Your monthly round-up of market access news
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This section on the MAP UK site is about how to successfully engage with members of parliament. Here you can learn where to identify and how to prioritise parliamentary contacts and government stakeholders. This section also explains how to develop and track your meetings programme as well as providing a template approach letter to help you engage with MPs.
The country overviews on the MAP Europe site have been updated to provide information on topics such as:
The MAP Germany site has been updated across a number of pages, particularly, the pricing and reimbursement section which now includes additional information about the reimbursement of innovative medical devices in the inpatient sector which are not covered by Diagnosis-Related Groups (DRGs).
This section on the MAP France page addresses a number of frequently asked questions that medical device manufacturers have about placing a device into the French market. Some of the questions that this page answers include:
This table on the UK site contains information on all published MIBs, with positive, neutral and negative comments highlighted using a traffic light system. This table is also searchable and is useful for identifying technologies with MIB guidance that may resemble your product.
In the Department of Health, Lord Prior, Parliamentary Under-Secretary of State, is the key Minister. His responsibilities include medicines and industry; cancer drugs fund; life sciences industry; specialised commissioning; academic life sciences centres; and NHS procurement.
Although he does not have a science background, as a Health Minister in the House of Lords since 2015 he has to answer all healthcare issues raised in the Lords, including life sciences. He is sensible and level headed, and has spoken seriously about the science research challenges in the UK after the referendum.
Nicola Blackwood, also Under-Secretary of State, is focussing on Public Health England, which alone is pretty much a full-time job. With the remainder of her time she has to cover sexual health, mental health services, prison health services, R&D and global health security, as well as life sciences innovation, genomics and anti-microbial resistance. This is a formidable list, so it would be sensible to expect Lord Prior to take the overall lead for life science issues.
In the new Department for Business, Energy and Industrial Strategy, Jo Johnson, Minister of State for Universities and Science, is the key person. His responsibilities include research funding, public engagement in science, STEM (science, technology, engineering and mathematics) skills; open access/research data and relations with Government Office for Science. He is seen as ambitious, steady and hard-working, eschewing much personal publicity. However, he has further responsibilities for higher education, and innovation and commerce, and is also based in the Department of Education, so he has limited time for life sciences.
The Office for Life Sciences (OLS) has confirmed that, although it is still based at the Department for Business, Energy and Industrial Strategy, it will answer to Jo Johnson there and to Lord Prior and Nicola Blackwood at the Department of Health.
In the new Department for International Trade, Greg Hands MP, the Minister of State for Trade and Investment, leads on high value export and investment campaigns in five sectors, one of which is healthcare and life sciences.
NHS England has today announced the appointment of 40 Clinical Reference Group (CRG) clinical leads to drive its reform of specialised services.
The three year role of Clinical Lead, will include chairing the programme’s Clinical Reference Group and supporting local CCGs and trusts to implement changes to care pathways.
NICE intend to introduce charges to their HTA processes. They are now inviting industry trade associations to comment on the proposals set out here.
The prices proposed can be found on the link below.
Annual 2% efficiencies by 2020-21 would not be enough to close the funding gap, meaning providers must find savings of 4% next year and 3% in 2018-19 – but because such sustained efficiencies have never been achieved, money will have to be taken from the sustainability and transformation fund (STF) to balance NHS deficits in the meantime.
NHS England will not be signing off on sustainability and transformation plans (STPs) unless they are supportive of GPs.
NHS England said that commissioners in each area were allowed to decide themselves how they would engage with the workforce in their area. However, it said it expects “robust engagement” from commissioners, including with frontline GPs, while emphasising that the plans will have to support general practice.
NHS England has invited 26 acute trusts to bid for grants (worth up to £10m each) which will allow them to become centres of digital excellence.
To access the £100m funding pot, trusts will need to demonstrate that they can deliver comprehensive use of electronic patient records, where they are available to doctors and nurses in real time and can be accessed by patients online.
The new Innovation and Technology tariff, which has been designed to provide a clear “route to market” for innovations has extended its deadline to the 16th August in order to ensure that the best devices and apps reach NHS patients.
The MHRA have updated their guidance issued to help identify the apps which are medical devices and make sure they comply with regulations and are acceptably safe.
To read more about this, please click here for more details.