Precision medicine is advancing. Now systems have to catch up.
| This is not another health news digest. It’s a twice-weekly readout of where evidence meets power and where power must turn into action. |
The big question
Who gets access to personalised medicine? For years, we’ve been asking whether researchers could deliver better biomarkers, diagnostics, targeted therapies, screening, AI tools, and risk-based prevention. We now know they can. But we’ve got a new question: who can actually receive them?
Getting political: Personalised medicine has now entered a highly political phase just as health systems are under pressure, especially in regions where aging populations are already loading public health budgets. Regulatory decisions made today on detection influence the cost and availability of that screening and ultimate the take-up of treatments.
Oncology: The EU’s Health Technology Assessment coordination group expects around 50 joint clinical assessments this year for cancer medicines, new active substances and advanced therapy medicines. Approval of each of these will be followed by a harder test: evidence, comparators, subgroups and national affordability.
For breast cancer, the US FDA’s approval of vepdegestrant for ESR1-mutated advanced or metastatic disease makes access dependent on detection by an FDA-authorized test. ESR1 is therefore not only a biomarker, but a gate into treatment. For lung cancer, UK guidance from NICE on EGFR-mutated and BRAF V600E-mutated non-small cell lung cancer shows precision oncology being built into payer pathways, but via eligibility rules, line-of-therapy limits and commercial arrangements.
The WHO and IARC’s finding that up to four in ten cancer cases could be prevented globally pushes the focus upstream to determining who is at risk, who gets screened and who can avail of targeted prevention before the disease appears.
An industry-wide phenomenon: The same politics can be seen beyond oncology. The EMA’s positive opinion for tolebrutinib in non-relapsing secondary progressive multiple sclerosis raises a neurology access question around disability progression, evidence and system readiness.
Digital pathology adds another complication. Roche’s acquisition of PathAI shows how AI diagnostics and AI pathology are becoming infrastructure for precision medicine.
Where do we go from here?
Eligibility for personalised medicine now has to survive budgets, diagnostics, and regulatory assessments as well as the personnel capacity that can ensure real-world delivery. The research breakthrough is only the beginning; the real test is getting the treatments to the patient.
You’re reading the IPM Brief. The last mile starts here.
Patient access doesn’t immediately follow treatment breakthroughs.
This newsletter tracks the fast-moving politics of personalised medicine. It lays out what has to happen with regulation, reimbursement, diagnostics, clinical pathways, workforce capacity, political decisions and real-world delivery.
Based on the expertise of the European Alliance for Personalised Medicine (EAPM), the IPM Alliance is a global, federated platform, working across diseases and across regions, including Europe, North America, Latin America, Asia-Pacific, the Middle East and Africa.
Chinese biotech eats America’s lunch
What just happened:
A cancer treatment developed in China and tested solely on Chinese patients unveiled stunning results at the American Society of Clinical Oncology last week. Akeso Biopharma’s lung cancer treatment ivonescimab showed a 34% lower risk of death compared to the current standard treatment.
It’s the first time a drug developed in China and tested solely on Chinese patients took the main stage at ASCO.
The world’s largest cancer conference is usually a showcase for the best innovations that the world’s leading companies – mostly American companies – have to offer.
Their lunch is now being eaten by Chinese biotech, both at the high-end with new treatments and at the supply side, where regulators are getting worried about the global pharmaceutical industry’s reliance on substances developed and supplied by China.
There are real concerns about whether Chinese clinical trials can be applied to patients in North America or Europe: Chinese patients smoke more and seem to respond better to immunotherapy.
How will this play out?
The US Food & Drug Administration has until November to rule on an application for ivonescimab, which could be the drug’s first approval outside China.
US health secretary Robert F Kennedy complained at an April hearing that “China is eating
our lunch.” Smaller US biotech companies complain of Chinese copycats and unfair
competition because Chinese state support means rivals have far lower costs.
China’s growing chokehold on essential medicines has prompted both the US and the EU to try and ramp up production at home. This is costly and slow.
Political action like trade tariffs or curbs on dealmaking are also costly. But they’re fast.
