Pricing, reimbursement and access
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Pharmaceutical
Stakeholders deliberate accessibility, debate whether pricing hinders access to health care in India
To address the burgeoning concern about the need to ensure health care access in India, ASSOCHAM organized the conference 'Access to Healthcare' in New Delhi, India, on November 17. The event brought together health experts and industry leaders to elicit their views on aspects such as affordability and outreach, health care innovations and health insurance. Health care organizations, NGOs and pharmaceutical companies shared their contributions towards the improvement of healthcare in the country. 17 November 2011
Generics
The proliferation of brand drug "co-pay coupon" promotions, which lure insured consumers from generics to more expensive brands, will increase costs by $1.1 billion in the state of Michigan, USA, over the next decade for employers, unions and state employee plans, according to new research from Visante and released by the Pharmaceutical Care Management Association (PCMA). The use of these promotions by state and local government workers alone will cost Michigan taxpayers an extra $170 million over 10 years, the report notes. 17 November 2011
Pharmaceutical
In a second negative from the UK's National Institute for Health and Clinical Excellence, in final draft guidance the NICE says it has not been able to recommend Japanese drug major Eisai's (TYO: 4523) Halaven (eribulin) for the treatment of locally advanced or metastatic breast cancer in people whose disease has progressed after at least two chemotherapeutic regimens for advanced disease. 17 November 2011
Generics
Japan has the lowest generic utilization rate of developed markets. Thus, as you might expect, Japan has the highest market share from off patent brands. Is this unique position a kind of “generic drug lag” or does it reflect fundamental market dynamics? 17 November 2011
Pharmaceutical
A report by Premier healthcare alliance incorrectly calculated the percent markup charged by small distributors in the USA, overstating the high-end by 3,804 percentage points or 521% (The Pharma Letter August 7), according to an exclusive update obtained by Pharmaceutical Commerce, a trade publication that provides news about the pharmaceutical industry. The reported error comes on the heels of the White House stating it was going to look into the profits made by small companies in the industry based on the Premier report (TPL November 1). 16 November 2011
Generics
Sergei Lisovsky, a well-known Russian senator and public figure, has put forward an initiative to make controversial amendments in the Russian Federal Law 'On the Circulation of pharmaceutical drugs in Russia,' the basic law in the Russian pharmaceutical market, which may negatively affect the Russian business of multinational pharmaceutical producers. 16 November 2011
Pharmaceutical
Japan's former Health Minister, Yoichi Masuzoe, and current leader of the New Renaissance Party, alluded to the drug pricing system during intensive deliberations at the Upper House Budget Committee held on November 11 on Japan's participation in the Trans-Pacific Trade (TPP) accord, reports Pharma Japan. 15 November 2011
Generics
A global campaign to challenge US health care major Abbott Laboratories' (NYSE: ABT) monopolistic hold on Kaletra (lopinavir+ritonavir), a critical HIV/AIDS medicine, was launched yesterday by public health groups in a dozen or so countries. The goal is to spur competition by generic drugmakers and thereby lower the medicine's price, as well as to free up its components for new and improved combination treatments. 11 November 2011
Pharmaceutical
There was negative news this morning for Anglo-Swedish drug major AstraZeneca (LSE: AZN), when the UK's the National Institute for Health and Clinical Excellence (NICE) issued its latest draft guidance saying it intends to advise the National Health Service against routinely prescribing the firm's Faslodex (fulvestrant) that can be used to delay the growth of a particular type of breast cancer. 10 November 2011
Generics
A new estimate from the USA's Congressional Budget Office (CBO) estimate finds that a bipartisan bill aimed at cutting costs by encouraging competition from generic drugs would save taxpayers nearly $4.8 billion over the next decade. 9 November 2011
Pharmaceutical
South Korea's Ministry of Health and Welfare has issued an advance notice of the legislation of detailed regulations to reform the drug-pricing system, which includes proposals to cut the prices of a wide range of pharmaceutical products by an average of 14%. 8 November 2011
Generics
The US subsidiary of Anglo-Swedish drug major AstraZeneca (LSE: AZN) yesterday launched a new savings card which allows eligible patients to get their prescription for the firm's cholesterol lowerer Crestor (rosuvastatin) for just $8 more than the average co-pay of a generic statin. Eligible patients can pay just $18 for a prescription of Crestor (up to 30 tablets), noted AstraZeneca. 7 November 2011
Generics
US Congressman Charles Bass (Republican, New Hampshire) has introduced bipartisan legislation in the House of Representatives that will encourage and incentivize states to use cost-saving generic prescription drugs in the Medicaid program, saving the program millions of dollars every year. Representatives Jo Ann Emerson (Republican, Missouri) and Peter Welch (Democrat, Vermont) are original cosponsors of Rep Bass' bill, the Affordable Medicines Utilization Act of 2011 (HR 3342). 7 November 2011
Pharmaceutical
The Indian government's new pharmaceutical pricing policy recently proposed by the Ministry of Chemicals and Fertilisers will create distortions in the market and hamper the industry's growth, some drugmakers and regulatory experts have claimed, reports the Economic Times of India. 3 November 2011
Pharmaceutical
In final draft guidance published today (November 1), the UK's drug watchdog the National Institute of Health and Clinical Excellence (NICE) has recommended German independent drugmaker Boehringer Ingelheim's Pradaxa (dabigatran), in accordance with its licensed indications, for the prevention of stroke and systemic embolism in people with atrial fibrillation. 1 November 2011
Generics
Martin Cross, chairman of Australia's Generic Medicines Industry Association (GMiA) has warned that the country's pharmaceutical industry faces the threat of demise if the federal government continues to reform the Pharmaceutical Benefits Scheme (PBS) and neglects to recognize the vital importance of this sector. 31 October 2011
Pharmaceutical
In Germany's tight market for new and existing drugs to gain reimbursement, Swiss drug major Roche (ROG: SIX) is proposing to refund hospitals and public insurers in Germany for the cost of Avastin (bevacizumab) if initial courses of the cancer drug fail to help patients, according to Michael Fitzhugh, writing in California, USA, investment bank Burrill & Co's Burrill Report last week. 31 October 2011
Pharmaceutical
In final draft guidance published today, by the UK drugs watchdog the National Institute for Health and Clinical Excellence (NICE) is recommending Swiss drug major Roche's (tocilizumab) for treating systemic juvenile idiopathic arthritis (JIA). 27 October 2011
Pharmaceutical
The UK's National Institute for Health and Clinical Excellence (NICE) issued two final guidances this morning, reversing a previous opinion on Japan largest pharma firm Takeda's Mepact (mifamurtide; The Pharma Letter October 8) and confirming its backing for National Health Service use of Anglo-Swedish drug major AstraZeneca's (LSE: AZN) blood thinner Brilique/Brilinta (ticagrelor; TPL September 16). 26 October 2011
Generics
Budget Perspectives 2012, a paper published last week by the Economic and Social Research Institute (ESRI), suggests high rates of spending on pharmaceuticals in Ireland could be attributable to the low penetration of generic drugs in the Irish market. According to the report, OECD data shows per capita spending in 2009 on pharmaceuticals in Ireland - at 1.7% of Gross Domestic Product (GDP) - was fourth highest among OECD countries after the USA, Canada and Greece. 24 October 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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