A New Standard Of Providing Subjects Unblinded Medication And Supplies

Transcription

1 A New Standard Of Providing Subjects Unblinded Medication And Supplies Tom Heck May 2017

2 Introduction Tom Heck President RxSolutions, Inc. 24 years in Pharmaceuticals Integral or in leadership at six specialty pharmaceutical companies that have all exited successfully since Expertise in all commercial functions of US based pharmaceuticals Provided leadership in twelve clinical programs at various companies 2

3 Market Research Study Findings October 2016 Current Challenges and Difficulties with the Traditional Clinical Supply Chain Processes

4 Traditional Methods of Unblinded Clinical Supply Management Reimbursement Model Reimbursement to sites or subjects for unblinded materials Bulk Purchase Model Bulk purchase and management of physical inventory 4

5 Clinical Supply Professionals - Respondents Other 19% Sponsor 62% CRO 19% N = 137

6 What are the Most Time Consuming Steps in the Clinical Supply Process? Sourcing 9.1 Labeling Packaging Forecasting Purchasing Inventory Management Shipping 5.8 Storing 5.3 Reconciliation 4.8 Reclamation And Destruction 3.8

7 How Does Your Company Provide Unblinded Supplies? Bulk Purchase Local Sourcing Reimbursement Pharmacy Card

8 # of People Involved in the Supply Process? % % % 11% Research showed that our upper bound needs expanding Process includes sourcing, procurement, packaging, labeling, storing, inventory management, shipping, reconciliation, reclamation and destruction

9 How Many Steps are Involved in Your Supply Process? % % % Verbatim s reflect 16 or more steps in the bulk supply process 3-5 5%

10 When There are Production Issues, What is the Typical Delay? 1 Month 54% 2-3 Months 38% 3+ Months 8%

11 Typical Average Time To Get Supplies to Sites? 3-5 Weeks 47% 2-3 Months 21% 3-5 Months 16% 5+ Months 16%

12 If You Did Not Have to Manage the Entire Supply Process, How Much Time Could You Save Individually? 50+ Hours 53% Hours 26% Hours Hours 11% 11% Data was reflective of only the respondents time. Did not reflect total time for all

13 Can you Avoid Temperature Excursion Issues if Supplies are Dispensed by Pharmacies? No 15% Yes 85%

14 Do you Feel the Overall Clinical Supply Process has Room for Improvement? No 25% Yes 75%

15 A Paradigm Shift in the Clinical Supply Process for Unblinded Medicines and Supplies The Pharmacy Card

16 Traditional Bulk Supply vs. Pharmacy Card BULK PURCHASE PROCESS Source & Procure Ship to depots Labeling / Packaging Manage depot inventory Pick, pack, & ship to sites Inventory management at site Site dispenses supplies to patients Reconcile, return and destroy supplies NEW CLINICAL STUDY PHARMACY CARD SYSTEM Determine Protocol Formulary Forecast real world utilization via PBM Program cards with approved formulary Distribute Cards to Sites / Monitor & Manage Utilization 16

17 Traditional Reimbursement Model SUBJECT ACTIONS SITE ACTIONS Site Reimburses Subject Purchase At Pharmacy

18 The Evolution of Paradigm Change Rationale for New Solutions Sponsors, CROs & Sites desire less inventory management Need to find additional Administrative / Financial savings Efficiencies in procurement, distribution and management will allow for more time for other important study issues Growth in Pharmacy adjudication 18

19 The Pharmacy Card Un-Blinded Study Medicine, Devices and Supplies Dispensed To Subjects Through Pharmacies

20 What does it look like? 4 sided bi-fold card Front: Identifies the protocol by name & provides the pharmacy with numbers necessary for processing Back: Directions for Subject Inside: Program information and business rules for pharmacy Numbers on the Pharmacy Card ensure Study Protocol and Formulary

21 Pharmacy Card Each Study Has Unique Group # Each Card Has Unique Cardholder ID # All Card Activity Monitored for Each Subject Consistently Throughout Study 21

22 Business Rules CLINICAL STUDY PHARMACY CARD ENSURES Program business rules (Protocol & use of card) Flexibility Card works like an insurance card at any pharmacy Approved Study Investigators Approved Study Formulary Increased Safety in distribution * Approved medicine and supplies only 22

23 Who, What & Where WHICH STUDIES CAN BENEFIT? ANY PHASE STUDY REQUIRING UN-BLINDED MEDICINE, SUPPLIES OR MEDICAL DEVICES WHAT STUDY NEEDS CAN BE MET? Any use of un-blinded medicine such as Standard of Care Comparator Rescue Medications Adjunctive Any supply with a NDC# ANY PHARMACY ALL 66,000 CHAINS, RETAIL, INDEPENDENTS & SPECIALTY UNITED STATES, CANADA & PUERTO RICO 23

24 Pharmacy Card Process Distribute Pharmacy Cards to sites Study site gives subject pharmacy card along with their prescription Subject takes prescription and pharmacy card to pharmacy for medicine and supplies Vendor reimburses pharmacy 24

25 Start-Up Efficiencies FAST, 30-DAY PROGRAM DEVELOPMENT AND LAUNCH TIMELINE MORE ACCURATE FORECASTING FOR CLINICAL SUPPLIES ELIMINATE COMMON HASSLES RELATED TO SOURCING PRODUCTS 25

26 EFFICIENCIES Pharmacy Cards: Benefits & Management FLEXIBILITY Easy modification of your study needs as protocol changes over time DECREASED WASTE No Temperature excursions Reduced reclamation and destruction at the end of the study MANAGEMENT & REPORTING PORTALS Budget reconciliation Enables easy management of administrative functions Online Portal captures & reports customized information 26

27 EFFICIENCIES Patient Benefit ENHANCED SAFETY REGARDING RX DISPENSING EASE OF USE, LIKE AN INSURANCE CARD CUSTOMIZED PATIENT COMPLIANCE PROGRAMS MAY BE ATTACHED TO CARD 27

28 ELIMINATES: Benefits of a Pharmacy Card For Unblinded Clinical Supplies SOURCING & PROCURING clinical supplies LABELING multiple products PICK, PACK & SHIP of supplies MANAGING INVENTORY at multiple locations month after month DISPENSING to subjects WASTED TIME AND MONEY in excess supply, destruction, errors, etc. 28

29 Data Captured With Use Of Card Prescription Information Investigator Information Pharmacy Information Subject Information ACCOUNTABILITY COMPLIANCE 29

30 Data Captured With Use Of Card Prescription Information Date Written & Filled NDC and Name of Product Quantity & Days Supply Cost Cardholder ID # Investigator Information Prescriber Number Name Address (street, city, state, zip) 30

31 Data Captured With Use Of Card Subject Information Gender Age Pharmacy Information NABP Number Name Address (street, city, state, zip) 31

32 Real World Applications Any phase study requiring un-blinded supplies Large formularies Fast study start or start-up in the middle of study Ancillary Supplies (ex s. Diabetes, Asthma) Rescue medications Hard to procure medicines like biologics Studies with Infusion / Injection (Ex. Oncology) Scheduled Medications dispensed at pharmacies 32

33 Thank You and Stop by Our Booth! Tom Heck President RxSolutions, Inc. Office: