Pricing, reimbursement and access
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Biotechnology
The Janus kinase (JAK) inhibitor baricitinib, marketed by US pharma major Eli Lilly as Olumiant, is strongly recommended for patients with severe or critical COVID-19 in combination with corticosteroids, an expert group from the World Health Organization has written in the British Medical Journal (BMJ). 14 January 2022
Biotechnology
Research from industry analyst GlobalData underscores the uncertainty surrounding the prospects for Aduhelm (aducanumab), the newly-approved Alzheimer’s med from Biogen and Eisai. 13 January 2022
Biotechnology
Hundreds of children are set to benefit from a ‘miracle’ treatment for cystic fibrosis, which has already changed the lives of thousands of people, the UK’s National Health Service (NHS) has announced today. 12 January 2022
Biotechnology
America’s federal health insurance program, Medicare, has said it will restrict access to Aduhelm (aducanumab), ending months of speculation over how administrators would respond to the product’s mixed reception. 12 January 2022
Biosimilars
Biosimilar drugs could drive down prices for expensive medicines used to treat illnesses such as cancer and rheumatoid arthritis, with savings estimated to be $38.4 billion or 5.9% of projected total US spending on biologics from 2021 to 2025, according to a new RAND Corporation study. 11 January 2022
Pharmaceutical
More than half of total spending on brand medicines went to the supply chain, middlemen and other stakeholders in 2020, according to a new analysis from the Berkeley Research Group (BRG). 10 January 2022
Biotechnology
Boston, USA-based cost-effectiveness watchdog The Institute for Clinical and Economic Review (ICER) has posted a revised “Evidence Report” for Eli Lilly’s tirzepatide. 6 January 2022
Pharmaceutical
In the UK, a negative reimbursement decision could limit the ability of prostate cancer patients to receive treatment with the PARP blocker Lynparza (olaparib). 5 January 2022
Pharmaceutical
A new supply agreement between the research-based biopharmaceutical industry and the State will improve patients’ access to the latest innovative medicines, according to the Irish Pharmaceutical Healthcare Association (IPHA), the representative organization for medicines innovators. 24 December 2021
Pharmaceutical
Johnson & Johnson’s pharma arm Janssen has won a positive reimbursement decision in the UK, from the country’s health technology assessor. 24 December 2021
Biotechnology
USA-based biotech Aimmune Therapeutics, which is now fully owned by Swiss foods giant Nestle, today announced that the UK’s National Institute for Health and Care Excellence (NICE) has recommended Palforzia [defatted powder of Arachis hypogaea L, semen (peanuts)] or use within the National Health Service (NHS) for the treatment of peanut allergy in patients aged four to 17. 23 December 2021
Biotechnology
US healthcare giant Johnson & Johnson subsidiary Janssen today welcomed the decision from the UK’s National Institute for Health and Care Excellence (NICE) recommending the use of Darzalex (daratumumab) in combination with Velcade (bortezomib), thalidomide and dexamethasone (DVTd) as induction and consolidation treatment for untreated multiple myeloma in adults, when an autologous stem cell transplant (ASCT) is suitable. 22 December 2021
Pharmaceutical
Russia is faced with a significant delay of drug supplies to the domestic market, as producers delay signing of contracts with the local state in an attempt to make a deal with higher prices for them, according to a recent report published by the Institute of State and Municipal Administration of the Higher School of Economics (ISMU), one of Russia’s leading research institutions in the field of finance, reports The Pharma Letter’s local correspondent. 22 December 2021
Biotechnology
In a bid to rescue its controversially approved Alzheimer’s drug that has failed to produce significant sales, US biotech Biogen today announced that, effective January 1, 2022, it will reduce the wholesale acquisition cost (WAC) of Aduhelm (aducanumab-avwa) 100mg/mL injection for intravenous use in the USA by around 50%. 20 December 2021
Biotechnology
The US Food and Drug Administration (FDA) has approved Vyvgart (efgartigimod alfa-fcab) for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive, said Belgo-Dutch clinical-stage immune-oncology biotech argenx. 20 December 2021
Pharmaceutical
Jürgen Polifka, Director of Global Market Access at Advanz Pharma, provides a Special Report on the company's approach to securing rapid access for essential medicines. 17 December 2021
Biotechnology
The USA’s Institute for Clinical and Economic Review (ICER) yesterday released a Final Evidence Report assessing the comparative clinical effectiveness and value of tezepelumab, which is under development by the UK’s AstraZeneca in partnership with US biotech Amgen for the treatment of severe asthma. 17 December 2021
Pharmaceutical
The UK’s National Institute of Heath and Care Excellence (NICE) has published its final technology appraisal guidance (TAG) for Ontozry (cenobamate), a treatment for focal onset seizures in uncontrolled epilepsy from Arvelle Therapeutics, a unit of privately-held Italian drugmaker Angelini Pharma. 16 December 2021
Biosimilars
Over the next decade, many more biological medicines are set to lose market exclusivity, representing an opportunity to increase competition and offer invaluable resources for healthcare systems to improve patient access and healthcare budget sustainability while significantly reducing equity gaps across Europe. 15 December 2021
