Drawing on a large and diverse national sample, researchers found that formulary rejections occurred frequently and, in many cases, resulted in treatment being delayed or never received at all. The findings underscore the persistent tension between efforts to control drug spending and patients’ ability to obtain the medications their clinicians prescribe.

Single-source branded drugs—medications available from only one manufacturer with no generic equivalent—can be particularly vulnerable to access problems when insurers decline to cover them under their formularies, the lists of drugs a health plan agrees to pay for.

The authors say the results highlight the real trade-offs patients face between cost and access, and point to the need for closer scrutiny of how formulary decisions affect the people who depend on these treatments.

The study was led by corresponding author Joseph F. Levy, PhD, of Johns Hopkins University. Additional details, including author affiliations, conflict of interest disclosures, and funding sources, are available in the full article (doi:10.1001/jama.2026.8702).

The June cycle also includes a significant update to the existing recommendation for nusinersen in spinal muscular atrophy, as well as a positive second appraisal for a CAR-T cell therapy in large B-cell lymphoma — a treatment pathway that continues to expand within the NHS.

Oncology

Tivdak recommended for cervical cancer

Tisotumab vedotin (Tivdak), an antibody-drug conjugate developed by Genmab and Pfizer (via Seagen), received a positive NICE recommendation on 11 June 2026 for previously treated recurrent or metastatic cervical cancer. Tivdak targets tissue factor, a protein highly expressed on cervical cancer cells, and delivers a microtubule-disrupting payload directly to tumour cells. The approval addresses a population with limited options following progression on first-line platinum-based chemotherapy.

Libtayo recommended for non-small cell lung cancer

Cemiplimab (Libtayo), developed by Regeneron, was recommended on 16 June 2026 for previously untreated non-small cell lung cancer (NSCLC) in patients whose tumours express PD-L1. Libtayo is a PD-1 checkpoint inhibitor that restores the immune system’s ability to recognise and destroy cancer cells. The recommendation offers a further immunotherapy option in first-line NSCLC alongside existing PD-1 and PD-L1 inhibitors already available on the NHS.

Darzalex Faspro quadruplet recommended for multiple myeloma

NICE recommended the four-drug combination of daratumumab SC, lenalidomide, bortezomib, and dexamethasone (D-VRd; Darzalex Faspro, Revlimid, Velcade) on 24 June 2026 for newly diagnosed multiple myeloma. Submitted by Janssen Biotech, this subcutaneous daratumumab-based quadruplet regimen builds on the established VRd backbone by adding the anti-CD38 monoclonal antibody daratumumab, which has consistently demonstrated improved response rates and progression-free survival in myeloma. The approval positions D-VRd as a potential new standard of care for eligible transplant-eligible and ineligible patients.

Hansizhuang recommended for extensive-stage small cell lung cancer

Serplulimab (Hansizhuang), in combination with chemotherapy and submitted by Shanghai Henlius Biotech and Fosun Pharma, received a positive recommendation on 18 June 2026 for extensive-stage small cell lung cancer (ES-SCLC). Small cell lung cancer is an aggressive malignancy with a historically poor prognosis, and first-line chemoimmunotherapy has become the standard approach following earlier immunotherapy approvals in this setting. Serplulimab is an anti-PD-1 antibody, and its recommendation provides a further immunotherapy option for patients presenting with extensive disease.

Imfinzi plus FLOT chemotherapy recommended for gastric and gastro-oesophageal junction cancer

Durvalumab (Imfinzi) in combination with FLOT chemotherapy (fluorouracil, leucovorin, oxaliplatin, and docetaxel) was recommended by NICE on 3 June 2026 as a neoadjuvant and adjuvant treatment for resectable gastric cancer and gastro-oesophageal junction cancer (GEJC). Developed by AstraZeneca, the perioperative regimen adds PD-L1 blockade to an established chemotherapy backbone, reflecting evidence that immunotherapy can improve surgical outcomes and reduce the risk of recurrence in patients with potentially curable disease.

Breyanzi receives positive recommendation for diffuse large B-cell lymphoma

Lisocabtagene maraleucel (Breyanzi), a CD19-directed CAR-T cell therapy developed by Bristol Myers Squibb (via Juno Therapeutics and Celgene), received a positive second appraisal recommendation on 3 June 2026 for relapsed or refractory diffuse large B-cell lymphoma (DLBCL). CAR-T therapies represent a complex and highly personalised treatment modality in which a patient’s own T cells are engineered to recognise and destroy cancer cells. The updated recommendation reflects revised cost-effectiveness evidence and expands NHS access to this potentially curative one-time treatment for patients who have failed two or more prior lines of therapy.

Respiratory & Cardiovascular

Nucala recommended for eosinophilic COPD

Mepolizumab (Nucala), developed by GSK, received a positive recommendation on 17 June 2026 for eosinophilic chronic obstructive pulmonary disease (COPD). Nucala is an anti-interleukin-5 monoclonal antibody already established in severe eosinophilic asthma, and this approval extends its indication to a subset of COPD patients characterised by elevated blood eosinophil counts. It represents an important development in COPD management, which has traditionally relied on bronchodilators and inhaled corticosteroids, by targeting an underlying inflammatory mechanism in eligible patients.

Winrevair recommended for pulmonary arterial hypertension

Sotatercept (Winrevair), developed by Acceleron and Merck, received a positive NICE recommendation on 3 June 2026 for pulmonary arterial hypertension (PAH). Sotatercept is an activin signalling inhibitor — a first-in-class mechanism of action in PAH — that addresses vascular remodelling, the underlying pathological process driving the progressive increase in pulmonary artery pressure that characterises this condition. Current PAH therapies largely target vasodilation; sotatercept’s distinct mechanism makes it a meaningful addition to the treatment armamentarium, particularly in combination with existing background therapy.

