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EFPIA Champions TEE as the “Only” Way to…

In a new EFPIA-commissioned report, the Charles River associates have found transferable exclusivity extension (TEE) to be the most credible and workable solution for driving antibiotic research in Europe, noting that it could potentially bring two new antibiotics to the EU market a year with a conservative value estimate of EUR 90 billion per antibioticIn 2021, there were just 27 new antibiotics in clinical development against priority pathogens, of which only six fulfill at least one of WHO’s criteria for innovation, and, on average, resistance to antibiotics is reported to most new agents two to three years after market entry - according to EFPIA, TEE could potentially be “the only existing option capable of incentivizing antibiotic R&D in a sustainable manner"To determine the impact of the initiative, CRA conducted a cost-benefit analysis and ultimately found that using the steps could save countries hundreds of millions of euros and provide a more sustainable environment for antibiotic development. The analysis finds TEE to be a “sufficiently powerful incentive to stimulate the development of new antimicrobials that is feasible and relatively straightforward to implement at the joint EU level, with minimal up-front administrative costs to the European Medicines Agency (EMA) and a cost that is spread across all European MS”

NICE Issues Draft Rejection for PTC’s Translarna…

PTC Therapeutics Duchenne muscular dystrophy (DMD) treatment, Translarna (ataluren) has been provisionally rejected by the National Institute for Health and Care Excellence (NICE)NICE's decision follows its commitment to re-evalutate the drug and to decide whether it should be available for routine funding on the NHS following a six-year period during which it was available under a managed access agreement (MAA), however, even if NICE is unable to make a positive final recommendation the MAA period ends on January 20, 2023After considering all the available evidence, and the opinions of the clinical and patient experts, the committee concluded that the benefits provided by Translarna over standard treatment do not justify its current cost—the Institute underscores that the drug would cost around £220,000 per year per patient at its current list price

PMPRB Asks Horizon Pharma to Slash Price of Procysbi

A Patented Medicine Prices Review Board (PMPRB) Hearing Panel has asked Horizon pharma to reduce the price of Procysbi (cysteamine bitartrate), which is used for the treatment of proven nephropathic cystinosisThe panel ruled that Procysbi was and is “excessive” under section 83 and 85 of the Patent Act, and Horizon must pay to His Majesty in right of Canada an amount calculated by the Parties and approved by the PanelThe PMPRB initially formally challenged the price of Procysbi in 2019, at the same time investigating Alexion Pharmaceutical Inc's Soliris. Patented drug prices in Canada are some of the highest, globally, and the federal government has even previously admitted that many nations with lower prices offer comparable or superior access to drugs

Greece to Reference Croatia in IRP as Croatia Joins…

Croatia is set to join the eurozone as of January 2023, stipulating that Greece will begin to reference Croatia when using international reference pricing (IRP), based on its existing rule that it references “countries that utilize the same currency (i.e., Eurozone countries) and that are also similar on the economic-level.”In 2019, Greece decreased its basket by nine countries to hone in on the eurozone, removing Bulgaria, Croatia, the Czech Republic, Denmark, Hungary, Poland, Romania, Sweden, and the United Kingdom and solely referencing Austria, Belgium, Cyprus, Estonia, Finland, France, Germany, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Portugal, Slovakia, Slovenia, and SpainAlong with the shrinking of its selection of countries to conduct IRP, Greece decided to use the two lowest prices for medicines, instead of the three lowest prices, in the Eurozone for price reductions

NLS Days 2022: Strengthening the Nordics ATMP Network…

Speaking at the Nordic Life Science Days 2022 conference in Malmö, Dr. David J. Sexton - Collaboration Executive at the UK's Cell and Gene Therapy Catapult, moderated a fireside chat on supporting and accelerating the Advanced Therapeutics industry in the Nordics and UKThe chat was attended by Dr. Eva-Karin Gidlund, Head of Alliance and Innovation at NorthX, Mr. Klaus Langhoff-Roos, CEO of StemMedical, Dr. Jim Lund, Researcher at the Research Institutes of Sweden (RISE), and Dr. Remy Martin, Commercial Manager at eXmoor The group discussed key differences between the U.S., UK, and the Nordics, including the advantages of single-payer systems, issues with bottlenecks and their solutions, as well as the sharing of resources

