Pricing, reimbursement and access
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Pharmaceutical
Speaking to the Federation of German Industries Conference in Germany last week, John Lechleiter, chairman, president and chief executive of US drug major Eli Lilly (NYSE: LLY), slammed the German health care system which he said is stifling innovation and the country's approach to drug pricing could lead to drugmakers refusing to launch new medicines and cut back on their investments. 11 July 2011
Pharmaceutical
Following the intensive efforts of the Secretariat General of the Greek Ministry of Health, which is responsible for the pricing of medicines in the country, and the respective Directorate for Medicines and Pharmacies, the new Price Bulletin has now been uploaded on the web sites of the Ministry of Health and the Greek pharmaceutical industry association, the SFEE. Last year, the Greek government introduced draconian drug price cuts of 25% (The Pharma Letters passim. 11 July 2011
Generics
As the USA seeks to expand health care coverage to more citizens without adding burdensome costs, researchers from Harvard University, Brigham and Women's Hospital and CVS Caremark (NYSE: CVS) reported that preventative health care may be significantly less costly than previously thought, due to expanded use of cost-effective generic medications for the treatment and prevention of chronic disease. 7 July 2011
Biotechnology
There was a batch of good news for Seattle, USA-based Dendreon (Nasdaq: DNDN) that support broad availability for on-label use of its novel, but expensive ($93,000 therapy cost), prostate cancer treatment Provenge (sipuleucel-T). Also, the Food and Drug Administration approved the company's second manufacturing facility for the product. 4 July 2011
Pharmaceutical
In a draft guidance issued last Friday, the UK's drug watchdog, the National Institute for Health and Clinical Excellence (NICE) said that the clinical and cost effectiveness of two breast cancer drugs that may be offered alongside hormone therapy to some postmenopausal women who have a particular type of the disease has not been clearly demonstrated and therefore recommends .against their use in the National Health Service for this condition. 3 July 2011
Pharmaceutical
Having previously issued negative opinions on the cancer drug, this morning the UK's National Institute for Health and Clinical Excellence (NICE) declared that it has been unable to recommend the use of Swiss drug major Roche's (ROG: SIX) Tarceva (erlotinib) as a maintenance treatment for people with non-small-cell lung cancer (NSCLC) who have had first line treatment with platinum-based chemotherapy and their disease has remained stable. 29 June 2011
Pharmaceutical
The UK drugs watchdog the National Institute for Health and Clinical Excellence (NICE) has issued final guidance recommending National Health Service use of US pharma giant Merck & Co's (NYSE: MRK) Simponi (golimumab) as an option for treating rheumatoid arthritis in specific circumstances where previous treatments have not worked. 23 June 2011
Generics
In its annual report for 2010 released to Canada's Parliament last week, the Patented Medicine Prices Review Board's (PMPRB) said that sales of patented drug products declined to C$12.9 billion ($13.17 billion) in 2010, a decrease of 3.4% from C$13.3 billion in 2009. 22 June 2011
Generics
The USA's Medicaid program is likely paying far more than necessary for medications and not offering patients the most effective ones available, by ignoring international evidence-based lists of safe and effective medications, according to a new study by researchers at University of California, San Francisco. 20 June 2011
Pharmaceutical
In final draft guidance published on Friday, UK drug watchdog the National Institute for Health and Clinical Excellence (NICE) recommends two treatments for multiple myeloma: USA biotech firm Celgene's (Nasdaq: CELG) Thalidomide (thalidomide) and Johnson & Johnson (NYSE: JNJ) subsidiary Janssen-Cilag's Velcade (bortezomib). The NICE issued a positive draft guidance on both drugs earlier this month (The Pharma Letter June 3). 20 June 2011
Pharmaceutical
The UK's drug watchdog body the National Institute for Health and Clinical Excellence (NICE) last week issued draft guidance suggesting that GlaxoSmithKline's (LSE: GSK) epilepsy drug Trobalt (retigabine) and USA-based The Medicine Company's (Nasdaq: MDCO) heart drug Angiox (bivalirudin) should be available for use on the National Health Service. 20 June 2011
Biotechnology
Orphan drugs are a rapidly expanding subsector of the pharmaceuticals industry. Martina Ochel, chief executive of Genzyme and acting chairman of vfa bio, the biotechnology branch of the German pharmaceutical association the VFA, noted last week that more and more pharma companies, notably in biotech, are working on developing new drugs for rare diseases. 17 June 2011
Pharmaceutical
Several pharmaceutical majors, including the UK's GlaxoSmithKline (LSE: GSK), US giants Merck & Co (NYSE: MRK) and Johnson & Johnson (NYSE: JNJ) and France's Sanofi (Euronext: SAN) have agreed to cut prices for their vaccines in the developing world through the international public/private partnership, the GAVI Alliance. 7 June 2011
Generics
In the framework of the European Commission consultation of the possible revision of the directive on the transparency of measures regulating the pricing of medicinal products, the European Public Health Alliance (EPHA) has developed a position paper on the consultation. 7 June 2011
Generics
The UK's Office of Fair Trading (OFT) has published an evaluation of its 2001 abuse of dominance case against Napp Pharmaceuticals. The report finds increased competition in the sustained-release morphine (SRM) market over the past decade, following the OFT's intervention. Sustained release morphine is used to manage severe pain and commonly used in the treatment of cancer-related pain. 7 June 2011
Pharmaceutical
In a bid to increase transparency and stimulate competition to bring down the prices of vaccines needed in the developing world, UNICEF has decided to publish the prices it pays to vaccine manufacturers. 31 May 2011
Pharmaceutical
Patient access and industry competitiveness at stake in EU Transparency Directive review, says EFPIA
With the review of the European Union's Transparency Directive (Directive 89/105/EEC) gaining momentum, improving the competitive environment for pharmaceuticals and strengthening access to innovation for patients must remain core objectives in the review's next steps, says the European Federation of Pharmaceutical Industries and Associations (EFPIA), which represents the research-based drug industry. 26 May 2011
Pharmaceutical
The National Institute for Health and Clinical Excellence (NICE) has today issued final guidance recommending naftidrofuryl oxalate as an option for the treatment of people who have intermittent claudication caused by peripheral arterial disease and for whom vasodilator therapy is considered appropriate after taking into account other treatment options. 26 May 2011
Pharmaceutical
The UK's coalition government has embarked on a set of health care reforms designed to transform the country's National Health Service and, among those, the introduction of Value-Based Pricing (VBP) is set to radically change the way medicines are priced and reimbursed in the country. 25 May 2011
Pharmaceutical
The UK's drug rationing watchdog the National Institute for Health and Clinical Excellence (NICE) today issued a positive Final Appraisal Determination (FAD), recommending extended use of Swiss drug major Roche's (ROG: SIX) already blockbuster antibody MabThera (rituximab, also marketed as Rituxan) as a first-line maintenance treatment for patients with follicular lymphoma (FL). 24 May 2011
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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