Interventional cardiology continues to advance toward precision-based care, where treatment strategies are matched to patient characteristics and real-world outcomes guide decision-making. Coming out of TCT 2025, one of the leading interventional cardiology conferences, Trinity sees four trends shaping the next 2-3 years in the interventional cardiology market.  

1. Alternatives to Drug-Eluting Stents Are Back in Focus 

For years, drug-eluting stents (DES) have been the default in percutaneous coronary intervention (PCI), but that dominance is being challenged. The SELUTION DeNovo trial (n≈3,300) showed that a “leave nothing behind” approach using sirolimus-eluting drug-coated balloons (DCBs) and provisional stenting was non-inferior to routine DES at one year with nearly 80% of patients avoiding a stent, an important validation of metalsparing PCI strategies. Similarly, SELUTION4ISR reinforced the credibility of DCBs such as Cordis’ SELUTION for instent restenosis. Resorbable scaffolds also re-emerged, with next-generation designs aiming to overcome earlier limitations – it’s clear that alternatives to DES are increasingly gaining clinical acceptance. 

2. Device Options for Calcium Modification are Expanding   

Severe calcification remains one of the toughest challenges in PCI. While Shockwave (J&J) continues to dominate with its intravascular lithotripsy (IVL) platform, randomized trials like ShortCUT and VICTORY suggest that cutting balloons and ultra-high-pressure balloons, like the SIS Medical OPN, can achieve comparable stent expansion in certain lesions, and potentially with cost and workflow advantages.  

The result is a more tailored approach to calcium modification, where device choice reflects lesion characteristics and operator preference. Continued evolution in crossing systems and next generation IVL platforms are expected to expand therapy options and improve workflow efficiency. 

3. Monopolistic Device Markets Are Facing Real Competition

Two markets, both built and historically “owned” by their founding products – Left Atrial Appendage Closure (LAAC) and Temporary Mechanical Circulatory Support (tMCS) – are entering a more competitive phase. 

• In LAAC, Boston Scientific’s WATCHMAN still anchors a >$2 billion category, but challengers are emerging with differentiated designs and trials exploring new antithrombotic strategies. ANDES antithrombotic strategies, long-term Amulet outcomes, and ongoing head-to-heads signal a more competitive and evidence rich phase. 

• In tMCS, Abiomed’s Impella remains the incumbent, but small-bore devices promising lower hemolysis and easier deployment are gaining attention. Whether these challengers can build the same depth of evidence to drive adoption and differentiate beyond engineering features remains unclear; however, it’s likely that Abiomed will soon have competition.  

4. Renal Denervation Shows Cautious Optimism 

Long-term data for renal denervation (RDN) continue to validate blood pressure reductions without medication escalation, positioning RDN as a potential adjunct therapy for select hypertensive patients. Several physicians and industry experts have compared the uptake of RDN to the early days of Watchman, with talks of becoming a “blockbuster” device. With the recently announced positive Medicare National Coverage Determination, enthusiasm continues to rise for Medtronic’s Simplicity and Recor Medical’s Paradise as these systems move closer to broad clinical adoption.  

Precision and progress

As 2025 draws to a close, the trends presented at TCT and echoed throughout the interventional cardiology community reinforce a core principle: the future hinges on agility and evidence-driven care. Trinity MedTech works closely with leading and emerging MedTech organizations to translate insights and clinical realities into strategies that capture new opportunities, spark category leadership, and drive commercial momentum. In the years ahead, those who champion both innovation and practical adoption—matching the right device to the right patient, every time—will set the pace in interventional cardiology.

Authors: Robert Cohen, Paul O’Mahoney, MD 

The post Catalysts of Change: Four Innovations Redefining Interventional Cardiology appeared first on Trinity Life Sciences.

The Most Favored Nation (MFN) pricing policy is once again under consideration in the U.S. First put forward in a 2020 Executive Order (EO) by the Trump Administration, the 2025 MFN policy aims to eliminate global free riding by aligning United States (U.S.) drug prices with the lowest prices paid in any comparable developed nation. This strategy is intended to address the longstanding concerns that American patients and taxpayers have been subject to higher drug prices, and, in doing so, subsidizing pharmaceutical innovation costs for the rest of the world. Industry stakeholders such as Eli Lilly’s CEO David Ricks continue to emphasize the stark differences between the U.S. and ex-U.S. healthcare system structures and stakeholder incentives, which raises uncertainty around whether importing pharmaceutical pricing systems from ex-U.S. markets into the U.S. healthcare system would achieve the intended EO aim.

Negotiated prices in Europe come with broad access, low patient copays and without administrative hurdles like prior authorizations. There are also no intermediaries that distort prices, and hospitals do not seek profits by selling medicines and marking them up. If we import foreign price controls and insert them into a U.S. system that isn’t built to function for patients, we risk embracing the worst of two worlds: the low productivity and output of Europe’s biopharma sector with the high out-of-pocket and distorted prices of the U.S. insurance market.”

—David Ricks, Eli Lilly, CEO

Since the initial 2020 EO was unveiled, legislative changes such as the introduction of the Inflation Reduction Act (IRA) have granted Medicare the authority to negotiate drug prices, creating a statutory pathway for the implementation of the MFN policy that was not previously possible.

On August 31st, the administration sent letters to manufacturers outlining near-term expectations and deadlines to:

1. Provide MFN pricing for all drugs to all Medicaid patients.
2. Enter a contract with the US to provide MFN pricing for newly launched drugs.
3. Enter a contract agreeing to repatriate increased foreign revenue to reduce US prices.
4. Participate in direct-to-consumer (DTC) distribution for high-volume, high-rebate drugs.

While the 2025 EO and letters sent to manufacturers outline a renewed policy direction, several key components remain undefined or subject to interpretation, demonstrating government willingness to pursue bold policy measures while delegating operationalization to relevant rulemaking agencies. The active dialogue that has been created by the MFN policy vision, and manufacturer first steps among key industry players, signals that manufacturers may be compelled to take action without the need for the MFN reference price system being formally implemented. Together, the combination of IRA implementation and MFN policy vision signals a shift in the U.S. market from low to increasing price sensitivity.

How Can Manufacturers Follow MFN Principles and Mitigate Associated Risks?

