Walgreens steps up Microsoft partnership, adds Adobe deal to roll out new digital tools

https://www.fiercehealthcare.com/tech/walgreens-steps-up-microsoft-partnership-to-roll-out-new-digital-tools

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https://www.medscape.com/viewarticle/933227

HCQ Trial to Resume

A global randomized controlled trial testing whether the antimalarial drugs hydroxychloroquine and chloroquine can prevent COVID-19 in healthcare workers or other high-risk workers will resume, Reuters reports. The UK Medicines and Healthcare Products Regulatory Agency had paused the COPCOV trial after another British trial found hydroxychloroquine to have no benefit for already-infected COVID-19 patients.

“Hydroxychloroquine could still prevent infections, and this needs to be determined in a randomized controlled trial,” said the trial’s co-leader. “The question whether (it) can prevent COVID-19 or not remains as pertinent as ever.”

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NACDS urges mandatory electronic prescriptions for controlled substances

https://drugstorenews.com/nacds-urges-mandatory-electronic-prescriptions-controlled-substances

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COVID-19 drug remdesivir to cost $3,120 for typical patient on private insurance

https://www.foxbusiness.com/healthcare/covid-drug-remdesivir-private-insurance

Gilead Sciences Inc. detailed its pricing plans for Covid-19 drug remdesivir, saying it will charge U.S. hospitals $3,120 for a typical patient with commercial insurance.

The drugmaker on Monday disclosed its pricing plans as it prepares to begin charging for the drug in July. The U.S. has been distributing remdesivir donated by Gilead since the drug was authorized for emergency use in May.

Under the company’s plans, Gilead will charge a higher price for patients with private insurance in the U.S., and a lower price for U.S. government health programs like Medicare and all other developed countries that insure their patients directly.

The government price will be $390 per dose or $2,340 per patient for the shortest treatment course and $4,290 for a longer treatment course.

Gilead said in the U.S. it will charge nongovernment buyers such as hospitals about $520 per dose, or a third more than the government price, for patients who are commercially insured. That works out to $3,120 for a patient getting the shorter, more common course of treatment, and $5,720 for the longer treatment duration.

The U.S. is the only developed country where Gilead will charge two prices, Gilead Chief Executive Daniel O’Day said in an interview. In other nations, governments negotiate drug prices directly with drugmakers. “The logic is that we wanted a single government price around the developed world,” Mr. O’Day said.

The higher price for U.S. commercially insured patients is because government health programs such as Medicaid typically receive statutorily-defined discounts off the prices companies receive in the private market.

“This medicine is priced far below the value it brings to health-care systems and that’s true for private payers and government payers,” Mr. O’Day said.

On average, the drug should help reduce hospital costs by $12,000 per patient, he said. Gilead estimated the savings based on data showing that each day of hospitalization costs $3,000 and that patients taking remdesivir are discharged four days sooner than those receiving standard treatment, Mr. O’Day said.

Covid-19 patients get two doses of remdesivir by infusion on the first day, and one dose daily afterward. The shortest treatment course is five days, while a longer treatment course takes 10 days.

Currently, 90% to 95% of patients receive five-day treatment courses, Mr. O’Day said.

Remdesivir is the first antiviral drug shown to be effective at treating Covid-19 in a major clinical trial, reducing patients’ recovery times by four days compared with the placebo group in a large study funded by the National Institute of Allergy and Infectious Diseases.

So far, few other drugs have proven in human testing to help coronavirus patients. One drug that recently produced positive results in a clinical trial was the steroid dexamethasone.

The drug, which treats Covid-19 by a different mechanism than remdesivir, has been on the U.S. market for decades to treat other diseases. It hasn’t been authorized in the U.S. to treat Covid-19, but doctors are allowed to prescribe it “off-label” under U.S. regulations.

Given its unique status, remdesivir’s pricing has been widely anticipated–and hotly debated–among doctors, health insurers and investors. It could serve as the starting point for other drugs that eventually prove to safely treat coronavirus patients.

The Institute for Clinical and Economic Review, a nonprofit group that analyzes pharmaceutical prices, said last week that a cost-effective price for remdesivir would be $2,520 to $2,800 per patient if dexamethasone becomes a standard medication for Covid-19.

Without dexamethasone, a cheap generic medication, remdesivir would be cost-effective at a range of $4,580 to $5,080 a patient, ICER said.

The U.S. Food and Drug Administration on May 1 authorized emergency use of remdesivir through the course of the pandemic. Gilead plans to seek a full, permanent approval.

In July, Gilead will start charging for the drug, but federal and state officials will continue deciding which hospitals receive it. In September, Gilead expects to have enough supply to meet demand and will distribute the drug in the same way it distributes other medicines.

One issue that has already factored into debate over what remdesivir should cost is the U.S. government’s role in funding its development.

The NIAID funded the study that showed it sped the recovery of hospitalized Covid-19 patients, and expects to spend at least $30 million on the study through the end of the fiscal year, an NIAID spokesman said in February.

Gilead has also invested in researching remdesivir. The company previously developed the drug to treat Ebola patients, but it didn’t work as well as other drugs. Gilead and other researchers explored remdesivir’s Covid-19 use after the virus emerged.

Gilead has said it spent about $50 million on research and development related to the drug in the first quarter, or about 4.5% of its total R&D spend. Through the end of 2020, Gilead expects to spend more than $1 billion on developing and manufacturing remdesivir, Mr. O’Day said.

