Thursday, May 2, 2024

Teva Discontinuing Digihaler Products Used for Asthma Treatment

(5/1, Diana Ernst, Rph, MPR) ...Teva is discontinuing its Digihaler® products, ProAir® Digihaler® (albuterol sulfate), AirDuo® Digihaler® (fluticasone propionate and salmeterol inhalation powder) and ArmonAir® Digihaler® (fluticasone propionate inhalation powder), according to the Food and Drug Administration (FDA)'s drug shortage tracker... Full

Boehringer Puts a Target On Humira, Says Pushing it Off Formularies is Necessary

(5/1, Zachary Brennan, Endpoints News) ...The German drugmaker on Wednesday said that its goal of getting more uptake for Humira biosimilars will require pushing AbbVie's drug off of PBM formularies. Boehringer's high-concentration, citrate-free formulation of its Humira biosimilar Cyltezo won FDA approval on Wednesday. The company's formulary push follows a significant uptick in market penetration by Sandoz's Humira biosimilar, thanks to a new partnership with CVS Health that cut AbbVie's Humira from its spot on major national formularies. Boehringer is now looking to make a similar move, and it already has a relationship with Cigna's Evernorth to reduce out-of-pocket costs with its biosimilar... Full

FDA Approves Second Formulation of Humira Biosimilar Cyltezo

(5/1, Lauren Massaro, Drug Topics) ...The FDA has approved adalimumab-abdm (Cyltezo), Boehringer Ingelheim's high-concentration, citrate-free, interchangeable Humira (adalimumab; AbbVie) biosimilar, to treat several chronic inflammatory diseases, the company announced in a release...The approval of adalimumab-abdm, along with the previously established interchangeability of Cyltezo, represents a significant step towards improving affordability and accessibility of adalimumab treatment for patients in the US... Full

Healthy Returns: Sales of Humira Are Plunging, But AbbVie Has Two Promising Successors

(5/2, Annika Kim Constantino, Ashley Capoot, CNBC) ...Humira competition could also heat up in other ways: Health insurer Cigna announced on April 25 that it plans to make certain Humira biosimilars available with no out-of-pocket payment to eligible U.S. patients using its specialty pharmacy business beginning in June. Alvotech and Teva Pharmaceuticals also announced a deal with an unspecified company to boost access to their biosimilar Simlandi, which mimics Humira's most popular formulation and can be directly substituted at the pharmacy... Full

Pfizer Sets Up DTC Marketing Platform as Q1 Sales Beat Expectations

(5/1, Kevin Dunleavy, Fierce Pharma) ...Pfizer expects to have the website up before the end of this year. It will connect patients with consultants to prescribe the drugs, with a supplier filling and shipping the prescriptions, sources told FT...The moves are part of a broader effort in the industry to simplify the distribution of products—especially those in high demand such as obesity treatments—and to cut costs associated with going through middlemen... Full

Novo Boosts Wegovy Supply as Lilly Rivalry Pressures Prices

(5/2, Naomi Kresge, Bloomberg) ...Novo Nordisk A/S is shipping more introductory doses of its blockbuster weight-loss drug Wegovy in the US as it grapples with supply constraints and competition from Eli Lilly & Co...About 80% of Wegovy patients in the US with commercial coverage for the drug are paying $25 or less per month, according to Novo. The drugmaker will continue to impose some restrictions on access to the lower doses of Wegovy that are used as patients slowly ramp up on the drug... Sub. Req'd

Blockbuster Obesity Drug Demand Drives Novo Nordisk Profit Boost

(5/2, Maggie Fick and Stine Jacobsen, Reuters) ...As volume and competition have increased, the price of Wegovy came "slightly down" in the first three months of the year, Chief Financial Officer Karsten Munk Knudsen said...Novo launched Wegovy on Wednesday in Spain and will launch the injection in Canada on May 6, Knudsen told Reuters... Full

Wegovy, Mounjaro Prices Cut as British Pharmacies Compete for Weight-Loss Patients

(5/2, Ludwig Burger, Reuters) ...Online pharmacies and slimming clinics are cutting prices for Wegovy and Mounjaro in Britain just months after the weight-loss drugs were launched there, as initial supply shortages ease. But growing competition between retailers has raised fears that some patients who buy the drugs themselves, rather than relying on the National Health Service (NHS), will miss out on long-term aftercare if they keep switching providers... Full

Cencora Misses Revenue Estimates On Weight-Loss Drug Shortage

(5/1, Mariam E Sunny, Reuters) ...Cencora beat Wall Street estimates for second-quarter profit on Wednesday, driven by robust demand for costly specialty medicines that treat complex diseases such as cancer and rheumatoid arthritis. The drug distributor has been benefiting from specialty drugs and biosimilars - close copies of complex biotech drugs - at a time when intense competition pulls down prices of generic medicines... Full