Targeting PBMs & GTN Relief

A noticeable reaction among large pharmaceutical manufacturers has involved accelerating direct-to-consumer (DTC) distribution channels as a strategic response to bypass traditional intermediaries such as pharmacy benefit managers (PBMs), offering patients a channel to purchase drugs directly at lower prices. DTC approaches focus on reducing medication costs, primarily for patients without insurance or with limited coverage. Industry leaders including Pfizer, Bristol-Myers Squibb (Eliquis 360), and Eli Lilly (Zepbound, LillyDirect), have publicly accelerated DTC strategy recently. The Eliquis 360 support program enables uninsured or underinsured patients to gain access to the drug at more than a 40% list price discount. The LillyDirect program was expanded to include Zepbound at a 50% list price discount, with insulin products repriced with a 70% discount and $35 monthly cap. Pursuing the DTC pathway provides large manufacturers with well-established distribution logistics, a relatively straightforward and rapid strategy to directly address the MFN policy vision to provide the best available price to U.S. consumers. However, while this strategy is demonstrating impact within the consumer market, broader influence will require active participation from employer groups and government stakeholders. From the patient perspective, manufacturers should consider that the DTC process can feel unfamiliar, complicated and expensive for patients, many of whom may not fully understand how medications are sourced and sold, potentially leading to doubts around whether their prescriptions are legitimate. To address this, manufacturers should focus on creating a smooth and supportive DTC experience, offering clear guidance and reliable information to help patients feel confident and informed throughout the process.

Withdraw Launch (Launched Products), Prioritize Alternative Market Segments / Launch Approach

Manufacturers may opt to mitigate the risk of MFN by withdrawing launched products or prioritizing the private vs. public market channel for pipeline assets in low-price RoW markets, where there is greater flexibility for the manufacturer to be the price setter vs. the public channel, where manufacturers are typically price takers. The revenue implications of this strategy are an important consideration and may vary depending on the therapeutic area in question. Furthermore, manufacturers will also need to consider reputational implications, as well as the availability of historical pricing information for launched products, which may still be referenceable as part of MFN price calculations. Manufacturers may also consider a more patient-centric approach in the context of indication expansions, including publishing clinical trial data to support incorporation into treatment guidelines without engaging in centralized HTA or reimbursement procedures, which can facilitate patient access to innovative therapies that are valued by KOLs and patients alike. This strategic shift raises a key question around how manufacturers might adjust their launch strategy in markets where the public channel comprises the major patient access route.

HTA body concerns around the impact that the U.S. MFN policy vision may have on patient access to drugs in ex-U.S. markets are starting to emerge, with NICE’s CEO Sam Roberts recently publishing a baseline analysis of drug approvals and availability to track baseline data to understand the potential impact of MFN, stating that “There are huge uncertainties. There could be a reduction in medicines launched, a reduction in commercial flexibilities, and there could be an increase in medicines terminated.”

Pursuing Alternative Discounting Methods & Out-Licensing

Manufacturers may look towards alternative discounting methods including expenditure caps, population and volume-based agreements, as the visibility and complexity of information within these agreements challenges the ability to back-calculate the net price. Differential net pricing guidance by market may therefore be established by manufacturers, depending on ease of ability to back-calculate the net price based on the visibility of information within such agreements.

Additionally, out-licensing ex-U.S. drug sales and marketing rights to a partner pharmaceutical manufacturer may also be a strategic route that manufacturers may pursue to maintain confidentiality of ex-U.S. net prices. Out-licensing agreements typically mandate strict net pricing confidentiality across partner manufacturers, effectively creating a pricing visibility firewall.

However, pursuing alternative discounting approaches and out-licensing does not directly address the call to action around rebalancing the funding of innovation between the U.S. and ex-U.S. markets, instead simply obscuring the visibility of ex-U.S. net prices. This strategy may also provoke a regulatory response, although the details of how this might manifest are currently unclear.

What Should Manufacturers Consider as MFN Policy Evolves?

Manufacturer objectives among this changing policy landscape will be focused on maintaining their existing level of revenue to support continued investment and funding into R&D and innovation, while improving patient affordability in the U.S. and continuing to provide access to patients in ex-U.S. markets. In navigating the evolving landscape shaped by the MFN policy vision, manufacturers face a multifaceted set of potential actions—both direct and indirect—to address the administration’s goals, and/or mitigate risk associated with the administration’s MFN policy vision.

The overarching recommendation is one of cautious vigilance: carefully watch and wait as clearer guidance emerges, particularly regarding pre-launch products, while actively engaging in scenario planning and evaluating options for products already on the market. Given the current uncertainty and remaining questions surrounding the legality of the directives, implementing significant changes to commercial planning will likely be premature. However, manufacturers should prepare by building flexibility and readiness to adapt quickly as the policy environment evolves.

Looking Ahead: Agility in a Shifting Policy Landscape

A crucial aspect of this preparation will be to ensure that ex-U.S. evidence packages are payer-relevant to maximize both value and pricing opportunity in ex-U.S. markets, which will help to mitigate the impact of ex-U.S. price translation into the U.S. should the MFN policy be implemented as intended, as well as rebalance the distribution of revenue generation globally. Moreover, meaningful legislative changes in pharmaceutical pricing have historically been difficult to achieve, with significant legal and practical hurdles, suggesting the administration may face continued challenges in charting a definitive course. Ultimately, success in this uncertain environment will hinge on manufacturers’ ability to remain agile and prepared, balancing the demands of the MFN policy vision while safeguarding innovation and access across global markets.

