Employees working together at a table

We can deliver a fully comprehensive HTA evidence package

We help to place your technology in the strongest position to withstand scrutiny from any HTA body and optimise the likelihood of a positive recommendation for reimbursement.

Our HTA service offerings span early HTA planning and strategy, the generation of HTA-standard literature reviews, statistical analysis and real-world evidence, and the development of the highest quality HTA submission dossiers and associated health economic models.

To date, we have supported the development of:

260+

HTA Submission Dossiers

110+

HTA Submission Dossiers to NICE

150+

HTA SUBMISSION DOSSIERS across Europe, North America and APAC

Our dedicated HTA team are true experts when it comes to devising the optimal strategy for your technology, generating a robust HTA-ready evidence package, and delivering the highest quality HTA submission dossiers.

To date, we have supported the development of over 260 health technology assessment (HTA) submission dossiers, including over 110 submission dossiers to NICE, and over 150 submission dossiers across Europe (Scotland, Wales, Ireland, Sweden, Greece, Belgium, Spain), North America (CADTH, AMCP) and the APAC region (Singapore).

We deliver a fully comprehensive HTA evidence package that places your technology in the strongest position to withstand scrutiny from any HTA body and optimises the likelihood of a positive recommendation for reimbursement. Our service offerings cover early gap analyses and scientific advice, the generation of HTA-standard literature reviews, statistical analysis and real-world evidence, and ultimately the development of the highest quality HTA submission dossiers and associated health economic models.

Planning & Strategy

  • HTA strategy workshops and strategy slide deck development
  • HTA gap analyses and evidence generation plans
  • HTA landscape analyses and prior HTA appraisal reviews
  • HTA-focused critical reviews of HTA deliverables (literature reviews, indirect treatment comparisons, health economic models, real-world evidence studies)
  • Scientific Advice (NICE, EMA-EUnetHTA, CADTH), Office for Market Access (OMA) and Innovative Licensing and Access Pathway (ILAP) support

Evidence Generation

  • HTA-standard clinical and economic literature reviews
  • HTA advisory boards (payer, clinician, health economic experts)
  • Patient advisory boards for HTA

Economic Modelling

  • Early cost-effectiveness modelling and feasibility assessment
  • HTA-ready cost-effectiveness models
  • HTA-ready budget impact models
  • Economically justifiable price and other cost-effectiveness-based pricing analyses

Submission Dossier Writing

Complete HTA submission dossier development, including project and stakeholder management

  • Europe: NICE, SMC, NCPE, AWMSG and others
  • North America: CADTH submissions, AMCP dossiers
  • APAC: ACE, PBAC and others
  • Pre-HTA submission writing and strategic support

Post-Submission Support

  • Complete post-HTA submission support, including written responses and economic and statistical analyses
  • Publications support, including abstracts, posters, oral presentations
  • Mock HTA body Committee meetings and HTA body Committee meeting representation

What makes HTA support from Costello Medical different?

A comprehensive HTA solution

We work as one internal team to deliver all components of your HTA evidence package. We firmly believe that in doing so we can offer a solution that is not only more efficient, but that also results in a strong, consistent and self-reinforcing HTA narrative throughout the HTA submission dossier.

Provision of strategic advice

We are experienced in advising clients on wide-ranging strategic HTA challenges, such as immature survival data and uncertainty in long-term clinical effectiveness, lack of data for relevant comparators and the use of real-world evidence, difficulties in demonstrating cost-effectiveness at the desired price, and the use of the most appropriate methods for indirect treatment comparison.

High quality writing support

Our extensive experience in writing for HTA, coupled with thorough postgraduate-level training in health economics received by most of our medical writers, makes us ideally placed to seamlessly weave together the clinical and economic stories within your HTA submission dossier, and develop a clear, evidence-based and persuasive narrative.

Exceptional customer service

We genuinely care about the outcome of our clients’ HTA submissions as much as they do. We aim to become an integral part of the client team, providing technical expertise and the highest quality deliverables to form the complete HTA evidence package alongside proactive and responsible project management support.

Specialist HTA expertise

We have a dedicated Rare Diseases team who specialise in the delivery of HTA evidence generation and submission dossier delivery in the rare diseases space. We also provide guidance on engaging with patients/patient organisations throughout the appraisal process. Beyond pharmaceuticals, we have experience in the delivery of early HTA planning and strategy, HTA evidence generation, economic modelling and HTA submission dossier writing for devices and diagnostics, in collaboration with our MedTech team.

Passion for the field

We are keen contributors of research on key advances in HTA methods and processes at international conferences, including posters, oral presentations, workshops, and issue panels presented at ISPOR and HTAi. Explore our dedicated pages to find out more.

Opinion piece illustration

NICE Transformation Plan: Our Reflections on Methods and Process Changes

As part of their transformation plan, the UK National Institute for Health and Care Excellence (NICE) are introducing important changes to their methods and processes to focus on relevance, timeliness, usability and impact, in order to meet the pressures of a rapidly changing health and care system and an ever-increasing demand for their products. Our HTA team were delighted to participate in public consultations on these changes in March 2024, and have summarised our key takeaways on integrated topic prioritisation and the inclusion of technology appraisal guidance in NICE guidelines and their implications for UK health technology assessment (HTA).

We have also reflected on our experience developing over 10 appraisals under NICE’s proportionate approach to technology appraisal (PATT), highlighting the key challenges and opportunities we have encountered so far – we participated in the public consultation on the PATT in summer 2023, which informed the first modular update to the NICE manual for health technology evaluation in October 2023.

For more information on our HTA services or to request a quote, please contact Matt Griffiths

Get In Touch

Loading