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A U.S. hospital on Wednesday will give the first infusion of an expensive, controversial new Alzheimer's drug from Biogen Inc (BIIB.O) before Medicare had even said what it will pay for - and with some doctors upset by its approval last week.

The first administration of the drug, Aduhelm, outside of a clinical trial is scheduled to take place in Providence, Rhode Island, at Butler Hospital's Memory and Aging Program.

"We are opening a new era in treatment," Brown University Medical School neurology professor Dr. Stephen Salloway told Reuters. He said the Butler Hospital program has around 100 patients likely to be good candidates for the drug, which is given as a monthly intravenous infusion.

Aduhelm was approved based on evidence that it can reduce brain plaques, a likely contributor to Alzheimer's, rather than proof that it slows progression of the fatal mind-wasting disease.  

The U.S. Food and Drug Administration approved the drug - despite the objection of its own expert advisory panel - for all patients with Alzheimer's, although Aduhelm has only been tested for patients in the early stages of the disease.

"Hopefully clinicians will follow the clinical trial guidelines, because we really don't have any evidence for more advanced patients with Alzheimer's," Salloway said.

Some doctors are wary even of prescribing Aduhelm for that group.

Dr. David Knopman, a neurologist at the Mayo Clinic in Rochester, Minnesota was one of three experts who resigned from a panel of advisors to the FDA which had recommended that the agency not approve Biogen's drug.

Between questionable trial results and potential side effects, he did not see reason for most patients to get the medicine. He said he is walking a line between being paternalistic and honest about his concerns to patients as Mayo prepares to treat them with the new drug.

"I may have talked one person out of" using it, he said. "I will turn over some of the responsibility to this team of people we are putting together. They will get my opinion."

Biogen has estimated around 1.5 million of the 6 million people in the United States with Alzheimer's would be considered to have early-stage disease.

Cigna Corp (CI.N) Chief Clinical Officer Steve Miller said he expects Cigna, as well as other health insurers and Medicare, will only agree to cover the drug for patients with early Alzheimer's.

Biogen, which is partnered on the drug with Japanese drugmaker Eisai Co Ltd (4523.T), has set an average price of $56,000 a year, which the Alzheimer's Association - a longtime outspoken supporter of the company - called "simply unacceptable."

The vast majority of patients will be covered by the federal Medicare health program. But Robert Egge, chief public policy officer at the Alzheimer's Association, said most Medicare recipients are responsible for 20% of the cost of drugs given by doctors, and about 10% of them have no cap on those costs.

"This could further exacerbate health equity challenges that we have across the country," he said.

Biogen said it hoped the "value-based contract" it agreed to with Cigna last week that will track the drug's effectiveness was a step toward "efficient and affordable patient access." It added that patients with Medicare fee-for-service were presumed to be automatically covered. 

Butler Hospital's first patient is a 70-year-old man with Medicare insurance. Salloway said the hospital would ask the government health plan to cover costs.

The U.S. Centers for Medicare & Medicaid Services said it will have more information on coverage soon.

The Institute for Clinical and Economic Review (ICER), an influential drug pricing research group, has said trial data for Aduhelm, known chemically as aducanumab, indicate a cost-effective price of no more than $8,300 per year. Looking only at favorable trial results - one of two pivotal aducanumab trials failed - that price rises as high as $23,100, ICER said.

After discounts, Biogen's net price for Aduhelm is likely to be around $30,000 per year, Oppenheimer analyst Jay Olson said in a research note. In addition to those costs, patients must have tests to diagnose Alzheimer's such as a brain scan, which is not covered by Medicare, or tests using spinal fluid.

Still, given that this is the first approved drug that might slow the lethal, memory-robbing condition, hospitals are gearing up. "All the major centers that have an interest in Alzheimer's disease are taking this seriously," Salloway said. (Reuters)

The nominee to be the top U.S. diplomat for East Asia said on Tuesday that Washington should develop its relationship with Taiwan in every sector, hours after China's largest reported incursion to date into the island's air defense identification zone.

Daniel Kritenbrink said it was important for Washington to demonstrate its resolve to meet its "rock-solid obligations" toward Taiwan in the face of pressure from China, which claims the self-governing island as its own territory.

"It's ... incumbent upon us to further develop our robust relationship with Taiwan in every sector," Kritenbrink told a Senate Foreign Relations Committee hearing on his nomination to be assistant secretary of state for East Asia.

Earlier, Taiwan said 28 Chinese aircraft, including fighters and nuclear-capable bombers, entered its air defense identification zone. read more

The Group of Seven leaders issued a statement on Sunday scolding China for a series of issues and underscoring the importance of peace and stability across the Taiwan Strait, comments that China called "slander." read more

Kritenbrink, a career foreign service officer who was most recently ambassador to Vietnam and a former deputy head of mission in China, was asked if Washington should switch from a long-standing stance of "strategic ambiguity" to make a clear commitment to defend Taiwan in the event of a Chinese attack.

He said the U.S. "one-China" policy that formally recognizes Beijing and not Taipei had ensured cross-strait stability and Taiwan's security for many decades.

He added: "I do think that maintenance of that status quo and of that security is a dynamic situation. As the threat from (China) grows, as Beijing's aggressive and bullying behavior vis-a-vis Taiwan grows, I think that our response has to be calibrated as well."

Responding to a request for comment, Chinese Embassy spokesman Liu Pengyu said Washington should "stop elevating its relationship with the Taiwan region in any substantive way ... so as to avoid serious damage to China-U.S. relations and peace and stability across the Taiwan Strait."

