Are Technology Appraisal and Highly Specialised Technologies charges set to rise?

Health technology assessment (HTA) is the systematic evaluation of properties, effects, and/or impacts of health technologies, aiming to respond to decision-makers’ needs for information relating to the introduction, coverage, use or disinvestment of health technologies. The majority of countries have some level of HTA procedure in place for the assessment of pharmaceuticals and often use horizon scanning procedures to support topic selection, however this may differ significantly from country to country in terms of key decision drivers, robustness of the procedures or level of evidence to be submitted. HTA initiation is often associated with manufacturer’s willingness for public funding of the technology with Ministries for Health and payers applying topic selection criteria, most frequently being based on economic or resource impact, potential health benefits, severity or disease burden, unmet need, population size, importance to healthcare and innovativeness.

HTA systems across the European Union, the UK, Canada and Australia vary significantly in the way they are set up, according to their role and based on how funding decisions are made. The process across all, however, aims to be robust, dynamic and transformative with a collective need for transparency. One area where each HTA differs across countries is the way they are funded. A number of countries do not charge the industry any fee for conducting a HTA, including Austria, Sweden, Demark and Norway, others like Germany, only charge an initial consultation fee if advice is required and for those that do charge, the charges vary enormously from a relatively moderate fee of approximately £5,000 for France and Italy for example, to a large significant fee for Australia, where a HTA submission would cost in excess of £185,000.

To keep pace with the changing health and care system and to ensure financial stability of the Technology Appraisals (TA) and Highly Specialised Technologies (HST) programme, NICE is currently holding a consultation on making changes and adjustments to its cost recovery mechanisms. The current costs, which are mandatory, for a larger company range from £106,200 for a Cost comparison (CC)/Rapid review (RR), through to £151,700 for a Single technology appraisal or highly specialised evaluation through to £303,400 for a Multiple technology appraisal (MTA) complex with more than 3 technologies. For smaller companies there is a 75% discount on the cost of the assessment, small companies are defined as those with annual turnover of less than £10.2M, a balance sheet total of not more than £5.1m and not more than 50 employees. For the 2024-25 business year, the fees for TA-HST guidance evaluations will increase by 23%, however NICE are not asking for comments on the new fees for 2024-25, the consultation paper focuses on the following key areas:

i. Confirming evaluation timelines and commitment to pay

ii. Introduction of a change fee

iii. A charge for technical engagement

iv. The charge for pilot topics and amendments to processes

v. Updates to refund procedures.

The current NICE consultation is live and closes on Tuesday 19th December 2023. NICE is in its 4th year of charging for TAs and HTAs and is yet to achieve full cost recovery and whilst year on year the deficit has been reducing, the current gap that exists needs to be closed to secure the programme’s financial sustainability and comply with Managing Public Money guidance https://www.nice.org.uk/about/what-we-do/our-programmes/nice-guidance/nice-technology-appraisal-guidance/charging/consultation

Over the last 2 years, inflationary changes have required an increase in the fees charged but this has apparently not gone far enough in successfully manage NICE’s deficit. The core 5 proposals that form the NICE consultation are as follows:

Proposal 1 – Confirming evaluation timelines and commitment to pay

NICE plans to propose changes to the charging mechanism and associated timelines for charging and the topic selection, scheduling, and scoping stages by accelerating the point at which companies are asked to pay. Once a company confirms in writing they accept the evaluation timelines including the ITP date and submission deadline, they will be asked to provide a URN, which demonstrates a commitment to the agreed timelines and to pay the associated charge, this 1st proposal aims to drive forward a more predictable work programme to better inform financial forecasting, reporting, and resourcing.

Proposal 2 – Introduction of a change fee

To address the impact of topic rescheduling and to recover lost opportunity costs, NICE proposes implementing a change fee. The change fee will apply after the company has confirmed the evaluation timelines, in the following scenarios.

· A company request to change the timelines

· There are regulatory delays

· A company no longer wishes to provide a submission for the evaluation

Proposal 3 – A charge for technical engagement

If NICE decide that technical engagement is required to support a topic's progression and to recuperate all costs associated with the evaluation, the exceptional charge for technical engagement will be fixed at 5% of the STA charge, and payment will be required from the company before final guidance publication.

Proposal 4 – The charge for pilot topics and amendments to processes

Where guidance evaluations are delivered via a pilot, topics will be subject to a divergent fee. For example, ‘pathways’ topics will have a different fee during the pilot phase. Should these ‘Pathways’ become a standard business-as-usual approach, the fee will be written into charging procedures. In this scenario, the fee is expected to be no more than the largest or lowest fee set out within the NICE charging procedures.

Proposal 5 – Updates to refund procedures

Currently, there is no eligibility for a refund once a company has submitted to NICE and the submission review has started. The procedures will be updated to allow companies the opportunity to receive a proportionate refund depending on the key milestones met, resource and unit capacity used. However, once the External Assessment Report has been completed, a refund will not be applicable.

These changes for England will significantly impact the way companies currently plan and budget for potential launches over the coming years, which will be further complicated by the new Voluntary Scheme for Branded Medicines Pricing, Access and Growth (VPAG) coming into place in January 2024 (Navigating the Evolving UK Life Sciences Landscape: Unveiling of the VPAG Scheme). Additionally, the impact of higher HTA fees in England will be more far reaching if other countries follow suit and look at the way they charge for HTAs.

Are you considering how the current NICE consultation may impact your existing portfolio? Are you concerned that other countries may follow suit in increasing submission fees or are you just starting your access journey for your potential launches?
Get in touch with Decisive Consulting Ltd to explore how we can help navigate your journey through Market Access.

Written by Alison Oliver