inspirator schreef op 6 oktober 2015 23:00:
OCTOBER 06, 2015 / 1:00PM, EXAS - Exact Sciences Corp Conference Call to Discuss The U.S. Preventive Services Task Force
And Cologuard today in the new draft recommendation summary is included in a distinctly new category, which is not the category that Exact Sciences expected. The main category of recommended tests include the FIT test, high-sensitivity FOBT, flexible sigmoidoscopy with annual FIT, and every 10 year colonoscopy. The conventional -- or the conventional FOBT test was specifically removed from the guidance statement and is no longer recommended.
So what we have now is a new category that was created of alternative tests. Cologuard was included in this category along with CT colonography to be used in select clinical circumstances which the task force did not define. We believe this will be defined in practice and we believe that the circumstances that Cologuard is being used in today include the many patients who either can't, for medical reasons, or won't adhere to either colonoscopy or FIT screening recommendations.
The task force importantly says that given the lack of evidence from head-to-head comparative trials, that any of the other recommended tests have a greater net benefit than the others. Clinicians should consider engaging patients in informed decision-making about the screening strategy that would most likely result in completion with adherence -- with high adherence over time, taking into consideration both the patient's preference and local availability.
The task force found that Cologuard's use as an annual test is having the biggest impact on mortality and life years gained per thousand screened. However, they critique this screening approach because it requires more total lifetime colonoscopies than the FIT test.
Cologuard used every three years was not considered by the task force in its decision. The reason seems to be technical in nature, and it's not clear that the task force reviewed the powerful evidence that Cologuard used every three years yields about the same life years gained and mortality benefit at a lower burden of colonoscopy utilization. How does this affect our strategy going forward?
Our plan remains the same. We will continue to aggressively engage patients, physicians and payors in detailing the strong clinical performance and positive impact that Cologuard has as a screening tool and the many unique advantages over the current approaches which have failed to increase the screening rate beyond 60%, the latest figures published by the American Cancer Society. There is no change to the strong value proposition of Cologuard.
We've had a strong launch to date. I know that, even with the current I rating, we have had over 20,000 physicians order at least one Cologuard test, well over 100,000 total test orders, over 30 healthcare systems have adopted Cologuard, over 20 payors, representing -- these payors represent 57% of the population covered.
We have no reason to believe that the task force decision will impact our strong launch and we will continue to evaluate and assess the impact of the draft guidance while simultaneously putting in place a proactive plan to work with US PSTF through its public comment period to modify its draft guidance to include Cologuard as one of the recommended screening strategies.