Pricing, reimbursement and access
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Pharmaceutical
Amid multiple Congressional investigations into drug pricing in the USA, and a febrile political atmosphere around the role of the state in insurance and pricing negotiations, the nonpartisan Congressional Budget Office (CBO) released a report into so-called “Medicare for all” on Thursday. 2 May 2019
Pharmaceutical
The UK government has unveiled improvements to its Accelerated Access Collaborative (AAC) with the promise of making it the new umbrella organization for UK health innovation. 2 May 2019
Pharmaceutical
First congressional hearing on 'Medicare for all' shows no signs of consensus on controversial issue
The US House Committee on Rules held the first hearing on Medicare for all legislation this week, and, while the subject matter was familiar, the hearing itself was unusual, according to Stephanie Kennan of McGuireWoods Consulting. 2 May 2019
Pharmaceutical
The US Justice Department (DoJ) announced yesterday that US WorldMeds (USWM) has agreed to pay $17.5 million to resolve allegations that it violated the False Claims Act, by paying kickbacks to patients and physicians to improperly induce prescriptions of its drugs, Apokyn (apomorphine) and Myobloc (botulinum toxin type B). 1 May 2019
Pharmaceutical
Japanese drugmaker Astellas and US biotech Amgen have agreed to pay a total of $124.75 million to the Department of Justice (DoJ) in the USA over alleged kickbacks. 26 April 2019
Biotechnology
The USA’s Centers for Medicare & Medicaid Services (CMS) has proposed a rule that focuses the agency’s efforts on a singular objective: transforming the healthcare delivery system through competition and innovation to provide patients with better value and results. 25 April 2019
Pharmaceutical
Looking back as news last week, Gilead Sciences’ collaboration with start-up insitro on non-alcoholic steatohepatitis (NASH) was noteworthy. On the M&A front there was the news that Catalent is acquiring Paragon Biosciences aimed at the gene therapy sector, and Kiadis Pharma buying CytoSen Therapeutics also to expand into gene therapy. On the pricing front, Amgen announced that its newly US approved osteoporosis drug Evenity would carry an annual price tag of $21,900. Featured clinical trial news included new data from Novartis subsidiary AveXis on its spinal muscular atrophy (SMA) drug Zolgensma. 21 April 2019
Biosimilars
An alternative to biosimilars has been proposed as a means of bringing down the prices of off-patent biologics. 18 April 2019
Pharmaceutical
The Pharmaceutical Price Regulation Scheme (PPRS) is dead; long live the Voluntary Scheme for Branded Medicines Pricing and Access (Voluntary Scheme)! 16 April 2019
Biotechnology
Following swiftly on its US regulatory approval last week, biotech major Amgen yesterday announced that its Evenity (romosozumab-aqqg) is now available for shipment to wholesalers in the USA. 16 April 2019
Biotechnology
Bowing to pricing pressure in the key US market, French pharma major Sanofi has said it will cap the cost of its insulin products at $99 per month for certain patients. 11 April 2019
Pharmaceutical
The UK’s health technology assessor is leaning against reimbursing Novartis’ breast cancer drug Kisqali (ribociclib), plus Faslodex (fulvestrant), for treating certain people with breast cancer. 10 April 2019
Pharmaceutical
Representatives from pharmacy benefit managers (PBMs) were the latest to be grilled by lawmakers in Washington DC on Tuesday. 10 April 2019
Pharmaceutical
The Institute for Clinical and Economic Review (ICER) yesterday released a Draft Evidence Report assessing the clinical effectiveness and value of two new technologies to induce immune tolerance — Viaskin Peanut, and AR101 — as well as non-commercialized oral immunotherapy (OIT). 10 April 2019
Pharmaceutical
Merger and acquisition was in the news last week, with Novartis making its first M&A deal this year, buying IFM Tre along with its immunology pipeline for up to $1.575 billion. Also on the company front, a dispute has broken out between Amgen and Novartis regarding their migraine prevention drug Aimovig. Research news included ViiV Healthcare’s presentation of new data on its two-drug combination HIV drug Juluca. Meantime, with a Food and Drug Administration decision expected soon on Novartis’ gene therapy Zolgensma for spinal muscular atrophy (SMA), the latest ICER report on pricing for such drugs could be important. 7 April 2019
Biotechnology
Bristol-Myers Squibb has secured a positive reimbursement decision for its Opdivo (nivolumab) plus Yervoy (ipilimumab) combination, for use against kidney cancer, in the UK. 5 April 2019
Pharmaceutical
The year-long US-China tension demands a fairer Chinese market access for global companies, and it might benefit China’s drug innovation, said speakers at the annual China Healthcare Investment Conference (CHIC) event held in Shanghai on March 27. 4 April 2019
Biotechnology
Biogen and Novartis have been given a reminder of their responsibility to patients in pricing their spinal muscular atrophy (SMA) therapies in the USA. 4 April 2019
Biotechnology
Major US insurer Cigna has moved to cap insulin prices for customers, together with its new acquisition Express Scripts, a pharmacy benefits manager (PBM). 4 April 2019
Pharmaceutical
Next week will be the turn of insulin manufacturers to testify about US drug prices in the House of Representatives. 3 April 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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