Pricing, reimbursement and access
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Pharmaceutical
As part of draconian measures to reduce its debt, the Greek government has ordered that the prices of pharmaceutical products, both branded and generics, be slashed by some 25% - effective early last month (The Pharma Letter May 6), but two companies. Denmark's Novo Nordisk (the world's largest insulin supplier) and privately-held LEO Pharma have said they will not comply, arguing that such reductions would be economically unviable and risk repercussions in other markets. 1 June 2010
Generics
Further confirming its abhorrence of deals made by originator and generic drugmakers delaying the arrival of copy medicines, the US Federal Trade Commission has filed an amicus brief in the US Court of Appeals for the Second Circuit, recommending that it hold a rehearing before all the judges ("en banc") of the ciprofloxacin (Cipro) "pay-for-delay" case. 27 May 2010
Pharmaceutical
Despite strong appeals by German drug major Bayer, as well as various cancer patient groups, the UK's National Institute for Health and Clinical Excellence (NICE) has decided, not to recommend the use of Nexavar (sorafenib) on the National Health for UK liver cancer patients with hepatocellular carcinoma (HCC), the most common form of primary liver cancer (The Pharma Letters passim). 26 May 2010
Generics
Egypt's total pharmaceutical spending has been on a steady rise, reaching a calculated $2.48 billion by the end of 2009 and forecast to rise to $4.24 billion by 2014 at an 11.4% compound annual growth rate (CAGR), according to the latest report from Business Monitor International. 26 May 2010
Pharmaceutical
In what it says is a world first, UK retailer Asda, part of the giant US Walmart, announced a commitment to sell all privately prescribed cancer treatment drugs on a permanent 'not for profit' basis potentially saving thousands of pounds for sufferers. 21 May 2010
Pharmaceutical
Improved treatment of severe epilepsy could reduce the overall cost of the condition, according to research presented at the annual meeting of the International Society of Pharmacoeconomic Outcomes Research (ISPOR) in Atlanta, Georgia, USA. 20 May 2010
Generics
Efforts by the Indian Department of Pharmaceuticals (DoP) to promote unbranded generic drugs through Jan Aushadhi (peoples drug) Stores (which supply cheaper medicines in India's state-run hospitals) received a boost this week with the state of Rajasthan government issuing guidelines to the doctors in the government hospitals to prescribe generic drugs. Some more states are expected to follow suit. 19 May 2010
Generics
A new AARP Rx Watchdog report finds that US consumers were hit with nearly 10% increases in brand name drug prices over the 12-month period ending in March of this year. The 9.7% jump in manufacturer prices for brand name drugs widely used by people in Medicare was the largest 12-month spike since the AARP, which represents US seniors, began tracking drug prices in 2002. By comparison, general inflation during the same twelve-month period remained nearly flat at 0.3%. 18 May 2010
Generics
In a move that has been described as a 'mortal blow' to Spain's pharmaceutical in some Spanish press reports, the nation's government has announced that it is cutting the prices of patented prescription drugs by as much as 23% in the hope of reducing what the public health system spends on medicines. The savings should amount to roughly 1.3 billion euros ($1.6 billion). 17 May 2010
Pharmaceutical
The MDS UK Patient Support Group and the health care professional body, the MDS UK Forum, today presented a 655-signature petition to the UK's new Prime Minister, David Cameron, asking for the same standard of care for UK patients with bone marrow diseases as that available throughout most of Europe. 17 May 2010
Pharmaceutical
Health organizations in the USA face more than 60 major regulatory deadlines over the next 10 years to meet the timetable and goals of US health reform, and the changes will create a profoundly different health care environment in which current business practices and markets may no longer be relevant, according to a new report published today by PricewaterhouseCoopers' Health Research Institute. 13 May 2010
Generics
The Irish Osteoporosis Society believes that generic drugs for osteoporosis do not treat the disease as effectively as branded drugs, and has recently sent out a letter to all members outlining its concerns about plans to introduce a scheme called "Reference Pricing and Generic Substitution" for all prescription drugs in Ireland. 12 May 2010
Pharmaceutical
As has been forecast, trade group Medicines Australia member companies today signed a historic agreement with the Commonwealth Government that will, it says, ensure a stable environment for business and continued access to new medicines for all Australians. 11 May 2010
Pharmaceutical
Under changes being made to the USA's Medicare's Low-Income Subsidy Program for Part D prescription drug costs (also known as LIS or "Extra Help") that take effect this year. Medicare beneficiaries who qualify for "Extra Help" may be eligible to pay no more than $2.50 for generic drugs and $6.30 for each brand name. These changes make it easier for people on Medicare with limited incomes to save on their drug costs. 11 May 2010
Generics
European generic drugmakers appeal to Spanish govt for measures to increase volume of copy medicines
The European Generic Medicines Association (EGA) has written to the Spanish Health and Social Policy Minister saying that price cuts must be followed by an increase in patients' access to generic medicines. 10 May 2010
Pharmaceutical
The Australian government plans to extract more savings through the Pharmaceutical Benefits Scheme, following reforms which began in 2007, and it expects to generate about A$6 billion ($5.59 billion) in savings, through exploiting the use of generic drugs once patents expire on more expensive originator medicines, reported the Sydney Morning Herald last week. 10 May 2010
Biotechnology
The European biotechnology trade group EuropaBio hosted a high-level workshop on Health Technology Assessment (HTA) at the International BIO Conference this week in Chicago, USA, highlighting the patients' needs and improving access to novel drugs. 7 May 2010
Pharmaceutical
On April 1 this year, the reference drug price system in Finland had been in place for one year. In those 12 months, Finnish society saved over 150 million euros ($199.5 million), generated through the price competition between pharmaceutical companies and the generic substitution performed at pharmacies. 5 May 2010
Pharmaceutical
Reviewing last week's US approval of Dendreon's Provenge (sipuleucel-T) for the treatment of advanced prostate cancer (The Pharma Letter April 30), Fleur Pijpers, senior oncology analyst at Datamonitor, comments: 'While a significant step forward in the treatment of cancer, it remains to be seen how frequently Provenge is used. The current standard of care is Taxotere (docetaxel)-based chemotherapy, which is comparatively easier to manufacture and administer, but is associated with significant toxicity.' 4 May 2010
Pharmaceutical
Australia's headline consumer price index (CPI) rose 0.9 per cent in the March quarter, for an annual rate of 2.9 per cent, the Australian Bureau of Statistics (ABS) said on Wednesday. The major elements driving the CPI increases were pharmaceutical prices, which rose 13.3%, vegetables, up 19.3% and the cost of electricity, up 5.9% 29 April 2010
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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