IHS Healthcare and Pharma Blog
Gaëlle Marinoni
European pharmacovigilance legislation: It’s everyone’s business as payers look to make use of benefit-risk data
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
Dismantling commonly held stereotypes about pharmaceutical prices
Last week, after 4 months of data crunching and analysis, we published our latest study entitled Dynamic pharmaceutical pricing 2012: What is really behind drug price changes? In a nutshell, the study analyses drug price changes over time (up to 10 years) within and across 36 strategic markets and within and across 12 key therapeutic … Continue reading
Blurring the Boundaries Between Regulatory and HTA Agencies: A Risk-Benefit Analysis
A few weeks ago, I attended the 9th annual HTAi meeting in Bilbao, Spain, where there were a few sessions on, and a lot of debate over, the “interface between regulatory and HTA processes.” There seemed to be a consensus among the audience that, in future, there will be increased alignment between the regulatory and … Continue reading
Industry-Payer Partnerships in Emerging Markets: What to Do When the Payer Is the Patient?
Following up on our study on payer-industry partnerships in the developed markets, we recently completed a similar study in the BRIC-MT markets, which involved extensive secondary and primary research, including in-depth interviews with national, regional and local payers as well as relevant industry representatives. The Patient as a Payer We came to a number of … Continue reading
Market Access Lessons From Benlysta’s Failure to Wow European Payers
GlaxoSmithKline’s (GSK) Benlysta (belimumab) is the first therapy to be approved for the treatment of lupus in over 50 years. Yet, despite Benlysta’s first-in-class status and the high unmet medical need associated with lupus, GSK is struggling to convince some of the top-5 European markets that its medicine is worth funding. So why is this … Continue reading
Relative Effectiveness Assessments (REA) of Pharmaceuticals — The Latest Key to Market Access and Price Premiums
With the introduction of AMNOG early last year, Germany jumped on the relative effectiveness assessment (REA) bandwagon by linking pharmaceutical prices to added therapeutic benefit scores. Later in the year, France passed legislation that allows the national regulator to request comparative clinical data when evaluating a medicine for marketing authorisation. The country intends to take … Continue reading
Relative Efficacy and Effectiveness: The Next Pharmaceutical Market Access Barriers?
At the end of December 2011, France finally passed into law its much discussed pharmacovigilance reform. In the aftermath of the German healthcare reform (AMNOG), which linked pharmaceutical pricing to added therapeutic benefit scores, one of the measures in the French draft bill that really caught my attention was the prospect of linking marketing authorisations … Continue reading
Is the PIP Breast Implant Health Scare Symptomatic of an Under-Regulated Medical Device Industry?
One of the hot healthcare topics of the moment is the Poly Implant Prosthese (PIP) breast implant cancer scare, which has already led France to call for tighter regulations of the medical device industry in Europe. As the European Commission is scheduled to review its Medical Devices Directives in the first half of 2012, this … Continue reading
Pharmaceutical Industry and Payer Partnerships — Choice or Necessity?
We recently published a study on the partnerships between the pharmaceutical industry and payers, which involved interviews with national, regional and local payers as well as industry representatives across nine developed markets. From these interviews, we gauged the level of awareness of — and appetite for — a wide range of industry-payer partnerships, including those … Continue reading
Life after AMNOG – German Healthcare Reform Starts to Impact Pharma
A few months back we held a webcast that looked at the potential impact of AMNOG on the pharmaceutical industry. In the webcast we predicted that greater visibility on the German reform would come at the end of October when the German authorities publish their first benefit assessment for cardiovascular medicine ticagrelor. But in the … Continue reading
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