Herceptin (Roche/Genentech’s trastuzumab) in combination with chemotherapy is well established for treatment of HER2-positive CaB, but recent approvals and anticipated entries of emerging HER2-targeted agents are making for an increasingly competitive environment in this patient segment. Roche/Genentech’s Perjeta (pertuzumab) in combination with Herceptin is the most recent addition to the treatment armamentarium for HER2-positive CaB, and in August 2103 a line extension was granted for GlaxoSmithKline’s Tyverb (lapatinib) in combination with Herceptin. Furthermore, Roche/Genentech’s Kadcyla (trastuzumab emtansine [T-DM1]) and Novartis’s Afinitor (everolimus) (in combination with Herceptin) are also expected to enter the HER2-positive CaB market. The need to combine novel and existing HER2-targeted agents with Herceptin will further increase the cost of treatment in this patient segment. At a time of increased scrutiny of healthcare costs, especially in European countries implementing severe austerity measures, physicians and payers are charged with balancing clinical need for this high-incidence cancer with diminishing budgets. As additional targeted therapies fill the late-stage drug development pipeline, physicians will become increasingly challenged to make economical prescribing decisions. Through assessing the many funding, budgetary, and reimbursement factors that influence prescribing trends for approved targeted agents in breast cancer, this report identifies levers that will promote access for premium-priced targeted agents in this highly competitive market.
Questions Answered in This Report: *
Understand medical oncologists’ drivers and constraints of prescribing of targeted agents for breast cancer: What factors determine the choice of HER2-targeted therapy in the first-line setting for HER2-positive advanced/metastatic CaB? What are oncologists’ estimated current and anticipated prescribing levels for current and emerging HER-targeted therapies? How widely is Perjeta currently prescribed across the EU5? How will Afinitor in combination with Herceptin be added to the increasingly complex treatment algorithm for HER2-positive patients? How does the use of Avastin vary across the EU5? How do oncologists expect to prescribe emerging HER2-targeted agents in the adjuvant treatment setting? How do oncologists perceive the benefit of combining costly agents in times of austerity? What will emerging drugs need to demonstrate to optimize prescribing?
Payers’ attitudes toward reimbursement of high-cost targeted therapies: How do payers prioritize diminishing budgets? What drug attributes secure optimal pricing and reimbursement? As the HTA bar continues to rise, what must an emerging therapy offer to secure favorable review? How do reimbursement and prescribing constraints vary between and within EU5 countries? How and to what extent do healthcare authorities monitor prescribing? How might evolving healthcare reforms and increasing cost-containment strategies affect reimbursement and uptake of novel agents?
Decision Resources’ European Physician & Payer Forum report “Tightening Healthcare Budgets and Elevated Cost-Effectiveness Expectations: How Will Payers and Prescribers Prioritize Targeted Agents for Breast Cancer in the EU5?” draws on insights from 259 surveyed medical oncologists in the EU5 and from interviews with 15 European payers, all of whom have influence at a national or regional level. Interviewed payers include the following:
France: A national payer and past member of the Transparency Commission (CT), hospital head pharmacists.
Germany: An affiliate of the Joint Federal Committee of Physicians, Dentists, Hospitals, and Health Insurance Funds (GBA); a senior oncology consultant who is chair of the hospital formulary committee; a pharmacy director and member of the Federal Pharmacy Association.
Italy: Italian Medicines Agency (AIFA) advisors and a hospital head pharmacist from various Italian regions.
Spain: Pharmacy directors and regional formulary committee members from various autonomous communities.
United Kingdom: A Clinical Commissioning Group (CCG) and acute trust pharmaceutical advisor; a chief pharmacist and hospital formulary committee chair; a CCG head of medicines management.