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  • 1. What does ‘gold’ look like in MS management?
  • 2. What Does ‘Gold’ Look Like in MS Management? • Introduction • Gavin Giovannoni • Royal College of Physicians audit • Pam Macfarlane, MS Trust • New approaches in MS - turning change into opportunity • Bernie Porter, MS Consultant Nurse, UCLH • A ‘holistic’ approach to MS • Gavin Giovannoni, Consultant Neurologist, Barts Health • Panel discussion and questions
  • 3. Introduction
  • 4. CLINICAL SERVICE V AC P T R L UL U R E E EI C A S HN Q C A E UI S H A A EC L I R R IA S N C TL Y G H
  • 5. “All those who work on the frontline should be thinking carefully,and imaginatively, about how we can do things differently. TheQIPP process is a home for this in the NHS and the way that wecan implement the best and brightest ideas across the service.As the Prime Minister said: ‘Don’t hold back – be innovative, beradical, challenge the way things are done.” Andrew Lansley, Secretary of State for Health – 2 July 2010.
  • 6. “We need to fashion a vibrant, creative NHS that really fizzeswith ideas of how to improve quality and how to reducecosts........ So, instead of relying on ever more funds flowingfrom the Treasury, we must look to ourselves to make savings.This practical imperative is what QIPP is all about......... Wehave the resources, we have the knowledge and we have theability to give the people of this country a truly first class NHSand to deliver it within our means.” Earl Howe, Minister for QIPP - 2 July 2010
  • 7. Dr Janet WilliamsonNational Director, NHS Improvement
  • 8. A ‘holistic’ approach to MS Gavin Giovannoni
  • 9. www.ms-res.org
  • 10. Restless legs Swallowing Balance problems Bowel Falls Sexual dysfunction Tremor Palliative Care Prevention Gait DMTs Rehab Relapses Spasticity Counselling CNS Bladder Clinical trials OTPrimary Care Referral Diagnosis Minimal Moderate Severe End of impairment impairment impairment life care Neurophysiology Studying Pain ITB Radiology Fertility Fatigue Employment ST Depression Physio Insomnia Cognition Suprapubic catheter
  • 11. Who of you routinely measures bloodvitamin D levels in people with MS?
  • 12. Sustained-release oral fampridine in multiple sclerosis: a randomised, double-blind, controlled trial Goodman et al. Lancet 2009; 373: 732–38.
  • 13. Restless legs Swallowing Balance problems Bowel Falls Sexual dysfunction Tremor Palliative Care Prevention Gait DMTs Rehab Relapses Spasticity Counselling CNS Bladder Clinical trials OTPrimary Care Referral Diagnosis Minimal Moderate Severe End of impairment impairment impairment life care Neurophysiology Studying Pain ITB Radiology Fertility Fatigue Employment ST Depression Physio Insomnia Cognition Suprapubic catheter
  • 14. Bone Health
  • 15. Fracture risk in multiple sclerosis Dobson et al. Submitted 2012.
  • 16. Risk of fractures in patients with MS: record-linkage study Ramagopalan et al. Unpublished data 2012
  • 17. Osteoporosis in multiple sclerosis Dobson et al. Submitted 2012.
  • 18. Restless legs Swallowing Balance problems Bowel Falls Sexual dysfunction Tremor Palliative Care Prevention Gait DMTs Rehab Relapses Spasticity Counselling CNS Bladder Clinical trials OTPrimary Care Referral Diagnosis Minimal Moderate Severe End of impairment impairment impairment life care Neurophysiology Studying Pain ITB Radiology Fertility Fatigue Employment ST Depression Physio Insomnia Cognition Suprapubic catheter
  • 19. Who delegates MS bladder dysfunction to the continence team?
  • 20. Restless legs Swallowing Balance problems Bowel Falls Sexual dysfunction Tremor Palliative Care Prevention Gait DMTs Rehab Relapses Spasticity Counselling CNS Bladder Clinical trials OTPrimary Care Referral Diagnosis Minimal Moderate Severe End of impairment impairment impairment life care Neurophysiology Studying Pain ITB Radiology Fertility Fatigue Employment ST Depression Physio Insomnia Cognition Suprapubic catheter
  • 21. Preserving cognitive function for patients with overactive bladder Kay et al. Int J Clin Pract. 2008 Nov;62(11):1792-800.
  • 22. Systemic infections and inflammation affect chronic neurodegeneration Perry et al. Nat Rev Immunol. 2007 Feb;7(2):161-7.
