Owing to the large size of the advanced/metastatic, HR-positive/HER2-negative breast cancer market, as well as the long durations of treatment typically associated with treating these patients, this subpopulation is of high commercial interest to drug developers. Two premium-priced targeted therapies have received FDA approval specifically for this population; Ibrance (Pfizer’s palbociclib), a CDK4/6 inhibitor, and Afinitor (Novartis’s everolimus), an mTOR inhibitor, are both first-in-class agents in this market and represent the beginning of a new wave of targeted therapies being investigated in combination with hormonal therapy for the treatment of this disease. Both current and emerging premium-priced therapies in this market segment face the challenge of wresting market share from heavily genericized and less-expensive hormonal agents, which represent a standard of care. In the context of escalating drug costs within the HR-positive/HER2-negative breast cancer population, devising a smart pricing strategy for novel therapies will be crucial to ensure market access, secure reimbursement, maximize uptake, and realize commercial potential.

Questions Answered:

  • Currently available treatments for hormone-receptor-positive/HER2-negative (HR+/HER2-) breast cancer include both highly genericized and premium-priced agents. What factors most strongly influence and constrain surveyed physicians’ prescribing of current therapies used for the treatment of HR-positive/HER2-negative breast cancer?
  • Several novel agents are in late-phase development for HR+/HER2- breast cancer. What are surveyed oncologists’ views on emerging CDK4/6 inhibitors and PI3K inhibitors in late-phase development? How do surveyed oncologists anticipate using these therapies? How do surveyed physicians expect prescribing of hormone therapies, chemotherapies, and targeted therapies currently used for the treatment of HR+/HER2- breast cancer to change in the future, and what factors, if any, will drive these changes?
  • The rising costs of new breast cancer therapies are a growing concern for payers. What is the current commercial managed care organization (MCO) coverage of therapies used to treat HR-positive/HER2-negative breast cancer? How will it change in the future? What factors have the most influence on surveyed payers’ formulation decisions for breast cancer therapies? Which restrictions are most commonly used in commercial plans for breast cancer therapies?

Scope:

This report, titled The Escalating Cost of Treating HR-Positive/HER2-Negative Breast Cancer: U.S. Physician and Payer Perception of Premium-Priced Prescribing, captures surveyed medical oncologists’ and payers’ views on anticipated prescribing and reimbursement barriers for current and emerging therapies for HR+/HER2- breast cancer.

Markets covered: United States.

Primary research: Online survey with 100 medical oncologists and 30 MCO PDs/MDs.

Emerging therapies: Phase III: 4 drugs.

