The PharmAccess Leaders Forum is Europe’s most respected event for stakeholders involved in achieving patient access for innovative medications. Attendees from the global pharmaceutical industry, payers, health technology assessors, physicians and patient groups, all come together to listen to the opinions of thought-leaders, to network with experts from different perspectives and to achieve actionable insights in this challenging area. The major themes include issues like understanding what is “value” in the eyes of payers and patients, as well as how stronger evidence can be developed and communicated so that budget holders can be more effective in decision making. The overall goal is to ensure that there is rapid access to innovative yet effective medicines, in a budget-effective manner and health-outcomes can be improved to enhance the lives of patients.

This meeting will provide an ideal opportunity for “payers” and other decision makers from both public and private organisations, to benchmark with peers internationally and provide pharma companies an invaluable insight into the decision making processes and approaches of these vital stakeholders. Attendees will be able to understand and develop best practice approaches to such vital and common challenges, with the ultimate goal of encouraging innovation and improving patient access to novel and powerful medications.

Download agenda here for complete speaker list

Payers & HTA Agencies

Head of Department Medical Staff
Head of Pharmaceuticals Unit
Stockholm Läns Landsting, SLL, Sweden

Officer
Stockholm Läns Landsting, SLL, Sweden

Director, Lombardy HTA program and National Steering Committee for Medical Devices at Ministry of Health
Lombardy Region, Welfare Directorate

Senior Vice President, Innovation and Solutions
America’s Health Insurance Plans (AHIP), USA

Director, Drug Department
The National Institute for Clinical Excellence in Health and Social Services Quebec (INESSS), Canada

Advisor to the President, Director, International Affairs
HAS, Haute Autorité de Santé, France

Co-president of the Belgian Entry Agreements Working Group
RIZIV-INAMI, Belgium

Technical Analyst, NICE Scientific Advice Program
National Institute for Health and Care Excellence, UK

Principal Pharmacist
Scottish Medicines Consortium, Scotland

Director, The National Center for HTA
The National Institute of Health, Ministry of Health, Italy

Head of the Department of Medicines,Therapeutic Appliances and Remedies
Product and Billing Management Division
DAK–Gesundheit, (Leading German statutory health insurance)

President
The Italian Society of Health Technology Assessment (SIHTA)

Head of Health Technology Assessment Department
Deputy Head of Pricing & Reimbursement Regulation Branch
State Institute for Drug Control (SUKL), Czech Republic

Associate Professor, Economic Evaluations in Health Care
Institute of Health Policy & Management (iBMG)
Institute for Medical Technology Assessment (iMTA)
Erasmus University Rotterdam, Netherlands

Health Economist, Health Technology Assessment and Innovation Unit
Gemelli Teaching Hospital, Rome, Italy

Industry Experts

Vice President, Head of Operations and Payer Intelligence
Global Market Access
Sanofi, UK

Vice President, Global Reimbursement and Real World Evidence
Janssen, Pharmaceutical Companies of Johnson and Johnson, Belgium

Head Global Payor Marketing, Sales and Relations, Sandoz Biopharmaceuticals
Sandoz International, Germany

Global Head Pricing & Payer Excellence, Global Market Access & Pricing
Biopharma, Global Operations
Merck KGaA, Germany

Senior Director, HEOR Excellence
Novartis, USA

Director, Health Technology Assessment & Outcomes Research
Pfizer, Germany

Lead, EMEA Market Access
Astellas Pharma, UK

Associate Director Market Access and Pricing - EMEA
Astellas Pharma, UK

Director
Vree Health, MSD Group, Italy

Payer Evidence Leader, Market Access
Roche, Italy

Market Access Lead, Europe
Chairperson, Vaccines Europe Access Working Group
Sanofi Pasteur, France

Director, Country Market Access Head
Sanofi, Italy

Global Market Access Manager
Norgine, UK

Global Market Access & Health Outcomes Manager
Almirall, Spain

Head of Patient Access
Novartis, Italy

Senior Manager Market Access & Value Added Medicines
Medicines for Europe, Belgium

 

Patient Networks, Pharmacists & Policy Researchers

Professor of Health Economics
MIUR - Italian Ministry of Research and Education

Chief Pharmacist
NPA - National Pharmacy Association, UK

Former Member, The Regional HTA Committee of Lombardy
School of Economics and Management
LIUC University, Italy

Chair, Consumer Forum
National Cancer Research Institute, UK

Program Director, Executive MBA Healthcare Management
SRH University, Berlin (SRH Hochschule), Germany

