Pricing, reimbursement and access
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Pharmaceutical
AARP prescription drug Price Watch report shows cost of medicines vastly outpacing rate of inflation
The latest Rx Price Watch Report from the American Association of Retired Persons (AARP) has found that the retail price for widely-used brand-name prescription drugs has increased faster than the rate of inflation between 2006 and 2013. 24 November 2014
Pharmaceutical
The discount negotiated by the French government on hepatitis C drug Sovaldi (sofosbuvir), produced by US biotech major Gilead Sciences, makes it the ‘lowest price in Europe,’ according to the country’s health ministry. 21 November 2014
Pharmaceutical
Japanese drug major Eisai has expressed “utmost disappointment” that the German Federal Joint Committee (G-BA) has decided that the additional benefit for its new generation anti-epileptic drug (AED) Fycompa (perampanel) has not been proven. 6 November 2014
Pharmaceutical
Following a benefit:cost re-assessment, the German Institute for Quality and Efficiency in Health Care has concluded that an additional benefit exists of Japanese drug major Eisai’s Halaven (eribulin). 4 November 2014
Pharmaceutical
US Pharma major Bristol-Myers Squibb has recently revealed a commercial strategy for sales of its new direct-acting antiviral (DAA) hepatitis C drug daclatasvir – trade name Daklinza - in developing countries. 3 November 2014
Pharmaceutical
Swedish drugmaker Medivir says it has entered into an agreement with Swedish county councils regarding the treatment of hepatitis C with Olysio (simeprevir). 31 October 2014
Generics
Atlantic Canadians will save an estimated C$560 million ($500 million) through an unprecedented three-year agreement reached between Canada's provinces and territories and the generic pharmaceutical industry, Jim Keon, president of the Canadian Generic Pharmaceutical Association (CGPA), said today. 30 October 2014
Biosimilars
The European Biosimilars Group – a sector group of the European Generic medicines Association, together with the Polish Generic Medicines Association organized a multi-stakeholder event in Warsaw this week gathering patient and hospital representatives, health economists, prescribers, industry delegates and research institutes to discuss the challenges and opportunities offered by biosimilar medicines. 29 October 2014
Pharmaceutical
The Russian government is considering introducing state regulation of prices for drugs in the country, reports The Pharma Letter’s Russia correspondent. 27 October 2014
Pharmaceutical
According to the findings of an early benefit assessment under the German Act on the Reform of the Market for Medicinal Products (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) says that no added benefit was proven for UK pharma major GlaxoSmithKline's Anoro Ellipta (vilanterol/umeclidinium). 21 October 2014
Pharmaceutical
UK health costs watchdog the National Institute for Health and Care Excellence (NICE) has issued new final draft guidance proposing to recommend Swiss pharma major Novartis’ Glivec (imatinib) people who have had a gastro-intestinal stromal tumor (GIST) removed and who are at high risk of the cancer recurring. 17 October 2014
Biotechnology
As was largely expected, the US Food and Drug Administration on Friday approved biotech firm Gilead Sciences’ Harvoni (ledipasvir and sofosbuvir) to treat chronic hepatitis C virus (HCV) genotype 1 infection. 12 October 2014
Generics
Letters have been sent to 14 drug manufacturers, including several major Indian firms, requesting information about the escalating prices they have been charging for generic drugs in the USA by Congressmen. 10 October 2014
Pharmaceutical
Cancer care is advancing, but policymakers and the cancer care community must find ways to make it more affordable, according to an article published in the October issue of Health Affairs by Lee Newcomer, senior vice president of oncology at US health care provider UnitedHealthcare. 9 October 2014
Biotechnology
US biopharma company Incyte says that it has earned a $60 million milestone payment from Swiss pharma major Novartis related to reimbursement of Jakavi (ruxolitinib) in Europe. 2 October 2014
Pharmaceutical
New Zealand’s Pharmaceutical Management Agency PHARMAC has announced the approval of an agreement with Bayer New Zealand, the local subsidiary of German pharma major Bayer for the listing and supply of Jadelle (levonorgestrel). 26 September 2014
Pharmaceutical
The median price of the top 100 drugs has skyrocketed from $1,260 in 2010 to $9,400 in 2014, representing a seven-fold increase, according to Evaluate’s new report, titled Budget-busters: The Shift to High-Priced Innovator Drugs in the USA. 26 September 2014
Biotechnology
The UK’s drug watchdog the National Institute for Health and Care Excellence (NICE) has today issued final guidance recommending US biotech major Celgene’s Revlimid (lenalidomide) as an option for treating some people with myelodysplastic syndromes on the National Health Service. 24 September 2014
Biosimilars
As physicians continue to adopt a more individualized approach to patient care, branded type 2 diabetes therapies continue to experience increased use despite attempts by payer and reimbursement authorities to limit use of these more expensive drugs, new research suggests. 19 September 2014
Biotechnology
The Pharmaceutical Benefits Advisory Committee (PBAC) has recommended to the Australian government that Soliris (eculizumab) - the new and novel treatment for atypical hemolytic uremic syndrome (aHUS) from US drugmaker Alexion Pharmaceuticals - be subsidized on the Pharmaceutical Benefits Scheme (PBS). 18 September 2014
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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