HTA Quarterly | Spring 2022
By Xcenda
In this issue our editors provide insights on the new European Union Health Technology Assessment regulation, the United Kingdom's Innovative Licensing and Access Pathway, and the drug reimbursement environment in Canada.
HTA Quarterly | Spring 2022
Joint clinical assessment in the EU: Pan-European HTA for drugs and medical devices will become reality
With the new European Union (EU) Health Technology Assessment (HTA) regulation coming into force in January 2022, the transition phase to a European joint clinical assessment—which will be applied in full for certain drugs from January 2025—was initiated. This article aims to provide an overview of the current understanding of the new process and time frame of implementation, as well as some considerations for manufacturers.
HTA Quarterly | Spring 2022
The UK Innovative Licensing and Access Pathway—A new paradigm in market access
Following the departure of the United Kingdom (UK) from the European Union (EU) on January 31, 2020, the Medicines and Healthcare products Regulatory Agency (MHRA) became the main body for the regulation of medicines in the UK. In parallel, and as a result of Brexit, a new and unprecedented era was born for the approval of medicines in the UK. This article explores the Innovative Licensing and Access Pathway (ILAP) and the opportunities it has introduced in potentially transforming the future of UK market access.
HTA Quarterly | Spring 2022
The drug reimbursement environment in Canada: An overview
The Canadian environment is a key opportunity for pharmaceutical manufacturers to launch therapies. To gain drug reimbursement from public and private payers, there are many stakeholders along the commercialization pathway who need to be proactively engaged. This article considers the various stakeholders and elements that need to be considered when launching a specialty medication in Canada.
Heard on the Street
“Going forward, NICE will adopt a more modular approach to updates to its methods and processes. This will enable us to be more agile and responsive, monitoring, reviewing, and improving our methods and processes into the future, making sure they remain cutting edge as the healthcare landscape continues to evolve.”
- Professor Gillian Leng, CBE, NICE chief executive
