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U.S. Medicare plans to cover Biogen Alzheimer’s drug only for trial patients

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The U.S. government Medicare program on Tuesday said it plans to cover Alzheimer’s treatments including Biogen Inc’s Aduhelm but will require patients to be enrolled in a clinical trial, limiting access to the treatment more than many expected.

Biogen shares were down 7.3% at $224 in extended trading on Tuesday.

The decision from the U.S. Centers for Medicare and Medicaid Services (CMS), the health agency that runs Medicare, could change as it seeks comment from companies and patients. A final decision is due on April 11.

The final CMS coverage terms are expected to apply to all drugs in the class, including experimental medications in development by Eli Lilly & Co, Roche Holding AG and Biogen partner Eisai Co Ltd.

Patient advocacy group UsAgainstAlzheimer’s chairman George Vradenburg said he was angry Medicare placed conditions on the use of the drugs that were more limiting than the regulator, the Food and Drug Administration, put on Aduhelm, and that the Medicare decision applied to any amyloid drug.

The government’s health service was “at war with itself,” he said.

“The FDA has approved this drug and now Medicare has disapproved the drug,” Vradenburg said.

The FDA approved the drug in June last year despite its 11-member committee of outside experts voting nearly unanimously in November 2020 that the drug should not be approved, citing inconclusive evidence the drug was effective.

Many experts have questioned the FDA’s rationale for Aduhelm’s approval without more definitive proof of benefit, and doctors have held back on prescribing it.

“The wholesale rejection of this product by payers and health systems around the country is notable but not shocking, given how little evidence the manufacturer produced at the time of its FDA approval,” said Dr. Caleb Alexander, a professor with the Johns Hopkins Center for Drug Safety and Effectiveness, in Baltimore. Alexander was a member of the FDA advisory panel that voted not to approve the drug.

Demand for an Alzheimer’s treatment, he said, “should fuel our investments in drug development, not a lowering of standards that Americans rely upon to know whether their drugs are safe and effective.”

UNUSUAL RESTRICTIONS

The unusual move to require clinical trials for recipients of the already approved drug comes after a six-month process in which CMS had been working on a national coverage policy for the drug.

The decision to require the trial “will exclude almost all patients who may benefit,” Biogen said in a statement.

The requirements “can take months to years to initiate,” it said, and promised to urge the agency to align its coverage policy with the populations that have been studied in previous clinical trials.

“We believe Alzheimer’s patients should have access consistent with other therapies with FDA accelerated approval,” Biogen said.

Sales so far have been weak and Biogen last month cut the medication’s list price by about half to $28,200 per year.

Cowen analyst Eric Assaraf said in a research note the decision to restrict coverage to clinical trial participants was more restrictive than he had expected, noting the agency could have simply required Biogen to maintain a registry of patients that documented responses to the drug. He said CMS may change its stance in the final decision.

Aduhelm’s high price also has raised concerns over the toll it might take on the Medicare program, the U.S. government health plan for people age 65 and over. Because Alzheimer’s is an age-related disease, around 85% of people who might use the medicine are in the government plan.

With the proposed decision, the cost will shift to patients, Vradenburg said.

“Unless you are a very wealthy person, you are not going to get access to the drug,” he added.

Aduhelm, given as a monthly infusion, is a monoclonal antibody designed to remove a type of brain plaque associated with Alzheimer’s Disease. Patients need to be monitored for potential side effects including brain swelling.

(Reporting By Deena Beasley, in Los Angeles, Julie Steenhuysen in Chicago and Leroy Leo in Bengaluru;Editing by Caroline Humer, Bill Berkrot, Devika Syamnath, Peter Henderson and Lincoln Feast.)

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Nova Scotia reports 68 people in hospital because of COVID-19 – CBC.ca

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Nova Scotia has reported that 68 people are in hospital because of COVID-19, including 10 in intensive care.

A news release from the province Sunday said the patients are receiving specialized care in a COVID-19 designated unit.

The average age of the patients admitted for COVID-19 is 65, the release states. The majority of the patients, 65, were admitted during the Omicron wave. 

There are also two other groups currently in hospital related to the virus, according to the release.

  • 60 people who were identified as positive upon arrival but were admitted for another medical reason, or were admitted for COVID-19 but no longer require specialized care
  • 112 people who contracted COVID-19 after being admitted to hospital.

The abbreviated release did not provide the number of COVID-19 admissions and discharges. 

Nova Scotia Health labs completed 3,711 tests on Saturday and 696 new cases have been reported.

There are 447 cases in the central health zone, 108 in the eastern zone, 105 in the western zone and 36 in the northern zone.

