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NICE Backs Novartis' Glivec, Tasigna for CML, Rejects Sprycel


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#1 CallMeLucky

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Posted 07 December 2011 - 11:42 AM

http://www.nasdaq.co...rejects-sprycel

LONDON -(Dow Jones)- The U.K.'s health-cost regulator backed Novartis AG's ( NOVN.VX) cancer drug Tasigna and older oncology medicine Glivec for first-line treatment of chronic myeloid leukemia, but it rejected Bristol-Myers Squibb's ( BMY) rival CML product Sprycel, after Novartis offered a discount on Tasigna, it said in draft guidance Tuesday.

The National Institute for Health and Clinical Excellence, or NICE, which decides which treatments should be used in the U.K.'s publicly funded National Health Service, said its appraisal committee concluded from indirect comparisons that Sprycel, generically known as dasatinib, and Tasigna, generically named nilotinib, could be considered equally as effective in treating CML, a cancer of the white blood cells.

Both drugs are expensive, costing over GBP30,000 per patient per year and CML is also a chronic condition, meaning the drugs will be used for a long period of time, NICE said. The discount offered on Tasigna enabled the committee to approve it for use on the NHS.

NICE didn't disclose the size of the discount Novartis offered.

-By Sten Stovall, Dow Jones Newswires; +44 207 842 9292; sten.stovall@ dowjones.com


Date  -  Lab  -  Scale  -  Drug  -  Dosage MG  - PCR
2010/Jul -  MSKCC  -  Non-IS  -  Gleevec  - 400 - 1.2%
2010/Oct -  MSKCC  -  Non-IS  -  Gleevec  - 400 - 0.25%
2010/Dec -  MSKCC  -  Non-IS  -  Gleevec  - 400 - 0.367%
2011/Mar -  MSKCC  -  Non-IS  -  Gleevec  - 400 - 0.0081%
2011/Jun -  MSKCC  -  Non-IS  -  Gleevec  - 400 - 0%
2011/Sep -  MSKCC  -  Non-IS  -  Gleevec  - 400 - 0.00084%
2011/Dec -  MSKCC  -  Non-IS  -  Gleevec  - 400 - 0%
2012/Mar -  MSKCC  -  Non-IS  -  Gleevec  - 400 - 0.004%
2012/Jun -  MSKCC  -  Non-IS  -  Gleevec  - 400 - 0%
2012/Sep -  MSKCC  -  Non-IS  -  Gleevec  - 400 - 0%
2012/Dec -  MSKCC  -  Non-IS  -  Sprycel  - 100 - 0%
2013/Jan -  Quest  -  IS  -  Sprycel  -  50-60-70  - 0%
2013/Mar -  Quest  -  IS  -  Sprycel  -  60-70  - 0%
2013/Apr -  CUMC  -  Non-IS  -  Sprycel  - 50 - 0.036%
2013/May -  CUMC  -  Non-IS  -  Sprycel  - 50 - 0.046%
2013/Jun -  Genoptix  -  IS  -  Sprycel  - 50 - 0.0239%
2013/Jul -  Genoptix  -  IS  -  Sprycel  - 70 - 0.0192%
2013/Jul -  Genoptix  -  IS  -  Sprycel  - 70 - 0.0034%
2013/Oct -  Genoptix  -  IS  -  Sprycel  - 70 - 0.0054%
2014/Jan -  Genoptix  -  IS  -  Sprycel  - 70 - 0.0093%
2014/Mar -  Genoptix  -  IS  -  Sprycel  - 100 - 0.013%
2014/Apr -  Genoptix  -  IS  -  Sprycel  - 100 - 0.0048%
2014/Jul -  Genoptix  -  IS  -  Sprycel  - 100 - 0%
2014/Nov -  Genoptix  -  IS  -  Sprycel  - 100 - 0.047%
2014/Dec -  Genoptix  -  IS  -  Sprycel  - 100 - 0%
2015/Mar -  Genoptix  -  IS  -  Sprycel  - 100 - 0%
2015/Jun -  Genoptix  -  IS  -  Sprycel  - 100 - 0%
2015/Sep -  Genoptix  -  IS  -  Sprycel  - 100 - 0%
2015/Dec -  Genoptix  -  IS  -  Sprycel  - 100 - 0%
2016/Mar -  Genoptix  -  IS  -  Sprycel  - 100 - 0.0228%
2016/Jun -  Genoptix  -  IS  -  Sprycel  - 100 - 0%
2016/Sep -  Genoptix  -  IS  -  Sprycel  - 100 - 0%
2016/Dec -  Genoptix  -  IS  -  Sprycel  - 100 - 0%
2017/Mar -  Genoptix  -  IS  -  Sprycel  - 100 - 0%
2017/Jun -  Genoptix  -  IS  -  Sprycel  - 100 - 0%
2017/Sep -  Genoptix  -  IS  -  Sprycel  - 100 - 0%
2017/Dec - Genoptix  -  IS  -  Sprycel  -  100 - 0%
 

 


#2 PhilB

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Posted 07 December 2011 - 01:02 PM

UK Govt played chicken with Novartis and BMS.  Novartis blinked, BMS didn't.  Hopefully this is the start of drawing a line in the sand to stop te drug companies from just increasing prices ad infinitum.  No-one likes the idea of putting a price on human life, but unfortunately that's what you have to do.  Either that or have the US model where every time the drug companies increase their prices, so do the insurance companies until fewer and fewer people can afford the insurance - which I suppose lets your politicians pretend they have clean hands.

Ho hum



#3 Ludwigh

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Posted 08 December 2011 - 03:48 AM

So what becomes of those patients that have mutations that do not respond to Tasigna, however are known to respond to Sprycel. So, off to transplant if Tasigna doesn't work for them?



#4 Happycat

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Posted 08 December 2011 - 04:39 AM

If I read it right, they won't cover sprycel for first line therapy.  I assume this means they will cover it for second line therapy if a patient loses response to G or T.

Traci



#5 PhilB

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Posted 08 December 2011 - 10:30 AM

This latest is for first line, but the same decision was taken some months ago for intolerance / resistance.  That is still going through the appeals process.  If the appeals fail then a local health authority would not be required to prescribe Sprycel, even if you had failed everything else and they knew you had a mutation it would treat.  They could still choose to fund it as an exceptional case, but they wouldn't be required to.  If they don't and you aren't suitable for BMT or a trial then all you get is Hydrea to manage the white counts.  Should it come to that, the interesting choice is do you go and die publicly in front of the offices of the 'callous' government who say they can't afford to pay, or the 'evil' drug company that won't supply the drug at an affordable price?

Regarding the first line decision, call me cynical, but I would suspect allowing Tasigna as a first line drug  was a condition of Novartis giving a discount on it as a second line drug.

Ho hum



#6 scuba

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Posted 08 December 2011 - 10:37 AM

Big problem with drug invention, cost management, government control.  No easy answer.

But somehow - the patient-doctor relationship needs to be "first line".


Diagnosed 11 May 2011 (100% FiSH, 155% PCR)

with b2a2 BCR-ABL fusion transcript coding for the 210kDa BCR-ABL protein

 

Sprycel: 20 mg per day - taken at lights out with Quercetin and/or Magnesium Taurate

6-8 grams Curcumin C3 complex.

 

2015 PCR: < 0.01% (M.D. Anderson scale)

2016 PCR: < 0.01% (M.D. Anderson scale) 

March        2017 PCR:     0.01% (M.D. Anderson scale)

June          2017 PCR:     "undetected"

September 2017 PCR:     "undetected"





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