Authors: Max Hunt, Annabelle Brough, Nicolle Jaurre and Giulia Voto

REFERENCES

1. https://www.whitehouse.gov/presidential-actions/2025/05/delivering-most-favored-nation-prescription-drug-pricing-to-american-patients/
2. https://www.accc-cancer.org/docs/documents/advocacy/phrma-complaint-on-mfn-rule-filed-2020-12-04.pdf
3. https://www.federalregister.gov/documents/2021/12/29/2021-28225/most-favored-nation-mfn-model#:~:text=The%20November%202020%20MFN%20Model%20interim%20final%20rule%20
   established%20a,and%20the%20MFN%20Model%20website. 
4. https://www2.mdd.uscourts.gov/Opinions/Opinions/ACCC%20v.%20Azar%2023%20Dec%202020%20CCB-20-3531.pdf
5. https://phrma.org/blog/no-matter-how-you-look-at-it-the-most-favored-nation-rule-is-bad-policy
6. https://petrieflom.law.harvard.edu/2025/05/22/the-global-risks-of-americas-most-favored-nation-drug-pricing-policy/
7. https://www.whitehouse.gov/presidential-actions/2025/05/delivering-most-favored-nation-prescription-drug-pricing-to-american-patients/
8. https://www.hhs.gov/press-room/cms-mfn-lower-us-drug-prices.html
9. https://www.deloitte.com/content/dam/assets-zone3/us/en/docs/industries/life-sciences-health-care/2025/us-lshc-navigating-the-evolving-drug-pricing-policy-download.pdf  
10. https://www.democrats.senate.gov/imo/media/doc/inflation_reduction_act_one_page_summary.pdf
11. https://www.biospace.com/business/with-pharma-throwing-billions-at-us-manufacturing-where-is-the-cash-going
12. Fact Sheet: President Donald J. Trump Announces Actions to Get Americans the Best Prices in the World for Prescription Drugs – The White House
13. Trump Directs Pharma Companies on Cutting Drug Prices Under Most-Favored-Nation Order
14. Pfizer Launches PfizerForAll™, a Digital Platform that Helps Simplify Access to Healthcare | Pfizer
15. Bristol Myers Squibb – Bristol Myers Squibb and Pfizer Announce Direct-to-Patient Eliquis® (apixaban) Option
16. https://www.novocare.com/obesity/products/wegovy/get-product.html
17. https://www.fiercepharma.com/pharma/amid-mfn-talks-lilly-chief-warns-adoption-international-drug-prices-could-bring-worst-two  

The post U.S. MFN Drug Pricing: What 2025’s Executive Order Means for Global Pharma appeared first on Trinity Life Sciences.

The momentum behind AI-driven advancements in life sciences has never been stronger, and this trend was spotlighted in Everest Group’s new 2025 PEAK Matrix^® report, “Life Sciences AI and Analytics Services for Commercial PEAK Matrix^® Assessment 2025.”

Trinity Life Sciences is honored to be recognized as a Leader in this comprehensive assessment, a distinction rooted in exceptional, tangible outcomes delivered for life sciences clients across the sector.

What Is the PEAK Matrix^® Assessment? 

Everest Group’s PEAK Matrix^® is a rigorous, comprehensive framework assessing the overall vision, capability, and market impact of platform providers. The 2025 report features detailed profiles and evaluations of 30 leading service providers. This research is grounded in an extensive annual Request For Information process (covering calendar year 2024), direct interactions with commercial life sciences providers, client reference checks, and ongoing tracking of the digital services market.

Why Trinity Was Named a Leader 

Our leadership position in the 2025 PEAK Matrix^® Assessment reflects Trinity’s unwavering commitment to delivering value at every stage of the commercial lifecycle. Recognizing that every decision our clients make impacts a life, we lead with evidence-based solutions purpose-built for the unique needs of life sciences organizations. 

The growing emphasis on patient- and HCP-centricity to deliver superior customer experiences has modernized commercialization strategies, placing data, analytics, and AI at the core of life sciences enterprises’ go-to-market efforts. As a result, they are turning to strategic partners with domain-led digital expertise and scalable technology solutions to navigate the evolving landscape. Trinity Life Sciences’ generative and agentic AI investments, the TrinityEDGE suite of commercial solutions, its targeted domain-centric partnerships, and its thought leadership are augmented by its client flexibility and responsiveness. This focus has led to its recognition as a Leader in Everest Group’s Life Sciences AI and Analytics Services for Commercial PEAK Matrix^® Assessment 2025.

—Durga Ambati, Practice Director at Everest Group

 

Transformative AI and Analytics in Action: Featured Case Studies 

A hallmark of the 2025 report is its spotlight on real, client-validated outcomes. Some highlights:

• Faster Decision-Making with GenAI: For a rare-disease biotech, Trinity’s Brand Insights AI unlocked accessible, searchable data archives—speeding up strategic decision-making and reducing information silos. 
• 10X ROI for Small Biopharma: Trinity enabled a small biopharma manufacturer to accelerate brand growth through an integrated, data-driven commercial strategy—achieving a tenfold return on investment with a 100-day acceleration plan. 
• Informed Market Expansion: For a clinical-stage company, Trinity’s research and forecasts guided commercial resource allocation and expansion into additional patient populations. 
• 20–30% Lift in Field Rep Productivity: At a midsize pharma company, Trinity’s AI-powered call planning dramatically boosted field force efficiency—reducing non-target calls by ~20% and increasing new-to-brand prescriptions. The client’s CEO recognized these advances in public communications. 

The Road Ahead: AI, Analytics, and Life Sciences Commercialization 

The industry’s shift toward patient- and HCP-centricity is reshaping commercialization strategies, driving demand for partners who blend domain expertise with scalable digital innovation. Trinity’s recognition as a Leader reflects our continuing investment in technology, data, and client-responsive solutions to help life sciences organizations compete and thrive in this evolving marketplace.

Want to Learn More? 

Trinity’s experts have created a library of thought leadership exploring the impact of GenAI and analytics on life sciences, featuring: 

• Blog: Empowering Field Teams: A Case Study in AI-Driven Call Planning 
• On-demand Webinar: The GenAI Advantage: Empowering Pharma Customer-Facing Teams 
• Blog: Can GenAI be Used to Improve Data Operations Efficiency?

Questions?

We’re here to help. Contact us. 

Disclaimer
Licensed extracts taken from Everest Group’s PEAK Matrix® Reports may be used by licensed third parties for use in their own marketing and promotional activities and collateral. Selected extracts from Everest Group’s PEAK Matrix® reports do not necessarily provide the full context of our research and analysis.  All research and analysis conducted by Everest Group’s analysts and included in Everest Group’s PEAK Matrix® reports is independent and no organization has paid a fee to be featured or to influence their ranking.  To access the complete research and to learn more about our methodology, please visit Everest Group PEAK Matrix® Reports. 

The post AI-driven Advancements in Life Sciences appeared first on Trinity Life Sciences.

President Trump signed the “One Big Beautiful Bill Act” (OBBBA) into law on July 4, 2025. The OBBBA is projected to reduce federal health spending by an estimated $900 billion^[1] over the next decade.

Central to the legislation is the estimated loss of insurance coverage for 16 million people^[2], fundamentally reshaping access to care for millions and redefining the role of federal programs like Medicaid and the Affordable Care Act (ACA) Marketplaces. The biopharma industry will face a new set of challenges as these changes are implemented. Life sciences companies must navigate a shifting access landscape of rising uninsurance rates and evolving payer dynamics.

