United Kingdom
The UK branded drug industry is calling for adjustments to be made to the UK voluntary scheme framework for branded medicines, after the payment rate increased to 22.9% for 2025. Meanwhile, the generics industry says the scheme is functioning “as intended” and opposes any changes.
An initiative run by health technology appraisal (HTA) bodies in the US, Canada and England is looking at how non-traditional treatment benefits, such as the value of hope and scientific spillover, can inform appraisals and understanding of a product’s value.
The UK’s medicines regulator is pressing on with clarifying its expectations on decentralized manufacturing of medicines.
Payers and health technology assessment bodies in the Netherlands, Germany and Italy are either unwilling to use real-world data in assessments or cannot due to their existing frameworks, say representatives from Gilead Sciences and Autolus Therapeutics.
The Clinical Trials Regulation was “supposed to harmonize” requirements in the EU, but instead it is giving some countries the chance to get ahead by offering faster approval timelines, notes Telethon’s head of regulatory affairs.
The government wants to raise the statutory scheme payment rate for newer branded medicines from 15.5% to 32.2%, after sales data for Q2 and Q3 2024 showed “higher than expected newer medicines sales growth.”
Pharming has convinced NICE to reverse its rejection of its treatment for APDS by providing the health technology assessment institute with more data. It has also dropped the price it was asking for the drug, which has a list price of £352,000 per year per patient.
ILiAD Biotechnologies explains why it is confident that it will secure approval for the first-ever pivotal Phase III study using a human challenge model for a whooping cough vaccine. Also, it outlines why the UK is the preferred destination for this ground-breaking study.
The UK drug regulator has made a number of improvements to its innovative licensing and access pathway, including a more “core” role for National Health Service partners, which is expected to facilitate flexible commercial discussions around drug reimbursement.
Cost and evidence gaps remain barriers for Kisunla and Leqembi as NICE rejects the drugs again but opens further consultations on the reimbursement of the Alzheimer's disease-modifying treatments.
Lawrence Tallon has been announced as the new CEO of the UK drug regulator, the MHRA, more than a year after its current CEO, Dame June Raine, announced she would retire from the role.
The health technology assessment institute, NICE, has reversed its rejection of Sobi’s once-weekly drug for preventing and treating severe hemophilia A, meaning that the treatment has now secured reimbursement in three European countries.
Health technology assessment agencies are willing to pay more than usual for advanced therapies that treat rare or severe diseases, but an advanced therapy for a common condition would not qualify for such a modifier, a former senior figure at England’s NICE says.
A new collaboration of health technology appraisal bodies in the US, England and Canada could lead to better alignment on HTA methodology in the future.
A lower asking price from BMS and more insight into the benefits Breyanzi offers have convinced the health technology assessment institute, NICE, to reverse its rejection of the one-off treatment for large B-cell lymphoma.
While CSL Behring has successfully negotiated reimbursement contracts for its one-time gene therapy Hemgenix in several European countries, it says there are still “barriers to innovative contracting solutions” in some member states that need to be addressed.
CSL Behring explains how it worked with authorities in Denmark, Austria, England, Scotland, Spain and Switzerland to secure innovative access arrangements suitable to each nation’s “unique needs” for its one-time gene therapy, Hemgenix.
In its latest draft standard contract for 2025/26, the National Health Service in England has proposed enhanced prescribing requirements “in recognition of the increasing importance of biosimilars in the provision of biological medicines.”
The pharmaceutical industry was not sufficiently involved in designing updates to England’s health data infrastructure, leading to a “misalignment” between company needs and what is currently being delivered, according to the results of a survey by the Association of the British Pharmaceutical Industry.
The UK drug regulator says that men under the age of 55 years who are already taking valproate will not need to be reviewed by two specialists, as this measure is “unlikely to minimize risks” of neurodevelopmental disorders in children conceived by them any further.