Pricing, reimbursement and access
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Pharmaceutical
Despite a narrow focus on drug spending, roughly 30% of every dollar spent on health care in the USA can be attributed to hospitals. 1 September 2023
Biotechnology
An Expert View from Luigi Angelillo and Cecile can Steen from Santen, and Kirsty Ross-Stewart, Justus Dehnen and Walter Colasante from the global consulting firm CRA. 31 August 2023
Pharmaceutical
Japanese drugmaker Taiho Pharmaceutical, a subsidiary of Otsuka Holdings, has announced that its FGFR inhibitor Lytgobi (futibatinib) has now been listed on the National Health Insurance (NHI) reimbursement price list. 30 August 2023
Pharmaceutical
Today, the US Centers for Medicare & Medicaid Services (CMS) has for the first time selected 10 drugs for negotiation. Seniors paid $3.4 billion in out-of-pocket costs for these drugs in 2022, the CMS stated. 29 August 2023
Pharmaceutical
The list of companies and groups that are suing the US government over its Medicare price-setting policies continues to grow. 25 August 2023
Pharmaceutical
The trade body for the British pharmaceutical industry has issued a response to a report from the Journal of Royal Society of Medicine, which raised concerns about the Innovative Medicines Fund. 25 August 2023
Generics
The US Department of Justice (DoJ) yesterday announced deferred prosecution agreements (DPAs) resolving criminal antitrust charges against the US subsidiaries of Israel’s Teva Pharmaceutical Industries and India’s Glenmark Pharmaceuticals. 22 August 2023
Biotechnology
The USA’s health technology assessor, the Institute for Clinical and Economic Review (ICER), today released a Final Evidence Report assessing the comparative clinical effectiveness of two sickle cell disease gene therapies. 21 August 2023
Pharmaceutical
Companies supplying medicines in Australia will be required to provide additional information to the Therapeutic Goods Administration (TGA) if their products go into shortage. 21 August 2023
Pharmaceutical
Although Latin America has a broad portfolio of innovative medicines to treat orphan diseases and cancer, only 13% of patients who would benefit from these therapies have access to them. 18 August 2023
Pharmaceutical
Humanitarian organization Médecins Sans Frontières/Doctors Without Borders (MSF) revealed today that it has requested ViiV Healthcare to withdraw conditions in negotiations for a purchase agreement for an important HIV treatment. 17 August 2023
Generics
The UK’s Competition and Markets Authority (CMA) has welcomed the landmark judgment, which endorses all the main elements of the CMA’s decision in respect of liothyronine tablets – an essential medicine to treat thyroid hormone deficiency. 17 August 2023
Biotechnology
US rare diseases focused biotech Amicus Therapeutics today revealed that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorizations for Pombiliti (cipaglucosidase alfa) + Opfolda (miglustat) for adults living with late-onset Pompe disease (acid α glucosidase [GAA] deficiency). 15 August 2023
Generics
Even as a parliamentary panel in India has asked the government to rationalize the annual price hike limit for cancer drugs, its call for subsidizing cancer drugs in India carries multi-faceted implications for the pharmaceutical industry. 14 August 2023
Pharmaceutical
Two of the world’s largest pharmaceutical companies - Merck & Co and Pfizer - last week reported second-quarter financial results that were seriously impacted by the decline in the need for COVID-19 vaccines and treatments, but still came out with impressive figures. Troubled US biotech EQRx, which launched with the promise of reforming drug pricing, has given up its dream and accepted an all-stock merger proposal from Revolution Medicines. Japanese drugmakers Sumitomo Pharma and Otsuka suffered a setback in their two clinical trials of the schizophrenia candidate ulotaront. 6 August 2023
Biotechnology
The UK's National Institute for Health and Care Excellence (NICE) has issued a draft Appraisal Consultation Document recommending against CSL Behring’s Hemgenix (etranacogene dezaparvovec) for severe and moderately severe hemophilia B (congenital factor IX deficiency) patients without a history of Factor IX (FIX) inhibitors. 2 August 2023
Pharmaceutical
US House and Senate Committees this week passed legislation to control the way pharmacy benefit managers (PBMs) can profit by increasing drug price. 28 July 2023
Pharmaceutical
US healthcare conglomerate Johnson & Johnson and Japanese drugmaker Astellas have joined a growing list of companies and groups that are suing the US government over its Medicare price-setting policies. 20 July 2023
Pharmaceutical
Negotiations over the future of drug pricing in the UK are off to a rocky start, as the UK government seeks to sustain the high rebate rates in the current statutory regime. 20 July 2023
Generics
Prices for imported active pharmaceutical ingredients (APIs) are rising again in Russia after the decline in 2022. This year the growth is equivalent to by 40%-100% year-on-year due to the devaluation of the rouble and the need to use intermediaries for these procurements, reports The Pharma Letter’s local correspondent. 20 July 2023
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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