Nexlizet recommended for dyslipidaemia

The combination of bempedoic acid and ezetimibe (Nexlizet), submitted by Esperion Therapeutics and Daiichi Sankyo, was recommended on 24 June 2026 for dyslipidaemia in patients unable to tolerate statins or with an inadequate response to statin therapy. Bempedoic acid inhibits ATP-citrate lyase, an enzyme upstream of HMG-CoA reductase in the cholesterol biosynthesis pathway, while ezetimibe reduces intestinal cholesterol absorption. The combination provides a non-statin LDL-lowering option for a patient group that includes those with statin intolerance, an issue frequently encountered in clinical practice.

Hepatology & Gastroenterology

Livdelzi recommended for primary biliary cholangitis

Seladelpar (Livdelzi), developed by Gilead Sciences and CymaBay Therapeutics, received a positive recommendation on 24 June 2026 for primary biliary cholangitis (PBC), a rare chronic autoimmune liver disease that can lead to cirrhosis if inadequately treated. Seladelpar is a selective PPAR-delta agonist that reduces the production of bile acids and suppresses biliary inflammation. The recommendation is significant for patients who have had an inadequate response to or cannot tolerate ursodeoxycholic acid, which has long been the only licensed first-line treatment for PBC in the UK.

Neurology & Paediatrics

Spinraza recommendation updated for spinal muscular atrophy

Nusinersen (Spinraza), developed by Biogen and Ionis Pharmaceuticals, received an updated NICE recommendation on 4 June 2026 for spinal muscular atrophy (SMA). SMA is a rare and often severe inherited neuromuscular disease caused by mutations in the SMN1 gene. Spinraza was among the first disease-modifying treatments to be approved for SMA and works by modifying splicing of the SMN2 gene to increase production of functional SMN protein. The updated recommendation likely reflects revised clinical or cost-effectiveness evidence, potentially expanding eligible patient groups or amending existing access criteria.

Terminated Appraisals

Inluriyo appraisal terminated for ER-positive breast cancer

The appraisal of imlunestrant (Inluriyo), an oral selective oestrogen receptor degrader (SERD) submitted by Eli Lilly and Loxo Oncology, was terminated on 18 June 2026 for oestrogen receptor-positive, HER2-negative breast cancer with ESR1 mutation. ESR1 mutations are a recognised mechanism of resistance to aromatase inhibitors and represent a clinically important unmet need. The reasons for termination were not specified in the available data, though terminated appraisals typically reflect a withdrawal by the company or an inability to agree a managed access arrangement.

Anktiva appraisal terminated for BCG-unresponsive bladder cancer

The appraisal of nogapendekin alfa inbakicept (Anktiva), submitted by ImmunityBio and Accord Healthcare for BCG-unresponsive non-muscle-invasive bladder cancer, was terminated on 4 June 2026. BCG-unresponsive disease represents a challenging clinical situation in which patients have failed intravesical BCG immunotherapy — the standard treatment for high-risk non-muscle-invasive bladder cancer — and face a choice between radical cystectomy or further bladder-sparing treatments. The termination leaves this patient population without a new approved option via NICE at this time.

Decisions referenced carry NICE Positive 1, NICE Positive 2, NICE Update 1, or Terminated status, issued between 3–24 June 2026. This article is based on data from the NICE Technology Appraisal Programme for England and Wales.

A privileged but pressured role

GPs sit “at the forefront” of the NHS, seeing large numbers of patients each day, often within 10 or 15-minute consultations, says Dr Vautrey. The role spans the full spectrum of life, from young children to elderly patients living with long-term conditions or reaching the end of life. Much of the challenge lies in the unpredictability of each consultation: clinicians frequently do not know in advance what a patient will bring to them, making it a “real privilege” but also a demanding job, particularly when trying to spot emerging conditions among the many patients whose long-term conditions are already well understood.

What “seamless” means for patients

Patients simply expect their GP and pharmacist to be working from the same information, says Dr Vautrey. Electronic prescribing has already transformed this relationship, replacing handwritten and printed prescriptions with direct electronic transfer to the pharmacy. Where practices and pharmacies have a good working relationship, patients experience this as a single, joined-up local health service, with consistent messaging from both sides. Co-located or closely-linked pharmacies and surgeries tend to achieve this most effectively, he notes.

The 10-year plan: promising rhetoric, uncertain delivery

Asked about the NHS 10-year health plan, Dr Vautrey is cautiously optimistic but wary of a familiar pattern. The ambition to move care into the community and build up neighbourhood health services is “long overdue”, he says, but it must be matched by sustained investment, since community services – including community nursing – have been “overstretched and underfunded” for years. Real investment is needed not only in workforce but in premises, many of which are currently too small to expand services such as community cardiology, dermatology, ENT or gynaecology clinics that could otherwise be delivered locally.

Digital records and data confidence

General practice has led the NHS on digital records for years, says Dr Vautrey, citing electronic prescribing as a case in point: patients can now receive a prescription within minutes wherever they are in England, rather than having to track down a local GP while travelling. Increasing use of the NHS app and shared access to patient information is welcome, but any new digital systems must preserve patients’ confidence that their data will remain confidential and properly safeguarded, he emphasises.

Prevention: good intentions, but funding gaps remain

On the plan’s emphasis on tackling obesity and smoking, Dr Vautrey highlights the frustration many GPs feel at being unable to prescribe newer, highly effective weight-management medications more widely because of cost. He also points to years of cuts to locally commissioned preventive services – weight management, smoking cessation, drugs and alcohol and sexual health services – as local authority budgets have come under pressure, warning that a long-term, wholesale commitment to prevention funding is needed to reduce future NHS costs.

