Pricing, reimbursement and access
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Pharmaceutical
UK drugs watchdog the National Institute for Health and Care Excellence is currently appraising Invokana (canagliflozin), from US health care giant Johnson & Johnson subsidiary Janssen-Cilag, when used in combination with other anti-diabetic drugs, including insulin, for the treatment of type 2 diabetes. 24 February 2014
Pharmaceutical
In an early benefit assessment under the Act on the Reform of the Market for Medicinal Products (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) examined whether the drug combination indacaterol/glycopyrronium (trade name: Ultibro Breezhaler, Xoterna Breezhaler) offers an added benefit over the appropriate comparator therapy. 19 February 2014
Pharmaceutical
The European Federation of Pharmaceutical Industries and Associations (EFPIA) and the European Generic medicines Association (EGA) said this morning that they fully support the agreement between the pharmaceutical industry associations in Romania to put forward a constructive proposal to the Romanian government that would improve patients’ access to medicines. 10 February 2014
Generics
The Spanish Ministry of Health last week announced pharmaceutical spending data, which showed a new drop in 2013. Last year, the National Health System (SNS) spent 9.18 billion euros ($12.38 billion), 587.69 million euros less than the previous year (-6.1%), reports The Pharma Letter’s local correspondent. This compares with 2011, when savings increased to near 2 billion euros (-17.5%). 4 February 2014
Pharmaceutical
UK drugs watchdog the National Institute for Health and Care Excellence (NICE) today approved the use of Swiss drug major Roche’s MabThera (rituximab) for two potentially life-threatening auto-immune diseases, severe forms of granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) and which result in the inflammation and damage of small blood vessels and frequently involve multiple organs. 24 January 2014
Biotechnology
In final guidance, UK drugs watchdog the National Institute for Health and Care Excellence (NICE) has recommended the use of French drug major Sanofi’s biotech subsidiary Genzyme’s oral multiple sclerosis drug Aubagio (teriflunomide). 22 January 2014
Biotechnology
US antivirals specialist Gilead Sciences has received marketing authorization from the European Commission for Sovaldi (sofosbuvir), a once-daily oral nucleotide analogue polymerase inhibitor for the treatment of chronic hepatitis C (CHC) infection in adults, in combination with other antiviral agents (ribavirin (RBV) and pegylated interferon alpha [peg-IFN]). 20 January 2014
Biotechnology
Belgian biotech firm ThromboGenics says that the Transparency Commission of the French National Health Authority (HAS) has issued a positive opinion for the reimbursement and hospital listing of Jetrea (ocriplasmin) by the French National Health Insurance. 17 January 2014
Pharmaceutical
There was a hint of positive news for German drug major Bayer, when the German Institute for Quality and Efficiency in Health Care (IQWiG) announced that, following an early benefit assessment under the Act on the Reform of the Market for Medicinal Products (AMNOG), it has concluded that the company’s cancer drug Stivarga (regorafenib) offers an added benefit over the appropriate comparator therapy specified by the Federal Joint Committee (G-BA). 13 January 2014
Pharmaceutical
In yet another negative opinion from the German Institute for Quality and Efficiency in Health Care (IQWiG) this week, the agency has issued a negative view of French drug major Sanofi’s multiple sclerosis drug Aubagio (teriflunomide). 8 January 2014
Pharmaceutical
For the third time in one year, the German Institute for Quality and Efficiency in Health Care (IQWiG) reviewed aflibercept, drug major Bayer’s ophthalmic drug Eylea, returning a negative opinion. 8 January 2014
Pharmaceutical
In 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) examined whether UK pharma giant GlaxoSmithKline’s drug Tafinlar (dabrafenib) offers an added benefit over the appropriate comparator therapy. 7 January 2014
Biotechnology
Novel biologics must demonstrate improvements in efficacy, safety and cost-benefit compared with currently listed agents for a given disease to be included on both national and institutional formularies in Argentina, Brazil and Mexico. 23 December 2013
Pharmaceutical
Drug majors Bristol-Myers Squibb and AstraZeneca have reportedly decided to stop marketing their diabetes drug Forxiga (dapagliflozin) in Germany, having failed to reach agreement on pricing of the drug with the country’s regulatory authorities. 14 December 2013
Pharmaceutical
New Zealand’s Pharmaceutical Management Agency PHARMAC has declined the funding application for eculizumab for paroxysmal nocturnal hemoglobinuria (PNH), a rare blood disorder. 13 December 2013
Pharmaceutical
A new agreement with the local subsidiary of UK pharma giant GlaxoSmithKline by New Zealand’s Pharmaceutical Management Agency PHARMA will see two newly listed medicines, improved access to commonly used asthma inhalers, and millions of dollars of savings. 11 December 2013
Pharmaceutical
Following a consultation, New Zealand’s Pharmaceutical Management Agency PHARMAC said this morning that it has made a decision to approve a proposal to widen funded access to Swiss drug major Roche’s Tarceva (erlotinib). 9 December 2013
Biotechnology
US antiviral biotech specialist Gilead Sciences says that the Food and Drug Administration has approved its Sovaldi (sofosbuvir), a once-daily oral nucleotide analog polymerase inhibitor for the treatment of chronic hepatitis C (CHC) infection as a component of a combination antiviral treatment regimen. 8 December 2013
Biotechnology
US biotech firm Cell Therapeutics has concluded an agreement with the Germany’s National Association of Statutory Health Insurance Funds (GKV-Spitzenverband) for Pixuvri (pixantrone). 4 December 2013
Pharmaceutical
UK drug watchdog the National Institute for Health and Care Excellence (NICE) has issued final guidance that does not recommend US pharma giant Pfizer’s Bosulif (bosutinib) for previously treated chronic myeloid leukemia. 27 November 2013
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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