NAVLIN by EVERSANA

This week from NAVLIN by EVERSANA's “Last Week in Review,” recapping the latest regulatory changes, pricing & reimbursement updates, drug approvals and more from across the world. ◾ Policy: The Medical Research Act (MFG) is now in force in Germany, introducing confidential pricing and incentives for clinical trials. #MedicalResearch ◾ Pricing & Reimbursement: Mark Kramer highlights the Netherlands’ success in controlling medicine spending but notes delays in patient access. #HealthcareCosts ◾ HTA: The European Commission adopts new guidelines for managing conflicts of interest in joint clinical assessments under the HTA Regulation. #HealthTech ◾ Cell & Gene Therapy: Danish regions offer Hemgenix gene therapy for hemophilia with a pay-for-performance model. #GeneTherapy ◾ Conferences: At WVCE 2024, experts discuss public-private partnerships to fund Phase 3 antibiotic trials, inspired by COVID-19 vaccine success. #VaccineDevelopment ◾ Other: The European Commission fines Teva EUR 462.6 million for delaying competition and spreading false information about rival products. #PharmaRegulation Read all these stories and much more: https://ow.ly/VWaT50TZhBJ

This week from NAVLIN by EVERSANA's “Last Week in Review,” recapping the latest regulatory changes, pricing & reimbursement updates, drug approvals and more from across the world. ◾ Policy: The ABPI is calling for increased investment in medicines as Health Secretary Wes Streeting opens a national dialogue on the NHS’s future. What could this mean for the pharma industry? #HealthcarePolicy ◾ Pricing & Reimbursement: JPMA argues it’s time to end Japan’s off-year drug price revisions. With decreasing price differences and rising manufacturing costs, is this policy outdated? #DrugPricing ◾ HTA Update: NICE’s final draft guidance recommends Ipsen’s Iqirvo for previously treated primary biliary cholangitis. What impact will this have on treatment options? #HTA ◾ Cell & Gene Therapy: France’s Official Journal announces CSL Behring’s Hemgenix will no longer be covered under the direct access scheme. What led to this decision? #GeneTherapy ◾ Conferences: At World Orphan Drug Europe 2024, Nick Meade from Genetic Alliance UK discusses the challenges in rare disease treatment pathways and NICE’s severity modifier. Are current definitions and assessments up to date? #RareDiseases ◾ Other: Judge Zahid Quraishi rejects Novartis’ bid to block the IRA’s Medicare Drug Price Negotiation Program. What does this mean for the future of drug pricing negotiations? #PharmaLaw Read all these stories and much more: https://ow.ly/85n750TVntc

What does operational pricing excellence look like now and in the future? Drawing on an extensive benchmarking survey and detailed data and expertise, Alan Crowther and Maria Merinova will present the state of operational pricing excellence and what the future will hold during this EPP Digital Partner Webinar on 21 November at 3pm CET. REGISTER TODAY: https://ow.ly/slPl50TL4SV

This week from NAVLIN by EVERSANA's “Last Week in Review,” recapping the latest regulatory changes, pricing & reimbursement updates, drug approvals and more from across the world. ◾ Policy: The French government proposes EUR 1 billion in drug price cuts and maintains a clawback cap at EUR 1.6 billion in the draft Social Security Finance Bill (PLFSS) for 2025. Discover the new “safeguard clause” and its impact on reimbursement transparency. #HealthPolicy ◾ Pricing & Reimbursement: Zibo, China, includes Eisai and Biogen’s Alzheimer’s drug, Leqembi (lecanemab), in its local supplementary health insurance scheme. Learn how this affects coverage based on expenditure, age, and pre-existing conditions. #DrugPricing ◾ HTA: NICE recommends MSD’s Keytruda (pembrolizumab) for high-risk resectable NSCLC as neoadjuvant and adjuvant treatment. Explore the final draft guidance and its implications. #HealthTechnologyAssessment ◾ Drug Approval: MHRA grants marketing authorization to AstraZeneca’s Wainzua (eplontersen) for treating hereditary transthyretin amyloidosis (ATTRv). Understand the significance of this approval for rare disease treatment. #DrugApproval ◾ Conferences: At EPP’s Life Science Pricing Forum, Novo Nordisk’s VP of Global Pricing, Ulrik Haagen Panton, discusses the impact of pricing on patient behavior and treatment adherence. Get insights into data-driven pricing strategies. #LifeScienceConferences ◾ Managed Entry Agreements: France’s HAS withdraws early access for Bristol-Myers Squibb’s Abecma (idecabtagene vicleucel) for relapsed and refractory multiple myeloma. Find out what this means for patients and market access. #ManagedEntryAgreements ◾ Other: The FDA reconsiders its ban on compounding pharmacies selling copycat versions of Eli Lilly’s Zepbound (tirzepatide) following a lawsuit by the Outsourcing Facilities Association. Read about the potential changes in drug availability. #FDARegulations Read all these stories and much more: https://ow.ly/Egse50TPOyw

