Centene to invest $100M in Alzheimer’s, diabetes research at Washington U

St. Louis-based Centene Corp. announced it will fund up to $100 million in research at Washington University School of Medicine.

The funding will be aimed at research in Alzheimer’s disease, breast cancer, diabetes and obesity at Washington University, also based in St. Louis. Those particular diseases were targeted because they are common, debilitating and often deadly diseases that affect individuals worldwide, officials said.

Under the agreement, Centene’s funding would be dispersed over 10 years to the School of Medicine’s Personalized Medicine Initiative. Innovations that come from the initiative will be commercialized through a joint venture between the school and Centene.

Officials said the agreement would allow Centene to leverage the university’s research and biomedical capabilities in CRISPR as well as its talent in researching the microbiome, immunomodulatory therapies, cancer genomics, neurodegeneration, cellular reprogramming, chemical biology and informatics.

It’s the latest in a spending spree by Centene, which announced last month it would purchase rival insurer WellCare Health Plans in a deal valued at $17.3 billion. It will create one of the largest sponsors of government plans across the three main markets—Medicare, Medicaid and the Affordable Care Act exchanges—following the WellCare merger.

Last fall, it was announced Centene backed pharmacy benefit manager RxAdvance in a $50 million funding round.

“We share the goal of helping to improve the health of our communities through research, education and customized treatment for people suffering from chronic illnesses,” said Michael Neidorff, chairman and CEO for Centene, in a statement. “We believe personalized medicine is the path to ensure patients get the targeted health care they need to fight disease.”

The funds are also expected to support more than a dozen centers at the School of Medicine.

“We will be bringing together world-class resources and intellectual horsepower from every basic and clinical scientific discipline to urgently accelerate the timeline for developing therapies that are more precisely targeted, with aspirations to do so in the next five to seven years,” said David Perlmutter, M.D., executive vice chancellor for medical affairs at the School of Medicine.

https://www.fiercehealthcare.com/hospitals-health-systems/centene-to-fund-100m-alzheimer-s-diabetes-research-at-washington

5 drugs in development Optum says payers, employers should be watching

Amid rising drug costs, employers and payers should be keeping a closer eye on products in the pipeline as they design formularies.

Specifically, there are certain emerging therapies that could lead to significant costs down the road, according to Optum, which recently released its list of five drugs to watch in 2019.

Those drugs are:

1. Golodirsen, a treatment for Duchenne muscular dystrophy
2. Siponimod, which aims to delay the progression of multiple sclerosis
3. Zynquista, or sotagliflozin, a new oral insulin adjunct medication for people with Type 1 diabetes
4. Risankizumab, an injectable medication for plaque psoriasis
5. Ultomiris, a longer-lasting medication for paroxysmal nocturnal hemoglobinuria, a rare blood disorder

David Calabrese, OptumRx vice president and chief pharmacy officer, told FierceHealthcare that drugs like these, particularly those for rare diseases, have been consistent cost drivers. He said it’s crucial for insurers to be watching these products early, so those with limited value can be determined sooner.

“I think it’s just exercising a heightened level of due diligence,” he said. “Historically, organizations like ours would wait until the product was FDA approved, then dive into the data. We’ve taken a much more proactive approach over the course of the last half decade or so.”

Optum projects spending several years out in its analysis. For example, sales of Zynquista and other sotagliflozin products could peak at $1.3 billion by 2024, according to the report. That drug did hit a snag with the Food and Drug Administration, however, which declined to approve it in March, likely delaying a 2019 launch.

Golodirsen is in development by Sarepta Therapeutics, which also currently offers a similar product in that class, Exondys-51, priced at $300,000 per year—so Optum expects Golodirsen to be similarly costly.

Aside from greater awareness, what can payers do to better manage the costs of expensive new therapies? Alongside monitoring emerging therapies and treatments for rare conditions earlier, Optum has developed clear guidelines for physicians, so they know when it’s appropriate to provide these pricey drugs to patients, Calabrese said.

It does this using a digital tool called PreCheck MyScript, which notifies doctors within the electronic health record of their options for certain conditions, what a patient’s out-of-pocket costs would be and if a prior authorization is required. Physicians then have the option to apply immediately within in the system for prior authorization if they choose that drug, Calabrese said.

“They’d know immediately whether that product would be approved or not for that given patient at that given time,” Calabrese said.

In addition, Optum recommends that payers offer a robust list of biosimilars to ensure that patients have access to lower-cost alternatives to pricey brand drugs. While this is a challenge, as the biosimilar pipeline is limited at present, Calabrese said one of the key functions of its specialty pharmacy is to make patients and doctors more aware of these alternatives.