Senior Economist 
Office of Health Economics, UK

Senior Scientist
RAND Health, USA

The Federation of Italian GPs (FIMMG)
Head of Communications & Secretary of Lombardia Region, Italy

Experienced Solution Providers

Vice President, Head of Global Pricing & Market Access Solutions
QuintilesIMS

Vice President Europe, Market Access
GFK,UK

Principal, Consulting Services
Quintiles IMS

Managing Director
Valid Insight, UK

 

Download agenda here for complete speaker list

Payers, HTAs & Policy Makers:

Senior representatives from Payers, health plans & insurers, Public health experts, health technology assessors, hospital financial management, government & health ministry officials, health management and managed care organizations, epidemiology, horizon scanning, scientific advice, pharmacy strategy & budget management.

Industry: Corporate senior management, vice presidents, directors, senior managers in:

Market access, health economics, pricing & reimbursement, health outcomes, government & regulatory affairs as well as those focused on designing studies to achieve value-adding endpoints, such as R&D strategy, clinical development and medical affairs.

Other Stakeholders

Regulatory agencies, key-opinion leaders, independent health economists, health researchers and academics, physicians, patient groups, consultants & solution providers

 

“Payers” (health plans, sick funds & insurers, payers, health technology assessors, hospital financial management & health department officials) in almost all circumstances, in both developed and developing countries are under extreme budgetary pressure. Many health systems in the developed world, face ageing populations, economic crisis and rapidly increasing healthcare costs in general, including the sustained cost increases of innovative and novel drugs. This is forcing payers to make difficult choices regarding which medical procedures & medications to fund and reimburse. No longer are “me too” drugs that have achieved regulatory approval simply approved for reimbursement at high prices. Payers need to make tough decisions based on what they define as “value”, unfortunately sometimes at the expense of funding treatments in some “lower priority” disease indications or individual patients. Despite intense political pressure from patients and stakeholders who believe healthcare is an inalienable “right” and should be “free for all,” the reality is that payers have a finite and limited budget, and face a high-degree of risk in decision making. They operate within an environment where a multitude of products are on offer, each making various therapeutic claims of efficacy and safety, often with insufficient data to validate supposed health outcome improvements over existing treatment options. How can payers make the right decision in a high-risk, high uncertainty environment? Various options and decision-making tools exist, some old, some novel. Traditional decision making based on, for example, price referencing, DRGs budgets or generic substitution are still significant. However, recent advances in the sophistication of HTA analysis and modeling, flexible pay for performance models, risk-sharing and value-based pricing schemes have become increasingly important to mitigate payer risk and allocate financial resources to the areas of pressing need. Savings and outcome improvements can also be found through finding efficiency gains at the healthcare delivery level, providing the right incentives for prescribers and improving patient adherence. 

Speaker List - Day 1

Head of Department Medical Staff, Head of Pharmaceuticals Unit
Stockholm Läns Landsting, SLL, Sweden

President
The Italian Society of Health Technology Assessment (SIHTA)

Principal Pharmacist
Scottish Medicines Consortium, Scotland

Director, Drug Department
The National Institute for Clinical Excellence in Health and Social Services Quebec (INESSS), Canada

Senior Vice President, Innovation and Solutions
America’s Health Insurance Plans (AHIP), USA

Principal, Consulting Services
QuintilesIMS

Chief Pharmacist
NPA - National Pharmacy Association, UK

Chair, Consumer Forum
National Cancer Research Institute, UK

Vice President Europe, Market Access
GFK,UK

Vice President, Global Reimbursement and Real World Evidence
Janssen, Pharmaceutical Companies of Johnson and Johnson, Belgium

Head Global Payor Marketing, Sales and Relations, Sandoz Biopharmaceuticals
Sandoz International, Germany

Advisor to the President, Director, International Affairs
HAS, Haute Autorité de Santé, France

