Early Access to Medicines Scheme
Recognising that the process to authorize medicines is very long, expensive and challenging, especially for smaller companies with greatly limited funding, the Early Access to Medicines Scheme was introduced in March 2015. The programme aims to give patients with a life threatening or seriously debilitating condition when there is no other treatment available to them access to promising new drugs that have yet to go through the full licensing process. The Medicines and Healthcare Products Regulatory Agency (MHRA) makes decisions about these medicines using its Promising Innovative Medicine designation which can bestow an early signal that the medicine may be a possible choice for the EAMS scheme. After further investigation, if the MHRA decides that doctors can prescribe the drug, the positive scientific opinion lasts for one year, with the potential to be renewed.
U-turn over prostate cancer drug after price change Patients with prostate cancer in England will now have early access to a drug that can delay the need for chemotherapy. The National Institute for Health and Care Excellence now agrees that abiraterone is affordable. It had previously said the treatment was not cost-effective for the NHS until cancers were more advanced. The drug costs £3,000 a month, but a lower price has been agreed with the manufacturer Janssen. Abiraterone, also known as Zytiga, is a hormone therapy, and unlike chemotherapy which kills the cancerous cells, it stops more testosterone from reaching the prostate gland to stifle the tumour.
BBC News March 21, 2016
UK kidney cancer patients get early access to BMS’ Opdivo UK patients with advanced kidney cancer are being given the opportunity to be treated with Bristol-Myers Squibb’s investigational immunotherapy Opdivo ahead of a licensing decision in Europe. Opdivo (nivolumab) has been accepted by the Medicines and Healthcare Regulatory Products Agency onto the country’s Early Access to Medicines Scheme for patients with renal cell carcinoma, giving them the chance to access the drug before it is officially approved by regulators
PharmaTimes February 12, 2016
Pfizer’s Ibrance on track for UK early access scheme Pfizer UK’s Ibrance has cleared the first hurdle to joining the UK’s Early Access to Medicines Scheme after being awarded ‘Promising Innovative Medicine’ status by the Medicines and Healthcare Regulatory Agency. Ibrance (palbociclib) is being developed as a treatment for hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced/metastatic breast cancer.
PharmaTimes January 22, 2016
EAMS gave 500 UK melanoma patients early access to Keytruda UK patients with advanced melanoma were among the first in the world to access MSD’s Keytruda last year because of the country’s early access to medicines scheme. Keytruda (pembrolizumab) was the first medicine to be awarded a positive scientific opinion and thus accepted onto the EAMS scheme back in March, offering patients with limited options a new treatment alternative ahead of a licensing decision in Europe.
PharmaTimes January 4, 2016
Genomics England— 100,000 Genomes Project
Genomics England is a wholly owned company of the Department of Health set up to deliver the 100,000 Genomes Project. The project will sequence 100,000 genomes from around 70,000 NHS patients and their families focusing on rare diseases and common cancers. The aim is to transform patient care with more precise diagnosis and treatments. The project will study how to best use and interpret genomics in healthcare and kick-start a UK genomics industry. This is currently the largest national sequencing project of its kind in the world.
Scottish investment in genomic medicine Minister for Sport, Health Improvement and Mental Health, Jamie Hepburn has announced a £6 million investment in the Scottish Genomes Partnership (SGP), ahead of a parliamentary reception to mark Rare Disease Day. The SGP is a collaboration of Scottish Universities and the NHS capitalising on £15 million investment in whole genome sequencing technology by the Universities of Edinburgh and Glasgow.
Genomics England March 1, 2016
Illumina, Icon land data deals with UK mass genome sequencing program … Genomics England has revealed more details of what it is trying to achieve in collaboration with Illumina. The plan is to create a platform that automates the interpretation of genomes, making it simpler for clinicians and researchers to draw conclusions from the data. Genomics England wants the tools to have open application programming interfaces so its other bioinformatics partners can continue to provide services. … Icon has landed itself the role of data management partner. In this capacity, Icon will apply its capabilities to the validation of clinical data from participants in the 100,000 Genomes Project.
FierceBiotechIT February 12, 2016
First children receive diagnoses through 100,000 Genomes Project Both Georgia Walburn-Green and Jessica Wright had rare, undiagnosed, genetic conditions when they joined the Project. Whole genome sequencing pinpointed the underlying genetic changes responsible for their conditions. As well as removing a large amount of uncertainty for the families, the results stand to have a major impact on many areas of their lives including future treatment options, social support and family planning. They also have the potential to help many more children with undiagnosed conditions who may be tested for these genetic mutations early on and be offered a diagnosis to help manage their condition most effectively.
Genomics England January 11, 2016
Northern Ireland joins the 100,000 Genomes Project Health Minister in the Northern Ireland Executive, Simon Hamilton, today announced £3.3m investment to create a Northern Ireland Genomic Medicine Centre that will provide rare disease patients with a much earlier and more accurate diagnosis.
Genomics England October 29, 2015
Innovate UK (formerly the Technology Strategy Board) is the UK’s innovation agency. An executive non-departmental public body sponsored by the Department for Business, Innovation & Skills. Works with people, companies and partner organisations to find and drive the science and technology innovations that will grow the UK economy. Work with companies to de-risk, enable and support innovation. Fund the strongest opportunities, connect innovators with the right partners they need to success, help innovators launch, build and grow successful businesses. Innovate UK has established four sector groups, including health and life sciences.
Innovate UK’s Delivery Plan for the year 2016 to 2017 shows how it will invest £561 million, with a more focused approach to innovation support.