Wearables and shifting expectations

It is “too early to know for sure” how useful wearable technology will prove, says Dr Vautrey. Home blood pressure monitoring is already valuable, partly because it avoids the anxiety some patients feel in clinical settings, but other wearables can sometimes generate anxiety rather than reassurance. Simple tools such as phone step-counters, however, can meaningfully encourage physical activity. More broadly, patient expectations of living longer with long-term conditions are rising, and society will need honest conversations about what the NHS can sustainably provide versus what may need to be funded differently, particularly as highly specialised, expensive medicines become available.

Drug shortages: a persistent, largely economic problem

Medicine shortages remain a daily frustration for GPs, pharmacists and patients, says Dr Vautrey. The causes range from global manufacturing issues to manufacturers choosing to sell more profitably elsewhere rather than into the UK market. He believes government has yet to grapple seriously with the issue, including the case for greater domestic medicine production. At present, all too often, pharmacists bear the brunt of patients’ frustration when common medicines become hard to source.

A closing message

Reflecting on his years representing GPs nationally, Dr Vautrey’s message to government is unambiguous: practice teams, community pharmacists and other primary care professionals are already working closely together on patients’ behalf, but they need long-term, sustained investment. Strengthening these foundations, he argues, would improve care quality, ease pressure on secondary care, and ultimately leave both patients and the NHS as a whole better off.

About Dr Richard Vautrey

Dr Richard Vautrey is a GP partner, Meanwood Group Practice, Leeds and Clinical Director, Leeds Central North PCN.

Oncology and dermatology feature prominently in this cycle, with notable recommendations for novel antibody-drug conjugates, a new JAK inhibitor indication, and an innovative combination approach in multiple myeloma. The cycle also includes three vaccine recommendations addressing chikungunya, meningococcal disease, influenza, and orthopoxvirus infections.

Oncology

Datroway recommended for triple-negative breast cancer

Datopotamab deruxtecan (Datroway), an antibody-drug conjugate developed by Daiichi Sankyo and AstraZeneca, has received a positive CHMP recommendation for triple-negative breast cancer (TNBC). TNBC remains one of the most challenging breast cancer subtypes to treat, given its lack of hormone receptor and HER2 expression. Datroway targets TROP2, a protein overexpressed in many epithelial tumours, and delivers a cytotoxic payload selectively to cancer cells, offering a more targeted approach than conventional chemotherapy.

Tecvayli and Darzalex Faspro combination recommended for multiple myeloma

Johnson & Johnson has received a CHMP recommendation for the combination of teclistamab and daratumumab (Tecvayli and Darzalex Faspro) for multiple myeloma. Teclistamab is a bispecific T-cell engager targeting BCMA and CD3, while daratumumab is a well-established anti-CD38 monoclonal antibody. Combining the two mechanisms in a chemotherapy-free regimen represents a significant advance in the treatment of relapsed or refractory multiple myeloma, a condition that typically requires repeated lines of therapy over time.

Jaypirca recommended for chronic lymphocytic leukaemia

Pirtobrutinib (Jaypirca), a non-covalent BTK inhibitor developed by Loxo Oncology at Lilly and Eli Lilly, has been recommended for chronic lymphocytic leukaemia and small lymphocytic lymphoma (CLL/SLL). Unlike covalent BTK inhibitors such as ibrutinib, pirtobrutinib is designed to remain active in patients who have developed resistance mutations, offering a treatment option for a population with limited alternatives following prior BTK inhibitor therapy.

Denosumab biosimilar recommended for bone complications in cancer

Denosumab Ascend, a biosimilar of denosumab developed by Ascend GmbH, has received a CHMP recommendation for the prevention of skeletal-related events in patients with bone metastases and for giant cell tumour of bone. The availability of a biosimilar version of this widely used bone-targeted agent is expected to improve patient access and reduce costs for health systems across the EU.

Pegfilgrastim biosimilar recommended for neutropenia

Nylaspeg, a biosimilar of pegfilgrastim submitted by Qilu Pharmaceuticals, has received a positive recommendation for chemotherapy-induced neutropenia. Pegfilgrastim is routinely used to stimulate white blood cell production and reduce the risk of febrile neutropenia in cancer patients receiving myelosuppressive chemotherapy. The biosimilar recommendation supports continued access to this supportive care treatment at competitive cost.

Dermatology & Immunology

Rinvoq recommended for vitiligo and alopecia areata

AbbVie’s upadacitinib (Rinvoq), a selective JAK1 inhibitor, has received two separate CHMP recommendations expanding its indications into dermatology: one for vitiligo and one for alopecia areata. Vitiligo is a chronic autoimmune condition causing depigmentation of the skin, while alopecia areata results in patchy or total hair loss driven by immune-mediated attack on hair follicles. Both conditions have historically lacked effective systemic treatments, and these recommendations follow growing clinical evidence supporting JAK inhibition as a mechanism of action in autoimmune skin diseases. Rinvoq is already approved for several inflammatory conditions including rheumatoid arthritis, psoriatic arthritis, and atopic dermatitis.

Opzelura recommended for atopic dermatitis

Ruxolitinib cream (Opzelura), developed by Incyte Corporation and Maruho, has received a CHMP recommendation for atopic dermatitis (eczema). Opzelura is a topical JAK1/JAK2 inhibitor that provides targeted anti-inflammatory activity at the site of application, offering an alternative to topical corticosteroids for patients with mild to moderate disease. The recommendation addresses a highly prevalent condition that places significant quality of life burden on patients, particularly those with disease affecting visible areas of skin.

