New acquisition cost of Repatha

New acquisition cost of Repatha

Today we learn that Amgen is lowering the acquisition cost of Repatha by 60% in the US. This is an excellent message for millions of users who preferred risk to co-pay. It is indeed a significant change, not only for the potential change it is making on access to the drug and the harm to its direct competitor, but also it sends a very powerful message to the community: the drug was overpriced by at least 60%. How do we take it from there? Do we just have to wait 1-2 years to make innovation available so that it reaches the appropriate price? The move is giving payers a strong incentive to keep asking for discounts and only build mistrust on...
Gene therapy: Will it deliver its commercial promise?

Gene therapy: Will it deliver its commercial promise?

On April 10th 2018, Goldman Sachs published “The Genome Revolution” report on gene therapy, in which its analyst posed the thought-provoking question: “is curing patients a sustainable business model?” The question comes at a relevant time. Just last week, two of the world’s top pharma giants appear to have taken contrasting stances on the capacity of gene therapies to deliver on their expectations of commercial profit. Novartis has entered into an agreement to acquire AveXis, for a whopping $8.7 billion (€7 billion), in the hopes of expanding its capabilities in gene therapy and commercializing a potentially transformative treatment for Spinal Muscular Atrophy. Conversely, GlaxoSmithKline has decided to sell its rare disease gene therapy portfolio to British startup Orchard Therapeutics, for a mere 19.9% equity stake and a seat on the board. The dilemma arises due to the industry’s current business model, which heavily relies on the cash and profits that the products curate over time. In fact, despite their remarkable value for patients and society, and despite their hefty price tag, the attainment of sustained cash flow from “one-shot” cures remains challenging. We need to think beyond health economics, and explore industrial economics, if we wish for gene therapy to succeed. It will be critical not only to restructure the way in which the research and development business is modelled, but also adapt the way in which health care is delivered and financed in the absence of insurable risk. Collaboration between providers, payers and insurers will be key to prevent patients to be deprived of a...
Health Literacy, the resist subject

Health Literacy, the resist subject

According to WHO’s definition, Health literacy refers to the ability of individuals to “gain access to, understand and use information in ways which promote and maintain good health” for themselves, their families and their communities. Between 2009-2012 several countries in Europe participated in the European Health Literacy Survey (HLS-EU) project1. A review of the project by the European Commission in 2015 showed that in Europe we need to pay more attention to Health Literacy. In addition, we are not training our healthcare professionals in the management of low health literacy. In the United States, for instance, there are residency programs, for doctors, as well as for nurses and pharmacists, that already include health literacy within their curriculum. Should we not work with our decisionmakers to foster appropriate access to appropriate care? There is a lot of work to do to understand the increasing complexity of healthcare, and how to streamline it to achieve equitable health....
Innovative public purchase

Innovative public purchase

During The last two months HiTT has been working in 2 different projects of innovative public purchase, and last week we finally have presented them to the regional health service call. The Innovative public purchase is a tool used by the EU to foster the innovation purchase from the public institutions. It is a contract that public institution offers, to satisfy a present need through an innovative solution. The basis is the purchase through the service demand rather than from the solution supply. Both projects try to redefine the relationship between professionals and patients; the two projects are focused on the information system for the patient profile determination. That is to say, the personalization of the health through the phenotypes analysis and the revealed behaviour, not through the genomic studies. We hope we can continue along these...
ISPOR 20th annual European congress

ISPOR 20th annual European congress

From 4th to 8th November 2017 it will be held in Glasgow, Scotland, the ISPOR 20th annual European congress. ISPOR is recognized globally as the leading scientific and educational organization for HEOR (health economics and outcomes research) and its use in health care decisions. ISPOR Glasgow provides a forum for discussion and dissemination of HEOR information. The congress is a great opportunity collaborate and network with colleagues in the field, and hear about innovative research methods and new health policy developments. Reflecting on revolutionary transformations affecting today’s health care, ISPOR Glasgow will address medical technology development, health technology assessment, and policy and clinical decision making while exploring the theme, The Evolution of Value in Health Care. Dr. Sola Morales will discuss about the topic that in 1999, the EU enacted legislation to foster the introduction of new Orphan Medicinal Products (OMP) into the market. To date only partial evaluations of the success of this legislation have been made, so this analysis investigates the outcomes of the OMP legislation from a broader perspective. It is possible to find the program in this...
FDA clinical trials

FDA clinical trials

In the past months we’ve seen the approval of several drugs with limited data. Possibly this is the ‘natural’ consequence of both the Fast Track Designation and the Adaptative Pathway solutions that have been accepted. Though there is clear benefit in accelerating promising developments, we should not overlook two major issues: first, HTA bodies and the administrations they represent are not convinced with this looser approach, not to say some of the national Drug Agencies that are not willing to deal with provisional data; second, and most important, we may now start asking FDA and EMA why did they approve development plans everyone knew would not be accepted for access purposes. It has been argued that HTA bodies delayed access to medicines. We may discuss to which extent this is true, but should also be discussed is the frustration and economic loses a flawed albeit accepted development programme inflicts to...