Pricing, reimbursement and access
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Pharmaceutical
A new white paper authored by Bruce Pyenson and colleagues from Milliman explains why the US Institute for Clinical and Economic Review (ICER) cost-effective analyses (CEAs) will not be very useful for private payers’ medicine coverage decisions. 20 September 2018
Biotechnology
Although Novartis’ CAR-T therapy Kymriah (tisagenlecleucel-T) was accepted onto the UK’s Cancer Drugs Fund (CDF) for children with a type of leukemia, adults with diffuse large B-cell lymphoma (DLBCL) have not yet been afforded the same treatment. 19 September 2018
Generics
The Russian Ministry of Health plans to initiate talks with US biotech major Gilead Sciences on beginning production of generic versions of its sofosbuvir, marketed as Sovaldi, which is a drug for the treatment of hepatitis C, that was included in the list of vital and essential medicines in Russia for 2019, reports The Pharma Letter’s local correspondent. 17 September 2018
Pharmaceutical
The government of newly-inaugurated Australian Prime Minister Scott Morrison has announced it will invest A$48 million to list new treatments for lymphoma and multiple myeloma on the Pharmaceutical Benefits Scheme (PBS). 17 September 2018
Pharmaceutical
The USA spends about $3.3 trillion a year on health care, with about 10% of that spending for prescription drugs. Most Americans are very concerned about the high cost of prescription drugs. 14 September 2018
Biotechnology
Three patient advocacy groups in Europe are spearheading action against patents held by Gilead Sciences (Nasdaq: GILD) related to its hepatitis C drug Sovaldi (sofosbuvir). 12 September 2018
Pharmaceutical
Ahead of the European Cancer Organization’s (ECCO) European Cancer Summit 2018 in Vienna, Austria, Nathalie Moll, director general of the European Federation of Pharmaceutical Industries and Associations, reflects on the impact cancer has on people, on their families and carers and on healthcare systems. 10 September 2018
Biotechnology
Amid patient criticism of a failure to reach a deal over Ocrevus (ocrelizumab) for primary progressive multiple sclerosis (PPMS), Swiss pharma giant Roche has blamed a lack of flexibility within the system for getting drugs reimbursed on the UK’s National Health Service (NHS). 9 September 2018
Pharmaceutical
Following the recent warnings on SGLT2 diabetes drug risks from the US Food and Drug Administration, analysts suggest this could benefit Danish firm Novo Nordisk. Also on the regulatory front, Hutchison China MediTech’s approval in China of Elunate for colorectal cancer was seen as big news for the company. Last week, Japan’s Shionogi announced the launch of its thrombocytopenia drug Mulpleta in the USA, setting up a pricing war with Dova. Also of note, NHS England took a big leap into CAR-T therapy by allowing patient access to Novartis’ Kymriah. 9 September 2018
Pharmaceutical
New Zealand’s Pharmaceutical Management Agency PHARMAC has announced a major funding package involving ten medicines in seven key therapy areas through an agreement with Swiss pharma giant Novartis. 6 September 2018
Pharmaceutical
A new analysis from The Moran Company found nearly one in five hospitals in the USA marks up medicine prices 700% or more. 6 September 2018
Biotechnology
In a record 10 days after the drugs approval in Europe, NHS England has agreed that a groundbreaking new personalized CAR-T therapy can be made available to patients. 5 September 2018
Biosimilars
South Korean firm Celltrion Healthcare has called on the UK’s public healthcare provider, the National Health Service (NHS), to consider lowering the threshold for starting biologics in patients with rheumatoid arthritis (RA). 4 September 2018
Pharmaceutical
The new Morrison government in Australia has made medicines that treat rheumatoid arthritis and attention deficit hyperactivity disorder (ADHD) cheaper, with new additions to the country’s Pharmaceutical Benefits Scheme (PBS) as of September 1. 4 September 2018
Generics
Safeguarding patient access to critical medicines is a key responsibility of the US Food and Drug Administration. To continually fulfill this responsibility, the agency has recently created a working group tasked with developing a policy framework for the importation of foreign versions of sole source medicines. Sole source medicines are FDA-approved and marketed products in the US that are manufactured by only one company, writes Dr Nicola Davies in a regular FDA blog for The Pharma Letter. 3 September 2018
Pharmaceutical
Ireland is the latest European country where patients with highly-active relapsing multiple sclerosis (MS) will have access to Mavenclad (cladribine). 3 September 2018
Pharmaceutical
The Australian government has said that its establishment of an expert panel for the Life Saving Drugs Program (LSDP) will improve the scheme’s ability to provide free medicines for rare and life-threatening diseases to those who need them. 31 August 2018
Biotechnology
With both therapies already approved in the USA and backed by strong data sets, getting European health technology assessment (HTA) bodies on board over Yescarta (axicabtagene ciloleucel) and Kymriah (tisagenlecleucel) was always going to be a bigger battle than getting regulatory approval. 28 August 2018
Pharmaceutical
Sanofi Genzyme, the specialty care global business unit of French multinational pharma company Sanofi, has recently launched its multiple sclerosis (MS) drug Aubagio (teriflunomide, 14mg) in India. 28 August 2018
Biotechnology
Vertex Pharmaceuticals is still restless over the lack of a reimbursement agreement for Orkambi (lumacaftor/ivacaftor) in the UK, 1,000 days after the drug was initially green-lit by the European Medicines Agency. 24 August 2018
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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