Thursday, March 21, 2024

GSK to Cap Out-Of-Pocket Inhaler Costs in US

(3/20, Leroy Leo and Mariam Sunny, Reuters) ...British pharmaceutical giant GSK said on Wednesday it would cap out-of-pocket costs for all its inhaled asthma and chronic lung disease medicines at $35 per month for eligible patients in the United States, following similar moves by two of its rivals. GSK said the decision will take effect by Jan. 1, 2025...US lawmakers in January had criticized the top four inhalers manufacturers — AstraZeneca, Boehringer, Teva Pharmaceuticals and GSK — over high prices, and launched an investigation to look into the prices at which these were sold in the U.S. versus other countries... Full

Leading The Charge On US Humira Competition, Organon Sets Out Strategy

(3/20, David Wallace, Generics Bulletin) ...With US biosimilar competition to Humira slow to start in 2023, Organon's US biosimilars head Jon Martin talks about how the firm is pushing forward to ramp up progress on adalimumab this year, as well as longer-term opportunities...And now, as competition moves into its second year, Jon Martin – head of the US biosimilar business unit at Organon – tells Generics Bulletin that there are a number of reasons to be optimistic about the shape of Humira competition in 2024, as well as broader opportunities in biosimilars beyond... Global Sub. Full

Aurobindo One Step Closer To Xolair Biosimilar Registration

(3/20, Urte Fultinaviciute, Generics Bulletin) ...With originator Xolair's patents already expired or about to end next year, Aurobindo's CuraTeQ is on track with its omalizumab biosimilar for regulatory filings in 2024/2025, following a Phase I trial completion...The firm is now conducting a Phase III efficacy and safety trial with BP11 for the treatment of chronic spontaneous or idiopathic urticaria in 600 patients across seven European countries...Teva Pharmaceuticals is also conducting a Phase III trial investigating its TEV-45779 compared to Xolair in adults with chronic idiopathic urticaria. According to ClinicalTrials.gov, the study is set to finish in June 2024... Global Sub. Full

Biocon And Eris Strike Indian Deal Over Branded Formulations

(3/20, Adam Zamecnik, Generics Bulletin) ...Biocon Biologics has entered into a long-term commercial collaboration deal with pharma company Eris Lifesciences that features the sale of Biocon's metabolics, oncology, and critical care products in the Indian market, for a total transaction value of INR12.4bn ($149m)...Outside of the deal, Biocon remains focused on its biosimilars efforts around the world, including in Canada and the US as voiced by the company's' chief commercial officer for advanced markets Matt Erick in an interview with Generics Bulletin... Global Sub. Full

Alvotech Reports Financial Results for Full Year 2023 and Provides a Business Update

(3/20, Alvotech) ...Positive top-line results were announced from a confirmatory efficacy study for Alvotech's proposed biosimilar to Eylea® (aflibercept) and PK studies for proposed biosimilars to Prolia®/Xgeva® (denosumab) and Simponi®/Simponi Aria® (golimumab)...Alvotech and its commercialization partner in the U.S., Teva Pharmaceuticals, announced that the U.S. Food and Drug Administration (FDA) approved AVT02 (adalimumab-ryvk) for marketing in the U.S. an interchangeable biosimilar to Humira, under the tradename Simlandi... Full

Novartis-Backed MS Network Picks Seqster for Data Sharing Push

(3/21, Nick Paul Taylor, Fierce Pharma) ...Data sharing is central to how Novartis and its partners aim to achieve that goal. That is where Seqster comes in. The company is focused on breaking down silos and enabling access to de-identified health data, a mission that has led it to a Takeda deal and investment and alliances with Medable and United BioSource. CEO and founder Ardy Arianpour discussed his company's role in the MSIN, explaining that the network's need to facilitate data sharing and combine different sources "is where Seqster really shines."... Full

With Executive Shakeup and New Pharma Unit, Bayer's Overhaul Takes Shape

(3/20, Kevin Dunleavy, Fierce Pharma) ...Early this month at an investor event, Bayer CEO Bill Anderson—the agent for reform of the troubled company—declared that employees "are ready for change. They're saying bring it on." On Wednesday, Anderson answered the call with a revamp of the company's leadership team, which is being reduced from 14 members to eight. In the pharma sector, Bayer revealed a new Global Commercialization unit, which will be led by Christine Roth, who moves up from her former post as the head of oncology... Full

Pharma Execs Tell Investors Medicare Negotiations Won't Have a Big Impact

(3/20, Nathaniel Weixel and Joseph Choi, The Hill) ...AstraZeneca CEO Pascal Soriot told reporters last month that the initial offer from the Centers for Medicare and Medicaid (CMS) was "relatively encouraging," while Pfizer CFO David Denton told investors that the impact from negotiations would be "modest."...These recent comments contrast with what pharmaceutical lawyers have said in court, lamenting the serious harm companies have already begun to experience due to negotiations, a claim that several federal judges have been dubious of... Full

Biden Said Medicare Drug Price Negotiations Cut the Deficit by $160B. That's Years Away.

