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Script Care, Ltd.
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Pharmacy Benefits Manager Since 1986
Pharmacy Benefits Manager Since 1986

18 followers
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Lab tests have shown a promising microbe, found in a soil sample in Italy, is able to kill drug resistant bacteria in trials containing both test tubes and infected mice. By using a different mechanism of action to bind with bacteria, pseudouridimycin is not only an alternative to the antibiotic rifampin, but works as an added level of defense when administered with the existing drug. Pseudouridimycin also has a lower spontaneous resistance rate than its counterpart. Researchers point out that the discovery serves as a reminder that natural sources could play an important role in future antibiotic development.

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A recent survey published on the news site, Axios, indicates that the CEOs of the 70 largest healthcare companies took home, on average, $20 million per year since the Affordable Care Act (ACA) was started in 2010. Further, not only are these executives of pharmaceutical companies, health insurers and hospitals taking home huge sums of money, but the salaries have actually gone up for many in the last seven years. While health policy experts look for ways to reduce prices, eliminate waste and improve care, the CEOs, especially those of publicly traded companies, are rewarded for increasing sales and stock revenue, not developing new ways to save Americans money. Unfortunately, current government initiatives aren’t going to help, either, as the current emphasis is how to fund healthcare initiatives and there is virtually no focus on how the cut costs altogether.

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The abuse resistant opioid that turns blue if misused was voted down by the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) and the Drug Safety and Risk Management Advisory Committee (DSaRM). The panels rejected the drug, Rexista, due to the lack of required studies and concern over the use of shame to deter abuse in patients with addiction issues. Further, though the drug turns viscous if manipulated, researchers were still able to extract 20% of the opioid into a syringe.

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The FDA has approved 23andMe’s at-home tests to identify 10 genetic variations that indicate a risk for specific diseases, including Parkinson’s, Alzheimer’s, celiac and Dystonia. Users register the testing kit online, deposit saliva and mail the package back to 23andMe – results are available online. Experts warn that genetic risk does not directly indicate that disease will develop, and there remains the possibility of both false negatives and positives. Understanding risk, however, could provide motivation for individuals to implement preventative measures to avoid future onset and lead to earlier disease identification.

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While the industry has been slow to embrace and implement value-based contracting, the growing demand for new, cost effective solutions in health care has ensured that preliminary investigation into the potential success of the practice has continued. Experts cite three major hurdles that must be addressed before compensation for performance becomes a standard contracting approach: (1) difficulty and/or inability to accurately track outcomes, (2) if clinical and cost outcomes of the drug are not currently approved by the FDA, they cannot be included in negotiations and (3) concerns over the application of regulatory issues, including Medicaid Best Price and anti-kickback legislation, create an uncertain environment for manufacturers. Until technical/reporting systems and government practices/regulations are updated to meet the needs of value-based contracts, uptake will continue to be slow.

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Although it’s one of the most common condition in individuals covered by Medicare, inhalers for chronic obstructive pulmonary disease (COPD) are, oftentimes, unaffordable - even with the government assistance. In fact, experts suspect that, with multiple inhalers and the cost of oxygen tanks, patients with Medicare Part D coverage still spend thousands of dollars annually. A major contributing factor to the problem is that Medicare Part D was designed over 10 years ago - and hasn’t been amended to account for the accelerating growth of prescription drug costs. In turn, patients rely on free samples from their prescribers and are frequently forced to skip necessary doses, leading to additional hospital stays and unnecessary disease complications.

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While the new class of genetics-based cancer drugs is an exciting innovation in cancer treatment, experts warn that a true success story is unlikely until genetic testing becomes standard procedure. For instance, a new treatment that works on mutations in the TRK gene in multiple types of cancer (including breast, colon, lung and skin) has been highly successful, but is only applicable to between 1,500 to 5,000 people in the country, most of which have not had their genetics screened. In fact, only 12% of people with late stage metastatic cancer have screened for genetic mutations. A major factor in the low uptake of testing is, not surprisingly, cost: the tests needed to identify the TRK gene mutations can exceed $5,000.

https://www.technologyreview.com/s/607976/promising-new-cancer-drugs-wont-go-far-unless-everyone-gets-genetic-testing/

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Despite receiving approval in 2010, 500,000 side-effect reports for Actemra reveal an association with high rates of heart attacks, strokes, heart failure and other conditions – and none of these conditions are included on the drug’s label. Depending on which drug is used for comparison, the incidence of these side-effects is as high as or higher than Actemra’s competitors. The case reveals an important deficit in FDA post-approval drug monitoring and a severe lag in the review of newly discovered side-effects. Despite spending $207 million on Sentinel, a data system meant to increase the FDA’s ability to monitor side effects via insurance claims, the tool has not been as effective as the Agency had hoped. Additionally, political pressure to increase approval volume leaves less manpower, in an already over-burdened group. Finally, post-approval monitoring reports are created by the drug’s manufacturing company, creating a notable conflict of interest in honest reporting.

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FDA Commissioner, Scott Gottlieb, announced that the agency is undertaking a new initiative to decrease the costs of generic drugs by expediting review and approval of competing applications. The approach is in stark contrast to existing approval methodology that focuses on fast-tracking the application of the first company to apply for a new generic drug. The ultimate goal is to have at least three versions of every drug available in the market, incenting adequate competition and price reduction; analysts report that a single generic has little impact on drug pricing, adding a second generic to the market reduces the price by half and a third typically forces the price to around 20% of the original brand version. Additional initiatives include increasing generic manufacturer access to brand drugs for testing and publishing a list of brand drugs that are no longer under patent protection.

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After 42 states and the District of Columbia filed suit that Johnson & Johnson’s (J&J) manufacturing practices did not follow federal standards and that the company knowingly distributed adulterated medications, a $33 million settlement was reached. The payout comes after the company recalled seven of its over the counter products (including Sudafed, Pepcid and Zyrtec), as well as a $25 million judgment in 2015 for metal contaminants found in one of J&J’s liquid medications.
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