Mizuho analyst Salim Syed believes shares of Gilead Sciences (GILD) are sliding due to UnitedHealth’s (UNH) announcement of a new program called My ScriptsRewards that will “try to convince plan participants to take a cheaper HIV regimen in return for $500 debit cards.” However, the analyst views the worries as unwarranted, noting that an “inferior drug” is the “common thread” between all of the regimens that UnitedHealth’s program pushes. MY SCRIPTREWARDS: UnitedHealthcare has introduced My ScriptRewards, a new program that shares prescription cost savings directly with plan participants who choose doctor-approved, guideline-recommended and cost-effective medications. According to the company’s website, My ScriptRewards offers UnitedHealthcare plan participants the opportunity to realize additional cost savings and earn up to $500 in prepaid debit cards to use toward medical expenses, including other prescriptions and doctor’s office copays, when they consult their doctor to choose the lower-cost regimen that is right for them. “Select antivirals used to treat HIV will be the first medications included in My ScriptRewards due to the challenges that come with managing a high-cost medical condition. There are several HIV treatment regimens recommended by the Department of Health and Human Services, yet the cost among them can vary significantly. Through My ScriptRewards, plan participants can receive certain guideline-recommended HIV medications with proven effectiveness for no cost at the time of purchase,” the company stated. The most cost-effective treatment regimens available through UnitedHealthcare for $0 out of pocket include Cimduo plus Tivicay and Cimduo plus Isentress/Isentress HD. CONCERN SEEMS UNWARRANTED: In a research note to investors, Mizuho’s Syed blamed UnitedHealth’s introduction of the new program for weakness in shares of Gilead. However, the analyst argued that the worries appear unwarranted as Cimduo is the “common thread” between all of the regimens that UnitedHealth’s program calls out and it is an inferior drug to Gilead’s Biktarvy. Biktarvy is the backbone of the number one recommended regimen according to HHS treatment guidelines, noted Syed, who reiterated a Buy rating and $94 price target on Gilead shares. Voicing a similar opinion, Evercore ISI analyst Umer Raffat also attributed the pullback on Wednesday in shares of Gilead to concerns over the company’s HIV franchise given UnitedHealth’s promotions of cheaper alternatives. The analyst told investors in a research note of his own that he does not see risk to Gilead’s sales from the promotions. UnitedHealth’s is proposing a switch to two separate tablets, which is not in the HIV guidelines today, he contended. Raffat reiterated an Outperform rating on Gilead shares. PRICE ACTION: In afternoon trading, shares of Gilead have dropped about 5% to $68.65.
Wednesday, October 31, 2018
Express Scripts: 2019 retention rate for the 2018 selling season to exceed 98%
The Company now expects its 2019 retention rate for the 2018 selling season to exceed 98%, an all-time high for the Company. “We continue to earn the trust of those we serve through our ability to predict marketplace trends, create advantage for our clients, and develop innovative solutions that generate greater value. With trust comes the ability to help even more people achieve better outcomes. Now, more than ever, prospects and clients alike need more innovation, service and care, and we are well positioned to deliver. We are retaining our clients, winning prospects, and enrolling clients in more solutions and, as a result, expect to grow core business adjusted claims by 2% to 3% in 2019. From taking on the toughest challenges to uncovering innovative opportunities, Express Scripts is championing better healthcare every day,” said CEO Wentworth.
https://thefly.com/landingPageNews.php?id=2814789
AbbVie: Phase 3 trial of leukemia combo met primary endpoint
AbbVie (ABBV) announced positive results from CLL14, a Phase 3, randomized clinical trial evaluating venetoclax plus obinutuzumab versus obinutuzumab plus chlorambucil, a standard of care, in patients with chronic lymphocytic leukemia and coexisting medical conditions who have not received a prior treatment. The study met its primary endpoint of investigator-assessed progression-free survival with a 12-month fixed duration of treatment. Preliminary analysis suggests the safety profile observed in the combination of venetoclax plus obinutuzumab is consistent with the known safety profile of each medicine alone.Results from the CLL14 trial will be presented at a future medical meeting. Venetoclax is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group (RHHBY), in the U.S. and by AbbVie outside of the U.S.
https://thefly.com/landingPageNews.php?id=2814811
Augmented reality pre-surgery tech approved by US regulator
The US Food and Drug Administration (FDA) has approved a pre-surgery augmented reality imaging system that will allow doctors to see inside patients before a surgical procedure.
Tech firm Novarad’s OpenSight Augmented Reality System was given the green light by the US regulator, who granted 510(k) clearance.