Implications for Biopharma: Navigating a Shifting Access Landscape 

Quantifying the potential impact of these changes is essential to understanding their true effects on patients, providers, and payers. The significant changes facing patients covered by Medicaid and the ACA—including stricter eligibility redeterminations, increased administrative burden, cost-sharing mandates, and rollback of expansion incentives—are expected to result in 16 million² more uninsured lives. The largest share of coverage loss will likely be due to Medicaid changes, impacting 7.8 million lives², but the ACA Marketplaces are expected to see a greater proportional drop, with approximately 40% of current enrollees at risk of losing coverage (Figure 2 and Figure 3)^{[2],[3],[4],[5]}.

Coverage Contraction and the Rise of the Uninsured

Figure 2. Increase in Number of Uninsured People By Category in 2034

Figure 3. New Uninsured Lives vs. Medicaid & ACA Totals

For manufacturers, shrinking insured populations are expected to expand reliance on patient assistance programs and increase patient cost sensitivity amongst remaining ACA enrollees.

Pressure on Patient Assistance Programs

As millions lose insurance, patients may rely more heavily on manufacturer-sponsored patient assistance programs (PAPs) and bridge programs to afford medication. This increase in demand will place added pressure on manufacturers to scale operations and streamline eligibility verifications to manage the increased volume efficiently. Leveraging technological solutions, such as automated workflows and digital enrollment tools, may help manufacturers efficiently manage the increased burden.

Anticipated shifts in patient volume, particularly the rise in the number of uninsured individuals, coupled with potential resource constraints, will likely require budget adjustments across hub services and PAP programs. Additionally, increased patient inquiries around coverage are expected to drive up call volumes and demand for support services. Without proactive planning and investment, the resulting administrative burden could compromise the effectiveness of these programs.

Utilization of Safety Nets

Safety net providers, including 340B hospitals, federally qualified health centers, and community clinics, will likely absorb much of the newly uninsured patient population. Hospitals are expected to face a $63B increase^[6] in uncompensated care over the next 10 years.

The OBBBA’s proposed changes to DSH percentage calculations could disqualify hundreds of hospitals from the 340B program. This would reduce the number of eligible safety-net providers by ~12%,^[7] concentrating 340B utilization among fewer institutions, and increasing pressure on those that remain.

For manufacturers, this shift could lead to less exposure to discounted pricing as fewer 340B hospitals remain. The change also raises potential compliance risks tied to duplicate discounts (coined Medicaid “Double Dipping”), especially as patient tracking becomes more complex. To mitigate these impacts, manufacturers should consider tightening contract pharmacy oversight and revisiting distribution strategies.

Cost Sensitivity Among Remaining ACA Marketplace Enrollees

The discontinuation of premium tax credits is expected to destabilize the ACA Marketplace. A significant portion of healthy enrollees may exit the Marketplace due to rising premiums, leading to coverage losses. In turn, health plans may narrow formularies or increase cost-sharing amongst patients. As a result, manufacturers may see greater demand for copay assistance and a shift toward generics or lower-cost alternatives. Manufacturers may consider exploring tiered pricing models for chronic therapies and expanding copay assistance programs to minimize therapy abandonment and sustain access among ACA enrollees.

Conclusion

The OBBBA will bring about significant changes in the healthcare landscape and pharmaceutical industry. With a substantial increase in the number of uninsured Americans in the country, the bill is expected to place considerable strain on the safety nets provided by hospitals and manufacturers. This increased pressure will challenge the capacity of these institutions to effectively support vulnerable populations.

Pharmaceutical companies should act proactively and creatively to ensure ongoing patient access to essential medications. This includes estimating the impact of these policy changes on their patient populations, proactively educating patients and providers, optimizing patient assistance programs, strengthening oversight of contract pharmacies, and exploring new avenues to support ACA Marketplace enrollees. As the policy landscape shifts, it will be critical for industry stakeholders to embed access strategies into their core operations to maintain continuity of care for those most at risk.

Questions?

We’re here to help. Contact us. 

Authors: Max Hunt, Brenna Liponis and Abby Griffin

[1] Euhus, R., Williams, E., Burns, A., & Rudowitz, R. (2025, July 23). Allocating CBO’s Estimates of Federal Medicaid Spending Reductions Across the States: Enacted Reconciliation Package | KFF. KFF. https://www.kff.org/medicaid/issue-brief/allocating-cbos-estimates-of-federal-medicaid-spending-reductions-across-the-states-enacted-reconciliation-package/

[2] Swagel, P. (2025). CONGRESSIONAL BUDGET OFFICE. https://www.cbo.gov/system/files/2025-06/Wyden-Pallone-Neal_Letter_6-4-25.pdf

[3] Center on Budget and Policy Priorities. (2025). 16 Million People Would Lose Coverage and Become Uninsured Under House Republican Plan | Center on Budget and Policy Priorities. Center on Budget and Policy Priorities. https://www.cbpp.org/charts/16-million-people-would-lose-coverage-and-become-uninsured-under-house-republican-plan

[4] Centers for Medicare & Medicaid Services. (2025a). 2025 Marketplace Open Enrollment Period Public Use Files | CMS. Cms.gov. https://www.cms.gov/data-research/statistics-trends-reports/Marketplace-products/2025-Marketplace-open-enrollment-period-public-use-files

[5] Centers for Medicare & Medicaid Services. (2025c, April). April 2025 Medicaid & CHIP Enrollment Data Highlights. Medicaid.gov. https://www.medicaid.gov/medicaid/program-information/medicaid-and-chip-enrollment-data/report-highlights

[6] Blavin F, & Simpson M. (2025, June 13). Reconciliation Bill Effects on States’ Healthcare Spending and Uncompensated Care. RWJF. https://www.rwjf.org/en/insights/our-research/2025/06/reconciliation-bill-effects-on-states-healthcare-spending-and-uncompensated-care.html

[7] Williams, E., Mudumala, A., Hinton, E., & Rudowitz, R. (2024, October 23). Medicaid Enrollment & Spending Growth: FY 2024 & 2025 | KFF. KFF. https://www.kff.org/medicaid/issue-brief/medicaid-enrollment-spending-growth-fy-2024-2025/

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In today’s fast-evolving digital landscape, life sciences companies face a critical challenge: reach the right healthcare professionals (HCPs) with the right message, through the right channels, at the right time. At Trinity Life Sciences, we’re proud to help our clients meet that challenge head-on with the launch of Trinity Digital Affinity, powered by DeepIntent.

