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Soaring Specialty Drug Prices: Status & Solutions Mark Hiatt, MD, MBA, MS Executive Medical Director Regence BlueCross BlueShield of Utah Soaring specialty drug prices: status & solutions Prices of pharmaceutical drugs have been soaring. What is the status of this hyperinflation, & what are possible solutions to moderate the rise? What can you expect, & what can you do about this problem? 2 Soaring specialty drug prices 3 What is a specialty drug? No universally accepted definition Historically: expensive, injectable drugs to treat orphan conditions The specialty drug landscape is changing more difficult to define 4 Specialty drug characteristics Common qualities of specialty drugs: Treat specific, mainly chronic, & High-touch patient-management often rare conditions required Prescribed by a specialist Patients require financial assistance Injectable drug Requires special storage/handling Limited distribution (only available from certain pharmacies) 5 Expensive! Common specialty disease states Hepatitis C Multiple sclerosis Chronic inflammatory diseases (e.g., rheumatoid arthritis, ulcerative colitis, psoriasis) Oncology HIV Hemophilia Primary immunodeficiency 6 7 Social factors affecting health Image source: www.bestmasterofscienceinnursing.com 7 America’s disadvantage Image source: www.bestmasterofscienceinnursing.com 8 8 Healthcare costs: the opportunity 9 9 Healthcare costs 10 10 Average state health plan employee premiums (2013) 11 Specialty drug spend Fastest growing component of healthcare costs Source: JPMorgan 12 Specialty drug spend Managing specialty drugs is critical 50% of the drug pipeline comprises specialty products 10x the average cost of a traditional branded prescription drug Express Scripts; IMS 2014 13 Specialty drug costs are soaring 14 Price inflation: drugs outpacing general inflation 15 Mergers and acquisitions Monthly costs of drugs after an acquisition Drug 2 Drug 1 $7,000.00 $45,000.00 $40,000.00 $35,000.00 $30,000.00 $25,000.00 $20,000.00 $15,000.00 $10,000.00 $5,000.00 $0.00 $6,000.00 $5,000.00 $4,000.00 $3,000.00 $2,000.00 $0.00 5/1/2012 7/1/2012 9/1/2012 11/1/2012 1/1/2013 3/1/2013 5/1/2013 7/1/2013 9/1/2013 11/1/2013 1/1/2014 3/1/2014 5/1/2014 7/1/2014 9/1/2014 11/1/2014 1/1/2015 3/1/2015 5/1/2015 7/1/2015 7/1/2015 2/1/2015 9/1/2014 4/1/2014 11/1/2013 6/1/2013 1/1/2013 8/1/2012 3/1/2012 5/1/2011 10/1/2011 12/1/2010 7/1/2010 2/1/2010 9/1/2009 4/1/2009 6/1/2008 11/1/2008 $1,000.00 Drug 3 $30,000.00 $25,000.00 $20,000.00 = date of acquisition $15,000.00 $10,000.00 $5,000.00 $0.00 16 New drug technologies drive increases as well 17 Revolutionizing Hepatitis C treatment Nov/Dec 2013: Olysio and Sovaldi approved Dec 2014: Viekira Pak approved Total Cost Oct 2014: Harvoni approved 18 Medical benefit drugs: more difficult to manage 19 Upcoming specialty drug budget busters Source: Walgreens 20 Specialty drug management Challenges to managing specialty drugs Double-digit growth in specialty spend Lack of outcomes data for specialty drugs Managing across medical & pharmacy benefits Manufacturer copay coupons A variety of methods are required to manage specialty drug costs 22 Specialty drug management strategies Formulary/UM Contracting • Formulary status • Prior authorization/ reauthorization • Step therapy • Quantity limits • Provider reimbursement • Manufacturer rebates Clinical Case Management Benefit Design • Care management via specialty pharmacy • Health plan case management • Cycle management program/split fill program • Tiered copayments/costshares • Specialty pharmacies 23 Formulary management Be vigilant about managing drugs – make sure the right patients are receiving the right treatment All new drugs (traditional & specialty) evaluated by Pharmacy & Therapeutics (P&T) committee – Determines which drugs are included/excluded on the preferred drug list using the best available evidence – Goal: provide members with medications that