Sensipar, Fosrenol and Renagel/Renvela are Likely to be Negatively Impacted in 2

[okarol]

November 27, 2012 09:00 AM Eastern Time
Sensipar, Fosrenol and Renagel/Renvela are Likely to be Negatively Impacted in 2014 When
Oral Medications Become Included in the Dialysis Bundle, According to a Recent BioTrends

Report
EXTON, Pa.­­(BUSINESS WIRE)­­BioTrends Research Group, one of the world’s leading research and advisory firms for
specialized biopharmaceutical issues, finds that while very few changes in practice patterns have been made thus far in
anticipation of the inclusion of oral medications in the dialysis bundle, the scenarios that U.S. dialysis unit medical directors feel
are most likely in 2014 are an increase in the percent of dialysis patients on calcium versus non­calcium based binders, a
decrease in the percent of patients on Amgen’s Sensipar, and the availability of a wider range of calcium dialysate options.
From a non­calcium based binder perspective, Sanofi’s Renagel/Renvela and Shire’s Fosrenol are both expected to take a hit
with share shifts toward less expensive calcium carbonate, according to a new Special Report: Planning for the Inclusion of Oral
Medications in the Dialysis Bundle (US). The implementation of dialysis unit protocols, not currently standard practice for oral
medications, will likely help drive these product shifts.
The most commonly reported changes that have been made thus far in preparation for the
inclusion of oral medications in the dialysis bundle have focused on distribution strategies.
Both plans for how dialysis units will distribute oral medications and confidence in their ability
to distribute oral medications vary by dialysis unit affiliation. Medical directors primarily
affiliated with DaVita, for example, are most confident and those affiliated with free­standing
independent units are least confident in their ability to distribute oral medications.
“The consensus seems to be that the initial bundle implementation in January 2011 was not as
bad as many anticipated and that a number of dialysis units are either the same or actually
better off financially now than they were pre­bundling,” according to Associate Therapeutic
Class Director­Nephrology Rob Dubman. “But, many U.S. medical directors feel that the
inclusion of oral medications in the bundle may be more difficult. The high cost of oral
medications, the expected lack of adequate reimbursement, and the associated financial
burden to dialysis units, along with ensuring good patient outcomes and dealing with the logistics of dispensing oral medications,
are considered to be real challenges with the inclusion of oral medications in the bundle.”
Special Report: Planning for the Inclusion of Oral Medications in the Dialysis Bundle (US) is a syndicated report series that
provides a comprehensive view of the changes that are anticipated with the inclusion of oral medications in the dialysis bundle
in January 2014, and insights into how the nephrology community is preparing for and will handle this new dynamic. This primary
market research report is based on a quantitative survey with 170 dialysis unit medical directors and renal administrators. The
methodology also includes a qualitative component with medical directors and nephrology key opinion leaders.
About BioTrends Research Group, LLC
BioTrends Research Group, LLC provides syndicated and custom primary market research to pharmaceutical manufacturers
competing in clinically evolving, specialty pharmaceutical markets. For information on BioTrends publications and research
capabilities, please contact us at (610) 321­9400 or www.bio­trends.com.
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http://www.businesswire.com/news/home/20121127005294/en/Sensipar-Fosrenol-RenagelRenvela-Negatively-Impacted-2014-Oral

[cattlekid]

I figured as much. No for-profit LDO is going to allow their patients the binders that work best for them, we are all going to be shunted to generic calcium acetate until our CaPhos products get too high, and only then will we be begrudgingly allowed a different binder for a little while until it goes back down, then we'll be back on calcium acetate again. Just like EPO, just enough to get by.  Gone will be the days that you could manage your diet by taking a couple of extra binders with a high phos meal as I'm sure we'll only get enough binders for three meals a day and maybe one snack. I hope to God to have a transplant before then.

[Lillupie]

Does anyone know how this affects me?? My Tricare covers my meds.

Lisa

[cattlekid]

In 2014, Tricare will no longer be responsible for your phosphorus binders.  Just like EPO, you will get your binders through your dialysis clinic.  If you are on Medicare, you will have to pay 20% of the increased bundle payment amount, so if Tricare was paying meds 100% or very cheaply, your overall cost may increase. 

Does anyone know how this affects me?? My Tricare covers my meds.

Lisa

[Lillupie]

That is stupid because Medicare hasnt been paying for my prescriptions so far.

Lisa

[Rerun]

I don't get any of my oral drugs, including sensapar, from my unit. 

       

[Bill Peckham]

This was all part of the expanded bundle - the rule came out in Oct 2009 and there was a lot of comment activity against including oral drugs aka binders/calcimimetics. Just about every comment - over 1,200 - said it was a bad idea. Due to the comments CMS delayed it until 2014.

The fact is, as this report says, most units are doing better financially post bundle because the bundle anticipated that EPO doses would go from ~5700u per treatment to ~5,000u/treatment. What's happened is EPO doses have gone to ~3,000u. That's $20 worth of EPO that medicare thought the bundle would have to buy that it doesn't. There seems to be an idea that this same over use is going to be found in other meds but I doubt that is the case with these particular meds.

I don't think any one knows what an appropriate level of binders/calcimimetics use looks like, or how it would be monitored. Bone health/bone measures are very tricky. But yeah, come 2014, the expectation is, if you are Medicare Primary, your unit will be responsible for your bone health and thus your binders/calcimimetics meds.

You also might hear this come up as part of the fiscal cliff austerity crisis negotiations. The Senate Finance Committee might look to capture savings from the lower EPO use (however, advocates will note that Amgen has raised the price of EPO and Iron use is higher. And some units will be able to make the case that the bundle gives them flexibility to improve anemia control through the use of nursing, working one on one with patients to address issues that makes anemia harder to manage).

[sullidog]

my dietition has been talking about this 1 on 1 with every patient, this will be interesting as I can't take cal based binders at all as they make my cal go through the roof, you combine that with the zemplar I get and yes you've got a big cal jump. My dietition said that this will also take care of  recent reports of mailin farmicies having their patients getting their medication stollin off their portch, which that I can see that happening.

[lmunchkin]

I havent recieved any notices of any of this?  Maybe its down the pike!  Who knows, we'll deal with it when it arrives.  For now, Im just not going to stress over it.  God has really been putting on my heart, to not worry, so Im not going to.

God Bless,
lmunchkin