Genomics and Insurance. 30 November 2018 Julie Scott Underwriting Proposition Manager Munich Re UKLB Tel: +44 (20)

Transcription

1 Genomics and Insurance 30 November 2018 Julie Scott Underwriting Proposition Manager Munich Re UKLB Tel: +44 (20)

2 0 Introduction NOCA - Genomics and Insurance - Julie Scott Underwriting Proposition Manager 27 Munich November Re UKLB 20182

3 What I ll cover today 1. What is Genomics? 2. What s the impact of Genomics on insurance? 3. What are ctdna tests (liquid biopsies)? 4. What s the impact of ctdna tests on insurance? 5. The future/conclusions 6. Take any questions 27 November

4 1 What is Genomics? NOCA - Genomics and Insurance - Julie Scott Underwriting Proposition Manager 27 Munich November Re UKLB 20184

5 What is Genomics? April 2003 the complete genetic code of a human being their genome could now be published An individual has a complete set of genes in almost every healthy cell in their body One set of all these genes, plus the DNA between the genes, is called a genome 27 November

6 Genomics Glossary Terminology Genetics / Genomics Monogenic / Polygenetic / Multifactorial Predictive / Diagnostic Pharmacogenomics Definition Genetics and genomics are two terms that are often incorrectly used interchangeably. Genetics is the study of single genes and their role in the way traits or conditions are passed from one generation to the next. Genomics is a term that describes the study of all parts of an organism's genes, including mapping and editing Mono = Single, Poly = Many, Multi = More than one Predictive tests refer to genetic screening carried out in a patient without symptoms. Diagnostic tests refers to a genetic test to make a diagnosis in a patient exhibiting symptoms The branch of genetics concerned with determining the likely response of an individual to therapeutic drugs Tumour / Cancer Genomics Genetic Therapy / Gene Editing Cancer genomics is the study of the totality of DNA sequence and gene expression differences between tumour cells and normal host cells. Genome editing (also called gene editing) is a group of technologies that give scientists the ability to change an organism's DNA. These technologies allow genetic material to be added, removed, or altered at particular locations in the genome 27 November

7 2 What s the impact of Genomics on insurance? NOCA - Genomics and Insurance - Julie Scott Underwriting Proposition Manager 27 Munich November Re UKLB 20187

8 What s the impact of Genomics on insurance? - Genetic tests/screening cost, availability & limitations - Personalised medicine - Regulation / legislation - Estimation of claims impact/pricing - Use of and value of genetic tests in underwriting - Use of and value of family history in underwriting 27 November

9 Types of sequencing techniques and evaluation from a clinical point of view Microarray testing: Specific sequences of DNA are tested and compared to reference DNA to identify mutations and structural variants (used by e.g. 23andme) Low cost (~$100) and easy availability Not able to identify unexpected changes/only small part of DNA sequenced Exome sequencing: Specific subset of DNA that (potentially) encodes proteins is tested. The exome makes up 1% of the human genome, but harbours 85% of significant/disease causing mutations High level of information at relatively low cost (<$500) Regions of DNA remain un-sequenced/significant mutations can be overlooked Whole genome sequencing: (Nearly) all of the DNA is tested Full picture Relatively high cost (~$1000) Full interpretation has not been achieved 27 November

10 How will the prevalence of inexpensive genetic testing impact medical treatment in the future? Pharmacogenomics Aim is to assess a patient s genotype and then use this data to optimize efficacy and reduce toxicity of drugs Has application for diseases such as cardiovascular disorders, mental health, infectious diseases, asthma and diabetes Cancer genomics Cancer genomics looks at the genetic setup of malignant tumour cells and uses the information to determine prognosis (e.g. risk of recurrence) More aggressive cancers can receive a more aggressive therapy whereas other cancers might not need chemo- or radiotherapy at all Genome editing Example: CRISPR-Cas CRISPR-Cas technology allows for the specific cutting out and subsequent replacement of genes Diseases with a poor prognosis that until now have been incurable can be cured The prognosis of a considerable number of diseases could/will improve 27 November

11 Example: Gene therapy, genome editing (CRISPR-Cas) Assembly of complete gene sequences Repair/replacement of individual DNA components Removal of individual DNA components CRISPR-Cas technology allows for the specific cutting out and subsequent replacement of genes Diseases with a poor prognosis that until now have been incurable can be cured 27 November

12 Regulation/legislation world view Canada: Recent legislation effective May 2017 prohibits insurers from requiring an applicant to undergo a genetic test or disclose the results of a prior test in connection with the issuance of life insurance China: No current restrictions but being considered in draft legislation UK: Voluntary code of practice by life insurers limits use of predictive test result unless S/A is greater than 500,000 (for Life cover) 27 November

13 Use of genetic test results in underwriting individual life insurance by state Green Can use genetic test results in connection with underwriting individual life Yellow Written informed consent required of insured Grey Use of genetic testing results not allowed in connection with specific diseases Purple Use of genetic testing results in underwriting of individual life restricted Red Use of genetic testing results in underwriting of individual life not permitted Source: Piktochart Munich Re, U.S. (Life) 27 November

14 Claims/pricing considerations 1. Population? 2. Rates of predictive tests? 3. Prevalence of mutations and which diseases? 4. Anti-selection? 5. Genomic specific legislation? 6. Underwriting effectiveness? 7. Increased claims costs best and worse case scenario? Recent Studies Estimating Cost Impact Canada (CIA Studies 1,2 ): Life Qx (+35% for males, +60% for females), CI Claim (+16% for males, +41% for females) UK 3 : CI Cost (~0.1% of premium income with FHx, 2%-3% without FHx available for UW) November

