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Friday, January 7, 2022

Medicare Revamp May Be Part of 'Skinny Build Back Better' Bill

 Although the prospects appear dim now for passage in Congress of the Build Back Better Act in its current form, a pared-down version may survive and is likely to include some health provisions, a policy expert said at a webinar sponsored by Avalere, a healthcare consulting firm.

"The legislation passed in the House is likely not to advance in its current form," especially after Sen. Joe Manchin (D-W.Va.) said that he wouldn't support the bill, Matt Kazan, MPP, principal at Avalere, said during Thursday's webinar. "However, right now Democrats remain very motivated to get something done, and many have already talked about a more scaled-back or 'skinny' version of that legislation. That certainly could include healthcare, so provisions like [Medicare] Part B benefit redesign, inflation rebates, even Medicare [drug price] negotiation -- those policies are certainly on the table going forward."

Even if the Build Back Better Act doesn't advance, "Democrats are still going to have to act on healthcare because of a variety of deadlines related to the Affordable Care Act (ACA)," he added.

Drug pricing policies are one area of healthcare emphasis in proposed Build Back Better Act provisions, but "there are a set of other separate drug pricing-related changes that have already been finalized or enacted, and are scheduled to be implemented over the coming months and years," said Megan Olsen, MPH, principal at Avalere. "So it's important that stakeholders are not losing sight of these upcoming changes, particularly as there could be some interesting interaction effects."

Olsen highlighted four upcoming changes:

  • Removal of the 100% average manufacturer price (AMP) cap on Medicaid rebates in 2024. "This will allow Medicaid rebates for some products to exceed 100% of AMP for the drugs' cost," she said.
  • Changes to the calculation of AMP and "best price" -- the requirement that drugmakers must offer their lowest price to Medicaid plans -- in the context of copay accumulators. Accumulators are health insurers' way of keeping track of the drug company coupons and copay cards that patients use to help afford their drugs; often, the insurers don't allow the value of the coupons and cards to count toward a patient's deductible. "This will require manufacturers to ensure the full value of financial assistance is going to patients; otherwise they must reflect that in the reporting of best price," she said.
  • New flexibilities associated with value-based purchasing arrangements. "This will allow manufacturers to report multiple best prices in connection with a value-based purchasing arrangement, and this is intended to facilitate growth and adoption of new and innovative contracting arrangements across Medicaid and commercial markets," said Olsen. "This could be particularly interesting as we think about rare disease drugs, cell and gene therapies, and the like."
  • Inclusion of U.S. territories in the Medicaid drug rebate program in 2023. "That will have some implications for manufacturer rebate liability overall," she said. "The combination of these changes with the potential for additional drug pricing changes via the Build Back Better Act certainly yield a complex outlook as we think about drug pricing moving forward."
One aspect missing from the Build Back Better Act is provisions to address prices of drugs just being launched or entering the market, said Rebecca Yip, MS, principal at Avalere. "How will the government participate in negotiating or setting these prices? I think we can anticipate the administration using CMMI [the Center for Medicare and Medicaid Innovation] as a vehicle to test out some of these models."

For example, a model might involve value-based pricing, which could be developed using an "ACA-like" entity or independent board, she said. Although Obama- and Trump-era demonstration projects along those lines were rescinded, "if and when the BBBA [Build Back Better Act] passes or some separate drug pricing package passes, we can expect the focus to turn to launch prices to round out meeting the objectives of drug pricing," said Yip.

Health equity and social determinants of health also are high priorities for the Biden administration, said Kazan. To address those issues, "Medicare Advantage does seem like a natural program that one could focus on, given its large number of low-income enrollees and large number of racial minority enrollees." The administration would have a lot of policy levers to choose from in that program, including supplemental benefits that address non-health-related factors, risk adjustment payments that vary reimbursement based on the characteristics of each enrollee, and quality ratings, he said.

However, Kazan added, "Democrats historically ... have been reluctant in the past years to give Medicare Advantage a lot of flexibility. I think the Biden administration has a really interesting choice to make as to whether or not they want to buck the previous trends and and focus on the Medicare Advantage program" as a way to improve health equity and social determinants of health.

