Pricing, reimbursement and access
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Pharmaceutical
Italy’s Menarini kicked off the May M&A news last week, announcing it would acquire USA-based Stemline Therapeutics, gaining access to an already approved drug for rare blood cancer, Elzonris. This was followed by Alexion agreeing a $1.41 billion takeover offer for Portola Pharmaceuticals, along with its clotting factor Andexxa. Meantime, US health technology assessor, the Institute for Clinical and Economic Review (ICER), has come up with two scenarios on fair pricing for COVID-19 treatment remdesivir from Gilead Sciences. On the regulatory front, the US Food and Drug Administration granted earlier-than-expected approval for Novartis and Incyte’s new lung cancer drug Tabrecta (capmatinib). 10 May 2020
Biosimilars
Truxima (rituximab-abbs) injection, a biosimilar version of Roche’s Rituxan, is now available in the USA for the treatment of: 4 May 2020
Pharmaceutical
How much should a potentially effective drug for COVID-19 cost? 4 May 2020
Biotechnology
Vertex Pharmaceuticals’ Trikafta (elexacaftor/tezacaftor/ivacaftor) comes with evidence of providing a major net benefit for patients, but the price tag needs to be massively reduced to align with these benefits. 30 April 2020
Biotechnology
There was a time when executives at Teva Pharmaceutical Industries thought that their product might be the third anti-calcitonin gene-related peptide (CGRP) drug to be recommended by the National Institute for Health and Care Excellence (NICE). 29 April 2020
Biotechnology
The National Institute for Health and Care Excellence (NICE) has issued a positive Final Appraisal Document (FAD) recommending Stelara for ulcerative colitis. 28 April 2020
Generics
Leading Russian drugmakers and foreign companies operating in Russia have opposed the introduction of amendments to the existing rules for registration and examination of drugs in the domestic market which create a single register of patented active ingredients in the market of Russia as well as some other post-Soviet states, reports The Pharma Letter’s local correspondent. 28 April 2020
Biotechnology
NHS England says that it has struck a deal which will see hundreds of people benefit form a ‘game-changing’ new cancer treatment. 23 April 2020
Pharmaceutical
Russia has faced a significant increase of drug prices in recent weeks, which is mainly due to the ongoing spread of COVID-19 throughout the country and the growth of costs for producers, according to recent statements by representatives of producers and some local media reports. 21 April 2020
Pharmaceutical
National Health Expenditure (NHE) projections in the USA suggest growth in spending could average 5.4% for 2019 to 2028, reaching nearly 20% of gross domestic product (GDP) by the end of the period. 17 April 2020
Pharmaceutical
The US Prescription Drug Pricing Reduction Act introduced by Senators Charles Grassley (Republican, Iowa) and Ron Wyden (Democrat, Oregon) could generate over $94 billion in savings over the next decade if enacted, according to an analysis from the Congressional Budget Office. 19 March 2020
Pharmaceutical
Russia may be faced with a significant increase of drug prices in the domestic market by the end of the first quarter of the current year, which will be mainly due to the recent fall of the rouble and a potential shortage of a number of active ingredients the are used by domestic drugmakers and foreign companies operating in the local market. 17 March 2020
Pharmaceutical
New money from the UK’s Department of Health and Social Care will ensure “anyone who is at a high risk of contracting HIV will receive PrEP from their local sexual health clinic,” the British Government announced on Sunday. 16 March 2020
Biotechnology
The US Institute for Clinical and Economic Review (ICER) has released an Evidence Report assessing the comparative clinical effectiveness and value of treatments for sickle cell disease. 13 March 2020
Biotechnology
UCB has announced the initiation of a Phase III clinical trial evaluating the efficacy and safety of dapirolizumab pegol (DZP) as an add-on treatment to standard of care (SoC) medication for lupus. 12 March 2020
Biotechnology
The UK National Institute for Health and Care Excellence (NICE) has recommended Ajovy (fremanezumab) for preventing chronic migraine. 12 March 2020
Pharmaceutical
The UK's Competition and Markets Authority (CMA) has failed to overturn a decision from the Competition Appeal Tribunal (CAT), which set aside certain penalties imposed on Pfizer and UK-based Flynn Pharma. 10 March 2020
Pharmaceutical
In response to a sharp price increase in the domestic market caused by the spread of the novel coronavirus (COVID-19), the Russian government and the national Parliament (State Duma) are considering introducing state regulation over prices for drugs and medical devices in the domestic market 10 March 2020
Biotechnology
New data has demonstrated that using Andexxa [coagulation factor Xa (recombinant), inactivated-zhzo] to treat patients with intracranial hemorrhage (ICH) associated with the oral Factor Xa inhibitors apixaban or rivaroxaban is projected to provide a net reduction in costs to an acute care hospital. 5 March 2020
