Pricing, reimbursement and access
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Pharmaceutical
US health insurer UPMC Health Plan has reached an innovative reimbursement arrangement with the UK’s AstraZeneca for the heart medicine Brilinta (ticagrelor). 29 January 2019
Generics
Medicines for Europe welcomes the publication of the European Commission Report on Competition Enforcement in the Pharmaceutical Sector (2009-2017). 29 January 2019
Pharmaceutical
A new report from industry analyst IQVIA finds that global drug spending reached $1.2 trillion in 2018, and that total spending on medicines is expected to top $1.5 trillion by 2023, up 50% from 2016. 29 January 2019
Pharmaceutical
A leading US pharmacy benefit manager (PBM) trade group, the Pharmaceutical Care Management Association (PCMA), has sent letters to several congressional committees urging consideration of several policy options aimed at reducing prescription drug costs. 29 January 2019
Biotechnology
The Australian government said on Friday that it will make two new medicines for the treatment of the skin condition psoriasis more affordable, saving patients up to A$32,600 ($23.453) per year. 28 January 2019
Pharmaceutical
Having been somewhat slow on approving biosimilars, the US Food and Drug Administration last week added clearance to a third version of Roche’s Herceptin, Samsung Bioepis’ Ontruzant. On the research front, Aurinia Pharmaceuticals is pushing ahead with its dry eye therapy candidate voclosporin despite disappointing trial data. Also last week, the UK government set out plans to help control antibiotic resistance, including a new payment model. Additionally, the fourth-quarter 2018 financial results season kicked off, with disappointing figures from AbbVie and mixed ones from Johnson & Johnson. 27 January 2019
Pharmaceutical
Love it or loathe it, the Institute for Clinical and Economic Review (ICER) is not about to go away. 25 January 2019
Pharmaceutical
In a world where what patients, physicians and health systems really want is a cure, how much should drug companies that come up with one be paid? 25 January 2019
Pharmaceutical
More than half of consumers lack confidence in their ability to properly take new medications as directed, according to a survey released today by DrFirst, a leading US provider of e-prescribing and patient medication management solutions. 23 January 2019
Pharmaceutical
Pharma trade group Medicines Australia has today lodged its submission to the 2019-2020 Federal Budget. 22 January 2019
Pharmaceutical
Russian and foreign drugmakers operating in the local market, will be obliged to reduce prices of drugs, which have a status of vital and essential in Russia if prices for these drugs have declined in the country of origin or in a number of countries abroad, according to the latest initiative of the Russian government. 21 January 2019
Pharmaceutical
The UK’s reimbursement agency has reversed a conditional decision not to recommend funding for the breast cancer therapy Verzenio (abemaciclib) through the country’s national healthcare provider. 21 January 2019
Pharmaceutical
There has been plenty of angry discourse but little real action around US medicine prices in recent years, but the end of 2018 and the beginning of 2019 are offering evidence of change that is making drug companies sit up and take notice. 21 January 2019
Pharmaceutical
Patients in England who have a mutation of the most serious and life-threatening type of skin cancer will now have a new treatment option. 21 January 2019
Pharmaceutical
Government affairs were the focus of pharma on both sides of the Atlantic last week. Drug prices remained top news in the USA, with the Democrats launching a sweeping investigation, while in the UK Prime Minister Theresa May suffered a historic and crushing defeat of her proposed Brexit deal, with significant implications for the pharmaceutical industry and patients. On the research front, Array and Pierre Fabre presented encouraging Phase III data on the triple combination colorectal cancer therapy -Braftovi, Mektovi and Erbitux. Regulatory news included a Food and Drug Administration advisory panel recommending approval of Amgen and UCB’s osteoporosis drug candidate Evenity, and another panel failing to reach agreement on the benefits of Lexicon Therapeutics and Sanofi’s diabetes candidate Zynquista. 20 January 2019
Pharmaceutical
The USA’s Institute for Clinical and Economic Review (ICER) yesterday posted a draft protocol describing a new annual analysis - an ICER “Unsupported Price Increase” (UPI) report - that will analyze significant prescription drug increases and determine whether or not new clinical evidence exists that could be used to support those increases. 18 January 2019
Biotechnology
Just a couple of months after it won European approval, Venclyxto (venetoclax) has been recommended for routine use alongside rituximab on the National Health Service (NHS) in England for previously-treated chronic lymphocytic leukemia (CLL). 18 January 2019
Pharmaceutical
The noise around cross-country collaborations on access to medicines has been constant. The results? Not so much, according Nathalie Moll, director general of the European Federation of Pharmaceutical Industries and Associations. 17 January 2019
Pharmaceutical
A powerful committee of the freshly inaugurated Democrat-led US House of Representatives has launched a far-ranging investigation into the drug pricing practices of the US pharmaceutical industry. 15 January 2019
Pharmaceutical
The USA is a 'better country' than one that forces its people to decide between paying their bills or their prescriptions, a Democrat has said as he joined colleagues in proposing a sweeping plan to lower drug prices. 11 January 2019
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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