State-level drug pricing reforms also are something to watch for in 2022, according to Olsen. "Over the past couple years we've seen states move from more drug price transparency and manufacturer reporting measures to more aggressive drug price control measures, and [they are] also looking at additional aspects of transparency, including PBM [pharmacy benefit manager] reporting requirements," she said. "I'd also look out for additional activity around drug price affordability review boards at the state level."

https://www.medpagetoday.com/practicemanagement/reimbursement/96555

Another mRNA company gets snapped up as Merck buys Exelead

The latest pharma company to make a move for an mRNA specialist is Germany’s Merck KGaA, which has offered a $780 million cash buyout to US biotech Exelead.

Unlike other recent deals however the takeover isn’t focused on adding a pipeline of mRNA candidates, as Indianapolis-based Exelead is a contract development and manufacturing organisation (CDMO) provide derives to other drugmakers.

Rather, it brings with it platform capabilities in formulations of mRNA drugs, including lipid nanoparticles used to deliver them safely to target tissues, as well as additional manufacturing capacity that will be offered to partners.

In that respect it follows a similar model to Merck’s takeover of AmpTec, another CDMO that uses a PCR platform to make mRNA drugs, for an undisclosed sum last year.

Outsourcing services are on of the pillars of Merck’s business, delivered via its process solutions unit, part of the group’s life sciences division. The unit contributed almost €3.4 billion out of Merck’s total revenues of €14.4 billion in the first nine months of 2021.

mRNA emerged as the most important new technology for the biopharma sector in 20021, as COVID-19 vaccines from Pfizer/BioNTech and Moderna – which both use lipid nanoparticles for delivery – quickly became the mainstay of many immunisation programmes around the world.

Exelead was part of that success, helping to manufacture vaccine precursors for the Pfizer/BioNTech shot Comirnaty.

The stellar success of the COVID-19 jabs – bringing in billions of dollars in revenues and profits for their developers – prompted a string of M&A and licensing deals last year, notably Sanofi’s $3.2 billion acquisition of Translate Bio and $470 million purchase of Tidal Therapeutics.

“Novel modalities, particularly mRNA, present a highly attractive business opportunity as pharma and biotech pipelines are increasingly building on them beyond COVID-19,” said Merck chief executive BelĂ©n Garijo.

Just this week Pfizer and BioNTech added an mRNA-based shingles vaccine to their ongoing alliance, which also includes new flu vaccines, and the technology is also showing promise in non-infectious disease applications including heart failure.

“The acquisition of Exelead will further enable Merck to capture the significant potential of the fast-growing market for mRNA therapies by providing leading CDMO services to our customers,” he added.

Exelead – which until 2017 was known as Sigma Tau Pharmasource – has around 200 staff members, with 50 added as a result of the Pfizer/BioNTech contract. Last year the company undertook a major expansion project, adding new formulation suites and filling lines at its main Indianapolis campus.

The deal is scheduled to close in the first quarter of this year, pending the usual closing requirements and antitrust reviews.

https://pharmaphorum.com/news/another-mrna-company-gets-snapped-up-as-merck-buys-exelead/

Cue Health to develop omicron-specific portable COVID test with BARDA backing

 Cue Health is working to develop an omicron-specific COVID-19 test to help healthcare professionals quickly identify the variant through a project backed by the U.S. government.

With funding from the Biomedical Advanced Research and Development Authority, better known as BARDA, Cue aims to provide the targeted diagnostic alongside its current molecular COVID-19 test, which has been shown to detect all coronavirus variants including omicron. The new, cartridge-based, nasal swab test will also be compatible with the company’s portable reader.

Cue’s 20-minute nucleic acid amplification test relies on identifying a portion of the coronavirus’s genome that makes up its inner nucleocapsid protein—as opposed to the RNA that codes for its spike protein, which carries several mutations in the omicron variant.

Following the rise of the delta variant last year—but before the emergence of omicron—Cue signed onto a project with Google Cloud to help connect its point-of-care tests and provide real-time data on the spread of new coronavirus strains.

The Fierce 15 winner’s system aims to provide public health officials with geographic information tracking COVID-19 cases—and, in the future, potentially keep tabs on other infectious diseases with separate tests for influenza and respiratory syncytial virus.

