Specialty Pharmacy in Community Pharmacy: The Time Is Now and How! Genesis Pharma Consultants and Bio Launch Strategies

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1 Specialty Pharmacy in Community Pharmacy: The Time Is Now and How!

2 Dean Erhardt MBA Mr. Erhardt offers nearly 20 years of strategic marketing and management Analysis and development of pharmaceutical support programs Pharmaceutical and consumer product distribution Specialty pharmaceutical product management. Mr. Erhardt has demonstrated expertise in sales and marketing leadership, business development and the negotiations and structuring of complex multimillion dollar contracts. His leadership has lead high performance teams to achieve outstanding growth experience in startup to Fortune 500 environments. Mr. Erhardt's sales and marketing leadership enabled a division of a fortune 200 company to grow from 6 employees to more than 500 and more than $1.5 billion in specialty program products dispensed annually. In a separate endeavor, Mr. Erhardt led the sales effort that increased revenues of a national specialty pharmacy by over 270% in less than one year. Express Scripts Cardinal Health US Healthcare BA in Marketing from the University of Oklahoma MBA from the Keller Graduate School of Management. 2

3 Dan Steiber R.Ph Principal, Genesis Pharma Consultants INC (S-Corp) General Manager Integrated Commercialization Solutions, Executive Vice President ABSG Full Profit and Loss responsibility for 200+ associate organization focused on pharmaceutical third party logistics and nurse-based case management for over 40 specialty pharma manufacturers. Vice President, Product Development Branded Rx - AmerisourceBergen Corporation Oversaw all supplier relationships and trade/business development functions for branded pharmaceutical category in excess of $35BB in purchases for Fortune 25 Company with all customer segments including retail, health systems, mail-order, specialty pharmacy and long-term care. Vice President, Retail Marketing Bergen Brunswig Lead BBDC s portfolio of retail initiatives with over 60 associates in chain of command and 8 budget centers with payroll in excess of $5MM/year. Directed clinical program development and managed care efforts. Pharmaceutical Marketing/Director of Clinical Programs, Longs Drug Stores/IHC Responsible for Corporate Pharmacy Advertising, Marketing, and Continuing Education. Negotiated contracts with pharmaceutical manufacturers for inclusion on 300,000 live HMO Formulary in addition to other managed care services. Pharmacy Manager Gemco-Lucky Stores Pharmaceutical Sales Representative Eli Lilly EDUCATION AND LICENSES Washington State University, College of Pharmacy Pullman, Washington Licensed Pharmacist in Washington, Pennsylvania, Texas and California States 3

4 Goal of Presentation This session's goal is to provide an understanding of the current biotechnology marketplace and pipeline, its impact on community pharmacy, and how community pharmacy can prepare itself to be a major provider of specialty pharmaceuticals and biotechnology drugs. 4

5 Overview Definition of biotech and specialty products Biotech Market and Relationship to Specialty Specialty Pharmacy Overview How does community pharmacy get involved 5

6 What Is Biotechnology? Break biotechnology into its root words and you have bio the use of biological processes; and technology to solve problems or make useful products. From Bio.Org 6

7 Definition of Specialty Pharmaceuticals Specialty pharmaceuticals are defined as high-cost injectables, infused, oral or inhaled drugs generally requiring close supervision and monitoring of the patient s drug therapy. 7

8 Why Specialty Pharmaceuticals are Different Frequent dosage adjustments Dosage administration of injectables and infusables (Nursing care) More severe side effects than traditional drugs Special storage, handling and/or administration Narrow therapeutic range Complex Reimbursement Support Periodic laboratory or diagnostic testing Higher costs than traditional products ($10,000-$100,000 annually) Target small numbers of patients (5, ,000) Patient registration Patient training and Clinical call center Compliance management Clinical data reporting and analysis 8 Source: SPN Oct, 2005

