After attending the Society of American Gastrointestinal and Endoscopic Surgeons meeting, where Intuitive Surgical hosted an analyst event, Cantor Fitzgerald analyst Craig Bijou reiterates an Overweight rating on the shares with a $620 price target. The analyst sees “several reasons” to believe that Intuitive Surgical’s momentum should continue, including “rapid” adoption of robotic hernia repair and robotic penetration expanding across a broad array of general surgery procedures. Intuitive Surgical is “years ahead of its competition in developing an intelligent surgery system, and its integrated ecosystem and vast data collection should help protect its lead,” Bijou tells investors in a research note.
Friday, April 5, 2019
Centene CEO expects divestitures for WellCare acquisition, Bloomberg reports
Centene (CNC) CEO Michael Neidorff said the planned takeover of WellCare Health Plans (WCG) will require divestitures in two states with limited competition in the Medicaid market, Bloomberg’s John Tozzi reports, citing Neidorff. “There are two states, Nebraska and Missouri, where there’s three plans, and WellCare’s one, we’re one,” Neidorff said. “We know one of the plans is going to have to be divested.”
https://thefly.com/landingPageNews.php?id=2889013
https://thefly.com/landingPageNews.php?id=2889013
Judge To Rule On Rockland Banning Unvaccinated Children From Public
In the midst of a measles outbreak, should unvaccinated children be barred from public places?
A judge in Rockland County is expected to deliver a decision on the issue today.
The county has seen 166 confirmed measles cases since October.
In an effort to keep the disease from spreading, the county executive declared an emergency order last week, banning unvaccinated minors from school and other public spaces.
Lawyer Patricia Finn represents a family who, for religious reasons, did not vaccinate its children. With only a relative handful of current active cases centered in the ultra-Orthodox community, she says the order is unnecessary and should be overturned.
“It violates several Constitutional provisions,” she said. “This is executive order in invalidating the religious exception is having a huge financial impact on families that now have to homeschool their kids.”
In New York, families can claim a religious exemption from vaccination rules. Some state lawmakers are now pushing to end that exemption, as California did in 2015.
“Your right to express your sincerely held belief or your religious belief does not extend to the right to endanger our children and our community from measles,” said Brad Hoylman.
Judge Rolf Thorsen heard arguments against the emergency order Thursday and said he would rule on a request to lift it later today.
The county attorney said if the outbreak becomes an epidemic, the cost of treating it would be enormous.
The health department will hold another free measles vaccine clinic this afternoon. For more information, click here.
Biotech crops still a sticking point in U.S.-China trade deal
China’s lengthy approval process for genetically modified crops remains a sticking point in talks to end the trade war between China and the United States, according to two sources with knowledge of the talks.
Beijing has taken years to approve new strains of GM crops, which U.S. companies and farmers have complained stalls trade by restricting the sales of new products from companies such as DowDuPont Inc, Bayer AG, and Syngenta AG.
The issue is one of a host of U.S. complaints that the administration of President Donald Trump is demanding China address if it wants to end trade disputes that have cost both countries billions of dollars and slowed the global economy.
Trump on Thursday said the two sides were getting very close to a deal that could be announced in about four weeks, though there were still differences to be bridged.
GM crops and the approval process are still a “big issue” in the discussions, said one of the sources, who spoke on condition of anonymity.
The issue has been a source of tension between the two countries for years. China is the biggest buyer of U.S. soybeans, the bulk of which are genetically modified. If it does not approve new strains, then farmers in the United States cannot plant them because China may reject shipments that include them.
Seed companies cannot fully commercialize sales of new strains without those approvals. The two sides had appeared to make some progress on the issue in January, when China approved a handful of GMO crops for import. They were the first in about 18 months. The move did not address the core U.S. concerns over delays to the process.
A spokeswoman from the Office of the U.S. Trade Representative, who is leading the Washington team in the discussions, did not respond immediately to request for confirmation or comment.
It is unclear what differences on the issue remain. The United States wants China to accelerate its approval process and make it more similar to Washington’s.
Beijing allows imports of GMO soybeans and corn for use in animal feed, even though it does not permit planting of them.
China bought about 60 percent of U.S. soy exports, worth about $12 billion, before the ongoing U.S.-China trade war and could reject shipments of unapproved varieties.
Beijing promised to speed up its review of applications during previous trade talks with the United States in 2017. In the past, Beijing has held back approvals of imported GMO products amid concerns about anti-GMO sentiment in China.
The trade deal, should it be agreed, is expected to include a six-year time frame for purchases of more than $1 trillion in U.S. goods, including commodity products.