When it comes to the new test, Cue is no stranger to BARDA and government funding. The company first received $30 million from the agency in 2018 to develop its initial, over-the-counter system for the flu and other respiratory diseases.

After pivoting to address the COVID pandemic, Cue received another $13 million in March 2020 to support its coronavirus work and secured an FDA emergency authorization for its test in June. It then won full over-the-counter approval in March 2021. In between, the company inked a $481 million contract with the Department of Defense to dramatically scale up production.

https://www.fiercebiotech.com/medtech/cue-health-to-develop-omicron-specific-portable-covid-test-barda-backing

Singular Genomics upped to Buy from Neutral by B of A

 Target $21

https://finviz.com/quote.ashx?t=omic

COVID vaccine can lengthen menstrual cycle: study

 Following reports from scores of women online who said that the COVID vaccine had altered their menstrual cycles, a government-funded study has ultimately confirmed their claims.

Now, a new study published Thursday in the journal Obstetrics & Gynecology has revealed that many of those vaccinated against COVID-19 saw a slight delay — by less than one day, on average — in the onset of their menstrual periods, compared to unvaccinated women.

However, it did not substantially affect the number of bleeding days, according to findings from more than 4,000 participants.

For the ongoing, yearlong study — announced in September and funded by a $1.67 million grant from the National Institutes of Health — scientists retrieved data from a fertility tracking app utilized by women aged 18 to 45 who were not using hormonal contraception, which typically regulates a period into a stricter schedule.

About 2,400 participants were vaccinated with either the Pfizer (55%), Moderna (35%) or Johnson & Johnson (7%) vaccines. The remaining 1,500 women were unvaccinated and included in the study as a control group.

The average increase in women’s cycles after the first vaccine dose was 0.64-day (about 15.36 hours), and 0.79-day (about 18.96 hours) following the second dose.

Lead author Alison Edelman of the Oregon Health & Science University told Agence France-Presse that the jab’s impact is now believed to be minimal and temporary, an outcome she called “very reassuring” — and validating for the women who reported the changes.

“It validates that there is something real here,” Dr. Hugh Taylor, the chair of the department of obstetrics, gynecology and reproductive sciences at Yale School of Medicine, told the New York Times.

Researchers believe that the change may be related to immune system response. “We know that the immune system and the reproductive system are interlinked,” said Edelman. 

According to the International Federation of Gynecology and Obstetrics, a margin of change fewer than eight days within the average 28-day cycle is considered normal — and most women in the study experienced an increase in cycle length by little more than 15 to 19 hours.

Among the vaccinated, researchers followed women beginning three consecutive cycles prior to vaccination, plus three more following the shot, while the control group was observed for six consecutive cycles, generally.

On average, women saw an increase in their menstrual cycles by less than one full day.
On average, women saw an increase in their menstrual cycles by less than one full day.
Obstetrics & Gynecology

Researchers noted that women who experience the greatest change in their periods were vaccinated at the start of the follicular phase of their menstrual cycle, which begins around day six, following the menses (bleeding) stage.

“Our goal is to provide menstruating people with information, mainly as to what to expect, because I think that was the biggest issue: Nobody expected it to affect the menstrual system, because the information wasn’t being collected in the early vaccine studies,” said Diana Bianchi, director of the National Institute of Child Health and Human Development, in a statement to Washington Post’s the Lily last year.

They also hope their study will help quell vaccine hesitancy — by giving patients as much information as possible. “We were worried this was contributing to vaccine hesitancy in reproductive-age women,” said Bianchi.

Taylor told the Times that the results of the study should be encouraging to women.

“I want to make sure we dissuade people from those untrue myths out there about fertility effects,” Taylor said. “A cycle or two where periods are thrown off may be annoying, but it’s not going to be harmful in a medical way.”

https://nypost.com/2022/01/07/covid-vaccine-can-lengthen-the-menstrual-cycle-study/

White House to ask Congress for billions more in COVID-19 aid

 White House officials are reportedly preparing to ask Congress for tens of billions of dollars in additional COVID-19 aid.

The funding plan hasn’t been finalized but is likely to focus on COVID therapeutics — such as an antiviral pill — and ramping up vaccine distribution, sources told the Washington Post on Friday.