This breakthrough data offering unlocks new levels of visibility into the digital behavior of 3.5 million+ HCPs, enabling our clients not just to strategize—but to translate those strategies into coordinated, insight-driven real-world actions across both field and digital teams.

A Closed-Loop Advantage with DeepIntent Integration

This launch also reinforces Trinity’s end-to-end customer engagement orchestration platform, powered by AI decision engines that align field and digital activities for maximum impact. And when clients use DeepIntent for digital activation, Trinity provides direct integration of campaign data back into the orchestration engine—making refinement and optimization faster, easier, and more effective. This continuous feedback loop means tactical decisions—like where to increase digital touch and where to prioritize field support and how best to blend field and digital—are always informed by the latest real-world results.

With Trinity and DeepIntent working seamlessly together, clients gain a closed-loop solution for real-time, omnichannel customer engagement:

 

Unified insights

 

Faster decision-making

 

Stronger ROI

More Than Segmentation—From Blank Slate to Integrated Real-World Action Across Field and Digital Channels

Our groundbreaking insights offering gives unprecedented visibility into the digital behaviors of 3.5 million+ HCPs, allowing clients to define meaningful, data-driven segments based on real prescribing and engagement patterns. But we know segmentation is only half the journey. Too often, insightful segmentations are developed, only to be handed off—leaving field and digital teams to independently interpret and act on them. This can lead to inconsistent approaches, inefficient resource use, and missed opportunities to amplify impact through coordination.

Bridging Strategy and Tactics for True Commercial Impact

Trinity Digital Affinity changes that story. By integrating cutting-edge HCP behavioral data with actionable planning tools, we help you bridge the gap from high-level segment definitions to coordinated, tactical execution across field and digital teams.

Imagine a segmentation that doesn’t just live in a slide deck, but instead becomes a shared blueprint for action:

• Field teams can see which HCPs are more accessible through digital means, letting them focus on in-person visits where they will have the most impact.
• Digital engagement teams get clear guidance on targeting HCPs who prefer virtual interactions, maximizing efficiency, and minimizing duplication of effort across channels.

Turning Data Into Day-to-Day Decisions

With Trinity Digital Affinity, segmentation is just the start. The real value is in how your teams can use these insights—every day—to tactically coordinate, adapt, and get better results from every investment in HCP engagement.

Real-World Example: Strategy Made Tactical

Suppose your segmentation reveals a group of HCPs who write high volumes of prescriptions but rarely take in-person meetings. With Trinity Digital Affinity, your digital team is immediately equipped to design targeted messaging and virtual campaigns for this specific group, ensuring high-value outreach is not dependent on costly face-to-face time. Meanwhile, your field team can realign its schedule to focus on HCPs who truly benefit from in-person engagement. Together, the two teams avoid duplicating effort or missing critical touchpoints—turning a segmentation insight into a tactical engagement plan that’s both coordinated and efficient.

Driving Tactical Planning with Integrated Data

With Trinity, commercial teams plan together on a unified analytics platform—using the same segmentation, access, and behavioral data to strategically and tactically align outreach. This not only eliminates silos but also ensures that every HCP receives the right engagement, in the right channel, from the right team.

The result: A seamlessly coordinated approach where segmentation becomes a shared playbook—empowering your teams to drive tactical decisions that maximize reach, ROI, and HCP satisfaction.

Why This Matters Now

The digital transformation of customer engagement is well underway—but to stay ahead, it’s not enough to participate. Brands must lead with actionable insights, align across channels, and continuously optimize.

With Trinity Digital Affinity we’re helping clients do just that — strategy made actionable for measurable results.

If you’re ready to elevate your customer engagement strategy, get in touch to learn how Trinity can help.

Author: Nancy Phelan

Want to learn more?

Contact us at info@trinitylifesciences.com or connect with our team.

The post Trinity Life Sciences Unveils Groundbreaking Trinity Digital Affinity, Powered by DeepIntent, to Transform HCP Engagement for Life Sciences appeared first on Trinity Life Sciences.

China’s pharmaceutical landscape is not only vast in scale but also rapidly evolving with an emphasis on balancing access with affordability. This year’s NRDL update stands out. The introduction of the value rating system continues to raise the bar for clinical innovation, rewarding innovation that truly addresses unmet needs and demonstrates clear differentiation. 

The National Reimbursement Drug List (NRDL) in China is a government-approved roster of medications that are covered by the national health insurance system. Inclusion on this list greatly enhances the accessibility and affordability of a drug for patients throughout the country.  

Here we discuss key updates from the 2024 NRDL outcome analysis, including an introduction to the new NRDL value rating system and its implications.  

The Significance of the New NRDL Value Rating System

Since 2023, the NRDL introduced a new value rating framework to assess the value of drugs seeking inclusion on the list. This framework categorizes products based on clinical characteristics, efficacy, safety, innovation and fairness, considering factors such as unmet needs addressed and replaceability of existing NRDL drugs. 

The Value Rating Framework aims to enhance the chances of a drug passing the NRDL expert review process. A higher tier rating increases the likelihood of progressing through the review process and advancing to the negotiation phase, highlighting the NRDL’s interest in innovative therapies. 

The pricing impact resulting from the value rating framework will vary depending on the perceived value of the product, pricing relative to relevant NRDL benchmarks, and the expected overall budget impact. 

The value rating categories include: 

Breakthrough: Addresses a treatment gap in a specific therapeutic area and enhances public satisfaction. 

Improvement: Demonstrates a high level of innovation with a favorable clinical profile, contributing to optimizing the NRDL. 

Equivalent: Complements existing NRDL drugs and expands treatment options. 

Inferior: Perceived as having lower clinical value compared to current options on the NRDL 

The implementation of the NRDL value rating system has supported the NRDL experts to determine a product’s value objectively. 

Figure 1: The Value Rating Framework Categories Established in 2023

The 2024 NRDL Highlights: Rare Disease 

The 2024 NRDL underwent a familiar process compared to previous years, with a substantial attrition rate from initial application to final negotiation. 

A total of 574 manufacturers submitted applications for their products to be considered for inclusion, which underwent review by the NRDL expert panel.  Out of the 440 products that underwent expert evaluation, only 162 advanced to the price negotiation phase, with a final of 117 drugs successfully enlisted onto the 2024 NRDL, representing a 72% success rate for products that entered negotiation.  

Out of the 117 drugs that were included in the NRDL 2024 listing, eight treatments in the rare disease category were successfully enlisted. This underscores the National Health Security Administration’s (NHSA) ongoing commitment to addressing unmet needs and giving priority to reimburse treatments indicated for rare diseases.  

