Welcome to European Tribune. It's gone a bit quiet around here these days, but it's still going.
[SARS-CoV-2]omnicron [variant] complicates [marketing] at-home Covid pill [in USA]; UK, EU marketing omitted
The FDA will likely specify which "high risk" populations should have access to the Merck-Ridgeback Biotherapeutics pill if they contract Covid-19. That still will leave [licensed medical] doctors and other providers [of WHAT?] on the hook for making ["]judgment calls["] on whether to prescribe the pill -- and to do it within five days of a patient showing symptoms -- in order to realize the potential benefits.
supply chain controversy: US licensed pharmacists do not prescribe Rx; they compound, fulfill, dispense pharmaceutical products.
But supplies of the pill will likely be limited at first. The federal government has purchased 3.1 million courses of molnupiravir, which it will acquire between the date of FDA authorization and early next year. It has the option of purchasing an additional two million doses later, if needed.

A senior federal health official said if authorized, the pills bought by the federal government will be provided free of cost to localities[sic] that can distribute [market] them through health departments, community health centers and pharmacies [marketing channels]. "We continue to work with jurisdictions to plan for distribution and use of these products that will be consistent with clinical guidelines [medical diagnostic criteria] and recommendations for who should receive them," the official said.

"death panelists" or "equity" avengers?
In Merck's trials, however, the pill was only tested on unvaccinated adults, which makes some health experts wonder if the pills will only be available to that group. With an unvaccinated population at just over 99 million people, according to the Centers for Disease Control, three million doses is "a drop in the bucket," said Eunice Neeley [MD, PHP], a preventive medicine specialist and primary care provider based in New Orleans, Louisiana.
Carlos del Rio [MD], an executive associate dean and infectious disease specialist at the Emory School of Medicine, said that the pills "should work" against other variants because of how they stop the virus from replicating. But it will be important to collect more clinical data to be sure, he added.
If pharmacists don't participate [diagnose COVID-19], patients might have to make doctors appointments, delaying when they can begin the regimen.
novel EUA launch? From prescription pad to store shelf
To get FDA approval to change a prescription drug's classification to ["over-the-counter"] OTC [medicine], the product's manufacturer must prove its medication's safety and efficacy.11 Generally drugs can become OTC if:
  • They have low potential for misuse and abuse.
  • They are used for self-diagnosed conditions.
  • They can be used safely and effectively without a health care provider's instruction.
  • They can be adequately labeled.
In late-stage clinical trials, molnupiravir was shown to be about 30 percent effective at preventing hospitalization in at-risk patients, compared to a placebo. For comparison, [monoclonal] antibody treatments [intravenous or subcutaneous injection] that are administered in clinics and hospitals are about 70 percent effective.
The most important thing, they argue, is stopping future infections before they happen. "This will not help us out of the pandemic because it is a treatment and not a prevention," said [Dorry] Segev[MD, PhD]. "The way out of this pandemic is prevention."
too late! NEXT! ...
by Cat on Sat Dec 4th, 2021 at 05:34:41 PM EST
[ Parent ]
US drugstores squeezed by vaccine demand, staff shortages
pharmacists worry another job might soon be added to their to-do list: If regulators approve antiviral pills from drugmakers Merck and Pfizer to treat COVID-19, pharmacists may be able to diagnose infections and then prescribe pills to customers
On top of that workload and [filling] routine prescriptions, many drugstores also have been asking pharmacists to ["]counsel["] patients more generally on their health Rx dosage and adverse indications or about [medical insurance plan pricing of brand name and generic drugs for] chronic conditions like diabetes and high blood pressure.
[proprietor pharmacist Theresa] Tolle noted that it is not clear yet how pharmacists will be reimbursed for the time they take to diagnose and prescribe. That will have to be clarified, especially if cases surge again and drugstores need to add even more ["]workers["] to help [do WHAT?].
David Brailer's "consumer-patient" complaints
Sherri Brown, a city employee in Omaha, Nebraska, was searching for a vaccine booster dose, but two nearby pharmacies didn't have appointments available and a third didn't have the brand she wanted. She wound up getting a shot at a county-run clinic on Friday.
This is a marketing plan that will not end well, if it even launches this decade, and not only because Mr Murphy hasn't synthesized his own reporting: CVS Health to close hundreds of drugstores over next 3 years
archived Mon Aug 21st, 2006
by Cat on Sun Dec 5th, 2021 at 03:07:50 AM EST
[ Parent ]
market-based solutions to market-based problems
Ire over pharmacy middlemen fuels lobbying blitz
While there is little agreement among PBM opponents about what actions Congress should take, industry lobbyists are offering a menu of options for Democrats to consider, such as requiring [Pharmacy Benefit Managers] PBMs to pass on more of the rebates they negotiate with drugmakers to consumers or employers. They could also ban a common practice called spread pricing in which PBMs charge health plans [insurance carriers] more than they pay to the a pharmacy corporation dispensing a drug, and pocket the difference.
JC Scott, who leads the Pharmaceutical Care Management Association, the trade group for PBMs, said targeting his members might be good politics and take the focus off drugmakers during a critical moment in the debate, but it would not lower drug costs.
Although dozens of PBMs exist, the industry is consolidated, with three of them -- CVS Caremark, Express Scripts and OptumRx -- controlling nearly 80 percent of the prescription market. Health insurers, employers and [federal and states'] government hire PBMs to manage prescription benefits for their health [employees' commercial medical insurance group] plans -- putting them at the center of a supply chain consisting of drugmakers, insurers and pharmacies.

WHO.int, "Medicines Reimbursement Policies in Europe" (2018), 200pp

An increasing number of countries in the WHO European Region have concluded managed entry agreement (MEAs). These are contractual arrangements between a pharmaceutical company and a public payer that enable reimbursement of a medicine, subject to specified conditions. A variety of different types of MEAs exist, which can be classified, in principle, as either finance-based (such as simple discounts or price-volume agreements) or performance-based (linked to health outcomes); the former are applied more frequently. Common indications covered by an MEA are oncology, rheumatology, hepatitis C and diabetes. In general, MEAs tend to be confidential - at least those aspects relating to the prices and discount arrangements.
Federal and states' HHS agencies underwrite expense of CMS price schedules for Medicare and Medicaid beneficiares enrolled public insurance plans, administered by commercial insurers licensed by the states.
archived Tue Jan 30th, 2018
by Cat on Sun Dec 5th, 2021 at 06:57:46 PM EST
[ Parent ]
by Cat on Sun Dec 5th, 2021 at 07:11:30 PM EST
[ Parent ]
The symptom that tells you you've caught omicron
"Many of those infected have reported having a scratchy throat as opposed to a sore throat."
by Cat on Wed Dec 15th, 2021 at 06:01:31 PM EST
[ Parent ]


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