Obamacare's mandatory contraception coverage is a hot-button issue. But flying well below the national media's radar is the other side of the coin - how insurance companies are denying care to pregnant Americans.
According to WebMD, “Nothing can blast the euphoria of discovering you're pregnant faster than morning sickness.” Perhaps a close second is knowing there's a Food and Drug Administration-approved treatment for this condition - and that your insurance company refuses to pay for it.
As my wife commented, “If men got morning sickness, this wouldn’t be a problem.”
In a study based on a survey recently published in the medical journal Obstetrical and Gynecology Survey, more than two-thirds of all survey respondents reported that morning sickness diminished their general enjoyment of pregnancy, and some women, especially those with moderate/severe symptoms, reported anxiety about the health of the baby and lacked confidence that they were doing the best they could for their unborn child.
The repercussions of choosing short-term savings over long-term results, of cost-based choices over patient-centric care, or “fail first” policies over the right treatment for the right patient at the right time – are pernicious to both the public purse and the public health.
Consider Diclegis, a medication specifically developed and recently approved by the FDA to treat nausea and vomiting from pregnancy (aka morning sickness), a condition experienced by 70 percent to 85 percent of pregnant women. Diclegis is the first and only treatment for nausea and vomiting of pregnancy approved by the FDA in more than 30 years, and the only treatment granted a Pregnancy Category A rating by the FDA, the highest level of pregnancy product safety.
Not only are some insurers (such as Aetna) restricting access to this FDA-approved treatment, they're requiring health care providers to first prescribe off-label medications, or a combination of over-the-counter treatments neither developed nor approved for use during pregnancy. It's only after a pregnant woman has failed to control her morning sickness through trial and error with these untested-in-pregnancy propositions before being allowed access to the only medication tested and FDA-approved as safe and effective for pregnant women who suffer from this condition.
Importantly, for women who have morning sickness, it's critical to get treatment early to reduce complications — and that means getting the best treatment as soon as possible, not “failing” up the therapeutic ladder.
Aetna’s decision to deny cutting-edge care for America’s moms also illustrates the danger to the development of important new treatments for a host of other diseases. According to Tufts University it costs about $1 billion to bring a new medicine to market. That's $1 billion per drug — and those are the ones that make it through the clinical and regulatory processes. The innovation ecosystem is a fragile wetland and investment dollars are harder to come by than ever before. Why would a pharmaceutical company invest in high risk research and development if there is likely to be no insurance company willing to pay for the therapeutic benefits it can deliver?
Pregnancy is a difficult journey – but its travails are worth the result. That’s also true for health care innovation. Today, it takes about 10,000 new molecules to produce one FDA-approved medicine. And only three in 10 new medicines earn back their research and development costs. And here's the kicker: Unlike other R&D-intensive industries, biopharmaceutical investments generally must be sustained for more than two decades before the few that make it can generate a profit. But ask any patient whose life has been saved or prolonged through the miracles of modern medicine whether or not the investment has been worthwhile.
Protecting “sustainable innovation” is crucial for both the public health and to maintain America’s lead as the global hub for biotechnology.
Harvard University health economist (and Obama health care adviser) David Cutler has noted that: "Virtually every study of medical innovation suggests that changes in the nature of medical care over time are clearly worth the cost." To borrow an overused adjective from the world of global climate change -- we must protect "sustainable" innovation.
America's mothers-to-be are on the front lines. A “pregnant pause” in appropriate access is not acceptable.Peter J. Pitts, a former FDA associate commissioner, is president of the Center for Medicine in the Public Interestâ€©â€©Thinking of submitting an op-ed to the Washington Examiner? Be sure to read our guidelines on submissions for editorials, available at this link.