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The recent 11th HTA Coordination Group (HTACG) meeting, chaired by Roisín Adams and co-chaired by Marco Marchetti and Niklas Hedberg, resulted in the adoption of nine guidance documentsThe group finalized and approved the "Annual Work Programme for 2025," defining key strategic priorities for the upcoming yearNew guidance documents include procedural instructions for Joint Clinical Assessment (JCA) and Joint Scientific Consultation (JSC) on medicinal products, as well as templates for briefing documents and scoping processes
The European Commission has issued “Procedural Guidance for Joint Clinical Assessments (JCA) of Medicinal Products”, outlining the steps for producing JCAs as per the EU Health Technology Assessment Regulation (EU HTAR)In the standard procedure, the Population/Intervention/Comparator/Outcomes (PICO) scoping phase is allocated 87 days, with 21 days specifically designated for the PICO surveyThe document states that there are no clock stops in the JCA procedure, even in cases where the indication changes
Industry stakeholders are raising urgent concerns over the limited capacity for advice meetings available to pharmaceutical companies planning their clinical trials in 2025With the implementation of the EU Regulation on Health Technology Assessment (HTA) set for January 2025, the first Joint Clinical Assessments (JCA) will be conducted, primarily focusing on new cancer treatments, cell and gene therapiesDespite supporting the goals of the EU regulation, industry leaders point out a significant shortfall. Only five to seven Joint Scientific Consultations are scheduled for 2025, which is far less than the predicted need. With an increasing influx of innovative therapies, more than 50 products are forecasted to require advice
During a webinar hosted by the Office of Healthcare Economics (OHE), experts discussed the challenges posed by current pricing models for combination therapies, particularly in cancer treatmentAstellas' Stan Jackson stressed that the industry needs to support bodies like OHE in presenting credible solutions to policymakers. Carole Longson, with experience at NICE & the ABPI, suggested the creation of a "sandbox" to explore possible solutions together and test-drive methodologiesOHE’s report, published in June, proposes a framework for pricing combination therapies using a Combination-Based Differential Pricing (CBDP) model. The framework involves scenario-based classification, flexible pricing models, and value alignment, emphasizing the importance of each component's clinical benefits and cost-effectiveness
In its final draft guidance, the National Institute for Health and Care Excellence (NICE) has recommended Eli Lilly’s Mounjaro (tirzepatide) for adults with a BMI of ≥35 kg/m² and at least one weight-related comorbidity, to manage overweight and obesity alongside diet and exercise, highlighting its clinical benefits and cost-effectiveness for this populationMounjaro, priced at £122 for four Kwikpens, is not recommended for individuals with a BMI ≥30 kg/m² due to exceeding NICE’s cost-effectiveness thresholdOver the initial three years, around 220,000 people are expected to benefit, and evidence collected during this period will guide the broader rollout to eligible patients
Vertex and bluebird bio have agreed to participate in the Centers for Medicare & Medicaid Services' (CMS) new Cell and Gene Therapy (CGT) Access ModelThe CGT Access Model allows CMS to coordinate and administer multi-state outcomes-based agreements (OBAs) with manufacturers for certain cell and gene therapies on behalf of state Medicaid agencies. Under this first iteration of the model, Vertex and bluebird have signed agreements covering their respective gene therapies for Sickle Cell Disease (SCD), Casgevy and LyfgeniaCMS will now move forward with engaging states and U.S. territories that participate in the Medicaid Drug Rebate Program to help them decide whether to participate in the model
The Member State Coordination Group on Health Technology Assessment (HTACG) plans to conduct 17 JCAs for new cancer therapies and eight for advanced therapy medicinal products (ATMPs) in 2025 under HTA regulation (EUHTAR)In 2025, 5-7 joint scientific consultations (JSCs) for medicines and 1-3 for medical devices are planned, with submission windows in February and JuneThe JCA and JSC subgroups will convene monthly, while the subgroup for the identification of emerging health technologies (EHT SG) and the subgroup for the development of methodological and procedural guidance (MPG SG) subgroups will meet every two months
China's finalized 2024 National Reimbursement Drug List (NRDL) includes 91 newly added drugs The success rate for negotiations came out to 76% with an average price cut of 63%The new NRDL goes into effect on January 1, 2025. The full list is available in the article
The Department of Health (DoH) in Abu Dhabi has issued new guidelines for Health Technology Assessment (HTA). These will provide a more structured approach to better manage the adoption and use of emerging health technologies Costly and innovative health technologies, such as gene therapies and specialized biologics, will need to undergo an HTA for coverage and reimbursement decisions. However, generics, biosimilars and low-cost products won't require HTA and will be automatically eligible for reimbursement - please see the article for the full list of inclusions and exclusions Key aspects of the HTA process will include an in-depth clinical evaluation and a budget impact analysis. The clinical evaluation will consider the effectiveness and safety of treatment, measured by clinical trial results and real-world studies. The budget analysis will estimate the potential financial implications of bringing in the new technology, including calculating potential savings achieved from improved health outcomes
Bristol Myers Squibb (BMS) is taking legal action against the U.S. Health Resources and Services Administration (HRSA), after the company's proposed rebate model for Eliquis (apixaban) was dismissed by the agencyThe company’s proposed rebate model, set to launch with Eliquis in spring 2025, would require hospitals to pay full price for drugs upfront and submit data confirming 340B eligibility before receiving reimbursementHRSA rejected the plan earlier this month, prompting the lawsuit, in which BMS called the agency’s decision “unlawful three times over.” The company is now seeking court approval to overturn HRSA’s decision and proceed with its rebate model, which it claims is designed to restore compliance and integrity to the program
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