Pricing, reimbursement and access
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Generics
In the USA, the cost paid for statins (drugs to lower cholesterol) in people under the age of 65 who have private insurance continues to exceed comparable costs paid by the government in the UK by more than three fold. These results from Boston University's Boston Collaborative Drug Surveillance Program are a follow up of an ongoing comparison of prescription drug costs between the USA and UK. The initial results reported on relative drug costs in 2005. The current updated results for 2009 appear this week in the journal Pharmacotherapy. 4 November 2012
Biotechnology
US drug major Eli Lilly (NYSE: LLY) has announced a $140 million expansion to the company's Indianapolis insulin manufacturing operations. The 80,000-square-foot expansion, which will enable the manufacturing of insulin cartridges to meet the growing diabetes demand in the USA, represents one of the most significant investments in Lilly's USA-based manufacturing operations in the past decade. 2 November 2012
Pharmaceutical
The UK's drugs watchdog the National Institute for Health and Clinical Excellence (NICE) this morning (November 2) issued new final draft guidance recommending two new treatments for advanced malignant melanoma: US drug major Bristol-Myers Squibb (NYSE: BMY) Yervoy (ipilimumab) and Switzerland-based Roche's (ROG: SIX) Zelboraf (vemurafenib). 1 November 2012
Biotechnology
The UK Ethical Medicines Industry Group (EMIG) has welcomed the House of Commons Health Select Committee's inquiry into the drugs watchdog the National Institute for Health and Clinical Excellence (NICE). This is a timely opportunity for the SME specialist bio-pharmaceutical sector to reflect on the workings of the medicines regulator, in particular its future role in supporting the new commissioning environment and how the value of innovative new medicines will be assessed, says the EMIG. 31 October 2012
Generics
In most countries, promoting generics to save money in the health care budget is considered good policy. There is no downside to this position. Practitioners are not criticized, in fact they are lauded for taking on pharma companies who allegedly charge outrageous prices for branded drugs, according to long-time Japanese industry watcher P Reed Maurer, president of International Alliances Limited. 30 October 2012
Pharmaceutical
More than 110,000 Australians will benefit from better access to affordable medicines following the Australian government's approval of new and extended listings for medicines on the Pharmaceutical Benefits Scheme (PBS). 28 October 2012
Biotechnology
New guidance published today (October 24) by the UK's drugs watchdog the National Institute for Health and Clinical Excellence (NICE) commits the National Health Service to funding US biotech firm Amgen's (Nasdaq; AMGN) Xgeva (denosumab) for cancer patients whose disease has spread from most solid tumour sites (eg, breast, lung, liver) to their bones, known as bone metastasis. 24 October 2012
Pharmaceutical
Two new reports published this week have found that medicine prices in the UK are firmly under control. The first, published today by OHE Consulting for the Association of the British Pharmaceutical Industry (ABPI), has shown that UK branded medicine prices continue to be amongst the lowest of developed nations. 23 October 2012
Pharmaceutical
The Cyprus Association of Research and Development Pharmaceutical Companies (KEFEA) says it believes that the change in the pricing policy for medicines, as has been approved by Cabinet, ensures, under the circumstances, the continued availability of the majority of medicines on the Cypriot market. 21 October 2012
Biotechnology
Pharmaceutical brand teams design their global launch sequencing strategies to mitigate the risks associated with reference pricing, a top challenge at many drug companies, according to a new study by Cutting Edge Information. 18 October 2012
Pharmaceutical
The Irish Pharmaceutical Healthcare Association (IPHA) this week announced a very significant new supply agreement with the country's Department of Health and the Health Service Executive, which will ensure that new medicines are made available to Irish patients, by reducing the price of hundreds of commonly used medicines by an average of 10%. 17 October 2012
Generics
In a move that was announced in early September but which just came to light last week, the government of Indonesia has issued an order overriding multinational drugmakers' patents on seven important drugs for the treatment of HIV and hepatitis B, allowing local drug companies to make cheap and affordable versions. 15 October 2012
Pharmaceutical
In a little more than a year after its launch, a sizeable proportion of surveyed US oncologists indicate they are prescribing Johnson & Johnson/Janssen Biotech/Janssen-Cilag's Zytiga (abiraterone), according to its approved indication, according to a new report from Decision Resources. 14 October 2012
Biotechnology
The European Federation of Pharmaceutical Industries and Associations (EFPIA) welcomes the European Commission Communication on industrial policy as an important step to seeking to secure the competitiveness of the European Union pharmaceutical industry and protect access to medicines for all of Europe's citizens. 12 October 2012
Pharmaceutical
PHARMAC, the pharmaceutical management agency in New Zealand, has made decisions on the proposal for various products from Swiss drug major Roche (ROG: SIX). This was the subject of a consultation letter dated 30 July 2012. 11 October 2012
Pharmaceutical
Trade group Pharma Industry Finland (PIF) reports that it has submitted its written opinion on the reform of the medicines reimbursement system to the Finnish Ministry of Social Affairs and Health. The opinion focuses on the savings proposed in the medicines reimbursement expenditure in the context of the government's austerity measures. 7 October 2012
Biotechnology
UK drugs watchdog the National Institute for Health and Clinical Excellence (NICE), in new draft guidance issued this morning (October 5) has recommended Swiss drug major Novartis' (NOVN: VX) Lucentis (ranibizumab) as a National Health Service option for treating visual impairment caused by diabetic macular edema (DME). 5 October 2012
Generics
Ukraine may restrict imports of foreign drugs to the country, the quality of which do not comply with international standards, according to the press-service of the Ukrainian government. In addition, according to sources close to the government, this should make drugs more affordable to local population, the purchase power of which remains low, reports The Pharma Letter's Russian correspondent. 4 October 2012
Biotechnology
New Zealand's national pharmaceuticals funding agency PHARMAC is seeking feedback on a proposal in relation to bosentan (Tracleer) as a result of a provisional agreement with the local subsidiary of Actelion (SIX: ATLN), Europe's largest biotechnology firm which developed and markets the pulmonary arterial hypertension (PAH) drug. 1 October 2012
Generics
India's Group of Ministers (GoM), headed by Agriculture Minister Sharad Pawar, yesterday finalized the pharmaceutical pricing policy under which 348 essential drugs will come under price control of the government, according to a report by India's moneycontrol.com. 28 September 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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