'FOLLOW THROUGH CRITICAL'

Kritenbrink described China as the "major challenge the United States faces today" and said new guidelines adopted by the Biden administration for Taiwan relations were "significantly liberalized" and "explicitly designed to further develop our relationships and our partnership." He said Washington should continue to take steps to hold to account Chinese leaders responsible for what it calls genocide against Uyghurs and other Muslims in China's Xinjiang region.

"The ongoing genocide in Xinjiang shocks the conscience," he said. "We estimate more than 1 million Uyghurs have been forcibly detained, put into re-education camps, forced to provide labor, and many other disturbing allegations about how they are being treated," he said.

"We need to continue to take steps using all the tools that the U.S. government has at its disposal to hold to account the leaders who are carrying out these atrocities," Kritenbrink said.

Liu repeated Chinese denials of abuses in Xinjiang, saying: "Facts have proved that there has never been any genocide in Xinjiang."

In a tweet, Sophie Richardson, China director for Human Rights Watch, called Kritenbrink's Xinjiang remarks a "strong pledge," while adding: "Follow through critical." (Reuters)

South Korea is trying to increase its future working population by making it easier for children of foreign residents to become citizens, but its plans have run into trouble in the face of rising anti-China sentiment.

A measure proposed by the Ministry of Justice - first made public in April - called for easing the pathway to citizenship for children born to long-term foreign residents, by simply notifying the ministry.

A presidential petition opposing the revision has gathered over 300,000 signatures. The chatroom of an online hearing held to discuss the proposal in May was overwhelmed with expletive-laced complaints by the tens of thousands of viewers.

The justice ministry has said it is still taking into account public opinion and the advice of experts before submitting the proposal to the Ministry of Government Legislation.

"Given the strong backlash, I would say the ministry has already lost much of the momentum to push ahead with the proposal," said Jang Yun-mi, an attorney who specializes in issues related to children.

The controversy highlights the challenges South Korea faces as it seeks to ensure a robust future population in the face of declining birthrates and rapidly aging workers, and the potential policy implications of increasingly negative views of China, its biggest trading partner.

Data from last year suggests only about 3,930 people would be eligible under the rule change, but the fact that 3,725 of them were of Chinese heritage prompted much of the criticism.

South Korean views have been coloured by what some see as economic bullying by Beijing, its poor handling of the COVID-19 crisis, and the assertion by some Chinese that dearly held aspects of Korean food and culture, such as kimchi and the traditional hanbok dress, have roots in China.

Among immigrant communities, the proposed measures are not seen as worth the backlash, said Kim Yong-phil, editor-in-chief of E Korea World, a local newspaper for Chinese-Koreans.

"Anti-Chinese people could use this issue as a pretext to attack Chinese-Koreans," he said.

POPULATION DECLINE

Naturalization was rare in South Korea until the early 2000s - just 33 foreigners gained South Korean citizenship in 2000, for example – but rose to nearly 14,000 last year, immigration data show.

Of them, nearly 58% were from China, and 30% from Vietnam. The rest included people from Mongolia, Uzbekistan and Japan, Korea Immigration Service data showed.

The latest proposal is needed to encourage future workers to stay by allowing them to foster a South Korean identity from an early age and stably get assimilated into society, the justice ministry told Reuters in a statement.

Kim Yong-seon, who came from China in 2004 to study and was naturalized in 2014, said the amendment is useful as it provides more options for immigrants, but that the more pressing matter is making it easier for adults to become citizens.

"Over the past few years, the requirements for permanent residency and citizenship have only gotten harder," he said, citing changes that require high amounts of income or assets.

Like the majority of Chinese nationals residing in South Korea, Kim is ethnic Korean - his grandfather migrated to China a century ago.

More than 70% of the 865,000 Chinese nationals residing in South Korea are of Korean descent, according to immigration data.

Negative views of China among South Koreans have hit historic highs recently, with as much as 75% having an unfavourable opinion of them late last year, compared to around 37% in 2015, according to Pew Research.

"Some Chinese people are already committing a 'cultural fraud' against the whole world by making unreasonable claims that kimchi and hanbok are also Chinese," opposition People's Party chairman Ahn Cheol-soo said.

"If left as is, it will lead to a 'cultural invasion' in which they claim that even Korea's priceless culture is theirs." (Reuters)

Japan's government will include a pledge to achieve a "safe and secure" Tokyo Olympic Games in its economic blueprint due out on Friday, according to a final draft seen by Reuters on Wednesday.

An earlier draft blueprint only called for making the Olympics leave "various legacies" behind, while the final version appeared to stress the government's resolve to go ahead with the Games.

The final draft came days after Prime Minister Yoshihide Suga said he had won support at a G7 summit meeting in Britain for holding the Olympics despite public concern that the sports extravaganza could worsen the spread of coronavirus infections.

"(We) will realise the safe and secure Games while creating various legacies," the draft said.

The government will also clarify its resolve to complete its vaccination programme by the end of November, according to the draft which is due to be approved by the cabinet on Friday.

It said the government would do the utmost to curb infections, while firmly backing businesses, jobs and people's livelihood by conducting flexible macroeconomic policy.

"We will ensure economic recovery by deploying all policy tools while tapping external demand, with the resolve never to push Japan back into deflation," the draft read, citing green, digital, local regions and childcare as key areas of investment.

It called for doubling outstanding foreign direct investment in Japan to 80 trillion yen ($727.80 billion) by 2030.

"We will strive to make the size of the economy 600 trillion yen and achieve the aim of fiscal reform."

To achieve fiscal reform, the draft kept the government's pledge to achieve a primary budget surplus by fiscal year-end in March 2026 while reassessing the target by the end of this fiscal year taking into account coronavirus fallouts. (Reuters)