  • 23. Do you agree that after making a diagnosis of MS the main role of the neurologist, in the management, of MS is to prescribe DMTs?
  • 24. Restless legs Swallowing Balance problems Bowel Falls Sexual dysfunction Tremor Palliative Care Prevention Gait DMTs Rehab Relapses Spasticity Counselling CNS Bladder Clinical trials OTPrimary Care Referral Diagnosis Minimal Moderate Severe End of impairment impairment impairment life care Neurophysiology Studying Pain ITB Radiology Fertility Fatigue Employment ST Depression Physio Insomnia Cognition Suprapubic catheter
  • 25. Theoretical model: treat early and aggressively Natural course of disease Later treatmentDisability Later intervention Treatment at diagnosis Intervention at diagnosis Time Disease Onset
  • 26. Who discusses mortality with their patients?
  • 27. Survival in MSers is shortened by 8 to 12 years Survival Probability of Norwegian Patients with RRMS (Hordaland County, Western Norway, 1953–2003) 100 General Population 90 RRMS 95% CI 80 70 Survival (%) 60 50 40 30 20 10 0 0 5 10 15 20 25 30 35 40 45 50 Years After Onset 30 35 40 45 50 55 60 65 70 75 80RRMS=relapsing-remitting MS. Approximate Patient AgeAdapted from Torkildsen NG et al. Mult Scler. 2008;14:1191-1198.
  • 28. The survival disadvantage in MS is greater than in other chronic diseases Standardized Mortality Ratios in Chronic Diseases Disease SMR (range) Cardiovascular disease1* 1.34 (1.23–1.44) Ischemic stroke2† 1.75(1.38–2.19) Early breast cancer3 2.0 (1.6–2.7) Crohn’s disease4 2.8 MS5 2.8 (2.6–3.1) MS (2–9.9 years after diagnosis)5 2.4 (1.9–2.9) MS (≥10 years after diagnosis)5 3.1 (2.8–3.4) Parkinson’s disease6 3.66 (3.37–3.95) Type 2 diabetes1 4.47 (3.91–5.10)*In patients with type 2 diabetes; †in patients with valvular heart disease in Olmsted County, Minnesota.1. De Marco R et al. Diabetes Care. 1999;22:756-761; 2. Petty DW et al. Mayo Clin Proc. 2005;80:1001-1008; 3. Hooning MJ et al. Int J Radiat OncolBiol Phys. 2006;64:1081-1091; 4. South East England Public Health Observatory, Mortality trends. 2006; 5. Sumelahti ML et al. Mult Scler.2010;16:1437-1442; 6. Hristova DR. Folia Medica. 2009;51:40-45.
  • 29. Population-based MS mortality studies Population Size First Author and Time Period of Cohort SMR Additional Survival Measures GryttenTorkildsen Western Norway 878 2.66 • Median survival time from onset: 41 years Mult Scler 2008 1953–2003 (95% CI: 2.31–3.06) MS vs 49 years general population – 8 years of life lost in MS Smestad Oslo 368 2.47 • Reduction of median life expectancy Mult Scler 2009 1940–1980 (95% CI: 2.09–2.90) vs general population – Female: 11.2 years – Male: 7.4 years Bronnum-Hansen Danish MS 9881 2.89 • Median survival time (from disease onset) Brain 2004 Registry (95% CI: 2.81 2.98) vs general population: 1949–1996 – ≈10 years of life lost in MS Hirst South Wales 373 2.79 • Median age of death: 63.1 years MS JNNP 2008 1985–2006 (95% CI: 2.44–3.18) vs 70.6 years general population – 7.5 years of life lost in MS Sumelahti Finland 1595 2.8 • Survival decreases with disease progression Mult Scler 2010 1964–1993 (95% CI: 2.6–3.1) – SMR, 2–9.9 years after diagnosis: 2.4 – SMR, ≥10 years after diagnosis: 3.1 Wallin USA 2489 2.18 • Healthy soldier effect speculated to have a Brain 2000 1956–1996 (not specified) favorable effect on survival Leray West France 1879 1.3 • Mean follow-up duration = 12.7 years from Mult Scler 2007 1976–2004 (95% CI: 1.01–1.7) clinical onset; may be basing estimate on relatively immature datasetMS=multiple sclerosis; SMR=standardized mortality ratio; CI=confidence interval.
