Specialty medicine: Pearls from the PBMI conference, Scottsdale, Arizona Dr. Elsa Badenhorst

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1 Specialty medicine: Pearls from the PBMI conference, Scottsdale, Arizona 2012 Dr. Elsa Badenhorst

2 The Magic Bullet Paul Ehrlich ( ) if a compound could be made that selectively targeted a diseasecausing organism, then a toxin for that organism could be delivered along with the agent of selectivity.

3 Specialty medicine Biologics: Monoclonal antibodies Recombinant cytokines Therapeutic fusion proteins Personalized Medicine

4 Personalized medicine Pharmacogenomics Study of inherited differences in drugs metabolism & response Genome-tailored drug selection and dosage Ensure maximum efficacy with minimal adverse events

5 Personalized medicine- efficacy of various drugs Class of drug % Refractory or Insufficient Response Selective Serotonin Reuptake Inhibitors (Depression) ACE Inhibitors (Hypertension, Proteinuria) Beta Blockers (Cardiac) Tricyclic Anti-Depressants (Depression) HMG-CoA Reductase Inhibitors (Statins) Beta 2-Agonists (Bronchodilators) 40-70

6 The need for specialty medicine Targets disease with unmet medical need rheumatoid arthritis, oral oncology, multiple sclerosis, hepatitis C, infused oncology, transplants, growth deficiency, blood cell deficiency, respiratory conditions, infertility, pulmonary hypertension) Potentially highly effective control of Sx slowing disease potential remission Often the only option for treatment

7 Challenges regarding specialty medicines Increased spending: High cost medicines, relatively small population Development pipeline Pharmacy vs. medicine benefit Many traditional management methods not effective

8 The specialty medicines pipeline Over 250 specialty medications have been approved by FDA Approvals for specialty drugs likely to outnumber small molecule drugs 633 specialty drugs in development for more than 100 diseases 254 for cancer 162 infectious disease 59 auto immune

9 Biologic pipeline Condition Launched in SA Upcoming Asthma Omalizumab COPD Hepatitis C Lupus Pegylated interferon alpha-2a (Pegasys TM ) Pegylated interferon alfa-2b (Pegintron A TM ) Alpha-1 Proteinase inhibit Telaprevir Boceprevir Belimumab Multiple sclerosis Copaxone TM Interferon beta-1b (Betaferon TM ) Interferon beta-1a (Avonex TM, Rebif TM ) Osteoporosis Teriparatide (Forteo TM ) Denosumab Fampiridine (oral) Fingolimod (oral) Laquinimod (oral) Teriflunomide (oral) Natalizumab (Tysabri TM ) Respiratory syncytial virus Palivizumab (Synagis TM ) Rheumatoid arthritis Adalimumab (Humira TM ) Infliximab (Revellex TM ) Etanercept (Enbrel TM ) Tocilizumab (Actemra TM ) Rituximab (MabThera TM ) Abatacept (Orencia TM ) Motavizumab Golimumab (Simponi TM )

10 Biologic pipeline- oncology Condition Launched in SA Upcoming Prostate cancer Lymphoma Alemtuzumab(Mabcampath TM ) Ibritumomab tiuxetan (Zevalin TM ), Interferon alfa-2a (Roferon-A TM ) Interferon alfa-2b (Intron A TM ) Melanoma Degarelix Sipuleucel-T (Provenge TM ) Cabazitaxel Abiraterone acetate Tositumomab Ipilimumab Vemurafenib Trabedersen

11 Specialty medicine spending Used by a small percentage of the population (1 to 5%)1 Spending has grown between 15 and 20% for the last several years Accounted for 21% of U.S. drug expenditures in 2009.

12 Global spending on biologics Spending in billion U.S. dollars Total global biologics spending in 2006, 2011 and 2016 (in billion U.S. dollars)* * Source: IMS Health, The Global Use of Medicines: Outlook Through 2016, page 9

13 Leading therapeutic classes 2015

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15 Management problems Many traditional management methods not effective Generic substitutes Creation of formularies Therapeutic substitutions Quantity restrictions Patient cost share through tiered copayments

16 PBM coverage of specialty medicine Pharmacy benefit Self-administered Medical benefit Infusions Differences in reimbursement rates, billing systems, cost share and utilization management approaches Example Humira TM (injectable) vs Revellex TM (infusion)

17 Specialty medicine management solutions More clinical and utilization management Benefit design

18 Clinical management Appropriate use based on disease severity and diagnosis Limit off-label use Ensure tried and failed first line therapy Preferred drugs when available in therapeutic class (growth hormone, multiple sclerosis, hepatitis) Coverage criteria National and international guidelines

19 Utilization management Prior authorization, step therapy, and quantity limits to ensure appropriate diagnosis and dosing of medication(s). Limit off label use (Oncology) Prevent inappropriate use based on national guidelines (respiratory syncytical virus, growth hormone) Require trial and failure of other agents first (rheumatoid arthritis, psoriasis and asthma) Future strategies focus on targeting based on laboratory values and genetic testing

20 Benefit design Include a specialty tier (usually a fourth tier) with fixed copayments coupled with minimum and maximum dollar amounts per script. Ensure specialty therapies remain affordable - impacts whether a patient refills the drug and persists with therapy.

21 Cost shifting Adherence to treatment multi-factorial costs, complex regiments, side effects Significant impact on outcomes and medical costs Increasing cost share may reduce funder drug costs - but will likely impact hospital/er costs and clinical outcomes Studies have found decrease in fill rate 4.6 more likely if out of pocket costs greater than $250 vs. less than $100

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23 Thank you! For further information contact: Dr. Elsa Badenhorst Mediscor PBM (Pty) Limited Reg. No 2005/012049/07 Mediscor House 1257 South Street Centurion 0157 PO Box 8796 Centurion 0046 South Africa Tel: Direct: Fax: Cell: Web-site: