Specialty Pharmacy SPRx

Transcription

1 Specialty Pharmacy SPRx In Less Than 60 Minutes Presented by Robert Gruszynski, R.Ph Pharmacist in Charge of Specialty Pharmacy Geneva Woods Pharmacy

2 Objectives Define Specialty Pharmacy Identify disease states covered Discuss key drivers of future specialty spend Questions and discussion

3 Define Specialty Pharmacy SPRx Specialty pharmaceuticals are generally defined as products used to treat chronic, high-cost, or rare diseases and can be injectable, infusible, oral, or inhaled medications. Specialty pharmaceuticals tend to be more complex to maintain, administer, and monitor than traditional drugs; therefore they require closer supervision and monitoring of a patient s overall therapy. Key characteristics are as follows: 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 ($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

4 Often, specialty pharmaceuticals can be broken down into four distinct categories and are commonly defined and/or classified by the method of administration: Office-administered injectable products Self-administered injectable products Clinic/office administered infusible products Select oral agents

5 Specialty pharmaceuticals have at least 4 of the following characteristics (CPPA) Typically high in cost ($600 or more per month) Involve complex treatment regimens that require ongoing clinical monitoring and patient education Have special handling, storage or delivery requirements Are generally biologically derived and available in injectable, infusible or oral form Are dispensed to treat individuals with chronic and/or rare diseases Frequently have limited or exclusive product availability and distribution Treat therapeutic categories such as oncology, autoimmune/immune, or inflammatory conditions marked by long-term or severe symptoms, side effects, or increased fatality

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7 Disease States Covered omultiple Sclerosis- Lemtrada oinflammatory Conditions-UC, RA, Crohn s, psoriasis, arthritis - Entyvio, Remicade ohepatitis B, C Viread, Harvoni orare Diseases- NORD --7,000 diseases rare in the U.S. oig Therapy - Hyqvia SQ ohiv - multiple ooncology - multiple o Hypercholesterolemia -PCSK9 proprotein convertase subtilisin kexin 9 - Praluent

8 Disease States cont. ocystic Fibrosis - Kalydeco oasthma & Allergy - Xolair ogrowth hormone deficiency - Genotropin otransplant - Simulect, Zenapax omale Infertility Phase III trials? orespiratory syncytial virus - Synagis ohemophilia - Eloctate

9 Trends that effect future spends Age Drug approval rates

10 Age Trends Average life expectancy has increased by 10 years to 80 years since years years 2010 People over the age of 60 consume pharmaceuticals (Rx and OTC) at 2.7x the rate of people under the age of x 2.7x < 60 YO 60+ YO

11 There will be fewer people aged per person aged 65+; fewer people to fund healthcare for those 65+ 7: : :

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14 New patient Populations: Key Takeaways Patient population growing in size and complexity Aligning services with patient expectations will be key -not just for supply chain partners, but for all healthcare stakeholders

15 Drug Approval Trends FDA approvals have increased in recent years: 45 novel new drug approvals in biologics ( as of 12/30/15) 41 novel new drug approvals in biologics 25 novel new drug approvals per year on average from Of the 54 new drug and biologic approvals in 2015: Approximately half are considered specialty pharmacy products Many new drugs are received special FDA designations, such as breakthrough, fast track, orphan, accelerated approval, and priority review, on their way to approval Disease states with the greatest number of approvals in 2015 Rare diseases (25) Oncology (13)

16 Specialty drugs among most common FDA approvals in 2015 The FDA approved 54 new drugs last year, including more than half that were considered specialty therapies, 25 for rare diseases and 13 for cancer, according to a report from Diplomat Specialty Pharmacy that also anticipates a high volume of specialty drug approvals in 2016.

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18 "Piece of the Pie" Specialty medications account for about 33% of annual spending on drugs in the United States, up from 19% in 2004 and heading toward 50% in the next 10 years, according to IMS health. With this boom has come a corresponding boom in specialty pharmacy, which is estimated to have grown from $20 billion in sales in 2005 to $78 billion in WOONSOCKET, R.I. Specialty drug spend is expected to more than quadruple by 2020, reaching approximately $402 billion a year, according to a new CVS Caremark report released today. (Drug Store News, November 20, 2013)

19 Future Challenges and Opportunities Novel products get the attention - but patients need to remain the priority. What is the patients' best interest? "patient centric" As costs and sites of care change, engagement across stakeholders is crucial to positive clinical outcomes. Growing patient populations with expectations driven by a consumer mindset will require new approaches to achieve optimal, cost-effective results.

20 Seven $1 billion-plus drugs seen reaching market in 2016 (Reuters 2/3/2015) Drug companies are likely to launch seven "blockbuster" drugs in 2016, each with $1 billion-plus annual sales potential, led by new treatments for liver disease and HIV, according to a Thomson Reuters analysis. The assessment means the pharmaceuticals industry is on track for another productive year, although not as good as 2015, which saw the arrival of 11 new blockbusters. The two top hits of 2016 are tipped to be Intercept Pharmaceuticals' (ICPT.O) chronic liver disease drug obeticholic acid, with a consensus sales forecast of $2.6 billion in 2020, and Gilead Sciences' (GILD.O) new fixed dose HIV drug emtricitabine plus tenofovir alafenamide, on $2.0 billion. Other products expected to launch this year with forecast sales above $1 billion in 2020 include a new hepatitis C drug from Merck (MRK.N) and a leukemia medicine from AbbVie (ABBV.N), according to the annual "Drugs to Watch" report. Two keenly awaited Roche (ROG.VX) drugs, each with forecast sales of around $3 billion, are not on list because it is unclear if atezolizumab for cancer and ocrelizumab for multiple sclerosis will be commercially available this year or next

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22 Adherence Tools Mobile device reminder Videos, Skype, Facetime: Patients 2X more likely to be adherent after receiving video consultation Briova omedset boxes

23 Clinical Therapy Management Modules odata capture and submission to Pharma/biotech manufacturers, health plans, prescribers and other industry partners oprior authorization oclinical outcome management oco-pay and patient assistance programs oaccess to REMS (risk evaluation mitigation strategies) programs, limited distribution channels.

24 Cold Chain Technology Adherence tools

25 Accreditation tools

26 Profitability

27 Mergers and Acquisitions (M&A) Major M&A occuring daily on a global level

28 Shire announces $32B deal to acquire Baxalta Shire will purchase Baxalta in a cash-and-stock deal worth $32 billion, the companies announced Monday. The acquisition, expected to be completed in the middle of this year, will form the largest rare disease treatment developer in the world, the firms say. Baxalta shareholders could receive $45.57 per share and will own a 34% stake in the combined company.

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30 Job Satisfaction, Fulfillment and Friendships HCV 97% cure

31 Objectives Defined Specialty Pharmacy Identified disease states covered Discussed key drivers of future specialty spend

32 Questions and Discussion

33 THE REASON WE DO WHAT WE DO!

34 THANK YOU