Some generic drugmakers have said they plan to charge less than $1,000 per treatment course in India and Bangladesh, where Gilead has licensed rights to sell the drug. ICER estimates that the raw materials needed to make remdesivir cost about $10 per patient for a 10-day treatment course, citing a recent academic paper

Write to Joseph Walker at joseph.walker@wsj.com

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Sir I’ve been trying To get my prescription  filled,, but the pharmacy keeps turning it down  C V S, Walgreens,  and Walmart.. I’m a amputee with Fandom  pain and constant burning, plus on  Dialysis 3 times a week.. I’ve been on my pain killers for over 5 years and now they don’t want to give them to me. What options do I have.  please  Help me

Are we drifting back to the “Reagan years” ? Maybe the spirit of Nancy Reagan is haunting many that have a pharmacy/pharmacist license.  This woman is from Texas and I wonder why people keep going back to chain stores ? Do they like to be abused and intimidated ?

Once again here is website that will help “abused chain pts” to find a independent pharmacy  https://ncpa.org/pharmacy-locator

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Hello there, I’m reaching out to you because I feel that there is seriously something wrong with Walgreens right now. I wish to remain anonymous please.

I’m in the DFW area and as you may already know, Texas has had a huge surge of COVID-19 cases. Saturday night, I had 3 of my techs coming down with symptoms. I asked Walgreens what to do? “Go see their primary care doctor and pharmacy stays open.” Is there a way to get them fast tracked for testing? “They need to see their primary care doctor first.” With how my tech’s symptoms are and THREE of down coming down with the same symptoms at the same time, I am positive that it is COVID19 yet Walgreens has refused to do anything. No doctors are going to be open on the weekend for such late notice COVID testing. Walgreens will not close the pharmacy, they will not do a deep cleaning, they do not allow us that extra time to clean before and after closing. I’m so tight on hours that if I have my techs stay after closing to clean, I would be over my budget. I’m really damned if I do damned if I don’t. I had to advise my other techs to make an appointment at CVS to get themselves tested for COVID because it takes 2-3 days to make an appointment. Isn’t that sad? As Walgreens employees we have to go to CVS to get tested. My worst fear is, there is a technician at another store who tested positive, that Walgreens still is operating like normal. Nothing was done. Walgreens does not care about its customers nor their employees by pretending that there’s nothing wrong when there is a positive COVID case. I feel like we need to call out this behavior because it really is detrimental to our community as a whole. Who knows how many other Walgreens is doing this?

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https://therappreportpodcast.podbean.com/e/e12-interview-with-dr-thomas-kline-md

In this episode, we interview Thomas Kline, MD.

Dr. Kline lives in Raleigh, in the Great State of North Carolina. He not only treats patients suffering with chronic pain, but also advocates for them. Many of whom rely on opioid analgesics to survive. 

He has more than 40 years experience with long-term diseases, and has a very distinguished resume, including as the former Chief of Hospital in Home Service at Harvard Medical, a physician at Boston Children’s Hospital, his MD from The University of Maryland, completed his residency at the distinguished Stanford University, and he also has a PhD from The University of Oregon.

Dr. Kline has also authored several publications, been quoted in various medical articles, has been a guest on the Roy Green Radio Show, and is featured in a number of YouTube videos. 

These can be found at https://thomasklinemd.com/

He is also on JATH Educational Consortium at https://www.jatheducational.com/

Opioids in America: Misconceptions and Misperceptions https://www.youtube.com/watch?v=qJZOqbbro-8

Any questions for Dr. Kline? You can reach him via email at thomasklinemd@gmail.com

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FDA names five companies recalling NDMA-contaminated metformin

https://www.raps.org/news-and-articles/news-articles/2020/6/fda-names-five-companies-recalling-ndma-contaminat

The US Food and Drug Administration (FDA) announced on Thursday that five companies have now voluntarily recalled extended-release metformin drugs because of elevated levels of N-nitrosodimethylamine (NDMA), a potential carcinogen.

The five companies who were notified of the agency’s testing results and who are recalling their extended-release (ER) product, and specific labeling and lots recalled, are:

• Apotex – all lots
• Amneal – all lots
• Marksans, branded as Time-Cap – one lot (XP9004)
• Lupin – one lot (G901203)
• Teva, branded as Actavis – 14 lots

There are additional companies that manufacture ER metformin and supply a significant portion of the US market, whose products are not being recalled at this time,” said FDA. Immediate release metformin formulations have not contained NDMA in the FDA’s testing thus far. The substance is ingested in low levels through normal dietary pathways but can raise the risk of cancer with long-term elevated exposure.

(RELATED: FDA recalls some ER metformin for NDMA impurity, Regulatory Focus 29 May 2020)

The agency has now posted updated results of its NDMA testing in a sortable tabular format that includes all companies whose product has been tested, which formulations and lots were tested, and what levels, if any, of NDMA were found.

A second testing method using liquid chromatography-electrospray ionization-high resolution mass spectrometry has been posted by the FDA “to provide an option for regulators and industry to detect eight different nitrosamine impurities in metformin drug substances and drug products,” said the agency.

Companies manufacturing ER metformin should evaluate the risk that it contains NDMA at elevated levels. Companies should conduct per-batch testing, notify the FDA of any test results showing NDMA above the acceptable intake limit, and not release that batch to the US market.

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