Pharmaceutical Market Europe • December 2023 • 8-9

NEWS

Landmark UK medicines deal to save NHS £14bn

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The UK government, NHS England and the Association of the British Pharmaceutical Industry (ABPI) have agreed to a landmark deal that is set to save the NHS £14bn in medicine costs over the next five years.

The Voluntary Scheme for Branded Medicines Pricing, Access and Growth will provide patients with the latest life-saving treatments and boost the UK’s global position in advanced healthcare, technology and clinical research.

The agreement, which will run until 31 December 2028, will secure savings for the NHS to provide the best possible treatments and care for patients, grow the workforce and cut waiting lists.

Additionally, it will set a yearly cap on the total amount of sales allowed of branded medicines to the NHS annually, which will double from 2% in 2024 to 4% by 2027.

Medicines currently represent the second highest proportion of NHS spending worth £19.2bn, £14bn of which was branded, with the pharmaceutical industry paying back the NHS £2bn in rebates in 2022 to 2023.

As part of the agreement, a new affordability mechanism for older medicines will be introduced, which will be required to pay a top-up rate of 25% in addition to the older medicine rate of 10% if they have not seen price reductions.


Data reveals increase in antibiotic resistant infections

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New national surveillance data announced at the UK Health Security Agency (UKHSA) annual conference has demonstrated an increase in antibiotic-resistant infections and associated deaths in England.

Antibiotic resistance occurs when bacteria change and adapt to antibiotics over time. As a result, infections become harder to treat and the risk of serious complications, including bloodstream infections and sepsis, increases.

According to the latest data, an estimated 58,224 people in England had an antibiotic-resistant infection in 2022, marking a rise of 4% since 2021, and deaths due to severe antibiotic-resistant infections increased from 2,110 in 2021 to 2,202 in 2022.

Although antibiotic resistance occurs naturally, the inappropriate and excessive use of antibiotics can accelerate the process.

The use of antibiotics in England dropped from 2014 to 2020, with a significant decline in 2020 associated with the COVID-19 pandemic.

However, the latest data shows that total antibiotic prescribing rose by 8.4% in 2022 compared with 2021.

The increase in antibiotic prescribing has been partly attributed to decreased immunity and exposure to infections during the COVID-19 pandemic that may have underpinned the upsurge in the co-circulation of influenza, respiratory syncytial virus and group A streptococcus.


New WHO initiative to accelerate vaccine development

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The World Health Organization (WHO) has commissioned 16 ‘Vaccine Value Profiles (VVPs)’ to prioritise key endemic pathogens and accelerate vaccine development.

The VVPs are a result of collaboration between several pathogen and vaccine experts.

Led by the Product Development and Research team in WHO’s immunisation, vaccines and biologicals department, the aim of the VVPs is to advance the development of vaccines for pathogens that pose the biggest threat to public health and socio-economic burden, particularly in low- and middle-income countries.

The forthcoming supplement in the journal Vaccine will feature the VVPs of 16 pathogens with vaccines in late-stage clinical development to give comprehensive summaries of critical evidence and provide guidance for vaccine funding, research initiatives, and clinical and policy development strategies.

The supplement’s first volume will include the VVP for respiratory syncytial virus, alongside other profiles including Group B Streptococcus, cytomegalovirus and enterotoxigenic Escherichia coli norovirus, as well as a commentary on neglected tropical diseases.

A second volume will follow to include vaccines for Klebsiella pneumoniae or Neisseria gonorrhoea.

Dr Katherine O’Brien, director of immunisation, vaccines and biologicals at WHO, said: “We will leverage learnings from these VVPs to work in step with key stakeholders to accelerate vaccine development and ensure access, to fortify global health and improve equity.”


New UK research institute launched for motor neurone disease

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A new research institute aimed at discovering a cure and new treatments for motor neurone disease (MND) has been launched in the UK.

The UK Motor Neuron Disease Research Institute (UK MND RI) will bring together a virtual network of MND labs, clinical centres and researchers to carry out MND research across the UK.

Affecting one in every 300 people in the UK, MND is a neurodegenerative disease that affects the nerve cells in the brain and spinal cord.

Around one-third of patients with MND die within one year of diagnosis, and more than half within two years.

Sanofi-Aventis’ Rilutek (riluzole) is specifically licensed for amyotrophic lateral sclerosis, a fatal MND disease, in the UK.

Collaboratively, doctors, clinicians, scientists and people living with MND, along with funders and charities, will work to speed up drug discovery and drug development and aim to test potential treatments in clinical trials.

LifeArc, the MND Association, MND Scotland, My Name’5 Doddie Foundation and the National Institute of Health Research and Medical Research Council will fund peer-reviewed research programmes within the UK MND RI.

Institutions that are already involved in the new UK MND RI include King’s College London, the Universities of Sheffield, Edinburgh, Liverpool, Oxford and University College London.


Spinal stimulation implant offers new hope for Parkinson’s

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Researchers from the French National Institute of Health and Medical Research, the French National Center for Scientific Research and the University of Bordeaux in France, along with Swiss researchers and neurosurgeons, have successfully designed and tested a spinal stimulation implant to treat Parkinson’s disease.

Conducted in collaboration with the Swiss Federal Institute of Technology in Lausanne and the Lausanne university and hospital, the implant was tested to correct disabling gait disorders, which are associated with 90% of advanced Parkinson’s cases.

The implant directly stimulates nerve cells in the spinal cord responsible for controlling leg movement, as an alternative to deep brain stimulation, the standard surgical option to change electrical signals in the brain that cause symptoms of Parkinson’s.

After developing the spinal implant on primates, the researchers carried out surgery on a 62-year-old patient, which involved carefully imaging the spine with scans to determine an optimal site to implant electrodes.

The electrodes were then able to deliver electrical pulses to activate and control leg movement, and external sensors successfully sensed the body’s intention to move, triggering the electrical impulse to the spine and providing feedback to control this movement. Since the surgery, the patient’s gait looks virtually normal when the device is switched on.


Janssen reveals results for rheumatoid arthritis drug

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Janssen, a Johnson & Johnson company, has announced positive results from a mid-stage study of its investigational FcRn inhibitor in rheumatoid arthritis (RA).

The phase 2a IRIS-RA trial has been evaluating nipocalimab in adults with moderate-to-severe RA who have tested positive for anti-citrullinated protein antibodies (ACPAs) or rheumatoid factor (RF) and had an inadequate response or been intolerant to at least one anti-TNF therapy.

Approximately 13 million people worldwide are affected by RA, a chronic inflammatory disease that causes joint pain, swelling and stiffness, and in some cases, permanent damage and deformity in structural joint elements.

The presence of autoantibodies is a distinctive feature of RA, with ACPAs and RF being two autoantibody systems commonly used as aids for diagnosing and classifying the disease.

Results from IRIS-RA showed that nipocalimab reduced levels of circulating IgG antibodies, including ACPAs, indicating they may play a key role in driving RA disease activity.

Nipocalimab also demonstrated improvements in primary and secondary endpoints, and patients with higher baseline ACPAs had more than twice the placebo-adjusted Disease Activity Score 28 using C-reactive protein remission compared to the overall study population.

The data from the study establishes proof of mechanism for nipocalimab in RA and supports its progression into a combination study, Janssen said.