By James L. Martin
Texas Insider Report: AUSTIN Texas Thousands of Texas seniors who chose Part-D Medicare in order to access affordable & vital gout drug coverage have received a rude wake-up call from local Part-D insurers including those offered in Texas by Cigna & United Health Group.
Gout is a form of arthritis common amongst seniors. Patients with this disease often experience excruciating flare-ups which can be effectively treated by colchicine-based drugs.
Until last year when the Food and Drug Administration (FDA) removed unapproved colchicine from the market various Part-D Plans including those offered in Texas by Cigna and United Health Group offered patients only unapproved colchicine options at affordable prices while the FDA-approved drug was placed in a more expensive pricing-tier.
Unapproved drugs can be dangerous for patients as they have never been tested by the FDA for safety and efficacy and lack proper labeling meant to help patients avoid drug to drug interactions.
To help rid the market of these products the FDA announced its Unapproved Drugs Initiative" in 2006 which calls for the removal of unapproved drugs from Americas pharmacy shelves. The agencys removal of untested colchicine in 2010 came as part of this important safety initiative which the
60 Plus Association has long supported with our
Keep Seniors Safe Project.
In the FDAs Marketed Unapproved Drugs Compliance Policy Guide the agency estimated that there are up to several thousand" unapproved drugs
available in the United States today. Clearly protecting patients from the potential dangers posed by unapproved drugs is no easy task for the agency which must prioritize which drugs pose the most potential danger to patients and should be removed first.
The FDAs choice to remove unapproved colchicine from the marketwhile thousands of other untested drugs remainspeaks volumes on the severity of the dangers associated with the drug.
Patients are unquestionably safer due to the FDAs action but surprisingly some Part-D insurers have failed to adjust their coverage of the remaining FDA-approved colchicine products leaving many patients who were guaranteed access to colchicine when they signed up for the plans unable to afford their medication.
Part-D insurers in Texas and around the country must adjust their colchicine coverage immediately as Medicare Part-Ds open enrollment period takes place only once a year and patients cannot switch plans in between enrollment periods. Failure to address this problem would be reprehensible as many patients will have no choice but to suffer through the pain caused by their disease.
This is why I sent letters earlier this month to the CEOs of all offending Part-D insurers including Cignas David Cordani and United Health Groups Stephen Hemsley asking them to make approved colchicine affordable to patients.
I hope these CEOs will do what is best for Texas gout-patients but if they fail to
act local lawmakers and average citizens must take action to let these plans know that Texas seniors deserve better.
James L. Martin is the Chairman of 60 Plus Association and spokesperson for their Keep Senior Safe project.
