Uof L Hospital Specialty Pharmacy Providing therapies and

Uof. L Hospital Specialty Pharmacy Providing therapies and services to make managing your condition easier so you can focus on what really matters. Live better. Stay healthy.

Improving Medication Access for Patients with Hepatitis C Through Specialty Pharmacy Services in an Academic Medical Center Lynne Michelle Woosley, Pharm. D. Pharmacy Operations Manager Uof. L Hospital Specialty Pharmacy

Presentation Outline • Define “Specialty Pharmacy” and “Specialty Medication” • Outline the ULH Specialty Pharmacy Service Model • Describe the role of the Specialty Pharmacist and Medication Access Coordinator • Demonstrate ULH Specialty Pharmacy’s effect on medication access and patient care

What is Specialty Pharmacy?

The Specialty Pharmacy The Three Cs of Specialty Pharmacy: Cost Complexity Compliance

Defining “Specialty Pharmacy” Key Characteristics of a Specialty Pharmacy: • High complexity--Treat complex, chronic and/or rare conditions • High cost--Often exceeding $10, 000 with some costing more than $100, 000 annually • High “touch”--Special storage, handling, and/or administration requirements • Patient-Centric Clinical Support--Ongoing monitoring for safety, efficacy and adherence https: //www. pharmacist. com/specialty-pharmacy-unique-and-growing-industry

Specialty Pharmacy Overview There is no universal specialty medication definition. • CMS definition - greater than $600/script • Most are over $2, 000 per fill • Accreditation definition - usually require specialty handling, administration, unique inventory management, a high level of patient monitoring, and more intense support than conventional therapies • The same drug may or may not be considered a specialty drug by insurer, drug manufacturer, pharmacy, hospital, etc. • Specialty pharmaceuticals are the fastest growing segment of drug spend

Specialty Pharmacy Overview Typical Characteristics of Specialty Medications • Expensive • Small patient population (<2% of total population) • Includes all routes of administration • Many require close supervision, monitoring, and handling requirements (temperature controlled)

Growth of Specialty Pharmacy Spending in Billions (USD) $401, 70 109% At least 50% Percentage of new medications considered specialty Almost 40 New specialty medications approved or label expanded in 2016 $192, 20 $87, 10 121% Greater than 700 Specialty medications in development 2012 2016 2020 PWC Health Research Institute. Medical Cost Trend: Behind the Numbers 2016 Diplomat Clinical Services. Specialty Drug Approvals, 2016 Highlights & 2017 Projections PWC Health Research Institute. Medical Cost Trend: Behind the Numbers 2015

Specialty Drug Spend by Disease State PMPY Spend Inflammatory Diseases Oncology Multiple Sclerosis HIV Hepatitis C $- Express Scripts: 2017 Drug Trend Report. 2017 $ 20 $ 40 $ 60 $ 80 $ in Millions $ 100 $ 120 $ 140

Specialty Drugs: Costly Hepatitis C Treatment Costs Ø While fewer than 4% of people use specialty Ø Harvoni® treatment costs an drugs, those medications average of $113, 430 for a 12 compromise nearly a third week course. of drug spending, and that is expected to rise to at least 50% by 2020. Ø Epclusa treatment costs an average of $89, 742 for a 12 -week course Ø An 8 -week course of Mavyret costs as average of $31, 699. 98 which is approximately $528/dose

“If you’re in the kitchen and one of these new specialty drugs rolls under the refrigerator, you’ll throw out your fridge, because the pill costs more. ” Mike Thompson, President and CEO, National Alliance of Healthcare Purchaser Coalitions

ULH Specialty Pharmacy Service Model • Academic Medical Center – PGY 1 Residency Program, 13 residents – PGY 2 Residency Program, 2 Ambulatory Care residents • Integrated service model with Hepatitis C Clinic – Hepatitis C Clinic opened in November 2017 as a hospitalowned Specialty Clinic • • • Nurse Practitioner-lead clinic Specialty Pharmacists Pharmacy Students and Ambulatory Residents Medication Access Coordinator Medical Technician Administrative Support Staff

ULH Specialty Pharmacy Service Model • Specialty Pharmacists and Medication Access Coordinators (MAC) function as an extension of the ULH Outpatient Retail Pharmacy • ULH Outpatient Retail Pharmacy provides the dispensing function for the ULH Specialty Pharmacy • ULH Specialty Pharmacy team provides all patient education, conducts follow-up calls and oversees delivery of the medication

ULH Specialty Pharmacy Service Model Specialty Pharmacist Clinical Functions Medication Reconciliation • Accurate medication list • Screen for common drug interactions: statins, PPIs, ethinyl estradiol, protease inhibitors Immunizations • Immunization history • Provide immunizations during clinic visit Medication Education • Provide face-to-face counseling and education materials • Adherence assessment and counseling • Conduct 7 day follow-up calls

Common Drug Interactions Hep C Meds Drug Class Statins Interaction Increased Statin Levels Managed Switch to lowest equivalent dose of Rosuvastatin or Pravastatin (Except in Voseviavoid Rosuvastatin) PPIs May result in decreased levels Low doses of PPis, separate of HCV meds doses out if indicated clinically HIV Protease Inhibitors (with Duplicate therapies (2 Use non PI containing HCV Mavyret, Zepatier, Vosevi) protease inhibitors) Increased Drug or discuss change in HIV ALT levels therapy if appropriate Ethinyl Estradiol (Mavyret Increased ALT Levels D/C Ethinyl Estradiol during only) duration of therapy OR Use alternate DAA

ULH Specialty Pharmacy Service Model • Medication Access Coordinator Role Script is written • Prior authorization is started Authorization received • Contact made with patient • Co-pay/foundation assistance requested Financial Determination • Communicated with patient • Delivery set-up

Foundation and Co-Pay Assistance Foundation Patient Access Network (PAN) Healthwell Foundation Patient Advocate Foundation Qualifications • Proof of income • Proof of residence • Household income limit 500% of Federal poverty level • Minimum copay $5. 00 • • • Co-Pay Assistance Cards • • Proof of income Proof of residence Household income limit 400% of Federal poverty level Support Provided Maximum $7, 200 per patient Maximum $30, 000 per patient Maximum $24, 000 per patient Commercial plans only Depends on manufacturer Excludes Medicare & Medicaid Renewed annually

ULH Specialty Pharmacy Effect on Access to Medications • After initial PA request, regardless of payer or insurance coverage, 100% of patients receive initial access to medication • Demonstrates extraordinary level of medication access • Surpasses recent data reported by a large pharmacy network showing a non-start rate of 45% in patients • Average turn-around time from date script written to patient start-date is 3 days Younossi ZM, Bacon, Br, Dietrerich, DT, et al. Disparate access to treatment regimens in chronic Hepatitis C patients: data from the TRIO network. J Viral Hepat. 2016; 23(6): 447 -54. Crossref, Medline, Google Scholar

ULH Specialty Pharmacy Effect on Patient-Centric Care • Specialty pharmacists integrated into the Hepatitis C Clinic have a positive effect on patient care • Follow-up calls provide the necessary support for patients to maintain treatment • See improved patient adherence and medication effectiveness • High therapy completion rate ~95%

Conclusion • The integrated ULH Specialty Pharmacy Service Model in the Hepatitis C Clinic helps patient obtain their medication as simple and stress-free as possible • By partnering with the patient, provider and pharmacist, we can demonstrate superior outcomes for our patients • We will continue to ensure affordable medication costs, quick access for patients and work together to screen and treat patients with Hepatitis C in Kentucky

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