Introduction: This research explores the reimbursement and utilization landscape for acute coronary syndrome (ACS) drugs and the impact of accountable care organizations (ACOs) on payers’ and cardiologists’ decision-making. ACOs are provider organizations that manage the full continuum of care and take accountability for the total costs and quality of care for a defined patient population. ACS is a condition whose treatment can benefit from the integrated, patient-centered, evidence-based care practiced within ACOs and for which the goal of cost-effective treatment can influence prescribing.

Questions Answered in This Report:

  • Generic clopidogrel dominates antiplatelet treatment of ACS, but Brilinta’s superior clinical profile has helped it gain patient share despite its higher price and greater restrictions. How is prescribing different for ACS in the ACO environment? How do cardiologists regard the various agents? How do MCO restrictions affect utilization?
  • Two relatively new PCSK9 inhibitors—Repatha and Praluent—will probably have their labels expanded to secondary prevention of ACS. What is their use currently in this indication? How are MCOs likely to cover these drugs for this indication? Which of them is likely to have an advantage?
  • ACOs are expected to take on more risk in terms of the medical and pharmacy costs of their patients. What formularies do ACO physicians commonly use for ACS patients? When do MCOs expect to require ACOs to take on risk? How many ACOs have their own dedicated formularies?

Scope:

  • Markets covered: United States.
  • Methodology: Surveys of 100 cardiologists and 30 managed care organization (MCO) officials, including 14 pharmacy directors and 16 medical directors, in January 2017.
  • Indication coverage: Acute coronary syndrome (ACS).
  • Key Drugs covered: Brilinta, clopidogrel, Effient, Plavix, Praluent, Repatha, Vascepa, Zontivity.
  • Key companies mentioned:  Amgen, AstraZeneca, Eli Lilly, Merck, Sanofi.

