The benefits of utilizing Early Scientific Advice within market access

In this, the second of his 2-part series for market access professionals seeking to understand the key principles and benefits of Early Scientific Advice, Harrison Davis explores the:

• Benefits for manufacturers in utilizing HTA Early Scientific Advice as part of early development planning 

• Common development issues that can be discussed through Early Scientific Advice 

• Feasibility of obtaining HTA Scientific Advice across key markets. 

Harrison is a Senior Consultant at PRMA Consulting, part of Fishawack Health, and has worked on a number of successful projects relating to HTA Early Scientific Advice. 

What are the benefits of utilizing HTA Early Scientific Advice? 

HTA Early Scientific Advice enables discussions with HTA agencies about the proposed clinical development program, proposed economic analyses, and supplementary evidence generation plans. 

There are 4 key benefits for manufacturers: 

1. The ability to optimize trial design elements that will be examined by HTA committees 

Input can help optimize the development process by identifying recommendations for aspects of trial design that later will be examined by HTA committees, such as enrollment, duration, and choice of endpoints or comparator 

2. The opportunity to explore strategies to address statistical issues, to ensure appropriateness and validity of results to HTA payers 

Validating the proposed approach toward stratification, subgroups, and the statistical analysis plan will ensure appropriate analysis and validity of results 

3. Greater understanding of payer expectations 

Awareness of the payer’s perspective at an early stage could inform strategic plans and methodology, enabling manufacturers to tailor a submission dossier that is relevant for each market 

4. Development of evidence that demonstrates additional value 

Engaging with payers on supplementary evidence needs, such as real-world evidence, allows manufacturers to strengthen supporting arguments and generate a comprehensive evidence package faster. 

Ultimately, when scientific advice is implemented, these recommendations routinely result in stronger HTA submissions, by reducing the payer uncertainty often associated with suboptimal HTA outcomes. 

Source: www.nice.org.uk/about/what-we-do/life-sciences/scientific-advice/case-studies] 

Early Scientific Advice allows common development issues to be discussed 

I have briefly outlined the principles and benefits of ESA, but determining whether and which assets should be explored is a question that manufacturers face early in their development programs. 

Here are some areas for exploration through HTA Scientific Advice which may help you strengthen your clinical development plan and subsequent HTA submissions. 

Key to identifying discussion topics that will provide the most value from Early Scientific Advice consultation is to consider candidate assets in the context of their clinical development plan. 

These case studies illustrate this: 

• One leading manufacturer sought a fast-to-market approach, based on accelerated approval on Phase 2 trial data. As HTA bodies prefer to evaluate head-to-head data, our focus for consultation was on approaches to mitigating this data gap (e.g., the appropriateness of certain data sources for use as an external control and the preferred approaches to generating a network of evidence through indirect treatment comparisons) 
   
• Another case study included a situation where the manufacturer was planning to launch a combination treatment, where two components new to the indication were added to an existing backbone. The comparator was clearly relevant, being established in the disease already – but our advice was to discuss how HTA bodies would view the contribution of the new components to the improved efficacy seen to show both new components were needed and efficacy was not driven predominantly by one. From the manufacturer’s perspective, introducing another arm in the trial would increase enrollment time and costs, so they sought to discuss approaches that avoided this. 

The feasibility of seeking ESA for an asset varies between markets 

Not all HTA bodies will provide input on every topic. Part of being able to leverage HTA Scientific Advice is to recognize the applicable value for your asset and in which markets. 

In France, for example, the product MOA must be novel to the indication or advice cannot be sought. 

When seeking advice from NICE in the UK, the pivotal trial may already be under way, unlike advice sought from other markets. 

This is a major reason why HTA Scientific Advice is often called Early Scientific Advice – as not only does the consultation need to occur prior to the start of the pivotal trial, but the lead time for ESA application, and of course time to then implement the recommendations, means considering ESA too late in development is the biggest barrier to its usage. 

Being aware of these variations allows you to better access and utilize early HTA Scientific Advice.

For a deeper dive into the considerations for, and feasibility of, obtaining HTA Scientific Advice across key markets, you can watch our on-demand webinar: 

This free resource provides practical recommendations for preparation and implementation of HTA Scientific Advice meetings that will increase the value of your consultation.