Author: Peter

The U.S. government has placed a series of multibillion-dollar bets on potential COVID-19 vaccines. But actually getting those vaccines to patients is another story, and now the government has picked a distributor to aid that effort...The Trump administration has tapped Dallas-based distribution giant McKesson to partner with the Centers for Disease Control and Prevention as a national distributor for COVID-19 vaccines...Under a 2016 childhood vaccine deal, the CDC had an option to draft McKesson to distribute vaccines in case of a pandemic, according to a Department of Defense...McKesson's Warp Speed pact comes as the Trump administration looks to flesh out a production and distribution framework for one or more approved vaccines by the end of the year...READ MORE

The U.S. Department of Justice has been hot on the heels of some of pharma's biggest players in a yearslong probe into an alleged industrywide co-pay kickback scheme...Federal prosecutors accused Teva in a new lawsuit of paying kickbacks to two patient copay assistance charities as part of a scheme to pump up prescriptions of multiple sclerosis med Copaxone...The filing in a Boston district courthouse alleged the company paid more than $300 million to those third-party organizations and defrauded Medicare of "hundreds of millions" in reimbursements...READ MORE

GoodRx has released its latest list of the most expensive drugs in America, with orphan drugs and therapies for rare conditions continuing to top the ranking...The most expensive drug as of July is Myalept, an orphan drug that treats leptin deficiency in patients who have generalized lipodystrophy, which is a genetic disorder where a patient has an almost total lack of body fat...Myalept's list price is $5,093 per vial, and patients typically use 14 vials in a year, GoodRx said. The drug's price most recently went up January...READ MORE

Ravicti
Mavenclad
Actimmune
Oxervate

Barriers to adoption include hearing issues, lack of tech abilities and visual difficulties...While telemedicine may be having a boom, a new study published in JAMA warns that it may not be suitable for everyone...The study, which looked at data from adults over the age of 65, found that over a third of people weren’t ready for video visits...“Although many older adults are willing and able to learn to use telemedicine, an equitable health system should recognize that for some, such as those with dementia and social isolation, in-person visits are already difficult and telemedicine may be impossible,” authors of the study wrote. “For these patients, clinics and geriatric models of care such as home visits are essential.”...READ MORE

Potential accuracy issues with a widely used coronavirus test could lead to false results for patients, U.S. health officials warned...The Food and Drug Administration issued the alert...to doctors and laboratory technicians using Thermo Fisher’s TaqPath genetic test. Regulators said issues related to laboratory equipment and software used to run the test could lead to inaccuracies. The agency advised technicians to follow updated instructions and software developed by the company to ensure accurate results...Dr. Albert Ko of Yale’s School of Public Health said the potential accuracy problems have “pretty serious implications” given that Thermo Fisher’s test is used widely both in the U.S. and around the world to screen for coronavirus...The FDA has used its emergency powers to OK more than 200 tests for coronavirus since February. No test is perfect and all are expected to give at least a small percentage of false negatives and false positives...READ MORE

Hospitals and health systems are building a major presence in the specialty pharmacy industry...nine out of ten large hospitals now operate a specialty pharmacy. Hospitals and other healthcare providers account for one-third of all U.S. accredited specialty pharmacies...Clinical and general financial motivations are driving hospitals’ DIY specialty pharmacy growth. The enormous profit opportunities from the 340B Drug Pricing Program offer further encouragement for hospitals. In-house specialty pharmacies are also a valuable hedge against the potential loss of contract pharmacies...READ MORE

The positive impacts of pharmacists in supporting medication without harm are described in a new publication from FIP released today. FIP’s new reference document, entitled “Patient safety — Pharmacists’ role in ‘Medication without harm’”, provides information about what pharmacists can do to promote patient safety at an individual patient level, as well as at organisational and policy development levels...READ MORE

A New Jersey medical office has filed suit against Cigna, alleging that the insurer failed to pay for diagnostic testing and treatment related to COVID-19 in violation of the CARES Act...Open MRI and Imaging of RP Vestibular Diagnostics claims that Cigna owes it nearly $400,000 in unpaid claims for care related to the novel coronavirus, and that the decisions to decline coverage were "arbitrary."..."The explanations given by [Cigna] for its refusal to make payment include unelaborated denials that the services were rendered as billed, or matched the services billed, as well as the occasional contention that the billing was duplicative," according to the lawsuit. "The grounds for rejecting plaintiff's claims were, upon information and belief, false and invalid."...READ MORE

This past week Minnesota became the second state to reject regulations that effectively ban the controversial drug hydroxychloroquine for use by COVID-19 patients...The decision, which comes two weeks after the Ohio Board of Pharmacy reversed an effective ban of its own, was rightfully praised by local health care advocates...The reversal by (Gov Tim Walz) Walz, a first-term Democrat, clears the way for doctors to prescribe hydroxychloroquine, a drug commonly used to treat malaria and other conditions but one the FDA has declined to recommend for COVID-19 treatment...The politics of hydroxychloroquine are unlikely to cool before November’s presidential election. Yet, if Walz’s decision is any indication, at least some leaders are starting to recognize the ethical dilemma of using the long arm of government to stand between suffering patients and a drug that may have the potential to save them...READ MORE

As President Trump wrestles with trying to rein in the high cost of medicine in the United States, he is contemplating an executive order and a proposed rule from the Center for Medicare & Medicaid Services that would set Medicare Part B prescription drug costs based on an International Pricing Index (IPI). The problem is that the IPI includes countries that utilize socialized medicine and artificial price controls. Here, President Trump is mistakenly focused upon the symptom rather than the cause of the problem.  The symptom is the cost, the cause is the incredible barriers to approval and pernicious middle-men known as Pharmacy Benefit Managers which make medicines more expensive...READ MORE