Spain
Teva has been fined €463m – just over half a billion US dollars – over a breach of EU antitrust rules, after the European Commission found that it abused its dominant position to delay competition to Copaxone, including by misusing the patent system and disparaging rivals. The firm has strongly disagreed with the decision – which is claims is “legally untested” and “not supported by the facts” – and says it will appeal.
Hemgenix has now secured reimbursement in several European markets, with more talks ongoing. While the path to reimbursement has not always been easy, innovative access deals have helped to smooth the way.
New rules on health technology assessments in Spain make room for real-world evidence and early dialogue.
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.
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to demonstrate that its Duchenne muscular dystrophy drug Agamree was a cost-effective use of resources, according to draft guidance from England’s health technology assessment body, NICE.
Spanish competition regulator the CNMC has fined Merck Sharp and Dohme €39m for abusing its dominant position, by blocking Insud Pharma’s rival to the Nuvaring vaginal contraceptive ring through “unjustified legal action” that sought to delay market entry of Insud’s Ornibel version. The originator is considering an appeal.
France is set to become the first country in Europe to fund Imcivree for a second – and as yet unapproved – indication. Meanwhile, England has agreed to reimburse the drug for its approved indication as did Germany earlier this year. Reimbursement discussions are underway in the rest of Europe.
With efforts continuing to maximize access to medical countermeasures against the pandemic threat, a webinar organized by NGOs looked at progress with and the shortcomings of the WHO’s C-TAP initiative, recent moves by the WHO on access provisions in funding agreements, and plans for a global C-TAP database.
The current system means Spain is not a priority launch country.
EU stimulus funding marks opportunity to establish health technology appraisal agency in Spain.
US, EU, global authorities share experiences, insights, advice for industry on remote alternatives even after inspectors can resume travels.
Demand surges, supply surges and investigator travel restrictions are forcing FDA to adopt less restrictive regulatory approaches during the pandemic.
A new study argues that certain procurement methods could be hitting vaccine coverage rates and that wider debate is needed among policy makers, payers and procurers to find more sophisticated purchasing models.
Vertex has struck a reimbursement deal in Spain for Orkambi and hopes that it will also make progress in England where a new proposal has been made by the company.
Novartis has managed to temporarily overcome payer reservations about the real-world value of Kymriah by engaging early with payers and heath technology assessment bodies and by developing tailored outcomes-based deals for key European markets. Approaching each payer with a responsible attitude has helped too.
Payment for outcomes has played an important role in enabling Gilead to secure reimbursement for Yescarta in some EU markets. It is likely to be the key focus for the company as it works to expand patient access to the potentially transformative CAR-T therapy across Europe.
Speakers from several EU countries at last week's Medicines for Europe conference discussed the reasons behind the often wide inter-country disparities in biosimilar usage and the policies they are pursuing to try to remedy the situation.
Metamizole is in the safety spotlight again after the Spanish regulator said it was investigating reports of deaths and serious side-effects in expatriate and holidaymaking Britons caused by the painkiller.
The Valletta group of southern EU states on improving access to medicines continues to expand and now includes Croatia.
Five countries appear to be ahead in the battle to host the European Medicines Agency after Brexit, judging by the results of a European Commission assessment and an EMA staff survey, although much horse-trading among member states is expected before the winner is announced in November.