Are you ready to transform your post-LOE pricing strategy? Discover how leveraging tender data can give you a competitive edge and optimize your pricing decisions in our latest blog post. Why is Tender data so important? ◾ Competitive Price Benchmarking: Understand where your pricing stands against competitors. ◾ Market Dynamics Insight: Gain a deeper understanding of market share distribution and procurement trends. ◾ Predict Future Pricing Trends: Use historical data to anticipate and adjust your strategies. ◾ Localized Insights: Align your pricing strategies with local market dynamics. ◾ Optimize Bids for Profitability: Develop strategies that maximize profitability, not just win tenders. What’s in it for you? ◾ Real-time tracking of global tenders. ◾ High-precision predictive pricing models ◾ Insights into price trends, award notices, and open tenders. Don’t miss out on this opportunity to stay ahead in the competitive post-LOE market. Read the full article: https://ow.ly/yJuG50TLMIR #Pharma #MarketAccess #PricingStrategy #TenderData #PostLOE #EVERSANA #NAVLINInsights

This week from NAVLIN by EVERSANA's “Last Week in Review,” recapping the latest regulatory changes, pricing & reimbursement updates, drug approvals and more from across the world. ◾ Policy: The Trump Campaign’s surprising reversal on the “most favored nations” pharmaceutical pricing model—what does this mean for the 2024 elections? #PolicyUpdate ◾ Pricing & Reimbursement: Korea’s HIRA Cancer Review Committee’s innovative approach to reviewing new and existing therapy combinations—how will this impact cancer treatment? #HealthcareReform ◾ HTA: CIRS’s latest workshop report on the upcoming joint clinical assessment (JCA) under EU Regulation—are we ready for the changes starting January 2025? #HealthTechAssessment ◾ Drug Approval: MHRA’s green light for Ipsen’s Iqirvo (elafibranor) in treating primary biliary cholangitis (PBC)—a new hope for patients. #DrugApproval ◾ C&G: Six months into the VPAG scheme—ABPI’s review reveals key successes and challenges. What’s next for branded medicines pricing? #PharmaGrowth ◾ Conferences: Insights from EPP’s Life Science Pricing Forum—Natalie Mochova on the hurdles generic products face with international reference pricing in the digital age. #LifeScienceForum ◾ Managed Entry Agreements: The potential complications of MHRA’s International Recognition Procedure (IRP) for NICE evaluations—what should stakeholders expect? #ManagedEntry ◾ Expert Opinion: Dr. Thomas Kaiser reflects on 20 years of IQWiG—celebrating achievements and acknowledging areas for improvement. #ExpertInsight ◾ Other: GSK Pharma’s bold move into India’s oncology market with two high-value therapies—an exclusive interview with Managing Director Bhushan Akshikar. #PharmaInnovation Read all these stories and much more: https://ow.ly/3wlz50TLZzR

What does operational pricing excellence look like now and in the future? Drawing on an extensive benchmarking survey and detailed data and expertise, Alan Crowther and Maria Merinova will present the state of operational pricing excellence and what the future will hold during this EPP Digital Partner Webinar on 21 November at 3pm CET. REGISTER TODAY: https://ow.ly/slPl50TL4SV

Register to attend today: https://ow.ly/iFTB50Tlj5E Join Chad Gibson, EVERSANA's Senior Vice President for NAVLIN Consulting, in the upcoming EPP Partner Webinar, "Price & Market Access in the Pipeline: How  P&MA is Evolving to Meet New Pipeline Challenges." During this informative session, we'll tackle innovative ways to do early asset valuation and how to think about indication sequencing due to changing global rules like the United States Inflation Reduction Act.

Join Us at EPP 2024: https://ow.ly/87EL50TgIFL Alan Crowther, General Manager, Global Pricing & Access Solutions, will present on October 11 to conference attendees on, “The State of Operational Pricing: Benchmarking & Best Practices”. Join Alan for this comprehensive review of survey and additional data on the data, processes, people tools and data that companies are using to drive their operational pricing teams.  Don’t miss this informative session on October 10 – register for the conference today.

Read the NAVLIN Last Week in Review Now: https://ow.ly/u8ws50TFBLS This week from NAVLIN by EVERSANA's “Last Week in Review,” recapping the latest regulatory changes, pricing & reimbursement updates, drug approvals and more from across the world. ◾ Policy: Discover how the new Medical Research Act (MFG) in Germany is shaking up the landscape with confidential pricing and clinical trial incentives. ◾ Regulation: The FDA’s latest move on Eli Lilly’s tirzepatide products—what it means for compounding pharmacies and patent protection. ◾ Pricing & Reimbursement: Unpack the finalized guidance from CMS on the second cycle of Medicare Drug Price Negotiations under the IRA. ◾ HTA: NHS England’s phased rollout of Mounjaro (tirzepatide) for obesity management—who qualifies now and what’s next? ◾ C&G Therapy: WuXi AppTec and WuXi Biologics consider selling pharmaceutical units amidst new U.S. legislation—what’s at stake? ◾ Industry Deals & Agreements: Gilead’s strategic partnerships for lenacapavir licensing—will it truly meet global health needs? ◾ Managed Entry Agreements: OECD’s latest findings on the surge of approved cancer medicines in the EU and OECD countries—what does this mean for access? And so much more... Click through to read more on each story and stay informed! #MarketAccess #PricingStrategy #PharmaNews #HealthcarePolicy #RegulatoryUpdates #HTA #CGTherapy #IndustryDeals #ManagedEntryAgreements