Pricing, reimbursement and access
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Pharmaceutical
David Baker, a business consultant at J+D Forecasting, provides an Expert View on potential implications for the pharmaceutical industry of UK Labour Party leader Jeremy Corbyn's recently-announced proposals. 17 October 2019
Pharmaceutical
The first drug pricing report, mandated under California’s new price transparency law, has been released by the Office of Statewide Health Planning and Development (OSHPD). 15 October 2019
Pharmaceutical
The Irish Pharmaceutical Healthcare Association (IPHA) says that the country’s government must make sure that Brexit does not cause access to medicines to fall further relative to other European countries. 14 October 2019
Biotechnology
Following the surprise withdrawal of US health technology assessor, the Institute for Clinical and Economic Review’s (ICER) initial draft evidence report last month, the organization’s latest draft, published October 11, has seen AbbVie’s Rinvoq (upadacitinib) make a substantial leap in cost-effectiveness, commented industry analytics firm GlobalData’s senior immunology analyst Rose Joachim. 12 October 2019
Pharmaceutical
US trade group the Pharmaceutical Research and Manufacturers of America (PhRMA) has raised objections to a drug pricing plan outlined by House Speaker Nancy Pelosi. 11 October 2019
Biotechnology
Clovis Oncology’s Rubraca (rucaparib) will be funded for English women with relapsed ovarian cancer through the Cancer Drugs Fund (CDF), following a recommendation from the National Institute for Health and Care Excellence (NICE). 11 October 2019
Pharmaceutical
Médecins Sans Frontières/Doctors Without Borders (MSF) is today calling on pharmaceutical company Johnson & Johnson to lower the price of its anti-tuberculosis medicine bedaquiline to no more than $1 per day for those who need it. 10 October 2019
Pharmaceutical
The USA’s Institute for Clinical and Economic Review (ICER) has published its first annual report on Unsupported Price Increases (UPI) of prescription drugs in the United States, showing that Humira (adalimumab) and Rituxan (rituximab) topped the list of costliest medicines. 9 October 2019
Pharmaceutical
International aid group Médecins Sans Frontières (MSF) acknowledges the lower price offered to the government of South Africa for newer anti tuberculosis (TB) drug, delamanid, marketed under the trade name Deltyba, but calls for it to be significantly lower and expanded to all countries in need. 9 October 2019
Pharmaceutical
In the complex world of US drug pricing, any new snippets of evidence of rises or declines in medicine prices are used to further the claims of the corresponding side of the debate. 7 October 2019
Pharmaceutical
Martin Price, vice president of health economics, market access and reimbursement for Europe, Middle East and Africa, at Johnson & Johnson (NYSE: JNJ) pharma subsidiary Janssen, in a posting on the European Federation of Pharmaceutical Industries and Associations (EPFIA) website, says that the key issue that keeps him awake at night is how we, at Janssen, can best collaborate with payers to accelerate patient access to ground-breaking treatments. 7 October 2019
Biotechnology
The UK’s reimbursement agency has provided draft guidance against reimbursing Roche’s Tecentriq (atezolizumab) plus chemo in triple-negative breast cancer (TNBC). 4 October 2019
Generics
Africa’s largest drug company will have to pay back ill-gotten gains to the UK’s National Health Service (NHS) after accepting its role in an illegal agreement that resulted in significant price hikes for an essential medicine. 3 October 2019
Pharmaceutical
As the incurable Duchenne muscular dystrophy (DMD), a rare genetic disease, takes a heavy toll of children in India, the Ministry of Health and Family Welfare has given instructions to speed up the process of formulating the National Policy for treatment of Rare Diseases, reports The Pharma Letter’s India correspondent. 1 October 2019
Biotechnology
The Institute for Clinical and Economic Review (ICER) has posted a draft scoping document on its planned review of the cost-effectiveness offered by Vertex Pharmaceuticals’ (Nasdaq: VRTX) cystic fibrosis (CF) drugs in the USA. 1 October 2019
Biotechnology
South Korean company Celltrion, which is best known as a biosimilars manufacturer, is about to launch its first innovative product in the USA. 1 October 2019
Pharmaceutical
More than 700 drugs have disappeared from the Russian pharmaceutical market since the beginning of the current year, according to recent statements by officials of the Russian Ministry of Health and industry’s analysts, reports The Pharma Letter’s local correspondent. 30 September 2019
Biotechnology
The cost-effectiveness watchdog for England and Wales has ruled that Novartis’ anti-CGRP migraine therapy is too expensive at its current price to be provided on the National Health Service (NHS). 26 September 2019
Pharmaceutical
Studies looking at three drugs that were discovered and developed with the help of public funds have raised the question of why the approved products carry high prices that earn pharma companies such significant revenues. 26 September 2019
Biosimilars
The founder and chairwomanof India’s biggest biopharma company has made a pledge to offer recombinant human insulin for less than $0.10 per day in low- and middle-income countries (LMICs). 26 September 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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