Trying to find the fly in the ointment.

[Conductor71]

Hi all,

I am going to jump into the ring here. Let's brush emotion aside and apply our good common sense.

End stage- I am not sure why we are hung up on this. If you look at the ads for Duodopa and especially the "how to" videos by Europeans who have the pump, the age range is 30's on up. People were living in their homes not institutionalized. End stage means feeding tube. Why would an insurance company dole out all that money for a person nearly bed ridden likely to catch pneumonia or aspirate- do not mean to offend but I can't see that happening.

Clinical trial- I have met young onset patients online who have the pump as part of clinical trial. Why would they not just be testing it with end stage people if that is only who gets it?

Sky-high cost- I suspect that it will be high at first but predict that as more people see it as an alternative to DBS, the prices will come down.

If not, we can make argument that in bigger picture this is better for everyone as it reduces number of people going into assisted living or nursing homes. Keeps people independent longer and reduces disability this means less government subsidy like SSDI. With the pump, I most likely would not have lost my livelihood. The med side effects were what impacted my work performance (for most part was not PD).

I am thinking this may help drive down cost too.

What is so freakin expensive anyway, the gel? The markup must be like 400%!!!

[Conductor71]

Originally Posted by lurkingforacure

Ok, so if I dissect this, you cannot get this in Canada unless you

1. have ADVANCED PD (this will probably mean that you are really bad off)-to me, this seems like a very good way to significantly limit this option only to those who they expect will not need it very long
2. your PD responds to ldopa
3. you have to be able to show that you have tried all the available combinations of PD meds and that they were not sufficient to obtain "satisfactory control" (aka we-are-not-giving-this-to-just-any-PWP)...in other words, if someone decides that you get "satisfactory control" with drugs, you will not meet the criteria to get this treatment
4. you have motor fluctuations that are not only severe (again, who gets to decide this, what may be severe to the patient may not be considered such by the person making the decision (and I doubt that person will be the patient's doctor, that decision-maker maybe won't ever have even seen the patient, but I'm cynical)...so they have to be "severe" as well as "disabling", again, a subjective definition. What is disabling to a patient might not be considered disabling to a healthy administrator sitting behind a desk reading application after application....again,

I can see those purported justifications now:

PD not advanced enough
motor fluctuations not severe or disabling enough
drugs are working well enough to control satisfactorily said fluctuations

LFAC

I feel your skepticism, but let's look at a couple of things.

What is ADVANCED PD? We all have advanced PD. I would say by the time we show motor signs we are all "advanced." How is this measured? Normally by that Hahn& Yoer number 1-5 but I think in this case they will look at meds as a determining factor.

The trouble with meds. The amount of medication we take puts us on the razor's edge of being functional/normal and a Sinemet eating dyskinetic freak side show. There have been no studies that prove that the more medication we take the more advance we are. This is a myth. Personally, I have had varying doses of meds and functioned asymptomatically first on 12 mg of Requip XL then down to 8 mg- I am still getting same coverage at the lesser amount 3 years later- the 12 or 8 mg of Requip did not alter my Sinemet one iota. How in the world can we use amount of med as a measure of disease progression or severity?

I think advanced does not force you to try every possible drug cocktail out there first. What works is taking high daily doses of levodopa. When you do that the motor fluctuations start as does dyskinesia. These are signs of dopamine excess not disease progression per se. If you do not believe it check out the statement from Abbott UK:


The reduced fluctuations in the plasma concentration of levodopa reduce fluctuations in the treatment response. The levodopa dose needed varies considerably in advanced Parkinson's disease and it is important that the dose is individually adjusted based on the clinical response. Development of tolerance over time has not been observed with Duodopa. On the contrary, many patients, after a period of satisfactory treatment with Duodopa, may find that a lower dose of levodopa will provide a satisfactory clinical response.

Further support on that last statement:

It is less disease progression and more tolerance levels that result in need for increased ldopa doses and dopamine excess. Our bodies still react to same dose but our brain has been told otherwise. Shhh!! no one wants us to know that our bodies stop producing what is being provided for it and that in overstimulating our dopa receptors we essentially shut them down- paradoxically we then start requiring more and more of the substance to get same relief (or kick). This is the same as a drug addiction.

My neuro: "DBS resets your clock with Sinemet"

There we have it. Both are invasive treatments to manage drug dependence. I prefer the one that does not invade my brain, thank you.

