Pricing, reimbursement and access
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Generics
A raft of measures adopted by the US government to enhance the availability of drugs are impacting the margins of Indian companies. While several Indian drugmakers have witnessed a decline in their US generic business on a quarter-on-quarter (QoQ) and year-on-year (YoY) basis, few companies have taken inventory write-offs and also tried to liquidate the high inventory carried by them in the US market, reports The Pharma Letter’s India correspondent. 31 August 2021
Pharmaceutical
Eva Marchese, Abhishek Kumar and Kees Chamberlain from Charles River Associates examine how the COVID-19 pandemic is expected to impact payers’ management of pharmaceutical budgets in Europe in an Expert View column. 26 August 2021
Pharmaceutical
The hematological (blood) cancer therapy market is diverse and highly genericized, with chemotherapies currently accounting for the highest number of marketed drugs. 26 August 2021
Pharmaceutical
Boston, USA-based pricing watchdog The Institute for Clinical and Economic Review (ICER) has published an update to its cost-effectiveness model for therapies in hereditary angioedema (HAE). 25 August 2021
Pharmaceutical
The Russian Ministry of Health spent more than 26.1 billion roubles ($351 million) on the procurements of drugs against HIV this year, an increase of 10% compared with the year earlier, according to recent statements by Ministry’s press-service, reports The Pharma Letter’s local correspondent. 25 August 2021
Biotechnology
Children in England are set to be the first in the world to be offered direct acting antiviral (DAA) tablets for hepatitis C, as part of National Health Service (NHS) plans to eradicate the disease entirely. 24 August 2021
Pharmaceutical
Swiss pharma giant Novartis has been granted a positive reimbursement decision in the UK for Rydapt (midostaurin). 19 August 2021
Pharmaceutical
In the UK, drug developers and other stakeholders have until October 13, 2021 to provide input on proposed changes to the health technology assessment (HTA) methods used by the country’s HTA body. 19 August 2021
Biotechnology
Boston, USA-based non-profit The Institute for Clinical and Economic Review (ICER) has released its final report into the cost-effectiveness of a range of atopic dermatitis (AD) therapies. 18 August 2021
Biotechnology
The Russian government may expand the list of purchased high-priced drugs for its needs by beginning purchases of risdiplam – a drug for treatment of spinal muscular atrophy (SMA), reports The Pharma Letter’s local correspondent 17 August 2021
Pharmaceutical
US President Joe Biden believes that health care is a right, not a privilege. No American should have to face difficult choices between paying for their prescription medications or other essential needs., he said, as he announced his vision for reducing the high cost of prescription drugs. 14 August 2021
Biotechnology
The US Department of Veterans Affairs (VA) has snubbed Biogen and Eisai’s Aduhelm (aducanumab-avwa) by excluding it from its national formulary. 13 August 2021
Pharmaceutical
Eli Lilly has won a positive reimbursement decision in the UK for Verzenios (abemaciclib) as an option for people with advanced HR+ HER2-breast cancer. 12 August 2021
Pharmaceutical
The Indian subsidiary of Anglo-Swedish pharma major AstraZeneca has reported a 45.03% decline in its net profit to $1.37 million for the June ended fiscal quarter. 9 August 2021
Biosimilars
The approval of Biocon Biologics and Viatris' insulin glargine product as an interchangeable biosimilar by the US Food and Drug Administration will be a test of whether such designations can make a difference in patient access, Jeff Baldetti of Cardinal Health explains. 9 August 2021
Biotechnology
The USA’s Institute for Clinical and Economic Review (ICER) has released a Final Evidence Report assessing the comparative clinical effectiveness and value of aducanumab (trade name Aduhelm) for the treatment of Alzheimer’s disease. 7 August 2021
Pharmaceutical
The UK Competition and Markets Authority (CMA) has provisionally found that US pharma giant Pfizer and its UK distributor Flynn Pharma, abused their dominant positions to overcharge the NHS for vital anti-epilepsy drugs, after reassessing the case. 6 August 2021
Biotechnology
The UK’s National Institute for Health and Care Excellence (NICE) has issued a Final Appraisal Determination recommending UCB’s bimekizumab as an option for adults with severe plaque psoriasis. 3 August 2021
Generics
The share of domestic drugs in public procurements in Russia grew to a record figure of 87% this year, according to recent studies conducted by some leading local analysts in the field of pharmaceutics and Russian media, reports The Pharma Letter’s local correspondent. 3 August 2021
Biotechnology
A new medicine that helps reduce unacceptably high ‘bad cholesterol’ and the risk of cardiovascular events like heart attack and stroke has gained long-awaited listing on Australia’s Pharmaceutical Benefits Scheme (PBS). 2 August 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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