WIN Symposium 2013

Demonstrating the value of genomic cancer medicine

Dr Scott Ramsey - Fred Hutchinson Cancer Research Center, Seattle, USA

The context I presented was the reality that we’re going to, in the world, have a huge increase in the number of cancers in our population, partly due to the aging of the population and also the growth in the population. What this means is over the next twenty years we could see in some countries a 50% increase in the number of cancers. The problem is, of course, all those cancers are very expensive to treat and the cost of treating those individuals is rising, in some cases exponentially over time. This is straining both public and private health systems and their ability to pay those very high prices.

So you talk mainly about the situation in the United States where you have funding, how do you see that the drug companies are going to deal with this?

It’s unclear to me yet how drug companies are going to deal with this problem. They’re currently working under a model where they’re trying to maximise revenue on individual products which, of course, is a business model which makes sense for them. The problem is that currently, especially in the US, the access to these drugs is essentially open and they’re being used in settings both where there’s high evidence of good value but also in settings where there’s very low evidence or there’s evidence of little or no value. In those latter cases we’re spending quite a lot of money and not actually helping patients. So we’ve got to find a system where the drugs can be developed to their high value but also ensure that those products are only given to patients where they actually have a strong benefit.

You talked a little bit about the system that works in the UK, the NICE system, and you gave some examples. Do you see something like this could actually start to happen in the States?

In the public sector I don’t think in the near term there’s going to be a NICE-like system where we establish cost effectiveness thresholds and we make choices about approving or not approving or giving access to cancer drugs based on that. There’s a strong cultural resistance in the US to such centralised decision making. Now in the private sector where much of the care is delivered there have been some innovative models where cost effectiveness analysis has been used. Instead of denying access what happens is the price that the patients are being asked to pay varies depending on the value of the product. So very high value products, the price is actually reduced or the co-pay is such that the patient may actually pay nothing for the drug but in very low value situations the co-pay and the price that the patients eventually pay could be quite a bit higher.

In the scenario of personalised medicine where now lots of new drugs are coming out, how do you think this is going to change?

The central conflict for personalised medicine is that it is by its very definition making the number of patients that are eligible for particular therapies or combinations smaller and smaller. So for manufacturers that poses the dilemma of having development costs that could be still quite high coupled with a market that actually shrinks rather than expands over time. So that leaves them with difficulties in terms of managing their risk. The way they’re dealing with that right now is by charging very, very high prices and then hoping in the future that they can expand the indications for that product. But for individual patients, what it’s leaving them with is alternatives between generic therapies which have been used traditionally and are very inexpensive and branded targeted therapies that may help them but are much, much more expensive.

One question you had after your presentation was that maybe the numbers won’t reduce, that if you take a single mutation across different types of cancers you could actually not increase but significant increase over a certain type of cancer. How would you respond to this?

I think this is the great hope that for pharma they can use these new technologies to find common pathways across cancers where their products could be used. Of course they’re still going to have to go through the FDA process of one drug, one disease, one setting. What conflict that sets up with them and the payers is that when they go out and develop evidence in a different cancer for which they were approved, that evidence may not be of the same level or quality that the FDA require and it could put them in conflict with manufacturers who say ‘You haven’t developed good evidence even though you did for colon cancer, for breast cancer you don’t have that same level of evidence so we aren’t going to pay for it.’

Some researchers now are pulling up some of the older drugs that have been used for other types of diseases such as metformin which is used in diabetes is now showing… What about some of these drugs coming back into play?

To the extent that those drugs work on pathways that are in the tumour cascade that’s a very promising development. The trick, of course, is finding someone to come up with the money to pay for those trials because those are generic drugs and by definition there’s no manufacturer that’s necessarily interested in investment in a drug that’s very inexpensive. That’s where I think governments have to step in and help provide the funding to allow researchers to generate that evidence.

One point I think you made is that in the States the Medic Aid, is it called Medica…?

Medicare.

Medicare, they can not negotiate on prices of drugs?

That’s correct.

Do you think this will remain like this?

That’s an area of quite a bit of political controversy right now. I would say in the long run that that system has to change because it’s simply not supportable and when you look at the price increases that are going on over time, Medicare just can’t afford to pay those prices given that the elderly population is the fastest growing population in the US. The budget for Medicare is the fastest growing budget in the entire US public sector and it’s crowding out every other sector. They will have to find ways to lower their exposure to that increase and negotiating on drugs will be a piece of that puzzle, I predict.