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NIPT Insurance Coverage for All Risk Groups Expected to Pick up After New Guidelines, Cost Studies

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NEW YORK (GenomeWeb) – Following a number of recent developments in the field of noninvasive prenatal testing, at least some test providers are confident that most insurance companies will cover their tests for pregnancies of all risks going forward.

These developments include the fact that a number of health insurance providers are now covering NIPT for fetal aneuploidy screening in women of all risk groups, and that professional societies issued guidelines that no longer restrict the use of NIPT to high-risk women.

In addition, recent studies have suggested that such coverage can be cost-neutral to the healthcare system, while another large study demonstrated the superiority of NIPT over conventional screening for trisomy 21 detection.

"The clinical utility of NIPT as a primary screening test for the general pregnancy population is now well accepted, especially following the publication of the NEXT study in the [New England Journal of Medicine]," Ken Song, CEO of Roche's Ariosa, told GenomeWeb.

That study, which was sponsored by Ariosa and published this spring, involved almost 16,000 women of all risk groups and found that the Harmony test had better sensitivity, a lower false-positive rate, and a higher positive predictive value for trisomy 21 detection than standard screening.

"With recent medical policy updates from Anthem and other payers, we fully expect all other payers to follow in updating their medical policies to ensure their members have access to the best prenatal screening tests," Song said.

"To date, we know of eight insurance providers, including the second largest private insurer in the United States, who have updated their coverage policy to include NIPT for all women, regardless of age or prior risk," Steve Chapman, senior vice president of Natera, told GenomeWeb.

Anthem Blue Cross and Blue Shield changed its medical policy last month and now regards cell-free DNA-based prenatal screening for trisomies 21, 18, and 13 as medically necessary for all women carrying a single fetus, irrespective of risk status.

The decision was considered as groundbreaking since Anthem, the company's parent, is one of the nation's largest health insurers, with a total of about 38.5 million members.

Other members of the Blue Cross Blue Shield Association have followed suit. According to a report from Piper Jaffray this week, several are now covering NIPT for average-risk pregnancies, including Blue Shield of California, Blue Cross Blue Shield of Western New York, Blue Cross Blue Shield of South Carolina, Arkansas BlueCross BlueShield, Blue Cross and Blue Shield of Kansas City, Horizon Blue Cross Blue Shield of New Jersey, and Regence.

"While we anticipated gradual releases of average risk coverage decisions, the rapid traction (~41.5M lives in ~2 months) leaves us bullish on near-to mid-term average risk reimbursement," Piper Jaffray analysts wrote.

The coverage decisions follow a recent change in guidelines by the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine that no longer restricts NIPT to women with high-risk pregnancies.

In a committee opinion released in June, ACOG and SMFM said that because of limitations in the performance of cell-free DNA screening and limited data on its cost-effectiveness in the low-risk population, "conventional screening methods remain the most appropriate choice" for most pregnant women. However, "any patient may choose cell-free DNA analysis as a screening strategy for common aneuploidies regardless of her risk status," the document stated, a departure from earlier guidelines that recommended NIPT screening only for women at increased risk of fetal aneuploidy.

The new recommendations failed to endorse NIPT as a primary screening tool for fetal aneuploidies in all women, but the authors acknowledged that this might change in the future. "The technology involved in cell-free DNA analysis and its application to prenatal screening for aneuploidy is a rapidly changing field," they wrote. "Therefore, any recommendations regarding its use in screening also will likely evolve quickly."

While some insurance companies appear to be covering NIPT broadly now, it is unclear how much they are willing to pay for the tests. Generally, NIPT is more expensive than conventional screening tests but promises to save insurers money downstream, according to several recent cost studies.

"We would hope that payers provide a uniform contracted rate for all NIPT providers to ensure a level playing field," Ariosa's Song said.

List prices for NIPT vary widely between providers, and their tests differ in how many conditions they report on, but according to both Ariosa and Natera, list prices are not that meaningful as reimbursement rates vary and as health plans often negotiate discounted rates for their members.

Ariosa had previously negotiated a contracted rate of $795 for its Harmony test for high-risk pregnancies with some US insurance carriers. However, a recent cost-effectiveness study that was funded by the company and published in the Journal of Maternal-Fetal and Neonatal Medicine, found that if first-trimester combined screening (FTS) was replaced by NIPT for the general US pregnancy population, overall healthcare costs would remain the same if the price of NIPT was no more than $453, while the detection rate for fetal trisomies would go up.

The study assumed 4 million US pregnancies per year and a 70 percent screening uptake by women, either with FTS or NIPT. Using NIPT alone, almost 9,000 trisomy cases would be detected, whereas FTS would only discover about 7,800 cases.

Also, NIPT would require 17,300 confirmatory invasive procedures, including about 8,300 unnecessary ones, leading to the loss of 42 healthy fetuses. FTS, on the other hand, would result in 147,300 invasive procedures, of which 139,500 would be unnecessary, resulting in the loss of almost 700 healthy fetuses.

Using FTS, total costs — including costs for screening tests, invasive tests, office visits, counseling, pregnancy termination, and a cost assigned for each child born with a trisomy — would add up to $3.88 billion, according to the study, assuming a cost of about $170 for first-trimester screening. That total cost would be matched by NIPT if the test was no more than $453.

A similar recent economic analysis, sponsored by Natera and published in PLOS One, came to the conclusion that overall healthcare costs would stay the same if NIPT were provided at no more than $744.

Like Ariosa's, the Natera study assumed 4 million annual US births and 70 percent of women receiving some type of fetal aneuploidy prenatal screening.

NIPT would detect 12,700 fetal aneuplodies and conventional screening about 11,300. Assuming certain termination rates, about 1,200 fewer affected children would be born with NIPT than with conventional screening.

NIPT would lead to 24,600 invasive tests, with 70 losses of healthy fetuses, compared to 61,400 invasive tests with conventional screening, leading to about 260 healthy fetuses lost.

At $744 per NIPT, there would be no net increase in healthcare costs if NIPT replaced conventional screening, for which the study assumed a cost of $370. The key cost variables of the study were screening costs, the cost of invasive testing, and the lifetime costs of a child affected with an aneuploidy.

Natera does not disclose its contracted reimbursement rates, but Natera's Chapman said that "most industry reports find NIPT being reimbursed near the break-even point in the economic model."

A third recent cost analysis, published by ARUP Laboratories in PLOS One, found that universal NIPT would only be cost-effective compared to conventional maternal serum screening if certain downstream costs are included in the calculation.

According to the analysis, if both direct and indirect lifetime costs of a child affected with a trisomy are included — direct costs being medical and educational costs, and indirect costs accounting for lost productivity due to the syndrome — NIPT is cost-effective over conventional screening if it is provided at $619 or below.

If indirect lifetime costs or all lifetime costs are excluded, conventional screening with NIPT as a contingent test is a cost-effective alternative to conventional screening alone. NIPT alone, on the other hand, would be more expensive, though it would be more effective in detecting aneuploidies.

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