Pricing, reimbursement and access
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Pharmaceutical
In an early benefit assessment under the Act on the Reform of the Market for Medicinal Products (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) examined the clot-inhibiting drug Eliquis (apixaban) from USA-based Pfizer (NYSE: PFE) and Bristol-Myers Squibb (NYSE: BMY), finding proof of minor added benefit for adult patients who had undergone hip replacement: symptomatic clots in the deep veins of the leg occurred less frequently with apixaban treatment than with the comparator therapy. 2 April 2012
Generics
On April 1, 2012, in Australia, publicly funded generic medicines on the Pharmaceutical Benefits Scheme (PBS) underwent an overnight average minimum 23% price reduction. This is the largest single price cut in the PBS history. The impact of this reform will be extensive and will deliver substantial savings to government, notes the Australian Generic Medicines Industry Association (GMiA). 2 April 2012
Generics
The next few years will spell considerable growth and change for the Indian health insurance industry, as providers rush to respond to calls for reference pricing and the rising demand for drugs, according to a new report by health care intelligence experts GBI Research. 1 April 2012
Pharmaceutical
Following the receipt of further evidence from Bayer HealthCare, a unit of German drugmaker Bayer (BAY: DE), of the clinical and cost effectiveness of its Xarelto (rivaroxaban), UK drug watchdog the National Institute of Health and Clinical Excellence (NICE) this morning published final draft guidance recommending the drug as an option for the prevention of stroke and systemic embolism in people with atrial fibrillation. 30 March 2012
Pharmaceutical
Depending on the tumor type, around one-quarter to one-third of surveyed Brazilian and Mexican oncologists' patients who are eligible for treatment with angiogenesis inhibitors do not receive such therapy, primarily because of reimbursement and/or budget-related factors, according to a new report from advisory firm Decision Resources. 28 March 2012
Pharmaceutical
In final draft guidance issued this morning, UK drugs watchdog the National Institute for Health and Clinical Excellence ( NICE) has recommended National Health Service use of Tasigna (nilotinib) and Glivec (imatinib), both made by Swiss drug major Novartis (NOVN: VX), for the first line treatment of chronic myeloid leukemia (CML). 22 March 2012
Pharmaceutical
In the USA, Citizens for Responsibility and Ethics in Washington (CREW), the National Legislative Association on Prescription Drug Prices (NLARx), the Campaign for America's Future (CAF), and the US Public Interest Research Group (US PIRG) have issued a call for the Federal Trade Commission to immediately investigate the vaccine bundling practices of Sanofi Pasteur and Merck & Co (NYSE: MRK), which make it harder for pediatricians to use the best vaccines for children. 21 March 2012
Pharmaceutical
As the second anniversary of the US Affordable Care Act approaches, new data shows that more than 5.1 million seniors and people with disabilities on Medicare saved over $3.2 billion on prescription drugs because of the new health care law, Kathleen Sebelius, Secretary of the US Department of Health and Human Services (HHS), announced yesterday. 20 March 2012
Pharmaceutical
The Pharmaceutical Management Agency of New Zealand, PHARMAC, has announced reaching agreement with US drug major Eli Lilly (NYSE: LLY) to approve listing of its drug Effient (prasugrel) for use by patients allergic to clopidogrel, the blockbuster blood thinner Plavix from Sanofi. 19 March 2012
Pharmaceutical
USA-based InterMune (Nasdaq: ITMN) says that the German Federal Joint Committee (G-BA) has announced its decision granting the additional benefit of Esbriet (pirfenidone) in adults for the treatment of mild-to-moderate idiopathic pulmonary fibrosis (IPF), with the news sending its shares price 15% higher to $17 in morning trading yesterday. 16 March 2012
Pharmaceutical
There was good news from the UK drugs watchdog the Institute for Health and Clinical Excellence (NICE) this morning (March 16), when the agency announced recommendations for multiple sclerosis drug Gilenya (fingolimod) from Swiss drug major Novartis (NOVN: VX) reversing an earlier decision - and hepatitis C agent Incivo (telaprevir) from a unit of US health care giant Johnson & Johnson (NYSE: JNJ). 16 March 2012
Pharmaceutical
In final guidance published today (March 15), the UK drug watchdog the National Institute of Health and Clinical Excellence (NICE) has recommended Pradaxa (dabigatran), from independent German drug major Boehringer Ingelheim, as an option for the prevention of stroke and systemic embolism in people with atrial fibrillation. 15 March 2012
Pharmaceutical
The amendments envisaged in the European Union legislation could accelerate the price and reimbursability examination process in Finland, says the local trade group Pharma Industry Finland (PIF), commenting on the recent European Commission announcement of proposals for faster access to medicines (The Pharma Letter March 2). 13 March 2012
Pharmaceutical
Until recently, pharmaceutical companies could set prices for new drugs in Germany. But now their "monopoly is broken," says the journal Pharmazeutische Zeitung. The government Act on the Reform of the Market for Medicinal Products (AMNOG) has erected a series of hurdles for drugmakers hoping to bolster revenues with new drugs and thus made the German regulatory environment a great deal more arduous and uncertain for the industry. 13 March 2012
Pharmaceutical
UK health care price watchdog the National Institute for Health and Clinical Excellence (NICE), which is currently reviewing Xarelto (rivaroxaban) from German drug major Bayer (BAY: DE) for the treatment of deep vein thrombosis (DVT) and preventing recurrent DVT and pulmonary embolism (PE) following an acute DVT in adults, has asked the company to provide further evidence relating to the drug's clinical and cost effectiveness. 13 March 2012
Pharmaceutical
As scientists continue making breakthroughs in personalized cancer treatment, delivering those therapies in the most cost effective manner has become increasingly important. Now researchers at the University of Colorado School of Medicine, USA, have identified new ways of doing just that, allowing more patients to benefit from this revolution in cancer care. 12 March 2012
Pharmaceutical
UK drug watchdog the National Institute for Health and Clinical Excellence (NICE) has today (March 9) issued final draft guidance recommending Victrelis (boceprevir) in combination with peginterferon alfa and ribavirin, as an option for the treatment of genotype 1 chronic hepatitis C in adults with compensated liver disease. 9 March 2012
Generics
A look at US retail prices for a combined set of widely used prescription drugs finds the cumulative change in prices from 2005 through 2009 was almost double the rate of inflation. The not-for-profit organization AARP Public Policy Institute (PPI) examination of widely used drugs - brand name, specialty and generic - found that even with substantial decreases in the prices of generic drugs, the average annual cost of drug therapy continued to rise. 8 March 2012
Pharmaceutical
The Pharmaceutical Management Agency of New Zealand, PHARMAC, says it is funding two new targeted cancer medicines following an agreement with UK pharma giant GlaxoSmithKline (LSE: GSK). 5 March 2012
Generics
Prescription drug spending in the USA reached $307 billion in 2010 - an increase of $135 billion since 2001 - and comprised approximately 12% of all health care spending in the country, according to a new report for the US Government Accountability Office (GAO). 4 March 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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