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Synagis guidelines revised by AAP??

Our Medimmune rep was in our office today telling us that the AAP has
issued revised guidelines for the use of Synagis that drastically
curtails who will receive the drug--revisions supposed based upon cost
analysis rather than new efficacy findings. I've been Googling, etc. and
haven't found anything yet.

Any of you AAP members know about this? If you find a link to the
official revised guidelines, please forward.

Thanks,

--
Gary Mirkin, MD

http://alliedpeds.com/

Synagis guidelines revised by AAP??

Coincidentally, one of the Red Book editors, Sarah S. Long, MD,
FAAP spoke at our annual chapter meeting yesterday and addressed this.

It's not as simple as being based on cost rather than efficacy. They
were trying to find a balance, based upon the fact, as she explained
it, that there are no studies that show a single baby was ever
"saved" by Synergis... rather was demonstrated was "a 50% reduction
in hospitalizations" in the studied groups. The rest I suppose is supposition.

Regardless, the new regulations will appear in the 2009 Red Book
which comes out later this month. I don't have the hand out but gist
is the recommendations for the more premature infants remain the
same, but for the older ones it is different, including not giving
any shots after 3 mo. of age in the ~32-35 weekers and a cap of 5 for
any one.

Dan

At 06:45 PM 6/10/2009, Gary Mirkin, MD wrote:
>Our Medimmune rep was in our office today telling us that the AAP has
>issued revised guidelines for the use of Synagis that drastically
>curtails who will receive the drug--revisions supposed based upon cost
>analysis rather than new efficacy findings. I've been Googling, etc. and
>haven't found anything yet.
>
>Any of you AAP members know about this? If you find a link to the
>official revised guidelines, please forward.
>
>Thanks,
>
>--
>Gary Mirkin, MD
>
>http://alliedpeds.com/
>

Synagis guidelines revised by AAP??

Daniel I. Schwartz wrote:

> It's not as simple as being based on cost rather than efficacy. They
> were trying to find a balance, based upon the fact, as she explained
> it, that there are no studies that show a single baby was ever
> "saved" by Synergis... rather was demonstrated was "a 50% reduction
> in hospitalizations" in the studied groups. The rest I suppose is supposition.

Given all the MRSA and C. diff going around hospitals these days, in my
book I'd score a "save" as avoiding a hospitalization. OTOH, if
Medimmune is dumb enough to double the price of Synagis, particularly on
the heels of this AAP policy change, perhaps the company is getting what
it deserves. I just don't want to see more of these premies needlessly
hospitalized.

--
Gary Mirkin, MD

http://alliedpeds.com/

Synagis guidelines revised by AAP??

The biggest change is for those least needy. It's still 5 months of coverage, just like last year, for infants under 32 weeks of age. The decrease is for those 32-35 wks, who can "only" get it for three months. By the time a 35 weeker is 3 months old, he/she is term or nearly two months post-term.

There were several fat, healthy 35 weekers who were getting huge doses of synagis in my office last year because they "qualified". I welcome the changes, as I think this is the "chaff" that should have been separated before. I also had a 26 weeker who did receive synagis who was in the ICU for RSV in January...

The Red Book committee was under serious lobbying and pressure by medimmune a few years ago before they initially included this 32-35 week group. There was a cost-analysis done several years ago as well out of NC that, from a pure cost standpoint (not m & m) it was not worth it.

Brian

Brian Bowman, MD, PhD
Apex Pediatrics

-----Original Message-----
From: hidden@email-address on behalf of Gary Mirkin
Sent: Wed 6/10/2009 11:03 PM
To: 'Peds List'
Subject: Re: [PedTalk] Synagis guidelines revised by AAP??

Daniel I. Schwartz wrote:

> It's not as simple as being based on cost rather than efficacy. They
> were trying to find a balance, based upon the fact, as she explained
> it, that there are no studies that show a single baby was ever
> "saved" by Synergis... rather was demonstrated was "a 50% reduction
> in hospitalizations" in the studied groups. The rest I suppose is supposition.

