The University of California San Diego, Skaggs School of Pharmacy and Pharmaceutical Sciences Drug Commercialization course brings you lectures from both faculty and industry experts. With this course, recorded on campus at UCSD, we seek to share our access to top people in the field who bring an unprecedented range of expertise on drug commercialization. This course will cover pharmacoeconomic, marketing strategy, intellectual property strategy, portfolio management, managed markets and strategic alliances. It will also have a lecture case study from startup to success. In addition, the course will discuss post-marketing clinical trials or Phase 4 trials. These are conducted after a new drug has been approved by the regulatory agencies and launched. In these studies, the new drug is prescribed in an everyday healthcare environment using a much larger group of patients. This enables new treatment uses for the new drug to be developed, comparisons with other treatments for the same indication to be made, and determination of the clinical effectiveness of the new drug in a wider variety of patient types, and more rare side effects, if any, may be detected . Pre-marketing strategy should be instigated as early as Phase 1 clinical trials to ensure that the market's needs are incorporated into the new drug's overall development. Later phases when clinical results are presented at international medical conferences the marketing strategy is then refined in order to develop an awareness amongst the medical community who will be prescribing the new drug. In addition to the marketing strategy, pricing strategy and a tactical plan will be developed. Promotional material, and the sales force will be trained so that when the product is approved they can promote the drug to physician, pharmacist and nurses. This course is intended as part 3 of a series: Drug Discovery (https://www.coursera.org/learn/drug-discovery), Drug Development (https://www.coursera.org/learn/drug-development) and Drug Commercialization. We would highly recommend that you take the courses in order since it will give you a better understanding on how a drug is discovered in the lab before being tested in clinical trials and then launched in the market place.
Pharmacoeconomics in Drug Development I
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Del curso dictado por University of California San Diego
Drug Commercialization
135 calificaciones
De la lección
Pharmacoeconomics in Drug Development, Jan Hirsch, Ph.D.
Conoce a los instructores
Williams S. Ettouati, Pharm.D.Director, Industrial Relations & Development; Health Sciences Associate Clinical Professor, N.S.
Skaggs School of Pharmacy and Pharmaceutical Sciences
Joseph D. MaAssociate Professor of Clinical Pharmacy
Skaggs School of Pharmacy and Pharmaceutical Sciences
Welcome, to the class I'm Jan Hirsch. I teach at the University of California
San Diego. Skaggs School of Pharmacy and
Pharmaceutical Sciences, very long name. there I am responsible for a class in
pharmacoeconomics and also I teach in the area of health policy and healthcare
systems. Prior to my academic life I have been
involved for many years in the pharmaceutical industry.
So I have worked both on the developmental side you know the clinical
research side. R and D side and also in the commercial
side and all of my experiences have been related to, pharmaco-economics or open
I'm going to talk about today, outcomes research.
Eh, and I have been, I have, I've done that for the U.S.
markets, then I've also done that for the Eur, mainly European, Australian,
Canadian markets. Haven't done a lot in, haven't done
anything basically in Asia so I can't answer questions about that.
So, okay. So, alright.
Let's get started. Okay.
So the objectives of what we want to cover today is,
I want to tell you about, what is pharmacoeconomics.
And give you some ideas of the types of pharmocoeconomic analyses that are done,
within the drug development process. And I'm going to show you some examples
and you can actually see some pictures. And I'm not going to show you all of the
research methodology behind all of these examples, I'm just going to sort of show
you the results. So you can get an idea of what the
pharmacoeconomic analyses are like. And then at the end, I want to leave time
to go through actually how to how the pharmacoeconomic process, research
process is folded into the drug development process.
Because you've been studying about that drug development process already.
Okay. So first of all what is
pharmacoeconomics? pharmacoeconomics is a field or a
discipline that is used by health care payers to really compare the cost versus
the benefit of alternative drugs. It could also be alternative devices or
alternative services but I'm going to be referring to it as with drugs since we're
talking about drug developments. a definition, another definition is
really looking at your balancing the costs of an intervention with the costs
of an intervention. Those consequences are also called
outcomes. In this whole field of pharmacoeconomics
the terminology there's several terms utilized to describe certain things.
So you'll hear people use different terms and that's why I've given a couple of
terms throughout the lecture. As I said, it could be comparing the cost
and consequences of products. Or it could also be of services.
So this could applied to I, I apply at my research to evaluating the value of
pharmacists services. But it could certainly be physicians
services, nurses services. It could be dieticians services.
All the methodologies are the same. It's just picking what the out, the
outcomes are, which we'll talk about. And picking what the interventions are
you want to look at. The cost equals the cost over some
outcome equals the value, you guys can see that from here.
the cost always stays the same. And we're going to talk about that.
But the way that we measure the outcomes changes over the types of
pharmacoeconomic analyses and I'll walk you through that.
But all the value is, it's always some sort of expression of what am I paying.
And what am I buying for that what am I getting for the money I'm paying.
This is a a form for economic grid a cost effective plane there are lots of other
types of grids like this that you'll see in the literature.
