Pricing, reimbursement and access
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Biotechnology
Influential cost-effectiveness watchdog ICER - the Institute for Clinical and Economic Review - has found that three therapies for the ultra-rare and potentially fatal disorder hereditary angioedema (HAE) are not cost-effective. 19 November 2018
Biosimilars
South Korean drugmaker Celltrion Healthcare outlined its vision of ‘shaping future healthcare by improving access to biosimilars’ at the 5th Annual Biosimilars USA Conference in New Jersey, USA. 19 November 2018
Biotechnology
The UK’s National Health Service (NHS) will pay for eligible English children and young people with pediatric acute lymphoblastic lymphoma (ALL) to be treated with Novartis’ CAR-T therapy Kymriah (tisagenlecleucel). 16 November 2018
Biosimilars
After a number of setbacks on the path to market, US pharma giant Pfizer has announced the introduction of Retacrit (epoetin alfa-epbx) injection in the USA. 15 November 2018
Pharmaceutical
As Indians are at a higher risk of rare genetic diseases, the Indian government in May last year put in place a National Rare Disease Policy, allocating $12.86 million towards genetic disorders. However, implementation of this policy has yet to see the light of the day, with experts raising concerns over the long delay, reports The Pharma Letter’s India correspondent. 15 November 2018
Pharmaceutical
One of the USA’s largest insurers has pointed to the increase in the cost of branded medicines as a key reason for US healthcare costs going up even as generics grab a greater share of the market. 15 November 2018
Biotechnology
A report from the Institute for Clinical and Economic Review (ICER) finds that a group of new asthma drugs are priced at twice the price that they should be to deliver value for money. 14 November 2018
Pharmaceutical
The USA’s leading pharmacy benefit manager (PBM) has announced that it is introducing a new formulary to provide employers and health plans a better opportunity to leverage changing dynamics to help lower their members' out-of-pocket costs. 14 November 2018
Pharmaceutical
Findings presented by Japan’s largest drugmaker Takeda at ISPOR 2018 report that where standards of care are not clearly defined in terms of cost or outcomes, the ability of payers to accurately estimate the cost effectiveness of new therapeutic options can be hindered. 13 November 2018
Biotechnology
The stand-off between Vertex Pharmaceuticals and the UK’s cost watchdog for medicines over the cystic fibrosis (CF) drug Orkambi (lumacaftor/ivacaftor) has now gone on for two-and-a-half years. 12 November 2018
Pharmaceutical
Prices for drugs in Russia may rise significantly as soon as the beginning of 2019, according to recent statements by an official spokesman of the Russian Pharmacy Guild, a public association, which unites Russian leading pharmacies and some local drugmakers, reports The Pharma Letter’s local correspondent. 12 November 2018
Generics
Pricing concerns have re-emerged for Gilead Sciences and other participants in the HIV class after suggestions that United Healthcare would be offering incentives to HIV-infected individuals to use lower priced generic, or partially generic, HIV regimens, instead of Gilead and GlaxoSmithKline’s recently introduced best-in-class combinations, comments Leerink Research analyst Geoffrey Porges. 12 November 2018
Pharmaceutical
Anglo-Swedish pharma major AstraZeneca is calling for a change of heart at England’s medicines cost regulator after it failed to consider its cancer drug Lynparza (olaparib) as cost-effective. 9 November 2018
Pharmaceutical
Much like US politics as a whole, opinions are divided about what the midterm results mean for prescription drug prices. 8 November 2018
Pharmaceutical
The National Institute for Health and Care Excellence (NICE) on Thursday recommended routine National Health Service (NHS) funding for first-line treatment with Lenvima (lenvatinib) in adults with untreated, advanced, unresectable hepatocellular carcinoma (HCC). 8 November 2018
Pharmaceutical
Ireland-based drugmaker Jazz Pharmaceuticals has had its Vyxeos (daunorubicin and cytarabine) product for adults with specific types of secondary acute myeloid leukemia (AML) recommended for public funding in England and Wales. 8 November 2018
Biotechnology
The Australian government has made a new medicine available, from today, for free for an extremely rare and potentially life-threatening disease, saving patients hundreds of thousands of dollars a year. 1 November 2018
Pharmaceutical
The Institute for Clinical and Economic Review (ICER) is to consider what might constitute a fair price for two drug candidates that are of great importance to the companies developing them. 1 November 2018
Biotechnology
Two major new listings on the Australian Pharmaceutical Benefits Scheme (PBS) have the potential to extend the lives of Australians with advanced lung cancer and those at risk of a heart attack, saving patients up to nearly A$190,000 ($135,714) a year. 29 October 2018
Generics
Aiming to curb unhealthy practices in the pharmaceutical sector, the Competition Commission of India (CCI) has identified key issues hurting the sector and is looking at ways to better regulate it. With branded generics dominating the Indian drug market, the CCI has called for regulation to allow consumers to buy standardized consumables from the open market, reports The Pharma Letter’s India correspondent. 29 October 2018
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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