Your monthly round-up of market access news No Images? Click here What was new to MAP in FebruaryIndividual Patient Funding Requests (IPFR) in WalesEach year, requests are received for treatments that are not routinely available within NHS Wales as they fall outside of the typically funded range of services. These requests are referred to as Individual Patient Funding Requests (IPFR) and are made to an individual health board or the Welsh Health Specialised Services Committee (WHSSC). Although such requests are more commonly for access to drugs, they can be made for access to devices too. This page explains the different types of IPFR that are available in Wales and the policies that are in place for them. MAP Summary of Independent Review IPFR Process in WalesIn 2016, Vaughan Gething, Cabinet Secretary for Health, Wellbeing and Sport in the Welsh Government commissioned an independent review of the Individual Patient Funding Requests (IPFR) process in Wales. MAP have provided a summary of the review and have highlighted areas which are likely to impact the process. We have also provided insights as to whether we believe these changes are likely to be positive. NHS England Methods for National Service SpecificationsNHS England has published a document which sets out the methods for the development of national service specifications. These service specifications are an important part of the NHS contract between NHS England and providers of specialised services. The process consists of three phases:
Each of these phases have been covered in detail on the National Service Specifications page, which is new to the England section on the MAP UK site. Individual Funding Requests (IFRs) in EnglandIFRs can only be requested by clinicians for patients with exceptional clinical circumstances that are not already covered by existing policies. The process can be time consuming and is only appropriate if potential patient numbers are small, or the annual cost of treatment per individual is below a threshold. This page on the MAP UK site explains the criteria for IFRs, the steps in the IFR process and provides insights on the likely success of IFRs in England. NHS England Methods for National Clinical PoliciesNHS England has redefined the methods for the development of national clinical policies. Clinical policies are used to determine NHS England’s commissioning position on new treatments and technologies for patients or to revise existing treatments and technologies. Clinical policies are developed via the Clinical Reference Groups (CRGs) following a standard process called the Clinical Policy Pipeline which is comprised of three phases:
Each of these phases have been covered in detail on the National Clinical Policies page, which is new to the MAP UK site. Government Responds to Science and Technology Committee’s ReportsThe Government has published its response to the Science and Technology Committee’s Reports “A Time for Boldness: EU Membership and UK Science After the Referendum” and “EU Membership and UK Science”. In the report, the Government responded to a number of recommendations made by the committee. MAP have created a summary of the response which highlights key areas of development for Biopharmaceutical and MedTech companies. February Market Access NewsBMG and BfArM start Innovation Office as a Contact Point for Start-UpsThe Federal Institute for Drugs and Medical Devices ( BfArM ) has set the goal to increasingly offer support to promising new drugs and medical devices from small start-ups and research institutions so as to ensure that they receive early advice and assistance and do not fail due to a lack of regulatory experience. With this goal in mind, BfArM, together with the Federal Ministry of Health ( BMG ) have launched the Innovation Office, which will provide early regulatory advice to developers of drugs and medical devices. To read more about this, please click here. (In German) NHS England Specialised Commissioning Arrangements – Acting Director Appointed to Replace Jonathan FieldenThe Health Service Journal has reported that Jonathan Fielden, National Deputy Medical Director and Director of Specialised Commissioning is away from his NHS England role. There is limited information available at this time but the article states that they believe that Dr Fielden has been off work since January. This is very important for any companies engaged in negotiations with NHS England. In the article, an NHS England spokesperson confirmed that John Stewart has become acting Director of Specialised Commissioning. His permanent role is Director for Strategy and Policy, Specialised Commissioning. Industrial Strategy Investment in Science, Research and InnovationThe Minister for Universities, Science, Research and Innovation, Jo Johnson has today confirmed Sir Mark Walport’s appointment as Chief Executive designate of UK Research and Innovation. Sir Mark will now work closely with the UKRI Chair Sir John Kingman and the research and innovation communities across the UK to shape the new organisation over the coming months, delivering on the Industrial Strategy proposals for investing in science, research and innovation in the UK. In addition, Business and Energy Secretary Greg Clark has announced £15m of government grants to back 125 cutting-edge research and development projects across the country. This is further to the launch of the Industrial Strategy last week. Projects receiving funding cover a wide range of themes including rapid charging for electric vehicles, 3-D printing and drone technology, with each concept designed to help businesses develop new products, processes and services with commercial potential. NHS England Publish New Guidelines on Tackling Conflicts of InterestNHS England has published new guidelines which are designed to strengthen the management of conflicts of interest within the NHS, to “ensure that the NHS is a world leader for transparent and accountable healthcare”. The guidelines allow for small gifts such as chocolates or cards for a nurse to be accepted but gifts over £50 will need to be declared. The guidance is applicable across CCGs, NHS Trusts and NHS England. Areas that are highlighted as risking conflicts of interest include sponsored events, sponsored research and sponsored posts. This might include a range of pharmaceutical sponsored research activities. Under the terms of hospitality, it is stated that meals and refreshments under £25 can be accepted, those valued between £25 and £75 can be accepted but those over £75 should be refused unless there are exceptional circumstances and senior approval is gained. The guidance comes into force from 1st June 2017. Proposal on Increases and Additions to Current Medical Devices Fees – Consultation ConcludedThe consultation on the proposal on increases and additions to current medical devices fees has now closed. The majority of respondents were content with the fee changes proposed. However, the MHRA noted the concerns over increasing costs and aims to minimise the burden on businesses by reviewing its fees regularly. Discontinuation of NICE Diagnostic Services GuidelineAs a registered stakeholder following the progress of the NICE guideline, Diagnostic Services, NICE have informed MAP that the work on this guideline has now been discontinued. More News:For more news, events and consultations, please click here. |