IHS Healthcare and Pharma Blog
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Collaboration between European regulators and payers: Are post-authorisation studies the next frontier?
Having explored the emerging interface between European regulators and payers as part of our recent study on what the pharmacovigilance reforms mean for development and market access, I was heartened to see that collaboration in the post-authorisation space featured prominently in the joint EMA/EUnetHTA discussions held last month. As the publicly available minutes from that … Continue reading
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Last week I attended ISPOR’s 18th annual international meeting in New Orleans, Louisiana. The theme of the event was “Finding the Patient in Health Research and Policy” and, not surprisingly, capturing patient outcomes was the focus of many discussions. Among the key topics discussed were the usefulness of new diagnostic techniques and Whole Genome Sequencing … Continue reading
A joint post from Tim Dall, Tericke Blanchard, Paul Gallo, and April Semilla The Medicare Part D drug benefit was introduced in January 2006 to improve care for the elderly population. Prior to implementation, 30% of Medicare beneficiaries lacked creditable drug coverage. By the end of Part D’s first year, over half of previously uninsured … Continue reading
Two months after the election of the new Parliament, the new Italian Minister of Health Beatrice Lorenzin has outlined the main priorities for healthcare and pharma policy. Although the Minister has not unveiled–in detail–the government’s programme on health, it is possible to glimpse a loosening of the grasp of cost containment in the coming months. … Continue reading
In addition to our booth and presentations at ISPOR next week, The IHS Healthcare & Pharma team will have a strong presence at PBIRG, 19-22 May in Naples, Florida. Come by booth #6 to meet members of our team and learn about our products and latest research. Research being presented at PBIRG High-Potential Emerging Markets: … Continue reading
The dust has hardly settled following debates over the creation of health insurance exchanges – under the provisions of the Affordable Care Act (ACA; often referred to as ‘Obamacare’) in the United States – and there is a new battle under way. This one has attracted less attention in the media that the controversial insurance … Continue reading
The IHS Healthcare & Pharma team is pleased to announce that we will again have a strong presence at the Annual International Meeting of ISPOR, 18-22 May in New Orleans. Come by booth #3057 to meet members of our team and learn about our products and latest research. We are also pleased to announce our … Continue reading
With cost-containment policies implemented in a large number of countries, the economic downturn has also had a large impact on the healthcare sector. To generate savings, cost-containment policies have been implemented. The growing number of HTA (Health Technology Assessment) agencies and the various changes in P&R procedures demonstrate that innovative drugs have been targeted by … Continue reading
The temperature is rising again in the German pharmaceutical sector, with the recent publication by the G-BA of the schedule for the first six drug groups to retroactively undergo a benefit assessment under AMNOG. While the regulations of AMNOG foresee the application of benefit assessments to drugs marketed before its coming into force, the announcement … Continue reading
With the end of April come and gone, the EMA has, as promised, published the final advice from each of the five clinical trial advisory groups that were conceived back in November to advance the discussion on access to clinical-trial data. As a quick reminder, the EMA has been releasing clinical and non-clinical information upon … Continue reading
The US Congress is again discussing development of a nationwide tracking system for pharmaceutical products that would replace state programs. The House Energy & Commerce’s Health Subcommittee held a hearing April 18, 2013 on a track & trace discussion draft and heard testimony from the FDA, manufacturers, distributors, and pharmacists. The draft legislation would establish … Continue reading
As Sir Andrew Dillon, Chief Executive Officer of the United Kingdom’s National Institute for Health and Clinical Excellence (NICE) recently announced, the Institute’s name is changing. It will be henceforth known as the National Institute for Health and Care Excellence – in formal recognition of its expanded role in healthcare provision guidance. The acronym NICE … Continue reading
I recently attended the BioMedical Device conference held in Boston, Massachusetts. The event brought together several hundred attendees focused on all things medical devices – from engineers and supply chain experts, to public affairs managers and strategic planners. My interest was more narrowly focused around the growing field of drug-device combinations and I gleaned insight … Continue reading
Recently I attended an interesting web conference on the topic of “Achieving effective market access in Latin America”. The talk gathered experts from all over Latin America, and my attention was drawn specifically to the debate around the role of Health Technology Assessment (HTA) in achieving market access in the region. In Latin America, as … Continue reading
April 5, 2013, marked the 1000 day until the end of the Millennium Development Goals (MDG) – a 15 year program to bring about meaningful changes in global development. The initiative began in the year 2000 with world leaders coming together to attempt eight development goals by 2015: eradicate extreme poverty and hunger; achieve universal … Continue reading
Depending on how you define the proverbial “patent cliff”, we are now roughly well into our third year of this unusually dense constellation of best-selling drugs whose patent protection period is running out. By some estimates, 2013 may actually represent a peak year in the patent cliff, but our assessment is that this occurred last … Continue reading
