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Saturday, August 13, 2022

Shanghai extends weekly COVID-19 testing requirement until end of September

 China's most populous city Shanghai has extended its weekly COVID-19 test requirement and extended free testing until the end of September in a bid to keep the virus in check, authorities announced on Saturday.

Citizens without a record of a nucleic acid test from within seven days will be assigned a yellow code on Shanghai's health code system, the official notice said. A yellow code restricts access to some public venues.

On Saturday health authorities in the financial hub of 25 million said they detected one symptomatic and three asymptomatic cases a day earlier.

The southern province of Hainan is currently China's worst hit region, with 594 symptomatic cases and 832 asymptomatic cases reported on Saturday for 24 hours earlier.

Tight restrictions and lockdowns in the popular tourist destination are expected to last over the weekend.

On Saturday China's National Health Commission reported a total of 2,144 new COVID-19 infections on Aug. 12, of which 704 were symptomatic and 1,440 were asymptomatic.

'U.S. and Switzerland working on facilitating pharma trade - U.S. ambassador'

 

The United States and Switzerland can move towards free trade between their countries with sectoral deals and they are working on facilitating business in the pharmaceutical sector, the U.S. ambassador to Switzerland told the Tages Anzeiger newspaper.

Scott Miller said that in the last round of trade negotiations between the two countries, Switzerland was not prepared to open its agricultural market for U.S. products.

Talks on a free trade agreement between the two countries have stalled.

But Miller said that with the United States now the no. 1 export market for Switzerland, "we can take steps towards free trade by concluding sectoral agreements."

"With regard to the pharmaceutical industry, we are working on facilitating trade," he said in comments published on Saturday.

Switzerland is home to pharma giants Novartis and Roche.

https://www.marketscreener.com/quote/stock/NOVARTIS-AG-9364983/news/U-S-and-Switzerland-working-on-facilitating-pharma-trade-U-S-ambassador-41301872/

Pushing their luck again: Moderna CEO touts plan for triple combo respiratory shot in '3-5 years'

 During the worst of the COVID-19 pandemic, Moderna worked its way into the public consciousness by speeding an effective vaccine through the FDA authorization process. But as demand slows for the first generation of coronavirus vaccines, Moderna is laying plans to build out its portfolio in the years to come.

Alongside its planned omicron-targeting shots for this fall, Moderna expects a combination COVID, flu and respiratory syncytial virus shot will be developed over "three to five years," CEO Stéphane Bancel told CNN Business.

Bancel compared the continual improvement of the company's COVID-19 vaccine franchise to that of Apple's hugely successful iPhone. "You don't get the amazing camera, amazing everything the first time you get an iPhone, but you get a lot of things." Then, over time, the product improves, he added.

Meanwhile, Moderna is testing a suite of COVID-19 shots tailored to individual virus variants. The company's pipeline shows seven tweaked versions of the original vaccine, plus the "next-generation" mRNA-1283 with a longer expected refrigerated shelf life.

And Moderna doesn't plan to be solely a COVID-19 vaccine maker. The company's pipeline shows dozens of candidates against numerous infectious diseases, cancer and more.

Over the last two-plus years, Moderna has kept busy—and grown significantly—as the pandemic vaulted it into biopharma's top 20 companies by revenue.

But even after Moderna recently revealed expansions in four Asian markets and six European countries, the company isn't done growing its geographic reach, Bancel told CNN. The company aims to operate in "40 to 60 countries" in the next three years.

Amid the expansion push, recent months have provided new challenges for the company. Moderna posted a 2,200% revenue jump in 2021, but vaccine demand has been slipping lately. In fact, the company recorded a $499 million write-off for unused inventory in the second quarter of 2022. 

"We ended up destroying the vaccines," Bancel told CNN, adding that it was "heartbreaking."

Moderna and other vaccine makers say the demand decline is temporary. Late last month, the company inked its latest supply deal with the U.S. government. The deal covers 66 million doses of a bivalent booster for a total cost of $1.74 billion. The deal includes an option for another 234 million doses.

