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Speaking at the EPA World conference 2023 in Amsterdam, EUCOPE’s secretary general, Alexander Natz called for constructive dialogue to address the issues identified in the upcoming joint EU health technology assessment (HTA), such as the duplication of work “The devil is in the detail,” Natz added, referring to the final text agreed between Member States, which he believes does not allow for a full binding effect on Joint Clinical Assessment (JCA) reports Echoing Natz, AbbVie’s Greek Market Access & External Relations Director, Penny Retsa, stated: “EU member states need to work together in order to reach an alignment because even though I am very optimistic as a person, there are a lot of concerns within the process at the moment”
The National Institute for Health and Care Excellence (NICE) has published a draft guidance recommending Novartis’ Zolgensma (onasemnogene abeparvovec) as an option in babies with presymptomatic 5q spinal muscular atrophy (SMA) with a bi-allelic mutation in the SMN1 gene and up to three copies of the SMN2 geneThe list price for Zolgensma is £1,795,000 (excluding VAT), but the company has a commercial arrangement in place making the gene therapy available to the NHS at a confidential discountThe recommendation means that Zolgensma will be the first treatment to be routinely commissioned for presymptomatic babies with SMA in England, which will help them have the best chance for optimal outcomes
On March 9, the Pharmaceutical Research and Manufacturers of America (PhRMA) announced new policy proposals for Japan’s FY2024 drug pricing reformSpeaking at a press conference in Tokyo, Simone Thomsen, chair of PhRMA’s Japan-based Executive Committee, called FY2024 a “turning point,” as in recent years several important drugs have not been launched in Japan due to “drug lag”At the meeting, she laid out some priorities for the FY2024 drug pricing reform to prevent the drug lag from worsening, such as a review of actual market price-based revisions, improvement of market expansion repricing rules and amendments to the initial price-setting rules
Last year, the National Institute for Health and Care Excellence (NICE) underscored its ongoing efforts to place the UK as a “world leader in medicines evaluation” by announcing its intention to take a “proportionate approach” to technology appraisals - Ultimately, NICE hopes to increase its capacity by 20% by April 2023, to keep up with clinical practices. To achieve this, the organization is currently “piloting ideas for real appraisals and learning from the real world,” which results in a simultaneous capacity benefit and provides guidance and accessSpeaking at a recent webinar, “A proportionate approach to technology appraisals - pilot learnings and next steps,” on Thursday, 9 March, Jenna Dilkes, Associate Director of Planning & Operations, Technology Appraisals & HST at NICE outlined some of the concepts and principles underlining the initiative, while other NICE members highlighted ongoing initiatives to achieve the aimsNICE is currently running pilots to help inform what a light-touch approach might be for appropriate treatments. These include a novel approach to entry for managed access, pathway appraisals, the use of pre-specified assumptions and pair appraisals
DAK-Gesundheit (DAK), together with the University of Bielefeld and VANDAGE, has carried out a structured analysis of the financial effects of the measures contained in the “Financial Stabilization of the Statutory Health Insurance System” (GKV-Finanzstabilisierungsgesetz) billThe report analyses potential outcomes from the new orphan drug threshold, the reduced free pricing, combination discounts and the amended AMNOG rebate negotiation guardrailsBased on its analysis, DAK sees that three quarters of the newly registered active substances considered from the last three years - up to 2021 - would be affected by a restriction by the guardrails after their initial assessment. The average discount that would result from the specifications for the 70 active substances considered with a quantifiable guardrail discount was found to be 44.4% and thus more than 50% above the average reimbursement discount after the initial assessment
Democratic lawmakers have advanced a bill to tackle prescription drug prices through the Minnesota House of RepresentativesThe bill would establish a Prescription Drug Affordability Board with the authority to set upper limits for certain high-cost drugs, as well as prohibit manufacturers from imposing or causing to be imposed an excessive price increase on the sale of any generic or off-patent drugHF 17 and its companion bill, SF 168, have garnered considerable pushback from the pharmaceutical industry
Bristol Myers Squibb has revealed that it plans not to launch Opdualag (nivolumab and relatlimab) for the first-line treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older with tumor cell PD-L1 expression < 1% “for the foreseeable future”According to the company, it sees “no possibility of achieving a benefit assessment for Opdualag that would reflect the value of this medical innovation compared with the comparator therapy,” as the Federal Joint Committee (G-BA) does not accept progression-free survival (PFS) as a patient-relevant endpointAccording to media reports, BMS said that it is “disappointed that this is not possible in Germany at this time due to the current benefit assessment system and recent GKV-FinStG reforms,” however, it remains open to reconsidering should that change in the future
According to the National Institute for Health and Care Excellence (NICE), Novo Nordisk is planning to launch Wegovy (semaglutide) “soon” following a final positive recommendationA newly released appraisal consultation document backs the drug for the treatment of adults with at least one weight-related condition and a body mass index (BMI) of at least 35 kg/m2, and exceptionally, to people with a BMI of 30.0 kg/m2 to 34.9 kg/m2The decision is based on results of the STEP clinical trial, which involved more than 1,500 people who were treated with the drug over a 68-week period – the trial showed that people who received Wegovy lost an average of 12.4% of their initial body weight compared to individuals who received placebo, which is considered to be a clinically important result. However, following the endorsement, Helen Knight, director of medicines evaluation at NICE, said that Wegovy “won’t be available to everyone,” as the committee has “made specific recommendations to ensure it remains value for money for the taxpayer, and it can only be used for a maximum of two years”
France’s High Health Authority (HAS) has expanded the post-marketing authorization (MA) early access scheme for Yescarta (axicabtagene ciloleucel) to include patients with diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL), who have relapsed within 12 months after the end of the first line of chemo-immunotherapy, or who are refractory to itThe early access request is based on the phase III ZUMA-7 study, in which comparative versus salvage chemotherapy followed in the event of an intensification response and an HSC autograft in patients with refractory DLBCL or patients in relapse within 12 months after a first line of treatment and eligible for intensification chemotherapy with a view to an autograft of CSHFollowing the Transparency Commission’s (CT) decision to initiate the early access scheme, the initiative is set for a period of 12 months from the notification of the decision, but the ultimate decision to authorize early access or not rests with the HAS Board
Japan’s Ministry of Health, Labor and Welfare (MHLW) has announced the new national health insurance (NHI) prices to be applied through the FY2023 “off-year” drug price revisionPublished in the official gazette on March 3, the revision targets items exceeding 0.625 times the average discrepancy rate of 7% and includes special raises for the price maintenance premium (PMP) to be applied to 143 products. The revisions will be implemented on April 1, 2023According to a document released by the MHLW, the repricing efforts will cover 18,197 listed products, including 11,875 oral drugs, 3,871 injectables, 2,425 topical agents, and 26 dental medicines
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