(3/21, Amy Sherman, PolitiFact, KFF Health News) ...The CBO has estimated that the negotiated prices will translate to nearly $100 billion in federal savings from 2026 to 2031. "Biden is jumping the gun on claiming savings for seniors," said Joe Antos, an expert on health care at the conservative American Enterprise Institute. "Price negotiations haven't been completed; the new prices for selected drugs aren't in place until 2026."... Full

Mark Cuban: Five Ways that Big PBMs Hurt U.S. Healthcare–And How We Can to Fix It

(3/21, Adam J. Fein, Ph.D., Drug Channels) ...I can go on and on about the big three PBMs. They are everything that is wrong with this industry. Here's the crazy part: There is a fix. The federal government, states, and self-insured employers can stop doing business with the big three PBMs...State and federal agencies and big companies could switch out from those big PBMs and use their competitors. This would change an entire industry in less than five years... Full

A Battle Between Drugmakers and Insurers Hits Patients in the Wallet

(3/20, Julie Appleby, KFF Health News) ...The issue is whether coupons and other copay aid many patients get from drugmakers should count toward annual insurance deductibles and out-of-pocket spending limits, enabling them to more quickly get fuller coverage for their medicines or other care. Insurers and employers gripe that the assistance is just a marketing ploy, intended to keep patients on costlier drugs even when cheaper alternatives are available... Full

House-Passed Bill Instructs Congressional Budget Office to Take Longer View When Grading Preventive Health Laws

(3/20, Dave Muoio, Fierce Healthcare) ...On Tuesday, the House of Representatives passed a bill that would allow lawmakers to request the Congressional Budget Office (CBO) to generate budgetary savings estimates of prospective preventive healthcare legislation over a 30-year window, as opposed to the current 10-year scoring window..."With chronic diseases accounting for over 70% of health care spending, this bill will ensure the Congressional Budget Office has access to the necessary tools to calculate the long-term cost saving potentials of preventive health care initiatives," [Dr. Michael C.] Burgess said in a statement... Full

Becerra: CMS Will Work With Congress To Ensure Telehealth Extension

(3/20, Emma Beavins, Jalen Brown, InsideHealthPolicy) ...HHS Secretary Xavier Becerra said the "last thing" Congress needs to do is allow telehealth flexibilities to expire at a House Ways & Means hearing on the president's fiscal 2025 budget request Wednesday (March 20). Permanent telehealth policy was excluded from HHS' policy asks in Biden's budget request, but Becerra still urged Congress to extend Medicare telehealth flexibilities that will expire at the end of the year... Sub. Req'd

U.S. Chamber Mobilizes Entrepreneurs for New Coalition to Protect U.S. Innovation from Government Confiscation

(3/20, U.S. Chamber of Commerce) ...However, proposals from Washington pose a threat to progress and risk fostering a hostile environment for U.S. innovation and IP rights. In response, the U.S. Chamber today announced the creation of the Business Alliance to Stop Innovation Confiscation Coalition (BASIC Coalition), bringing together diverse voices from the energy, technology, manufacturing, telecommunications, semiconductors, and pharmaceutical industries who share a common belief in the benefits of public-private partnerships to deliver solutions, solve problems, and enhance lives... Full

Biosimilars Forum Announces Support for Increasing Access to Biosimilars Act

(3/20, Biosimilars Forum) ...[Juliana M. Reed, executive director the Biosimilars Forum] "The Biosimilars Forum fully supports the Increasing Access to Biosimilars Act. This legislation would increase access to lower-cost, FDA-approved biosimilars. Biosimilars could save Medicare beneficiaries and taxpayers billions of dollars each year. The Forum and I stand ready to help policymakers increase patient choice and cost-savings to these lower-cost medicines.”... Full

When Can Observational Studies Support a Drug's Effectiveness? FDA Explains in New Draft Guidance

(3/20, Zachary Brennan, Endpoints News) ...The FDA on Wednesday released highly-anticipated draft guidance on when drug sponsors can use observational studies to help demonstrate a drug's effectiveness, for the first time offering clarity on what data and explanations sponsors should provide the agency. A major focus of the FDA's new guidance is making sure data from observational studies are reliable and relevant... Full

