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During a hearing led by the Committee on Public Health Ordinary of the European Parliament, Dr. Vanessa Gregorc explained that the U.S. Most Favored Nation (MFN) policy has slowed EU access to advanced therapies. She urged streamlined EU trials and better funding to stay competitive with the U.S., China, and JapanProfessor Domas Vaitiekus then highlighted Lithuania's solution for smaller markets. With no access to commercial CAR-T therapies, Lithuania uses hospital exemptions to produce affordable, in-house treatments (€130,000/patient)Professor Miguel Forte later emphasized the need to work together across the EU to improve access to advanced treatments. He called for permanent investment in biotech and funding for early-stage development to avoid the "valley of death." Forte also called for specialized centers of excellence to collaborate, not compete
The European Commission has published the fifth Joint Clinical Assessment (JCA) under the EU HTA Regulation for AstraZeneca's Etcamah (camizestrant), which in combination with a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor (palbociclib, ribociclib, or abemaciclib) is indicated for the treatment of adult patients with estrogen receptor (ER)-positive, HER2-negative, locally advanced or metastatic breast cancer upon detection of ESR1 mutation during first-line endocrine therapy in combination with a CDK4/6 inhibitor, without disease progressionFollowing a revision of Etcamah's proposed indication in January 2026, two of the seven originally defined PICOs were removed from the assessment scope, narrowing the JCA's focus to patient populations and comparators aligned with the final approved indicationThe phase 3 SERENA-6 trial showed that Etcamah improved progression-free survival and second progression-free survival versus continued aromatase inhibitor therapy, while the report highlighted uncertainties around the novel ESR1 mutation-guided early-switch treatment strategy, repeated testing requirements and long-term treatment sequencing
The National Institute for Health and Care Excellence (NICE) and NHS England are piloting a new approach that could reduce the time it takes for promising medicines to enter managed access from approximately 12 months to as little as six monthsThe Streamlined Managed Access Route for Therapies (SMART) pilot will introduce a shorter initial assessment, allowing eligible medicines to reach NHS patients while additional clinical evidence is collected, before undergoing a full NICE evaluationMedicines considered for the pilot must demonstrate promising potential, be suitable for relatively rapid NHS implementation, have clear evidence-generation plans and represent good value for money, with financial safeguards protecting the NHS and manufacturers
Belgium’s ongoing budget deadlock has created uncertainty over healthcare funding, with the pharmaceutical industry warning that delays to reimbursement and innovation funding could slow patient access to new medicines Proposed federal spending cuts include significant healthcare savings measures, raising concerns that a lower healthcare growth budget could reduce funding available for medicines and lead to stricter reimbursement conditions The political impasse has pushed Belgium towards a provisional emergency budget, as Prime Minister Bart De Wever’s resignation was rejected by King Philippe, with coalition partners now resuming negotiations in an effort to reach a budget agreement before the new year
U.S. Democrats have regained control of both the House and Senate following the 2026 midterm elections, setting the stage for increased congressional oversight of the Trump administration’s healthcare and drug-pricing initiativesWhile the administration’s Most Favored Nation (MFN) agenda is likely to continue advancing through executive and regulatory channels, Democratic lawmakers are expected to intensify scrutiny of MFN agreements, tariff-related negotiations, and other pharmaceutical pricing policies. The election outcome could also revive Democratic priorities such as expanding Medicare drug price negotiationsHowever, the president retains veto power, meaning that for the next two years, any major legislative changes will require bipartisan backing
The Centers for Medicare & Medicaid Services (CMS) recently published a proposed rule that would implement pharmacy benefit manager (PBM) reform provisions passed through the Consolidated Appropriations Act (CAA) of 2026 in Medicare Part DThe proposal would limit PBM compensation under Part D to bona fide service fees, while requiring expanded reporting on drug pricing, utilization, formulary placement, pharmacy reimbursement, contractual guarantees, and certain manufacturer-PBM arrangementsThe rule would also create new compliance and enforcement tools, signaling enhanced CMS scrutiny of PBM business practices and financial relationships within the Medicare Part D program
Last week, NAVLIN Daily brought you key market access developments from across the globe In China, Beijing urged the U.S. to refrain from restricting cross-border economic activities following plans to limit American pharmaceutical investments in the country In the UK and Poland, the governments advanced changes affecting medicine access and reimbursement. The UK moved to remove VAT on medicines supplied free of charge by pharmaceutical companies, while Poland adopted a draft amendment to its medicines reimbursement law
NAVLIN Daily reporters sat down with J. Philip Ludvigson, a partner at King & Spalding,* to understand the evolving dynamic between the U.S. and China as both countries mull over restrictions on cross-border biotech dealmakingLudvigson believes the proposed U.S. restrictions on cross-border activities, which are currently subject to public comment, are highly likely to become law, but the fine details are still in fluxThe legal expert advised the industry to weigh in during the comment period and to strategically prepare for the different ways such policies could evolve in the future
A new report commissioned by the Norwegian Pharmaceutical Industry Association (LMI) argues that Norway's health economic assessments overstate long-term medicine costs by assuming drug prices remain unchanged for 20 to 40 years despite expected price declines after tenders and patent expiry Modeling 29 hospital medicines introduced between 2023 and 2026, the report found that incorporating expected price reductions could lower estimated year-five budget impact by 27% to 43%, from NOK 3.1 billion to as low as NOK 1.8 billion Industry representatives warned that current assessment practices may disadvantage medicines compared with other healthcare interventions and, together with broader pricing pressures such as US MFN policies, could make Norway a less attractive market for launching innovative therapies
The U.S. Food and Drug Administration (FDA) issued draft guidance creating an “Individualized Feature Space” framework that would allow sponsors to manage multiple patient-specific genome-editing variants under a single Biologics License Application (BLA), potentially reducing the need for separate approval applications and additional clinical trials for qualifying variantsThe guidance is designed to accelerate development and access for personalized gene therapies targeting ultra-rare genetic diseases by establishing clearer regulatory expectations for manufacturing, safety testing, labeling, and post-approval variant additionsSeparately, the Centers for Medicare & Medicaid Services (CMS) plans to expand its CGT Access Model beyond sickle cell disease by inviting manufacturers of cell and gene therapies for additional conditions to participate in multi-state Medicaid outcomes-based agreements through an upcoming application process
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