Pricing, reimbursement and access
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Pharmaceutical
Efforts to combat antimicrobial resistance (AMR) are gaining momentum in Europe, with the introduction of innovative measures to drive the development of new antimicrobials. 25 November 2024
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major AstraZeneca today announced that the National Institute for Health and Care Excellence (NICE) published its final draft guidance (FDG) recommending Wainzua (eplontersen) as a treatment option for hereditary transthyretin-related amyloidosis (ATTR) in adults with stage 1 or stage 2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
Generics
Prescription drug spending in the USA reached $307 billion in 2010 - an increase of $135 billion since 2001 - and comprised approximately 12% of all health care spending in the country, according to a new report for the US Government Accountability Office (GAO). 4 March 2012
Generics
With the intention of getting new medicines to the market faster, the European Commission yesterday proposed to streamline and reduce the duration of national decisions on pricing and reimbursement of medicines. The move was welcomed by Europe's pharma industry which, however, stressed that more is needed to help the sector remain innovative. 2 March 2012
Pharmaceutical
The chief executive of the UK's largest pharmaceutical company, GlaxoSmithKline (LSE: GSK) has accused the government of "systematically delaying" the release of new drugs ' particularly those for treating cancer - to try to save money. 27 February 2012
Pharmaceutical
In another warning to drugmakers trying to get approval of new drugs under Germany's AMNOG reform law not to deviate from appropriate comparators specified by the Federal Joint Committee (G-BA), the country's Institute for Quality and Efficiency in Health Care (IQWiG) examined whether retigabine, UK pharma giant GlaxoSmithKline's Trobalt, offers an added benefit compared with the present standard therapy, concluding that no such added benefit can be inferred from the dossier, as the drug manufacturer deviated from the specifications of the G-BA and chose a different comparator therapy. 27 February 2012
Generics
A UK Department of Health released yesterday endorses the current voluntary agreement between the DoH and the pharmaceutical industry and confirms that UK medicines are representing good value for money for the National Health Service. 24 February 2012
Generics
Pharmacists in Australia need to act now to try to increase their dispensaries' profitability in 2012, despite Expanded and Accelerated Price Disclosure (EAPD), says the country's Generic Medicines Industry Association (GMiA). 24 February 2012
Pharmaceutical
Australia's Federal Minister for Health, Tanya Plibersek, yesterday announced the listing of nine prescription medicines on the nation's Pharmaceutical Benefits Scheme (PBS). The combined cost of the new medicines and additional Medicare Benefits Schedule items is A$141 million ($151 million) over five years, she said, but adding: 'The PBS listings are subject to final arrangements being met by the suppliers of the medicines before they can be listed.' 22 February 2012
Pharmaceutical
UK drugs watchdog the National Institute for Health and Clinical Excellence (NICE) has today recommended that the National Health Service in England and Wales can offer Swiss drug major Roche's (ROG: SIX) RoActemra (tocilizumab) at an additional stage in treating rheumatoid arthritis. 22 February 2012
Pharmaceutical
The UK's health care guidance body the National Institute for Health and Clinical Excellence (NICE), has today confirmed its initial draft and final draft positive recommendation of US drug major Eli Lilly and biotech firm Amylin's (Nasdaq: AMLN) Bydureon (exenatide, prolonged release). 22 February 2012
Pharmaceutical
PHARMAC, the Pharmaceutical Management Agency of New Zealand, is seeking feedback on a proposal to fund prasugrel hydrochloride (brand name Effient) through a provisional agreement with its manufacturer US drug major Eli Lilly (NYSE: LLY). 21 February 2012
Pharmaceutical
Commenting on proposals by the Finnish government on reimbursement savings through cuts in drug wholesale prices, the trade group Pharma Industry Finland (PIF) says savings should be primarily sought through a structural reform of the drug reimbursement system. In addition to generating savings, this would promote patient equality and support an overall development of the healthcare system. 20 February 2012
Generics
A report in the latest issue of the Medical Journal of Australia (MJA), has backed the case for the government making substantial budget savings by implementing policies that encourage the uptake of high quality but more affordable generic medicines, says the Australian Generic Medicines Industry Association (GMiA), which itself is arguing the same point (The Pharma Letter February 9). 20 February 2012
Pharmaceutical
In an early benefit assessment under the German Act on the Reform of the Market for Medicinal Products (AMNOG), the country's Institute for Quality and Efficiency in Health Care (IQWiG) examined whether Japanese drug major Eisai's (TYO: 4523) breast cancer drug Halaven (eribulin) ' which was approved by the European Commission last spring (The Pharma Letter March 25, 2011) - offers an added benefit compared with the present standard therapy, concluding that it does not. 17 February 2012
Pharmaceutical
UK drug watchdog the National Institute for Health and Clinical Excellence (NICE) today issued new draft guidance requesting that Swiss drug major Roche (ROG: SIX), the manufacturer of Tarceva (erlotinib), provides further information on the use of this drug for the first-line treatment of locally advanced or metastatic EFGR mutation-positive non-small-cell lung cancer (NSCLC). The draft guidance has been issued for consultation. 17 February 2012
Pharmaceutical
Anglo-Swedish drug major AstraZeneca (LSE: AZN) has launched what it says is its first-ever direct-to-patient program offering those with a valid prescription for its breast cancer drug Arimidex (anastrozole), which has lost patent exclusivity, the opportunity to have the brand Arimidex delivered directly to their home by Express Scripts, a specialty pharmacy services provider in the USA, for $40 per month, including shipping. 16 February 2012
Pharmaceutical
German drug major Bayer's (BAY: DE) oral anticoagulant Xarelto (rivaroxaban) has been accepted by the Scottish Medicines Consortium (SMC) for use in eligible patients within the National Health Service in Scotland in two new therapeutic indications, based on licences granted by the European Commission: 14 February 2012
Pharmaceutical
The UK drug watchdog the National Institute for Health and Clinical Excellence (NICE) has published draft guidance today which proposes to advise the National Health Service that lapatinib or trastuzumab with aromatase inhibitors should not be prescribed for a particular type and stage of breast cancer. This is because the extent to which they can improve overall survival compared to existing treatments is uncertain and so they do not appear to represent value for money for the NHS. 14 February 2012
Pharmaceutical
With the Irish government planning to introduce a bill for a reference pricing system in 2012, serious misgivings have been expressed about such a legislative development. Currently awaiting publication, the government has claimed that the new legislation will lead to a considerable reduction in the medicines bill for the state, an assertion that has been challenged by Anne Nolan, chief executive of the Irish Pharmaceutical Healthcare Association (IPHA). 12 February 2012
Biotechnology
The biopharmaceutical industry today is facing a multifaceted 'value challenge'. It is no longer enough for biopharma companies to create products that are simply safe and effective: they must also develop medications which provide results that are superior to those already on the market, according to a report from Quintiles prepared by the Economist Intelligence Unit (EIU). 7 February 2012
Pharmaceutical
UK drugs watchdog the National Institute for Health and Clinical Excellence (NICE) has issued new draft guidance not recommending the use of US health care giant Johnson & Johnson (NYSE: JNJ) subsidiary Janssen's Zytiga (abiraterone) in combination with prednisone or prednisolone for the treatment of castration-resistant metastatic prostate cancer that has progressed on or after docetaxel-containing therapy. 2 February 2012
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