In addition, the company and European officials inked an updated supply agreement earlier this week. In that deal, the European Commission purchased an additional 15 million doses of the company's vaccine.

https://www.fiercepharma.com/pharma/moderna-ceo-touts-plan-triple-combo-respiratory-shot-three-five-years-report

Are vaccine makers pushing their luck?

 While Pfizer won its competition with Merck to get its next-generation pneumococcal vaccine to the market, it lost its more critical battle in June when the FDA said its rival could administer its next-gen shot to young children and infants.

Two months later, in catch-up mode, Pfizer has responded with clinical data that could clear the way for its shot, Prevnar 20, to be blessed for babies.

Pfizer said it hopes to file its Biologics License Application with the FDA for Prevnar 20's approval by the end of the year, according to a press release.

In the pediatric population, Prevnar 20 is roughly a year behind Merck’s next-gen shot. Merck presented its phase 3 data for Vaxneuvance use in infants in August of last year.

An unexpected stumbling block came in March when the FDA delayed its decision on Vaxneuvance, which pushed the eventual approval back by three months.

Once its shot is approved, Pfizer may be able to claim an edge over Merck, as Vaxneuvance protects against 15 serotypes. 

In the phase 3 trial, Prevnar 20 elicited immune responses, with all 20 of the serotypes covered by the shot meeting the study’s non-inferiority criteria. The trial also measured immune responses after a third dose of the four-dose series of Prevnar 20, with 14 of the 20 serotypes meeting the criteria. Of the six that didn’t, four missed by a narrow margin and two came up more significantly short, per the release.

Merck gained its initial green light for Vaxneuvance use in adults in July 2021. But children are the key demographic, as they make up 80% of the lucrative market. Sales of Prevnar 13 reached $5.3 billion last year.

https://www.fiercepharma.com/pharma/playing-catch-merck-pfizer-shows-data-could-fetch-prevnar-20-key-approval-babies

Will Americans ever feel impact of Inflation Reduction Act?

 The House moved Friday to pass a sweeping climate and health care bill, delivering a long-awaited legislative win to President Biden’s desk for his signature. 

The White House is preparing to deploy officials across the country to promote the historic action on climate change and lowering prescription drug costs contained in the bill, pitching it as a solution to ease the pain of consumers grappling with high inflation. 

However, while some of the provisions will take effect immediately or in early 2023, others will take years. Here are some answers on the timeline of the bill’s impact. 

A long road to reducing health care costs

On health care, some provisions take effect next year. Others, like most of the drug pricing provisions, won’t kick in for years. 

The enhanced subsidies for ObamaCare plans are already in effect, and the legislation will extend them for another three years. If the House doesn’t pass the bill, those subsidies will expire on Dec. 31, putting Americans on the hook for major premium increases.  

A provision capping insulin costs at $35 per month for diabetic Medicare patients takes effect in 2023. So too will a requirement that drug companies pay the government a rebate if they raise the price of a drug used by Medicare patients more than inflation.

A $2,000 cap on annual drug costs for people enrolled in Medicare’s prescription drug benefit won’t begin until 2025. And the most well-known aspect of the bill, letting Medicare negotiate the costs of select drugs, won’t start until 2026. Even then, the start will be limited to just 10 drugs; it will be expanded to 20 drugs by 2029.

The climate provisions of the bill will be felt soon, with some taking effect immediately and others at the beginning of next year. 

Most of the new residential clean energy credits will take effect immediately and apply to purchases made this calendar year. 

An existing credit of up to $7,500 for new clean vehicles will be extended through 2032, and the legislation adds a new credit of up to $4,000 for used clean vehicles that will apply to cars purchased next year. 

Still, there are complicating factors. Whether a vehicle qualifies for a full or partial $7,500 credit depends on it getting battery components for countries where the U.S. has a free trade agreement starting in 2024. It could take longer than that for most automakers to shore up their supply chains, meaning there could be a period of time where not all people can take advantage of the credit.

Credits for companies producing clean energy sources, like clean hydrogen, will also take effect in 2023. And credits for companies investing in clean energy manufacturing and energy security will be available at the start of next year. 

