Dems’ Medicare win faces long, uncertain future- POLITICO

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— Medicare’s looming ability to barter some drug prices is an enormous feat for Dems, however the laws’s complexity leaves experts unsure of how it is going to exactly play out.

— The Biden administration will likely empower the FDA in the approaching days with the power to authorize emergency use of recent monkeypox treatments, vaccines and tests.

— A study funded by the NIH is being cited to support a possible dose-sparing strategy for an FDA-approved monkeypox vaccine.

It’s Tuesday. Welcome to Prescription Pulse. Do you have got additional time for source coffees now that August recess is upon us? Reach out!

Send suggestions and feedback to David Lim ([email protected] or @davidalim), Lauren Gardner ([email protected] or @Gardner_LM) or Katherine Ellen Foley ([email protected] or @katherineefoley).

Toby Anderson, 82, watches as his wife Amy, 83, divides his eight prescription drugs into a weekly schedule

For now, Medicare beneficiaries might be the one ones to directly profit from CMS’ negotiating powers. | Jeff Topping/Getty Images

SENATE DEMS ENABLE MEDICARE TO NEGOTIATE (SOME) DRUG PRICES — Senate Democrats pushed through a provision of the Inflation Reduction Act that may allow Medicare to barter prescription drug prices with drugmakers. The bill passed in a 51-50 vote Sunday morning. The section inside the bill, which the House is predicted to pass Friday, has been on the minds of lawmakers on either side of the aisle in some form for greater than a decade.

“This can be a monumental step forward and tackling the prices of among the most perniciously expensive pharmaceuticals within the Medicare program, drugs which have been in the marketplace for substantial periods of time and yet don’t face any generic competition,” Sean Dickson, the director of health policy on the West Health Policy Center, a nonprofit organization focused on lowering health care costs, tells Katherine.

Negotiating will start with a narrow sliver of medicine: In 2026, Medicare will have the option to barter the worth of 10 predetermined pharmaceuticals patients can take at home. Those drugs, which fall under Medicare Part D, should have been in the marketplace for at the least nine years with none competition. The overall annual amount the Centers for Medicare and Medicaid Services paid pharmacies most recently for the drugs will largely inform which products make the list. Then CMS and the drugmakers will negotiate the costs for the drugs that CMS can pay.

Medicare will add 15 more drugs to its negotiated list in next yr and on the other hand in the next yr. Within the third yr, it is going to add 20 more drugs that, in some cases, may have a health care provider to manage. Drugs for which a generic involves market might be faraway from the list, and drug prices might be renegotiated if a drug reaches 13 years and not using a competitor.

Stunted growth? The pharmaceutical industry has argued that the negotiations will discourage competition and has threatened to fight the bill with litigation even after it’s signed into law.

But experts say that is probably not the case. There’ll at all times be demand for higher therapies — whether or not they are simpler or easier to take. “You possibly can still capture a bigger market share of the unmet medical need by developing a therapy that’s more patient-accessible,” Dickson said.

Rachel Sachs, a law professor at Washington University in St. Louis who focuses on innovation policy and drug regulation, thinks the availability may encourage competition, at the least for some varieties of drugs. “You could possibly imagine that it might be in a biologic manufacturer’s interest to permit biosimilar competition somewhat than to be eligible for negotiation,” she told Prescription Pulse.

“What this [bill] does is say, ‘Let’s take a look at how price declines often occur when generics come in the marketplace and let’s attempt to mimic that set of price changes,’” said Dickson.

Beyond negotiation: For now, Medicare beneficiaries could be the one ones to directly profit from CMS’ negotiating powers and an annual $2,000 out-of-pocket limit on drug spending in the availability. People on Medicare who use insulin would also profit from that drug’s $35 out-of-pocket copay cap.

The bill also requires drug corporations to pay a rebate to Medicare in the event that they raise prices faster than inflation. Although the Senate parliamentarian stripped private insurance from the availability, Dickson argues that it is going to still ultimately affect the industrial market: “Inflation penalty on only a component of the market does hold down price growth for your complete market, but it surely won’t do it within the one-to-one perfect way that the laws has been intending,” he said.

Experts still don’t have a transparent picture of the whole impact of those provisions. “There have been other efforts and can proceed to be other efforts — legislative, administrative and economic — to attempt to make these products more available to patients,” said Sachs.

President Joe Biden speaks to members of the media.

