Anthem Health has issued a decision deny coverage of Exondys 51, the first drug to treat a form of Duchenne’s muscular dystrophy. As STAT’s Ed Silverman reports : Anthem “claims that the drug is “not medically necessary” and that “the clinical benefit … has not been demonstrated.” Duchenne is a rare disease that confines boys to wheelchairs and condemns them to an early death.
The decision was followed by this: "Exondys 51 failed to show it improves health outcomes, and therefore it is not a covered benefit for our members," Anthem spokeswoman Leslie Porras said in an emailed statement on Friday.
Not exactly. Anthem conveniently ignored the fact that the FDA does not approve drugs that have no medical benefit or more precisely, the FDA approves drugs that are likely to promote treatment of specific conditions. Anthem claims it is denying coverage because a multitude of limitations cast further doubt on the reliability of dystrophin levels as a surrogate endpoint for clinical efficacy in DMD (FDA, 2016). But these limitations were considered and approval was given. In fact, in ignoring the FDA’s decision Anthem is taking refuge in the statements of FDA reviewers who raised concerns about clinical trials but were overruled by Janet Woodcock and Robert Califf, the FDA commissioner.
I wonder if Anthem would have a problem with doctors and its utilization review munchkins ignoring the company’s medical policy on any treatment based on evidence ultimately rejected by Anthem. And I wonder what a disability rights attorney will do with the fact that Anthem is willfully misapplying the term medically necessary.
In fact, Anthem has no problem covering acupuncture, massage therapy, spine manipulations and naturopathy.
Compare Anthem’s demand for more evidence before covering Exondys with the statement accompanying it’s decision to cover acupuncture:
"Acupuncture as a therapeutic intervention is widely practiced in the United States. There have been many studies of its potential usefulness. However, many of these studies provide equivocal results because of design, sample size, and other factors. The issue is further complicated by inherent difficulties in the use of appropriate controls, such as placebo and sham acupuncture groups…Further research is likely to uncover additional areas where acupuncture interventions will be useful.”
Anthem covers treatments that have less medical evidence of benefit for less severe ailments than DMD. And it covers treatments based on the it’s belief that research will find acupuncture useful” (though not clinically effective.) That’s because they attract millions of fairly healthy consumers.
There are about 17000 boys with DMD. Providing the drug also means paying for all the other supportive services, emergency care, hospitalizations that such kids may require. To Anthem, spending money to help boys with DMD stay independent and alive is a money loser.
That’s the only evidence Anthem cares about.
The decision was followed by this: "Exondys 51 failed to show it improves health outcomes, and therefore it is not a covered benefit for our members," Anthem spokeswoman Leslie Porras said in an emailed statement on Friday.
Not exactly. Anthem conveniently ignored the fact that the FDA does not approve drugs that have no medical benefit or more precisely, the FDA approves drugs that are likely to promote treatment of specific conditions. Anthem claims it is denying coverage because a multitude of limitations cast further doubt on the reliability of dystrophin levels as a surrogate endpoint for clinical efficacy in DMD (FDA, 2016). But these limitations were considered and approval was given. In fact, in ignoring the FDA’s decision Anthem is taking refuge in the statements of FDA reviewers who raised concerns about clinical trials but were overruled by Janet Woodcock and Robert Califf, the FDA commissioner.
I wonder if Anthem would have a problem with doctors and its utilization review munchkins ignoring the company’s medical policy on any treatment based on evidence ultimately rejected by Anthem. And I wonder what a disability rights attorney will do with the fact that Anthem is willfully misapplying the term medically necessary.
In fact, Anthem has no problem covering acupuncture, massage therapy, spine manipulations and naturopathy.
Compare Anthem’s demand for more evidence before covering Exondys with the statement accompanying it’s decision to cover acupuncture:
"Acupuncture as a therapeutic intervention is widely practiced in the United States. There have been many studies of its potential usefulness. However, many of these studies provide equivocal results because of design, sample size, and other factors. The issue is further complicated by inherent difficulties in the use of appropriate controls, such as placebo and sham acupuncture groups…Further research is likely to uncover additional areas where acupuncture interventions will be useful.”
Anthem covers treatments that have less medical evidence of benefit for less severe ailments than DMD. And it covers treatments based on the it’s belief that research will find acupuncture useful” (though not clinically effective.) That’s because they attract millions of fairly healthy consumers.
There are about 17000 boys with DMD. Providing the drug also means paying for all the other supportive services, emergency care, hospitalizations that such kids may require. To Anthem, spending money to help boys with DMD stay independent and alive is a money loser.
That’s the only evidence Anthem cares about.