Josh Freed, who leads the climate and energy program at the centrist Democratic think tank Third Way, said that anticipation of the bill’s passage is already spurring investment in clean energy and would steadily reduce the cost of clean energy overtime. 

“Month on month, year on year, consumers are going to be able to have more and more affordable and cleaner energy that is less expensive,” he said.

New taxes on the horizon

The law also has some significant tax provisions that will go into effect in relatively short order. 

The bill directs $80 billion to the Internal Revenue Service to beef up enforcement, funding that will flow immediately once the legislation is signed into law. 

The new 15-percent minimum tax on corporations will take effect in the tax year beginning in January 2023, as will the 1 percent excise tax on stock buybacks. 

The bill’s passage comes just in time for Democrats to promote it as a major accomplishment with less than three months until the November midterm elections that will decide the balance of power in Washington. 

The White House made clear in a new memo this week that Biden and his Cabinet intend to make the case to voters that Democrats delivered for American families despite an onslaught of opposition from special interests and Republicans. 

But it may ultimately be difficult to convince some voters of the bill’s impact when many of the provisions do not take effect until after the midterm elections. 

https://thehill.com/homenews/administration/3598958-when-will-americans-feel-the-impact-of-the-inflation-reduction-act/

OIG: Part D plans sidestepped cheaper hep C generics

 Some Medicare Part D plans did not cover generic versions of pricey hepatitis C drugs in 2019, leaving millions in savings on the table, according to a new watchdog report. 

The report, released Thursday by the Department of Health and Human Services' Office of Inspector General (OIG), said the structure of Part D, including manufacturer rebates, may be incentivizing plans to steer customers to higher-cost drugs. The findings come as Part D plans could be in line for greater liability of drug costs under a landmark reform bill.

“Although rebates from manufacturers reduced overall Part D spending for higher cost hepatitis C drugs (such as Epclusa and Harvoni), they provided little relief to beneficiaries or the Medicare program,” the report said.

The watchdog looked at Part D spending for authorized generics of the high-priced hepatitis C drugs Epclusa and Harvoni. Such authorized generics were approved by the brand-name manufacturer Gilead Sciences to reduce costs. Reliance on the authorized generics could help beneficiaries save thousands, as the list prices for both hepatitis C drugs can cost between $22,000 and $36,000 a treatment.

OIG used prescription drug event data to calculate the proportion of Part D beneficiaries using the authorized generics in 2019 and 2020. 

Gilead launched the authorized generics in January 2019. In that first quarter of availability, less than 10% of Medicare patients and under 25% of Medicaid beneficiaries got the cheaper versions. 

“Through the end of 2020, authorized generic use increased in both programs, though Medicare still lagged far behind Medicaid,” OIG said. 

For example, at the end of 2020, 77% of Medicaid beneficiaries used the authorized version of Epclusa compared with 30% for Medicare. For Harvoni, 41% of those on Medicaid used the cheaper generic compared with 19% of Medicare beneficiaries. 

“Notably, the utilization rate of these two authorized generic versions among Medicare beneficiaries is considerably lower than Part D’s 90% overall utilization rate of generic drugs,” the report said. 

OIG estimated that a lack of inclusion of the generics on Part D formularies was a “primary factor” affecting use of the cheaper versions.

“In 2020, nearly half of Part D plans covered Epclusa or Harvoni but did not cover the authorized generic versions that were specifically launched to reduce patient costs,” the report said. “The lack of coverage may largely explain why so few Medicare beneficiaries received an authorized generic to treat hepatitis C in 2020, and instead so many received the more expensive brand-name version.”

Larger rebates offered by manufacturers could also play a role.

The rebates enable plan sponsors to recoup much of their gross spending, but some experts have “raised concerns that the reduction in net sponsor spending for higher-cost drugs caused by large rebates has weakened sponsors’ incentives to negotiate lower prices,” OIG wrote.