9 Retail Relevance: See a mix challenge $ Billions 500 US Pharmaceutical Market Est CAGR 6.9% 400 Specialty 13% CAGR 36% 12.9% CAGR 300 Oncology 13% CAGR 22% Generics 14% CAGR % 85% Direct 40% Specialty 40% Traditional 20% Specialty 60% Traditional 40% 78% Wholesale 60% Direct 40% Wholesale 85% Direct 15% Branded Pharmaceuticals 3% CAGR 64% 4.6% CAGR Source: IMS/UBS Estimates Projected, Retail Generic Bubble Analysis

10 Quickly Changing Market Dynamics 10

11 Products in Development 06 11

12 Products in Development 06 12

13 Products in Development 07 13

14 Products in Development 08 14

15 Routes of Administration 15

16 Disease States and Practice Sites Specialty Product Purchases by Provider Channel (including Oncology) Retail, 15% Home Infusion, 7% Physician, 28% Traditional SPP, 23% PBM/SPP, 27% 16 Source: SPN Oct 2005

17 Projected Spend for Specialty Drugs, 2004 vs $300 $200 $100 $0 $155 $73 $ $210 Specialty Rx Spend Traditional Rx Spend IMS

18 18 Future issues 1. Bio-pharmaceuticals and emerging targeted therapies will increasingly require customized supply chains 2. Traditional full service, broad distribution is not well suited for products with complex handling requirements or very limited end points 3. Payer relationships will become a significant success driver for everyone involved in specialty pharmacy care. 4. As branded pharma becomes increasingly reliant on Specialty and Biotech their relationship with providers will change significantly Retail and mail are at risk in becoming less important to branded manufacturers Manufacturers will increasingly focus their sales efforts on specialty providers 3

19 So the Time is NOW How? Steps to Implementation 19

20 Characteristics of Specialty Products Frequent dosage adjustments More severe side effects than traditional drugs Special storage, handling and/or administration Narrow therapeutic range Periodic laboratory or diagnostic testing Higher costs than traditional products 20

21 21 Specialty High level of patient training and enlightenment regarding usage and proper handling High and continued patient interactions beyond the initial dispensing process Drug therapy may result in a higher frequency of side effects and are potentially more severe Dosage administration, side effects, storage condition and other factors may require altering daily patterns Patient non-compliance has potential for significant impact on expected improvements from therapy and can increase related costs. Rigorous patient education is required often provided by nursing or pharmacist staff together with monitoring to assure optimal outcomes Traditional Little patient training and enlightenment regarding usage and proper handling other than traditional counseling. Generally a one time patient counseling session on first fill and availability to respond to questions as needed Potential drug therapy side effects are less frequent and not as potentially debilitating Drug therapy generally does not require alteration to patients daily patterns Lack of patient compliance may have modest impact and likely be a progressive rather than immediate negative process. Patient compliance education is generally limited to counseling and labeling of the product.

22 Key Success Factors for Community Pharmacy The opportunity to be reimbursed using pharmacy adjudication. Aggregated contracting. Capturing of key revenue streams. Location, location, location. The opportunity to get reimbursed for ancillary support services. 22

23 Why Time is Now for Community Pharmacy in Specialty Focus on professional services and patient services Having a local relationship with patient and physician community Key relationships with the manufacturer for purchasing power Reporting capability by capturing data currently lost within medical benefit Potential tie in of financial management services 23

24 Step One Develop a Marketing Plan: Questions What are the marketing opportunities/objectives of entering into specialty? What customers/patients want from our specialty service? Who will benefit from our specialty service? What do we want to accomplish through specialty marketing efforts? How will the service be perceived by the marketplace? How do we compete with the existing players? SWOT Analysis 24

25 Step Two Pick the Model That Works Distribution Option Description of Services Low Cost, Complexity, Channel Conflict High 1. Direct to Physician Basic Specialty Pharmacy Limited Specialty Pharmacy plus Specialty Retail Network Broad Specialty Pharmacy plus Specialty Retail Network Plus Infusion Services Required Reimbursement and Patient Registry capabilities to compete for basic specialty distribution deals. Required Specialty Pharmacy services to provide direct-to-patient distribution in support of retail, mail order and managed care business. Required administrative services and PBM marketing capabilities required to create a network offering for retail chain. Position to compete aggressively for specialty pharmacy business in addition to enabling retail network. Most comprehensive offering including full service SPRx and extension to infusion services = Reimbursement Support 2 = Patient Registry 4 = Limited Specialty Pharmacy 5 = Broad Specialty Pharmacy 7 = Infusion Services 25 3 = Clinical Services 6 = Retail Network Hub 12

