Four targeted small molecules are available in Europe for the treatment of non-small-cell lung cancer (NSCLC). Reversible EGFR tyrosine kinase inhibitors (TKIs) Iressa (AstraZeneca’s gefitinib) and Tarceva (Genentech/OSI Pharmaceuticals/Roche’s erlotinib), to which patients with EGFR
-mutated tumors respond especially well, paved the way for personalized medicines in this therapeutic area. Pfizer’s Xalkori (crizotinib), targeted at patients whose tumor harbors an ALK-EML4
gene translocation, is rolling out across the EU5, and Boehringer Ingelheim’s irreversible EGFR TKI Giotrif (afatinib), also directed at EGFR
-mutated disease, was approved in September 2013. In addition, Eli Lilly’s folate antimetabolite Alimta (pemetrexed) and Roche/Genentech’s VEGF monoclonal antibody Avastin (bevacizumab) are used in patients with select tumor histology only. With the health technology assessment (HTA) bar rising steadily amid tightening healthcare budgets across the EU5, this report explores the market access challenges faced by these premium-priced therapeutics and the emerging agents waiting in the wings. Oncologists’ experiences of implementing biomarker testing and the barriers and lessons learned for optimizing testing rates are examined, together with the power of biomarker- and histology-driven prescribing in NSCLC as well as prescriber and payer expectations for future drugs. By looking at these key factors, the report identifies levers that well help secure long-term access to this highly competitive market.
Questions Answered in This Report:
The drivers and barriers of biomarker testing and drug prescribing in NSCLC:
How do prescribers select between Iressa and Tarceva for patients harboring an activating EGFR
mutation? How will Giotrif impact use of Iressa and Tarceva? How onerous is the use of biomarker testing; what are the barriers to uptake? Does biomarker-driven prescribing facilitate drug use? What new targets excite physicians? Will future drugs need to be biomarker-driven to compete in the NSCLC arena?
Payers’ attitudes toward targeted therapies and biomarker reimbursement:
To what extent is molecular testing of patients carried out, and what is the impact of such testing on healthcare budgets? What cost control measures are employed to guide molecular testing and molecular therapy prescribing? How and to what extent are these cost control measures monitored? Does the capacity for biomarker-driven prescribing and patient selection ease the road to reimbursement in times of austerity? How do prescribing restrictions, reimbursement conditions, and cost-containment measures vary between and within EU5 countries? How will each evolve as the targeted treatment armamentarium grows?
Decision Resources’ European Physician & Payer Forum report “Non-Small-Cell Lung Cancer: Drivers of European Prescribing and Reimbursement in an Indication with High Unmet Need at a Time of Increasing Austerity” 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.