Biden administration officials have been deliberating whether to increase the Covid-19 public health emergency declaration. | Evan Vucci/AP Photo

BIDEN ADMIN PLANS TO CONTINUE COVID DECLARATION — The Biden administration is predicted to increase the Covid-19 public health emergency declaration again, ensuring that federal measures expanding access to health coverage, vaccines and coverings remain in place beyond the midterm elections, three individuals with knowledge of the matter told POLITICO’s Adam Cancryn and David.

The planned renewal follows extensive deliberations amongst Biden officials over the emergency declaration’s future, including some who questioned whether it was time to let the designation lapse. Under the proposed extension, HHS would proceed the declaration potentially into early 2023 — pushing the U.S. into its fourth calendar yr under a Covid PHE.

HHS WEIGHING MONKEYPOX EMERGENCY USE AUTHORIZATION PLAN — The FDA could also be empowered in the approaching days to authorize emergency use of monkeypox vaccines, treatments and tests.

Such a step would mirror the early months of the Covid-19 pandemic when the federal government deployed joint emergency declarations inside days to unlock funding and staffing and permit FDA emergency use authorizations along with no-cost tests and coverings, increased payments to hospitals and expanded telehealth services.

“This declaration would significantly increase FDA’s ability to hurry the delivery of therapeutics to people affected by monkeypox,” said Stacy Cline Amin, former chief counsel on the FDA through the Trump administration. “There’s a sentiment within the industry that this motion is urgently needed.”

The EUA motion, a separate declaration than the general public health emergency declared by HHS last week, highlights the differing emergency authorities nested inside the Public Health Service Act and the Federal Food, Drug and Cosmetic Act. David and Lauren break down the small print.

NOVAVAX SHOT OFFERED ACROSS U.S. AMID GLOOMY FINANCIAL OUTLOOK — Novavax’s protein-based Covid vaccine is now being administered in 47 states, the vaccine maker announced Monday ahead of its second-quarter earnings call. The Maryland-based company plans to submit booster dose data to the FDA this month and file for an Omicron-containing dose by the fourth quarter.

However the time it’s taking for Novavax to win authorizations for boosters and teenagers, in addition to a drop in demand internationally for the shot, spurred the corporate to halve its revenue outlook for 2022, The Wall Street Journal reports. It reported a net lack of $510 million within the second quarter, bringing in $186 million in revenue.

Company officials said Monday that they now not expect to receive an order this yr from Covax, a world alliance aiming to vaccinate people in low-income countries. Expanding the vaccine’s label to cover other populations and uses is a top priority, they said.

“I feel that, over time, we’re going to indicate that our vaccine will display longer-lasting protection than other platforms,” including as a booster, CEO Stanley Erck said on the decision.

NIH-BACKED STUDY UNDERPINS FEDS’ DOSE-SPARING DEBATE — The Biden administration is using a 2015 study funded by the National Institutes of Health to support a possible dose-sparing advice for the monkeypox vaccine to assist stretch supply, POLITICO’s Erin Banco reports.

The National Institute of Allergy and Infectious Diseases is studying the approach for the FDA-approved Jynneos vaccine, but that would take months to finish. Within the meantime, the agency is counting on the older study, which shows the shot might be administered between layers of skin with a smaller-than-usual dose and remain effective.

OIRA FINISHES OTC HEARING AID FINAL RULE REVIEW — The White House Office of Information and Regulatory Affairs accomplished its review of the FDA’s over-the-counter hearing aid final rule, clearing a path for the long-awaited regulation to be published within the Federal Register and subject to public comment.

PFIZER LAUNCHES LATE-STAGE LYME DISEASE VACCINE TRIAL — Pfizer said Monday it’s starting a Phase III clinical trial of a Lyme disease vaccine candidate in partnership with Valneva. The businesses plan to enroll about 6,000 participants ages 5 and up at sites across the U.S. and Europe, with a goal of applying for FDA approval in 2025, pending the study’s results.

Sen. Tim Kaine (D-Va.) spoke with POLITICO’s Alice Miranda Ollstein about his own long Covid struggles and his frustration with congressional stalls on laws that may help others living with it.

The FDA is inviting comment on the data collection tied to the agency’s medical device Q-Submission Program, a mechanism that may enable manufacturers to offer feedback to insurers before a pre-submission meeting.

The FDA announced it’s holding a Vaccines and Related Biological Products Advisory Committee meeting on Sept. 22 to debate Rebiotix’s biologics license application for Rebyota, a product intended to scale back the reoccurrence of clostridioides difficile infection after antibiotic treatment.

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