present the best treatment value in terms of efficacy, safety & cost – Foundation of clinical management strategy 24 Utilization management Steers patients to preferred, cost-effective products; reduces inappropriate utilization Prior Authorization • Defines the appropriate population for treatment • Appropriate dose or length of therapy • Step therapy • Monitor efficacy and/or safety through re-authorization Step Therapy • Ensures use of generics or other 1st-line alternatives Quantity limits, dose optimization 25 Drug pipeline update: specialty drugs for a common condition PCSK9-inhbitors 1st specialty drugs approved for high cholesterol in high-risk patients Category Proprotein convertase subtilism/kexin type 9 (PCSK9) inhibitors Products Approval Dates #1) PRALUENT 07/24/2015 • Evidence shows that they lower LDL (bad cholesterol) 08/27/2015 • No evidence showing they improve important outcomes (death, heart attacks) (alir ocumab) #2) REPATHA (evolocumab) 26 Notes Proactively managing the specialty drug pipeline Medication Name Therapeutic Use Kanuma Lysosomal Acid Lipase Deficiency Keytruda Lung Cancer Repatha Hypercholesterolemia Nucala Asthma Drisapersen Duchenne Muscular Dystrophy Cinquil Asthma Eteplirsen Duchenne Muscular Dystrophy Rociletnib Lung Cancer Strensiq Hypophosphatasia = strategy under consideration Supply Limit Step Therapy PA Genetic Testing Not being considered Not being considered Not being considered Not being considered = strategy strongly considered 27 Not being considered Biosimilars Source: Express Scripts Challenges: Legal issues (patent dance) Pricing 28 Physician acceptance Substitutability Biosimilars Encourage adoption of biosimilars when evidence shows they are interchangeable with branded drugs Regence will evaluate the evidence of all FDA-approved biosimilars Formulary status & utilization management will take into account evidence of similarity to the branded product & product cost 29 Benefit design Support an integrated approach to benefit design & reimbursement across pharmacy & medical benefits Tiered cost-share, copayments Limiting to a 30-day supply Management of medical benefit drugs • Clinical management • Site-of-care management • Reduction of administrative waste Regence’s integrated PBM services are administered by OmedaRx 30 Medical + pharmacy benefits = valuable programs 31 Source: Express Scripts accessed at: http://lab.express-scripts.com/insights/specialty-medications/9-billion-wasted-on-nonpharmacy-specialty-medications Using specialty pharmacies Advantages Lower drug costs Improved patient outcomes through care management More data on utilization & outcomes Management across benefits Walgreens Specialty Select program Access Medical vs. pharmacy benefit Drug cost Practical considerations 32 Care management Educate members about coverage options & support services, like those offered by specialty pharmacies Adherence is an issue for all chronic medications Larger problem with specialty drugs due to administration & drug costs A comprehensive approach to patient care is required to optimize drug therapy – many types of services offered by specialty pharmacies Adherence should be monitored closely to improve patient outcomes & reduce waste 33 Examples of care management programs 34 Source: Walgreens Specialty Pharmacy Care management Hepatitis C medication adherence Managed by a specialty 35 pharmacy Not managed by a specialty pharmacy Source: Walgreens Specialty Pharmacy What else can you do? Integrate high-quality case management, step therapy & prior authorization to help manage cost & outcomes Use knowledgeable service providers who understand your market trends, patient population & challenges Share clinical resources with employees to improve personal health accountability & engagement http://www.specialtyrxtoolkit.com/ 36 Soaring Specialty Drug Prices: Status & Solutions Mark Hiatt, MD, MBA, MS Executive Medical Director Regence BlueCross BlueShield of Utah