Get Adobe Flash player
Partnering to Accelerate Access to Therapy Access Through Partnership – A Stakeholder Dialogue Mary Baker, 1 Tom Isaacs, 2 Reijo Salonen, 3 Damien Bové, 4 Ken Paterson 5 and Angelo Antonini 6 1. President, European Brain Council and Immediate Past President, European Federation of Neurological Associations, Brussels, Belgium; 2. Co-Founder, Cure Parkinson’s Trust, London, UK; 3. Senior Vice President, Research and Development and Chief Medical Officer, Orion Corporation, Espoo, Finland; 4. Chief Regulatory Consultant, IDA Consultants Ltd, Doncaster, UK; 5. Chair, Scottish Medicines Consortium, Glasgow, UK; 6. Director, Parkinson Unit, IRCCS San Camillo, Venice and University of Padua, Padua, Italy Abstract A major barrier to optimal care in Parkinson’s disease (PD) is the many years it takes for patients to gain access to new therapies and the best neurological services. A new treatment has to overcome many hurdles to become a clinically and cost-effective new therapy for patients, for example, gaining regulatory approval and reimbursement. Sharing opinions between the industry, neurologists, patients and other stakeholders about the benefits and risks of new treatments is important in influencing this process. The complex chain of events that currently characterises the development of new treatments for PD could be enhanced and accelerated by group discussions and collaborative care – right from the outset of the development process. Developing the process in this way would optimise patients’ receipt of the best treatments in a timely manner. Keywords Parkinson’s disease, access to new therapies, shared decision-making, regulatory approval, patient advocacy Disclosure: Mary Baker has received honoraria for attending healthcare advisory boards for GlaxoSmithKline (GSK), Novartis, Roche, Bayer, Lundbeck, Pfizer, Medtronic, Celgene and Boehringer Ingelheim. Reijo Salonen is an employee of Orion Pharma. Damien Bové has received payment for consulting services from NXPharmaGen Development Corporation, Duopoly Pharma, Bio-Botanica – Natures Answers, United Therapeutics, Nucana BioMed, General Resonance, Leeds University, Edinburgh University, Aberdeen University and Ethical Nicotine Solutions. Angelo Antonini has received honoraria for consulting services and symposia from Abbott, Boehringer Ingelheim, GSK, Lundbeck, Union Chimique Belge (UCB), Novartis and Merck Serono. Tom Isaacs and Ken Paterson have no conflicts of interest to declare. Acknowledgements: The V International Forum on Parkinson’s Disease (Helsinki, Finland, 6–7 May 2011) was funded by an unrestricted educational grant from Abbott. Abbott funded the development of this supplement by ESP Bioscience (Crowthorne, UK). Emily Chu and Nicole Meinel of ESP Bioscience provided medical writing and editorial support to the authors in the development of this publication. Abbott had the opportunity to review and comment on the publication’s content; however, all decisions regarding content were made by the authors. Received: 22 June 2012 Accepted: 6 July 2012 Citation: European Neurological Review, 2012;7(Suppl. 1):36–8 Correspondence: Angelo Antonini, Parkinson Unit, IRCCS San Camillo, Via Alberoni 70, 30126 Venice, Italy. E: With an ageing European population comes an ever increasing societal burden of brain diseases. These illnesses, if managed sub-optimally, cause terrible distress and consume a major proportion of the budgets of healthcare systems. Societal changes also contribute to the growing requirements for the care of those with brain disease. For example, women were traditionally the care-givers in the family structure whose caring was freely given, but their role has changed. Thus, there is an increasing number of people with neurological illness and a decreasing number of care-givers. In addition, the longer we live, the more diseases we acquire. 1 Most patients with brain disease are likely to be taking several different types of drugs. There is also migration across Europe on a larger scale than ever before, but not one country has developed a culturally-competent care programme. In addition, access to medication is very variable: in some countries, there is access to medication and a reimbursement system, while in others, there is access but no reimbursement, or no access to medication at all (data from the National Institute for Health and Clinical Excellence 2 ). Furthermore, the rules for access and reimbursement are not transparent and vary from country to country, sometimes even between different regions within one country. After Europe-wide approval, reimbursement often takes years to obtain and 36 is sometimes not achieved at all, and this is generally a longer process than regulatory approval. Thus, access to Parkinson’s disease (PD) healthcare professionals and medication needs to be improved. In summary, there is a need to develop strategies to optimise the quality of life of people with PD, but a major obstacle to optimal care in PD is the length of time it takes for patients to have access to new treatments and the best neurological services. This differs considerably across Europe, but is many years wherever the person lives. Many complex barriers have to be overcome in the process a new treatment goes through from the laboratory bench to regulatory approval, reimbursement, and becoming a clinically and cost-effective new therapy for patients. The barriers to access and the role of partnership between stakeholders in overcoming some of these barriers are discussed here in the context of a hypothetical scenario. A Hypothetical Scenario Imagine a fictional country where an imaginary new potential treatment for PD, called Doparestore, has been developed by a fictional company called SimuloPharma. Doparestore must pass a process of review by an imaginary regulator, the Agency for Review of Therapeutic Advances (ARThA), and then by the health technology assessor (HTA), called the © TOUCH BRIEFINGS 2012