Pricing, reimbursement and access
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Generics
Pharmaceutical analysts in India and the UK believe cost-based pricing is not suitable to safeguard the interests of patients as well as the pharmaceutical industry. In their opinion, the regulatory authorities have wrongly been focusing on price controls in the belief this will boost access to health care. But the experience of other nations, and India's past experience, indicates the desired outcome will not be achieved via price caps because multiple hurdles hinder health care access in India - and it is these that need to be addressed. 25 May 2012
Generics
Scientists are reporting development of a new, higher-yield, two-step, less costly process that may ease supply problems and zigzagging prices for the raw material essential for making the mainstay drug for malaria. That disease sickens 300-500 million people annually and kills more than 1 million. 24 May 2012
Pharmaceutical
There was good news today (May 23) for German drug major Bayer (BAYN: DE), when the UK's drug watchdog, the National Institute for Health and Clinical Excellence (NICE) published final guidance recommending National Health Service use of its anticoagulant Xarelto (rivaroxaban) as an option for the prevention of stroke and systemic embolism in people with atrial fibrillation. 23 May 2012
Biotechnology
Pharmaceutical companies that are first to meet health care's new expectations of value could have an advantage in the competition for market share and brand differentiation, according to a report published today by the Health Research Institute (HRI) at PricewaterhouseCoopers US. Physicians, health insurers and patients now want to know how well a drug will work and affect total medical costs. Yet an HRI survey of health plan executives finds the information currently provided by the biopharmaceutical industry no longer suffices. 20 May 2012
Biotechnology
By 2020, eight countries in the European Union could save a cumulative total of between 11.8 billion euros ($15.2 billion) and 33.4 billion euros ($4.38 billion) on their health care spending through the use of biosimilar medicines. Faster access and interchangeability between reference drugs and biosimilars is seen as critical to realizing savings. 16 May 2012
Pharmaceutical
UK drugs watch dog the National Institute for Health and Clinical Excellence (NICE) has reversed an earlier negative decision (The Pharma Letter February 2), issuing new draft guidance recommending the National Health Service use of Zytiga (abiraterone), from Johnson & Johnson's (NYSE: JNJ) Janssen unit, in combination with prednisone or prednisolone for the treatment of castration-resistant metastatic prostate cancer that has progressed after one docetaxel-containing therapy. 16 May 2012
Pharmaceutical
Confirming previous negative guidance (The Pharma Letter January 12), UK drugs watchdog the National Institute for Health and Clinical Excellence (NICE), has today (11 May) published final guidance in which it recommends against the routine National Health Service use of French pharma major Sanofi's (Euronext: SAN) Jevtana (cabazitaxel) in combination with prednisone or prednisolone as a second line treatment for prostate cancer. 11 May 2012
Biotechnology
In light of the upcoming FDA guidance for biosimilar approval, Novation, health care supply chain expertise and contracting company, has released a white paper, "Biosimilars - FDA Guidance Update," to help hospitals and health care providers better understand the key components of the Food and Drug Administration's draft guidance documents and suggested next steps. 10 May 2012
Pharmaceutical
Outside observers have long predicted the mandated price reductions of drugs will kill the Japanese pharmaceutical industry, reduce the motivation to introduce new drugs, and stifle innovation, says P Reed Maurer, president of International Alliances Limited, and a pharma industry watchers who has lived and worked in Japan since 1970. 10 May 2012
Pharmaceutical
Having received further previously requested data from Swiss drug major Roche (ROG: SIX), the UK drugs watchdog the National Institute for Health and Clinical Excellence (NICE) has today issued final draft guidance recommending the company's Tarceva (erlotinib) as an option for the treatment of people with locally advanced or metastatic EFGR mutation-positive non-small-cell lung cancer (NSCLC) under the National Health Service (The Pharma Letter February 17). 10 May 2012
Biotechnology
The German Institute for Quality and Efficiency in Health Care (IQWiG) in the past few days issued a mixed batch of opinions for backing the use three drugs under Germany's new legislation, the Act on the Reform of the Market for Medicinal Products (AMNOG). 9 May 2012
Pharmaceutical
One-year results from the UK.'s Inhibition of VEGF in Age-related Choroidal Neovascularisation (IVAN) study were presented at the Association for Research and Ophthalmology meeting being held in Fort Lauderdale, Florida, USA , which showed that patients in Britain treated with the cancer drug Avastin (bevacizumab) did just as well as those treated with Lucentis (ranibizumab), which is marketed by Swiss drug major Novartis (NOVN: VX) and is approved for this indication, while Avastin is used off-label. 8 May 2012
Generics
Indian drugmaker Cipla (BSE: 500087) has slashed the prices of certain life-saving cancer drugs used in the treatment of brain, lung and kidney cancer by up to 76%, according to domestic media reports. 4 May 2012
Pharmaceutical
The Pharmaceutical Management Agency of New Zealand, PHARMAC, is seeking feedback on a proposal to fund NovoMix 30 FlexPen and NovoSeven RT and to amend the listing for Glucagen Hypokit from July 1, 2012 through a provisional agreement with the supplier, NovoNordisk Pharmaceuticals, the local subsidiary of Danish insulin giant Novo Nordisk (NOV: N). 2 May 2012
Generics
The Ukraine Ministry of Health and domestic producers of pharmaceuticals have signed a memorandum of understanding to regulate the prices of hypertension and diabetes drugs, reports Sebastian Gensior, writing on the europe-health-care-eu web site. 1 May 2012
Biotechnology
After years of consistent growth, the German biopharmaceuticals market came to a juddering halt last year. Turnover stagnated at around 5.4 billion euros ($7.13 billion), noted Frank Mathias, chairman of VFA bio and chief executive of biotech firm MediGene, as he introduced this year's report on medicinal biotechnology in Germany compiled by Boston Consulting Group. 30 April 2012
Generics
The economic recession has been a double-edged sword for the international generic drugs business. Driven by the need to control costs, the use of generic drugs has grown considerably in recent years, even in markets where traditionally they have not been favored. 29 April 2012
Pharmaceutical
There was a batch of bad news emanating from the US drugs watchdog the National Institute for Health and Clinical Excellence (NICE) has today (April 27) for UK pharma major GlaxoSmithKline (LSE: GSK) regarding its lupus drug Benlysta (belimumab) and its breast cancer agent Tyverb (lapatinib, as well as for Switzerland's Roche (ROG. SIX) on its Herceptin (trastuzumab). 27 April 2012
Generics
In Poland, the recent procurement problems of cancer drugs is far from solved, writes Sebastian Gensior on the europe-health-care.eu web site. While most of the hospitals received urgently needed drugs this week, health care experts argue that there will be problems throughout the year. The problems emerged when Swiss pharma major Novartis (NOVN: VX) generics drug unit Sandoz's Austrian production facilities faced problems in early April. 26 April 2012
Pharmaceutical
Speaking today at the annual meeting of the Association of the British Pharmaceutical Industry (ABPI), its chief executive, Stephen Whitehead, told company leaders that the UK must prioritize patient access to lifesaving medicines, and ensure proper funding for the development of new, innovative treatments, or run the risk of failing to meet the demands of tackling diseases in the future. 25 April 2012
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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