1. PCSK9 Inhibitors and Cardiovascular Outcomes Trials

2. Background

3. FOURIER Trial Design

4. FOURIER LDL-C Reduction

5. FOURIER: Results

6. FOURIER: Lower CV Event Rates With Lower LDL-C Levels, as Low as 20 mg/dL (~0.5 mmol/L)

7. Proportional Reductions in Risks of MVEs
Proportional Reductions in Risks of MVEs* per mmol/L Reduction in LDL-C During Each Year of Scheduled Statin Treatment

8. The SPIRE-2 Cardiovascular Outcomes Trial: Baseline LDL-C ≥ 100 mg/dL Primary Prespecified Endpoint*

9. ODYSSEY OUTCOMES: Study Design

10. ODYSSEY OUTCOMES and FOURIER Demographics: Patient Histories

11. ODYSSEY OUTCOMES and FOURIER Demographics: LLTs and Lipids

12. ODYSSEY OUTCOMES and FOURIER: Primary Endpoints

13. PCSK9 CVOTs: Key Scientific Points

14. Barriers in Access to CVD Therapies: PCSK9 Inhibitors

15. The Initiative in 2016: Unraveling the Therapeutic Conundrum

16. The Initiative in 2017: Advancing the Conversation for PCSK9 Inhibitor Access Barriers

17. Clinical Cardiology Consensus Paper: Open Access

18. Barriers in Identifying the Patient: Prescribing Indication

19. PCSK9 Prior Authorization Form

20. PCSK9 Appeal Process Letter

21. Why the Faulty Process?

22. Unharmonized Lipid Guidelines

23. 2013 ACC/AHA Guidelines

24. 2016 ESC/EAS Guidelines for the Management of Dyslipidemias

25. 2017 AACE Guidelines for the Management of Dyslipidemia

26. Unharmonized and Complex PCSK9 Inhibitor Statements

27. 2017 Focused Update of the 2016 ACC Expert Consensus Decision Pathway: Nonstatin Therapies for ASCVD

28. Access to PCSK9 Inhibitors: Characteristics of Patients

29. FH Foundation’s Findings: Access to Nonstatin LLTs in Patients at High-Risk of ASCVD or With ASCVD

30. Access Barrier Through Prior Authorization and High Co-Pays

31. Drug Valuation Models: Key Points

32. Drug Valuation Models: Key Points (cont)

33. Why Such Differences in Model Outputs
Why Such Differences in Model Outputs? Inputs Determine Outputs and Inputs Are Subjective

34. Important Caveat

35. These Access Issues Are Not Unique to the PCSK9 Inhibitors

36. Pragmatic Tools to Gain PCSK9 mAb Access for Appropriate Patients

37. Abbreviations

38. Abbreviations (cont)

39. Abbreviations (cont)

40. Abbreviations (cont)