This could hit big pharma firms, like Pfizer, Merck and Bristol Myers Squibb, who are rolling out anticancer drugs developed in China for the US market. Pfizer just struck a $10 billion deal with China’s Innovent Biologics to develop 12 early-stage cancer drugs.
Healthcare is a new front in the China trade wars.
IPM Latest
The IPM Alliance launched its oncology pillar at the American Society of Clinical Oncology in Chicago. This set up an Oncology Leadership Circle and a 12-month roadmap for diagnostics and biomarker readiness, data-to-decision pathways, clinical trials, reimbursement, system readiness, regional equity, patient navigation and access.
IPM is focusing on what happens next, whether evidence becomes access and access becomes deliverable at scale.
What’s moving
US pricing politics: The US Supreme Court refused to hear a pharmaceutical challenge to a law on Medicare drug price negotiation that can cut the price of medicines. CMS, the government agency that runs Medicare, had targeted 10 drugs sold by six companies, including Novo Nordisk.
The decision effectively confirms government-backed court rulings from lower courts to cap drug prices.(Reuters)
Rare disease approval: The EMA’s conditional marketing authorisation for Vijoice (alpelisib) is justified to allow early access to medicines where there’s currently no other option, the regulator said. The drug, made by Novartis, treats severe PIK3CA-related overgrowth spectrum and the company will carry out further safety studies.
This shows how rare conditions are testing the boundaries of routine access. (European Medicines Agency (EMA))
Japanese health centres: Japan’s Ministry of Health, Labour and Welfare approved national reimbursement for a lung cancer treatment device, Novocure’s Optune Lua, but will require access via qualified health centres. Optune Lua is a portable device that produces alternating electric fields and lung cancer is one of the leading causes of cancer death in Japan.
Getting treatment depends on whether patients can reach the centres and combine device-based therapy with routine cancer care.
What are the obstacles?
No stock, no access: The EMA reported an ongoing shortage of intravenous cyclophosphamide-containing medicines across the EU that’s expected to last until Q1 2027. This includes intravenous ifosfamide and cyclophosphamide which have already experience shortages since late 2025.
When supply fails, access is rationed without anyone calling it rationing.
Early access is limited access: The FDA issued a “safe to proceed” letter for Revolution Medicines to initiate an expanded access treatment protocol for daraxonrasib in previously treated metastatic pancreatic cancer. Reuters reported that US cancer centres were racing to enroll patients after the early-access decision.
Early access is not automatic access. It is navigated access.
Cheers for cancer gamechanger, pressure for regulators
Cancer conferences don’t usually cheer. But the results for daraxonrasib, an RAS inhibitor, got a standing ovation after a phase 3 clinical trial showed it almost doubled median survival rates for metastatic pancreatic cancer, one of the most lethal forms of common cancers.
The pressure is already on to roll out the drug to patients. In the US, the FDA in May issued a “safe to proceed” letter for Revolution Medicines to initiate an expanded access treatment protocol and Reuters reported that US cancer centres were racing to enroll patients after the early-access decision. In the EU, the drug has been designated as an orphan medicine, the first step toward authorisation.
Demand in the US is high and some patients are already worried about whether there’ll be enough of the drug to go around. Payers will be have to make the tough call on the cost of the drug, given that the cancer has such high mortality rates.
Patient Access
Being eligible for treatment doesn’t mean you get treated: For patients, personalised medicine begins when a problem is identified correctly, when the right test is ordered, the result comes back in time, the referral happens, and the system is ready to act.
That can’t happen if testing is delayed, reimbursement is restricted, specialist capacity is concentrated in only a few centres, or the treatment path is unclear. Scientific progress can exist but patients are excluded if they can’t benefit from it.
When science identifies the right patient, what still prevents that person from reaching the right care?
From Pipeline to Pathway
Retatrutide sets new bar for weight-loss: Lilly reported Phase 3 TRIUMPH-1 data showing that participants on 12 mg retatrutide lost an average of 28.3% of body weight, over 80 weeks, easily outpacing other obesity drugs on the market.
With obesity drugs and obesity drug use multiplying, who qualifies, who pays and for how long? Some health payers are already questioning whether they should treat obesity as a chronic disease.
