We can’t believe it’s already July and we’re two weeks into Q3! With that in mind, we’ve prepared a summary of our key market access blogs and news articles from the second quarter of 2021 for you.
In case you missed any, below you’ll find an overview of:
– How managed access agreements are used in NICE’s Highly Specialised Technology process
– Key takeaways from EESC’s positive opinion of a joint EU HTA body
– Summary of NICE’s 5 year strategy
– Clinical trial design considerations for Health Technology Assessments
– Explanation of NICE’s Highly Specialised Technologies process
– Benefits of Early Dialogue with HTA
Take a look in PDF format:
How are managed access agreements used in NICE’s Highly Specialised Technology process?
Highly specialised technologies have the potential to offer life-changing treatment to small numbers of patients but often come to market with immature data sets.
In this article we explore if managed access agreements, in the context of the NICE’s Highly Specialised Technology (HST) evaluation process, offer a solution to bridge the data gap in the best interests of patients, the NHS and pharma companies alike?
The ESSC publishes its positive opinion of a joint EU HTA body
At the beginning of the quarter the European Economic and Social Committee (EESC) released its positive opinion of a potential joint EU HTA body.
Here are the key takeaways from the opinion:
EESC agrees with the initiative of submitting one dossier and considers it a cost-effective option.
It recommends shortening the initially proposed 6 year transition period for its full implementation.
The committee additionally makes a controversial suggestion to introduce EU-level pricing analysis as a reference to improve transparency.
UPDATE: Since this, a provisional agreement has been put in place for the Joint EU HTA
NICE releases its 5-year strategy to drive innovation and faster patient access in the UK
NICE’s vision is to be at the forefront of developing innovative ways to appraise technologies and generate world-leading value assessments. In the wake of Brexit and the COVID-19 pandemic, the HTA agency has worked with key opinion leaders from around the globe to construct its’ 5-year strategy.
The plan, which has been based on the four pillars of transformation, details how they aim to achieve their vision and tackle the healthcare inequalities which have been exacerbated by the pandemic.
Clinical trial design considerations for Health Technology Assessments
Clinical evidence relating to therapeutic efficacy and safety is one of the most valuable criteria of the HTA process.
However, with differing demographics between countries and at times, small patient populations it can be difficult to design one trial that meets the requirements of each country’s HTA body.
This article highlights the most common criticisms of clinical evidence from the HTA perspective and provides recommendations on how to reduce such uncertainty.
NICE’s Highly Specialised Technologies process explained
The Highly Specialised Technology (HST) process is NICE’s method of evaluating medicines and treatments for rare diseases. As HST guidance is uncommon and its qualifying criteria can be unclear, it can be difficult to understand if your product will follow this or the Standard Technology Assessment (STA) process.
This article outlines: the process, its qualifying criteria, how you can prepare for it and the key differences between the HST and STA processes.
Benefits of Early Dialogue with HTA
It is critical that a pharmaceutical company designs its pivotal study to satisfy the evidence requirements of payers as well as regulators. To achieve regulatory approval a product must not only demonstrate clinical efficacy but also answer additional questions beyond this.
This article explores the benefits of early engagement with HTA bodies to capture such questions early on in the process and identifies where country-specific insights can be sought out.