Given all the MRSA and C. diff going around hospitals these days, in my
book I'd score a "save" as avoiding a hospitalization. OTOH, if
Medimmune is dumb enough to double the price of Synagis, particularly on
the heels of this AAP policy change, perhaps the company is getting what
it deserves. I just don't want to see more of these premies needlessly
hospitalized.

--
Gary Mirkin, MD

http://alliedpeds.com/

Synagis guidelines revised by AAP??

Another reason for you to join the AAP...

Herschel Lessin MD

Begin forwarded message:

> From: AAP COID
> Date: June 8, 2009 4:32:35 PM EDT
> To: "hidden@email-address"
> Subject: Ebreaking News: AAP Modifies Indications for Use of
> Palivizumab in High-risk Infants and Young Children
> Reply-To: "hidden@email-address"
>
>
> AAP Modifies Indications for Use of Palivizumab in High-risk Infants
> and Young Children
>
> Respiratory syncytial virus (RSV) is the most common cause of
> bronchiolitis and pneumonia in young infants. Based on additional
> data regarding the seasonality of RSV disease and the risk factors
> for disease severity in 32 through 35 weeks gestation preterm
> infants, AAP guidelines for immunoprophylaxis have been modified to
> ensure optimal balance of benefit and cost. The updated
> recommendations are in the 2009 Red Book (published in June 2009)
>
> The updated recommendations and major policy changes include:
>
> 1. Modification of recommendations for initiation and termination
> of RSV prophylaxis based on current CDC descriptions of seasonality
> in different areas of the United States.
> 2. Emphasis on need for no more than a maximum of 5 doses in all
> geographic areas.
> 3. Modification of risk factors for severe disease in infants born
> between 32 and 35 weeks of gestation.
> 4. For infants 32 through 35 weeks of gestation who qualify for
> prophylaxis based on presence of risk factors, prophylaxis is
> recommended until 90 days of age (maximum of 3 doses).
>
> For further details please see the article in AAP News Online that
> summarizes the recommendations and major changes present in the 2009
> Red Book (pages 562-568) and in the AAP Policy Statement soon to be
> published in Pediatrics.
>
> American Academy of Pediatrics - 141 Northwest Point Boulevard - Elk
> Grove Village, IL - 60007 - 847/434-4000
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Synagis guidelines revised by AAP??

Herschel Lessin wrote:

> Another reason for you to join the AAP...
>

Yes and no . . .

I'm eager to learn what studies if any the new recommendations are based
upon. Was this a purely economic-driven policy change (perhaps a preview
of Obamacare?) and if so, at what price point would we resume protecting
these patients? Or is there real data showing that the now ineligible
infants were not at an increased risk of hospitalization? I dropped an
email to my friend on the Red Book Committee to get his feedback--I
asked him what he would do if he had a child of his own who was now
ineligible under the new criteria.

--
Gary Mirkin, MD

http://alliedpeds.com/

Synagis guidelines revised by AAP??

This was based upon the data on Synagis that have shown it does not
save any lives and in infants born at 32-35 weeks gestation it only
decreases hospitalizations in infants under the age of 3 months. Did
everyone see that Medimmune just doubled the price of Synagis??

Jill Stoller, MD, FAAP
Managing Partner
Chestnut Ridge Pediatric Associates
595 Chestnut Ridge Road
Woodcliff Lake, NJ 07677
201-391-2020
201-391-0265 (fax)

On Jun 10, 2009, at 10:35 PM, Gary Mirkin wrote:

> Herschel Lessin wrote:
>
>> Another reason for you to join the AAP...
>>
>
> Yes and no . . .
>
> I'm eager to learn what studies if any the new recommendations are
> based
> upon. Was this a purely economic-driven policy change (perhaps a
> preview
> of Obamacare?) and if so, at what price point would we resume
> protecting
> these patients? Or is there real data showing that the now ineligible
> infants were not at an increased risk of hospitalization? I dropped an
> email to my friend on the Red Book Committee to get his feedback--I
> asked him what he would do if he had a child of his own who was now
> ineligible under the new criteria.
>
> --
> Gary Mirkin, MD
>
> http://alliedpeds.com/
>