Pricing, reimbursement and access
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Pharmaceutical
A controversial proposal to change the Inflation Reduction Act’s pricing framework for rare disease drugs has been dropped from the Senate’s reconciliation package, marking a win for patient advocacy groups that lobbied against it. The ORPHAN Cures Act, which sought to shield some rare disease drugs from Medicare price talks, was notably absent from the text released this week by the Senate Finance Committee. 18 June 2025
Pharmaceutical
US trade association PhRMA (Pharmaceutical Research and Manufacturers of America) has cited a new IQVIA study that found that Medicare Part D plans routinely deny access to prescribed medicines for patients with newly-diagnosed chronic conditions. 17 June 2025
Biotechnology
The National Institute for Health and Care Excellence (NICE) has issued a draft guidance recommending GSK’s Blenrep (belantamab mafodotin) in combination with bortezomib and dexamethasone (BVd) for second-line multiple myeloma treatment of adults who are refractory to or intolerant of lenalidomide. 13 June 2025
Biotechnology
Africa is grappling with a worsening mpox crisis, with a critical shortfall of vaccine doses threatening to derail containment efforts. Public health leaders are warning that the scarcity is exacerbating the spread of the virus, even as the World Health Organization (WHO) maintains that mpox remains a public health emergency of international concern. 10 June 2025
Pharmaceutical
A sweeping legislative package backed by US President Donald Trump could strip health insurance from more than 16 million Americans over the next decade, according to a new analysis from the Congressional Budget Office. 5 June 2025
Pharmaceutical
The NHS Business Services Authority (NHSBSA) has published the annual Prescription Cost Analysis (PCA) for 2024/25. 5 June 2025
Pharmaceutical
Sogroya (somapacitan injection) has been recommended by UK health technology assessor the National Institute for Health and Care Excellence (NICE) as a treatment for people aged 3 to 17 years with pediatric growth hormone deficiency, the UK subsidiary of Denmark’s Novo Nordisk revealed yesterday. 4 June 2025
Pharmaceutical
The UK risks losing £11 billion ($14 billion) in pharmaceutical R&D investment by 2033 unless urgent reforms are made to high and unpredictable clawback payments imposed on medicine sales to the National Health Service, according to a new report commissioned by the Association of the British Pharmaceutical Industry (ABPI). 3 June 2025
Pharmaceutical
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has published updated Final Draft Guidance recommending Forxiga (dapagliflozin) as an option to treat chronic kidney disease in adults, AstraZeneca announced today. 30 May 2025
Pharmaceutical
The UK’s National Institute for Health and Care Excellence (NICE) has published final draft guidance recommending that Filspari (sparsentan) can be used in the National Health Service (NHS) in England as an option to treat primary IgA nephropathy in adults with a urine protein excretion of 1.0g/day or more, or a urine protein-to-creatinine ratio of 0.75g/g or more. 23 May 2025
Pharmaceutical
A week after US President Donald Trump signed an executive order to bring back the Most Favored Nation (MFN) idea he introduced at the end of his first term, the US Department of Health and Human Services (HHS announced it is proceeding with implementing the order on prescription drug pricing. 20 May 2025
Pharmaceutical
A US district court judge has found that the Department of Health and Human Services (HHS) must preapprove the use of 340B rebate models before they can be implemented. 19 May 2025
Pharmaceutical
The European Federation of Pharmaceutical Industries and Associations (EFPIA) has released new data that sheds light on why patients in some European countries wait significantly longer than others for access to innovative medicines. 19 May 2025
Biotechnology
The Institute for Clinical and Economic Review (ICER) has released a Final Evidence Report assessing the comparative clinical effectiveness and value of sonpiretigene isteparvovec for the treatment of advanced retinitis pigmentosa. 16 May 2025
Pharmaceutical
US President Donald Trump released an executive order on May 12 calling for a 30-day negotiation period between the Department of Health and Human Services (HHS) and the biopharma industry, with the threat of a rule from the Centers for Medicare and Medicaid Services (CMS) to lower US drug prices if no deal is reached. 14 May 2025
Pharmaceutical
US pharma stocks regained ground Monday after Donald Trump signed an executive order aiming to slash prescription drug prices, a move that initially rattled investors but left many analysts unconvinced about its impact. 13 May 2025
Pharmaceutical
US President Donald Trump sent shivers through the pharmaceutical industry as he vowed to dramatically reduce the high drug prices that have long been a feature of the US market. 12 May 2025
Pharmaceutical
New figures from European industry group EFPIA paint a stark picture of the growing divide in access to innovative medicines across the EU, with patients in some countries waiting more than seven times longer than others for the same treatment. 12 May 2025
Pharmaceutical
