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...
Drugs in the graveyard increase costs

Drugs in the graveyard increase costs

This week we learned that Merck & Co. was ending the Phase III APECS study of Verubecestat (formerly known as MK-8931) for the treatment of prodromal Alzheimer Disease. Yet another drug in AD graveyard!! Being this now a relatively common fact in the development on AD therapies, there are several immediate consequences that would need to be borne in mind for the future: first, investors will pot a much higher tag to their lending offers, making cost of capital more expensive, and therefore less new ideas being pursued. Hence, the natural chances of finding a solution less likely, hence a potential successful story having more value. Second: a potentially successful research story will want to capitalise on their unique success, and investors will request higher return on their investment, therefore pushing even more the facial prices of drugs. Given the large target population and previous failures it looks like this will be rather high, and the budget impact simply unbearable. Can healthcare systems cope with that? The need is clear, but the willingness to pay is limited. As in basic economics, demand and supply seem not to meet, so everyone unhappy. Should we not ask for a shared vision on what are the needed investments and where is there potential payment. Some urgent reforms are needed if we want success stories in areas of high demand / need. If we’re happy to play at the margins, current system may be acceptable for many, certainly not for patients, nor taxpayers. Oriol.    ...
Biotech and pharmaceutical Postgraduate study

Biotech and pharmaceutical Postgraduate study

Dr. Solà-Morales has been selected to become one of the professors that will teach in this postgraduate study provided by the IQS (Instituto Químico de Sarrià). The Biotech and pharmaceutical Postgraduate study combines the acquisition of essential knowledge (lectures, mentoring, round-tables discussions…) with the development of negotiation and problem solving capabilities ( case studies, workshops, group works…). The program has been designed to students that are willing to develop their professional potential in companies of the biotech or pharma sectors, according to the demand of such companies for high skilled workers. The objectives of this postgraduate are: The Biotech and pharmaceutical Postgraduate study prepare the students to face successfully an international, professional and competitive environment and to be able to adapt to a changing environment. More specifically: Acquire business vision Add real value to the companies based on the knowledge acquire during the training Analytical capability Learn how to work in multicultural environments where English is the principal communication...
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...
Assessing the Value of New Antibiotics

Assessing the Value of New Antibiotics

Dr. Solà-Morales Serra has participated in the formulation of a new study called, Assessing the Value of New Antibiotics: Additional Elements of Value for Health Technology Assessment Decisions. The study wants to highlight the key challenges with the current approaches to assessing the clinical, economic and health system value of antibiotics. The study faces the actual approaches, and proposes additional elements of value that address these challenges from all relevant perspectives. To conclude the analysis, the paper suggests the next steps needed to refine and implement the additional concepts proposed. This paper was developed by a project team, which included partners from the pharmaceutical industry. The brienfing is available in this web...