Friday, March 21, 2025

New Optum Rx Pharmacy Pay Model Met With Skepticism

(3/20, Gabrielle Wanneh, Inside Health Policy) ...Optum Rx says these new shifts in its reimbursement model build on another recent commitment by the PBM to pass through 100% of drug rebate discounts negotiated with drug companies to clients by 2028...But the National Community Pharmacists Association (NCPA) is wary of the new move by Optum Rx and says the policy could be a move to dissuade Congress from passing legislation to crack down on certain PBM business practices and reform how the entities interact with other supply chain stakeholders. Regardless, NCPA says, the change is just an initial step in the right direction... Sub. Req’d

AstraZeneca Investing $2.5 Bln in China As Drugmaker Seeks to Recover from Scandals

(3/21, Maggie Fick, Reuters) ...AstraZeneca said on Friday it will spend $2.5 billion on a research and development hub in Beijing, as the drugmaker scrambles to revive business in its second-biggest market after scandals including the arrest of its China president last year. Chief executive Pascal Soriot was in Beijing and met with the city's mayor to reveal the investment, along with two licensing deals with Chinese companies, saying they all showed the company's commitment to the world's No. 2 economy... Full

J&J Plans to Invest More Than $55 Billion in US Over Next Four Years

(3/21, Bhanvi Satija, Reuters) ...Johnson & Johnson plans to spend over $55 billion to build four plants in the U.S., it said on Friday, as a threat of drug import duties from the Trump administration forces companies to expand their manufacturing operations domestically...Last month, drugmaker Eli Lilly announced its plans to invest in the country, as companies brace for the impact of a potential 25% tariff on pharmaceutical imports. Companies such as J&J and Pfizer could be at risk as they operate large plants in countries like Ireland, which President Donald Trump said has lured them with its tax policies... Full

Pfizer's Wall Street Critic-Turned-Executive Digs into the Company's Problems, Obesity Plans

(3/20, Allison DeAngelis, STAT+) ...CEO Albert Bourla made a "pragmatic and thoughtful" assessment of the company when he approached Baum in early 2024, Baum told the crowd at STAT's Breakthrough Summit East Thursday. Pfizer's R&D team has created effective medicines, he assessed. They just haven't done so with revenue in mind...One of the most hotly watched drugs in Pfizer's pipeline, the obesity pill danuglipron, could deliver profits. The question is if the drug will work well for patients: Pfizer shelved — and then reversed course on — a once-daily version of the drug because it caused elevations in liver enzymes... Sub. Req’d

'Not a Cost-Cutting Exercise': Novo Nordisk CSO Explains Rationale Behind Pharma's R&D Shake-Up

(3/20, James Waldron, Fierce Biotech) ...The new R&D structure, unveiled March 20, will be headed up by three so-called "therapy area units:" Diabetes, Obesity and MASH; Cardiovascular and Renal; and Rare Disease. The aim of these units is to "drive what innovation priorities we will explore," according to a company spokesperson. Below these three therapy area units are other teams with names like AI and Digital Innovation, and Strategy, Portfolio, Operations and Communication. These groups will be "responsible for execution with the ability to scale and adjust based on evolving needs," the spokesperson said... Full

Hikma Announces Health Canada Approval of KLOXXADO® (Naloxone HCl) Nasal Spray 8 mg

(3/20, Hikma) ...KLOXXADO® Nasal Spray will be marketed and sold in Canada by Emergent BioSolutions under the terms of a recent six-year commercial agreement with Hikma, whereby Emergent will be responsible for all North America product sales and marketing. Hikma will continue producing KLOXXADO® Nasal Spray in its Columbus, Ohio manufacturing facility and will provide it to Emergent as its exclusive commercial partner. Following the approval of KLOXXADO® Nasal Spray, Emergent will engage Canadian agencies, private payers and provincial formularies, and aims to make KLOXXADO® available via prescription as early as 2026... Full

Sandoz And Delpharm Renew Canadian Injectables Supply Agreement For 10 Years

(3/20, Dean Rudge, Generics Bulletin) ...Sandoz's Canadian operation has inked a fresh ten-year supply agreement with French CDMO Delpharm Industrie, in a pact designed to secure a reliable supply of sterile injectables made in Canada. The deal is part of a larger scheme powering Delpharm's planned upgrades to its manufacturing facility in Boucherville, Quebec, which currently produces 20 of the 100 critical medicines "vital to the Canadian healthcare system."... Global Sub. Full

Glenmark Pharmaceuticals Secures US FDA approval for Olopatadine Ophthalmic Solution