Drug-Pricing Watchdog Thinks Biogen’s Spinraza Should Be Cheaper
Biogen’s Spinraza (nusinersen) is currently the only approved drug for infants with spinal muscular atrophy (SMA). SMA is a rare, autosomal recessive neuromuscular disease characterized by the degeneration of alpha motor neurons in the spinal cord. This results in progressive muscle weakness and paralysis. According to the Orphanet Journal of Rare Diseases, the estimated incidence is 1 in 6,000 to 1 in 10,000 live births.
The current price for Spinraza is $750,000 for the first year and $375,000 for every year after for the life of the patient. It is approved for all forms of SMA, types 0 through 5.
The Institute for Clinical and Economic Review (ICER), a drug-pricing watchdog organization,issued a Final Evidence Report and Report-at-a-Glance assessment comparing the drug’s effectiveness and value and its price. It also evaluated a likely competitive product not-yet-approved, Novartis/AveXis’ Zolgensma. Zolgensma has dazzled in Phase III trials and is likely to be approved by the U.S. Food and Drug Administration (FDA) in the last half of this year. At this time, it is only for patients with Type 1.
Although filled with quite a few exceptions and complicated rationales, the report ultimately believes that Spinraza is too expensive for what it’s worth and that Zolgensma, which doesn’t have a price yet, probably will too.
“Both Spinraza and Zolgensma dramatically improve the lives of children with SMA and that of their families,” stated David Rind, ICER’s chief medical officer. “However, the current price of Spinraza far exceeds common thresholds for cost-effectiveness. The price of Zolgensma is not yet known, but there has been public discussion of prices above commonly accepted cost-effectiveness thresholds as well. These treatments will be covered by U.S. insurers regardless of the pricing, but the ripple effect of pricing decisions like these threatens the overall affordability and sustainability of the U.S. health system.”
The ICER report took into account a dizzying range of factors, including clinical benefits and economic value, “including the ability of patients to gain dignity and independence even from very small improvements in motor function, and broader effects on families, including greater freedom, reduced stress, and lower financial burden related to transportation and other costs. Council members also unanimously recognized that Zolgensma, administered in a one-time dose, offers less complexity than Spinraza.”
Keeping in mind that ICER’s report doesn’t have any binding effect on the FDA, insurers or the companies themselves, the report calculated that Spinraza’s price for patients with presymptomatic SMA should be between $72,000 and $130,000 for the first year of treatment and between $36,000 and $65,000 for each successive year.
They also calculated an alternative price based on “100,000-$150,000 per Life Year Gained (LYG),” which would be $83,000 to $145,000 for pre-symptomatic patients in the initial year and $41,000 to $72,000 for each successive year.
They didn’t make a similar vote on Zolgensma because it hasn’t been approved and, as such, doesn’t have a price, but taking into consideration that Zolgensma will supposedly be a one-and-done therapy requiring no follow-up treatments, they suggest the price should be between $710,000 and $1.5 million per treatment.
Perhaps not surprisingly, the companies involved disagree. Biogen told Xconomy, that ICER “appropriately acknowledges the substantial health benefits of [nusinersen]” and the “significant difference in robustness and quality of evidence” between nusinersen and Zolgensma, but also pointed out that to date, Zolgensma had only been tested in 15 patients with a 2.5-year follow-up, while Spinraza has been evaluated in more than 300 patients for up to six years, and the ICER report didn’t take that into consideration. In addition, Biogen recently noted that more than 6,600 infants, children and adults have been treated with Spinraza worldwide.
Novartis, for its part, questioned ICER’s methodology, telling Xconomy that ICER’s methodology is designed around the “status quo of chronic care management and cannot possibly capture the full benefits” of a single-dose gene therapy. Novartis also pointed out that “multiple stakeholders,” including NICE, the UK’s drug pricing authority, have been looking at gene and cell therapies to “create more relevant models to assess potentially curative treatments.”
And Dave Lennon, president of AveXis, told Xconomy that Novartis is “working with payers to rethink established payments models with pay-over time options.” He added, “Chronic lifetime treatments are costing the healthcare system tens of millions of dollars over a patient’s lifetime. One-time, potentially curative gene therapies require our healthcare system to be just as innovative on the payment side.”
SMA type I, the severest form, is almost always fatal by two years of age, with a 50% mortality rate by 7 months and a 90% mortality rate by 12 months. A 2009 study found that with nutritional and respiratory care, a greater percentage of those patients were living beyond 2 years of age. Patients with Types II and III typically live into adulthood and could potentially have a normal life expectancy, although with a great deal of healthcare services. But now, with Spinraza and potentially Zolgensma, those patients have a chance of living a full, normal life. It’s hard to put a price on that.
Genmab Submits Application in Japan for Multiple Myeloma Combo
- Supplemental new drug application (sNDA) submitted in Japan for daratumumab in combination with lenalidomide and dexamethasone as treatment for patients newly diagnosed with multiple myeloma who are not candidates for high-dose chemotherapy and autologous stem cell transplant
- Submission based on data from Phase III MAIA study
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