The groundbreaking Augmented Reality (AR) system runs on the Microsoft HoloLens headset, allowing doctors to see 3D images at the same time as seeing the patient – in reality – simultaneously.
The ability to see the AR image as well as real-world surroundings avoids the
disorientation that can occur with virtual reality. AR is growing in popularity because it brings elements of the virtual world into the real world, enhancing what is seen, heard and felt.
OpenSight works by rendering 2D, 3D and 4D images of patients interactively, while overlaying them directly on to the patient’s body. It is superior to virtual reality because real world data is not overlooked, but is instead enhanced by AR.
Additionally, AR allows doctors to consult previous scans and could allow experts from remote sites to provide guidance on a medical case via the technology.
Dr Wendell Gibby, Novarad CEO and co-creator of OpenSight, said: “This is transformative technology that will unite preoperative imaging with augmented reality to improve the precision, speed and safety of medical procedures.
“This internal visualization can now be achieved without the surgeon ever making an incision, improving outcomes in a world of more precise medicine.”
Novarad explains that OpenSight AR allows doctors to have a better understanding of anatomical relationships, because the images are co-localised to the patient.
The software also enables doctors to carry out pre-operative planning, making it possible to highlight relevant anatomy and critical structures to avoid, as well as positioning virtual tools and guidance systems so that surgery can be planned with precision.
The headsets can be used in training, too, as several can be used simultaneously. A teaching version of the product is also available so that medical students can dissect cadavers virtually.
FDA clears cardiovascular claim for J&J’s Invokana
Johnson & Johnson finally has some good news to report for its diabetes blockbuster Invokana, after the FDA approved a new cardiovascular outcome claim on its label.
The US regulator has approved SGLT2 inhibitor Invokana (canagliflozin) to reduce the risk of major adverse cardiovascular events – including heart attack, stroke or death due to a cardiovascular cause – in adults with type 2 diabetes and established cardiovascular disease.
J&J says Invokana is the only oral diabetes treatment to reduce the risk of these cardiovascular events and is hoping that the new indication will help reverse a steep slide in sales of the drug in recent months.
The approval is based on the results of the CANVAS trial, which is ironically also the source of Invokana’s recent sales fall, shrinking by almost a quarter to $653 million in the first nine months of the year.
CANVAS showed that Invokana reduced the combined risk of heart attack, stroke and cardiovascular death by 14% compared to placebo overall, with an 18% advantage over control in patients with established cardiovascular disease. The problem was that the trial also showed that Invokana almost doubled the risk of lower limb amputations, and that was added to the product’s label as a ‘black box’ warning.
Cue a decline in market share against rival SGLT2 inhibitors from Boehringer Ingelheim/Eli Lilly and AstraZeneca, which have been growing at the expense of Invokana, particularly in prescriptions for new patients. The companies have worked hard to show with clinical data that the amputation risk is not a class effect.
Jennifer Taubert, chairman of pharmaceuticals at J&J, said at a conference last month that Invokana “really has been hampered by the warning in the label, and we’re still working closely with the agency and generating data, and a lot of real world evidence, to make sure that we understand and appropriately characterise any level of risk there.”
In June, the company reported real-world data at the American Diabetes Association (ADA) meeting from more than 140,000 patients treated with the product, saying it observed no elevated risk of below-knee lower extremity (BKLE) amputations.
J&J is also hoping for a boost later this year from its CREDENCE renal outcome study in patients with diabetic nephropathy, which was halted earlier this year on the recommendation of its data monitoring committee after hitting the mark on pre-specified efficacy endpoints.
The company said in July it would present the data at a medical conference before the end of the year, and would also be discussing the results with regulatory authorities.
In the meantime, J&J’s woes helped sales of Boehringer/Lilly’s Jardiance (empagliflozin) drug more than double last year to top the $1 billion threshold, with AZ hitting similar heights for its Farxiga (dapagliflozin) product.
Analysts at Evercore ISI have suggested that Jardiance could hit sales of $4 billion at its peak, driven by the results of the EMPA-REG cardiovascular outcomes study in diabetics, which showed an improvement in cardiovascular death with the drug.
Meanwhile, Farxiga has become the latest SGLT2 inhibitor to show it can reduce cardiovascular risk in type 2 diabetes last month, when AZ reported the results of the DECLARE-TIMI 58 trial, showing the drug achieved a statistically significant reduction in the composite endpoint of hospitalisations for heart failure or cardiovascular death.
Anthem raises FY18 adjusted EPS view to greater than $15.60 per share
Prior view was greater than $15.40 per share. FY18 consensus $15.50.
https://thefly.com/landingPageNews.php?id=2814073
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