Table of contents

  • Breast Cancer - Access & Reimbursement - Detailed, Expanded Analysis: HR-Positive/HER2-Negative Breast Cancer (US)
    • Actionable Recommendations to Optimize Market Access
      • Actionable Recommendations to Optimize Market Access for New HR+/HER2- Breast Cancer Therapies in the US
    • Successes and Stumbles
      • Successes and Stumbles Among HR+/HER2- Breast Cancer Therapies in the US
      • Reimbursement Successes and Stumbles for Commercial Plans
    • Key Stakeholders in the Road to Market Access
      • Stakeholder Dynamics on the Road to Reimbursement
    • Key Market Access Roadblocks
      • Key Market Access Roadblocks for Breast Cancer Therapies in the US
    • Reimbursement Dynamics
      • Reimbursement Summary
        • Lessons Learned and Key Takeaways
        • Most Important Factors Driving MCO Decision Making on Formulary Inclusion of Breast Cancer Therapies
      • Pricing and Reimbursement Drivers
        • Key P&R Drivers
      • Restrictions and Prior Authorizations
        • Restrictions in Commercial Plans
        • Restrictions Used in Commercial Plans for Breast Cancer Therapies
    • Pricing and Reimbursement, Policy, and Coverage: Impact on Prescribing
      • Patient Share in Key Payer Channel
        • Patient Share for Hormonal Therapies
        • Patient Share of Chemotherapies
        • Key Levers and Constraints on Hormone Therapies
        • Key Levers and Constraints on Chemotherapies
        • Key Levers and Constraints on Targeted Therapies
        • Strongest Clinical Factors Influencing Prescribing of HR+/HER2- Breast Cancer Therapies
      • Prescriber Preference
        • Impact of Payer Policy on Prescribing
        • Market Access Landscape for Emerging Therapies
          • Likely Impact of Emerging Therapy
            • Expected Patient Shares for Ribociclib 12 Months After Launch
            • Expected Patient Shares for Abemaciclib 12 Months After Launch
            • Expected Patient Shares for Buparlisib 12 Months After Launch
            • Expected Patient Shares for Taselisib 12 Months After Launch
          • Potential Placement of Emerging Therapy at Various Prices
            • Expected Coverage of Ribociclib for First-Line HR+/HER2- Advanced/Metastatic Breast Cancer
            • Expected Coverage of Abemaciclib for First-Line HR+/HER2- Advanced/Metastatic Breast Cancer
          • Prescriber and MCO Opinion on Remaining Unmet Need
            • Desired R&D Spending Toward Clinical Goals for a New Early-Stage HR+/HER2- Breast Cancer Therapy
            • Desired R&D Spending Toward Clinical Goals for a New Advanced/Metastatic HR+/HER2- Breast Cancer Therapy
        • Methodology
          • Abbreviations
          • Methodology: Survey Design Overview
            • Primary Market Research Methodology - Physicians
              • Where is your practice based?
              • How many HR+/HER2- breast cancer patients do you treat per month?
              • Which of the following agents do you currently prescribe outside of clinical trials?
              • In what region is your practice located?
              • In what state is your practice located?
            • Primary Market Research Methodology - MCOs
              • Are you a managed care organization (MCO) pharmacy director or medical director?
              • In what region is your managed care firm located?
              • In which state is your MCO located?
              • Which of the following best describes the operations of your MCO?
              • Which of the following types of plans does your company offer?
              • How many lives (prescription and medical benefit) does your MCO cover?
              • How many individual lives (prescription and medical benefit) does your MCO cover?
              • Commercial Plans’ Out-of-Pocket Cost
              • How is the out-of-pocket maximum calculated?
              • What is the amount out-of-pocket for the time frame?
              • P and T Committee Size and Meeting Frequency
              • For your MCO, please estimate the percentage of individual lives that are covered by the following plans.
              • How often does your P&T committee meet?
              • Tier Composition in Commercial Plans
              • Items Needed for Inclusion in Drug Review
              • Nature of Tiers in Commercial Plans
              • Positions of Greatest Influence on P and T Committee
              • Methodology: Copayment Values and Coinsurance in Surveyed MCO Commercial Plans
              • Which of the following agents do you currently prescribe outside of clinical trials?
          • Appendix
            • Physician Survey
              • Office-Based Medical Oncologists: Reimbursement of Breast Cancer Agents, by Line of Therapy
              • Hospital-Based Medical Oncologists: Reimbursement of Breast Cancer Agents, by Line of Therapy
              • Office-Based Medical Oncologists: Procurement of Breast Cancer Therapies via Specialty Pharmacy
              • Hospital-Based Medical Oncologists: Procurement of Breast Cancer Therapies via Specialty Pharmacy
              • Medical Oncologists: Expected Future Changes in the Procurement of Breast Cancer Therapies
              • No restrictions affect my prescribing Office-Based Oncologists
              • No restrictions affect my prescribing Hospital-Based Oncologists
              • Medical Oncologists: Treatment Practice for HR+/HER2- Breast Cancer
              • Medical Oncologists: Patient Shares of Hormonal Therapies for HR+/HER2- Breast Cancer
              • Medical Oncologists: Patient Shares of Chemotherapies for HR+/HER2- Breast Cancer
              • Medical Oncologists: Preferred Hormonal Therapies for HR+/HER2- Breast Cancer
              • Medical Oncologists: Preferred Chemotherapies for HR+/HER2- Breast Cancer
              • Medical Oncologists: Clinical Drivers of Prescribing HR+/HER2- Breast Cancer Therapies
              • Medical Oncologists: Nonclinical Drivers of Prescribing HR+/HER2- Breast Cancer Therapies
              • Clinical factors do not restrict my prescribing of this drug: Office-Based Oncologists
              • What clinical factors most restrict your prescribing of the following drugs for the treatment of HR+/HER2- breast cancer?
              • Hospital-Based Medical Oncologists: Clinical Constraints of Prescribing HR+/HER2- Breast Cancer Therapies