26 Step Three Picking the Right Products Category US Market ($MM) Est. Growth Delivery Method Cancer $1,800 20% IV infusion, SC injection Crohn's % IV infusion Gaucher s % Injection Growth Hormone 350 5% Injection, SC Injection Hemophilia 2,000 10% Injection Hepatitis 2,000 30% SC and IM Injection, Oral Hereditary Emphysema 1,025 NA IV Infusion HIV 3,500 10% Oral Immune Disorders 1,200 30% IV Infusion Infertility % Injection Multiple Sclerosis 3,000 15% IM Injection Pulmonary Hypertension % IV infusion, SC injection RSV % IM Injection Rheumatoid Arthritis 3,000 20% IV infusion, SC injection Transplant 2,100 NA NA Total $22,925 19% 26

27 Step Four Provide Disease State Management Use treatment guidelines Therapeutic interchange Formulary management Coordination of physician and support providers Patient education and support Outcomes measurements Routine reporting and feedback Self-administration oversight Clinical assessment Patient monitoring Side-effect management Drug utilization evaluation and poly-pharmacy review Care coordination with other healthcare providers Psychosocial support Community resources 27

28 Step Five Provider Dynamics The Payer ultimately determines how and where the specialty patient will be managed Manufacturers influence is very high when they have a novel therapy The ability to demonstrate the delivery of a superior outcome at low cost is the providers best leverage Vertical integration by the PBM s has created a new threat and opportunities for other providers A fragmented, healthy market will provide the best opportunities for Retail Large centralized specialty pharmacy providers will purchase high volume items direct and will need minimal services Community Pharmacy currently enjoys a significant portion of the specialty pharmaceutical volume Strong in less complex disease states in specific local markets 28

29 Step Six Creating Manufacturer Value Specialty distribution Specialty pharmacy Reimbursement assistance Hotline Assistance Patient Registry Programs Patient Assistance programs 29

30 Step Seven &.. The Essentials: Details to Leading to Success Staffing Do you have sufficient and adequately trained personnel including pharmacists? Store Design Does your footprint support an in store offering and do you have sufficient capital for remodels? Home Health Care Services Information Technology and Data Services Sales Strategy MCO, MD Financial Strategy and Analysis Clinical Programs Reimbursement Services 30

31 Parting Thoughts Community Pharmacy Challenges v. Opportunities Vertically integrated PBM s and payers inhouse Specialty Pharmacies will dominate Margins may significantly compress as large players compete for the small number of patients Winners will focus on capabilities and services that deliver superior outcomes at low cost to patients Significant long term risk in the market as specialty pharmacy is ultimately all about the number of patients being serviced Profitable growth will depend upon winning new products & services 31

32 Parting Thoughts Community Pharmacy Challenges v. Opportunities Reimbursement shifts (ASP/AMP) negatively impact pharmacy services Entering the right segments and excellent reimbursement capabilities are essential Regulators and payers will not support the projected growth rates long term. Will 2-3% of the population drive 30-50% of the drug spend. Long term top line risk If growth is artificially constrained profitability could be severely impacted Long-term growth will be contingent upon cost effectiveness of new therapies 32

33 Parting Thoughts Community Pharmacy Challenges v. Opportunities Community pharmacy s most profitable customers are at risk of being locked out of the highest growth segment The narrow specialty supply chain will invite new entrants (UPS, FedEx, etc) A major near and long term risk for the retail independent and regional chain segments Moving the game from pure logistics to logistics with clinical services, quality and efficiency will reduce the opportunity for new entrants 33

34 Parting Thoughts Community Pharmacy Challenges v. Opportunities Community Pharmacy is too late to the market to become a major provider Recent consolidation by the PBM s has created an opportunity for new models in specialty Strategic opportunity to create new models that are difficult for existing players to adopt 34

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