UK pharma major AstraZeneca has suffered a setback in its legal fight to block the US government's efforts to lower prescription drug prices, after a federal appeals court dismissed its challenge to Medicare’s negotiation powers. 9 May 2025
Pharmaceutical
The introduction of outpatient flat-rate payments approved today by the Swiss Federal Council poses significant risks for patients and for the pharmaceutical industry as a whole. Including medication costs in flat-rate payments creates a dangerous perverse incentive to treat patients with the cheapest rather than the most suitable medications, according to a website posting by Interpharma. 5 May 2025
Generics
A significant drop has been noticed in the prices of active pharmaceutical ingredients (APIs), bringing much-needed relief to the pharmaceutical industry and potentially translating to lower drug costs for consumers. 9 September 2024
Biotechnology
The Institute for Clinical and Economic Review (ICER) has posted its revised Evidence Report assessing the comparative clinical effectiveness of three medicines for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM). 6 September 2024
Generics
Glenmark Pharmaceuticals has agreed to pay $25 million, based on its ability to pay, to resolve its alleged liability under the False Claims Act for conspiring to fix the price of a generic drug, the US Department of Justice announced. 5 September 2024
Pharmaceutical
Research from AARP has found that around $1,100 in prescription drug costs could be saved by more than a million seniors, due to the Inflation Reduction Act (IRA). 2 September 2024
Pharmaceutical
US House Committee on Oversight and Accountability chairman James Comer is calling on the chief executives s of three major Pharmacy Benefit Managers (PBMs) - CVS Caremark, Express Scripts, and Optum Rx - to correct the record for statements made during their appearance before the House Oversight Committee. 29 August 2024
Biosimilars
Drug development consultancy Certara has published a report on the Inflation Reduction Act’s (IRA) impact on oncology biosimilar uptake. 29 August 2024
Pharmaceutical
August 28, 2024
US pharma major Eli Lilly yesterday announced Zepbound (tirzepatide) 2.5mg and 5mg single-dose vials are now available for self-pay for patients in the USA. 28 August 2024
Pharmaceutical
The Institute for Clinical and Economic Review (ICER) has published its final evidence report evaluating the clinical effectiveness and value of Rytelo (imetelstat), raising concerns about the drug's net health benefits and its high cost. 23 August 2024
Biotechnology
US pharma major AbbVie today revealed that the UK’s National Institute for Health and Care Excellence (NICE) had accepted the firms Skyrizi (risankizumab) for adults with modera 22 August 2024
Biotechnology
The UK’s National Health Service (NHS) got off to a good start with the introduction of cell and gene therapies but it must do more to get ready for the arrival of the advanced therapies of the future, according to a new report for the Association of the British Pharmaceutical Industry (ABPI). 19 August 2024
Pharmaceutical
Some two years after it was signed into law by US President Joe Biden, the Inflation Reduction Act (IRA) will soon start delivering the savings on drug prices that have long been promised. 15 August 2024
Pharmaceutical
The National Institute for Health and Care Excellence (NICE) has published its final guidance recommending Accord Healthcare’s Orgovyx (relugolix) for the treatment of hormone-sensitive prostate cancer, recognizing the treatment as cost-effective in England. 14 August 2024
Biosimilars
The US subsidiary of South Korea’s Celltrion announced its US Food and Drug Administration (FDA)-approved biosimilar adalimumab-aaty has been added to the Costco member prescription program. 14 August 2024
Biotechnology
Vertex Pharmaceuticalsrevealed a reimbursement agreement with NHS England for eligible transfusion-dependent beta thalassemia (TDT) patients to access the CRISPR/Cas9 gene-edited therapy, Casgevy (exagamglogene autotemcel), from today. 8 August 2024
Biotechnology
California’s BioMarin Pharmaceutical (Nasdaq: BMRN) has announced a strategic pivot for its Roctavian (valoctocogene roxaparvovec-rvox) business, focusing on the USA, Germany, and Italy. 6 August 2024
Pharmaceutical
In common with many European countries, there are concerns in Switzerland that patients' access to some vital medicines is getting worse and worse. 5 August 2024
Pharmaceutical
Ahead of Budget 2025, the Irish Pharmaceutical Healthcare Association (IPHA) reiterates the importance of funding new medicines which are an integral and vital part of our healthcare system. 5 August 2024
Biotechnology
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has issued a final draft guidance (FDG) recommending Brukinsa for MZL. 1 August 2024
Pharmaceutical
Domestic drugs and foreign drugs, the production of which is localized in Russia, will be given a priority when included in the list of vital and essential drugs (VED) and expensive drugs, according to a recent resolution signed by the Russian government, The Pharma Letter’s local correspondent reports. 1 August 2024
Pharmaceutical
The Russian government will be ready to significantly increase state procurements of drugs against hepatitis C in case of reduction price for them both by global drugmakers and Russian pharmaceutical companies. 31 July 2024
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