Multiple Sclerosis (MS) Aprile Royal, Novartis Pharma Canada Inc. September 21, 2011 Toronto, ON

Transcription

1 Multiple Sclerosis (MS) Aprile Royal, Novartis Pharma Canada Inc. September 21, 2011 Toronto, ON First-line DMTs Reduce Relapse Frequency by ~30% vs. Placebo Frequency of relapse with various DMTs, based on previous clinical trials Relapses per patient per year ~30% reduction with DMTs vs. placebo Betaseron Avonex Copaxone Placebo DMT All DMT placebo comparisons were statistically significant (p<0.002) 1. IFNB Neurology 1993;43(4):655 61; 2. Jacobs LD et al. Ann Neurol 1996;39(3):285 94; 3. Johnson KP et al. Neurology 1995;45(7):

2 AGENDA Multiple Sclerosis (MS) Impact of MS on the individual Current Treatments & Unmet Need MS is the Most Common Non-traumatic Cause of Neurological Disability in Young Adults MS is a chronic autoimmune inflammatory disease of the central nervous system (CNS) associated with progression of disability Causes of MS are unknown but are thought to involve a combination of genetic, environmental and autoimmune factors MS has an unpredictable and potentially devastating impact on those affected MS affects people in the prime of life, with a typical age of onset between 20 and 40 Canada has one of the highest prevalence of MS in the world, measured at 240 per 100,000 1 An estimated 55,000 75,000 Canadians have MS 2 3 new MS cases diagnosed every day (1,000 new cases/yr) 2 1. Beck CA et al. Mult Scler MS Society of Canada:

3 The Most Common Form of MS Is Relapsing Remitting Form (RRMS-85%) Demyelination, inflammation, neuronal damage Remyelination, resolution of inflammation, neuronal repair (complete or incomplete) RRMS Disease Severity Relapse Several days to several weeks in duration Remission Disability Time Time Hauser SL, Goodin DS. Harrison s Principles of Internal Medicine. 17th ed. New York, NY: McGraw-Hill; 2008: The Extent of Disability Ultimately Depends on the Balance Between Damage and Repair in the CNS Inflammatory attacks (relapse) Lymphocytes invade CNS and damage/destroy nerve cells Stimulates Balance of damage & repair determines accumulation of damage leading to progression Nerve damage Progressive disability Myelination Normal physiological process for nerve cell repair Protects Time is variable for progressive disability to become apparent Compston A et al. Lancet 2002;359(9313):

4 Expanded Disability Status Score (EDSS) is Used to Measure Clinical Disability Years Since Dx Walking Ability 10.0 Death due to MS Completely dependent Confined to bed/chair, limited help Confined to a Wheelchair or bed Confined to wheelchair Walks with aid (<500 m) Walking assistance is needed Increasing limitation in ability to walk Disability is moderate Walks with Assistance (22 yards or more) Walks unaided ( yards or more) Walks unaided ( yards or more) Disability is mild to moderate Disability is minimal No disability Fully ambulatory 0 Normal neurologic exam Dx = diagnosis; MS = multiple sclerosis Kurtzke JF. Neurology 1983;33: Economic Burden of MS

5 MS has Considerable Economic Impact on Patients and Employers Annual cost to Canadian private drug plans is $198.6M (2009) 1 Costs increase with EDSS scores. At all EDSS levels, inability to work was the main cost driver. EDSS Score Unable to work due to MS 16% 52% 74% Costs Work Time Losses $6,341 $15,995 $24,513 Unpaid Caregiver Time $1,701 $4,554 $3,704 *Less than 5% were on Disease modifying therpay (DMT) at time of study 1,PharmaStat, IMS-Brogan Inc., 2 Grima DT et al. Mult Scler. 2000;6: Relapses and Relapse Severity is also Associated with Employer Cost Relapses lead to productivity loss due to the impact on patients and caregivers 1 Low cost Low intensity Primary care consultation Symptomatic treatment Follow-up consultation Moderate intensity Out-patient/emergency room visit Day case/home administration of IV methylprednisolone Symptomatic treatment Follow-up consultation Therapist visits (speech, occupational therapy) High intensity Primary care consultation or emergency room visit In-patient care (accommodation, staff, relapse and symptomatic treatments) Post-discharge skilled nursing care Home health care Rehabilitation High cost Follow-up consultation 1. O'Brien JA et al. BMC Health Serv Res 2003;3(1):17 ( in 2010 dollars)

6 Current Treatments and Unmet Medical Need Current Treatments Symptomatic therapy and corticosteroids as needed Injectable Oral Infusion Avonex /Rebif (IFN-β1a) Conventional DMTs Copaxone (GA) Betaseron /Extavia * (IFN-β1b) Annual Drug Cost per Patient $15,725 $21,840 GILENYA * (fingolimod) Annual Drug Cost per Patient $31,000 Tysabri (natalizumab) Annual Drug Cost per Patient $38,818 IFN=interferon; GA=glatiramer acetate; DMT=Disease-Modifying Treatments Source: Drug Benefit Prices (DBPs) for products reimbursed under the EAP, accessed online July 15, 2011

7 Current DMTs Have Issues With Side Effects This is associated with higher risk of relapses and poor outcomes SE Up to 60% of people experience flu like symptoms 1 >80% of patients experience injection site reactions (redness, local induration and pain) 1 Injection anxiety was found to be a barrier to long-term adherence to therapy 2 Handling Avonex, Copaxone, Tysabri need be refrigerated 3. Special handling is required 3. Adherence At 4 months 74% of patients were persistent; At 14 months 57% of patients were persistant 4 Adherent patients tended to have a lower risk of relapses, ER visits and hospitalizations 5 SE = Side-Effects After one month needs to be refrigerated 1. Moses H, et al. Curr Med Res Opin. 2008;24: ; 2. Turner AP, et al. Rehabil Psychol. 2009;54:116-21; 3. Morrow TJ. J Neurol Sci ;256 Suppl:S39-44; 4. Lafata JE, et al. J Am Pharm Assoc. 2008;48: ; 5. Steinberg SC, et al. Clin Drug Investig. 2010;30(2): Novartis Patient Support Program for MS Vision Simple and Seamless for patients and health care practitioners Facilitates treatment with medication for patients with MS across Canada Collaboartion with MS clinics, MS neurologists and nurses Novartis is raising the bar on patient support