Neurology & Paediatrics

Daybue recommended for Rett syndrome

Trofinetide (Daybue), developed by Acadia Pharmaceuticals, has received a CHMP recommendation for Rett syndrome, a rare and severe neurodevelopmental disorder caused by mutations in the MECP2 gene, which predominantly affects girls. The condition leads to progressive loss of motor and communication skills and has no approved disease-modifying treatments in the EU. Daybue is a synthetic analogue of the naturally occurring tripeptide GPE (glycine-proline-glutamate) and represents the first pharmacological treatment specifically developed for this condition to receive a positive EU recommendation.

Crexont recommended for Parkinson’s disease

A prolonged-release combination of carbidopa and levodopa (Crexont), submitted by Amneal Pharmaceuticals and Zambon, has been recommended for Parkinson’s disease. Levodopa remains the cornerstone of Parkinson’s pharmacotherapy, but standard formulations are associated with motor fluctuations and wearing-off effects as the disease progresses. The extended-release formulation aims to provide more consistent plasma drug levels throughout the day, potentially reducing the frequency and severity of motor complications in patients with advanced disease.

Stelara recommended for paediatric ulcerative colitis

Ustekinumab (Stelara), developed by Johnson & Johnson, has received a CHMP recommendation for paediatric ulcerative colitis. Ustekinumab is an interleukin-12 and interleukin-23 inhibitor already established in adult inflammatory bowel disease and psoriasis. This paediatric recommendation addresses a significant unmet need in younger patients with moderate to severe ulcerative colitis who have an inadequate response to conventional therapy.

Infectious Diseases & Vaccines

Ixchiq recommended for chikungunya fever

Ixchiq, a live-attenuated chikungunya vaccine developed by Valneva SE and Instituto Butantan, has received a positive CHMP recommendation. Chikungunya is a mosquito-borne viral illness characterised by fever and severe joint pain, with outbreaks increasingly reported in southern Europe due to the northward spread of the Aedes albopictus mosquito. The approval of a preventive vaccine represents an important public health tool as the geographical range of the disease continues to expand.

MenQuadfi recommended for meningococcal disease

MenQuadfi, a conjugate vaccine targeting meningococcal serogroups A, C, W, and Y, developed by Sanofi, has received a CHMP recommendation. Meningococcal disease can cause life-threatening bacterial meningitis and septicaemia, particularly in infants, young children, and adolescents. The conjugate formulation is designed to produce a robust and long-lasting immune response and is suitable for use in paediatric populations.

Imvanex recommended for monkeypox and orthopoxvirus infections

Bavarian Nordic’s Imvanex, a modified vaccinia Ankara-based vaccine, has received a CHMP recommendation for protection against monkeypox (mpox) and other orthopoxvirus infections. Imvanex was already authorised for smallpox prevention in the EU and was used extensively during the 2022 mpox outbreak. This recommendation formalises its indication for mpox and broader orthopoxvirus prophylaxis, reflecting the continued public health relevance of the product.

Aujemflu recommended for influenza

Aujemflu, an adjuvanted trivalent influenza vaccine developed by Seqirus/CSL, has received a CHMP recommendation for the prevention of influenza. The adjuvanted formulation is designed to enhance immunogenicity, particularly in older adults and immunocompromised populations where vaccine responses may be suboptimal. The recommendation adds to the existing portfolio of seasonal influenza vaccines available to EU member states.

Symtuza and Prezcobix recommended for HIV

Two HIV antiretroviral regimens have received CHMP recommendations. Symtuza — a single-tablet combination of darunavir, emtricitabine, cobicistat, and tenofovir alafenamide (TAF), developed by Johnson & Johnson and Gilead Sciences — offers a complete one-tablet-once-daily regimen for HIV-1 infection. Separately, Prezcobix — a combination of darunavir and cobicistat developed by Janssen Therapeutics — provides a boosted protease inhibitor backbone for use in combination with other antiretrovirals. Both recommendations likely reflect updated indications or label revisions for these established regimens.

Cardiovascular & Diabetes

Leqvio recommended for hypercholesterolaemia

Inclisiran (Leqvio), a small interfering RNA (siRNA) therapy developed by Novartis, has received a CHMP recommendation for hypercholesterolaemia. Inclisiran works by inhibiting the production of PCSK9, a protein that reduces the liver’s ability to clear LDL cholesterol from the blood. Administered just twice yearly by subcutaneous injection, inclisiran offers a highly differentiated dosing schedule compared with daily oral statins or monthly PCSK9 inhibitor antibodies, which may improve adherence in patients requiring long-term lipid-lowering therapy.

Onswik recommended for type 2 diabetes

Insulin efsitora alfa (Onswik), a once-weekly basal insulin analogue developed by Eli Lilly, has received a positive CHMP recommendation for type 2 diabetes. The treatment represents a significant step forward in insulin therapy, offering a weekly injection as an alternative to the daily or twice-daily basal insulin regimens that many patients find burdensome. A reduced injection frequency is expected to support better adherence and patient quality of life, particularly in the early stages of insulin initiation.

All nineteen decisions listed carry CHMP Recommended status. CHMP recommendations are subject to final marketing authorisation by the European Commission. This article is based on data from the European Medicines Agency CHMP opinion cycle.

Researchers found that many online GLP-1 RA prescription vendors did not require any interaction with a clinician, instead relying largely on patient-reported questionnaires. According to the study, these questionnaires may fail to capture important elements of a patient’s clinical and social history.

Several findings pointed to limited safety oversight. Investigators observed multiple GLP-1 RA prescriptions being issued by the same clinicians, prescriptions granted even when required photos were missing, and prescriptions completed in five minutes or less.