Less than than 10 per cent of Nova Scotians are unvaccinated, according to provincial statistics.

As of Friday’s update, unvaccinated Nova Scotians were about four times more likely to be hospitalized due to COVID-19 than someone with two doses of vaccine. That is based on average hospitalizations since the province started releasing the daily hospitalizations by vaccine status on Jan. 4.

Summary offence tickets

Halifax Regional Police issued 11 summary offence tickets Sunday for violations of health regulations.

Police responded to reports of a party at a Bayers Road residence shortly before 1 a.m. Sunday.

Tickets were issued to 11 occupants for failing to comply with provisions of the Health Protection Act. 

The tickets carry a fine of $2,422.

Atlantic Canada case numbers

  • Newfoundland and Labrador reported one death and 384 new cases Sunday. There are 5,503 active cases and 12 hospitalizations. 
  • Prince Edward Island reported five hospitalizations Saturday. There were 309 new cases and 222 recoveries in Saturday’s report.
  • New Brunswick reported four more deaths and 115 hospitalizations Sunday. The province has 5,265 active cases.
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UK’s Johnson plans to scrap COVID-19 self-isolation law – The Telegraph

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The United Kingdom is drawing up plans under which people will not be legally bound to self-isolate after catching COVID-19, The Telegraph reported on Sunday.

Prime Minister Boris Johnson wants to permanently revoke emergency coronavirus laws as Britain’s COVID-19 cases continue to fall, the report said, adding official guidance would remain but would not result in fines or legal punishment if ignored.

The plans will be worked up over the coming weeks, with an announcement expected as early as the spring, the report said.

Last week, Health Secretary Sajid Javid said COVID-19 self-isolation in England will be cut to five days from seven if someone tests negative twice.

Johnson is also set to lift Plan B COVID-19 restrictions, introduced last month to slow the spread of the Omicron variant, according to an earlier Telegraph report.

 

(Reporting by Maria Ponnezhath in Bengaluru; Editing by Daniel Wallis)

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'Choose increased antibodies over brand': Moderna appointments still being cancelled in London, Ont. area – CTV News London

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Doctors and pharmacists continue to advocate for people to get the first available mRNA vaccine for their COVID-19 booster dose.

“We have had some feedback that appointments are being canceled because people are holding out for Pfizer,” says Dr. Joyce Lock, the medical officer of health for Southwestern Public Health (SWPH).

“I strongly strongly urge everyone, particularly those over the age of 50, to choose increased antibodies over brand,” she added.

Lock made those statements during her weekly briefing on Jan 12.

“Our immunity following our original two doses is decreasing over time,” says Lock. “Our bodies don’t care what brand they receive. They follow the science, not the manufacturer. Studies show that immunity shoots back up after the booster and it doesn’t matter which brand.”

This week, First Ave. Pharmacy in St. Thomas, Ont. took to Facebook saying it had openings due to people refusing Moderna as a booster dose.“We send out a mass email saying that there’s a shortage of Pfizer and we might have to offer them Moderna and some people would cancel their appointment online or they would call us and cancel their appointments,” says Minh Nguyen, pharmacist at First Ave. Pharmacy. “Both Moderna and Pfizer are mRNA vaccines and equally effective at preventing severe illness from COVID. So I would say get whatever mRNA vaccine you can.”

Sunday, the Metrolinx Go-VAXX bus returned to London, Ont. It was stationed in the parking lot at the new East Lions Community Centre on Brydges St.

They had some appointments booked, but we were even taking walk-ins with Pfizer being administered.

“I’ve had Pfizer for my first two shots and that’s what I preferred,” says Michael Sean MacVoy, a truck driver getting his booster. “At this point, I didn’t care.”

Diane Crozman was in the same scenario, getting Pfizer a third time. “It doesn’t really make a difference to me,” she said. “They said the Moderna is going to work the same, but Pfizer that’s good because I’ve already got the other two Pfizer.”

Justin Seaward showed up for a walk-in booster, minutes after his wife went home from her booked appointment.

“I’ve had Pfizer, Moderna, then Pfizer now,” says Seaward. “It didn’t really make a difference much to me. I just wanted to be Vaxxed so I can feel safer for my family.”The Middlesex-London Paramedic Service (MLPS) had administered 2,194 doses of vaccine over the past six days since starting pop-up clinics in Middlesex County.

The percentage of people upset that Moderna was being administered is very low.

“It has happened a few times at the front door, but very rare,” says Miranda Bothwell, acting superintendent for special operations with MLPS.

They will be back on the road, continuing their pop-up clinic tour Monday in Lucan, Ont. 

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