Re: Experimental? Well...that depends....

[Guest guest]

>

> Dan,

>

> You said you were denied your request for Proton Therapy by your

HMO. May I ask the name of your HMO? We have just applied and we were

told they would only pay 80% because the doctor is out of network.

>

> Sheila

It's a " small " HMO, Group Health of Southern Wisconsin. They have a

number of local clinics, and contract with the UW Health system for

surgery/radiation, etc. Easy to be " out of network " with them. Leave

Southern Wisconsin, or use someone other than their clinics or UW Health.

Good luck to you and your husband!

Dan

[Guest guest]

- What makes this more interesting, is that I talked with my local " in

> > network " oncologist, who says that my HMO will cover my 12 session

> > helical tomotherapy treatment, a treatment that IS (NCI

> > protocol RO02803)

>

> I would appreciate it if Dan would supply further particulars.

>

> A quick check of the NCI website fails to connect to such a protocol.

>

> How about a URL?

>

> Thanks,

>

> Steve J

>

Try this one, Steve.

http://www.cancer.gov/search/ViewClinicalTrials.aspx?cdrid=452021 & version=patien\

t & protocolsearchid=4253567

My best,

Dan

[Guest guest]

On Februarry 29, Dan replied to my inquiry:

Quoting himself

> - What makes this more interesting, is that I talked with my local

> " in

>>> network " oncologist, who says that my HMO will cover my 12

>>> session helical tomotherapy treatment, a treatment that IS (NCI

>>> protocol RO02803)

Dan replied to me

> Try this one, Steve.

>

http://www.cancer.gov/search/ViewClinicalTrials.aspx?cdrid=452021 & version=patien\

t & protocolsearchid=4253567

Tiny URL = http://tinyurl.com/32pr3b

Now I'm really mystified.

Dan's reference is to a clinical trial of hypofractionation in IMRT tx.

There is no mention of tomotherapy.

The title of the study is, " Phase I/II Hypofractionated Radiotherapy for

Prostate Cancer. "

The trial summary is:

" The purpose of this study is to examine the clinical feasibility of

using IMRT combined with daily pretreatment prostate localization to

deliver increasingly hypofractionated treatment courses. Progressively

larger fraction sizes will be delivered in a phase I design based on

both acute and long-term tolerances to the treatment. The

dose-per-fraction escalation design utilizes schemas that maintain an

isoeffective dose for late effects, while predicting that tumor control

will actually improve. The delivery of fewer, larger fractions of

radiation, if proven effective and safe, would result in significant

cost saving and more efficient use of resources. "

Please clarify.

Thanks,

Steve J

[Guest guest]

>

> On Februarry 29, Dan replied to my inquiry:

>

> Quoting himself

>

> > - What makes this more interesting, is that I talked with my local

> > " in

> >>> network " oncologist, who says that my HMO will cover my 12

> >>> session helical tomotherapy treatment, a treatment that IS (NCI

> >>> protocol RO02803)

>

> Dan replied to me

>

> > Try this one, Steve.

> >

http://www.cancer.gov/search/ViewClinicalTrials.aspx?cdrid=452021 & version=patien\

t & protocolsearchid=4253567

>

> Tiny URL = http://tinyurl.com/32pr3b

>

> Now I'm really mystified.

>

> Dan's reference is to a clinical trial of hypofractionation in IMRT tx.

> There is no mention of tomotherapy.

>

> The title of the study is, " Phase I/II Hypofractionated Radiotherapy

for

> Prostate Cancer. "

>

Steve,

Tomotherapy is more a " brand name " for the image guided,

hypofractionated IMRT...as delivered by the Hi-Art Tomotherapy

equipment. Look here for more detail

http://www.tomotherapy.com/difference/whytomo/

In essence...all tomotherapy is IMRT, but all IMRT is not tomotherapy.

Make sense?

Dan

[Guest guest]

On February 29, Dan replied to me:

> Tomotherapy is more a " brand name " for the image guided,

> hypofractionated IMRT...as delivered by the Hi-Art Tomotherapy

> equipment. Look here for more detail

> http://www.tomotherapy.com/difference/whytomo/

>

> In essence...all tomotherapy is IMRT, but all IMRT is not tomotherapy.

> Make sense?

How about this, which I think is more accurate: Intensity-Modulated RT

is an improvement on 3D-Conformal RT, which was an improvement on the

wide-field RT methods of earlier days.