The findings add to growing scrutiny of the direct-to-consumer telehealth market, which has expanded rapidly alongside surging demand for weight-loss and diabetes medications.

The study’s corresponding author is Reshma Ramachandran, MD, MPP, MHS, of Yale University. The full study is available in JAMA (doi:10.1001/jama.2026.9131).

The randomized clinical trial, which enrolled 400 participants with Type 1 diabetes ages 7 to 25 in Bangladesh and Tanzania, found that the long-acting analogue insulin glargine was associated with less time spent in dangerous hypoglycemia and fewer nighttime low blood sugar events – but those benefits didn’t emerge until a year into the trial. The findings point to a more complicated picture than a simple head-to-head win for newer insulin.

“The real question is not simply whether newer insulin is better, but whether the benefits we observed are compelling enough to inform purchasing, access and guideline decisions in places where choices are constrained,” said lead author Jing Luo, M.D., M.P.H., associate professor of medicine at Pitt. “That is the conversation this study helps move forward.”

At six months, researchers found no evidence of differences between the insulin analogue glargine and older human insulin in the trial’s co-primary outcomes: time spent in very low glucose range and time spent in the target glucose range. At 12 months, however, participants assigned to glargine spent less time in very low glucose range and had fewer nocturnal hypoglycemic events than those assigned to usual care. Researchers did not find meaningful differences in time in range, HbA1c, diabetic ketoacidosis, severe hypoglycemic events or symptomatic hypoglycemic events at 12 months.

Although glargine did not improve the study’s primary outcomes at six months, the 12-month data suggest that benefits related to serious hypoglycemia may emerge more gradually in real-world, low-resource care settings. Glargine was also associated with lower total daily insulin use and fewer injections per day, factors that may matter to patients, families and health systems alike.

The World Health Organization added long-acting insulin analogues such as glargine to its Model List of Essential Medicines in 2021. Still, Type 1 diabetes care remains profoundly unequal worldwide. Of an estimated 9.5 million people living with Type 1 diabetes globally, about 3.2 million are treated exclusively with older human insulins, most of them in low- and middle-income countries. While long-acting insulin analogues such as glargine are widely used in higher-income settings, their higher cost and limited availability have slowed broader adoption elsewhere.

“In many parts of the world, children do not have access to the therapies considered standard elsewhere,” said Luo. “These findings add new data to a global debate over whether health systems with constrained resources should prioritize access to newer insulin formulations despite their higher cost.”

Researchers say additional study is needed to better understand longer-term glycemic outcomes after patients in low-resource settings switch from older human insulin to analogue insulin.

Co-authors include Chung-Chou H. Chang, Ph.D., Christina M. Lalama, M.S., Jill Kirsch, M.S., Abigail Foulds, Ph.D., and Bruce L. Rollman, M.D., M.P.H., all of Pitt; Sylvia Kehlenbrink, M.D., of Brigham and Women’s Hospital; Éimhín Ansbro, M.Sc., of the London School of Hygiene and Tropical Medicine; Margaret L. Prust, M.P.H. and Alana Garvin, M.P.H., both of the Clinton Health Access Initiative; Bedowra Zabeen, M.B.B.S. and Ajmina Hasan Flabe, M.S., M.P.H., both of the Diabetic Association of Bangladesh; Edna Majaliwa, M.D., of the Tanzania Diabetes Association and Muhimbili National Hospital; Kaushik Ramaiya, M.D., of the Tanzania Diabetes Association and Shree Hindu Mandal Hospital; Neema Kayange, M.D., of the Catholic University of Health and Allied Sciences – Bugando; Renatus Fabiano Nyarubamba, M.D., M.P.H., of the Tanzania Diabetes Association; and Graham D. Ogle, M.B.B.S., of Life for a Child, Australia.

The study was funded by the Leona M. and Harry B. Helmsley Charitable Trust.

Reduced NHS spending on other health interventions would have an adverse impact on public health which could increase excess preventable deaths by 229,000 by 2036 – more than the covid-19 pandemic between March 2020 and June 2022 (137,000). If the indirect effect on adult social care is also included, excess deaths increase to 291,000, argue the authors. Most of these deaths are expected to be people with cardiovascular, respiratory, and gastrointestinal disease and cancer.

The UK-US pharmaceuticals deal was announced by the UK government on 1 December 2025 and described as a “landmark” deal that would “safeguard medicines access and drive vital investment for UK patients and businesses” through strengthening UK-US cooperation in sectors like life sciences and pharmaceuticals.

The agreement secured a 0% tariff on UK pharmaceutical and medical device exports to the US for three years, but also committed the NHS to substantially higher expenditure on new branded medicines over the next decade through changes to drug pricing arrangements and health technology assessment.

From April 2026 the government instructed the National Institute for Health and Care Excellence (NICE) to increase its cost-effectiveness threshold for new medicines from £20,000-£30,000 per quality adjusted life year (QALY) to £25,000-£35,000 per QALY for the same health benefits.

Changes in the way health benefits are measured by NICE’s assessments will also give more weight to benefits offered by new medicines. QALYs combine gains in survival and quality of life into a single measure and NICE has generally required a cost-effectiveness threshold of £20,000-£30,000 per QALY to balance the health gains offered by new medicines against the detrimental impact on health if NHS resources were displaced from other services.

An agreement between the pharmaceutical industry and the UK government (the voluntary scheme for branded medicines pricing, access, and growth; VPAG) designed to limit growth in NHS expenditure on branded medicines through industry rebate payments has also been watered down. In 2025 the rebate rate was 23% but under the new agreement this has been cut to 14.5%.

