Pharmaceutical Executive Europe - May 2008 - (Page 20) 20 Market Access May 2008 Pharmaceutical Executive Europe The fourth hurdle: how should we be thinking about the fifth hurdle? As financial controls tighten in the US and Europe, access will become more limited. Even in price controlled markets regional or local payers will limit access to products which have been approved nationally. Co-payment is increasing and physicians will make judgements about the patients’ ability to pay. In the US Medicare and Medicaid will be paying a much greater proportion of drug costs. Traditionally, trials have focused on getting a product to market. In the current environment the importance of products demonstrating cost-effectiveness is increasing dramatically. Our global focus has been on national approval, pricing and reimbursement. We need to build data to convince local decision makers to endorse our products, create the concept of a target access product profile (TAPP) and start this early in the product development process. Patient reported outcomes Market access issues all revolve around two aspects: the patient and challenges of evidencing benefit and value. PRO embraces both these concepts in its title. PRO is not a new term for health related quality of life (HQRL) — the terms are not equivalent. PRO is a methodology for collecting patient self-report data, so anything a patient reports directly is a PRO. PRO includes HRQL but also embraces efficacy and side effects. PRO involves talking to patients in their language — about their illness and their outcomes. Jane Scott, formerly the lead Study Endpoint Reviewer at the FDA, currently Director of PRO and Regulatory Consulting at MAPI Values at Adelphi, gave a thorough review of what was, and what was not, acceptable for different PRO measures. The term PRO developed at the FDA, who realised that the methods for asking patients about HRQL apply to any data patients report. Patients must understand what it is they are being asked. A good example of this comes from the respiratory area. When a physician asks the patient about the colour of their sputum, how many know what sputum is? Furthermore, few patients pay attention to the colour of sputum, so are unable to report an accurate description, yet this is exactly what the doctor might expect them to do. A key challenge we face is that stakeholders such as regulators, and influencers such as key opinion leaders require robust evidence. As we transition to using more PRO we need to ensure that these endpoints are rigorously developed, validated and implemented in clinical trials. PRO is often thought of as a marketing tool and is often overlooked but it is not a niche technique — it is increasingly a part of medical decision making. Neither is it a vague concept — it is a serious methodology integral to preparing product profiles. It goes beyond labelling to embrace any studies (including epidemiology) conducted to understand disease and treatment. Many of these studies are likely to use PRO to measure endpoints or help identify patients for inclusion. PRO fits increasingly into the decision making of regulators like FDA and EMEA, and bodies such as NICE, but requires rigorous design and validation — you can’t throw in a question last minute unless you have evidence that patients understand. PRO can be used in three ways to support drug indications. ● In certain illnesses, like erectile dysfunction, the most appropriate endpoint is PRO, and the PRO claim is essential to market approval. Figure 1: Support for market access activities. Clinical research Vision, goal setting, strategy, planning, consultancy Physician advocacy and endorsement Access & knowledge communication programs Disease and doctor association engagement Patient education Tablet-PC armed sales forces Journalist education and training Patient association impact networks PR cascading Patient & physician insights Disease & treatment insights Access mechanisms and stakeholder insights Payor profitability acceptance tools Gap analysis and forecasting Patient insights & preference Pricing & value research Market access decision making, price volume uptake modeling Market tracking for communication optimisation and access Budget impact studies Reimbursement & registration advice PE & Economic impact models PRO studies Message development and testing Communication strategy and planning Research & Understanding (the basics) Honing & refinement Crafting the Argumentation Multi-Channel Communications Figure 2: PRO data influence market access. PROs in well-controlled trials PROs outside pivotal trials Primary endpoint Primary endpoint M A RK E T Supportive endpoints Price Reimbursement Coverage Ease of use; Productivity ACCES S Patient satisfaction; caregiver impact Satisfaction and preference in real world
Table of Contents Feed for the Digital Edition of Pharmaceutical Executive Europe - May 2008 Pharmaceutical Executive Europe - May 2008 Contents From the Editor News and Analysis Calendar Rising in the East Use Your Strategic Discretion A Blueprint for Success Market Access and the Patient Activating Effective Product Differentiation What Doctors Want IC Success in Four Steps Pharmaceutical Executive Europe - May 2008 Pharmaceutical Executive Europe - May 2008 - (Page Bellyband1) Pharmaceutical Executive Europe - May 2008 - (Page Bellyband2) Pharmaceutical Executive Europe - May 2008 - Pharmaceutical Executive Europe - May 2008 (Page Cover1) Pharmaceutical Executive Europe - May 2008 - Pharmaceutical Executive Europe - May 2008 (Page Cover2) Pharmaceutical Executive Europe - May 2008 - Contents (Page 3) Pharmaceutical Executive Europe - May 2008 - From the Editor (Page 4) Pharmaceutical Executive Europe - May 2008 - From the Editor (Page 5) Pharmaceutical Executive Europe - May 2008 - News and Analysis (Page 6) Pharmaceutical Executive Europe - May 2008 - News and Analysis (Page 7) Pharmaceutical Executive Europe - May 2008 - Calendar (Page 8) Pharmaceutical Executive Europe - May 2008 - Calendar (Page 9) Pharmaceutical Executive Europe - May 2008 - Calendar (Page 10) Pharmaceutical Executive Europe - May 2008 - Calendar (Page 11) Pharmaceutical Executive Europe - May 2008 - Rising in the East (Page 12) Pharmaceutical Executive Europe - May 2008 - Rising in the East (Page 13) Pharmaceutical Executive Europe - May 2008 - Use Your Strategic Discretion (Page 14) Pharmaceutical Executive Europe - May 2008 - Use Your Strategic Discretion (Page 15) Pharmaceutical Executive Europe - May 2008 - A Blueprint for Success (Page 16) Pharmaceutical Executive Europe - May 2008 - A Blueprint for Success (Page 17) Pharmaceutical Executive Europe - May 2008 - Market Access and the Patient (Page 18) Pharmaceutical Executive Europe - May 2008 - Market Access and the Patient (Page 19) Pharmaceutical Executive Europe - May 2008 - Market Access and the Patient (Page 20) Pharmaceutical Executive Europe - May 2008 - Market Access and the Patient (Page 21) Pharmaceutical Executive Europe - May 2008 - Activating Effective Product Differentiation (Page 22) Pharmaceutical Executive Europe - May 2008 - Activating Effective Product Differentiation (Page 23) Pharmaceutical Executive Europe - May 2008 - Activating Effective Product Differentiation (Page 24) Pharmaceutical Executive Europe - May 2008 - What Doctors Want (Page 25) Pharmaceutical Executive Europe - May 2008 - What Doctors Want (Page 26) Pharmaceutical Executive Europe - May 2008 - What Doctors Want (Page 27) Pharmaceutical Executive Europe - May 2008 - IC Success in Four Steps (Page 28) Pharmaceutical Executive Europe - May 2008 - IC Success in Four Steps (Page 29) Pharmaceutical Executive Europe - May 2008 - IC Success in Four Steps (Page 30)
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