(3/20, Jomy Jos Pullokaran, CNBC TV-18) ...The product has been determined to be bioequivalent to Pataday Once Daily Relief Ophthalmic Solution, 0.2% (OTC), developed by Alcon Laboratories, Inc. With this approval, Glenmark Therapeutics Inc., USA, will distribute the product in the US market, further expanding the company's ophthalmic portfolio... Full

Five-Year Extension Found Just, As Aurobindo Loses On US Sugammadex Appeal

(3/20, Dean Rudge, Generics Bulletin) ...In a precedential decision, the US Court of Appeals for the Federal Circuit has determined the meaning of the language "the patent" as it applies to patent-term extensions for reissued patents, in the context of Aurobindo's bid to wipe out a reissued patent shielding Merck & Co's Bridion (sugammadex) injectable... Global Sub. Full

Aquipta Hailed As Game-Changer in Migraine Prevention at AbbVie Symposium

(3/21, You Ji-young, Korea Biomedical Review) ...Migraine is a disabling condition that not only impairs an individual's quality of life, but also causes societal losses. Therefore, it is important to treat migraine quickly and preventively. Expectations are higher than ever for Aquipta (atogepant), an oral CGRP treatment that is effective in preventing migraine and easy to take. This was evident at "AbbVie's Migraine Portfolio: from CM to EM Symposium," held at the Grand InterContinental Seoul Parnas on March 6... Full

Stelara Biosimilars Storm US Market With 85% Discounts Ahead Of Price Drop In Medicare

(3/20, Cathy Kelly, Pink Sheet) ...Stelara biosimilars are crowding into the market at 80% to 90% discounts to the innovator's wholesale acquisition cost, demonstrating a more aggressive effort to secure market share than was seen with Humira biosimilars. The discounts exceed the reduction Medicare secured for Stelara in the price negotiation process, raising questions about whether market competition is more effective than government price controls. The Associate for Accessible Medicines said situations where biosimilars enter the market after a Medicare negotiated price was implemented shows the program reduces incentives for biosimilar development... Global Sub. Full

Tapping the Potential of GLP-1 Drugs Requires Integrated Care and Overcoming Inequities, Executives Say

(3/20, Ed Silverman, STAT+) ...A key issue is the ongoing effort by many employers to present hurdles to coverage of the medicines, an approach that continues to emphasize cost savings at the expense of pursuing integrated health care, which can save money in the long term, said Owen Tripp, the chief executive officer at Included Health, which works with employers and health plans. But another issue is persistence rates - some people have difficulty remaining on the medicines... Sub. Req’d

Multiple Switches Between Adalimumab Biosimilar GP2017 and Humira for Psoriasis Maintain Biosimilarity

(3/20, Cameron Santoro, The Center For Biosimilars) ...The adalimumab biosimilar GP2017 and reference adalimumab used to treat patients with moderate to severe plaque psoriasis did not significantly impact immunogenicity, safety, or efficacy, even after multiple switches, suggesting potential cost savings and improved access to biosimilars, according to a study published in Expert Opinion on Biological Therapy... Full

What We're Getting Right in the Drug Overdose Fight: Lisa Jarvis

(3/21, Lisa Jarvis, Bloomberg) ...Last fall, when initial data from the Centers for Disease Control and Prevention showed a surprising drop in drug overdose deaths, the universal response was relief. We were finally getting something right in addressing the opioid epidemic, which accounted for most of the decrease and has killed hundreds of thousands of Americans. That progress has been hard-won and should be celebrated. Addiction specialists are hopeful we can push the still-too-high numbers of opioid deaths even lower in 2025... Sub. Req’d

Trump Tariff Talk Puts Pharma Overseas Profits in Crosshairs

(3/21, Caleb Harshberger, Bloomberg Law) ...Most of the companies declined or didn't return requests for comments, but Pfizer said in a statement March 17 that its US tax bill had risen since the 2017 tax law and that it paid more taxes in the US than outside of it for at least the last three years. "Substantially all of Pfizer's worldwide income is subject to tax in the United States," it said. "As a result of the 2017 Tax Cut and Jobs Act (TCJA), Pfizer is paying U.S. tax on a larger portion of its global income than it had pre-TCJA. Pfizer has paid over $12.8 billion in income taxes in the United States over the past four years, as disclosed in its publicly available financial statements."... Sub. Req’d