Overall, under the deal, the government has committed to more than double spending on new medicines from 0.3% of gross domestic profit (GDP) to at least 0.6% by 2036, with interim targets of 0.35% of GDP in 2028 and 0.4% of GDP in 2030.

The Department of Health and Social Care has undertaken an impact assessment on the wider costs of this trade deal, but this document has not been made publicly available.

The authors are calling for the full details of the deal and its impact assessment to be made public so the deal can receive parliamentary scrutiny. They also emphasise that many of the suggested benefits of the deal, such as claims that higher UK medicine prices will stimulate pharmaceutical innovation and investment in the UK, are uncertain.

Assuming these GDP targets are met and GDP rises by 1.5% annually, as predicted by the Office for Budgetary Responsibility (OBR), the additional annual costs to the English NHS will be at least £1.3bn in 2028 (£25m per week), and £8.8bn in 2036 (£170m per week). The cumulative additional cost will be £2.6bn by the end of 2028 and £44.7bn by the end of 2036.

Modelling of English local authority data suggests that every £1bn the NHS must find to fund this deal will increase the costs of publicly funded adult social care by £118m because of increases in morbidity and mortality.

NICE estimates that increasing cost effectiveness thresholds will result in only two to five additional medicines being approved annually. NICE already approves more than 90% of medicines it evaluates, suggesting that the agreement is more likely to increase the prices paid for medicines already entering the NHS rather than substantially expand access.

While the agreement establishes zero tariffs on UK pharmaceutical and medical device exports to the US for three years, the UK remains a net importer of medicines. The economic benefits of securing zero tariffs for UK pharmaceutical exports has also been substantially diminished since a US Supreme Court ruling reduced the proposed tariffs from 100% to 10%. The projected costs of the agreement are expected to exceed the total annual value of UK medical exports to the United States (£5bn) before 2031.

The authors say, “The government’s willingness to accommodate industry pressure while the NHS absorbs the resulting costs raises important questions about transparency and accountability.”

They add, “More importantly, it emphasises a broader structural problem at the heart of a health system conceived with the intention of delivering equitable, patient centred care, now reduced to underwriting risk in global pharmaceutical markets.”

The research findings have been published in the renowned journal Nature Communications: Dual human milk oligosaccharide-fibre utilisation is a selection cue for the weaning gut microbiome.

“We have long known that breastfeeding is important for infants’ health. What is new is that we can now explain how the sugars in breast milk, HMOs, also help to select the bacterial communities associated with a healthy gut microbiota later in life. This underlines the importance of combining breastfeeding with solid baby food at this stage of child’s development,” says Maher Abou Hachem, professor at DTU Bioengineering and senior author of the study.

The study reveals a previously unknown mechanism that gives specific gut bacteria an advantage in the competition to inhabit the infant’s gut during weaning, because they are endowed to metabolise both HMOs from breast milk and fibres from plant-based foods.

The results suggest that the weaning period is a crucial developmental window, during which the combination of breast milk and solid food, promotes the maturation of the gut microbiota to the adult-like community that is maintained during adulthood. On the long term, this new knowledge may contribute to the development of better nutritional solutions for infants and strengthen our understanding of how early nutrition affects health later in life.

“The findings are important in daily clinical practice as an additional justification to the already strong emphasis on promoting the mother’s own milk production and breastfeeding when infants and young children are admitted to a neonatal intensive care unit due to preterm birth or critical illness,” says Consultant Lise Aunsholt from the Department of Intensive Care for Newborns and Young Children at Rigshospitalet.

“It is encouraging to know that when we advise a mother to continue breastfeeding after discharge – and for as long as possible during the transition to solid foods – this will potentially have a positive impact on the child for the rest of their life,” she says.

According to the researchers, the study shows that breast milk not only supports the infant’s nutrition during infancy but also helps to select the bacteria that become a permanent part of the gut microbiota later in life.

Close collaboration between DTU and TUH

The study was carried out in close collaboration between researchers from DTU and clinical research environments at the Technical University Hospital (TUH – see fact box)

The researchers analysed the changes in bacteria and their genes over the weaning phase. This gave them insight into which bacteria were present and what the bacteria were doing. At the same time, the researcherscultured the bacteria in the laboratory under conditions resembling the environment in the human gut. In this way, they were able to identify the bacteria capable of metabolising both HMOs from breast milk and dietary fibres from solid food.

“The collaboration between DTU’s technological and biological expertise and the clinical environments at TUH has been crucial in enabling us to link knowledge about the bacteria’s functions to the development of the gut microbiota in children. This provides unique insight into how early dietary choices affect health later in life,” says Maher Abou Hachem.

Could pave the way for new nutritional solutions

The researchers believe that this new knowledge sets the stage for the development of future nutritional solutions for infants and targeted interventions that support the establishment of healthy gut bacterial community.

The results also suggest that the weaning period may be a crucial time for preventive measures against diseases that are later in life associated with disturbances in the gut microbiota.

Researchers at the Technical University of Munich (TUM), Imperial College London, and the Hasso Plattner Institute (HPI) demonstrate that earlier calculations of AI model security are misleading. Attacks that aim to determine whether an individual’s data was used to train a model are known as membership inference attacks (MIAs). Until now, common medical AI models were considered largely secure against MIAs.

“Unfortunately, previous risk assessments have only ever measured the average risk across all patients. We examined the risk at the level of individual patients for the first time – and it paints a very different picture,” says TUM researcher Moritz Knolle, first author of the study. While the attacks were unsuccessful for a large proportion of the datasets, some patients could be linked to the models with near‑100 percent certainty. “This is not a tolerable risk. Health data is highly sensitive,” says Daniel Rückert, Professor of Artificial Intelligence in Healthcare and Medicine at TUM and, together with Professor Georg Kaissis (HPI), senior author of the study.