CVS Shares Plummet as Health Company Slashes Profit Outlook On Higher Medical Costs

(5/1, Annika Kim Constantino, CNBC) ...CVS Health on Wednesday reported first-quarter revenue and adjusted earnings that missed expectations. The company also lowered its full-year profit outlook, citing higher medical costs that are dogging the broader U.S. insurance industry. Insurers have been seeing medical costs spike as an increasing number of Medicare Advantage patients return to hospitals to undergo procedures they had delayed during the pandemic... Full

Celltrion Seeks Bigger Footing in South America

(5/2, Shim Woo-hyun, The Korea Herald) ...Celltrion announced Thursday that the company has won public tenders in Peru to provide its autoimmune disease treatment Remsima (infliximab) and anticancer product Herzuma (trastuzumab) to the South American country. According to Celltrion, Remsima has won a tender held by the Peruvian Workers' Insurance System (EsSalud), which is the largest of its kind, accounting for 81 percent of the total infliximab volume in Peru. The company will supply Remsima for a year starting this month... Full

Scant Drug Ingredients Linked to US Generic-Drug Shortages in First 2 COVID Years

(5/1, Mary Van Beusekom, MS, CIDRAP) ...In the first 2 years of the COVID-19 pandemic, shortages of 11% of generic active pharmaceutical ingredients made by global manufacturers—35% of them from larger facilities in India—were tied to generic-drug unavailability in the United States, according to a research letter posted this week in JAMA... Full

Historic Drug Shortage Exacerbated by EPA Overreach

(5/2, W. Caffey Norman, RealClearHealth) ...Concerning new reports reveal that the drug shortage in the U.S. has reached its highest level since the American Society of Health-System Pharmacists began tracking data. In total, 323 medicines are now in short supply. However, the problem is about to get worse because of government regulations on an entirely different issue. Counterintuitive measures from the Environmental Protection Agency are set to effectively ban the domestic production of chemicals that are used in the process of manufacturing vital prescription drugs and vaccines... Full

Mark Cuban Cost Plus Drug Company to Supply ScionHealth Utilizing Safecor Health Program

(5/1, Safecor Health) ...ScionHealth announced today they will begin purchasing certain bulk drugs from Mark Cuban's Cost Plus Drug Company and delivered to Safecor Health's SafecorLogics program. The integrated approach, combining the expertise of three organizations, will enable ScionHealth to deliver exceptional value to patients while ensuring the sustainability of its healthcare delivery model... Full

Navigating Biosimilar Lifecycles: Key Considerations for Sustainable Cost Savings

(5/1, Alana Hippensteele, Pharmacy Times) ...Fifty biosimilar products have been approved by the FDA across 15 unique biological molecules, explained Chrys Kokino, president, Accord US, during Asembia's AXS24 Summit in Las Vegas. According to Kokino, reaching this number of FDA-approved products in the United States is a significant step for the field of biosimilars... Full

Cuban: More Deals In Works To Make Pediatric Cancer, Other Drugs In Shortage

(5/1, Maaisha Osman, InsideHealthPolicy) ...Mark Cuban, founder of the Mark Cuban Cost Plus Drug Company, tells Inside Health Policy he has more deals in the works to produce pediatric cancer and other drugs in shortages for hospitals, after having inked an initial agreement with Community Health Systems (CHS)...Cuban also tells IHP that Cost Plus will not use artificial intelligence (AI) to identify drugs in shortage, instead, the company adopts a strategy based on hospital demands... Sub. Req'd

DEA Reverses a Policy to Avert Morphine Shortages

(5/1, John Wilkerson, STAT Plus) ...The Drug Enforcement Administration is reversing a regulation that had been expected to create shortages of morphine and other opioid injectables, according to a DEA letter to drugmakers obtained by STAT. The DEA dictates the quantity of controlled substances that drug companies are allowed to make. Until this year, those quotas were set annually for Schedule II drugs, such as morphine and other injectable opioids that hospitals regularly use... Sub. Req'd

Senator Slams GlaxoSmithKline Over Cost Of Asthma Inhalers

(5/1, Aaron Gregg and Dan Diamond, The Washington Post) ...Pharmaceutical giant GlaxoSmithKline is sidestepping its pledge to lower asthma inhaler prices, a key senator charged Wednesday, in the latest effort by Democrats to pressure drug companies on the issue. Less than two months after GlaxoSmithKline pledged to cap out-of-pocket costs for its inhalers at $35 a month, Sen. Maggie Hassan (D-N.H.) is accusing the company of circumventing that vow through a preexisting licensing deal. That agreement discontinued a popular inhaler and replaced it with a more costly generic alternative not covered by most insurance companies... Sub. Req'd