PLFSS 2023 Proposes Innovative Financing Model for…

The French Pharmaceutical Companies Association (Leem) believes the 2023 social security financing bill (PLFSS) "threatens" access to medicines as the prices of many drugs could be cut, and there would be new measures to regulate expenditure on particular medicinesThe Association points out that the amount devoted to drug spending for 2023 appears to be consciously set below the needs of the population, as “it is 7% lower than the expenditure on medicines for 2022 (EUR 24.6 billion allocated in 2023, compared to EUR 26.4 billion in estimated expenditure for 2022)” Thierry Hulot, President of Leem, stated, “The PLFSS abruptly turns the page on a five-year period of reforms designed to improve not only the country's attractiveness but above all to ensure that our fellow citizens have access to innovations and a stable supply of medicines”

White House Outlines “Significant” Measures to…

The White House has suggested that recently enacted laws, such as the Inflation Reduction Act, can “expand health coverage and affordability for Americans, including many individuals with cancer.”The CEA estimates that the extension of the ACA enhanced premium subsidies means that up to 560,000 individuals with cancer living in the United States will continue to save on health insurance premiums, at an estimated saving of $800 per year, ultimately allowing up to three million Americans to keep their health insurance coverageIn its blog post, the White House also draws on an analysis from 2019, in which Medicare Part D beneficiaries taking Revlimid (lenalidomide) could save over $12,000 in out-of-pocket spending. Other examples from this analysis indicate that beneficiaries paid an expected annual out-of-pocket cost of over $8,000 for Zytiga (abiraterone acetate) and over $16,000 for Idhifa (enasidenib). The out-of-pocket cap would allow beneficiaries needing these drugs to save about $6,000 and $14,000 per year, respectively

Bundestag Passes German Insurance Financing Bill,…

On Friday, September 23, the Bundestag passed the draft law on the financial stabilization of statutory health insurance (GKV-Finanzstabilisierungsgesetz), referring the controversial bill to the lead Health Committee for further deliberationSix opposition motions were also referred to the Health Committee ahead of its hearing this coming Wednesday, following criticism that the draft law is not suitable for solving the statutory health insurance issues in the long termThe AfD parliamentary group raised four of the opposition motions, including a call for a new regulation for imported medicines to improve drug safety and a demand that companies must report the unavailability of a prescription drug immediately, and the Bavarian Minister for Health called for further dialogue to prevent Germany from being destroyed as a location for innovation

EFPIA-commissioned Report Proposes Elimination of IRP…

A report published by Charles River Associates (CRA), commissioned by the European Federation of Pharmaceutical Industries and Associations (EFPIA), has outlined further information regarding EFPIA’s equity-based tiered pricing (EBTP) proposalsIn April this year EFPIA announced that its members had pledged to step up measures to help deliver faster, more equitable access to medicines for millions of patients across the European Union (EU). As part of this commitment, the group suggested co-creating an equity-based pricing system, by “adopting an efficient system of EU assessments of relative efficacy and by sharing information on the implementation of novel pricing mechanisms.”The CRA report further elaborates EFPIA’s belief of a common consensus that the barrier to the use of EBTP is a “lack of solidarity between countries such that any lower price negotiated in relatively less wealthy countries is used as leverage to lower prices in higher income countries.” The document, presented as a selection of slides, also calls for a “commitment to the removal of the key barriers (including use of external reference pricing (ERP)) providing a pathway for EBTP to be applied”

CONITEC Approves Cost-effectiveness Threshold for HTA…

Brazil's National Committee for Incorporation of Technologies (CONITEC), which makes recommendations on the inclusion, exclusion, or alteration of health technologies, has adopted the use of cost-effectiveness thresholds in health technology assessments (HTA)Earlier this month, the committee held a hearing following the addition of Law No. 14.313, which mandated the establishment of indicators—including cost-effectiveness thresholds—for the reimbursement of health technologies by the National Health System (SUS) CONITEC stated that the value of R$40,000 per quality-adjusted life year (QALY) was recommended

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