Different data types tested

The researchers attacked models based on seven established medical datasets. Each model relied on a different type of data, such as imaging data, electrocardiograms, or electronic health records. “An attacker needs three things to carry out a MIA,” explains Georg Kaissis, Professor of Digital Health: Human-Centered Transformative AI at the Hasso Plattner Institute. “First, access to the AI model being targeted, for example via a hospital network. Second, access to a data point for which they want to know whether it was included in the model, for example, data obtained in a cyberattack. Third, their own AI infrastructure – that is, computers running models based on the same type of data as the target model.”

With this setup, it would be possible, for example, to attack an AI model that uses blood test results to predict the likelihood of success of cancer immunotherapy. On its own, a blood test does not reveal whether a person has a disease. However, if an attacker can show that a specific data point was used to train the model, it becomes more likely that the patient has or had cancer.

Potential impact on individuals

Such digital attacks can have serious real-world consequences, as Moritz Knolle illustrates with a hypothetical example: “Imagine you were treated for cancer and made your data available for research,” says the medical informatics expert. “Years later – the cancer has not returned since then – you want to take out private supplemental insurance. However, an attacker has discovered that your data was used to train a tumor analysis model. This information reaches the insurer, for example through data analysis by third-party providers or corresponding risk profiles. You are then classified as a high-risk patient, with the corresponding premiums – and may never even find out why.”

The MIAs were particularly successful when targeted individuals belonged to groups that were underrepresented in the dataset. This could include certain anatomical characteristics in imaging data, but also data from minority groups. “This is especially serious because discrimination in AI also plays a role in medicine, and some models, for example, make less accurate predictions when the patient belongs to a minority group,” says Daniel Rückert.

Larger models show greater vulnerability

The researchers show that the attacks become more successful as the models grow larger and more complex. In the researchers’ view, the fact that high-performance models are particularly vulnerable indicates that the problem could become significantly more severe in the coming years if no countermeasures are taken.

They therefore advocate assessing the risks of new models at the level of individual patients before their release. Additional countermeasures include strict control of access to AI models. “There are already effective safeguards against MIAs that can be applied during model training. For example, differential privacy introduces small modifications into the training data that do not affect the model’s calculations but make MIAs significantly more difficult,” says Georg Kaissis.

Publication:

Knolle, M.A., Menten, M.J., Jungmann, F. et al. Disparate privacy risks from medical AI. Nature (2026). DOI:10.1038/s41586-026-10688-0.

Further information:

• Prof. Daniel Rückert holds the Chair of AI in Healthcare and Medicine at the TUM School of Medicine and Health and is a member of the TUM School of Computation, Information, and Technology, the Munich Data Science Institute (MDSI) as well as the Munich Center for Machine Learning (MCML).
• Original article: https://www.tum.de/en/news-and-events/all-news/press-releases/details/study-reveals-privacy-risks-in-medical-ai

Heart failure affects approximately 860,000 Canadians, is associated with reduced survival and quality of life, and is the third leading cause of hospitalization in the country. Heart failure with reduced ejection fraction (HFrEF) accounts for approximately half of these cases.

Despite high-quality evidence supporting the benefits of guideline-directed medical therapy (GDMT) for patients with HFrEF, which entails the rapid initiation of four distinct classes of medication collectively known as quadruple therapy, use of these medications remains suboptimal. This is in part due to inadequate access to heart failure specialists and clinics for many Canadian patients living with HFrEF. This high unmet need underscores the importance of alternative models that expand beyond physician-led GDMT management.

“Heart failure is a serious medical condition that has several effective medications that are underused across Canada,” says lead investigator Ricky Turgeon, BSc(Pharm), ACPR, PharmD, Faculty of Pharmaceutical Sciences, University of British Columbia. “Pharmacists and nurse practitioners are important members of the healthcare team who can help to improve medication use for heart failure.”

The researchers evaluated whether getting pharmacists and nurse practitioners to initiate and manage heart failure medications would be good value for money for the healthcare system by comparing two different scenarios using an economic model.

In the first scenario, patients with heart failure received the usual care currently experienced by most British Columbians with heart failure. In the second scenario, patients with heart failure received the usual care plus additional medication management from pharmacists and nurse practitioners. The investigators then modelled what would happen to these patients over time and tracked how long they would live, how often they would be hospitalized, and how much healthcare resources they would need.

It was estimated that within the first year of implementation, this added service would save approximately 10 lives and prevent 25 hospitalizations per every 1,000 patients who received the pharmacist- or nurse practitioner-led intervention.

“While this service would require additional funding, we demonstrated that this investment would be well justified given what the Canadian healthcare system is generally willing to pay,” notes Dr. Turgeon. “The size of this benefit was far beyond what was anticipated. As a pharmacist caring for people with heart failure, I find these results genuinely empowering. They show that we play an important role in improving patients’ lives while also easing pressure on the healthcare system. We have the evidence; now we need to implement this approach.”

By quantifying the clinical and economic impacts of these additional medication management services, this study provides healthcare system planners with the insights needed to effectively address persistent gaps in care for heart failure patients.

Co-lead investigator Kelly Mackay, MA, Cardiac Services BC, Provincial Health Services Authority, comments, “Our research offers a roadmap to improving patient outcomes while strengthening the sustainability of our health system. The research also provides Cardiac Services BC with the evidence and innovation needed to drive meaningful system change.”