Healthcare and Drugmaker Groups Seek to Revive Challenge to US Drug-Pricing Law

(5/1, Brendan Pierson, Reuters) ...Healthcare and drug industry groups on Wednesday urged a U.S. appeals court to revive their challenge to a law requiring manufacturers to negotiate the prices of some drugs with the U.S government's Medicare health insurance program or pay heavy penalties... Full

Pharma's IRA Complaints Find Sympathetic Ear In US Appeals Court But Near-Term Relief Unlikely

(5/1, Cathy Kelly, Pink Sheet) ...Arguments in a lawsuit challenging Medicare's price negotiation program brought by the Pharmaceutical Research and Manufacturers of America, the National Infusion Center Association and others received a sympathetic reception from at least one of the three judges in the US Court of Appeals for the Fifth Circuit during oral arguments on May 1. But the appellate court is only considering a narrow jurisdictional ruling from the lower court... Sub. Req'd

J&J Follows Bristol Myers in Appeal of Judge's Ruling Against Companies in IRA Lawsuit

(5/1, Nicole DeFeudis, Endpoints News) ...As Bristol Myers did on Monday, J&J filed on Tuesday to appeal Judge Zahid Quraishi's decision to the federal Third Circuit. Quraishi's summary judgment on Monday marked the federal government's fourth court win, after the rejection of two cases brought earlier this year by AstraZeneca and a handful of organizations, including industry trade group PhRMA. Both PhRMA and AstraZeneca have also filed appeals..."The companies are looking to quickly appeal and move beyond the district court stage in hopes that they have more luck up in the appellate courts," Zachary Baron, an expert on health policy and law at Georgetown University, told Endpoints News... Full

Expert Breaks Down Impact of IRA On Drug Prices and Patient Access

(5/1, Pharmacy Times) ...Sarah Butler, chief commercial officer at ADVI Health, discusses the substantial impact that the Inflation Reduction Act will have on drug prices and patient access to medications. She explains how some negotiated drug prices under the new law may end up higher than current out-of-pocket costs for patients. She also reviews the potential outcomes of the upcoming election in expanding Medicare drug price negotiation or pursuing international pricing models... Full

NACDS: Change Healthcare Attack Shows Need For PBM Reform

(5/1, Gabrielle Wanneh, InsideHealthPolicy) ...The chain drug store lobby told lawmakers on both sides of Capitol Hill Wednesday (May 1) that pharmacy benefit managers' preexisting business practices exacerbated billing problems faced by pharmacies in the aftermath of the March Change Healthcare cyberattack that crippled the health care system and must be reformed. The National Association of Chain Drug Stores says Congress must swiftly pass bills to reform PBM practices in Medicare and Medicaid to address longstanding policies that worsened the effects of the attack on pharmacies and threatened patient access... Sub. Req'd

Change Healthcare Cyberattack Was Due to a Lack of Multifactor Authentication, UnitedHealth CEO Says

(5/1, Tom Murphy, Associated Press) ...UnitedHealth CEO Andrew Witty said Wednesday in a U.S. Senate hearing that his company, which owns Change Healthcare, is still trying to understand why the server did not have the additional protection. His admission did not sit well with Senate Finance Committee members who spent more than two hours questioning the CEO about the attack and broader health care issues. "This hack could have been stopped with cybersecurity 101," Oregon Democratic Sen. Ron Wyden told Witty... Full

Pharmacy Benefit Schemes Are Costing Patients Billions

(5/1, Craig Burton, DC Journal) ...Research by the Biosimilars Council and IQVIA reveals the extent and causes of the PBM stranglehold over the biosimilar market that blocks access to lower-priced biosimilar versions of Humira (adalimumab), once the top-selling pharmaceutical globally. According to the analysis, switching adalimumab patients from Humira to biosimilars would save $6 billion for patients and the U.S. health system, but that would mean that PBMs would lose up to 84 percent of their profit... Full

Biosimilars Could Fuel Potential Cost Savings in Health Care

(5/1, Pharmacy Times) ...Fran Gregory discusses the challenges of rising pharmaceutical costs and the opportunity presented by biosimilars. She noted that median drug costs upon market entry now exceed $200,000 annually... Full

FDA Makes It 50 With Accord Trastuzumab Biosimilar Approval

(5/1, David Wallace, Generics Bulletin) ...The US FDA has marked a milestone with the approval of the country's 50th biosimilar, in the form of Henlius and Accord BioPharma's Hercessi trastuzumab rival to Herceptin...Hercessi will enter a crowded market for trastuzumab biosimilars in the US. Approvals have previously been granted by the FDA for Amgen's Kanjinti (trastuzumab-anns), Pfizer's Trazimera (trastuzumab-qyyp), Samsung Bioepis and Organon's Ontruzant (trastuzumab-dttb), Celltrion and Teva's Herzuma (trastuzumab-pkrb) and Biocon's Ogivri (trastuzumab-dkst)... Global Sub. Full

