Technologies Inc. 4 x 44K genome-wide oligonucleotide multi-sample format arrays
    • Resource use and costs for staff, equipment, consumables and overheads
    • Several testing and reporting scenarios were identified e.g FISH
  • Results and Conclusions
    • Basic cost comparison of aCGH and Karyotyping per sample
    • aCGH (£442) versus Karyotyping (£117)
    • Fuller cost comparison per sample
    • Hypothetical cohort of 100 ILD children:
      • aCGH cost per diagnosis (£4,626) versus
      • Karyotyping and multi-telomere FISH (£4,909).
    • Testing for genomic imbalances in ILD using microarray technology is likely to be cost-effective.
    • Long-term savings can be made regardless of a positive (diagnosis) or negative result.
    • Earlier diagnoses saves costs of additional diagnostic tests.
  • Value of Genetic Information: Discrete Choice Experiments
    • DCE
      • Quantitative survey method that can assess the value (benefits) of a good or service
    • What attributes do people think are important?
      • What is the rank order of the attributes?
      • Do people make trade-offs between the different attributes?
    • Example
      • Aim: To identify which characteristics (attributes) of testing for inherited heart diseases patients value.
      • Patients offered genetic testing for inherited cardiac disease, which could lead to sudden cardiac death (hypertrophic cardiomyopathy, dilated cardiomyopathy and Long QT syndrome)
  • Sample Scenario 85% 65% Treatment Effectiveness £300 £500 Cost Lots Some Family Information 85% 70% Test Accuracy Test B Test A Scenario 8
  • Discussion
    • Limited but growing health economics activity in genetics
    • The discipline can:
      • Provide an insight into whether a genetic technology is likely to be a good use of limited NHS resources
      • Provide an insight into whether or not patients (and health care professionals) value the information that the technology can provide.
    • ESRC funded economics of genetics seminar series
      • 4 seminars 2006 – 2007
      • Aim: Bring together those working in the economics of genetics internationally.