Pricing, reimbursement and access
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Pharmaceutical
UK drugs watchdog the National Institute for Health and Clinical Excellence (NICE) has published draft guidance today (February 1) on the use of Swiss drug major Roche's (ROG: SIX) Avastin (bevacizumab) for treating advanced ovarian cancer that has returned six months or more after initial treatment with platinum-based chemotherapy (platinum-sensitive disease). 1 February 2013
Pharmaceutical
The UK drugs watchdog the National Institute for Health and Clinical Excellence (NICE), in a final draft guidance published today (January 25), the drugs watchdog has recommended National Health Service use of two treatments for lung infection in cystic fibrosis patients: USA-based Forest Laboratories' (NYSE: FRX) Colobreathe (colistimethate sodium) and Swiss drug major Novartis' (NOVN: DE) Tobi Podhaler (tobramycin) dry powders for inhalation (DPI). 24 January 2013
Biotechnology
The UK government's plans to overhaul the National Health Service pricing system for new drugs are poorly explained, leaving clinicians, patients and the drug industry in the dark over how the changes will work, according to a highly critical report released yesterday by Members of Parliament sitting on the House of Commons health select committee. They said it was "unacceptable" that proposed value-based pricing changes were still not explained despite government plans to implement the measures in less than 12 months. 17 January 2013
Generics
A new study published in the Annals of Internal Medicine that provides a snapshot of a simplified cost/benefit analysis of the potential economic savings gained by use of generic antiretroviral therapy to treat people with HIV/AIDS versus the slightly reduced efficacy of the drugs prompted advocates from the USA-based AIDS Healthcare Foundation (AHF) to reiterate its call on Gilead Sciences, a key maker of branded AIDS drugs, to reduce pricing on its key AIDS drugs such as Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate).and Stribild (elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate), as patents expire. 16 January 2013
Biotechnology
Increasing numbers of pharmaceutical companies are seeking to redefine their relationships with patients, recasting their companies as more patient-centric, according to PatientView's latest annual review of corporate reputation of the pharmaceutical industry during 2012, which found that patients' trust in drugmakers is declining. 14 January 2013
Pharmaceutical
The drug aclidinium bromide, trade names Eklira, Bretaris from Spain's largest drugmaker Almirall (ALM: MC), which has been approved in the European Union since October 2012 for widening the narrowed airways of adults with chronic-obstructive pulmonary disease (COPD), has been the subject of a German Institute for Quality and Efficiency in Health Care (IQWiG) examination of its added benefit of the drug pursuant to the Act on the Reform of the Market for Medicinal Products (AMNOG). 10 January 2013
Generics
The biggest non-event in the Japan health care market during 2013 will be no reimbursement price reductions, comments P Reed Maurer, long-time Japanese pharma industry watcher and president of International Alliances Limited (IAL). In fact, the next price revisions will not occur until April 2014. 3 January 2013
Pharmaceutical
In accordance with the decision taken at the Danish Association of the Pharmaceutical Industry (Lif) budget meeting on December 13, 2012, the Ministry of Health and Prevention, the Danish Regions and the Lif have now signed a new price-cap and price reduction agreement for hospital medicine. 20 December 2012
Pharmaceutical
The Brazilian market for atrial fibrillation will increase at a rate of 31% per year from 2011 to 2016, according to health care advisory firm Decision Resources' The Emerging Markets report titled Atrial Fibrillation in Brazil, which finds that this dramatic growth will be fueled by an increased drug-treated population and the proliferation of treatment alternatives for stroke prophylaxis in atrial fibrillation. 19 December 2012
Generics
More transparency and precise time limits for decision-making on pricing and reimbursement of medicines are needed to improve patients' access to affordable treatments and prevent barriers to getting medicines to market, said Environment and Public Health Committee Members of the European Parliament (MEPs) voting on the Transparency Directive 2012/0035(COD) in the Environment, Public Health and Food Safety Committee draft legislation on Tuesday. 19 December 2012
Pharmaceutical
In the assessment report by the German Institute for Quality and Efficiency in Health Care (IQWiG) on Japanese drug major Eisai's (TYO: 4523) Fycompa (perampanel), published yesterday on the Federal Joint Committee (G-BA) web site, the institute did not attest an additional benefit for the epilepsy drug. 19 December 2012
Pharmaceutical
A report into anticoagulation therapies released yesterday by Australian Minister for Health Tanya Plibersek found more work was needed before new oral anticoagulants (NOACs) such as Pradaxa (dabigatran), from Independent German drug major Boehringer Ingelheim, could be listed on the Pharmaceutical Benefits Scheme (PBS). 19 December 2012
Biotechnology
The UK drugs watchdog the National Institute for Health and Clinical Excellence (NICE) has published draft guidance (18 December 18) on the use of Swiss drug major Roche's blockbuster cancer drug Avastin (bevacizumab), saying it does not recommend the drug when used with paclitaxel and carboplatin for people with advanced disease, as a cost-effective treatment for the National health Service. 18 December 2012
Pharmaceutical
Once again, the German Institute for Quality and Efficiency in Health Care (IQWiG) has found no added benefit for German independent drugmaker Boehringer Ingelheim and US partner Eli Lilly's (NYSE: LLY) Trajenta (linagliptin; The Pharma Letter January 10), which has been approved since August 2011 to improve blood glucose control in adults with type 2 diabetes. 13 December 2012
Pharmaceutical
A study reported by broadcaster Deutsche Welle on the business practices of drug companies Bayer, Baxter and Boehringer Ingelheim in Brazil criticized their pricing and marketing strategies as well as choice of drugs. The companies reject the allegations. 11 December 2012
Pharmaceutical
Japanese drug major Eisai's (TYO: 4523) Fycompa (perampanel), a treatment for partial epilepsy, is now approved for use in Scotland after a decision by the drugs watchdog the Scottish Medicines Consortium (SMC). It is approved for use as a second-line adjunctive treatment in patients with refractory partial-onset epilepsy. 11 December 2012
Pharmaceutical
The Association of the British Pharmaceutical Industry (ABPI) yesterday expressed major concern on behalf of its member companies that the drugs watchdog, the National Institute for Health and Clinical Excellence (NICE), decisions are failing to recognize the progressive and iterative nature of medical discovery. Several desperately needed medicines have been rejected by NICE recently, the lobby group noted. 7 December 2012
Pharmaceutical
UK drugs watchdog the National Institute for Health and Clinical Excellence (NICE) has today (December 6, 2012) opened a consultation on draft guidance which recommends US pharma major Bristol-Myers Squibb's (NYSE: BMY) Orencia) for rheumatoid arthritis after conventional disease-modifying anti-rheumatic drugs (DMARDs) have failed, reversing a negative decision last year on National Health Service use of the drug which is deemed not cost effective (The Pharma Letter March 31, 2011). 6 December 2012
Generics
According to a study recently released by the Soros Foundation Moldova, the Moldavian pharmaceutical market needs reorganization. The study, which is reported by Sebastian Gensior writing on europe-health-care-eu, finds that there are certain market distortions created by excessive regulation and a lack of functional mechanisms that may cause import monopolies. 5 December 2012
Pharmaceutical
Global insulin market leader Novo Nordisk (NOV: N) of Denmark revealed this morning that its Ryzodeg (insulin degludec/insulin aspart) has passed the review by the First Committee on Drugs of Japan's Pharmaceutical Affairs. The remaining step in the regulatory process is an approval from the Ministry of Health, Labour and Welfare. 3 December 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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