Innovate UK has long played a pioneering role in connecting businesses with ‘lead customers’ for their new ventures – for example in the public sector through the Small Business Research Initiative (SBRI) programme – and this will continue.
Innovate UK’s network of Catapult centres has been established to support and encourage innovation and growth across the UK by transforming its capability for innovation in specific areas and helping to drive future economic growth. The three Catapult Centres focused on the life sciences are:
Cell and Gene Therapy Catapult works to drive the growth of the cell and gene therapy industry by helping cell and gene therapy organisations translate early stage research into commercially viable and investable therapies.
Medicines Discovery Catapult will operate at the earliest stages of medicines development, developing and validating new technologies for testing of potential medicines before human trials and supporting the key UK strength in pharmaceutical, biotechnology and contract research organisations.
Precision Medicine Catapult is focused on making the UK the most compelling location in the world for the development and delivery of this new targeted approach with priority given to capturing value in the UK in therapeutic, diagnostics, algorithm and data companies and demonstrators with the NHS.
NHS Innovation Acceleration (NIA)
The aim of the NIA is to deliver on the commitment detailed within the Five Year Forward View – creating the conditions and cultural change necessary for proven innovations to be adopted faster and more systematically through the NHS, and to deliver examples into practice for demonstrable patient and population benefit. In its first year, the 17 fellows who joined the programme received support to take their high impact innovations to more than 60 NHS organisations, benefited more than three million patients, and helped attract funding of over £8m. After this successful first year, NIA 2016 will be open for applications from healthcare innovators on Friday 17 June 2016, closing on 1 August 2016. This round of applications will focus on three challenges based on population health needs: prevention, early intervention and long-term condition management, with successful applicants announced in October.
NHS announces new funding route for medtech innovations The programme is designed to cut the hassle experienced by clinicians to get uptake across the NHS by removing the need for multiple local price negotiations. Instead, the new Innovation and Technology tariff category will guarantee automatic reimbursement when an approved innovation is used, while also allowing NHS England to negotiate ‘bulk buy’ prices for medtech devices and apps which can help patients with conditions such as diabetes, heart conditions, asthma, sleep disorders and other chronic health conditions.
Health Business UK June 17, 2016
Three million using health innovations under NHS scheme …tapping into new apps, safety devices, on-line networks, and a stream of other new technologies and services during the first nine months of a pioneering programme designed to introduce new innovations to the NHS. The NHS Innovation Accelerator programme was launched in July 2015 with the over-riding goal of creating the conditions and culture changes necessary to accelerate adoption of cutting-edge solutions and thus boost patient care.
PharmaTimes April 20, 2016
The Clinical Research Network (CRN)
The Clinical Research Network (CRN) is part of the National Institute of Health Research, the research arm of the NHS, and is wholly funded by the Department of Health in the UK. This unique initiative provides the infrastructure that allows high-quality clinical research to take place in the NHS, so that patients can benefit from new and better treatments. The organisation helps researchers to set up clinical studies quickly and effectively; supports the life sciences industry to deliver their research programmes; provides health professionals with research training; and works with patients to ensure their needs are at the very centre of all research activity.
Record-Breaking Trial Recruitment Now a Reality A unique, wholly government-funded initiative has made the UK the hot ticket in clinical trial recruitment. The National Institute of Health Research’s Clinical Research Network, wholly funded by the Department of Health in the UK, is a unique initiative aiming to aid researchers to set up trials quickly and easily, by working closely with pharma, healthcare professionals, and of course, patients.
Eye for Pharma April 14, 2016
The Avon Longitudinal Study of Parents and Children (ALSPAC)
Based at the University of Bristol, the Avon Longitudinal Study of Parents and Children, also known as Children of the 90s, is a world-leading birth cohort study that has been charting the health of 14,500 families in the Bristol area in order to improve the health of future generations. Between April 1991 and December 1992 we recruited more than 14,000 pregnant women into the study and these women (some of whom had two pregnancies or multiple births during the recruitment period), the children arising from the pregnancy, and their partners have been followed up intensively over two decades. ALSPAC is the most detailed study of its kind in the world, providing the international research community with a rich resource for the study of the environmental and genetic factors that affect a person’s health and development. ALSPAC aims to inform policy and practices that will provide a better life for future generations.
UK Biobank is a major national health resource with the aim of improving the prevention, diagnosis and treatment of a wide range of serious and life-threatening illnesses – including cancer, heart diseases, stroke, diabetes, arthritis, osteoporosis, eye disorders, depression and forms of dementia. UK Biobank recruited 500,000 people 40-69 years of age in 2006-2010 from across the UK to take part in this project. The recruits have undergone measures, provided blood, urine and saliva samples for future analysis, detailed information about themselves and agreed to have their health followed, including their lifestyle, weight, height, diet, physical activity and cognitive function, as well as genetic data from blood samples. Linkage to a wide range of health records is also under way, including data from general practices. Over many years this will build into a powerful resource to help scientists discover why some people develop particular diseases and others do not.
UK Biobank launches world’s largest imaging project to shed new light on major diseases It will create the biggest collection of scans of internal organs, and transform the way scientists study a wide range of diseases, including dementia, arthritis, cancer, heart attacks and strokes. The £43m study will involve imaging the brain, heart, bones, carotid arteries and abdominal fat of 100,000 current participants of UK Biobank, a visionary project set up in 2006 by the MRC & Wellcome Trust to create a research resource of half a million people across the UK to improve health.
Medical Research Council April 14, 2016