Image-Guided RT (IGRT) is an improvement on IMRT. It is profoundly

different in its means of administering the radiation, its power, its

accuracy, and its method of localizing the target for each tx session.

It is indeed a type of IMRT, improved as above. Just as IMRT is a type

of 3D-CRT, which is a type of wide-field RT.

However, we're drifting off topic and no doubt boring folks.

The point is whether tomotherapy/IGRT is " experiemental. " The topic of

the study Dan cited in support of that theory is hypofractionation of

IMRT tx, not IMRT itself; and certainly not IGRT/tomotherapy. I quoted

the summary in my post yesterday evening.

IGRT is more widely used as equipment, which is very expensive, becomes

available. I am acquainted with a rad onc who just bought his second

machine. This would not be happening if the tx were " experimental. "

However, I'm quite willing to be corrected.

Regards,

Steve J

[Guest guest]

Steve so much has to do with what is meant

by experimental. Since nuclear radiology has accounted for a large proportion

of the increase in medical costs there is pressure to show that they in fact

have a medical advantage in treating specific diseases. Then once the initial

tests are run they have to be verified so that it can be shown that the results

were not just chance.

From the NCI definition based on a drug:

experimental drug

(ek-SPER-ih-men-tul ...)

A substance that has been tested in a laboratory and

has gotten approval from the U.S. Food and Drug Administration (FDA) to be

tested in people. A drug may be approved by the FDA for use in one disease or

condition but be considered experimental

or investigational in other diseases or conditions. Also called

investigational drug.

Kathy

From: ProstateCancerSupport [mailto:ProstateCancerSupport ] On Behalf Of Steve Jordan

Sent: Saturday, March 01, 2008

1:19 PM

To: ProstateCancerSupport

Subject: Re:

Re: Experimental? Well...that depends....

On February 29, Dan replied to me:

> Tomotherapy is more a " brand name " for the image guided,

> hypofractionated IMRT...as delivered by the Hi-Art Tomotherapy

> equipment. Look here for more detail

> http://www.tomotherapy.com/difference/whytomo/

>

> In essence...all tomotherapy is IMRT, but all IMRT is not tomotherapy.

> Make sense?

How about this, which I think is more accurate: Intensity-Modulated RT

is an improvement on 3D-Conformal RT, which was an improvement on the

wide-field RT methods of earlier days.

Image-Guided RT (IGRT) is an improvement on IMRT. It is profoundly

different in its means of administering the radiation, its power, its

accuracy, and its method of localizing the target for each tx session.

It is indeed a type of IMRT, improved as above. Just as IMRT is a type

of 3D-CRT, which is a type of wide-field RT.

However, we're drifting off topic and no doubt boring folks.

The point is whether tomotherapy/IGRT is " experiemental. "

The topic of

the study Dan cited in support of that theory is hypofractionation of

IMRT tx, not IMRT itself; and certainly not IGRT/tomotherapy. I quoted

the summary in my post yesterday evening.

IGRT is more widely used as equipment, which is very expensive, becomes

available. I am acquainted with a rad onc who just bought his second

machine. This would not be happening if the tx were " experimental. "

However, I'm quite willing to be corrected.

Regards,

Steve J

[Guest guest]

>

> On February 29, Dan replied to me:

>

> > Tomotherapy is more a " brand name " for the image guided,

> > hypofractionated IMRT...as delivered by the Hi-Art Tomotherapy

> > equipment. Look here for more detail

> > http://www.tomotherapy.com/difference/whytomo/

> >

> > In essence...all tomotherapy is IMRT, but all IMRT is not tomotherapy.

> > Make sense?

Please, Steve, let's not abandon this... we need to beat this subject

to death, until we are all on the same page. I think I lost track

about page 254...

Ok: cut and pasted from some scholarly work...

" Three-dimensional conformal radiotherapy (CRT) involves the

application of novel imaging techniques in an attempt to maximize

radiation delivery to tumor and minimize the impact on surrounding

normal tissues. A next logical extension is to perform intensity

modulation radiation therapy (IMRT) -- a technique where the dose of

radiation to the tumor tissue is modified as treatment is delivered

using novel delivery systems such as multileaf collimators and portal

imaging . "

Then we make the Scan in real time, each session, and we have Image

Guided RT (IGRT)

Put deliver this wonderful product via a 360 degree helical system,

and we have " Hi-Art Tomotherapy " .

According to the oncologist, the " experimental protocol " is using far

fewer sessions than are considered standard for any other form of RT.