“Expedited and increased access to quadruple therapy has the potential to save lives and reduce some of the pressures in British Columbia’s hospitals. We believe this model could also be successful in other Canadian provinces. We’re thrilled that this research presents such an effective—and feasible—way for more heart failure patients to receive this gold-standard treatment,” concludes co-investigator Nathaniel Hawkins, MBChB, MD, MPH, Cardiac Services BC, Provincial Health Services Authority, and Division of Cardiology, University of British Columbia.

The analysis found that while healthy behaviour and lifestyle interventions remain an essential foundation of any effective weight management programme — delivering meaningful weight loss and improvements in body composition on their own — adding pharmacotherapy produced the strongest outcomes. Crucially, the study’s authors characterise medication not merely as a supplementary tool, but as a core component of treatment when combined with lifestyle change.

The review assessed short-term outcomes typically measured over six to twelve months, tracking improvements in body mass index (BMI) and BMI z score, a metric used to contextualise weight relative to age and sex in children and adolescents. Long-term sustainability and safety were also monitored across the included studies.

The findings come as obesity rates in children and adolescents continue to rise globally, placing growing pressure on clinicians and health systems to identify effective, evidence-based treatment approaches. The results suggest a shift in how pharmacotherapy should be framed in paediatric obesity care — not as a last resort or add-on, but as an integral element of a combined strategy.

The study was led by corresponding author Bjorn T. Tam, PhD, and is published in JAMA Pediatrics (doi:10.1001/jamapediatrics.2026.2248). The full text is freely accessible here.

Meanwhile, traditional, in-person visits to the doctor’s office have rebounded since the pandemic. And although digital medicine has become a routine part of healthcare, it is supplementing rather than replacing in-person care. This evolution, researchers say, is reshaping how hospitals and clinics operate daily.

These are the main conclusions of the study, which was led by researchers at NYU Langone Health and represents the largest review ever performed on communications recorded by Epic electronic health records. The team’s analysis involved more than 140 million patient records from 2,067 hospitals and 47,100 health clinics in the US. As part of the study, the researchers evaluated over 8 billion patient-provider interactions that took place between January 2020 and December 2025.

Publishing in the Journal of the American Medical Association (JAMA) online June 22, the study team found that online portal messages more than doubled between 2020 and 2025 (by 153 percent). By contrast, total telephone calls decreased by 6 percent over the same period. The number of Americans with an active Epic health record went from 94 million in 2020 to 140 million in 2025. Thirty percent of active patients on Epic (42 million) sent a portal health app message to their clinician during the first three months of 2025.

Patient portal visits, however, are not replacing in-office visits, which have returned to an average of between two and three per year per patient. Messages from patients to healthcare providers have doubled since the pandemic, from an average pace of 2.2 per year in early 2020 to 5.4 per year in late 2025.

“Our study shows that use of patient portals, health apps, and messaging are now a routine part of everyday patient care across America, not simply side channels used occasionally,” said study senior investigator Michal A. Mankowski, PhD.

Dr. Mankowski, an assistant professor in the Department of Surgery at NYU Grossman School of Medicine, said the study demonstrates that patients now have much more direct access to physicians and other clinicians.

“Our findings reveal that while digital health tools have become a core part of healthcare, delivery is becoming more continuous, timeless, and no longer tied to scheduled appointments during routine work hours,” said Dr. Mankowski.

Among the study’s other findings was that since 2020, Americans have, as logged in Epic record systems, booked at least 1.77 billion in-person visits to health clinics, sent 1.34 billion messages to their healthcare providers, and received some 3.25 billion online portal messages from providers. Also documented in Epic were 1.59 billion telephone calls and 146 million virtual telehealth portal visits.

Study co-investigator Dorry L. Segev, MD, PhD, said that the digital delivery of healthcare does not replace the old ways of working; it just adds another layer of more steps to existing workflows. To manage this new patient reality, hospitals, clinics, and healthcare workers have to plan future staffing and support.

“Modern delivery of healthcare means increasingly that healthcare providers will have to balance their digital workload on top of their traditional clinical workload,” said Dr. Segev, a professor and vice chair in the Department of Surgery at NYU Grossman School of Medicine. “Clinical staff will need to be trained in mastering the tools of messaging in healthcare; in using AI support programs, including chatbots that can frame content to minimize its complexity; and in making the most effective use of clinician time needed for online billing and online counseling,” said Dr. Segev, who is also a profession in NYU Grossman’s Department of Population Health.

Already, he noted, NYU Langone uses AI support tools to speed up drafting of physician and provider notes.

Dr. Segev said the team next plans to look more specifically at digital-use trends within healthcare systems, including NYU Langone, to break down any regional and outpatient clinic-specific shifts that could affect operational planning.

For the study, the team used Epic Cosmos, a national dataset of the electronic health records of more than 300 million American patients. The dataset includes information from a majority of hospitals and clinics that use Epic, the nation’s largest vendor of electronic health record systems, which had no role in performing the study.

Funding support for the study was provided by NYU Langone.

Along with Drs. Mankowski and Segev, NYU Langone researchers involved in the study were lead investigator Jane J. Long, MD, and co-investigators Mara A. McAdams DeMarco, PhD; Mark D. Schwartz, MD; Joshua Chodosh, MD; and Eric K. Oermann, MD.

Dr. Mankowski was recently elected to serve on the governing board of Epic Cosmos. Dr. Schwartz reported being president-elect of the Society of General Internal Medicine. Dr. Segev has received consulting and/or speaking honoraria from Sanofi, CareDx, Moderna, AstraZeneca, Roche, Optum, OrganOx, Hansa, and Biosidus and is a journal editor for Springer. None of these activities are related to the current JAMA study. NYU Langone is managing the terms and conditions of these relationships in accordance with its policies and procedures.