Table of contents

  • Acute Coronary Syndrome - Access & Reimbursement - Detailed, Expanded Analysis (US)
    • Key Updates
      • August 2017
      • April 2017
    • Market Access Overview
      • Overview of Market Access in Acute Cardiovascular Syndrome
    • Actionable Recommendations to Optimize Market Access
      • Successes and Stumbles
        • Overview of Successes & Stumbles for ACS
        • Successes Among ACS Therapies in the United States: Physicians
        • Stumbles Among ACS Therapies in the United States: Physicians
        • Cardiologists' Performance Rankings of ACS Drugs by Nonclinical Attributes
        • Cardiologists' Ranking of Performance of Specific ACS Drugs on Clinical Attributes
        • Successes Among ACS Therapies in the United States: MCOs
        • Stumbles Among ACS Therapies in the United States: MCOs
      • Key Stakeholders in the Road to Market Access
        • Influences on Cardiologists' Prescribing Decisions
        • U.S. Stakeholder Dynamics in the Road to Reimbursement
        • Healthcare Coverage in the United States
        • Healthcare Coverage in the United States
        • Major Commercial Insurers in the United States
        • 2017 DRG Data on ACOs
      • Key Market Access Roadblocks
        • Reimbursement Dynamics
          • United States: Commercial Managed Care Organizations
            • Lessons Learned and Key Takeaways
            • Formulary Tier Status of Antiplatelet Drugs for ACS
            • Anticipated Formulary Tiering of Antiplatelet Drugs for ACS
            • Pricing and Reimbursement Drivers
            • Key Findings - P&R
            • Value Assessment and Pharmacoeconomics
            • Most Important Clinical Factors in Reimbursement of Antiplatelet Drugs for ACS
            • Most Important Nonclinical Factors in Reimbursement of Antiplatelet Drugs for ACS
            • Most Important Factor in Reimbursement of Antiplatelet Drugs for ACS
            • Explanation of Pharmacoeconomic Models
            • Cost-Effectiveness Assessment of Emerging ACS Therapies in Commercial Plans, ACOs
            • Cost-Sharing for Key Therapies Treating ACS
            • Copay and Coinsurance Rates for Therapies Treating ACS
            • Restrictions Affecting Treatment of ACS
            • Restrictions Used in Commercial Plans
            • Step-Therapy Paths for Specific ACS Drugs
            • ACOs' Impact on Reimbursement of ACS Drugs
            • ACOs' Responsibility for Prescription Drug Costs
            • ACOs' Blend of Physician Incentives for Meeting ACO Goals
            • Most Important Cardiology-Related Metrics in an ACO Setting
        • Pricing and Reimbursement, Policy, and Coverage: Impact on Prescribing
          • Patient Share in Key Payer Channel
            • Key Findings
            • Percentage Receiving Specific Drug Therapies for ACS
            • Patient Share of ADP Receptor Antagonists in the Treatment of ACS
            • Patient Share of Repatha and Praluent Within the PCSK9 Class
            • Treatment Decision Drivers
            • Factors Influencing Prescriber Choices in Antiplatelet and Lipid-Modifying Therapies for ACS
          • Prescriber Preference
            • Prescriber Preferences for Antiplatelet Therapies in ACS
            • Effect of Removing Coverage Restrictions on Prescribing of Antiplatelet Therapies in ACS
          • Impact of Restrictions on Prescribing
            • Impact of Payer Policy on Prescribing: Key Findings
            • Prescribing Restrictions on Specific ACS Drugs, Ranked by Impact
            • Prescribing Restrictions on PCSK9 Inhibitors, Ranked by Impact
            • Most Influential Payer Restrictions on Antiplatelet Therapies, as Reported by Physicians Encountering Restrictions
            • Most Influential Payer Restrictions on PCSK9 Inhibitors, as Reported by Physicians Encountering Restrictions
          • ACO Impacts
            • Impact of ACOs on the Reimbursement of ACS Drugs
            • ACO Tracking of Individual Physician Performance Indicators
            • Effect of ACO Participation on Prescribing of Specific ACS Agents
            • ACOs' Encouragement/Discouragement of Prescribing Specific ACS Agents
        • Market Access Landscape for Emerging Therapies
          • Impact of Emerging Therapies on Prescribing
            • Likely Impact of Emerging Therapies for Acute Coronary Syndrome
            • Anticipated Market Access Roadblocks for Repatha, Praluent in ACS
            • Anticipated Prescribing in 2019 for ACO and Non-ACO Patients with ACS
            • Anticipated Prescribing of ADP Receptor Antagonists for ACO and Non-ACO Patients with ACS
            • Anticipated 2019 Patient Share for Repatha, Praluent
          • Potential Placement of Emerging Therapies at Various Prices
            • Potential Reimbursement of Emerging Therapies for ACS
            • Anticipated Tier Placement for Vascepa If Approved for Secondary Prevention of ACS
            • Coverage of Vascepa in an ACO Setting vs. a Non-ACO Setting
            • Effect of PCSK9 Approval for ACS Treatment on Reimbursement of Repatha, Praluent
            • Effect of Pricing on the Tiering of Anacetrapib Relative to Zetia
          • Prescriber and MCO Priorities for Emerging Therapy Evaluation
            • Key Findings
            • Top Five Attributes for the Development of Emerging ACS Drugs: Cardiologists
            • Top Five Attributes for the Development of Emerging Drugs for the Secondary Prevention of ACS: MCOs
        • Methodology
          • Primary Market Research Methodology: Physicians
            • Practice Settings of Surveyed Cardiologists
            • Cardiology Specialty
            • Years in Cardiology Practice Postresidency
            • Number of ACS Patients Under Management
            • Treatment Settings of ACS Patients
            • Current and Future ACO Participation
            • ACO Inclusion of ACS Patients in Acute and Posthospital Settings
            • ACS Patients by Type of Coverage
            • ACO-Contracted Payers by Type
            • Anticipated ACO-Contracted Payers by Type
            • Regional Demographics
            • Northeast Region Demographics
          • Primary Market Research Methodology: MCOs
            • Survey Sample: Percentage of MCO Medical Directors vs. Pharmacy Directors
