Pricing, reimbursement and access
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Generics
Providing adequate access to medicines and health care is one of the most challenging issues being faced by India today. While scientific knowledge and health care products and services have advanced exponentially over the last generation, millions of people in India still die from preventable and curable diseases because they lack access to basic medicines and medical services. 19 September 2011
Generics
US generic drugmaker Impax Laboratories (Nasdaq: IPXL) confirms that it has initiated a challenge of the patents listed in connection with UK pharma giant GlaxoSmithKline's Jalyn (dutasteride and tamsulosin hydrochloride 0.5mg/0.4 mg) capsules, indicated for the treatment of benign prostatic hyperplasia (BPH) in men with an enlarged prostate. 14 September 2011
Biotechnology
The Scottish Medicines Consortium (SMC), the equivalent of the UK's drug watchdog the National Institute for Health and Clinical Excellence (NICE) which backed the drug earlier this year (The Pharma Letter February 17), has now granted patients in Scotland access to USA-based Celgene's (Nasdaq: CELG) Vidaza (azacitidine) on the National Health Service in that country, having taken into account the benefits of a new patient access scheme. 12 September 2011
Pharmaceutical
New draft guidance from the UK's drug watchdog the National Institute for Health and Clinical Excellence (NICE) recommends the use of Daxas (roflumilast), in the context of research, as part of a clinical trial for adults with severe chronic obstructive pulmonary disease, associated with chronic bronchitis, as an add on to bronchodilator treatment for people with a history of frequent exacerbations. 9 September 2011
Pharmaceutical
In a U-turn by the UK drug watchdog, in its latest appraisal, the National Institute for Health and Clinical Excellence (NICE) has reversed its draft guidance and approved the use of Mepact (mifamurtide), from Japan's largest drugmaker Takeda (TYO: 4502), for high grade non-metastatic osteosarcoma in children, adolescents and young adults aged between two and 30 (The Pharma Letter October 8, 2010). 7 September 2011
Pharmaceutical
In new draft guidance issued this week, UK drug watchdog the National Institute for Health and Clinical Excellence (NICE) says it is not recommending the use of Erbitux (cetuximab) from Merck Serono, part of Germany's Merck KGaA (MRK: DE), Swiss drug major Roche's (ROG: SIX) Avastin (bevacizumab) and US biotech giant Amgen's (Nasdaq: AMGN) Vectibix (panitumumab) for the treatment of metastatic colorectal cancer that has progressed after first line chemotherapy. 6 September 2011
Pharmaceutical
More than 400,000 Australians will benefit from new subsidized medicines, effective September 1, as Minister for Health and Ageing Nicola Roxon announced that German drug major Merck KGaA's cancer drug Erbitux (cetuximab) and Swiss major Novartis' new multiple sclerosis treatment Gilenya (fingolimod) have been added to the Pharmaceutical Benefits Scheme (PBS). 2 September 2011
Biotechnology
As the USA's Joint Select Committee on Deficit Reduction examines options to reduce the deficit by $1.5 trillion over the next 10 years, the Pharmaceutical Care Management Association (PCMA) outlined in a letter to the committee opportunities to leverage greater use of pharmacy benefit management (PMB) tools to save more than $100 billion in prescription drug costs over that same time period. 1 September 2011
Pharmaceutical
In the USA, similar percentages of private health plan lives have formulary access to Pfizer's (NYSE: PFE) serotonin-norepinephrine reuptake inhibitor Pristiq (desvenlafaxine succinate), and Eli Lilly's (NYSE: LLY) antidepressant Cymbalta duloxetine), according to the findings of HealthLeaders-InterStudy and Fingertip Formulary. 31 August 2011
Pharmaceutical
A predictable regulatory and reimbursement environment, and a long-term policy outlook are essential if patients are to continue to have access to new medicines, Medicines Australia chief executive Brendan Shaw told a key policy conference in Canberra yesterday. 31 August 2011
Generics
Effective September 1, 2011, Germany-based BASF (BAS: XE), the world's largest chemical company, will increase the sales prices globally for all pharmaceutical excipients and generic active pharmaceutical ingredients by 10%. 30 August 2011
Pharmaceutical
There was mixed news for US drug majors Merck & Co (NYSE: MRK) and Bristol-Myers Squibb (NYSE: BMY) this week from the UK drugs watchdog the National Institute for Health and Clinical Excellence (NICE) regarding the use of the respective drugs Simponi (golimumab) and Orencia (abatacept) for use on the National Health Service. 26 August 2011
Pharmaceutical
Diabetes prescriptions now account for 8.4 per of the entire National Health Service net bill for primary care drugs in England, a new report from The NHS Information Centre shows today. The percentage increase in the total cost of prescriptions for the condition was four times that in prescription cost overall between 2005/6 and 2010/11 - taking the cost of diabetes prescribing to 725 million ($1.2 billion) in 2010/11. 24 August 2011
Pharmaceutical
An independent committee of experts that develops guidance on behalf of the UK drugs watchdog the National Institute for Health and Clinical Excellence (NICE) does not believe that a drug, which can be used to delay the growth of a particular type of advanced breast cancer, represents a good use of National Health Service resources. 24 August 2011
Pharmaceutical
UK drugs watchdog the National Institute for Health and Clinical Excellence (NICE) is asking independent German drug major Boehringer Ingelheim for more information on its product dabigatran Pradaxa) (dabigatran), its new drug for the prevention of stroke and systemic embolism in people with atrial fibrillation. 18 August 2011
Pharmaceutical
A Committee report tabled in the Australian Parliament yesterday strongly criticising the government's management of the Pharmaceutical Benefits Scheme reflects grave community concerns, said trade group Medicines Australia chief executive Brendan Shaw. 17 August 2011
Generics
As health care providers in the USA deal with record rates of drug shortages, some 'gray market" vendors are putting profits ahead of patients, offering drugs desperately needed at exorbitant price mark-ups. And in certain cases, the drugs being offered may be counterfeit, stolen, ineffective or unsafe. 17 August 2011
Generics
In a move that is likely to curb current growth prospects for the pharmaceutical industry in South Korea, the government says it plans to cut drug prices by an average of 17% starting in 2012 as part of its efforts to reduce excessive medical outlays that have become a social burden. Some 8,776 of the 14,410 drugs registered to the national health insurance system will be affected. 15 August 2011
Pharmaceutical
In a draft guidance published yesterday, UK drugs watchdog the National Institute for Health and Clinical Excellence (NICE) has asked Swiss drug major Roche (ROG: SIX) for more information on its RoActemra (tocilizumab) for treating systemic juvenile idiopathic arthritis (sJIA) in children and young people aged two years and older, where specific previous treatments have not produced an adequate response. 11 August 2011
Biotechnology
Northwest Biotherapeutics (OTCBB: NWBO.ob) yesterday reminded markets, in response to recent investor concerns about Dendreon's Provenge (sipuleucel-T), immune therapy, that NWBT's DCVax immune therapies for a broad range of cancers (including prostate, brain, ovarian and others) hold the promise, based on available data to date, of being cost effective and priced below other immune therapies while still providing substantial profit margins for the company and longer survival for patients. 11 August 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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