Sanofi multiple sclerosis drug: The EMA’s CHMP recommended Sanofi’s tolebrutinib, Cenrifki, for non-relapsing secondary progressive multiple sclerosis.
This approval asks how much health systems value slowing disability and whether payers and care pathways can take action before irreversible decline.
Guardant liquid biopsy panel: Guardant said it now has the largest FDA-approved liquid biopsy panel, with a 100-times wider genomic footprint than the previous Guardant360 CDx.
Broader genomic profiling may help identify more eligible patients, but reimbursement, interpretation and pathway integration will decide real uptake.
GSK positive early signal for gynaecological cancers: GSK reported positive early data for mocertatug rezetecan, Mo-Rez, a B7-H4-targeted ADC, with confirmed response rates of 62% in platinum-resistant ovarian cancer and 67% in recurrent or advanced endometrial cancer at the highest evaluated doses. There’ll be five global Phase 3 trials in 2026.
If the treatment confirms this promise, the next debate will be biomarker strategy, ADC sequencing, safety management and payer willingness to fund new gynaecological cancer options.
Public fight, private stakes
What happened in public: The US Preventative Services Task Force is the latest target of U.S. Health Secretary Robert F. Kennedy Jr. who fired two leaders of the panel which recommends what screenings and preventative procedures must be fully covered by insurers. The work of the panel has been stalled over the past year.
Why? Kennedy, a champion of the Make America Healthy Again movement, is battling the medical establishment as he aims to end what he calls the “corporate capture” of US health agencies. He previously removed members of a CDC panel that reviews vaccines ahead of controversial changes to the agency’s vaccination schedule.
What’s at stake in private? USPSTF sets the agenda for early detection and prevention. A threat to its scientific independence undermines public confidence in preventative medicine and forces individual insurers to make decisions on who gets screened for what.
Politicising preventative screening puts access to early detection at risk.
Changing cancer care
Getting personal: The mRNA-based cancer vaccine intismeran, which is based on a patient’s tumour tissue, can halve the risk of melanoma recurring and more than halve the risk of death, when combined with pembrolizumab, according to five-year follow-up data from an earlier clinical trial presented at ASCO.
For this treatment to be available, hospitals and healthcare providers will need systems for tumour sampling, sequencing, manufacturing coordination and treatment scheduling. Regulators and health authorities will need to assess the value of an individualised therapy. Patients will be watching closely whether the treatment is available outside of a few specialised care centres.
It’s in the blood: Blood sampling of patients of breast cancer patients can detect ESR1 mutations several months before resistance takes hold, allowing physicians to change treatment. Results from the phase 3 SERENA-6 trial were first unveiled at ASCO last year and a 2026 update confirms that blood monitoring can improve treatment and quality of life. The trial is now moving into a regulatory evidence discussion at the FDA.This marks a major shift in advanced breast cancer care, with a new warning sign from blood sampling. However, that requires serial ctDNA testing and clear guidance on what kind of result would trigger treatment.
The June watchlist
June is packed with signals: drug approvals, trial readouts, reimbursement moves and regulatory decisions that could reshape access to personalised medicine. Here’s what to watch.
| 10 June, US: |
| FDA Project Facilitate patient-first oncology session. |
| 11 June, US: |
| CMS manufacturer application deadline for GENEROUS Medicaid drug-pricing model. |
| 17 June, UK: |
| Daratumumab combination NICE third committee meeting. |
| 18 June, US: |
| FDA vaccine advisory committee on Moderna mRNA flu vaccine. |
| 18 June, UK: |
| NICE expected publication for acalabrutinib with venetoclax in untreated CLL. |
| 19 June, EU & online: |
| European Commission HTA webinar for high-risk medical devices and IVD developers. |
| 22-25 June, Amsterdam: |
| EMA committee for medicinal products for human use plenary. |
| 24-26 June, US & online: |
| CDC advisory committee on immunization practices. |
We want to hear from you
When a patient becomes eligible for personalised care, where does the system most often lose them: identification, testing, referral, reimbursement, delivery capacity or equity?
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