The Effect of Current Managed Care Trends on Patient Access in 3 Specialty Classes MS, Hepatitis C & Pulmonary Arterial Hypertension

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1 The Effect of Current Managed Care Trends on Patient Access in 3 Specialty Classes MS, Hepatitis C & Pulmonary Arterial Hypertension

2 DISCLAIMER The information within this CME/CE activity is for continuing education purposes only, and is not intended to substitute for the medical judgment of the healthcare provider. Recommendations for use of any particular therapeutic agents or methods are based upon the best available scientific evidence and clinical guidelines. Reference in this activity to any specific commercial products, process, service, manufacturer, or company does not constitute its endorsement or recommendation.

3 Faculty Biography Jayne Hornung, RPh VP, Pharmacy and Medical Data MMIT

4 DISCLAIMER: DISCLOSURES: The information within this CME/CE activity is for continuing education purposes only, and is not intended to substitute for the medical judgment of the healthcare provider. Recommendations for use of any particular therapeutic agents or methods are based upon the best available scientific evidence and clinical guidelines. Reference in this activity to any specific commercial products, process, service, manufacturer, or company does not constitute its endorsement or recommendation. I do not intend to discuss an off-label use of a product during this activity. I have not had any relevant financial relations during the past 12 months to disclose OR I currently have or have had the following relevant financial relations to disclose: If you have relevant relations to disclose, please list Commercial Interest Relationship with Commercial Interest Type of Compensation Received

5 OBJECTIVES 1. Identify current trends in managed care utilization management for 3 specialty classes MS, Hepatitis C & PAH 2. Discuss the prevalence of diverse utilization management techniques at a national, regional & local level 3. Discuss how current pipeline and future product releases will affect the competitive landscape in the MS, Hepatitis C & PAH classes

6 Multiple Sclerosis

7 Epidemiology Approximately 2.3 million individuals worldwide have MS, which includes more than 400,000 in the United States. 2 In addition, an estimated 200 persons are diagnosed with MS each week in the United States, which translates to roughly 1 diagnosis of MS every hour. 2 7

8 Multiple Sclerosis Treatments Route Drug Year Approved Injectable Pros/Cons Betaseron (Interferon b-1b) Avonex (Interferon b-1a) Copaxone (Glatiramer acetate) Pros: -More than 2 decades on market -Long term data available -Known safety Rebif (Interferon b-1a) 1998 and efficacy profiles Extavia (Interferon b-1b) 2009 Cons: -Needles -Injection site reactions -Post injection reactions Oral Gilenya (Fingolimod) Aubagio (Teriflunomide) Pros: -Route -Good efficacy Tecfidera (Dimethyl fumarate) Well tolerated Cons: -No long term data -Adherence

9 Multiple Sclerosis Restriction Analysis

10 Multiple Sclerosis Restriction Analysis (cont.) 4/3/

11 Moving Forward Several agents with neuroprotective activity have been shown to be protective in animal models and the challenge now is to translate promising pre-clinical candidates into meaningful designed trials in humans. In order to achieve such a goal, the development of more predictive models on CNS damage, new biomarkers and clinical tools (e.g. computational classifiers) for assessing the neuroprotective effects in patients with MS is required. Anti-inflammatory agents will continue to represent a major focus for MS therapy, however, combination therapy, with neuroprotective agents, is starting to show great potential in minimizing disability in MS. 11

12 Hepatitis C 12

13 Epidemiology Worldwide, an estimated million people have HCV infection. HCV prevalence is highest in Egypt at >10% of the general population and China has the most people with HCV (29.8 million).. Estimated 150 million people are chronically infected with hepatitis C virus, and more than people die every year from hepatitis C-related liver diseases 13

14 Hepatitis C Treatment -Alpha Interferon Therapy -Ribavirin -NS3/4A Protease Inhibitors -NS5B RNA Polymerase Inhibitor 14

15 Hepatitis C Restriction Analysis- Interferons

16 Hepatitis C Restriction Analysis - Ribavirin Products 4/3/

17 Hepatitis C Restriction Analysis - Protease Inhibitors 4/3/

18 Sovaldi 4/3/

19 Moving Forward All oral therapy for genotype 1 Gilead already evaluating Sovaldi and ledipasvir Eliminating need for ribavirin and pegylated interferon Vaccine for HCV HCV turnover rate Error prone polymerase

20 Pulmonary Arterial Hypertension 20

21 Epidemiology Pulmonary arterial hypertension (PAH) is a rare disease, with an estimated prevalence of cases per million, 1 the prevalence of PAH in certain at-risk groups is substantially higher. For example, in HIV-infected patients the prevalence is 0.5%, 2 in patients with systemic sclerosis it has been reported to be 7-12%, 3,4 and in patients with sickle cell disease the prevalence is around %. 5,6 Idiopathic PAH (IPAH) has an annual incidence of 1-2 cases per million people in the US and Europe and is 2-4 times as common in women as in men. 7,8 21

22 Epidemiology (cont.) PAH associated with the newborn is known as persistent pulmonary hypertension of the newborn (PPHN) and arises when the normal decrease in pulmonary vascular tone does not occur after birth. Due to the non-specific nature of the symptoms, PAH is unfortunately most frequently diagnosed when patients have reached an advanced stage of disease (WHO Functional Class III and IV) 4/3/

23 PAH Treatments Endothelial Receptor Agonists (ERAs) - Letairis, Tracleer, Opsumit Phosphodiesterase Inhibitors (PDE 5) - Revatio, Adcirca Prostacyclins - Ventavis-inhaled, Tyvaso-injection, Orenitram-oral Intravenous Vasodialator - Remodulin, Flolan, Veletri Soluble Guanylate Cyclase Inhibitor - Adempas 23

24 PAH Restriction Analysis

25 PAH Restriction Analysis (cont.) 4/3/

26 PAH Restriction Analysis (cont.) 4/3/

27 Moving Forward Elafin-Proteo, Inc. in preclinical trials

28 Conclusions 28

29 References Simplified diagram of the structure of Hepatitis C virus. March WHO Hepatitis C fact sheet. March Hepatitis C testing recommendations. March Patent Landscape - Pegylated Interferons. I-MAK (2013): Patent Landscape Report for Pegylated Interferon Alfa-2A & 2B. February Infectious Diseases in Clinical Practice: November Volume 11 - Issue 8 - pp Incivek and Victrelis AWP. MaxorPlus Clinical Newsletter. June Olysio AWP. Accessed March Bartlett, John G. Johns Hopkins ABX Guide: Diagnosis and Treatment of Infectious Diseases. Burlington, MA: Jones and Bartlett Learning, Print. Clinical SVR rates are reported from ADVANCE, SPRINT-2, ADVANCE-1, and NEUTRINO. 4/3/

30 This program has been brought to you by The National Association of Specialty Pharmacy and its education provider The Specialty Pharma Education Center. *All users must complete the post test to receive statement of credit. Credit must be claimed within 30 days of this program. 30