The standard, even for " Hi-Art Tomotherapy " has been about as many

sessions as IMRT/IGRT. 28-34. The dose escalation is the

" experimental " part of the protocol. If I did it, I'd be getting a

total of 12 treatments over a 2.5 week period. And you can bet I'll

post a blow by blow account of it here. Unless it hurts too much to

sit down.

From what I've researched so far, this dose escalation has good reason

to be better in terms of disease control and side effects. I'm still

looking to talk with some actual customers.

I expect my HMO to approve this, but it will be interesting to see if

they squirm at all if/when I point out that this is " officially " an

experimental treatment, which was grounds for rejection for

protons...which is not an experimental treatment.

For some reason, this all strikes me as funny. But then again, I've

been accused of being easily amused.

My best,

Dan

[Guest guest]

The difference is that they will probably

cover treatment that is part of an organized clinical trial. Is helical

tomotherapy treatment a clinical trial?

The cost vs benefit issue is probably the real

cause. When you have a clinical trial the cost is partially covered under other

mechanisms and the benefit is great because of the information gained through

the trial. By law they cannot reject people for participation in clinical

trials in many states. If you were entering a clinical trial on protons

treatment would probably be covered.

Do you have their definition of

experimental? May help if you ask for it.

Good luck with your appeals.

Kathy

From: ProstateCancerSupport [mailto:ProstateCancerSupport ] On Behalf Of roadlessgraveled

Sent: Friday, February 29, 2008

8:46 AM

To: ProstateCancerSupport

Subject:

Experimental? Well...that depends....

Hi Everyone,

My HMO denied my request for proton therapy, on the grounds that it

is, (in the opinion of the one MD who reviews these things)

" experimental " . I've submitted an appeal directly to him, and he

again

denied it. My next step is a formal appeal, which is reviewed by

others not associated with that original MD. Of course Proton beam is

NOT experimental.

What makes this more interesting, is that I talked with my local " in

network " oncologist, who says that my HMO will cover my 12 session

helical tomotherapy treatment, a treatment that IS experimental (NCI

protocol RO02803)

So what is it, HMO folks? Whole thing would be funny, if it wasn't my

butt. Literally.

My best,

Dan

[Guest guest]

>

> The difference is that they will probably cover treatment that is

part of an

> organized clinical trial. Is helical tomotherapy treatment a

clinical trial?

Hi Kathy,

No, the equipment is not " on trial " , the dose escalation is the

" trial " . The shift from 28 or more sessions to 12 or 15 is a

substantial change.

If they can deliver the same or better results with half the sessions,

obviously the cost is reduced.

What gets interesting is when the economic interests of the insurers

starts pushing around the quality of life interests for the insured.

One could imagine the conversations... " so we save 45% in treatment

costs, and it only increases rectal bleeding by 25%? Sounds like a

good deal to me "

They have since backed away from their original reason for rejecting

protons as " experimental " . I'm not at home now to review the

correspondence, but it appears they have opted for a more

" traditional " denial approach...(out of network, equal treatment

available in-network, etc.)

That one is harder to argue with, as protons have been proven to be

equal in efficacy in stopping the disease, but not conclusively proven

to have fewer side effects. So far there are no " head to head "

comparisons of protons to HiArt Tomotherapy.

Considering that I have access to a " World Class " radiation oncology

provider with the UW Carbone Comprehensive Cancer Center, they can

make a strong claim that I have access to top shelf treatment in-network.

I'm still a " believer " in proton beam as the best known

treatment...but it may be that HiArt Tomo is an equal...but it has not

been used long enough to know that yet. I'm looking to talk with

customers before I make any decision.

It is curious that so many of the people who got treatment at Loma

so actively champion Proton Beam. Many books are written about

the experience, there are large active groups online and IRL dedicated

to the treatment, etc.

There is no equal enthusiasm among those who got other forms of

treatment. Is the a " proton beam " phenomena? OR a " Loma "

phenomena? Will those who have proton beam treatment elsewhere join

such groups? Write books?

My best,

Dan

> The cost vs benefit issue is probably the real cause. When you have a

> clinical trial the cost is partially covered under other mechanisms

and the

> benefit is great because of the information gained through the

trial. By law

> they cannot reject people for participation in clinical trials in many

> states. If you were entering a clinical trial on protons treatment would

> probably be covered.

>

>

>

> Do you have their definition of experimental? May help if you ask

for it.