Measuring Patient Value

Transcription

1 Measuring Patient Value Galen Research Ltd. February 28, 2017

2 About Galen Research Manchester based research organisation Links with University of Manchester and Greater Manchester Council Growing at 30% p.a. with 99.5% of revenue as exports Disease-specific patient value measure developer 35 measures Undertake linguistic and cultural adaptations of measures for pharma customers and clinics Adapted for use in up to 70 different languages Applied research 2

3 Why is measuring patient value important? Outcomes based reimbursement/commissioning Value-based treatment Increasing costs of care as % of GDP Global phenomenon US health care costs $3.2Trn or 18% of GDP in Rising in all major economies. Figures exclude hidden costs, charities, social care, welfare benefits, family care. Integrated care Devo Manc devolution and merger of health and social care services and budgets 3

4 Clinical Model (HRQL) Disease Symptoms Functioning Clinical intervention

5 Traditional Approach Clinician generated Clinician, not patient, relevant Focused on symptoms and functioning - not holistic Profile rather than unidimensional Aimed at clinicians for use in the clinic Generally poor quality: Researchers add different profiles together to create a score or ignore profiles that give the wrong answer! Generally ordinal rather than interval scales

6 I try to lead as normal a life as possible and not think about my condition or regret the things it prevents me from doing, which are not that many. Stephen Hawking

7 The Needs-based Approach Patient-centric: items derived directly from patients Patient-relevant: needs rather than functioning Holistic: determine impact of both disease and its treatment Unidimensional, interval scales Unrelated to nature of intervention Able to evaluate packages of interventions, clinical and others. Able to evaluate interactions between different types of interventions

8 Disease limits patients abilities to fulfil the things that are most important to them role maintaining relationships socialising with others security safety autonomy identity purpose developing competency hygiene challenge

9 Integrated care requires an integrated approach and accurate measurement of patient value Clinical Intervention Diet Exercise What combination of treatments provides the greatest value for the lowest cost to a patient population? Social Care Training Need Fulfilment Counselling Technology Environment

10 What patients say You can tell that patients have written it, it s very good Good representation of areas that are important to me Feels like my voice, it captures the essence of TPN Good, well researched, a true picture of how hard it is to lead a normal life on TPN My life revolves around my feed perfect item, it does become an obsession The questions are all very pertinent and cover issues that I wouldn t discuss with my doctor

11 How are needs-based instruments used Phase II-IV Clinical Trials van der Heijde, D.M. et al (2009). Physical Function, Disease Activity, and Health-related Qualityof-life Outcomes after 3 Years of Adalimumab Treatment in Patients with Ankylosing Spondylitis, Arthritis Research Therapy. 11(4):R124 Abbott obtained a Quality of Life label from the FDA for Humira in AS using the ASQoL 11

12 How are needs-based instruments used Non-clinical intervention studies Aytekin, E. et al. (2011). Home-based exercise therapy in patients with ankylosing spondylitis: effects on pain, mobility, disease activity, quality of life, and respiratory functions. Clinical Rheumatology 31:91 97 DOI /s Our study showed that performing home-based exercises on a regular basis provided significant improvements in all the clinical and functional parameters and pulmonary functions in the exercise group, but the only significant difference between the exercise and the control group was found in ASQoL scores in favor of the exercise group at third month. 12

13 How are needs-based instruments used By health researchers investigating health care system impact of a drug Hernberg-Stahl, E. et al. (2001). Healthcare Consumption Decreases in Parallel with Improvements in Quality of Life during GH Replacement in Hypopituitary Adults with GH Deficiency, Journal of Clinical Endocrinology & Metabolism 86(11); The present analysis of data from KIMS has shown that 12 months of GH replacement therapy significantly decreases the number of days in hospital, the number of days of sick leave, and the number of visits to the doctor, This decrease in the use of healthcare resources also correlated with a significant improvement in QoL, as measured using the QoL-AGHDA questionnaire. 13