            • MCO Plan Types
            • ACO Contracting by Payer Type
            • MCO Territory Size
            • MCO Membership
            • MCO Mean Lives Covered
            • Regional Demographics of Surveyed MCOs
            • Regional Demographics of MCOs in the Northeast
        • Appendix
          • Physician Survey
            • Reasons for Choosing Praluent over Repatha in the Treatment of High LDL-C
            • Reasons for Choosing Repatha over Praluent in the Treatment of LDL-C
            • Number of ACOs in Which Surveyed Physicians Participate
            • Number of ACOs in Which Surveyed Physicians Expect to Participate in 12 Months
            • Year in Which Surveyed Physicians First Joined an ACO
            • Surveyed Physicians' Path to ACO Participation
            • Surveyed Physicians' Reasons for Joining an ACO
            • ACOs' Structural Incentives for Physicians
            • ACOs' Anticipated Structural Incentives for Physicians
            • Physician Compensation from ACO vs. Regular Practice
            • Effect of ACO Physicians' Compensation on Prescribing an ACS Therapy
            • Anticipated Performance Metrics for ACOs
            • Anticipated Effect of ACO Participation on Prescribing of Specific ACS Drugs
            • ACO Cardiologists' Attention to Cost-Effectiveness and Long-Term Outcomes Data
            • Future ACO Cardiologists' Anticipated Attention to Cost-Effectiveness and Long-Term Outcomes Data
            • Surveyed Cardiologists' Current and Anticipated Type of ACO Compensation
            • Type of Formulary Typically Followed for ACS Patients Within ACOs
            • ACO Cardiologists' Response to Conflicting MCO Formulary Requirements
            • ACOs' Use of Protocols/Algorithms/Guidelines for the Treatment of ACS, Other Indications
            • Anticipated Use of Protocols for ACS Treatment in ACOs
            • Prescribing Requirements in ACO Protocols for the Treatment of ACS
            • Prescribing Requirements of Anticipated ACO Protocols for the Treatment of ACS
            • Basis of ACS Treatment Protocols Used by ACOs
            • Methods That ACOs Use to Discourage Prescribing of Specific Treatments for ACS
            • Anticipated Improvement in Outcomes for ACS Patients in an ACO
            • Anticipated Effect of ACO on Overall Cost of Treatment in Afib, ACS
            • Anticipated Preferred Status of Specific Emerging Therapies for ACS
            • Anticipated Effect of ACA Repeal on the Future of ACOs
            • Future Participation in ACOs According to Type of Payer: MCO, Medicare, and Medicaid
          • MCO Survey
            • MCOs' Timing Between Drug Launch, P&T Review, and UM Criteria
            • MCOs' Delegation of Responsibility for Formulary and Pharmaceutical Contracting
            • PBM Formulary Used by MCOs' Largest Commercial Plan
            • Degree of Customization of PBM Formulary in MCOs' Largest Commercial Plan
            • Type of Formulary Used in MCOs' Largest Commercial Plan
            • Formulary Status of Newly Launched Drugs Prior to MCO Review
            • MCO P&T Committee Members with Greatest Influence on Formulary Decisions
            • Information Required for MCOs' Formulary Review of ACS Drugs
            • Pharmacoeconomic/Health Economic Data Viewed as Most Compelling for ACS Drugs
            • Pharmacoeconomic/Health Economic Data Viewed as Most Compelling for ACS Drugs (Exclusive)
            • MCOs' Utilization Management for Specific ACS Drugs
            • MCOs' Use of Deductibles for Brand-Name Drugs in the Largest Commercial Plan
            • Amount of Deductible for Brand-Name Drugs in MCOs' Largest Commercial Plan
            • Most Common Coinsurance for Specific ACS Drugs in MCOs' Largest Plan
            • Most Common Copayment for Specific ACS Drugs in MCOs' Largest Plan
            • Number of ACOs Under Contract by MCOs
            • Anticipated Number of ACOs Under Contract by MCOs in 12 Months
            • Percentage of Total MCO Membership Attributed to an ACO
            • Percentage of Contracted Physicians Reimbursed Through ACOs
            • MCOs' Anticipated Requirement of Full Risk from ACOs
            • Timing to Require Assumption of Full Risk by ACOs
            • Anticipated Use of Risk-Based Pharmaceutical Contracting by ACOs
            • Performance Measures Tracked by ACOs Under Contract
            • Performance Metrics Achieved by MCOs' Contracted ACOs
            • Formulary Used by MCOs' Largest ACO Under Contract
            • Development Approach Used for ACOs' Dedicated Formulary
            • Impact of ACOs' Dedicated Formulary at Point of Sale
            • ACO Dedicated Formularies' Relationship to ACO-Linked Insurance Product
            • MCO Resolution of Formulary Coverage Conflicts with Dedicated ACO Formulary
            • Anticipated Use of Dedicated Formularies by ACOs
            • Formulary Status of Specific ACS Drugs on Dedicated ACO Formularies
            • ACO Methods Used to Encourage Prescribing of Preferred ACS Drugs
            • MCOs' Hypothetical Response to Evidence of Superior Performance by a Branded ACS Drug
            • ACOs' Effect on Utilization Management Restrictions for ACS Drugs
            • Experience of ACOs Earning Shared Savings Compensation
            • Estimated ACO Savings Resulting in Shared Savings Compensation
            • Anticipated Effect of ACA Repeal on Future Growth of ACOs
            • Formulary Status of PCSK9 Inhibitors Considered for ACS Treatment
            • Path to Improved Formulary Placement of Vascepa for New Indication
            • Anticipated Impact of Emerging Therapies on the Treatment of ACS
            • Potential Pharma Collaborative Opportunities Re: ACOs and Cardiovascular Care

      Author(s): Paula Wade

      Paula Wade tracks and analyses the national trends in the U.S. health insurance industry for Decision Resources Group. She produces the company’s Managed Care Organization Analyzer products and has authored several of DRG’s Physician Payer Dynamics reports.

      A former newspaper journalist with a background in survey research, Ms. Wade has also worked in healthcare advocacy and for the Tennessee Department of Commerce and Insurance.