Alendronate Sodium

iStock, Baurzhan Ibrashev The Institute for Clinical and Economic Review flagged five drugs whose prices were raised in 2023 with no evidence to support it. Meanwhile, the makers of these drugs have been reporting double-digit sales growth for many of these products. $815 million. That’s how much U.S. payers shelled out for five top-selling drugs whose prices were raised without justification, according to the Institute for Clinical and Economic Review. The drug price watchdog flagged Gilead’s Biktarvy, Johnson & Johnson’s Darzalex, Novartis’ Entresto, Exelixis’ Cabometyx and Pfizer’s Xeljanz as the drugs with the highest unsupported drug price increases in 2023. The annual review calculates drugs that had substantial net price increases in the year prior, specifically flagging those without evidence supporting a new or greater clinical benefit that would justify the change. The analysis includes the top 250 drugs by U.S. sales revenue that had wholesale acquisition cost increases exceeding the consumer price index plus 2%. It also factors in rebates and whether U.S. spending increases were fueled by the net price increase rather than volume increases. That left the five drugs that had unsupported price increases. Topping the list was Gilead’s Biktarvy, a trio of HIV medications in one fixed dose. The price of treatment rose 5.9%, while the net price increased 3.8%. This led to $359 million in additional spending. “We continue to see list price increases that are far above the rate of inflation for many of the costliest drugs,” Foluso Agboola, ICER’s vice president of research, said in a statement. Meanwhile, these companies have been reporting double-digit sales growth for many of these products. Gilead saw a 14% increase to $11.8 billion in total sales of Biktarvy in 2023 compared to the year before. In a year-end earnings report, Gilead said this was due to higher demand and a higher price. Its HIV franchise, which also includes Decovy, Truvada and other therapies, had a 6% overall increase in sales to $18.2 billion for 2023, again chalked up to the higher price and demand. Gilead’s other HIV medicines were not flagged by ICER in the report. Interestingly, Gilead reported tha Biktarvy’s price was lower in the fourth quarter of that year. The drug clocked a 7% sales increase to $3.1 billion compared to the same period in 2022. The increase was driven by demand but “partially offset by lower average realized price due to channel mix.” ICER also noted price hikes on five other drugs that may be justified due to new evidence on their clinical benefit. The first four were in oncology—Merck’s cancer juggernaut Keytruda, AstraZeneca’s Imfinzi and Tagrisso and BMS’ Opdivo—and the final one was Amgen’s osteoporosis therapy Prolia. That said, ICER was careful to note that even though these drugs did have new evidence, the level of price hike may not be warranted. Prolia had a nearly 10% increase in its wholesale acquisition cost for 2023 compared to 2022, leading to $113 million in additional spending. ICER determined the price change to be justified due to new clinical evidence that Prolia showed a greater reduction in fracture risk as compared to competing therapy alendronate (Fosamax). Amgen reported a 12% increase in sales of Prolia for the full year 2023, with $2.73 billion in the U.S. and $4.05 billion worldwide. The increase was attributed to “volume growth and higher net selling price,” according to the company’s full-year earnings report released in February. ICER also dubbed BMS’ price increase for Opdivo justified given new evidence that came to light over the past year. The drug collected two more indications, which ICER said helped support the price hike. Opdivo is currently approved for melanoma, non-small cell lung cancer and renal cell carcinoma. A History of Hiking Prices In 2023, ICER flagged eight drugs for 2022 price hikes that were unjustified. Like this year, Darzalex made the list. Entresto, on the other hand, had a price change that was considered justified, but Prolia found itself on the unjustified side of the board. Other therapies that ICER thought had raised prices without justification include AbbVie’s Humira and Pfizer’s Ibrance. For 2024, the story could be different for Ibrance. Pfizer posted data on Thursday making the case for a new indication in breast cancer. Ibrance was included in this year’s analysis but did not make the final list. The drug had a 7.9% wholesale acquisition cost increase. ICER’s Agboola said that since beginning the report in 2019, the number of drugs that make the list each year has been declining.

BOSTON, MA / ACCESSWIRE / December 9, 2024 / Radius Pharmaceuticals, Inc., a wholly owned subsidiary of Radius Health, Inc. ("Radius" or the "Company"), a specialty biopharmaceutical company focused on bone health and related areas, announced today it has granted Theramex the exclusive commercialization rights to ELADYNOS® (abaloparatide), a novel bone forming agent indicated for the treatment of osteoporosis in postmenopausal women and men at increased risk of fractures, for Mexico, Canada, Israel, South Africa, and Russia. Theramex will also have the opportunity to commercialize ELADYNOS® in other agreed upon unpartnered regions. Abaloparatide is marketed in the U.S. by Radius under the tradename TYMLOS®.Under the License Agreement, Radius will receive an upfront and milestone payment plus tiered royalties."Theramex has been an excellent collaborative partner, and we are very pleased to expand our abaloparatide partnership to include additional important global markets," said Scott Briggs, Chief Executive Officer of Radius. "Radius is committed to making abaloparatide accessible to patients, and the expansion of our existing partnership helps provide access to additional patients in need of osteoporosis treatment options.""Following the launch of abaloparatide in Europe, we are excited to bring this innovative product to more patients globally and drive further growth through our direct markets and our commercial partnerships. This agreement expands our successful relationship with Radius, and we look forward to continuing our close collaboration," said Rob Stewart, Chief Executive Officer of Theramex.In addition to these new territories, Theramex will continue to commercialize and distribute ELADYNOS® on an exclusive basis in the European Economic Area, the United Kingdom, Australia, and Brazil. ELADYNOS® received approval in the European Economic Area in December 2022 and Australia in November 2024 and has been launched in select countries.About Radius:Radius is a global biopharmaceutical company dedicated to transforming the future for underserved, global patient populations in bone health and related areas. Radius' lead product, TYMLOS® (abaloparatide) injection, was approved by the U.S. Food and Drug Administration in April 2017 for the treatment of postmenopausal women with osteoporosis at high risk for fracture, and in December 2022 to increase bone density in men with osteoporosis at high risk for fracture. Radius also has an exclusive licensing and distribution agreement for the U.S. rights to BINOSTO® (alendronate sodium) effervescent tablet for oral solution, expanding the Company's presence in bone health.About Theramex:Theramex is a leading global specialty pharmaceutical company dedicated to women and their health. Theramex supports women at different stages of their lives by providing a broad portfolio of innovative and established brands covering osteoporosis, contraception, fertility, menopause and uterine health. Theramex's commitment is to listen to and understand its patients, serve their needs and offer healthcare solutions to help improve their lives. Theramex's vision is to be a lifetime partner for women and the healthcare professionals who treat them by providing patient-focused and effective solutions that care for and support women through different stages of their life.Contacts:Al Medwar: Senior Vice President, Business and Corporate Development, Radius Email: [email protected]Edward Rees: Chief Corporate Development Officer, TheramexEmail: to [email protected]SOURCE: Radius Health