Because the cost of hepatitis C drugs was so high, all Part D beneficiaries that got the treatments wound up the catastrophic coverage phase. Beneficiaries reach the phase after drug spending passes a certain threshold, wherein Medicare then covers most of the costs.

“Medicare’s average catastrophic coverage payment for a beneficiary prescribed a higher-cost drug to treat hepatitis C was more than $20,000—nearly double that of a beneficiary prescribed a lower-cost drug which averaged slightly more than $11,000,” OIG wrote.

In the catastrophic phase, Medicare covers 80% of the cost and plans cover 15%, with the beneficiary covering the remaining 5%.

However, plans are likely to take greater responsibility for catastrophic coverage phase spending if the House passes the Inflation Reduction Act this Friday. The major spending package would increase plan liability for catastrophic spending from 15% to 60%, which could spark a greater desire for plans to control drug costs, experts said.

https://www.fiercehealthcare.com/payers/oig-part-d-plans-sidestepped-cheaper-hep-c-generics-pricey-brand-name-versions

Health bill brings new liabilities to Part D plans

 A major spending package that passed the Senate on Sunday brings a new redesign to Medicare Part D benefits, increasing the liability for insurers, experts say. 

However, the package’s landmark policy to give Medicare drug price negotiating powers could help lower costs depending on what drugs the federal government chooses for negotiation.

All told, several experts said the overall impact financially for health insurers will reside in implementation of healthcare provisions in the Inflation Reduction Act

“At the end of the day, it cuts both ways for Medicare plans,” said Ryan Urgo, managing director of the policy practice division for consulting firm Avalere Health, in an interview with Fierce Healthcare. 

Urgo said a downside for plans lies in the “substantial shifting” in liability away from the federal government and onto Part D plans.

The legislation would install a $2,000 out-of-pocket cost cap for Part D beneficiaries. It also spreads out the cost of that cap in monthly installments to seniors over the course of the plan year.

It would also limit costs for seniors in the catastrophic phase of Part D coverage.

Once drug spending reaches a certain threshold, then Medicare pays for the bulk of the drug costs and the beneficiary is responsible for 5%. However, the bill would change that beneficiary responsibility to zero in 2024, according to an explainer from the Kaiser Family Foundation.

The bill would in turn increase liability for manufacturers and Part D plans in the catastrophic phase, Urgo said.

Current liability for Part D costs is 80% for Medicare in the catastrophic phase and plans 15%, with the beneficiary taking up the remaining 5%. The legislation would increase the plan liability for those catastrophic costs to 60%, Urgo said.

“[Part D plans] will have more skin in the game to more tightly manage costs in the catastrophic portion of the benefit,” Urgo added. “There is a premium stabilization policy in the bill as well that will mitigate some of that impact on plans. Premiums can only rise by a certain percentage at both the previous year’s bids and then the federal government will provide financial support to prevent them from going up any further.”

While plans have more liability for Part D catastrophic costs, the bill’s landmark policy that gives Medicare narrow drug price negotiating powers could be a boon to payers, experts said. 

But how much of a benefit could depend on what drugs are selected for negotiation. 

The bill empowers Health and Human Services to choose 10 drugs starting in 2026 to negotiate for lower prices for only Medicare. There could be a lot of jockeying on what those drugs are, said Darshak Sanghavi, M.D., chief medical officer for the digital health provider Babylon, in an interview with Fierce Healthcare. 

“Let’s say the secretary chooses to negotiate prices like Ozempic or others and drives down the price quite a bit,” said Sanghavi, referring to the pricey diabetes drug. “Payers could say that is fantastic we are going to prescribe that much more widely and much more effective at weight loss and lower total cost of care for diabetes. That could be a positive thing for payers’ bottom lines.”

While the negotiated drug price does not apply to commercial plans, it could help inform negotiations between commercial plans and manufacturers, Urgo said. 

“I wouldn’t be surprised if you didn’t see commercial payers if they emulate the changes Medicare is making,” he said.

https://www.fiercehealthcare.com/payers/health-bill-brings-new-liabilities-part-d-plans-possible-boon-drug-costs-experts-say