In comparison to other therapeutic areas, rare disease therapies tend to obtain a higher annual price due to the limited budget impact, but the informal historical price ceiling of CNY ¥500,000 / USD $70,000 for negotiation and CNY ¥300,000 / USD $42,000 reimbursement still holds true.  

FABHALTA® (iptacopan) and CAMZYOS® (mavacamten) are two examples of rare disease treatments listed in NRDL 2024 (see Figure 2 and 3). 

FABHALTA®

• FABHALTA has demonstrated notable clinical efficacy improvements over the standard of care (SoC) in PNH—SOLIRIS® and ULTOMIRIS®—supported by both global clinical trials and real-world evidence. However, the absence of direct head-to-head comparisons with SoC in the first line (1L) setting introduces uncertainty regarding its relative benefit. Consequently, broader use in both 1L and second line (2L) settings, along with real-world SOLIRIS titration practices, may limit its ability to command premium pricing 
• Nonetheless, FABHALTA’s inclusion in the NRDL underscores that therapeutically equivalent alternatives remain valued, and reflects the NHSA’s commitment to expanding treatment options for physicians

Figure 2: Expected Value Rating, Clinical Benefit and Pricing of FABHALTA®

Likely NRDL Value Rating & Rationale

Improvement (2L) / High Uncertainty(1L)

FABHALTA has shown significant improvement in clinical efficacy over the SoC in PNH, SOLIRIS/ULTOMIRIS, as evidenced in global trials and a real-world study

Clinical Benefit

PNH*	Global Ph3 RCT (no CHN sites)		Global Ph3 Single-arm (with CHN sites) Accepted for Full Approval	Real-World Study (no CHN sites)
	FABHALTA (2L post C5i)	SOLIRIS/ULTOMIRIS	FABHALTA (1L)	SOLIRIS/ULTOMIRIS
Increase in Hb**	82%	2%	92%	28%
Transfusion Avoidance	95%	26%	98%	59%
Serious AEs	5%	9%	2%	N/A

Pricing (vs. Benchmarks)

Despite significant advances in 2L post-SOLIRIS/ULTOMIRIS, FABHALTA’s lack of direct 1L SoC comparison creates uncertainty about its benefit; its broader 1L/2L use and real-world SOLIRIS titration likely further leads to no premium pricing between the drugs

* In the control group of the global Phase 3 RCT APPLY-PNH, 65% of patients received SOLIRIS while 35% received ULTOMIRIS; the real world study enrolled 98% patients treated with SOLIRIS and 2% treated with ULTOMIRIS

** An increase in haemoglobin of at least 2g/dL when compared to baseline

CAMZYOS®

• CAMZYOS represents a breakthrough as the first and only innovative therapy approved for obstructive hypertrophic cardiomyopathy (oHCM), achieving a compelling 26% vs. 4% complete response rate and 44% vs. 4% improvement in ≥1 NYHA class 
• In the absence of a branded comparator to guide pricing, Chinese payers are likely to benchmark CAMZYOS against therapies in adjacent disease areas with similar prevalence and innovation profiles

Figure 3: Expected Value Rating, Clinical Benefit and Pricing of CAMZYOS®

 

Likely NRDL Value Rating & Rationale

Breakthrough

The first and only innovative medication approved for oHCM, addressing critical unmet needs in this space

Clinical Benefit

oHCM	China Ph3 RCT Accepted for Full Approval
	CAMZYOS	Placebo
CR	26%	4%
≥1 NYHA class improvement	44%	4%

Pricing (vs. Benchmarks)

Manufacturers argue that VYNDAMAX® is an appropriate pricing benchmark, which is likely accepted by the NHSA, since both products target rare cardiovascular diseases and are deemed ‘highly innovative’

Considerations for the Future

The NRDL encourages the submission of alternative treatment options that offer comparable clinical profiles, reinforcing its commitment to broadening access and choice for patients and physicians. Based on the inclusion of rare disease therapies in the 2024 NRDL, it is evident that therapeutically equivalent products continue to have a place within the listing, with pricing expectations set at parity or modest discounts for such comparable products. 

Innovative therapies for rare diseases often carry higher annual costs compared to treatments for broader indications, primarily due to their limited overall budget impact. However, as affordability continues to be an important consideration when discussing price negotiations with NHSA, existing NRDL benchmarks and informal pricing thresholds will also be considered by payers to ensure the sustainability of public funding. 

For therapies granted breakthrough status, in the absence of a branded comparator to serve as a pricing benchmark, payers are likely to reference products from adjacent disease areas with similar prevalence and levels of innovation when determining pricing. 

Authors: Cindy Pang, Venus Leung and Wenting Zhang

Special thanks to: Allen Liu, Rya Zhang, Karen Yang and Peter Law

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Field sales serve as the primary bridge between companies and healthcare professionals to build trust, provide valuable information and drive product adoption. Effective call planning is essential, as it allows reps to prioritize their engagements, tailor messaging and maximize their impact.  

The introduction of new technologies to streamline or enhance field operations comes with inherent challenges, such as resistance to change, training needs and aligning new systems with existing workflows. Quite simply, the field can become overwhelmed.   

To overcome these hurdles, clear communication and robust training programs are essential for behavioral and operational transformations. As trust in AI grows over time, the field naturally seeks more innovative solutions.  

Trinity AI presents a case study of a successful AI initiative that has been embraced by the client, delivering consistent lift for more than 2 years. This initiative highlights the power of AI in field sales and the potential for scaling across different brands while deepening trust in technology. 

Background

Mid-Size Pharma, High-Potential HCP Identification

• A mid-sized pharmaceutical company partnered with Trinity AI to revamp its targeting strategy with the goal of reinvigorating one of their brands across multiple indications to drive new patient growth.  
• They wanted to develop a robust autonomous dynamic targeting solution, leveraging AIML to identify microclusters of high potential HCPs to drive new patient starts. 
• The engine would predict and create a pipeline of HCPs that were most likely to convert to the brand through targeted call activity promotion, thereby optimizing the effectiveness of the field force. 
• The project aimed to fix the inefficiencies of their traditional call planning method, which lacked field adherence and failed to impact sales significantly.  

