Your monthly round-up of market access news No Images? Click here What's new to MAP in OctoberAccelerated Access ReviewThe long awaited Accelerated Access Review (AAR) final report was published on 24th October and we have created a summary of the key topics including: the accelerated access pathway, the new strategic commercial unit, products with incremental benefits, NICE and Academic Health Science Networks (AHSNs). The French Health SystemThis section on the MAP France site, provides an easy FAQ-style introduction to the French healthcare system. On this page, subscribers can learn about how the healthcare system is funded, who is responsible for co-ordinating the health system and how patients are reimbursed for visits to GP's, Specialists or hospital stays. Part IX of the Drug TariffNew to the MAP site, this page on the Drug Tariff provides an explanation of what the Drug Tariff is, provides tips on how to access the information that you need within the Tariff and outlines the various sections of Part IX of the Tariff. This section also provides a useful guide on how to apply to have your medical device listed under Part IX of the Tariff as well as MAP insights on common problems faced by manufacturers during the submission process. MAP BioPharma Launches MAP ItalyOctober Market Access NewsAccelerated Access Review PublishedThis Accelerated Access Review sets out a bold new vision of better, more cost efficient and faster adoption of innovation, through:
House of Commons Library Publishes Briefing Paper on the Health Service Medical Supplies (Costs) BillThe HoC Library have published a briefing paper on the Health Service Medical Supplies (Costs) Bill. The Health Service Medical Supplies (Costs) Bill was introduced on 15 September 2016. It is tabled to have its Second Reading on the 24 October 2016. The Bill intends to make a number of amendments to the National Health Service Act 2006 on matters related to the control of medicine prices. EMA Transparency: Clinical Trials PublishingThe European Medicines Agency (EMA) has proactively started publishing clinical trials data, with the release of clinical reports for 2 drugs, Kyprolis and Zurampic, via a new online database. Clinical trials transparency has been a concern of public health advocates and regulators for decades. Specifically, EMA says it will publish the clinical overview, summary and study reports, including data from several appendices (protocol and protocol amendments, sample case report forms and documentation of statistical methods) for all marketing authorisation applications, so-called Article 58 procedures, as well as applications for new indications and variations to already-approved drugs. Going forward, EMA says it will work to tackle the backlog of clinical reports for marketing authorisation applications and variations submitted after the policy went into effect (1 January 2015 for initial marketing applications and 1 July 2015 for variations). Fast Track Appraisal for New Treatments with ICERs under £10k and Higher Thresholds for HST Proposed by NICE and NHSENICE and NHS England have launched a consultation about the process for authorising new treatments and the introduction of an affordability test. Summary of the proposals
MHRA and Swissmedic Sign Memorandum of Understanding (MoU)The MHRA has signed a MoU with its Swiss counterpart, Swissmedic. The basis of the MoU is a shared approach to complex challenges and the promotion of each other’s regulatory frameworks, requirements and processes. Estates and Technology Transformation Fund – Schemes From 2016/17Local Clinical Commissioning Groups (CCGs) submitted recommendations to NHS England for Estates and Technology Transformation Fund back in June 2016. In 2016/17, it is planned that approximately 300 schemes will be supported, subject to due diligence checks. More News:For more news, events and consultations, please click here. |