Your monthly round-up of market access news No Images? Click here What's new to MAP in NovemberISPOR 2016 - ViennaReview of Health Technology Assessment Requirements for Rare Diseases Across European CountriesRare diseases have become an important area of focus over the past decade due to the number of untreated rare conditions. The objective of this research was to review Health Technology Assessment (HTA) requirements currently in place for the reimbursement of rare diseases in 18 European countries, and to identify and compare differences between their approaches. Review of National Policies for Rare Diseases Across EU CountriesIn 2009 the European Commission (EC) released recommendations on actions in the field of rare diseases. The objective of this research was to review the policies in place for rare diseases before the EC recommendations, and evaluate levels of achievement of the policies in meeting the EC recommendations, in particular, focusing on EU collaborative research, neonatal screening and the number of rare disease registries per country. Review of the Recommendation made by NICE and SMC Relating to Treatments for Rare DiseasesThere are currently differences in the way that the NICE and SMC process treatments for rare diseases. Given the current and proposed differences in process for treatments for rare diseases, the objective of this research was to review all recommendations made by NICE and SMC for treatments of rare diseases to evaluate whether one is more favourable. Predicting Orphan Designation and Marketing Authorisation Based on a Review of the European Medicines Agency Orphan Disease RegisterCurrent projections of European and worldwide expenditure on orphan drugs are contrasting. The aim of this research was to identify trends in the orphan drug designations (ODDs) and marketing authorisations (MAs) awarded by the European Medicines Agency (EMA) following the introduction of the EU Regulation on orphan medicinal products in 2000. A Systematic Literature Review of Health Economics Evaluations of Treatments for Rare DiseasesA systematic literature review (SLR) was conducted to critically appraise the methodological approaches frequently taken when developing health economic evaluations of treatments for rare diseases, and to assess the potential impact of data scarcity. The Consequences of Brexit in Spain - A Life Sciences PerspectiveMAP's experts have written an article to help the Spanish life sciences industry assess the consequences, threats and opportunities that may arise following the UK's vote to leave the EU. This article has been published in the Spanish Health Economics Association Bulletin (Asociación de Economía de la Salud, AES).
Telemedicine and TelehealthTelemedicine or telehealth are used to describe the electronic exchange of information between sites with the view to improve the health of the patient. This page, which is new to MAP Europe, explores the different forms that telemedicine can take and where each of these types of technology can be applied in the healthcare system.
Brexit - Financial PlanningThe UK has much to offer as a location for new product development, including an established pharma infrastructure, a good talent pool and favourable IP protection, however, Brexit raises a number of uncertainties which will not be addressed until the negotiation process is complete. This page, new to the UK site on MAP, provides an overview of the current economic situation following Brexit to help companies with their financial planning through this uncertain time. Build a Business Plan for Your AppCreating a business plan for your health app can help you to devise a structured development programme for your device by analysing areas such as the market potential of the device, the target audience, the disease area, competition, funding and risks associated with it’s development. This presentation which is new to the MAP Europe site provides a useful breakdown of the points that you should consider when designing a business plan for your device. MAP BioPharma Launches MAP ItalyNovember Market Access NewsNHS Chooses First MedTech/App Innovations for NHS Payment SchemeThe first innovations to join a new fast track payment scheme designed to accelerate uptake of cutting-edge technologies have been chosen. The innovations chosen target women giving birth, patients with chronic lung problems, men having urological surgery, and acutely ill inpatients, and these six areas will be the first to benefit from the new NHS Innovation and Technology Tariff. Smartphone app launched to improve NHS patient careA new mobile app has been launched to help NHS patients monitor their long-term health conditions, reported the British Journal of Healthcare Computing. The app allows users to send health information to clinicians and in return receive dosage instructions, as services include the tracking of the international normalised ratio (INR) and blood glucose levels, heart rate, blood pressure, in addition to oxygen levels and weight. NHS Improvement and NHS England Publish Consultation for the 2017/2019 National TariffNHS Improvement and NHS England have today (2nd November) published the statutory consultation for the 2017/18 to 2018/19 national tariff. Due to the requirement to publish proposals as soon as possible the impact assessment report has yet to be finalised. It is currently being completed and will be published in around a week’s time. As the impact assessment is an important part of the consultation the 28 day period will only start when it is published. Therefore, the consultation period will run from 31st October until midnight on 6 December. A survey to gain feedback on the tariff proposals has been published. If you are a commissioner or provider delivering nationally priced services you will be able to accept or reject the method used to set the tariff. The survey can be found here. Support for Medical Device and Diagnostics Clinical Studies, Evaluations and Evidence GenerationThe National Institute for Health Research (NIHR), which is funded by the Department of Health was set up to help improve the health and wealth of the nation through research. The NIHR Office for Clinical Research Infrastructure (NOCRI) supports medtech companies with early phase research by signposting you to and facilitating meetings with NIHR expertise, facilities and funding streams (e.g. for proof of concept studies, product development, study protocol design, data collection and management). The NIHR has released a new brochure which showcases their experimental medicine clinical research facilities (CRF). This brochure compliments the existing NIHR MedTech brochure which can be accessed here. MAP Summary of the Autumn StatementThe Chancellor, Philip Hammond, delivered the autumn statement on 23 November 2016. The Chancellor set himself three main objectives: • To take a positive but realistic approach to the consequences of the UK leaving the EU • To maintain the process of cutting the level of public sector net borrowing (PSNB) • To take steps to meet some of the most urgent departmental demands UK PM to Promise £2bn a Year for Scientific ResearchThe Prime Minister, Theresa May, delivered her speech to the CBI. Boosting research, development and innovation was a key theme and the speech confirmed that the Chancellor will announce an extra £2bn investment in R&D by the end of the Parliament. “We will commit to substantial real terms increases in government investment in R&D – investing an extra £2 billion a year by the end of this Parliament to help put post-Brexit Britain at the cutting edge of science and tech.” More News:For more news, events and consultations, please click here.Merry Christmas and a Happy New Year from all of us at MAP! |