Pharmacoeconomics in Drug Development IV

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En provenance du cours de University of California San Diego

Drug Commercialization

172 notes

University of California San Diego

Drug Commercialization

172 notes

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.

À partir de la leçon

Pharmacoeconomics in Drug Development, Jan Hirsch, Ph.D.

Pharmacoeconomics in Drug Development III13:03

Pharmacoeconomics in Drug Development IV6:07

Pharmacoeconomics in Drug Development V8:03

Rencontrer les enseignants

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. Ma
Associate Professor of Clinical Pharmacy
Skaggs School of Pharmacy and Pharmaceutical Sciences

And the whole point is, what you want to be able to say is, that somehow or

another that your direct cost savings or the productivity increase that your drug

produces. Or the improvement in quality of life

that your drug produces is greater than the money that you're asking for your

product. And you would love to have a product in

which you, you could say all three of these.

Eh, but not necessarily going to happen. You would be happy with one of these,

probably. It's, it's great if you can say all three

of these. Okay.

So to, to make this sort of statements there are several types of

pharmacoeconomic analyses which I'm just going to show you so that you, you know

these terms. This is a table, as you go down, there's

different analyses types. The, it's all, except for the top one

it's just sort of a cost of illness. Okay.

They're all a cost over a denominator. So, cost minimization is cost over an

equal denominator that, the effectiveness of both th, of intervention is the same,

so all you have to do is look at the cost.

Cost effectiveness, which you see most, if cost over some natural units like the

number of patients cured, the number of, the percent with symptoms reduced.

If some sort of natural medical unit on the denominator.

Cost benefits, you've gotta take that denominator and say okay if it was number

of lives saved, I've gotta turn that into a dollar amount.

So now I've gotta put a dollar amount on those lives.

And you're probably going to argue with me of how I put that dollar amount on

there. And the last one is the one I just

alluded to is cost utility analysis. It's cost over QALY's or quality adjusted

life years. And you should probably argue with me

maybe not on the length of life, I might have measured that but how did I assign

the quality of life portion to that? So as you go down the table, the methods

get much more complicated. And the other thing that happens is the

uncertainty gets greater. Because it's, it's not as clear, the

methods are not as clear at the bottom of the table.

But you'll see all these types of analyses as part of pharmacoeconomic

analyses. I'll show you how you get the cost

effectiveness to cos, cost utility. So here's a drug, drug A cost $80.

Obviously it's not a real drug. 60% of people are cured.

Drug B costs $120. 80% are cured.

So it costs more but I buy more for it, right.

So but this is where a tradeoff is needed.

Okay, so I'm going to do my tradeoff. I'm going to do a cost effective

analyses, k, CEA. I take my $80 and divide it by my 60%

cured and I, I find out that it costs me $133 per cured patient for drug A.

Same thing for drug B cost me $150 per cured patient.

But what I really want to know is the incremental costs versus incremental

benefits. So I subtract my $80 from the $120.

The difference in the cost, the difference in the effectiveness.

And I find out really it's costing me $200 more per additional cured patient to

use B, okay. And so that's in naturals units now is

$200 a lot? Is it too much?

Is it too little? Is that a good deal?

From what I've told you. You don't know.

But for any of these things you really need some benchmarks.

You, you need something to tell you whether $200 is good or bad.

And there are different benchmarks out there in the literature and in your group

that you might be comparing to, your other products.

They might already have something that's, oh well, they're only $100 per different

cure. So you have to have something to compare

it to. If I want to change this to a cost

benefit analysis I take my $80 drug but I've gotta put the dollar value on the

60% of patients that are cured and so I'm going to tell you that's $1,000 per year.

That's the value. So my cost benefit is the 60% times

1,000. It's 80 every 600, and now I'm looking at

$0.13 cost per benefit, versus $0.15 cost per benefit.

That doesn't a make much sense to me cost per benefit although we call it a cost

benefit. You really kind of want to see what's the

benefit I'm getting for the cost. If turn them upside down and in this in

it's much easier to interpret. I'm getting $7.50 for every dollar I

spend on drug A. But I'm only $6.70 for every dollar I

spend on drug B. So it's just different ways to kind of

look at the analyses. Okay now I've put, I've done cost

benefits. Now if I want to go one step further and

change it to cost utility. I've still got the same two drugs.

I need to put the number of quality adjusted life years gained on the bottom.

So here's my 60% of patients and I'm going to tell you that these patients are

going to live 10 years but they're only going to be at 70% quality of life.

And I would have to measure this, I can't just make it up like this.

All right. so they're going to have 4.2 QALYs.

And my drug B, they're going to live longer 15 years but their quality of life

is going to be a little bit less. But they're going to end up with 7.2

QALYs. So if I take my dollar amount over my

QALYs it ends up that drug B is costing me a little bit less per quality adjusted

life year. And still left with the question, what's

a good value? I don't know whether 17's good, 19's

good. A benchmark that's used is $50 to

$100,000 per quality adjusted life year is kind of a good deal.

It's where most people would think okay, that's a good use of our resources as a

society. There are actual tables in different

countries would use cutoffs. And say no we are not going to reimburse

for that because it was a $150000 per quality adjusted life year.

We don't do that in the US as of now.

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