Pricing, reimbursement and access
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Biotechnology
In a final draft guidance issued today, (August 17), the National Institute for Health and Clinical Excellence (NICE), the UK's drug watchdog, has today (17 August) is recommending US biotech giant Amgen's (Nasdaq: AMGN) Xgeva (denosumab) as a treatment for people with bone metastases from most solid cancer tumors. 17 August 2012
Generics
Consumer groups Treatment Action Campaign and Medecins sans Frontiers have issued a call for the inclusion of fixed-dose antiretroviral (ARV) combinations purchased at reasonable prices in South Africa's new ARV tender. 16 August 2012
Pharmaceutical
Diabetes prescriptions in England have for the first time topped the 40 million level in year, a rise of nearly 50% on six years ago, Health and Social Care Information Centre (HSCIC) figures show. The net cost of diabetes drugs also rose by just under 50%in the same period, according to Prescribing for Diabetes in England: 2005/06 to 2011/12. 15 August 2012
Generics
Venezuela's national government has changed its policy with regard to the pharmaceutical sector. This year, government authorities have taken a number of steps, stripping the sector of its "priority" treatment, writes Roberto Deniz in the El Universal newspaper. 14 August 2012
Pharmaceutical
The Scottish Medicines Consortium (SMC) announced yesterday that it has accepted Johnson & Johnson (NYSE: JNJ) subsidiary Janssen's Zytiga (abiraterone acetate) for restricted use within NHS Scotland, as a treatment option for patients in Scotland with metastatic castration resistant prostate cancer (mCRPC) who have received only one prior chemotherapy regimen. 13 August 2012
Pharmaceutical
UK health care watchdog the National Institute for Health and Clinical Excellence (NICE) today (August 10) issued draft guidance requesting Swiss drug major Roche (ROG: SIX), the manufacturer of skin cancer drug Zelboraf (vemurafenib) provides further information on the use of its drug for the treatment of unresectable locally advanced or metastatic BRAF V600 mutation-positive melanoma. 10 August 2012
Pharmaceutical
In draft guidance published today (August 8) by UK drugs watchdog the National Institute for Health and Clinical Excellence (NICE) said it is not recommending National Health Service use of USA-based ophthalmic biopharma specialist Alimera Sciences' (Nasdaq: ALIM) Iluvien (fluocinolone acetonide) intravitreal implant for the treatment of chronic diabetic macular edema (DMO). 8 August 2012
Generics
Average basic premiums for Medicare prescription drug plans in the USA are projected to remain constant in 2013, according to Health and Human Services Secretary (HHS) Kathleen Sebelius. The average 2013 monthly premium for basic prescription drug coverage is expected to be $30. Average premiums for 2012 were projected to be $30 and ultimately averaged $29.67. 7 August 2012
Pharmaceutical
An uninformed, non-resident of Japan might respond to the title question as the Chairman of a major multinational pharma company did in July, comments long-time Japan industry watcher P Reed Maurer, president of International Alliances Limited. This chairman's remarks, quoted widely in Japan, were as follows: 7 August 2012
Pharmaceutical
The UK's drugs watchdog the National Institute for Health and Clinical Excellence (NICE), in draft guidance issued today (August 7), has recommended National Health Service use of independent French drugmaker Laboratoire Servier's Procoralan (ivabradine). 6 August 2012
Biotechnology
The Association of the British Pharmaceutical Industry (ABPI) and the UK Department of Health (DoH) on Friday published a joint statement on arrangements for pricing branded medicines from 2014. 6 August 2012
Generics
Due to the ever growing use of generic prescription medicines, the American health care system saved more than $1 trillion over the last decade, according to a new study released by the Generic Pharmaceutical Association (GPhA). 3 August 2012
Biotechnology
Gilead Sciences (Nasdaq: GILD), together with Mylan Laboratories, Ranbaxy Laboratories and Strides Arcolab have entered into agreements to collaborate on promoting access to high-quality, low-cost generic versions of Gilead's HIV medicine emtricitabine (FTC) in developing countries - including single tablet regimens containing emtricitabine, and fixed-dose combinations of emtricitabine co-formulated with other Gilead HIV medicines. 3 August 2012
Generics
Most of the Commonwealth of Independent States (CIS) markets do not have modern reimbursement policies, but the countries in question have recently been working in order to improve their drug policies, notes Poland-based market research firm PMR. 2 August 2012
Pharmaceutical
According to a new report issues this week by the UK's Health and Social Care Information Centre (HSCIC), just under 46.7 million prescriptions for antidepressants were dispensed in England in 2011; a 3.9 million item (9.1%) increase on 2010. 1 August 2012
Pharmaceutical
New Zealand's Pharmaceutical Management Agency PHARMAC is to fund a treatment for pre-schoolers with recurrent wheezing despite using other therapies, and for people with exercise-induced asthma. 31 July 2012
Generics
Middle-income countries are increasingly taking measures to overcome the patents that price drugs out of reach, according to a new report released last week by the international medical humanitarian organization Medecins Sans Frontieres (MSF), titled Untangling the web of antiretroviral price reductions. 29 July 2012
Pharmaceutical
Inflation figures released yesterday by the Australian Bureau of Statistics (ABS) measuring the Consumer Price Index (CPI) show that this rose 0.5% in the June quarter, for an annual rate of 1.2%. The headline annual inflation figure to June was well below the Reserve Bank of Australia's (RBA) target band of two to three per cent, but underlying inflation, which smoothes out the larger quarterly prices movements, was two per cent for the year to June. 25 July 2012
Biotechnology
In the UK, the role of assessing very high cost drugs for people who suffer with rare conditions, under the Health and Social Care Act 2012, currently managed by the Advisory Group for National Specialised Services (AGNSS), will pass to the country's main drugs watchdog, the National Institute for Health and Clinical Excellence (NICE), which has long been criticized by pharmaceutical companies for keeping expensive medicines out of the reach of National Health Service patients. 25 July 2012
Pharmaceutical
Confirming its final draft guidance last month (The Pharma Letter June 1), in final guidance published today (July 25), the UK drugs watchdog the National Institute for Health and Clinical Excellence (NICE) has recommended German drug major Bayer's (BAYN: DE) oral anticoagulant Xarelto (rivaroxaban) as an option for treating deep vein thrombosis and preventing recurrent deep vein thrombosis and pulmonary embolism in adults diagnosed with acute deep vein thrombosis (DVT). 24 July 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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