Pharmaceutical
Could the Build Back Better social spending bill deliver on the promise that previous US administrations have failed to, by passing new federal legislation that would regulate drug prices in the USA? 10 December 2021
Biotechnology
The UK’s health technology assessor the Institute for Health and Clinical Excellence (NICE) says that talks with the makers of Enhertu have ended without agreement, meaning guidance that does not recommend Enhertu for advanced breast cancer will remain unchanged. 20 November 2024
Pharmaceutical
Johnson & Johnson has taken legal action to defend a contentious rebate initiative, filing a lawsuit in the US District Court for the District of Columbia. 15 November 2024
Biotechnology
Sanofi has announced that the UK's health technology assessor will conduct a new review of its Sarclisa (isatuximab) combo therapy for relapsed or refractory multiple myeloma. 13 November 2024
Pharmaceutical
The US trade group Pharmaceutical Research and Manufacturers of America (PhRMA) today launched new advertisements urging Congress to make sure savings on medicines go to patients, not middlemen. 11 November 2024
Pharmaceutical
Danish patients are being offered fewer innovative treatments than Norwegians and Swedes, a new estimate from the Danish Medicines Council shows. 11 November 2024
Pharmaceutical
UK pharma major AstraZeneca today announced that the National Institute for Health and Care Excellence (NICE) published its final draft guidance (FDG) recommending Wainzua (eplontersen) as a treatment option for hereditary transthyretin-related amyloidosis (ATTR) in adults with stage 1 or stage 2 polyneuropathy across England and Wales. 29 October 2024
Biotechnology
Last week Vertex Pharmaceuticals released positive Phase III results for its suzetrigine for moderate-to-severed pain. Belgium’s UCB revealed that Swiss pharma giant Roche was terminating its collaboration on the Alzheimer’s candidate bepranemab. The UK’s health technology assessor the Institute for Health and Clinical Excellence (NICE) declined to recommend a second Alzheimer’s treatment, this time Eli Lilly’s Kisunla. Also of note, Lyell Immunopharma announced its planned acquisition of ImmPACT Bio and reprioritization of its own clinical pipeline. 27 October 2024
Pharmaceutical
The National Comprehensive Cancer Network (NCCN) has updated its Clinical Practice Guidelines for breast cancer, providing a boost to Novartis' Kisqali (ribociclib). 24 October 2024
Biotechnology
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved US pharma major Eli Lilly’s (NYSE: LLY) Kisunla (donanemab) for people in Britain with mild cognitive impairment or those in the early stages of Alzheimer’s disease. 23 October 2024
Pharmaceutical
The US Department of Health and Human Services (HHS), through the Office of Assistant Secretary for Planning and Evaluation (ASPE), yesterday released new data showing that nearly 1.5 million people with Medicare Part D saved nearly $1 billion in out-of-pocket prescription drugs costs in the first half of 2024 because of the Biden-Harris Administration’s Inflation Reduction Act. 23 October 2024
Pharmaceutical
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has recommended elafibranor 80mg tablets for the treatment of PBC, the drug’s French developer Ipsen announced today. 22 October 2024
Pharmaceutical
The Institute for Clinical and Economic Review (ICER) has released its final report assessing the effectiveness and pricing of key treatments for transthyretin amyloid cardiomyopathy (ATTR-CM). 22 October 2024
Pharmaceutical
Pharmaceutical Research and Manufacturers of America (PhRMA) says it has submitted comments to the Office of the United States Trade Representative (USTR) to inform the agency’s 2025 National Trade Estimate (NTE) Report on Foreign Trade Barriers. 21 October 2024
Pharmaceutical
“The new key figures from the NZa show that Dutch expenditure on expensive medicines remains stable,” says Mark Kramer, chairman of the Association of Innovative Medicines (VIG), adding: “That is good news from a social perspective.” 21 October 2024
Pharmaceutical
The Danish Medicines Council (Medicinrådet), responsible for evaluating and recommending new treatments for Denmark’s healthcare system, is facing a significant increase in processing times. 14 October 2024
Generics
Two US units of Israel’s Teva Pharmaceutical Industries have agreed to pay $450 million to resolve two matters that allege Teva violated the Anti-Kickback Statute (AKS) and the False Claims Act (FCA), the US Department of Justice (DoJ) announced yesterday. 11 October 2024
Biosimilars
South Korea’s Samsung Bioepis has released its Fourth Quarter 2024 Biosimilar Market Report, marking the seventh-edition of the Quarterly Biosimilar Market Report in the United States. 11 October 2024
Biotechnology
US healthcare giant Johnson & Johnson’s Tecvayli (teclistamab) has been recommended by the National Institute for Health and Care Excellence (NICE) as a first-line option to treat myeloma in England and Wales. 10 October 2024
Generics
CMS released a Request for Information (RFI) and a sample list of prescription drugs that the agency preliminarily intends to include under the proposed Medicare $2 Drug List Model. 10 October 2024
Pharmaceutical
US pharma major Bristol Myers Squibb’s recent approval from the US Food and Drug Administration (FDA) for Cobenfy (xanomeline and trospium chloride) for the treatment of adults with schizophrenia is a win for the company. 9 October 2024
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