It’s also key to closely monitor drugs like those on Optum’s list for effectiveness and any potential negative side effects after offering coverage, so that they’re included in formularies where it makes the most sense, he said.

https://www.fiercehealthcare.com/payer/optum-5-drugs-development-payers-should-be-watching

Senators Who Got Biggest Checks From CVS, Humana And Other PBMs Testifying

When executives from five of the country’s biggest pharmacy benefit managers testify before the Senate Finance Committee Tuesday, they’ll be staring down a group of senators who have benefited from their businesses. Political action committees for the companies have donated nearly $1 million to the senators’ campaign committees over the past 10 years, according to a Forbes analysis of Federal Election Commission filings.

The recipients spanned the political spectrum. Only one of the 28 senators on the committee, Maria Cantwell (D-Washington), has never accepted money from the companies’ PACs. In 2012, however, her joint fundraising committee, Cantwell Victory 2012, took in $1,000 from Cigna, one of the companies set to testify Tuesday.

In addition, some of the senators have received personal donations from the executives themselves. Derica Rice, who’s now president of Caremark, CVS Health’s PBM division, contributed $1,000 to the campaign committees of Michael Bennet (D-Colorado), Mark Warner (D-Virginia) and Rob Portman (R-Ohio)—plus $2,250 to the campaign of Todd Young (R-Indiana) between 2014 and 2016, when Rice worked at Eli Lilly.

John Prince, CEO of United Healthcare’s Optum, donated $2,500 in 2015 to the campaign committee of Senator Pat Toomey (R-Pennsylvania). Steve Miller, executive vice president and chief clinical officer of Cigna, has contributed $1,000 to the campaign committees of Toomey and Wyden. The other two executives testifying, Prime Therapeutics interim CEO Mike Kolar and Humana healthcare services president William Fleming have donated only to their companies’ PACs since 2009.

According to a review of contributions from the five companies set to testify (plus Express Scripts, which Cigna acquired in December), the campaign committee of Todd Young received the most of any senator on the committee. Since 2009 Young’s committee has received some $75,000.Others who received more than $60,000 in contributions to their campaign committees include Bob Casey Jr. (D-Pennsylvania), Michael Bennet (D-Colorado) and Bill Cassidy (R- Louisiana).  

Tuesday’s hearing marks the third in a series that Senators Chuck Grassley (R-Iowa) and Ron Wyden (D-Oregon), who lead the Senate Finance Committee, have held this year to examine the high cost of prescription drugs in America. The executives are expected to answer questions on how pharmacy benefit managers, which operate as middlemen between drug manufacturers and health insurers, affect the cost of prescription medications for patients.

Between 2017 and 2018, the PACs of companies like Humana and CVS contributed roughly a quarter of their campaign spending to members of the Senate Finance Committee. Prime Therapeutics, which is based in Minnesota, made very few contributions to this group. Since 2009, Prime’s PAC has made a $2,500 contribution in 2014 and a $2,000 contribution in 2017 to the campaign committee of Senator John Cornyn (R-Texas).

Executives from pharmaceutical firms AbbVie, Bristol-Myers Squibb, AstraZeneca, Pfizer, Johnson & Johnson, Merck and Sanofi testified before the Senate Finance Committee in February, acknowledging a broken pricing system. But rather than commit to lowering prices on their end, they placed some blame on insurance companies and pharmacy benefit managers, or PBMs. The trade group that represents PBMs, Pharmaceutical Care Management Association, has countered in statements since, noting that drugmakers are the only ones with the power to set medications’ list prices.

Forbes also examined campaign contributions before that hearing, finding that the political action committees of the seven companies that sent executives to testify had contributed over $1.5 million to the campaigns of committee members in the last decade.

Ahead of the hearing, there has already been some news about reducing prices for some patients. Last week Cigna’s Express Scripts announced plans to launch a new program capping out-of-pocket costs for some insulin prescriptions. While Senator Grassley praised the news in a statement, he questioned why it’s taken so long for this to happen. “It shouldn’t take bad press and congressional scrutiny to get health plans, their pharmacy benefit managers and pharmaceutical companies to arrive at a fair price for a drug that’s been on the market for nearly a century,” Grassley said.