Money to help with the global vaccine effort is also expected to be included in the plan, the sources added.

Officials in the White House’s Office of Management and Budget and the Department of Health and Human Services are working on the longer-term spending package. The formal request is expected to be made in the coming weeks.

Sources told the outlet the additional funding is necessary due to the rapid spread of the Omicron variant, which has caused a surge in COVID-19 cases. The White House has said it currently has sufficient funds to deal with the outbreak.

More than $100 billion in COVID-related spending was already approved as part of the $1.9 trillion American Rescue Plan that was passed in March 2021.

White House officials are reportedly preparing to ask Congress for billions of dollars in extra COVID-19 aid after the hit of the Omicron variant.
White House officials reportedly are preparing to ask Congress for billions of dollars in extra COVID-19 aid after the spread of the Omicron variant.
Photo by BRENDAN SMIALOWSKI/AFP via Getty Images

Former President Donald Trump approved nearly $900 billion in COVID-related funding in December 2020 as part of a larger $2.3 trillion pandemic aid and spending package.

Prior to that, Congress had allocated $3 trillion to combat the pandemic in the wake of widespread shutdowns in March 2020.

It is unclear if any additional funding requests would be supported by Republican lawmakers.

A sign advocating for mask wearing to protect against COVID-19 is seen on the National mall in Washington, D.C.
A sign advocating for mask wearing to protect against COVID-19 is seen on the National Mall in Washington, DC.
AFP via Getty Images

White House press secretary Jen Psaki told reporters Wednesday that the administration has “constant conversations” with lawmakers on additional anti-pandemic funding, but added that the US is “in a very different place than we were a year ago or six months ago.”

Reports emerged earlier this week that indicated lawmakers were discussing additional stimulus spending that would support restaurants, performance venues, gyms and minor league sports teams.

https://nypost.com/2022/01/07/wh-to-ask-congress-for-billions-more-in-covid-aid-report/

NY healthcare workers will soon be required to get booster shot

 All New York healthcare workers will be required to get a COVID booster shot as soon as next week, Gov. Kathy Hochul said Friday.

The plan must still be technically approved by the state Department of Health’s rule-making body, the Public Health and Health Planning Council, but it is expected to easily get the OK, Hochul said. The council is on track to meet Tuesday, Jan. 11. 

“We anticipate swift approval, and it’ll take effect immediately,” said Hochul during a press conference at her Manhattan office Friday.

Workers will be required to get the shot within two weeks of the proposed requirement passing.

“We’ll make sure that we are doing everything we can — all those levers, all those buttons, we can push — and this is why we wanted to make sure to get those healthcare workers boosted as well,” Hochul said of the state’s coronavirus-fighting steps. 

Healthcare workers wearing masks stand in front of a COVID-19 testing booth in Times Square.
Gov. Hochul’s plan still needs to be approved by the state’s Public Health and Health Planning Council.
Alexi Rosenfeld/Getty Images

The new requirement would permit a medical exemption, but there will be no test-out option for other workers, who were already ordered to be vaccinated.

Hochul, asked about healthcare workers who may refuse the extra shot, said there should be less of any issue because the idea isn’t new. She noted the controversial mandatory vaccination requirement that already took effect earlier this fall. She added that a worker shortage is creating an overwhelming crush of need.

“They overcame the hurdle,” she said of the workers, who had to get vaxxed. 

“Those who had overcome a hurdle, I believe they will view this, as ‘I did this once, I will do it again.

“We are already losing healthcare workers because of them testing positive without symptoms. They’ve been going home. … It’s been a source of enormous stress,” she said.

 A healthcare worker administers a shot of the Moderna COVID-19 Vaccine.
Gov. Hochul said she doesn’t expect healthcare workers to refuse the extra shot.
REUTERS/Mike Segar/File Photo

“We think it’s worth it to ask them to just do the right thing one more time.”

Hochul made waves earlier this fall when she approved a mandatory vaccination requirement for all healthcare workers in private and public facilities – including hospitals, nursing homes and long-term care facilities.

The rule faced legal challenges from staffers who sought medical exemptions, but none prevailed in court.

https://nypost.com/2022/01/07/ny-healthcare-workers-soon-required-to-get-covid-booster-shot/