Fasten seat belts

We have entered into an unknown new world: drug prices -for innovative drugs- are on track to disappear. The NHS has agreed a cap on expenditure for a hepatitis C (sofobusvir) new drug in €125m without disclosing the unit price. Some people may consider it an opaque strategy in times that politicians claim transparency.
In my opinion, such a situation allows to understand better that the pharmaceutical market for innovative drugs is mostly a monopsony (one buyer) in a monopoly (one seller), it is not a competitive market - and this is what I have always considered. Therefore, resource allocation is the result of a bargaining between both parties, and the unit price is irrelevant. The buyer wants to maximize health,  the seller is maximizing income, this is exactly the struggle.
The key question is: How much is NHS willing to pay for better health?. As far as  the budget is limited, the number of treatments times the price is not the right way to proceed to maximize health under constrained resources.
Any government has to set priorities for expenditure according to expected health value created. This information should be public. In any case, when a new drug is available the government should clearly define which benefits are cancelled and which are acceptable. A responsible minister can't  agree new expenditures without any budget.
Therefore, innovative pharmaceutical market is not really a market -right now is clear- and governments should set priorities according to resources available -right now is also clear that they haven't done it-.
Fasten seat belts, we are entering into trying times without any political compass-gps. Citizens are expecting something different. I still remember when Victor Fuchs told long time ago: usually health economists discuss incremental cost-effectiveness in limited marginal terms, the real issue appears when such an amount is enormous. The case of hepatitis C is the example of such a situation, and only health policy and deliberative democracy are the tools to confront it. Unfortunately, this was not the strategy applied nearby.

PS. Catalonia in contention, at Harvard Political Review. Must read, if you are interested on what's going on. Otherwise, try Bloomberg op-ed or LAtimes.

PS. Reading Francesc-Marc Alvaro op-ed I always learn something.

PS. Rating catalans' well-being by OECD.

Ricard Molina. Muntaner-Velódromo. Galeria Barnadas

An illusionary free lunch

Some months ago I started a series of posts under the title "Fasten seat belts". The topic is well known, how new skyrocketing drug prices are distorting budgets and access. Yesterday we got the final resolution. Fasten you seat belt, this is the moment of truth: The government has decided that hepatitis C patients under specific conditions will get treatment. And once he has decided coverage, he concludes that he will not pay the bill. Somebody else will have to do it, autonomous communities governments. Free lunchs exists in Sepharad!
This is a complete mess and it is only the begining, new drugs are knocking at the door. For catalans, this foreign decision represents 470 m €, an additional deficit for the 2015 budget of 5.7%!!! (if all expenditure were charged in one year). Does this make any sense?. Of course Basque country is not included in such arrangements...
There is an objective need to disconnect, the time is getting closer. Things couldn't have been done worse.

Fasten seat belts (3)

My former posts (1) and (2) alerted about the end of drug pricing as we have known and the begining of an opaque world where nobody knows how much money is involved in getting the value of a specific drug, except the manufacturer. The rationale for that are the confidential agreements between governments and drug firms. Up to now have been seven risk-sharing agreements, and beyond these, central government has set up additional five agreements. This latter agreements are really open-ended budgetary ceelings because it is difficult to estimate when the maximum amount is reached. This is precisely what it is explained by the official in charge of this issue in the journal.
Therefore we have changed the pricing system for an opaque open-ended budgetary ceeling system. It sounds incredible, but that's how it is. I can't believe that nobody worries about it.

PS. Genes and behaviour, on TE. I posted the initial research three years ago in this blog.

Germline editing: fasten seat belts

The Case for Remedial Germline Editing—The Long-term View

We conclude that so long as heritable genome editing interventions are consistent with the welfare of the future person and with social justice and solidarity, they do not contravene any categorical moral prohibition.
Nuffield Council on Bioethics (2018)

This statement changed the existing bioethics view on genome editing. From then, the door is open and nobody knows exactly what does it mean.

In this article, the authors open the possibilities without knowing exactly its implications:

 Two technologies under consideration to tackle this challenge are preimplantation genetic diagnosis (PGD) and remedial germline editing (RGE). Preimplantation genetic diagnosis is an established diagnostic technique, widely deployed today to identify a genetic defect in embryos created through in vitro fertilization, with the goal of transferring only embryos lacking the defect to the mother’s uterus. Remedial germline editing is a novel therapeutic paradigm that has has yet to be applied in the clinic to correct a heritable deleterious mutation in a fertilized egg. We predict that, in time, safe and efficacious RGE will eclipse PGD, the relative shortcomings of which are becoming increasingly apparent.

The final reports of the International Commission on the Clinical Use of Human Germline Genome Editing and the World Health Organization’s Expert Advisory Committee on Developing Global Standards for Governance and Oversight of Human Genome Editing are due later this year.
Meanwhile, take care!

Fasten seat belts (3)

In former posts I have argued that pharmaceutical pricing is forging a new trend. The summary is in this figure (US prices):

The latest FDA approved drug is Harvoni, for hepatitis C. This new drug will compete with Sovaldi, the best drug launch ever made by the same manufacturer, 9.000 million $ in sales in 9 months.
The soaring costs of drugs is also affecting the generics market in US. Have a look at this blog.
As far as the economy is not growing at the same pace, new resources are needed and this may come from reductions on current drug benefits (price or quantity) or less expenditures in non-pharmaceutical goods. Otherwise the option is to delay access. Is this an option for cost-effective therapies?

Fasten seat belts (2)

Let me ask you a question: Do you agree that your government spends 12% of the pharmaceutical budget in a new drug? I understand that if the answer is yes, you also agree to reduce 12% of current expenditures in patented drugs, reducing quantity, price or the benefit. Otherwise you have to explain clearly where to find 12% of additional resources.
This is what is happening in the UK NHS on new Hepatitis C drug. Have a look at this site for the details. And by now the decision is that it is "prohibitive" and "unaffordable".
Last Sunday CBS 60 minutes broadcasted an interesting report on "eye popping" cost of cancer drugs. I suggest you spend 15 minutes of your time watching it:



Don't miss the details on "financial toxicity" as WSJ highlights. How this can be true?
Nearby, new drug benefits are approved without any known cost-effectiveness-budget impact consideration. This is an example of  alleged "responsive government".

PS. My former post on the same issue.

PS. On bribes, again.

PS. Today this blog has reached the 100.000 visits. That's excellent!!!. I really appreciate your interest in my posts.

Fasten seat belts (4)

The times for drug prescription following prioritisation have arrived. Hepatitis C drugs have paved the way for such a move.There were some informal attempts for certain medicines and it was decided by clinical committees (i.e. for rare diseases), but now it has changed. The government has decided who has to get what and when, this is absolutely new. Have a look at this draft of strategic therapy for Hepatitis C treatment.
Any physician asking for hepatitis C drugs will have to explain the compliance with the criteria and ask for approval.
I said some weeks ago that a new paradigm in drug pricing was starting, right now I have to say that drug prescription priorisation by rules is the new trending topic, at least in our neighbourghood. Wether this prioritisation is based by cost-effectiveness criteria remains to be seen.