But this one I think is the easiest one to understand so the question is when do
you even need to do a pharmacoeconomic analysis.
So in the center we have a, a comparator. And let's say this is a drug that's
already on the market. And you're coming to market with a new
drug. So what's your most likely comparator?
We've put this in the center. And then you decide all right where's my
product in relation to this comparator? Or where is it likely to be because we
may not have eve, developed it yet? All right.
So, is it in the, top left hand corner here, on top of here we have
effectiveness and we have cost. Okay.
As we go up the the cost increases, as we go to the right the effectiveness
increases. So, if you're over here in this top left
hand corner, you've got your drug is more costly and it's less effective.
Do you want that drug? You really don't want to develop that
drug to begin with, right? But you could end up, because you don't
know how you're going to end up, right, in your clinical trials but this is not
where you want to be. Okay.
But if you do, then if I'm the payer, you're less costly, you're less, I'm
sorry you're more costly you're less effective if I'm the payer do I even care
about doing any kind of analysis? No I'm not going to do a pharmacoeconomic
analysis I'm not going to do anything. If I'm down here in this bottom right
corner and your new drug is less costly but is more effective.
What am I going to do as a payer will I like that I say sure bring it on you know
less cost more effective I'm I'm buying that you might want your drug to be
there. Where we normally see new drugs is in the
top right corner. You know, you you've gone to the trouble
in your company to develop a drug you hopefully are going to develop a drug
that is more effective. And you're reducing a charge a premium
price. So from the payer's perspective, your
drug is more costly and more effective. So what I've got to be able to do, as a
payer is I want to be able to trade off how much more costly and how much more
benefit am I getting from the greater cost.
And that's the trade-off. And that's where I would want to do our
pharmacoeconomic analyses. There's some reason to trade off cost and
effectiveness. If your drug is down here on the bottom
left hand corner, you're less costly and you're less effective, what do I think of
that as a payer? You cost me less but you're less
effective. [BLANK_AUDIO].
>> Do I want to buy your drug? >> Maybe.
>> Maybe, why when might I want to? >> Might give an alternative to the
less costly more effective because other options might be more costly.
>> Right. I might have other choices and that's a
good point. In all of these I'm usually looking at
one versus another. There may be other choices I want to put
in here too, okay? Just to simplify it.
But I also might think how much less effective is it?
Maybe it's just a little bit less effective for reducing the symptoms of
Rinitis, runny nose. Just a little bit less effective, okay.
Or maybe it's just a little bit less effective for reducing mortality rates.
That's a big thing, right? It sort of depends on what your outcome
is on whether that little less effective, how important that is.
All right. So, you don't normally end up in this
bottom left hand corner but you could. Most of what you're going to see you're
going to see pharmacoeconomic analysis between two drugs.
One's more costly than the other but it's more effective than the other.
And you're trying to balance, what am I buying with that extra money.
How much benefit am I getting? Alright.
There are just to put this in a big global perspective from a drug
development standpoint, there are pharmacoeconomic PE requirements across
most countries now. And so, there are countries that have
published recommendations, there are countries that have guidelines.
This on the submission guidelines. They call them different things.
But all it is, is really if you are a drug company and you have a new drug.
You have to submit a docier to the decision makers in the country.
And the docier has to include pharmacoeconomic data.
It has to be able to say, alright you're asking this price, what are you giving me
for this price? What's the value of your product?
You know, what is better than the other product?
So it's beyond just the clinical data, clinical safety and efficacy.
It's economic and quality of life data. And that's what I'm going to show you
some examples of. So it's not just an exercise, an academic
exercise. This is absolutely required to get your
drug marketed and to be reimbursed. You can get your drug approved in certain
countries to be marketed but the country will not pay for it.
It's not reimbursed yet until you submit a pharmacoeconomic, dossier and it's
accepted and your price is accepted. Okay, so here's a model.
This is called the ECHO model, on the bottom here.
ECHO model is the Economic, Clinical and Humanistic Impact model.
And it sort of sums up the whole thing with drug development and what we're
trying to do with pharmaeconomics. So every clinical trial starts with a
disease state. And it combines a group of patients with
the disease state with a drug and we observe some clinical effect.
And the clinical effect we observe is safety first, were there any huge adverse
events, you know, are we doing any harm to the patients first?
And then if we're not then the next thing to look at is efficacy.
Does the drug actually work? Is it producing a reduced symptoms or
improved mortality, improved morbidity? So this is where your typical clinical
trial ends, all right. But then the pharmacoeconomic part comes
next and says, okay. Because of those safety and efficacy
effects that I observed, what happens? So what?
And the so what is so what happened to the humanistic outcomes?
This is health related quality of life. Yeah, what happened to the patient's
quality of life because of the improved safety and efficacy?
What happened to their satisfaction? You know, and economic outcomes.
Because of this improved safety and efficacy, what happened to economic
outcomes? Direct costs, we divide this up into
direct costs and indirect cost. Now I'll show you some examples of these.
But the whole point is this clinical safety efficacy is driving the humanistic
and economic outcomes.
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