              • Medical Oncologists: Performance of HR+/HER2- Breast Cancer Therapies on Key Clinical Attributes
              • Medical Oncologists: Performance of HR+/HER2- Breast Cancer Therapies on Key Nonclinical Attributes
              • Medical Oncologists: The Impact of Ibrance Approval on Prescribing of Other Therapies for HR+/HER2- Breast Cancer
              • Medical Oncologists: Ease of Reimbursement of Off-Label Prescribing of Ibrance
              • Medical Oncologists: Statement Agreement on Ibrance for HR+/HER2- Breast Cancer
              • Medical Oncologists: Statement Agreement on Afinitor for HR+/HER2- Breast Cancer
              • Medical Oncologists: Statement Agreement on Faslodex for HR+/HER2- Breast Cancer
              • Medical Oncologists: Anticipated Patient Share of Ribociclib 12 Months After Its Launch
              • Medical Oncologists: Statement Agreement on Ribociclib
              • Medical Oncologists: Anticipated Patient Share of Abemaciclib 12 Months After Its Launch
              • Medical Oncologists: Statement Agreement on Abemaciclib
              • Medical Oncologists: Anticipated Patient Share of Buparlisib 12 Months After Its Launch
              • Medical Oncologists: Statement Agreement on Buparlisib
              • Medical Oncologists: Anticipated Patient Share of Taselisib 12 Months After Its Launch
              • Medical Oncologists: Statement Agreement on Taselisib
              • Physicians: Desired Achievements of a New HR+/HER2- Breast Cancer Therapy
            • MCO Survey
              • MCOs: Current and Expected Future Coverage of Breast Cancer Therapies in Commercial Plans
              • MCOs: Current Pharmacy Benefit Coverage
              • MCOs: Current and Expected Future Preferred and Nonpreferred Brand List Inclusion of Breast Cancer Therapies
              • MCOs: Drivers of Preferred List Inclusion for Breast Cancer Therapies
              • MCOs: Drivers of Formulary Exclusions or NDC Blocks for Breast Cancer Therapies
              • MCOs: Cost Controls for Breast Cancer Therapies in Commercial Plans
              • MCOs: Likelihood to Implement Prior Authorization for Faslodex, Afinitor, and Ibrance in the Next 12 Months
              • MCOs: Prior Authorization Restrictions for Faslodex, Afinitor, and Ibrance
              • MCOs: Distribution Channels for Breast Cancer Therapies in Commercial Plans
              • MCOs: Specialty Pharmacy Services Used for Breast Cancer Therapies
              • MCOs: Perception of the Overall Clinical Profiles of Approved HR+/HER2- Breast Cancer Therapies
              • MCOs: Current Reimbursement by Population for HR+/HER2- Breast Cancer Therapies
              • MCOs: Future Reimbursement by Population for HR+/HER2- Breast Cancer Therapies
              • MCOs: Restrictions on Duration of Therapy for Afinitor and Ibrance
              • MCOs: Bundled Payments for Breast Cancer Therapies
              • MCOs: Compensation via Bundled Payments for Breast Cancer Patients
              • MCOs: Current and Expected Future Composition of Bundled Payment Compensation
              • MCOs: Current and Expected Future Reimbursement of Breast Cancer Therapies via Bundled Payments
              • MCOs: Buy and Bill Programs for Breast Cancer Therapies
              • MCOs: Cost Shares for Oral vs. Injectable Therapies
              • MCOs: Expected Future Proportion of Breast Cancer Patients Treated According to a Clinical Pathway Program
              • MCOs: Preferred Comparators for an Emerging Therapy for Advanced/Metastatic HR+/HER2- Breast Cancer
              • MCOs: Key Drivers for Reimbursement of a Breast Cancer Therapy
              • MCOs: Expected Tier Placement/Coverage of Ribociclib if Approved for HR+/HER2- Advanced/Metastatic Breast Cancer
              • MCOs: Expected Tier Placement/Coverage of Abemaciclib if Approved for HR+/HER2- Advanced/Metastatic Breast Cancer
              • MCOs: Expected Tier Placement/Coverage of Buparlisib if Approved for HR+/HER2- Advanced/Metastatic Breast Cancer
              • MCOs: Expected Tier Placement/Coverage of Taselisib if Approved for HR+/HER2- Advanced/Metastatic Breast Cancer
              • MCOs: Desired Achievements of a New Advanced/Metastatic Breast Cancer Therapy
              • MCOs: Desired Achievements of a New Advanced/Metastatic Breast Cancer Therapy
              • MCOs: Awareness of Pharmacoeconomic/Health Economic Outcomes Data Submission for Breast Cancer Therapies
              • MCOs: Perceived Quality of Pharmacoeconomic/Health Economic Outcomes Data Submitted for Breast Cancer Therapies
              • MCOs: Impact of Submitted Pharmacoeconomic/Health Economic Outcomes Data
            • Additional Information
              • Breast Cancer Drug-Treated Cases, 2014 and 2020
              • Key HR+/HER2- Breast Cancer Therapies
              • Adjuvant Treatment Algorithm for HR+/HER2- in the United States
              • Commercial Context: Timeline of FDA Approvals for Key Current Therapies for HR+/HER2- Breast Cancer
              • Estimated Price per Cycle of HR+/HER2- Breast Cancer Therapies
              • Timeline of FDA Approvals for Emerging Therapies for HR+/HER2- Breast Cancer
              • Commercial Context: Clinical Profile for Ribociclib
              • Commercial Context: Clinical Profile for Abemaciclib
              • Commercial Context: Clinical Profile for Buparlisib
              • Commercial Context: Clinical Profile for Taselisib

        Author(s): Natalia Reoutova, MSc, MA

        Natalia Reoutova, M.A., M.Sc., is a senior business insights analyst in the oncology division at Decision Resources Group. Ms. Reoutova has worked on a range of oncology indications including prostate cancer and malignant melanoma. She has authored reports on non-small-cell lung cancer and colorectal cancer, and worked on publications covering both the major and emerging pharmaceutical markets.

        Natalia Reoutova holds a M.A. in natural sciences (specializing in pharmacology) from the University of Cambridge and a M.Sc. in drug discovery from the University of London. Her postgraduate research focused on developing small-molecule inhibitors of oncogenic transcription factors. Prior to working at Decision Resources, she was responsible for planning and estimating the cost of clinical trials at Pharm-Olam International.


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