  • 30. 21-year long-term follow-up of IFNb-1b study time from study randomization to deathEarly treatment (3 years) with IFNb-1b was associated with a 47% reduction in the risk of dying over 21 years compared with initial placebo treatment 100% Proportion of patients who are still alive 95% IFNB-1b 250 µg 90% Placebo 85% 80% 75% HR=0.532 (95% CI: 0.314–0.902) 70% 46.8% reduction in hazard ratio Log rank, P=0.0173 65% 0 2 4 6 8 10 12 14 16 18 20 22 At risk: Time (Years) IFNB-1b 250 µg 124 124 121 118 104 Placebo 123 120 117 109 88 Source: Poster Goodin et al AAN 2011
  • 31. Theoretical model: treat early and aggressively Natural course of disease Later treatmentDisability Later intervention Treatment at diagnosis Intervention at diagnosis Time Disease Onset
  • 32. Who likes doughnuts?
  • 33. The relapsing MS doughnutNatalizumab Highly active RRMS Fingolimod Suboptimal responders ? Active IFNb GA RRMS Inactive RRMS CIS RIS
  • 34. Who monitors prognostic factors of a treatment response to DMTs?
  • 35. Breakthrough disease after treatment initiation Patients with breakthrough disease can be identified with • Clinical measures – Relapses – EDSS progression • MRI measures – T2 and Gd+ lesions • Biological markers – IFNβ NAbs/lack of MxA gene induction – Natalizumab antibodiesGd+=gadolinium-enhancing; IFNβ=interferon beta; NAbs=neutralizing antibodies; Abs=antibodies; MxA= myxovirus protein A.
  • 36. Relapse on IFNβ therapy increases risk of sustained disability progression • Risk is not much greater for 2 relapses or more • Sensitivity is only 50% HR of EDSS Increase in Patients with No Relapses, 1 Relapse, and 2 or More Relapses During the First 2 Years of IFN Treatment HR SE P Value 95% CI No relapses (reference=1) 1 One relapse 3.41 1.47 0.005 1.46–7.98 Two or more relapses 4.37 1.74 0.000 1.90–9.57 1.00 No Relapses One Relapse Survival Probability Two or More Relapses EDSS Progression 0.75 0.50 0.25 0 0 20 40 60 80HR=hazard ratio; SE=standard error. Analysis Time (Months)Bosca et al. Mult Scler. 2008;14:636-639.
  • 37. MRI to monitor treatment response to IFNβ: a systematic review One New T2 Lesion Odds Ratio Study or Subgroup IV, Random, 95% CI Kinkel 2008 Pozzilli 2005 Prosperini 2009 Sormani 2011 Total (95% CI) 2.69 (0.72, 10.04) 0.01 0.1 1 10 100 Disease Less Likely Disease More Likely Two or More New T2 Lesions Odds Ratio Study or Subgroup IV, Random, 95% CI Kinkel 2008 Prosperini 2009 Total (95% CI) 9.86 (2.33, 41.70) 0.01 0.1 1 10 100 Favors Experimental Favors ControlDobson et al. Submitted 2012.
  • 38. MRI to monitor treatment response to IFNβ: a systematic review One New Gd+ Lesion Odds Ratio Study or Subgroup IV, Random, 95% CI Kinkel 2008 Pozzilli 2005 Tomassini 2006 Total (95% CI) 3.34 (1.36, 8.22) 0.01 0.1 1 10 100 Disease Less Likely Disease More Likely Two or More New Gd+ Lesions Odds Ratio Study or Subgroup IV, Random, 95% CI Kinkel 2008 Rio 2008 Total (95% CI) 5.46 (2.48, 12.04) 0.01 0.1 1 10 100 Disease Less Likely Disease More LikelyDobson et al. Submitted 2012.
  • 39. Strongest predictor of disability progression on IFNβ therapy is progression itself Disease Activity During 2 Years of Treatment and Prediction of Disability Progression* at 6 Years Sensitivity (%) Specificity (%) Group (CI) (CI) A. An increase of at least one EDSS step confirmed at 6 months 85 (64–95) 93 (86–97) B. Occurrence of any relapse 80 (58–92) 51 (41–61) C. Occurrence of two or more relapses 45 (26–66) 81 (72–82) D. A decrease in relapse rate less than 30% compared with 2 years 40 (22–61) 86 (77–91) before therapy E. A decrease in relapse rate less than 50% compared with 2 years 40 (–61) 81 (72–88) before therapy F. No decrease or identical relapse rate compared with 2 years 35 (18–57) 88 (79–93) before therapy G. Definition A or B 90 (70–97) 48 (38–58) H. Definition A or E 85 (64–95) 76 (66–83) I. Definition A and B 75 (53–89) 97 (91–99) J. Definition A and E 40 (22–61) 99 (94–99)*EDSS score ≥6.0 or increase in at least 3 EDSS steps.Río J et al. Ann Neurol. 2006;59:344-352.