15 Learnings from legal and regulatory regimes around the World Canada: Recent legislation effective May 2017 prohibits insurers from requiring an applicant to undergo a genetic test or disclose the results of a prior test in connection with the issuance of life insurance China: No current restrictions but being considered in draft legislation UK: Voluntary code of practice by life insurers limits use of predictive test result unless S/A is greater than 500,000 (for Life cover) 27 November

16 Value of family history compared to genetic testing Family History DTC Exome Sequencing Genome Sequencing Used for >150 years Free No 3 rd party interpretation Instant results Indicator of both genetic and environmental influences Little restriction of use Can be over-disclosed Can be non-disclosed (ND) ND unlikely to be proven Will miss de novo mutations Improving accessible (both cost and availability) No physician approval needed Very limited value Restrictions of use Results often delayed Less predictive value than FH e.g. BRCA mutations not reported Can identify 85% of significant disease causing mutations Better predictive value than FH for some diseases Needs physician approval Same cost as other UW tests - $500 Limited availability Restrictions of use Won t indicate environmental influences More complete picture than FH and Exome testing Expensive - $1000 Need physician approval & counselling Full interpretation not possible Restricted use Won t indicate environmental influences 27 November

17 3 What s a ctdna test (liquid biopsy)? NOCA - Genomics and Insurance - Julie Scott Underwriting Proposition Manager 27 Munich November Re UKLB

18 What s a ctdna test? As cells within the body die and are broken down, fragments of DNA are released into the bloodstream. If a patient has cancer, their bloodstream can contain both DNA from their normal cells and DNA from the cells in their tumour - circulating tumour DNA Analysis of ctdna requires sensitive scientific techniques that are able to detect very small amounts of ctdna among the non-cancerous DNA in a blood sample. These include next generation sequencing technologies such as exome sequencing and whole genome sequencing, and other methods such as PCR 27 November

19 How s ctdna currently being used? Making treatment decisions Monitoring emergence of resistance to treatment Monitoring treatment response and relapse So being used in those lives who already have cancer diagnosed 27 November

20 How could ctdna be used in the future? Early diagnosis Cancer screening Late stage cancer precision monitoring Post treatment and minimal residual disease (MRD) monitoring Longitudinal monitoring (trends over time) 27 November

21 Advantages/disadvantages for ctdna ves ves Increase accessibility of testing Biological factors Clinical utility Better capture tumour diversity Cost implications Diagnostic limitations Does ctdna testing give a patient better care and a better outcome? 27 November

22 4 What s the impact of ctdna tests on insurance? NOCA - Genomics and Insurance - Julie Scott Underwriting Proposition Manager 27 Munich November Re UKLB

23 The impact on insurance, especially CI - Pricing - Definitions and product development - Anti-selection 27 November

24 5 Conclusions NOCA - Genomics and Insurance - Julie Scott Underwriting Proposition Manager 27 Munich November Re UKLB

25 Conclusions/the future for Genomics In multifactorial diseases, the genetic background will be better understood and thus also improve predictability (through connection with other data) Progress in pharmacogenomics will contribute to an improvement in prognoses of diseases with regard to mortality as well as morbidity With cancer genomics, the prognosis of cancer will be improved further and prognostic criteria will conform more closely to the genetic configuration of a tumour With gene therapy, diseases can be cured that were previously difficult to influence with therapy DTC genetic tests could have an anti-selective effect in the portfolio during application and cancellation 27 November

26 Conclusions/longer term future for ct-dna - It is unlikely that ctdna testing will have a significant impact on CI policies now or in the near future - Industry needs to monitor developments - Could the term cancer disappear? If so CI would need to fundamentally evolve 27 November

27 Genomics - what does the industry need to do? Public relations / lobbying: so as not to endanger the life insurance business model, the public and politicians must be convinced of the need for the life insurance industry to use genetic information The life insurance industry should use the innovative potential of available genetic information in the interest of the customer (e.g. new products: pharmacogenomic testing as a service in the event of a claim) If DTC tests (possibly in combination with big data) become more precise in terms of prognosis, this must be consistently taken into account in pricing as an antiselection and cancellation risk The improved prognosis due to pharmacogenomics, cancer genomics and gene therapy should manifest itself in an increase in insurability 27 November

28 6 Questions? 27 November

29 7 Appendix slides NOCA - Genomics and Insurance - Julie Scott Underwriting Proposition Manager 27 Munich November Re UKLB

30 ABI Code of Practice - UK The code is based on two core principles: An insurer will not require (or pressure) an applicant to undertake a Diagnostic or Predictive genetic test in order to obtain insurance The results of a Predictive test may be considered in an application for insurance only when: o o Type of insurance The Predictive test in question is specified in the code and The sum assured exceeds the financial limit set out in the code (details in table below) Financial limit above which predictive tests may become relevant Medical conditions for which insurers may ask for and take into account of predictive test results, for policies above the financial limits Life Insurance 500,000 (per person) Huntington s disease Critical Illness Insurance 300,000 (per person) None Income Protection Insurance 30,000pa (per person) None Other types of Insurance Predictive genetic test results will not be asked for or taken into account, whatever the level of cover. The results of Diagnostic genetic tests are considered relevant medical information and, as such, insurers are able to access the results of Diagnostic genetic tests and may use these results to inform their underwriting decision 27 November

31 How will genomic testing impact claims costs? Present Value of Future claims from in-force and new business New business Claims costs? In-force business 2016 Base Anti-selection Improvement in mortality Overall Impacts on claims need to be analysed separately on in-force and new business What anti-selection on the new business can we tolerate for the improvement in mortality through personalised medicine? 27 November

32 Progress in technology makes whole genome sequencing affordable A whole genome can today be sequenced for less than 800* With the reduced costs a lot more research on more people will be performed More and more genetic data will available in the future Knowledge on prediction, prognosis and therapy will increase 27 November