Trinity’s Solution

A digitally-integrated, AI-enabled ecosystem powering rep effectiveness and personalized HCP engagement

Trinity AI assessed the client’s technology ecosystem and existing targeting engine to scope the context and needs for a more efficient solution. Trinity redesigned an AI-driven call plan engine to identify high-potential HCP targets in different territories based on their likelihood to convert to the brand. 

The engine synchronizes in-person and digital engagement strategies, establishing a cohesive and integrated approach across all customer interaction channels. By evaluating data from diverse sources such as claims, CRM and engagement metrics, it identifies top targets within territories through a multi-dimensional analysis. Adoption, measurement and evolution of the new tools were critical drivers of the impact of the new engine.   

• Trinity AI worked with the client to develop, operationalize and assist in a broad change management initiative.   
• Measurement systems were implemented to gauge performance of the AI engine over time.  
• The field feedback loop gathered insights used to refine and optimize the targeting strategy. 
• Impact assessment pipelines were set up to measure lift generated by the call plan engine over time 

Project Outcomes

AI-Driven Dynamic Targeting Solution

Trinity AI’s solution streamlined the targeting process and delivered tangible business outcomes, including: 

Monthly call plan operations reduced from 6 to 3 weeks

 

Lift analysis validated alignment with brand imperatives 

 

• Increased New-to-Brand Prescription in High & Medium Segments 
• Decrease in Dismissals 

 

Improved rep productivity by 20-30% 

 

Non-target calls reduced by ~20% 

 

 

The success of the AI engine for this product led to its implementation for multiple other brands. 

The solution was recognized by the client’s CEO during a quarterly earnings call as driving real business impact. 

 

Authors: Nancy Phelan, Nabha Nagasubramanya, Anushank Anand and Ankit Kohli

If you have any questions, we’re here to answer them.
We look forward to helping identify solutions for you.

The post Empowering Field Teams: A Case Study in AI-Driven Call Planning appeared first on Trinity Life Sciences.

Reflecting on the first half of 2025 including data from AACR, ASCO and EHA, we see several notable trends continuing to shape the oncology landscape. While development follows momentum observed the last few years, these learnings provide a clearer understanding into the next wave of innovation. 

Immunotherapy Moves Earlier in the Journey 

One of the most notable themes is the continued momentum of PD-L1 therapies moving into earlier lines of treatment. New data supporting neoadjuvant use in solid tumors suggests that triggering a systemic T-cell response before tumor resection may offer meaningful benefits. This shift could reshape treatment paradigms across multiple tumor types, including areas (e.g. head and neck cancer, melanoma) where PD-L1s are only recently or not yet indicated in these settings. 

ctDNA: From Mutation Detection to Prognostic Tool 

Circulating tumor DNA (ctDNA) – i.e. fragmented DNA shed by cancer cells into the bloodstream – is evolving beyond its role in mutation identification. There is growing evidence of ctDNA’s utility as a prognostic marker and as a trigger for treatment escalation. This could open the door to more personalized and dynamic treatment strategies, particularly in earlier-stage disease. 

ADCs and Bispecifics: The Next Generation of Targeted Therapies 

Antibody-drug conjugates (ADCs) continue to show incremental progress – although are not ubiquitously home-runs. At ASCO 2025, Enhertu’s continued run of practice-changing data, this time in HER2-low breast cancer, and the Trodelvy-Keytruda combination in triple-negative breast cancer (TNBC) were notable moments. These results reinforce the growing role of ADCs as a more effective alternative to traditional chemotherapy. 

Bispecifics also remain a hot topic, especially those with immune-stimulating mechanisms (e.g., CD3-targeting) and dual/tri-targeting constructs. While there are open questions on if early signals (e.g. PFS) will translate to durable outcomes (e.g. OS), there continues to be broader buzz from PD-L1/VEGF deals. There is also notable progress across a broad range of other targets in both solid tumors and heme – including continued conversation on the fit of bispecifics vs. CAR-T. 

AI: A Quiet Presence 

Despite the general buzz of AI everywhere, artificial intelligence hasn’t taken center stage in oncology. While there were hypotheses shared on the potential opportunity of AI to aid in assessing exploratory sub-group data and hope that AI can help more tangibly in the future, AI has not taken hold in either R&D or clinical decision-making – yet. 

Final Thoughts 

While 2025 has not delivered unexpected news, it offers a clear view of where oncology is heading: earlier intervention, smarter biomarkers and more impactful targeted therapies.  

At Trinity, we believe Every Decision Impacts a Life. We are excited to help our clients navigate this evolving landscape and translate these insights into real-life impact. Connect with us to discuss where Oncology is headed and how we can partner to support your success. 

Authors: Parker Jendrycki and Andy Wong

The post 2025 Oncology Mid-Year Check-in: Reflections & Expectations appeared first on Trinity Life Sciences.

March 2025 marked a pivotal moment for pharmaceutical and biotech companies operating in the European Union (EU) as the first two molecules began to proceed through the Joint Clinical Assessment (JCA) process. At a recent seminar hosted by Trinity Life Sciences, stakeholders gathered to explore the implications of this new regulatory framework and how to prepare for it. 

What is the JCA? 

The JCA is a centralized EU initiative designed to harmonize the clinical assessment component of Health Technology Assessments (HTAs) across member states. It runs in parallel with the European Medicines Agency (EMA) regulatory process and aims to streamline clinical evidence evaluation, reduce duplication and promote transparency. 

While the JCA focuses solely on clinical data – excluding value assessments and economic evaluations – it introduces a single, standardized clinical dossier for all EU countries. This marks a departure from the previous system, where each country conducted its own assessments based on localized submissions. While most markets will still require additional data to support market-specific frameworks for value assessments, the JCA dossier will be a common input for all EU member states’ assessment of clinical data. 

Key Milestones and Timeline 

The JCA rollout is phased: 

January 2025: Mandatory for first indications of oncology products and for advanced therapy medicinal products (ATMPs)

January 2028: Expanded to include all new orphan drug indications

January 2030: Applies to all new centrally authorized products

Anticipated Challenges for Manufacturers 

The JCA introduces several complexities: 

• More Complex, Simultaneous Evidence Requirements: Manufacturers must anticipate and address diverse clinical expectations across EU markets within the JCA dossier (rather than staging market-specific evidence over a sequential launch process). 
• PICO Complexity: The JCA relies on the PICO framework (Population, Intervention, Comparator, Outcome), which can result in numerous combinations. For example, the illustrative PICOs assessment of IMFINZI^® conducted in 2024 by the body executing the JCA process involved 13 different PICOs, derived from 7 populations and 6 comparators. Differences in advanced oncology therapy availability across member states and thus the population/therapy combinations in play, make it likely that oncology indications will generate numerous PICOs. 
• Tight Timelines: The JCA process leaves only 90 days between circulation of the assessment scope (including required PICOs) and the dossier submission deadline and 15 days to respond to additional data requests. All this happens in parallel with the EMA process, which may stretch resources for many manufacturers. 

