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Insmed Incorporated Message Board

  • rehdvm2004 rehdvm2004 Jul 6, 2013 7:52 PM Flag

    Non-inferiority designation and marketing inhalation antibiotics . . .

    What does it mean?

    Simply put, "non-inferiority" means that any of 6 inhalation antibiotics with similar "therapeutic effect" will probably be available for prescription by physicians to treat Pseudomonas aeruginosa infections of Cystic Fibrosis patients by 2014. Those antibiotics will be:

    TOBI (tobramycin solution for inhalation);
    Azithromycin;
    Cayston;
    TIP (tobramycin powder for inhalation);
    Levofloxicin; and
    Arikace
    A "back door inhalation antibiotic" might be Ciprofloxicin.

    How are these antibiotics going to be prescribed? By culturing a sputum sample and observing through sensitivity testing which antibiotic among the above has the largest "kill zone" for the bacterial isolate. The largest kill zone will take precedent over cost of therapy (which should all be pretty comparable, $4,000 per 28 days) and the frequency of patient administration (SID like Arikace and Ciprofloxicin, BID or TID like all the others) and the occurrence of side effects (in probably less than 10% of patients for any inhalational preparation). Then they will monitor patient FEV1 and sputum concentration of Pa and follow trends of improvement, trends of problems and culture for any development of antibiotic resistance in the Pa strain being treated, cultured and monitored. At a treatment cost of $4,000 per 28 day period, no physician wants to be caught prescribing the wrong antibiotic, have the patient begin deteriorating because of a mutant strain of Pa crept into the equation and/or have any patient advocate attorney find out that a better treatment course could have been prescribed for any given patient. The risk to benefit determinations that will make all this happen will be the algorithms developed by medical/health care insurance companies once these treatments are approved for insurance coverage. Any physician, hospital treating CF patients, et al better have an "iron clad" excuse for prescribing outside the boundaries of the above. EOS. Medicine is not guesswork.

    Sentiment: Hold

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    • rehdvm2004 • Jul 6, 2013 7:52 PM Non-inferiority designation and marketing inhalation antibiotics . . .
      What does it mean?

      Simply put, "non-inferiority" means that any of 6 inhalation antibiotics with similar "therapeutic effect" will probably be available for prescription by physicians to treat Pseudomonas aeruginosa infections of Cystic Fibrosis patients by 2014. Those antibiotics will be:

      TOBI (tobramycin solution for inhalation);
      Azithromycin;
      Cayston;
      TIP (tobramycin powder for inhalation);
      Levofloxicin; and
      Arikace
      A "back door inhalation antibiotic" might be Ciprofloxicin.

      How are these antibiotics going to be prescribed? By culturing a sputum sample and observing through sensitivity testing which antibiotic among the above has the largest "kill zone" for the bacterial isolate. The largest kill zone will take precedent over cost of therapy (which should all be pretty comparable, $4,000 per 28 days) and the frequency of patient administration (SID like Arikace and Ciprofloxicin, BID or TID like all the others) and the occurrence of side effects (in probably less than 10% of patients for any inhalational preparation). Then they will monitor patient FEV1 and sputum concentration of Pa and follow trends of improvement, trends of problems and culture for any development of antibiotic resistance in the Pa strain being treated, cultured and monitored. At a treatment cost of $4,000 per 28 day period, no physician wants to be caught prescribing the wrong antibiotic, have the patient begin deteriorating because of a mutant strain of Pa crept into the equation and/or have any patient advocate attorney find out that a better treatment course could have been prescribed for any given patient. The risk to benefit determinations that will make all this happen will be the algorithms developed by medical/health care insurance companies once these treatments are approved for insurance coverage. Any physician, hosp

      • 1 Reply to insm_truth_teller
      • rehdvm2004 • Jul 6, 2013 7:52 PM Non-inferiority designation and marketing inhalation antibiotics . . .
        What does it mean?
        Simply put, "non-inferiority" means that any of 6 inhalation antibiotics with similar "therapeutic effect" will probably be available for prescription by physicians to treat Pseudomonas aeruginosa infections of Cystic Fibrosis patients by 2014. Those antibiotics will be:
        TOBI (tobramycin solution for inhalation);
        Azithromycin;
        Cayston;
        TIP (tobramycin powder for inhalation);
        Levofloxicin; and
        Arikace
        A "back door inhalation antibiotic" might be Ciprofloxicin.

        How are these antibiotics going to be prescribed? By culturing a sputum sample and observing through sensitivity testing which antibiotic among the above has the largest "kill zone" for the bacterial isolate. The largest kill zone will take precedent over cost of therapy (which should all be pretty comparable, $4,000 per 28 days) and the frequency of patient administration (SID like Arikace and Ciprofloxicin, BID or TID like all the others) and the occurrence of side effects (in probably less than 10% of patients for any inhalational preparation). Then they will monitor patient FEV1 and sputum concentration of Pa and follow trends of improvement, trends of problems and culture for any development of antibiotic resistance in the Pa strain being treated, cultured and monitored. At a treatment cost of $4,000 per 28 day period, no physician wants to be caught prescribing the wrong antibiotic, have the patient begin deteriorating because of a mutant strain of Pa crept into the equation and/or have any patient advocate attorney find out that a better treatment course could have been prescribed for any given patient. The risk to benefit determinations that will make all this happen will be the algorithms developed by medical/health care insurance companies once these treatments are approved for insurance coverage

    • bump -

    • Good post ..............but Arikace will not be available in 2014.- anywhere.

    • What is the aggregate revenue potential for all CF treatments? From what I can tell in all the jabber it seems to be over $1 billion globally. I read that in the US alone, by 2015, it will be around $900 million. This seems to be a pretty big pie to split up.

      Sentiment: Buy

      • 1 Reply to jad9000
      • The marketing report that I found several months ago said $850 million by 2018. It projected increases in availability and entrance of new drugs across a 5-6 year period. There are not too many insurance programs that are going to pop for $4,000 plus 4 times per year. Much of the inhalation therapy will have to be directed towards preventing recurrent infections from the source and introducing new, multiple modality therapy. My foster daughter had secondary ciliary dyskinesia from radiation for throat cancer. If you go to NIH DOT gov and look up primary ciliary dyskinesia there is an excellent description and figures to show what happens. The point is, the bronchi and trachea can no longer clear the mucous and the infection is retained. Shelby stopped her lung infections simply by using bottled water for drinking, brushing her teeth, etc. What I am saying is that the frequency of reinfection has to go down with CF/Pa to extend longevity further. Not just new antibiotics, but new ways to make them effective for low level lung infections. But the big one for Arikace is NTM. That is a potential world wide, exclusive market. That CF/Pa will be totally competitive and based on diagnostic testing results. Especially if no one antibiotic shows superiority.

        Sentiment: Hold

 
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