我们已支持客户提交了超过 80 份的 HTA 申报材料。我们专业的 HTA 团队致力于制定最佳的申报策略，并撰写最高质量的申报档案。我们拥有向欧洲 NICE、SMC、AWMSG、NCPE 及新加坡 ACE 等卫生技术评估机构提交 HTA 报告的丰富经验。此外我们的 HTA 团队也提供高质量的 HTA 可行性评估、全球 HTA 文档、NICE Scientific Advice briefing books、ACE topic selection forms、AMCP 文档和卫生经济方面的文献发表
我们具有丰富的临床数据沟通经验，并于英国约克大学接受过全面透彻的卫生经济培训，能够为您的 HTA 申报、全球 HTA 档案及卫生经济文献发表等项目提供完善的临床和卫生经济学支持
我们和客户一样关心项目成果，比如 HTA 申报是否成功、卫生经济文献是否能顺利发表。我们致力于成为客户团队不可或缺的搭档，在为客户提供专业技术及高质量医学写作支持的同时，积极负责地帮助客户进行整体项目管理
我们具有应对各类 HTA 申报挑战的丰富经验，可以向客户提供超出药品说明书范围用药的比较、或是在缺乏随机试验证据或数据不成熟等情况下为客户提供建议。我们也可以就如何应对竞争对手的 HTA 申报进行指导，对先前提交的内容进行战略性分析，并通过临床和经济专家咨询会或专家调查收集建议
我们以各专业团队协作的方式，为客户 HTA 申报提供一站式服务，包括系统文献综述、网络荟萃分析、卫生经济建模和书面报告提交。我们坚信，通过公司内部各专业团队的密切配合，我们能够高效地为客户筹备一份完善可靠、具有说服力的 HTA 申报材料
We supported a small pharmaceutical company with their complete NICE and SMC submissions for a new product that they were bringing to market, including the systematic literature reviews, the network meta-analysis, the economic model development and the written submissions. We were able to advise the client on how best to present the benefits of their product within the clinical pathway, particularly given that there were issues with off-label use of other comparators and few randomised controlled trials in the disease area.
Due to her detailed knowledge of the submission, the manufacturer asked the Costello Medical project manager to be one of the manufacturer representatives at the NICE Committee meeting. The persuasive narrative within the submission coupled with the comprehensive statistical analysis that had been performed persuaded NICE to approve the new technology after just one Committee meeting.
We were approached by the global market access division of a large pharmaceutical company requiring urgent assistance in drafting their response to a Technology Assessment Review (TAR) issued by the NICE in the UK.
The report issued recommendations that misrepresented their product’s clinical efficacy and cost-effectiveness and would have been highly damaging to market access success globally if adopted in NICE’s final guidance. The NICE consultation and review process provided an opportunity for the pharmaceutical company to submit a response to the TAR.
As we had not been involved in the original NICE submission and tight deadlines are imposed during the consultation phase, we had to assimilate and evaluate in a matter of days an unfamiliar report of over 500 pages issued by the academic group commissioned by NICE. This report was highly complex because our client’s product had been assessed alongside a number of others in the same therapeutic area. Our detailed analysis of the clinical and economic data presented in the TAR helped to identify the inappropriate interpretation of the clinical evidence by the academic group as well as serious flaws in their approach to the economic model.
Drawing on these findings, we agreed the strategy for the response in close collaboration with our client’s market access team. We then swiftly drafted a targeted and persuasive, yet respectful, document for submission to NICE, which successfully influenced their decision-making process: the evaluation in the original version of the TAR, stating that our client’s product should not be considered cost-effective, was reversed in the final NICE guidance where it is now recommended for use in a key patient subgroup throughout England’s National Health Service.
We were requested to produce a full evaluation submission document for submission to the Agency of Care Effectiveness (ACE) in Singapore, for one of the first manufacturer submissions under the new HTA process. This was prior to the publication of the ACE process guidance or any appraisal documents, thus requiring us to use our background in UK HTA to best support our client. Complicating the submission further, the evaluation considered two different competing products from the same manufacturer against four competitor products, in a crowded indication with clear standards of care already well-entrenched.
We responded by working with the global, regional, and local medical, HEOR, and commercial teams to develop a strategy based on previous HTA experience and local priorities in Singapore. We attended all meetings with ACE to support the manufacturer and ask appropriate questions in order to advise on a practical approach to the submission, making use of existing materials, and understanding the decision drivers for ACE. We developed a budget impact model and conducted interviews with key opinion leaders to provide inputs for the model, as well as understanding the unmet need and the changes that would occur in local clinical practice with the introduction of these treatments. We also provided support to the commercial team on pricing scenarios, including possible competitor pricing strategies, and completed a thorough write-up of the full evaluation submission document comprising sections on the unmet need, the place in therapy, clinical effectiveness, cost-effectiveness and budget impact of the therapies.
Guidance documents published on the ACE website in July 2018 recommended that both products from our client were to be listed for subsidy on the Standard Drug List, the list of drugs assessed to be cost-effective and essential to the provision of medical care to all Singaporeans.
We were approached by the local team of a pharmaceutical company in Singapore requiring assistance in producing a dossier for topic selection by the Agency for Care Effectiveness (ACE).
We sought to highlight the unmet clinical need in this disease area to encourage evaluation by ACE. To do this, we conducted interviews with local clinical experts to support the arguments and gain more of an understanding about the extent to which there is adequate treatment in local clinical practice. In addition, the interviews provided us with local inputs for the simple budget impact model that we built to accompany the dossier. The presence of biosimilars in the market introduced certain complexities, but we used our experience across a variety of ACE submissions, and information obtained from communications with ACE, to support the client in developing a suitable biosimilar defence strategy, while providing a compelling case to ACE. We developed a suite of materials for the client, including an economic model, a topic selection dossier, and summary slides for presentation. The decision is expected by Q4 2018.