France
France’s health technology appraisal body, HAS, is putting more emphasis on the importance of economic evaluations in light of the rising costs of health technologies, including medicines and medical devices, and increasing budgetary pressures.
HAS, the French health technology assessment body, has issued positive recommendations for several orphan drugs, including for Vyloy, which was provisionally rejected for reimbursement in the UK last year.
The world’s first CRISPR gene editing therapy, Casgevy, has been made available to patients with sickle cell disease in England, adding to access arrangements in the US, Austria, Bahrain, Germany, Luxembourg, Italy and Saudi Arabia.
Debate on how to manage drug spending continues in France despite an ongoing disagreement between industry and the government about whether there was €1.2bn overspend on medicines in 2024.
The collapse of the French government brings more uncertainty for the pharmaceutical industry.
The 2025 social security financing bill includes measures to reduce spending on reimbursed drug costs, change the way that industry paybacks are calculated, and tackle medicine shortages.
France’s regulatory agency, which triggered the review, says it believes that the addition of suicidal ideation to the product information for finasteride and reports of cases of completed suicide “seriously alter” the product’s benefit-risk profile.
The French pharma industry body Leem says that the scale of its contribution to health insurance cost savings is undermining the industry’s financial sustainability.
A total of 748 key medicines are now affected by the four-month stock requirement, compared with 422 in 2021.
New requirements proposed by the French regulator are intended to increase the impact and effectiveness of the pictogram showing the risks of taking medicines in pregnancy.
Casgevy, the world’s first CRISPR gene editing therapy, is the second drug to be accepted onto a managed access scheme via England’s Innovative Medicines Fund, offering a new treatment for patients with transfusion-dependent beta thalassemia.
England’s NICE has “misclassified” HER2-low metastatic breast cancer as a medium severity disease, say AstraZeneca and Daiichi Sankyo, the co-developers of Enhertu. NICE said it would consider a rapid re-appraisal if the companies offered a “fair price” for the drug.
Scotland’s health technology assessment body has agreed to reimburse Chiesi’s Elfabrio for Fabry disease, mirroring the decision from several other European countries – however, France turned down the rare disease drug, while Germany questioned its benefit.
The Haute Autorité de Santé says that the risk of granting early access may only be justifiable if uncertainties over the clinical benefit of a drug can be addressed within a “reasonable” timeframe.
J&J says it has “exhausted all current viable avenues” to get its antidepressant nasal spray Spravato reimbursed on England’s National Health Service, after NICE decided against re-appraising the drug following numerous funding rejections.
The CNIL plans to update its data protection methodologies based mostly on the results of a new consultation and the outcome of a pilot in which companies are asked to identify the challenges they have faced when designing trials with decentralized elements.
A study from the health technology assessment department of France’s national health agency, HAS, has identified which pharmaceutical products are most likely to receive a request for post-market studies. The agency hopes this information will aid in companies’ forward planning.
Adult immunization programs can save “billions” for society, but their value is underestimated because of challenges around measuring broader value evidence and a lack of incentives for companies to collect this data, says the Office of Health Economics.
Santhera Pharmaceuticals did not provide enough evidence to demonstrate that its Duchenne muscular dystrophy drug Agamree was a cost-effective use of resources, according to draft guidance from England’s health technology assessment body, NICE.
The health technology assessment institute, NICE, is not yet ready to recommend Casgevy for sickle cell disease and says it wants more data. Meanwhile, an access agreement relating to the treatment’s use for transfusion-dependent β-thalassemia is making progress in England, as are reimbursement talks for SCD in other European countries.