The inquiries into drug pricing are only expanding. On Wednesday there will be a hearing in the House E&C Committee questioning executives from the three biggest insulin manufacturers: Sanofi, Novo Nordisk and Eli Lilly, as well as other executives from CVS Health, Express Scripts and Optum.

https://www.forbes.com/sites/michelatindera/2019/04/09/these-senators-received-the-biggest-checks-from-cvs-humana-and-other-pharmacy-benefit-managers-testifying-tuesday/#2eafc82e7d5d

Alkermes’ ALPINE data an incremental positive, says Piper Jaffray

After Alkermes (ALKS) reported this morning that its ALPINE trial met its primary endpoint and that Aristada showed similar efficacy to the current market leader, Invega Sustenna, at all time points assessed, Piper Jaffray analyst Danielle Brill said she views the data as an incremental positive. However, she thinks it will be challenging to capture share from Johnson & Johnson (JNJ), telling investors that she is “not sure these data will be enough to move the needle.” Brill maintains a Neutral rating on Alkermes.
https://thefly.com/landingPageNews.php?id=2890407

Amgen BLA for Evenity approved by FDA

A post to the FDA’s website indicates that Amgen’s Biologic License Application, or BLA, for Evenity was granted approval on April 9

https://thefly.com/landingPageNews.php?id=2890410

Cerner operational initiatives, expanded buyback encouraging, says Baird

Baird analyst Matthew Gillmor said he is encouraged by the operational initiatives and expanded stock buyback program announced by Cerner, stating that shareholders have been advocating for changes similar to those the company will implement in its agreement with activist fund Starboard Value. While stating that skeptics will argue this is a one-time step up in EPS power and that a revenue mix shift will continue to drag on margins, Gillmor counters that Cerner has "ample capacity" to keep buying back stock even after completing the program announced this morning. He keeps an Outperform rating on Cerner and raised his price target on the stock to $71 from $67.
https://thefly.com/landingPageNews.php?id=2890389

PrEP use linked with increased STD risk

Pre-exposure prophylaxis use to protect against HIV infection was associated with higher infection rates of other sexually transmitted diseases, according to a new study.

An analysis in Australia found more than 2,900 sexually transmitted infections were diagnosed in nearly half of the study’s participants from when they started using PrEP. Nearly 3,000 gay and bisexual men were given access to the medication. The study found infections per participant ranged from zero to 12.

The study, published Tuesday in JAMA, found 25% of study participants had multiple infections that accounted for 76% of all infections diagnosed. The incidence of infections increased among participants who already had been tested for STIs.

Researchers found that patients at greater risk of sexually transmitted infections tended to be younger, had used PrEP prior to the trial, and reported having a higher number of anal sex partners and greater participation in group sex compared with those who did not get infected.

The study did not find a significant increase in risk based on the frequency with which patients used condoms, indicating that there was not a clear association between consistent condom use and decreased risk of infection.

Condom use has historically been strongly associated with decreasing the risk of STIs. But the study found no significant difference between those who reported using condoms more than half of the time they had sex, compared with those who used them less than half of the time, all of the time, or never using them at all during sex with casual partners. Researchers deduced that could stem from study participants’ low consistent condom use.

“Findings suggested that STI prevention campaigns should not focus solely on condom use but also on reducing the time to STI diagnosis and treatment by promoting easy access to frequent testing,” the study concluded.

In an accompanying editorial, Drs. Monica Gandhi and Matthew Spinelli, both from the University of California at San Francisco’s medicine department, and Dr. Kenneth Mayer of the Fenway Institute in Boston, cautioned that the study’s results should be viewed in context with, and not outside of, current trends among gay and bisexual men—increases in sexually transmitted infections that have been occurring within that group even prior to the availability of PrEP in 2012.

The writers also stressed the importance of condom use. They said evidence has shown concerns among clinicians about whether patients who take PrEP would begin to engage in riskier behavior has led some not to offer the medication. A 2018 report in the journal Clinical Infectious Diseases found increasing rates of sexually transmitted infections among PrEP users who were engaging in unprotected sex.

Many experts see increasing the use of PrEP among high-risk individuals as one of the key factors toward achieving the Trump administration’s pledged goal of reducing new HIV infections by 90% by 2030.

PrEP was first approved in 2012 to prevent HIV transmission and has an efficacy rate of about 97% when taken consistently. But use has been relatively low among the population that it could benefit most. Of the estimated 1.1 million Americans identified in 2015 as possibly benefiting from taking PrEP, only 90,000 prescriptions were filled that year, according to the Centers for Disease Control and Prevention.

Encouraging greater use of PrEP was what prompted the U.S. Preventive Services Task Force last year to recommend clinicians offer PrEP to patients at high risk for contracting HIV.

“To continue to achieve the population-level influence on HIV incidence through PrEP that appears imminently achievable, PrEP will need to be available for and used by the populations that can benefit the most, including those having condomless sex,” the commentary stated.

https://www.modernhealthcare.com/safety-quality/prep-use-linked-increased-std-risk-study-shows