  • 40. Metrics for DMTs• What proportion of your patients are on a DMT? – 1st line vs. escalation? – What proportion of your patient have NABs?• What proportion of your patients have failed a first line DMT?• What proportion of your patients are in a clinical trial?• Etc.
  • 41. Who discusses employment with their patients?
  • 42. Unemployment Probability of Remaining in Active Employment After Onset of MS Control Persons 1.0 MS Patients 0.8 Probability 0.6 0.4 0.2 0 0 5 10 15 20 25 Time (years)Pfleger et al. Mult Scler. 2010;16:121-126.
  • 43. Who discusses relationships with their patients?
  • 44. Divorce and separation Crude probability of remaining in a relationship after onset of MS* 1.0 Population Controls MSers 0.8 0.6 Probability 0.4 0.2 0 0 5 10 15 20 25 Time to Event or End of Observation (years)*Life table method.Pfleger et al. Mult Scler. 2010; 16:121-126.
  • 45. Who discusses QoL with their patients?
  • 46. The effect of MS on Quality of Life 1† EDSS and Utility* Show a Significant Inverse Relationship • MS is one of the most common 0.9 0.8 causes of neurological disability 0.7 0.6 in young adults2 0.5 0.4 • Natural history studies indicateUtilityUtility 0.3 0.2 that it takes a median time of 8, 0.1 0 20, and 30 years to reach the –0.1 irreversible disability levels of –0.2 –0.3 EDSS scores 4.0, 6.0, and 7.0, –0.4 respectively3 0.0 1.0 2.0 3.0 4.0 5.0 6.0 6.5 7.0 8.0 9.0 EDSS Status*Utility measures are derived from EQ-5D using the EuroQoL instrument; †error bars depict 95% CIs. Half points on EDSSare not shown on graph axis, except at EDSS score 6.5.EDSS=Expanded Disability Status Scale; EQ-5D=European Quality of Life-5 Dimensions; QoL=quality of life.1. Adapted from Orme M et al. Value In Health. 2007;10:54-60; 2. WHO and MS International Foundation (MSIF).http://apps.who.int/bookorders/anglais/detart1.jsp?sesslan=1&codlan=1 &codcol=15&codcch=747. Accessed March 6, 2012;3. Confavreaux C et al. Brain 2003; 176:770-782. 4. Compston A, Coles A. Lancet. 2008;372:1502-1517.
  • 47. Treatment Strategy
  • 48. Theoretical model: treat early and aggressively Natural course of disease Later treatmentDisability Later intervention Treatment at diagnosis Intervention at diagnosis Time Disease Onset
  • 49. Impact of MS: cognitive functioning in the CIS stage Cognitive Test Performance in an Exploratory Study 60 Patients Failing ≥2 Cognitive Tests Deficits were found mainly in memory, speed of information processing, attention and executive functioning 40 57% 20 P<0.0001 7% 0 CIS Patients (n=40) Healthy Controls (n=30)CIS=clinically isolated syndrome.Feuillet L et al. Mult Scler. 2007;13:124-127.
  • 50. What is benign MS? • 163 patients with “benign” MS (disease duration >15 years and EDSS score <3.5) – 45% cognitive impairment – 49% fatigue – 54% depressionAmato MP et al. J Neurol. 2006;253:1054-1059.
  • 51. Healthcare costs are linked to disability Informal Care Inpatient Care (Disposable Income) (10.2%) (9.2%) Ambulatory Care (5.6%) Disease-Modifying Drugs (10.6%) Services (28.5%) Other RX & OTC Drugs (1.6%) Tests (0.4%) Investments (2.0%) Short-Term Absence (2.0%) Long-Term Sick Leave and Early Retirement (30.0%) Total mean annual cost per patient €53,601Rx=prescription drugs; OTC=over-the-counter.Berg J et al. Eur J Health Econ. 2006;7(suppl 2):S75-S85.
  • 52. Conclusion• Equity and excellence: Liberating the NHS – patients will be at the heart of everything we do • choice and control • easy access to the information they need about the best GPs and hospitals • patients will be in charge of making decisions about their care – a relentless focus on clinical outcomes • Success will be measured, not through bureaucratic process targets, but against results that really matter to patients – such as improving …… survival rates – we will empower health professionals