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 II
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Drug Commercialization
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Pharmacoeconomics in Drug Development, Jan Hirsch, Ph.D.
与讲师见面
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
So here is a chart that, sort of, gives you some examples of exactly what is
direct cost, indirect cost and different variables are.
So, the economic sign. Or you can also call this resource
utilization because these are resources that we're utilizing, all right.
So direct costs are things like the drug, things that you actually outlay money for
and say all right, this is directly related to either the treatment or to the
disease itself. So the drug is directly related.
Physician visits, you're outlying money, hospitalizations, nursing time,
transportation if its all related to the disease or its treatment.
Indirect costs are in pharmaco, in pharmacoeconomics world just like an
economics either things related to productivity, right its not like an
accounting in direct cost. And accounting are lively overhead, lives
everything is taking to rent the building.
That's not what we're talking about in Pharmacoeconomics.
So indirect costs or, or productivity. Kay?
So that could be things like lost days of work.
reduced productivity of either a patient but it can also be like the provider too.
So it can be broadly interpreted. The clinical outcome are familiar with
things like safety. Those can be things like headaches
nausea. You know could be big things like stroke
efficacy, cured patients, number of saved lives.
Those types of variables. On the humanistic side the, the most
common humanistic outcome of measured that's quality of life.
Its health related quality of life, so its not everything to do with your
quality of life, I mean what kind of car you drive where you live, your
socio-economic status that is always have something to do with your health.
We're talking about the types of the pieces of your quality of life that can
be effected by your health status and I'll show you some example of that.
patient satisfaction could be with the treatment itself.
It could be with a provider, it could be with the system.
Those are all humanistic type outcomes. And then there is a whole body of
literature which I'm not going to go into today about patient preferences.
And if you know, if you can think back to your basic economics class, you kind of
remember things about utilities maybe. And there, there are ways that you can
measure utilities to say how much something is valued also but I'm not
going to talk about that to today. I'm going to stick with the quality of
life underneath the humanistic outcomes. Okay.
So I'm going to show you three examples and these are real examples from the
published literature. And the examples are going to show you
about direct costs, the things that are, you know, outlays of money.
And that, another example on indirect costs for the productivity effect and
then finally a quality of life example. OK, so here's a study and I, as I told
you I'm not going to tell you a whole lot about the methods, I'm going to show you
what the results were. Alright, this is a study in schizophrenia
patients, alright? And what they did is they looked before
and after Risperidone therapy initiation. And risperidone is a medication for
schizophrenic patients. if you know anything about schizophrenia,
it's, it's a difficult, it's a very difficult disease to treat.
It's also a very difficult disease to do clinical trials in.
finding the patients. Having the patients come back.
Being able to track the patients. It's difficult.
And, that, sort of, you can see that in the number of patients here.
This is a small trial. 36 patients.
And these 36, which is not unusual for this typical patient group.
These 36 patients, they receive risperidone therapy for greater than
seven months, some were up to seven, eight, nine months but everyone had taken
the therapy for greater than seven months, right?
And what the researchers want to look at were things not just the clinical safety
and efficacy effects. If it did have good effects on improved
symptom, symptomotology. The other things I wanted to look at were
the economics. Specifically they looked at
hospitalizations and what they found is that the change in hospitalizations from
before to after the number of days per year, was a 25% reduction.
Before the risperidone therapy that group of patients had an average of 1.7 days in
the hospital, versus 4.2 days after they had done the risperidone kit therapy.
So, I'm spending on the risperidone therapy but I'm saving hospital costs.
Okay? And they also looked at.
Not just hospitalization costs. They looked at other costs.
So the drug costs actually went up. Alright.
And the risperidone cost was $1889. But, they didn't need to use other
psychotropic drugs. So, those prices, those costs went down
by $587. So, the drug cost ended up increasing a
mean. A mean of 1322.
So I'm adding a new more costly drug. I'm offsetting some other drug
utilization. And so far, I'm saving some
hospitalizations. The cost, the decrease in costs.
The average cost for the hospital was 762 dollars.
And then there were also some other savings.
[INAUDIBLE]. residential day care.
Outpatient kinds of, care. Case management.
That they also cost it. There was a reduction in those services.
So there was savings in the reduced use of those services.
a mean of 868. So, in total, the reduction in cost was
$308 per patient. Right.
on average. So, what I have here next to the 308 is
like a little three, that's a percentage. So it's kind of a small percentage if you
think about it, 3%. I'd say, oh, that doesn't seem like so
much. Okay, but this is over just a seven-month
and nine-month period. is over one small group of patients.
Imagine you're a payor who is, especially if you're a medical, medicaid.
You have a large population of schizophrenic patients.
This savings can add up. Alright.
And so this is a study that, actually, the, the manufacturers use to, to say.
You know what? Our drug, risperidone, costs more.
But we're saving you money elsewhere in the health care system.
And that's kind of the whole point about pharmacoeconomics.
This is a, this is a great story. this is what you would like to be able to
say about your product. It doesn't necessarily have to be just
savings and drugs. It can be savings and other portions of
the healthcare system. Yes?
>> so this was done by this sponsor but how can you be sure that it's not biased?
Because they would like to show this data in a higher [INAUDIBLE].
>> They, they would love to show this data to get a higher reimbursement.
so the question is, how can I be sure that this, these data are not biased?
Alright. two ways.
One, I, as a, a reader of the literature and if I'm working for a payor and I'm
making these kind of decisions, I need to be able to analyse the, the study
methods. I need to know about the clinical
research methods, I need to know where the bias is in the clinical research, the
safety and efficacy. Because that's driving the economics,
right? But I also have to know about the methods
used for the cost analyses. And I, we, I can teach a whole class on
that because there are many, many different ways that I could've costed the
hospital days, I could've collected the data.
And that's a good point because the user of these data and looking at these
studies, you've got to be very savvy on the methods that were used by the, by the
researchers. Having said that, there are standards.
There are guidelines and standards that researchers should use and there is a,
there's an international, international society of pharmical economics and
outcomes research. It's called Ispor, I S P O R.
And you can go their website and ISPOR and you'll see they'll have guidelines
for this kind of economic analysis, quality of life analysis, satisfaction
analysis. And so when the papers are published, the
peer review process that medical journals use should be using those guidelines to
judge the quality of the, papers. But when a paper is peer reviewed, how
many peers normally review it, do you think?
Got any idea? >> Two.
>> Two and it just had two, I mean [INAUDIBLE] a lot of studies.
I am not an expert on every little thing that's in there and so I can slide
through, you know the reader. And the person you like, you going to
know which you are looking at be able to [INAUDIBLE] your self can't rely
necessarily on the [INAUDIBLE] process. Not just for [INAUDIBLE] economic data,
for clinical safety and efficacy data to.