US FDA Developing Model Master File System To Grow Modeling, Simulation Field

(5/1, Derrick Gingery, Pink Sheet) ...Officials in the US Food and Drug Administration's Office of Generic Drugs are considering creating model master files, which would be similar to the drug master file system that has been in place for years. While DMFs contain confidential information about facilities, manufacturing and other processes for human drugs, model master files would house the algorithms or other systems used to simulate clinical trials... Sub. Req'd

FDA: Lack Of Funding Will Impact Staffing Levels, Inspections

(5/1, Luke Zarzecki, InsideHealthPolicy) ...The ability to hire more staff for inspections will be affected if FDA is not granted the funding it needs from Congress, Associate Commissioner Michael Rogers of FDA's Office of Regulatory Affairs said at an Alliance for a Stronger FDA webinar May 1. Rogers joined several other FDA officials who have said a lack of funding will inhibit staffing needs and said the agency has been "under recognized, under appreciated."... Sub. Req'd

An Ohio Pharmacy Was Fined $250K. It Represents Everything Wrong With the Prescription Drug Industry.

(5/1, Kelcey Blair, MedCity News) ...Much has been made of how we've gotten here, with blame spread to the pharma manufacturers, the pharmacy benefit manager middlemen, vertical integration and monopoly power of conglomerates, and more. But the question is: How do we move forward? The answer: We must realign the financial incentives and democratize access through data sharing. Pharma needs to lead the charge, but employers and pharmacies must also be agents of change. Here's how we can do it... Full

‘Lifesaving Medication': Bill Aims to Cut Prescription Drug Prices for Seniors

(5/1, Jessica Hill, Las Vegas Review-Journal) ...Nevada's Democratic Sen. Jacky Rosen and Sen. John Cornyn, R-Texas, introduced legislation on Wednesday that aims to reduce prescription drug costs for seniors. The Reducing Drug Prices for Seniors Act would require prescription drug coinsurance payments for seniors on Medicare to be determined based on the lower net price of the medication, rather than its higher list price, according to Rosen's office... Full

Maryland's Retirees Fear Mounting Healthcare Costs Due to Prescription Drug Plan Changes

(5/1, Rebecca Pryor, FOX 45 News) ...Early last year, the federal Fourth Circuit Court of Appeals decided against the temporary injunction, allowing the state to move forward with changes to its prescription drug coverage. In a last-minute attempt to intervene, this legislative session two republican backed bills moved to restore the previous plan. Both bills failed to make it out of committee. "The reason the bills didn't make out of committee was because Democratic Party leadership had no interest in making them out of committee. They felt that they would save money by basically throwing grandma from the train," said Political analyst John Dedie... Full

Bolar Exemption India Files: Roche Blocks Alleged Infringer Of Evrysdi Patent

(5/1, Anju Ghangurde, Generics Bulletin) ...More legal action in India that has the Bolar exception provision at its crux with Roche, in this instance, warding off a local drug maker in the Evrysdi patent infringement case. Roche appears to have thwarted, at least for now, an alleged infringement attempt pertaining to the patents for its oral spinal muscular atrophy treatment Evrysdi (risdiplam) in India... Global Sub. Full

Generics Continue to Dominate Canadian Prescriptions As Specialty Drugs Plateau

(5/1, Sarah Dobson, HR Reporter) ...After more than 15 years of steady gains, specialty drugs' share of the total eligible amount plateaued in 2023 — after declining for the first time in 2022. That's one of the findings of a report from TELUS Health looking at Canada's management of prescription drug plans...As for generic medications, they represented two-thirds (67.5%) of all prescriptions covered by private drug plans in 2023, compared to single-source brands (25.9%) and multi-source brands (6.6%)... Full

Asian Industry Groups Push For Universal Care, E-Labeling, Flexible Supply Chain

(5/1, Lisa Takagi, Pink Sheet) ...An annual meeting of Asian pharma industry groups in Tokyo recognized the need for faster joint regulatory allowance for second suppliers to stabilize the supply chain, drive e-labeling for patients and expand universal healthcare to better cover expensive therapeutics... Sub. Req'd

WHO Recommends Risk Management Plans for High-Risk Excipients

(5/1, Joanne S. Eglovitch, Regulatory Focus) ...The World Health Organization has released two draft appendices to a recent draft guideline on good manufacturing practices for excipients. The first document recommends manufacturers develop risk management plans for controlling and preventing contamination of high-risk excipients. A separate appendix lists the types of high-risk excipients that should be subject to scrutiny under these plans... Full

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