By Sian Tanner, PhD, Principal, Advisory Lead for EU HTA Solutions, IQVIA
Enterprise alignment is essential for launch success
The European Union Health Technology Assessment Regulation (EU HTAR) aims to align processes among European Union (EU) member nations to bring drugs to patients faster. While market access teams have been preparing for this significant change, the HTAR has impact beyond market access. Cross-functional teams must be prepared for the ripple of consequences across functions and outside the EU.
For example, new joint clinical assessment (JCA) reports will soon be produced under the HTAR. They will introduce a standardized framework for all member states to assess clinical efficacy and safety evidence for new medicines, vaccines and devices to reduce redundant practices and increase assessment quality.
JCA reports will be published in English and made available sooner after approval than traditional HTA reports. This early availability positions the reports as a valuable reference for global payer bodies and could influence regulatory and reimbursement decisions across international markets. The reports are also expected to shape the activities of cross-functional teams throughout the drug development lifecycle.
The HTAR raises the stakes for global development, regulatory, commercial, pricing and health economics and outcomes research (HEOR) teams to become strategically aligned and work collaboratively. To prepare for success, organizations need more than market access compliance — they need enterprise-wide alignment.
Uniting teams for action
The new JCA reports and the data within them can help teams make more informed decisions about such topics as pricing and reimbursement. However, if global teams aren’t working together, the lack of strategic alignment can impact the information in JCA reports and how an asset is viewed by stakeholders and competitors.
Market access leaders may find it difficult to bridge cross-functional teams that aren’t used to working together and whom they may not have authority or influence to lead. Similarly, global teams outside the EU may not initially appreciate the HTAR’s relevance to their work or that of their local or regional stakeholders.
This is where senior leadership plays a crucial role. Their endorsement signals the need for enterprise-wide action and to consider HTAR early in strategic planning.
With cross-functional teams on board, they can work with market access leaders to start addressing the HTAR’s broad and global implications. Five priorities to consider in an enterprise-wide strategy include:
1. Adjusting global asset strategies
The HTAR adds to the complex trade-off decisions that pharmaceutical companies need to make when operating across multiple regulatory and access environments. They now need to determine how to balance long-term evidence needs post-Inflation Reduction Act in the United States with those of the HTAR in the EU while also considering the U.S. Most Favored Nation policy, which heightens the implications of any early or lower EU prices.
Cross-functional leaders can reduce the risk of surprises — like late-phase evidence gaps — by factoring HTAR requirements and implications into their global asset strategy. This should be done early and across market access, research and development (R&D), regulatory and commercial functions. Leaders should also identify and evaluate trade-offs between conflicting needs that emerge from these and other policy trends.
One area where some companies are bringing enterprise-wide thinking to the HTAR is in registrational clinical studies. Companies are unlikely to conduct a separate, EU-only study. Because of this, companies are having early conversations about their registrational studies to verify that they are designed to meet the HTAR’s requirements.
2. Maximizing readiness outside the EU
The HTAR expands the evidence scope that pharmaceutical companies must provide as part of a launch package. For example, the regulation requires more analysis to show how well a new drug’s performance compares against a broader range of available treatments than has traditionally been expected at launch. This creates additional analytical work as well as the possibility for both favorable and non-favorable product comparisons.
For non-EU teams, having these broader data points will be crucial. Market access and HEOR teams will need to anticipate how JCA findings could be interpreted by local stakeholders and be prepared to address them in pricing and reimbursement submissions and negotiations.
3. Adjusting global launch sequences
It’s still too early to know how the HTAR will impact EU product launches or global launch sequences. It could put more pressure on pharmaceutical companies to launch in all member states earlier rather than staggering launches. On the other hand, the demands of meeting HTAR requirements and simultaneous launches in member states could lead to companies deprioritizing the EU in launch planning.
For now, companies should consider the HTAR when evaluating the business case of European launches and scenario planning for global launch sequences. R&D, regulatory and market access teams will need to collaborate on the development of sequences for both indication-specific strategies and lifecycle planning. If these are altered, companies should be prepared to adjust affiliate structure, resourcing and ways of working.
4. Managing brand perception
A JCA report “shall not contain any value judgement” on the health technology it assesses. However, how stakeholders or competitors perceive the report’s tone or information, such as a favorable or non-favorable product comparison, may influence brand perceptions. Similarly, a label of dossier noncompliance for reasons such as a missed timeline may also impact how an asset is perceived.
Pharmaceutical companies can’t control what’s published in a JCA report, but they can plan for it. For instance, market access and commercial and marketing teams can work together to identify potential scenarios or narratives that could stem from what’s published in a JCA report and then develop messaging for them.
Separate messaging to address real or potential needs should be crafted for proactive and reactive communications with stakeholders, such as physicians, payers and patient advocacy groups. Training can then be provided to sales personnel and other teams to prepare them to use the messaging. Done early, this work will help teams prepare for when a JCA report is published and avoid rushed, purely reactive responses to its findings.
5. Evolving price strategies
The HTAR’s impact on pricing remains unclear. However, if the regulation accelerates equitable access, international reference pricing could expose lower-priced markets earlier and cause average list prices in Europe to erode more quickly. Additionally, a JCA report that gives payers access to a broader scope of comparators could give them leverage to choose lower-priced comparators that they may not have otherwise considered.
Pharmaceutical companies should start factoring these dynamics into their long-term forecasting, pricing governance and launch business cases. Looking further ahead, market access teams should monitor for markets that start referencing JCA reports in pricing negotiations and assess the implications for their pricing strategies.
Ensuring enterprise readiness
The HTAR’s halo effect extends across functions and geographies, which means market access teams in Europe are only part of the equation for preparation. Cross-functional teams, including global development, regulatory, commercial, HEOR and pricing teams, play a critical role in launch success, as does the endorsement of senior leadership for strategic alignment of these teams.
Pharmaceutical companies that understand the HTAR’s broader implications and are prepared to address them across functions globally will be best positioned to not only comply with the HTAR but also anticipate its potential risks and leverage its opportunities.