”Risk-sharing” or flexible pricing and reimbursement schemes, have been in existence for around a decade in Europe and places like Canada, and is starting to become popular in the USA. They are known by many other names including Managed Entry Agreements (MEAs), Value-Based Pricing, Pay for Performance or Outcomes-based schemes. Most agreements so far, in reality, have been more basic financial-based arrangements (such as budget-capping and refunds for payers), rather than more sophisticated value-based models, based on improved health outcomes. As ‘’patient-centricity” becomes more of a focus for pharmaceutical companies and payers alike, most would agree that in principle, paying for outcomes is ideal and a “win-win” for all stakeholders, especially the patient.  In theory, this helps payers conditionally approve the reimbursement of an innovative, yet expensive therapy and allow patient access without delay. Quality evidence is very much lacking at the time of launch, so the “wait and see approach” that risk sharing can provide, can be a great compromise for the industry, payers and patients. Payers can also avoid wastage when drugs are unsuccessful, but only paying for positive outcomes. The pharmaceutical industry can benefit, by maintaining a higher list price to avoid the negative price spiral dude to reference pricing. They can also benefit from early-access. There have been also some high-profile value-based pricing schemes in the USA, which will pay for outcomes and look very innovative and promising promising. On both sides of the Atlantic, MEAs are here to stay. However, implementing complex outcomes-based schemes in practice is very challenging. It is difficult enough to measure outcomes across a patient population, let alone individual patients. Electronic Medical Records are still not widespread or integrated enough to provide sufficient real-world data, so busy doctors have to still keep records the manual way, which are prone to error. This stream will clarify the process of establishing, preparing, implementing and delivering a successful Managed Entry Agreement(MEA) and Outcome Based schemes, to improve the access of innovative medicines for patients.

Speaker List - Stream 1

Vice President, Head of Operations and Payer Intelligence Global Market Access
Sanofi, UK

Global Head Pricing & Payer Excellence | Global Market Access & Pricing Biopharma| Global Operations
Merck KGaA, Germany

Market Access Lead, Europe I Chairperson, Vaccines Europe Access Working Group
Sanofi Pasteur, France

Director
Vree Health, MSD Group, Italy

The Federation of Italian GPs (FIMMG)
Head of Communications & Secretary of Lombardia Region, Italy

Co-president of the Belgian Entry Agreements Working Group
RIZIV-INAMI, Belgium

Head of the Department of Medicines,Therapeutic Appliances and Remedies
Product and Billing Management Division
DAK–Gesundheit, (Leading German statutory health insurance)

Head of Health Technology Assessment Department, Deputy Head of Pricing and Reimbursement Regulation Branch
State Institute for Drug Control (SUKL), Czech Republic

Officer
Stockholm Läns Landsting, SLL, Sweden

 

Pharmaceutical companies are continuing to receive regulatory approval for new drugs, but are often still struggling to gain access at the prices and reimbursement levels which they expect. Often the drugs are simply “me-too” medications, but another major reason is simply a lack of sufficient clinical and economic evidence. Payers and health technology assessors and agencies (HTAs) are being asked to make decisions with huge financial ramifications, based on limited or questionable data. This problem is not new, but pharmaceutical companies still have not found the “magic bullet” and they still need to drastically improve how they develop clinical, economic and then real-world evidence. Demonstrating to regulators that a drug is of high-efficacy and is safe, does not prove to payers that a medicine is of great “value,” that it significantly improves health outcomes, relative to the existing standard of care. Clearly, pharmaceutical companies, as well as less-experienced biotech companies need to be a lot more effective in trial design in the earlier phases. One increasingly important input is to obtain official, early scientific advice from payers and HTAs, yet taking advantage of such advice is often a challenge in reality. Scientific advice is never binding and standards of care and comparator drugs can change over time. Different agencies and insurers also demand different evidence, not all needs can be catered for in reality. However, the pharma industry’s record in integrating economic endpoints into trials is still not good. Too often the problem is, different departments work in “silos” with different objectives: most clinical and regulatory teams are still primarily focused on gaining regulatory approval. Other teams like commercial, medical affairs, HEOR and market access need to work more closely or effectively with clinical teams to ensure that the trial’s broader access objectives are met. However, the right balance is required as trial designers also face the challenge of trying to simplify clinical protocols to maximize investigator engagement, patient recruitment, retention and trial performance. Adding complex health economic endpoints into a trial’s design can often be nice in theory, but counter-productive. Increasing trial complexity is also expensive, but hearing “insufficient evidence” from payers is usually a lot more so. Engaging with patient groups during early-phases is also crucial. If qualitative, patient-relevant outcomes and patient preferences can be integrated into a clinical study, the higher the chance of favourable access. This “Clinical Evidence” stream will be looking at how to improve the performance of clinical development to ensure that economic endpoints are measured and hopefully achieved, to avoid costly mistakes, delays or rejection. The objective is to ensure that the best possible evidence can be presented to payers at launch, so truly high-value drugs can achieve funding and access to patients with unmet need, with maximum urgency.

