Novel Oral Anticoagulants for Acute Coronary Syndrome, Atrial Fibrillation, and Venous Thromboembolism in the EU5 | Physician & Payer Forum | EU5 | 2015

Publish date: March 2015

Login to access report

The European oral anticoagulation market has undergone a dramatic expansion in the treatment armamentarium in recent years, with the emergence of the novel oral anticoagulants (NOACs) and their approval for use in a range of indications. While the NOACs offer certain clinical and dosing advantages over the traditional mainstays of oral anticoagulation—the vitamin K antagonists (VKAs)—their relatively high cost means that the increasingly cost-conscious European markets have sought to impose certain restrictions on the use of these agents.

Questions Answered in This Report:

  • Gain physician and payer perspectives on current and evolving prescribing trends. How widely have cardiologists adopted the various NOACs into their treatment algorithms for the conditions under study? How do prescribing patterns vary by country? By indication? What have been the main constraints to their uptake?

  • Understand the mechanisms by which the NOACs are reimbursed in the EU5 (France, Germany, Italy, Spain, and the United Kingdom). The NOACs are considerably more expensive than alternative therapies such as the VKAs. How, and to what extent, does the cost of the NOACs prevent access to these treatments in increasingly price-sensitive European markets? How does reimbursement vary among countries? How do healthcare authorities regulate the prescribing of the NOACs to manage costs?

  • Explore clinician and payer attitudes toward the expanding range of indications for which NOACs are approved, and the prospects for Lixiana (Daiichi Sankyo’s edoxaban). Which clinical attributes will be the most persuasive in influencing physician prescribing decisions as Pradaxa (Boehringer Ingelheim’s dabigatran etexilate) and Eliquis (Bristol-Myers Squibb/Pfizer’s apixaban) seek reimbursement for the treatment and secondary prophylaxis of venous thromboembolism (VTE)? How do physicians and payers view Xarelto (Bayer/Janssen’s rivaroxaban) as a therapeutic option for acute coronary syndrome (ACS)? Does Lixiana's clinical profile distinguish it from earlier-to-market NOACs for the treatment of atrial fibrillation (AF) or VTE?

Scope:

Decision Resources' European Physician & Payer Forum report, “Novel Oral Anticoagulants for Acute Coronary Syndrome, Atrial Fibrillation, and Venous Thromboembolism in the EU5: How are Payer Policies and Physician Preferences Shaping the Prescribing Landscape?” explores the many international, national, and local market access factors that can influence the utilization of the NOACs for the treatment of ACS, AF, and VTE in the EU5, particularly in response to increasingly challenging health technology assessments and more complex pricing and reimbursement negotiations. This report draws on insights from 252 surveyed cardiologists 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: Hospital pharmacy director; hospital pharmacist with expertise in the field of anticoagulants; hospital pharmacist, with expert knowledge of labeling and reimbursement of new therapies in France.

- Germany: Current member of, and advisor to, the G-BA; hospital pharmacy director who is also a member of G-BA; head of drug reimbursement for regional sick fund.

- Italy: Members of prontuario terapeutico ospedaliero (PTO), prontuario terapeutico ospedaliero regionale (PTOR), Comitato Prezzi e Rimborso (CPR), and Comitato Tecnico Scientifico (CTS) and hospital pharmacy directors with responsibility for assessing new drugs for formulary inclusion; Agenzia Italiana del Farmaco (AIFA; Italian Medicines Agency) advisors.

- Spain: Advisors to Dirección General de Farmacia y Productos Sanitarios (DGFPS; General Directorate of Pharmacy and Health Products) and to the Comisión Nacional para el Uso Racional del Medicamento (CNURM; National Commission for the Rational Use of Medicines) and hospital pharmacy directors.

- United Kingdom: Hospital pharmacy director and member of area prescribing committee; hospital pharmacy deputy director and NICE advisor; medicine optimization and pharmacy procurement secondary care lead.

Author(s): Eamonn O’Connor, Ph.D.