CMS is now lobbying Congress (although since technically they aren’t allowed to “lobby†they will “educate" our legislators) to support their decision at a time when it is supposed to "open" to reviewing additional comments and criticisms. Hmm.
According to CMS, the basis for their NCD is that there is an absence of adequate data to determine that ESAs show "proof of no harm" and therefore will not pay for their use in most cases. The litmus test for CMS of inadequate but troubling data was the early termination of Phase IV studies of cancer drugs that used ESAs where were excess deaths.
By that definition no drug should be paid for since there is no safety study ever developed that will be proven safe. And by defining the issue in terms of safety it has deftly avoided the question of whether CMS or a doctor should weigh the risks and benefits of ESA use in combo with chemotherapy. Rather, it has used the safety issue and the "proof of no harm" threshold to assert control over the practice of medicine at the expense of doctors and their patients.
Why would it stop at just ESAs? Why not other cancer drugs that are used in off-label settings where Phase IV studies have been terminated because of an increase in deaths? (A common occurrence because many investigational studies include very sick patients.)
The CMS approach -- which dovetails with the effort to impose a comparative effectiveness measure on all new drugs much like that in the UK would bring a halt to a continuing increase in cancer survivorship and declines in death rates from all forms of cancer.
An outrageous end run around patients and clinicians? You be the judge.
According to CMS, the basis for their NCD is that there is an absence of adequate data to determine that ESAs show "proof of no harm" and therefore will not pay for their use in most cases. The litmus test for CMS of inadequate but troubling data was the early termination of Phase IV studies of cancer drugs that used ESAs where were excess deaths.
By that definition no drug should be paid for since there is no safety study ever developed that will be proven safe. And by defining the issue in terms of safety it has deftly avoided the question of whether CMS or a doctor should weigh the risks and benefits of ESA use in combo with chemotherapy. Rather, it has used the safety issue and the "proof of no harm" threshold to assert control over the practice of medicine at the expense of doctors and their patients.
Why would it stop at just ESAs? Why not other cancer drugs that are used in off-label settings where Phase IV studies have been terminated because of an increase in deaths? (A common occurrence because many investigational studies include very sick patients.)
The CMS approach -- which dovetails with the effort to impose a comparative effectiveness measure on all new drugs much like that in the UK would bring a halt to a continuing increase in cancer survivorship and declines in death rates from all forms of cancer.
An outrageous end run around patients and clinicians? You be the judge.