Biotechnology
NHS England said on Saturday that it will fund a life-changing treatment for people with rare conditions causing repeated bouts of fever, joint pain and swelling. 2 March 2020
Pharmaceutical
Proposals from the National Health Service (NHS) England have been set out for a phased launch of Eli Lilly’s obesity injection Mounjaro/Zepbound (tirzepatide) at the start of a consultation. 4 October 2024
Pharmaceutical
The US Department of Health and Human Services (HHS) has released final guidance for the second cycle of Medicare drug price negotiations. 3 October 2024
Pharmaceutical
As stakeholders in the pharmaceutical industry, we all have a responsibility to ensure life-saving treatments promptly and safely reach patients regardless of where they live. To this end, by integrating early access programs and other less conventional strategies into a company’s business model for drug distribution, patients who are suffering from life-threatening conditions can gain access to needed treatments in regions where there is a lack of drug accessibility, while at the same time offering benefits to pharmaceutical companies. 2 October 2024
Biotechnology
CSL Behring has been granted a positive recommendation by the Spanish Interministerial Commission on the Pricing of Medicines (CIPM), resulting in national reimbursement for Hemgenix (etranacogene dezaparvovec) for eligible haemophilia B patients in Spain. 1 October 2024
Pharmaceutical
Johnson & Johnson has halted its plan to implement a 340B rebate model after pressure from the Health Resources and Services Administration (HRSA). 1 October 2024
Pharmaceutical
Healthcare plan provider Centivo has raised $75 million in equity and debt financing to support its goal of offering affordable care to employees and their families. 25 September 2024
Pharmaceutical
The Pharmaceutical Research and Manufacturers of America (PhRMA) is continuing its legal challenge against the US government’s drug pricing reforms. 24 September 2024
Pharmaceutical
On Friday, the USA’s Federal Trade Commission (FTC) brought action against the three largest prescription drug benefit managers (PBMs) - Caremark Rx, Express Scripts (ESI), and OptumRx 23 September 2024
Pharmaceutical
Scarcely anything unites lawmakers in America these days, but the ostensible iniquities of Big Pharma could be a rare exception. 22 September 2024
Pharmaceutical
Daiichi Sankyo’s today revealed that its Vanflyta (quizartinib) has been recommended by the National Institute for Health and Care Excellence (NICE) for routine National Health Service (NHS) commissioning in England and Wales. 19 September 2024
Pharmaceutical
Novo Nordisk is under increasing pressure over the cost of its blockbuster drugs in the USA, as chief executive Lars Fruergaard Jørgensen prepares to testify before a powerful Senate committee. 18 September 2024
Pharmaceutical
In a lawsuit filed in federal court in Missouri, USA, Health insurer Cigna (NYSE: CI) and its pharmacy benefit manager (PBM) Express Scripts demanded that the Federal Trade Commission (FTC) retract its July 2024 report. 18 September 2024
Biotechnology
The National Institute for Health and Care Excellence (NICE) has recommended access Vabysmo (faricimab) for the treatment of adults with visual impairment due to macular oedema secondary to branched and central retinal vein occlusion. 13 September 2024
Generics
A significant drop has been noticed in the prices of active pharmaceutical ingredients (APIs), bringing much-needed relief to the pharmaceutical industry and potentially translating to lower drug costs for consumers. 9 September 2024
Biotechnology
The Institute for Clinical and Economic Review (ICER) has posted its revised Evidence Report assessing the comparative clinical effectiveness of three medicines for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM). 6 September 2024
Generics
Glenmark Pharmaceuticals has agreed to pay $25 million, based on its ability to pay, to resolve its alleged liability under the False Claims Act for conspiring to fix the price of a generic drug, the US Department of Justice announced. 5 September 2024
Pharmaceutical
Research from AARP has found that around $1,100 in prescription drug costs could be saved by more than a million seniors, due to the Inflation Reduction Act (IRA). 2 September 2024
Pharmaceutical
US House Committee on Oversight and Accountability chairman James Comer is calling on the chief executives s of three major Pharmacy Benefit Managers (PBMs) - CVS Caremark, Express Scripts, and Optum Rx - to correct the record for statements made during their appearance before the House Oversight Committee. 29 August 2024
Biosimilars
Drug development consultancy Certara has published a report on the Inflation Reduction Act’s (IRA) impact on oncology biosimilar uptake. 29 August 2024
Pharmaceutical
August 28, 2024
US pharma major Eli Lilly yesterday announced Zepbound (tirzepatide) 2.5mg and 5mg single-dose vials are now available for self-pay for patients in the USA. 28 August 2024
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