Strategic Implications for Manufacturers 

To navigate the JCA successfully, manufacturers must: 

• Ensure Adequate Resourcing: Because JCA runs in parallel with the EMA process, manufacturers may encounter resource bottlenecks in functions with heavy burdens in both regulatory and HTA settings. Up to now, those resources have largely been able to fulfill regulatory and HTA needs sequentially; with JCA, those outputs will now be required in parallel. Manufacturers may need to adapt. 
• Engage Cross-Functional Teams: Collaboration across clinical, regulatory, HEOR, market access and commercial functions is essential. 
• Develop Robust Evidence Strategies: Early planning for pivotal trials and real-world evidence generation is critical. 
• Prioritize PICOs: Focus on high-priority markets and align trial designs with the most impactful PICO combinations. 
• Plan for Local Adaptation: Despite the centralized clinical review, country-level HTA assessments and pricing negotiations remain necessary. 

Looking Ahead 

While the JCA promises greater efficiency and consistency in clinical assessments, it also presents new hurdles. Manufacturers must be proactive, agile and collaborative to meet the demands of this evolving regulatory environment. 

As the EU moves toward full JCA implementation by 2030, staying informed and prepared will be key to ensuring timely access to innovative therapies across Europe. 

Author: Matthew Barrett

The post Joint Clinical Assessment in the EU: What Life Sciences Companies Need to Know appeared first on Trinity Life Sciences.

Strict assessment criteria and price reductions 

Germany is widely known for its rigorous HTA evaluations and tough pricing negotiations—scrutiny that intensified following the 2022 Financial Stabilization Act. Germany’s Association of Research-Based Pharmaceutical Companies (the Verband Forschender Arzneimittelhersteller or VFA) has noted that the share of drugs rated as offering additional benefit declined in 2023 and 2024. The VFA has expressed concern that the G-BA is applying increasingly strict criteria in its assessments, making it more difficult for new medicines to demonstrate added value compared to existing therapies.  

In 2024, several drugs faced steep price reductions, with the most significant cuts hitting Menarini’s NEXPOVIO^® (-64%), Santen’s ROCLANDA^® (-58%) and J&J’s TALVEY^® (-53%). ABECMA^® (BMS), EVKEEZA^® (Regeneron) and LUPKYNIS^® (Aurinia) were withdrawn from the market due to unfavorable assessment outcomes and anticipated low price potential. 

Premium pricing for innovative therapies

Despite widespread price cuts in Germany, 2024 also saw several cases where innovative therapies secured premium pricing—a clear signal that Germany will reward strong evidence packages and meaningful clinical value. Notably, PTC Therapeutics reached a landmark agreement for UPSTAZA^®, a gene therapy for ultra-rare AADC deficiency, priced at €3 million per patient—underscoring the system’s willingness to support transformative treatments.

Beyond gene therapies, three drugs—TIBSOVO^® (Servier), JEMPERLI^® (GSK) and TAGRISSO^® (AstraZeneca)—received the G-BA’s highest rating of “major added benefit” in 2024. This marks a significant uptick, considering that only 13 products have achieved this rating in the previous 13 years combined. The impact of this rating on pricing outcomes was mixed across these products. While TAGRISSO is yet to observe a price change (pending negotiations with the GKV-SV), JEMPERLI’s price rose by 54%. TIBSOVO’s price dropped by approximately 25% reflecting joint negotiation outcomes with a second indication which had a similar patient population size and was awarded a “non-quantifiable added benefit” rating. Arguably, TIBSOVO’s “major added benefit” rating for the first indication protected the brand from a steeper price drop. In addition, three drugs, JEMPERLI (GSK), LONSURF^® (Taiho Oncology) and DARZALEX^® (J&J) received price increases last year following positive G-BA ratings. High benefit ratings were driven by robust evidence packages showing superior efficacy, improved health-related quality of life (HRQoL) and better safety compared to appropriate comparators.

*Note: JEMPERLI’s 54% price increase is observed after a 51% fall in 2023, resulting in a price 23% lower than the launch price in 2021

These developments illustrate a dual dynamic in Germany’s pharmaceutical landscape. While cost containment is a top priority, innovation supported by robust data is also acknowledged and rewarded.  

At the start of 2025, the newly-elected government also demonstrated a strong commitment to innovation by endorsing the HEMGENIX^® pay-for-performance (P4P) agreement—a pioneering reimbursement model which reflects both the high therapeutic value and the innovative nature of HEMGENIX. Under this arrangement, HEMGENIX is priced at €2.482 million per patient for a single-dose treatment. This performance-based reimbursement model ties payment to individual treatment success, with pro-rated refunds issued if the product becomes ineffective for a patient. 

Confidential pricing 

Germany’s new pricing confidentiality provision – a strategy to prevent a lower negotiated price being referenced by other countries – applies to companies with R&D operations in Germany and active collaborations with public clinical or pre-clinical research institutions. The new Most Favored Nation (MFN) pricing initiative in the U.S. has heightened the importance of pricing confidentiality. This puts pressure on European markets, especially Germany, as pharmaceutical companies fear that launch prices may be integrated into the U.S. system, potentially causing delays or halting launches in Europe. Manufacturers choosing confidential pricing (which must happen within a brief post-negotiation window) triggers an extra 9% discount off the net price and manufacturers must also repay trade surcharges and sales taxes tied to higher list prices. As of April 2025, no product has taken this path and its future uptake remains uncertain. 

Conclusion

The new German government is committed to strengthening conditions for pharmaceutical development and advancing the National Pharmaceutical Strategy. The 2025–2028 coalition agreement outlines plan to further develop the AMNOG framework through continued dialogue with the pharmaceutical industry, aiming to balance access to innovative medicines with sustainable financing. 

In line with recent movements, Germany is increasingly embracing flexible value-recognition models tailored to diverse contexts. To secure an appropriate reward, manufacturers must continue to invest in robust evidence packages that clearly demonstrate product value. 

Authors: Mukesh Gupta, Andreia Ribeiro, Ismail Ismailoglu and Maximilian Hunt

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