1 Big Thing: A Big Sign Drug Pricing Changes Are Coming

(3/21, Caitlin Owens, Axios) ...The America First Policy Institute - the think tank founded and staffed by Trump officials to advance his vision for the country - has written a new paper making the case against what it calls pharmaceutical "global freeloading" and outlining various policy measures to address it. Why it matters: The policy paper - well-timed to the political moment and shared exclusively with Axios - signals that Trumpworld is serious about addressing the fact that the U.S. pays way more for prescription drugs than other countries... Full

2. Diving into the Weeds

(3/21, Caitlin Owens, Axios) ...AFPI's paper isn't super prescriptive about what should be done about the global freeloading issue; it instead presents a menu of options available to Congress and the administration... Full

PBMs Offer Innovative Cost-Sharing Programs to Address Patient Out-of-Pocket Costs

(3/20, PCMA) ...PBMs work closely with employers and other plan sponsors to create formularies that incentivize the use of generics and biosimilars, which generally place these drugs on preferred tiers and have lower out-of-pocket costs for patients. In 2022, more than 90% of prescription drugs filled were generics or biosimilars, helping to lower costs for patients. In fact, the average out-of-pocket (OOP) cost for a generic prescription for a commercially insured patient dropped to $5.35 in 2023, compared to $6.21 in 2018... Full

IRA-Induced Involuntary Enrollment Churn In Medicare Part D: Likely Consequences

(3/20, David M. Anderson Kelly E. Anderson, Health Affairs) ...Under the IRA changes effective this year, if there are no privately offered standalone prescription drug plans offered in a region, the Centers for Medicare and Medicaid Services (CMS) is obligated by law to stand up a publicly run prescription drug plan as a public option. This would substantially lower competition in the Part D market and may lead to CMS directly negotiating net prices with rebates with dozens of manufacturers. A competitively priced public option could lead to private-sector crowd-out over the long run in some regions... Full

US FDA Commissioner Nominee Recruiting More Hill Staff Ahead Of User Fee Reauthorization

(3/20, Michael McCaughan, Pink Sheet) ...FDA Commissioner nominee Martin Makary, who is approaching confirmation, apparently has recruited three FDA experts working on Capitol Hill for his leadership team. All of them have experience with user fee reauthorizations and other major FDA legislation, which will be valuable for the agency as the next user fee renewal process will begin later this year. But last-minute changes cannot be ruled out, given recent events involving the new FDA chief counsel... Global Sub. Full

The FDA Finally Visited An Indian Drug Factory Linked to U.S. Deaths. It Found Problems.

(3/20, Patricia Callahan, ProPublica) ...The inspection comes after a ProPublica investigation revealed that drugs made at the Glenmark Pharmaceuticals plant accounted for an outsized share of U.S. recalls for pills that didn't dissolve properly and could harm people... Full

Alabama Lawmakers Advance Regulations On Pharmacy Benefit Managers

(3/20, Kim Chandler, Associated Press) ...Dozens of independent pharmacies have shuttered in Alabama over the last two years, according to the Alabama Independent Pharmacy Alliance. Pharmacists said that is because of financial pressures, in part, because it can often cost more to dispense a drug than they are reimbursed by pharmacy benefit managers... Full

Virginia's Prescription Drug Affordability Board Proposal Awaits Youngkin's Action

(3/21, Charlotte Rene Woods, Virginia Mercury) ...If enacted, the legislation would create an independent, nonpartisan board of medical and health experts tasked with analyzing data to set payment limits on drug prices within state-sponsored health plans...March 24 is the deadline for Youngkin to take action on hundreds of bills that were sent to him this year... Full

Report: Healthcare Unaffordable for Many New Yorkers, Most Worried About Future Costs

(3/20, Anastassia Gliadkovskaya, Fierce Healthcare) ...Two-thirds of respondents delayed or went without healthcare due to cost over the past 12 months. Those in households with a person with a disability reported the highest rates of forgoing care (76%) and rationing medication due to cost (31%). Respondents of color also had higher rates of avoiding or having difficulty accessing care compared to white respondents. In a virtual press conference announcing the findings, Democratic state Sen. Liz Krueger advocated for consumers. "We're paying a lot more, but we're not getting better healthcare outcomes," she said... Full

Like the Cheshire Cat, US Reciprocal Tariffs Are Hard to Pin Down

(3/21, David Dodwell, South China Morning Post) ...Indian pharmaceutical groups account for nearly 50 per cent of the generic medicines bought in the US, and nine out of 10 prescriptions, saving Americans over US$200 billion a year. If the US placed a 10 per cent reciprocal tariff on such pharmaceuticals, the main victims would be sick Americans... Full

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