Speaker List - Stream 2

Lead, EMEA Market Access
Astellas Pharma, UK

Director, Health Technology Assessment & Outcomes Research
Pfizer, Germany

Chair, Consumer Forum
National Cancer Research Institute, UK

Technical Analyst, NICE Scientific Advice Program
National Institute for Health and Care Excellence, UK

Advisor to the President, Director, International Affairs
HAS, Haute Autorité de Santé, France

Associate Professor, Economic Evaluations in Health Care
Institute of Health Policy & Management (iBMG)
Institute for Medical Technology Assessment (iMTA)
Erasmus University Rotterdam
, Netherlands

Global Market Access Manager
Norgine, UK

Global Market Access & Health Outcomes Manager
Almirall, Spain

The Italian pharmaceutical market is one of the world’s largest, and a relatively older population ensures that the demand for pharmaceuticals and healthcare in general is increasing further. Yet the path to market and patient access is always very complex and the typical prices and reimbursement-levels for innovative drugs are often substantially lower that Italy’s European neighbours, whilst approval is also a much slower process. The Italian healthcare sector is very diverse and decentralized.  AIFA at the national-level makes the initial regulatory and health technology assessment, which usually includes a mandatory Managed Entry Agreement (MEA). Unfortunately, so far the MEA is focused more on cost-cutting, than maximizing and rewarding improved health outcomes and patient value, but this could change soon. After AIFA’s decision has been made, reimbursement procedures, methodologies and decisions are always widely different amongst Italy’s 20 regions. For example, wealthy northern regions such as Lombardia, Veneto or Emilia-Romagna, or even individual provinces or hospitals, often have their own “micro-HTA” processes and they set aside extra budget for expensive drugs. Unfortunately, by contrast, patients in southern regions, often have to miss out on advanced care. However, decision-making in Italy is changing fast and the regions are sometimes having less control than before. AIFA is expected to lead some significant reforms this year. Harmonisation between the federal and regional levels is expected to increase, with more transparency, predictability and clarity to be the expected result. HTA guidelines should be standardized which would allow the development of a simpler value-dossier, based on a harmonized template. Unfortunately, the patient’s perspective today holds little influence in decision making in Italy, but this is likely to soon change. It is likely a more “value-based” decisions will be made including more sophisticated HTA, based on sound health economic evidence, as well as a more integrated, holistic approach to define “value” to the entire healthcare system and patients. This unique “Market Access in Italy” stream will look at how pharmaceutical companies can navigate the complex Italian national and regional decision making processes and methodologies today. It will also provide an insight into the imminent and likely move towards a more sophisticated, transparent, harmonised and “value-based” system in the near-future.

Speaker List - Stream A

Director, Lombardy HTA program and National Steering Committee for Medical Devices at Ministry of Health
Lombardy Region, Welfare Directorate

Director, The National Center for HTA
The National Institute of Health, Ministry of Health, Italy

Health Economist, Health Technology Assessment and Innovation Unit
Gemelli Teaching Hospital, Rome, Italy

Former Member, The Regional HTA Committee of Lombardy, School of Economics and Management
LIUC University, Italy

Payer Evidence Leader, Market Access
Roche, Italy

Director, Country Market Access Head
Sanofi, Italy

This stream will feature best practice case studies of designing, collecting & presenting HEOR studies and economic models of products’ therapeutic and economic benefits to both enhance internal decision-making and value-demonstration to external stakeholders. Methodological robustness, realistic assumptions and local-level customisation will be discussed as well as the extent of data depth and breadth which HTAs, Payers & Hospitals require from their perspective to make the right reimbursement decision.

Speaker List - Stream B

Associate Director Market, Access and Pricing - EMEA
Astellas Pharma, UK

Senior Director, HEOR Excellence
Novartis, USA

Professor of Health Economics
MIUR - Italian Ministry of Research and Education

Head of Patient Access
Novartis, Italy

Senior Economist
Office of Health Economics, UK

Program Director, Executive MBA Healthcare Management
SRH University, Berlin (SRH Hochschule), Germany

Senior Economist 
Office of Health Economics, UK

Senior Scientist
RAND Health, USA

Senior Manager Market Access & Value Added Medicines
Medicines for Europe, Belgium

Associate Professor, Economic Evaluations in Health Care
Institute of Health Policy & Management (iBMG)
Institute for Medical Technology Assessment (iMTA)
Erasmus University Rotterdam
, Netherlands

 

This event will provide all delegates the chance to meet one another through our many networking opportunities. With pre-event, mid-morning and mid-afternoon breaks as a standard, this event will also feature a complimentary networking dinner for all participants.

This evening will allow you to meet with our expert speaker panel who represent many stakeholder groups in a less formal setting. Our networking lunches will also allow you plenty of time to meet with your peers and colleagues whilst you refuel through the event.

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