In all actuality, I think that who gets the pump will be decided by our doctors making a good candidate profile for us, much like for DBS. In essence, your symptoms play a part too but you need to push your candidacy if you prefer the pump. In other words, if you have anything remotely contraindicating DBS, do not downplay it. Things like anxiety, depression, freezing, speech, and balance issues can cast shadows on your DBS eligibility (our they should). They will screen you with a mini mental exam so forgetting how to draw the face of a clock can be helpful for your case. Seriously, you have to work with your doctor on this.

Let's all hope this is the case.

[daniscott]

Originally Posted by lurkingforacure

I would be very curious to know just what those "conditions" are....I have read that in other countries those "conditions" are that you have to be so bad off that it is cheaper to give you this than pay for your stay in a nursing home...gee, thanks so much. If they make you wait that long, years, decades even, what kind of a choice is that?

Even if one places financial gain over individual health, it wouldn't make sense to delay installment of the pump. For one thing, since nearly everyone with Parkinson's will, at some point, be bad enough off to need to stay in a nursing home, they would simply be delaying the bill, and in the meantime with the symptoms increasing at a more significant rate than they would with the pump, medical bills are piling up faster as well. So it may be more expensive to wait, and its certainly not cheaper - in the long run - to wait. Second, the fact that this treatment is so superior to oral dosages, would leave people physically capable of working, and adding financially to society.

BTW - I'm not arguing with you here, and I don't doubt that this is the claim that is made by those who delay the treatment. I'm just saying that their logic is flawed even if they are looking at it from a financial standpoint rather than a human rights stand point. I imagine that, while many people could be fooled by this argument, the people who enacted such a policy are well aware of it. It makes me wonder what their real reasons are for wanting to delay.

[Jim091866]

Sweden did a study over an interim short term that showed the duodopa therapy was NOT cost effective. They then did a long term study and granted approval stating that it was clearly beneficial. I did not have access to the full article but I propose they then factored in data on the impact to social services, demand on hospital stays and costs associated with long term caring for a parkinson's patient.
I don't know about the healthcare system in Sweden. But if it is a social medicine system, they are paying for it and they STILL said it was beneficial!

WHAT'S UP????

[lurkingforacure]

Thanks all for those points. I read what I posted based on reading posts from a British forum and it was pretty eye-opening. The gist of the thread was that there is a cost-analysis where they add up how much it costs to treat your PD now (whether you are in a nursing home or at home, getting ssdi, welfare, etc., or whether you are still able to work, cost of meds, etc.) vs. the cost to give you the pump and supply the monthly gel inserts. Unless you are working in a very lucrative job, almost every situation will result in the pump costing more on an annual basis (120K for those inserts) than taking meds, or even having DBS.

I remember that the posters were all complaining that they had been told they were not "bad enough off" and their requests for the pump were denied. I can totally see this happening here now that we have this new health care system, and I dont' want to get into politics but we all know there are only so many tax dollars to go around and you can only raise taxes so much.

So....I see everyone's points, and hope you are right. But when this much time has passed in the US, and the product has been available in other countries for over a decade, and the US has apparently made it so difficult to enter this market that the company almost scrapped plans to do so....something else is at play here. Let's hope they work out the power struggles (ie, money) so this becomes available to all.

[lindylanka]

As this is at the moment, for the vast majority of patients, a hypothetical treatment, i.e. either it has not been approved, or it falls outside of our means, dependent upon what healthcare system we live under, I think the real question to be asked is why this treatment is so phenomenally expensive. It would seem from all the literature that the actual placement of the pump is relatively affordable compared with the gel inserts. So what exactly is it that makes these inserts so expensive. L-dopa is a fairly cheap drug. I am assuming that the gel adds some potential for slow release. But this would negate the need for a slow delivery pump. Duodopa gives a different result to drinking a 'liquid sinemet' sippy drink, so the assumption is that the pump delivers direct to the best site for uptake of l-dopa and bypasses the digestive process, which is why it wouldn't work the same with a naso-gastric tube either.

I think there is a great need for clarity for the PD community on this. There is profit that is development related, but this has been around in Europe for a reasonable time now. The US issues seem to be about re-designing the delivery system. The cost of the inserts in both regions seem disproportionately huge.

These are questions that need to be asked. For instance, given that the main problems that lead to one needing this kind of device are not strictly speaking related to the disease, but the treatments for it, i.e. dyskinesias, l-dopa sensitivity, and related physical discomfort and damage, withholding a treatment or making it out of reach for most people seems to have not only a cost (personal, social, economic) implication, but an ethical one as well.

One has to think what this would mean, not just to someone from a developed country, but also to people in the developing world. Such a treatment would not go to those in most need, but those who could afford the astronomical cost.

So one has to ask again, what makes the gel inserts so extremely costly.