To meet HTA body requirements, our client needed to develop global SLRs supporting UK and Nordic submissions, while concurrently updating SLRs for an additional indication of the same product.

Solution

We applied our expertise in evidence and systematic literature reviews (SLRs) to develop concise, globally and locally compliant protocols and custom extraction templates. Records were rigorously screened against defined criteria, and findings were synthesized into focused reports across areas such as clinical outcomes and utilities. This approach ensured accurate capture of key parameters, a comprehensive overview of existing evidence, and high-quality deliverables that informed local HTA submissions and supported future filings.

Impact

In close collaboration with our client, NHTA managed to develop high-quality SLRs meeting the requirement of the authorities and the client’s internal timelines. The SLRs ultimately supported the HTA applications resulting in positive reimbursement decisions.

Indlægget Development of global & local clinical, economic, HCRU, and QoL SLRs in preparation for HTA submissions blev først udgivet på NHTA.

Our client required support with the development of a global value dossier to support early market access and reimbursement by demonstrating the clinical and economic value of a product. In addition, to anticipate and respond to payer objections during pricing and reimbursement negotiations a HTA submission tracker and objection handler was also required.

Solution

The solution combined robust data analysis to demonstrate efficacy, safety, and cost-effectiveness, aligned with prior payer decisions, and included structured materials to address common objections.

HTA developed an Excel-based submission tracker for the client, capturing key milestones: submission and decision dates, subgroups, and reimbursement outcomes.

The objection handler, built based on prior HTA feedback and payer interactions, paired each objection with a recommended response, supported by clinical data, real-world evidence, and economic models. Visual cues highlighted objection complexity, helping teams prioritise. Designed as a living document, it evolves with new insights and complements global value dossiers (GVDs), ensuring consistent messaging and local adaptability.

Impact

In close partnership with our client, NHTA developed a user-friendly Global Value Dossier and objection handler, successfully adopted and utilised across European market access teams.

Indlægget Global Value Dossier, HTA tracker & Objection Handler blev først udgivet på NHTA.

The challenge was to provide end-to-end HTA support including strategic advice, submission development, and negotiations for an orphan drug.

Solution

NHTA delivered a full-spectrum solution including strategic landscape and comparator assessments, development of request for assessments, country-specific adaptations of cost-effectiveness and budget impact models, dossier development, payer engagement, post-submission support, pricing and negotiation guidance, and in-depth interviews with local KOLs.

Our deep local expertise and early engagement with payers and KOLs ensured that all adaptations were tailored to national requirements and aligned with the specific treatment landscapes – maximizing the impact and relevance of the submission.

Impact

The result were positive reimbursement decisions by HTA agencies, despite initial data gaps, including the absence of relevant EU/Nordic/UK comparators. The submission led to successful reimbursement outcomes, with the base case effectively defended.

Indlægget Nordic, UK and EU Access & HTA Submissions blev først udgivet på NHTA.

In a previous submission in Norway our client was met with several objections to the submitted application and health economic model for their oncology product. The global model was poorly developed, overly complex, and the vendor supporting with the HTA submission in Norway did not fully capture the value proposition. NHTA were brought in to ensure that the previous decision from Decision Forum was overturned, as we had succeeded with this for several other drugs before.

Solution

Our experienced team conducted an initial feasibility analysis that considered whether a resubmission, informed by longer follow-up data and a new bespoke Global health economic model, could result in a different decision outcome.

NHTA developed the conceptual design of the Global cost-effectiveness model based on dialogue with NoMA. Instead of a decision tree + Markov model with 20+ disease states, we developed a more appropriate and user-friendly de-novo CE-model, following a standard three state Partitioned Survival model structure. This model illustrated the clinical benefits of the innovative oncology product much more accurately, was much easier to use and follow and improved the ICER significantly. In parallel with this work, we developed the required statistical analyses (survival analyses) in line with NICE guidance. Finally, our HTA team developed a bespoke submission dossier highlighting the benefits of the technology as well as the potential savings within the healthcare system. Additionally, following the submission we supported the client in the price negotiations.

Impact

We managed, in close collaboration with the client, to build a convincing case that resulted in Decision Forum overturning their original decision, allowing access for the technology in Norway.

Indlægget Overturning a negative reimbursement decision in Norway blev først udgivet på NHTA.

In preparation for global launch of an immuno-oncology combination treatment for metastatic oncology indication, our client required the development of a global core CE model and BIM.

The economic models needed to be flexible in design to support health technology assessment (HTA) submissions to health authorities, including UK, US, EU5, Canada, Australia, and the Nordics.

Solution:

Our team of HTA and HEOR specialists, systematic reviewers, statistical experts, as well as dedicated strategic experts performed analysis of existing evidence and economic literature to inform models specifications. Statistical analyses of time-to-event data was conducted to in line with NICE guidance to inform the model. High level of technical expertise ensured fast running models with an effective user interface that effectively demonstrated the assets clinical and economic value while still being adaptable to various markets, utilising a modular structure.

The HE & BIM models were supported by corresponding technical reports and summary slide decks making it as clear as possible for the affiliates how to adapt the models and concepts to their local HTA-setting.

Impact:

Our collaborative process and dialogue with our client resulted in state-of-the-art HE & BIM global models that effectively demonstrated the assets clinical and economic value while enabling smooth local adaptations.

Indlægget Development of Global CEM and BIM for immuno-oncology combination treatment within an oncology indication blev først udgivet på NHTA.

In preparation to optimise the chances of successful Global launches of selected pipeline assets, a major pharmaceutical company, wished to conduct an initial value assessment in potential new indication to understanding the value to key stakeholders.

Solution

We conducted a comprehensive initial value assessment to identify, prioritise, and propose methods for validating and quantifying key value elements. Our approach included a detailed review of existing evidence, categorisation of value blocks using targeted literature reviews (TLR), and the application of early quantification approaches considering core value components (survival, QoL, and costs).

We engaged both internal and external stakeholders to validate priorities and ensure alignment. This process provided a clear map of evidence strengths and gaps, informed early market access and health economic strategies, and expanded the definition of value by validating key value blocks with patients, clinicians, and payers.

Impact

Our support helped the client to successfully obtain a comprehensive overview and categorisation of existing evidence and data gaps to inform early market access planning, early health economic modelling and value proposition work.

Indlægget Identification and quantification of value blocks for early pipeline assets blev først udgivet på NHTA.

In preparation to optimise the likelihood of successful launches for selected pipeline assets, a major pharmaceutical company, wished to have a roadmap of innovative ways to gain access and fully understand the competitive landscape in the Nordics.

Solution

Our team worked together with the client to identify the specific challenges for their future assets and innovative access routes. Building on our vast experience within innovative access approaches, performed targeted reviews to identify and summarise non-traditional or innovative market access routes in the Nordics, as well as conducted interviews with Amgros in Denmark, NT council/County councils in Sweden, LIS in Norway, and HILA/FIMEA in Finland to understand future opportunities, trends and discussion topics.

The payer insights from the Nordic HTA-bodies and procurement agencies were combined with a comprehensive analysis of the competitive landscape through review of available assessments and decisions. Based on this, we developed the optimal strategy for each pipeline asset in the Nordics.

Impact

Our recommendations helped the client develop a clear and actionable Market Access strategy for their pipeline assets. The overview of the innovative market access routes available in the Nordics the allowed our client to prepare internal milestones as well as align the strategy with global offices before submission.

Indlægget A roadmap of innovative market access approaches in the Nordics blev først udgivet på NHTA.