Pricing, reimbursement and access
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Pharmaceutical
Yesterday, the US Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), said it is sending initial offers to the participating drug companies of the first 10 prescription drugs selected for negotiation in the first cycle of the Medicare Drug Price Negotiation Program. 2 February 2024
Biotechnology
A new cell and gene therapy initiative from the USA's White House will launch with an initial focus on treatments for sickle cell disease (SCD). 1 February 2024
Biotechnology
The UK’s health technology assessor the National Instituted for Health and Care excellence (NICE) has recommended Tepkinly (epcoritamab), from US pharma major AbbVie, as a treatment option for eligible adults with an aggressive and fast-growing blood cancer. 1 February 2024
Biosimilars
The Indian market for adalimumab is poised for significant growth. 1 February 2024
Biotechnology
UK health assessor the National Institute for Health and Care Excellence (NICE) has issued its Final Guidance in England and Wales recommending the use of Zynlonta (loncastuximab tesirine), from Swedish Orphan Biovitrum. 31 January 2024
Pharmaceutical
Swedish pharma trade body Lif has welcomed a decision from authorities regarding the reimbursement model for innovative antibiotics. 29 January 2024
Pharmaceutical
A response from the Ministry of the Interior and Health confirms that Denmark – compared to other European countries – has lower medical expenses per inhabitant, according to Danish trade group Lif. 29 January 2024
Pharmaceutical
Russia has faced a shortage of another important anticancer drug - Ixempra (ixabepilone), which is designed for the treatment of breast cahttps://mail.google.com/mail/cancer, reports The Pharma Letter’s local correspondent. 27 January 2024
Pharmaceutical
US health technology assessor the Institute for Clinical and Economic Review (ICER) has posted its revised Evidence Report assessing the comparative clinical effectiveness and value of KarXT (xanomeline tartrate/trospium chloride) drug KarXT, from Karuna Therapeutics for the treatment of schizophrenia. 26 January 2024
Pharmaceutical
In early December, the USA’s Biden administration announced a proposed framework under the Bayh-Dole Act that would allow the government to seize patent rights on products developed with any federal funding if they don’t agree with the price, using the “march-in” provision. 26 January 2024
Pharmaceutical
The convergence of cutting-edge technologies and breakthroughs in the scientific understanding of cancer have enabled unprecedented opportunities for precision oncology (PO), according to a posting on the European Federation of Pharmaceutical Industries and Associations (EFPIA). 22 January 2024
Biotechnology
The UK's National Institute for Health and Care Excellence (NICE) has published final draft guidance recommending Talzenna (talazoparib) for HER2- negative, locally advanced or metastatic breast cancer with germline BRCA1 or BRCA2 mutations in adults. 19 January 2024
Pharmaceutical
US healthcare lobbyist Vital Transformation has released a document outlining objections to the expansion of drug pricing policies under the Inflation Reduction Act (IRA). 19 January 2024
Pharmaceutical
Global spending and demand for medicines will increase over the next five years to approximately $2.3 trillion by 2028 as more patients get access to new and better medicines, according to a new report from the IQVIA Institute for Human Data Science titled, “The Global Use of Medicines 2024 – Outlook through 2028.” 17 January 2024
Biosimilars
Samsung Bioepis, a business of South Korea-based Samsung BioLogics has released a biosimilar market report. 17 January 2024
Generics
Russia plans to revise the main concepts of public procurements of anti-tuberculosis drugs in a move to switch on the purchases of more efficient drugs with lower cost and side effects, The Pharma Letter’s local correspondent reports. 15 January 2024
Pharmaceutical
The US Institute for Clinical and Economic Review (ICER) has released a Final Evidence Report assessing the comparative clinical effectiveness and value of Merck & Co’s sotatercept for pulmonary arterial hypertension (PAH). 9 January 2024
Pharmaceutical
The US Food and Drug Administration has authorized a drug importation program in Florida, as the state seeks to benefit from lower cost medicines across the border. 8 January 2024
Pharmaceutical
PwC’s report “Next in pharma 2024: Reinventing for returns,” has now been published. 8 January 2024
Biotechnology
Californian rare disease company Ultragenyx Pharmaceutical has received a positive reimbursement decision from the UK’s health technology assessor, the National Institute for Health and Care Excellence (NICE). 5 January 2024
Pharmaceutical
The UK government today launched its 10 Year Health Plan for the National Health Service (NHS), promising a "new era." A new network of neighborhood health hubs will be set up to shift care out of hospitals and into the community. 3 July 2025
Biotechnology
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has recommended Fruzaqla (fruquintinib) be reimbursed by the National Health Service (NHS), Japanese drug major Takeda’s local subsidiary revealed today. 3 July 2025
Pharmaceutical
A Republican-backed amendment to the sweeping budget proposal championed by US president Donald Trump would sharply reduce Medicaid spending, targeting one of the core features of the Affordable Care Act. 1 July 2025
Pharmaceutical
Despite major strides in antiretroviral therapy (ART), the human immunodeficiency virus (HIV) market still faces serious challenges that threaten long-term control of the disease. 1 July 2025
Pharmaceutical
US trade group Pharmaceutical Research and Manufacturers of America (PhRMA) last week submitted comments in response to the Centers for Medicare & Medicaid Services (CMS) draft guidance for implementation of the prescription drug price-setting program established under the Inflation Reduction Act (IRA). 30 June 2025
Biotechnology
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has announced that Japanese drugmaker Eisai and US biotech Biogen Leqembi (lecanemab) has not been recommended for use in the National Health Service (NHS) in England. 19 June 2025
Biotechnology
The UK’s National Institute for Health and Care Excellence (NICE) has today recommended Spevigo (spesolimab) for the treatment of generalized pustular psoriasis (GPP) flares in adults in England and Wales. 18 June 2025
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
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