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Questions about RT and U.K. NICE Guidance
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myrightfoot 

myrightfoot 
Questions about RT and U.K. NICE Guidance

Hello! I am quite new to this issue of plantar fibromatosis. I have posted this on the Dupuytren Board, because there seems to be much more attention paid to DD over LD.

Naturally, I am concerned about finding appropriate treatment and insurance support in the U.S. I have reviewed the U.K. NICE's guidance and observed that they concluded that the efficacy of RT is uncertain, but that it does not raise any serious safety concerns; and hence they approved its use under controlled circumstances.

I see on the forum that some U.S. patients are being turned-down by insurers for reasons such as: "We have reviewed the documentation provided. The requested service is not covered for the following reason: Radiation for Dupuytren's Contracture is considered experimental and investigational. Evidence comes from observational studies, or from randomized, prospective controlled trials." Clearly, it does not help our cause with U.S. insurers that the U.K. NICE has basically taken the same position.

I am hoping someone here can address these questions concerning supporting insurance appeals:

(1) Since the literature search conducted by NICE was last updated in July 2010 - have they subsequently been made aware of Dr. Seegenschmiedt's results on long-term outcomes for DD and LD as presented at the Miami Conference in 2010?

(1a) Would these results hold up as “observational studies or randomized prospective controlled trials?” It appears that NICE considers Dr. S's earlier results (References #1 and #2) as randomized controlled trials. I'm not sure why the U.S. insurer specified "prospective" vs. "retrospective" trials.

(1b) If NICE has seen these updated/long-term results for DD, are they considering updating their guidance? If not, should these results be brought to the attention of NICE?

(1c) Has NICE been approached to consider the long-term outcomes study by Dr. S. on LD?

(2) It appears that Dr. S. is the only source for randomized controlled studies of DD and LD treatment. I can appreciate the difficulty in conducting such a study. Has U.K. Dr. Shaffer or any other U.K. researcher published any observational results to-date?

Lanod 

Lanod 
Re: Questions about RT and U.K. NICE Guidance

Myrightfoot,

Prof. Seegensmiedt published his work on MD and LD radiotherapy this year - 2012 - as a properly conducted Phase III clinical study. Some previous radiotherapy treatment studies in this field would be considered as Phase II studies. So this Phase III study must carry some weight - using a population of circa 500 patients and circa 750 hands, and using a minimum follow-up time of 5 years.

If you wish to message me with an email address I can email the PDF to you for this paper.

Lanod

alcook101 

alcook101 
Re: Questions about RT and U.K. NICE Guidance - NICE letter to Sir Dillon...

myrightfoot:

Hi

I wrote this letter in July 2012 to NICE:


12th July 2012

Sir Andrew Dillon
Chief Executive
National Institute for Health and Clinical Excellence.
MidCity Place,
71 High Holborn,
London,
WC1V 6NA

NICE GUIDANCE FOR DUPUYTRENS
RADIATION TREATMENT
ERROR IN GUIDANCE

Dear Sir Dillon

I believe that this guidance is incorrect and could lead to unsatisfactory outcomes of radiation treatment. The current NICE guidance implies that only of phase of 15Gy is sufficient for most cases.

NICE Guidance Nov 2010 IPG368 Radiation therapy for early Dupuytren's disease

The long term studies have shown that two phases of radiation are required for all treatments of Dupuytrens with an interval of 12 weeks, resulting in a total dosage of:-

5 x 3Gy = 15 Gy

12 week gap

5 x 3Gy = 15 Gy

Total dosage for all patients of Dupuytrens and Ledderhose for each treatment area is 15Gy + 15Gy = 30Gy.

I enclose recent email correspondence with Prof Seegenschmiedt, Strahlenzentrum, Hamburg on matters of dosage.


REPLY:
======

I did receive a reply which was crafted by an "External Communications Advisor" from NICE.

I won't type it out here as it took two pages to say "Yes, we've received your letter and might look into it in the future, but don't hold your breath".

The type of wording, totally lacking expertise, could have been straight out of one of those UK programs "Yes, Minister".

NICE were set up in the pre-internet era. Their role is to review published information and then publish a statement.

For those looking into radiation therapy it is likely each patient knows more than the advisors from NICE by the time they get on the plane for treatment.

Al


Edited 11/08/12 20:00

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