Last week, IHS commented on a new study published in the New England Journal of Medicine which found that U.S. spending on dementia-related illnesses is at an all-time high – and indeed exceeds that of often more prominent diseases such as cancer and heart disease. And the picture does not get any better: spending currently … Continue reading
Since publication in February 2011 of its Geriatric Medicines Strategy, the EMA has been undertaking various initiatives to ensure that the development and evaluation of medicines take into account the unique considerations associated with the elderly patient population. The strategy itself identifies the agency’s vision to ensure that “…medicines used by geriatric patients are of … Continue reading
I’ve never been a fan of the term ‘War on Cancer’, but recent events have made me see the lure of this moniker. If a war is what is indeed being fought, I can’t help thinking that we have lost a few battles recently, with patients bearing the brunt. Battleground one: Indian generics market India … Continue reading
With the long-awaited formal transition of power in China completed at the National People’s Congress (NPC) on 18 March, there is a sense that the country’s health reforms process can begin again in earnest. In relation to healthcare, there was a significant reshuffling of chairs and ministries: Li Bin replaced Chen Zhu as the new … Continue reading
At a recent conference I attended, dedicated to the regulatory affairs in Russia, CIS, and Turkey, the overriding message from pharma company representatives (in terms of registering their products in Russia) was concern about the lack of clarity and “vagueness” of law defining the country’s drug registration process. There was much anticipation in relation to the … Continue reading
As of April 1st 2013, the prices of six commonly-prescribed generic medicines will fall across Canada, down to 18% of the price of the branded originator. This measure is the outcome of proposals originally put forward by the Health Care Innovation Working Group at the July 2012 meeting of the Council of the Federation. Representing … Continue reading
Tresiba, a basal insulin, was recently launched by NovoNordisk in Japan(the drug was approved in Europe in October 2012). The company has hailed the drug as better than existing insulin products, with a lower risk of hypoglycaemia, and as offering the promise of a better quality of life. In-spite of this hoopla there are many … Continue reading
A joint post from Tim Dall and Paul Gallo It was a cold and dreary day, with a major snowstorm responsible for the closing of offices throughout the Washington, DC area. The weather outside was perhaps a prelude to the sobering statistics being shared inside the Russell Senate Office Building where we presented the findings … Continue reading
After a swift passage through the security check-point, that included an airport style search, I was officially inside the UK House of Commons on 25th January. Not only was this my first visit to the House of Commons, but also the first time a Brazilian Health and Life Sciences Seminar has taken place in the … Continue reading
Since I last wrote about the 340B debate in the US, the controversy over this outpatient drug discount programme – originally designed to address uncompensated care costs for providers serving a significant number of uninsured and low-income patients – has gone full swing. Just last month, a number of prominent industry trade groups and other … Continue reading
The new European pharmacovigilance legislation was passed at the end of 2010 with large portions of it implemented last summer. With its emphasis on continuous benefit-risk assessment, and early signs that this may lead to currently marketed drugs facing re-evaluation, we are only just beginning to gain full visibility into the real and tangible impact … Continue reading
China’s economy has escaped a hard landing. Real GDP growth strengthened to 7.9% year-on-year in the fourth quarter, up from 7.4% in the third quarter of 2012. Industrial production growth is back above 10%, and electricity output growth (at 8%) is the strongest in a year. Fixed asset investment and retail sales continue to post … Continue reading
OMS-Europe statistics show that France lags behind its European counterparts in terms of vaccination rates. The French government is also of the opinion that national vaccine coverage is not as extensive as it should be and, as a result, is working to increase vaccination rates in the country. So does the French government face an … Continue reading
A joint post by Cameron Lockwood and Gaëlle Marinoni In its February 2013 edition, French monthly publication Prescrire released a list of marketed medicines which, according to the magazine, have an unfavourable risk-benefit profile. In France, healthcare professionals and patients will take notice of this list. Prescrire is not linked to the authorities (it is … Continue reading
A joint post by Praful Mehta and Sophia Walker On 25th December 2012, Journal of American College of Cardiology (JACC) published its most comprehensive report on the worldwide environment of cardiovascular disease (Praful’s earlier blog post titled “Cardiovascular Drug Research and Development – What’s the Current State?” was referenced in the report). One of the … Continue reading
Limits on pharmaceutical reimbursement–but improvements on their way The Russian pharmaceutical market has steadily increased over time, commonly enjoying double-digit growth rates. Despite this market attractiveness, funding of pharmaceuticals was not a government priority and was provided to a limited part of the population, benefiting around 20 million inhabitants (14% of the population). Additionally, people … Continue reading
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