默沙东、赛诺菲向欧盟EUnetHTA计划提交**种疫苗Zostavax
2013-10-22 MedSci MedSci原创
受财政状况的限制,欧洲国家一般都采取严格的审查制度来筛选可能被采用的疫苗产品。但是这也造成一种疫苗如果要登陆欧洲市场将可能面临多次重复的审 查,极大浪费公司和政府资源。有鉴于此,欧盟内部成立了一项名为Network for a Health Technology (EUnetHTA)的审查计划,以是欧盟内部成员国能够协同审批疫苗产品。 在过去几个月,赛诺菲和默沙东在欧洲合资的疫苗公司成为了
受财政状况的限制,欧洲国家一般都采取严格的审查制度来筛选可能被采用的疫苗产品。但是这也造成一种疫苗如果要登陆欧洲市场将可能面临多次重复的审查,极大浪费公司和政府资源。有鉴于此,欧盟内部成立了一项名为Network for a Health Technology (EUnetHTA)的审查计划,以是欧盟内部成员国能够协同审批疫苗产品。
在过去几个月,赛诺菲和默沙东在欧洲合资的疫苗公司成为了这项政策的第一个适用者,公司于今年四月向EUnetHTA提交了其用于治疗带状疱疹的疫苗Zostavax。预计整个流程将于年底完成,届时EUnetHTA将得出一系列报告以供欧盟成员国评估使用。
详细英文报道:
The tightening of healthcare budgets has driven countries across Europe to demand more evidence of a vaccine's value before agreeing to reimburse the product. And with each country having its own decision-making processes, this places a significant burden on companies.
Over the past few months, Sanofi ($SNY) and Merck's ($MRK) European vaccine joint venture has taken part in an initiative intended to shorten decision timelines and cut duplication from the process. The joint venture submitted Merck's shingles vaccine Zostavax to the European Network for a Health Technology (EUnetHTA) pilot project. Over four months, EUnetHTA, a network of 47 European health technology assessment bodies, produced a report on Zostavax that countries can use to help decide whether to reimburse the vaccine.
EUnetHTA has already used the Europe-wide assessment model for GlaxoSmithKline's ($GSK) cancer drug Votrient, but Zostavax is the first vaccine to take part in the pilot project. "Agreeing to run the first Rapid Relative Effectiveness pilot on a vaccine addressing an unmet medical need is another tangible sign of the increasing attention that European authorities give to prevention," Sanofi Pasteur MSD market access VP Andrea Rappagliosi said. The U.K. has already added Zostavax to its immunization program, and the EUnetHTA report could now help expand use across Europe.
Sanofi Pasteur MSD submitted Zostavax for EUnetHTA assessment in April, and the process was completed four months later. The speedy, centralized process could make Europe less of a headache for biopharma, which has suffered setbacks as governments push for greater evidence of a product's value. In July, Novartis ($NVS) became the latest company to have its plans dented when the U.K. decided against adding meningitis B vaccine Bexsero to its immunization schedule.
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