Pharma Companies and Their Allies Seek to Exempt Orphan Drugs from State Pricing Limits

(3/21, Ed Silverman, STAT Plus) ...As more states create dedicated boards to cap the costs of medicines, some drugmakers and their allies are pushing back with a controversial tactic — lobbying for legislation to set exemptions for so-called orphan drugs, which are used to combat rare diseases that afflict relatively small groups of patients... Sub. Req'd

Indiana Joins Fight Against Insulin Makers, PBMs Over Prices

(3/20, Celine Castronuovo, Bloomberg Law) ...The complaint, filed Tuesday by Indiana Attorney General Todd Rokita (R) in the Indiana Superior Court in Lake County, alleges insulin makers Novo Nordisk A/S and Sanofi SA have conspired with the nation's top pharmacy benefit managers to use a complicated rebate system that has driven up the prices of life-saving insulin products, violating Indiana consumer sales and antitrust laws. The lawsuit specifically names PBMs CVS Caremark, Express Scripts, and OptumRX—which together control about 80% of the market... Full

Baltimore Sues Eli Lilly, Other Drugmakers for Artificially Inflating Insulin Prices

(3/20, Angela Roberts, The Baltimore Sun) ...Mayor Brandon Scott, a Democrat, and the Baltimore City Council filed a lawsuit in the U.S. District Court of Maryland against Eli Lilly and 17 other companies, including CVS and drug maker Novo Nordisk. They are requesting a jury trial...In a statement, however, CVS spokesman Mike DeAngelis said pharmaceutical companies alone are responsible for the prices they set in the marketplace for the products they manufacture. "Nothing in our agreements prevents drug manufacturers from lowering the prices of their insulin products and we would welcome such an action," DeAngelis said... Sub. Req'd

Taxpayers Were Overcharged for Patient Meds. Then Came The Lawyers.

(3/21, Shalina Chatlani, Stateline) ...In 2018, when Mike DeWine was Ohio's attorney general, he began investigating an obscure corner of the health care industry...Three years later, after DeWine, a Republican, became governor of Ohio, the state announced an $88 million settlement with one of the nation's largest insurance companies, Centene...A New York Times investigation, drawing on thousands of pages of court documents, emails and other public records in multiple states, reveals that the case against Centene was conceived and executed by a group of powerful private lawyers who used their political connections to go after millions of dollars in contingency fees... Full

Kentucky Becomes Fourth State To Let Plans Substitute Non-Interchangeable Biosimilars

(3/20, Maaisha Osman, InsideHealthPolicy) ...Kentucky is joining three other states in enacting a law that will allow state and private health plans to switch prescriptions to non-interchanngeable biosimilars in a move the biosimilar industry says will yield substantial cost savings for patients and state health plans. Generic drug lobby the Association for Accessible Medicines, pushed for the state to modify an existing law that allowed health plans to substitute generics and interchangeable biosimilars but not non-interchangeable biosimilars... Sub. Req'd

European Commission Biotech Initiative Must Spearhead Next Wave of EU Biosimilar Advances for Patients and Stimulate Manufacturing

(3/20, Biosimilar Medicines) ...Our sector has already grown to represent over 20% of the volume of the accessible biological medicines market and this is expected to grow significantly up to 2030 with the upcoming loss of exclusivity of important molecules...To better support this key healthcare sector, the European Biotech and Biomanufacturing initiative must: ...Develop an inclusive industrial policy for all biotech actors including the biosimilar medicines sector, since all EU biomanufacturing sectors must adhere to the same level of EU quality standards and regulation... Full

EMA To Get The Ball Rolling On Making CTIS Global

(3/20, Vibha Sharma, Pink Sheet) ...The European Medicines Agency wants to further improve the visibility of data in the Clinical Trials Information System by establishing it as a World Health Organization primary registry...The EMA told the Pink Sheet that it intends to initiate the process to establish CTIS as a WHO primary registry by the third quarter of 2024. "The estimated time to become a primary registry is at least six months," an agency spokesperson said... Sub. Req'd

Older Medicines Rebate Will Test UK's New Pricing & Access Scheme

(3/20, Leela Barham, Pink Sheet) ...As the UK government implements a new rebate system for older medicines as part of the new pricing deal, industry trade bodies and experts suggest that exceptions will have to be made, such as higher prices or lower rebate levels for specific products. Industry experts are already predicting challenges in implementing the rebate on older medicines under the UK's new drug pricing and access scheme, VPAG, as companies with such products wait to hear what their rebate rates will be at the end of March... Sub. Req'd

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