14 How are needs-based instruments used By Healthcare providers to determine whether treatment is necessary National Institute for Clinical Excellence, Final Appraisal Determination. Human growth hormone (somatropin) in adults with growth hormone deficiency. 1 Guidance Recombinant human growth hormone (somatropin) treatment is recommended for the treatment of adults with growth hormone (GH) deficiency only if they fulfil all three of the following criteria. They have severe GH deficiency, defined as a peak GH response of less than 9 mu/litre (3 ng/ml) during an insulin tolerance test or a crossvalidated GH threshold in an equivalent test. They have a perceived impairment of quality of life (QoL), as demonstrated by a reported score of at least 11 in the disease-specific 'Quality of life assessment of growth hormone deficiency in adults' (QoL-AGHDA) questionnaire. They are already receiving treatment for any other pituitary hormone deficiencies as required. The QoL status of people who are given GH treatment should be re-assessed 9 months after the initiation of therapy (an initial 3-month period of GH dose titration, followed by a 6-month therapeutic trial period). GH treatment should be discontinued for those people who demonstrate a QoL improvement of less than 7 points in QoL-AGHDA score. 14

15 How are needs-based instruments used Multi-intervention intervention studies Royal National Hospital for Rheumatic Diseases (RNHRD) World-leading centre for the treatment of Ankylosing Spondylitis Runs a specialist two-week AS rehabilitation course Multi-specialist Current project to establish that patient value gained from the AS course plus biologic treatment provides greater patient outcomes. Using ASQoL as the only AS-specific instrument capable of measuring patient value from multiple-interventions. Chosen on the basis of: Superior psychometric properties Capable of detecting change from both clinical and non-clinical interventions 15

16 How are needs-based instruments used Manchester COPD Services Study Collaboration with Manchester City Council, University of Manchester, Central Manchester NHS Trust, and Galen Research Proof-of-concept study to establish the patient value received from a range of services Breathe Easy Groups, choirs, transport, drug treatments, community COPD clinics, Physical Activity Referral Scheme, Buzz Manchester, Expert Patient Programme, Pulmonary Rehabilitation, Home Care, Home Adaptations. Expectation is to help the council provide services that matter to patients: Eliminate services that do not work, focus on those that do. 16

17 Future directions Patient Engagement Collaborating with SAP s health care team: Patient Engagement Platform to deliver digital health services to patient populations Sourced from clinical and non-clinical providers including patient advocacy groups Plan to use Galen s measures to help providers improve services and to better co-ordinate different offerings to patient groups Measuring multimorbid populations +25% of US population have two or more morbidities Galen s measures share the same theoretical basis and statistical model. Have shown that instruments can be co-calibrated to produce a single score of patient value across treatments and diseases. Next step is to develop a dynamic system of measurement based on computer adaptive test methods 17

18 Summary The needs-based approach to patient value measurement: Assess patient value rather than health status A statistically significant symptom improvement rarely translates into a significant patient improvement Can be used to identify combinations of interventions that optimize costs and maximize patient value Delay / avoid need for expensive drug treatments Provide proof of patient value resulting from non-clinical services such as education, counselling, exercise programs, etc. Strong consumer focus patient-centric outcomes rather than physician-centric outcomes 18

19 Questions?

20 Towards personalised packages of treatments Moving beyond personalized medicine to personalized treatment requires the use of a measurement instrument that can identify patient value from a wide-array of clinical and non-clinical interventions and lifestyle behaviors. Only the needs-based Quality of Life measures have the necessary properties to be able to detect change in patient value from such disparate health factors. Environmental Lifestyle Work environment adaptation Social care Work role adaptation Mediterranean diet Meat-free diet Nutritional supplements Coping training Occupational therapy Transport adaptation Mindfulness Smoking cessation Home environment adaptation Cognitive behavioral therapy Disease population Family care Technology aids Recreation/ pass times Team sports Medical devices Drug A Dosing regimen Competitive Cold sport therapy Acupuncture Surgery Hospitalization Telehealth Drug B Adherence support Rehabilitation program Drug C Tai Chi Yoga Home exercise program Delivery mechanism Alternative treatments Swimming Drug D Walking Gym program 60+ year-olds, moderate to severe Physician visits Clinical Exercise Working-age year-olds, severe Massage Gamification (e.g. Wii sports) Working-age year-olds, mild to moderate severity

21 Source: BBC, NHS Health Check: Five examples of innovation in the UK, 10 Feb