A proposed rule would cut the Part D generic copay from $1 to $0 for the lowest-income dual eligibles in 2028, tighten Medicare Advantage directory accuracy, and add PBM transparency rules. Comments close 15 December.
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A final question-and-answer guidance tells biosimilar makers what data to file when they change how an approved product is made, fulfilling a 2022 user-fee commitment. It was issued on 13 October 2026.
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A hybrid public meeting on 26 October will discuss proposed BsUFA IV recommendations. The fees that fund FDA review of biosimilar applications expire in September 2027 and need new legislation to continue.
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THE DRUG DOCKETA mandatory CMS payment model finalised 2 October recalculates inflation rebates for certain physician-administered drugs against an international benchmark, and can cut a patient's coinsurance to 10%.
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ANALYSISCMS took comment through 18 September 2026 on draft rules for how manufacturers must deliver negotiated drug prices in 2028. The mechanism is a refund owed within 14 days, not a lower shelf price.
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EXPLAINERThe list price is the sticker; the net price is what the maker keeps after rebates. For one insulin, list rose 27% over five years as the net price fell 10%. Who you are decides which you pay.
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EXPLAINERA study estimated semaglutide's class could be produced for under $75 a month; it lists near $1,000. The gap is patent protection, and in the US it runs to 2032.
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THE DRUG DOCKETPBAC recommended subsidized listing in November 2025 for adults with obesity and a history of heart attack or stroke. Price negotiations with Novo Nordisk had not concluded.
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EXPLAINERPharmacy benefit managers sit between you, your insurer and the pharmacy. The three largest process nearly 80% of US prescriptions, and a federal regulator says the structure can raise costs.
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The public comment window just closed on a proposal that would govern how up to 20 high-cost drugs a year get their Medicare prices negotiated, starting with prices that take effect in 2029.
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EXPLAINERFor many older generics, discount cards and cost-plus pharmacies undercut insured prices. One analysis found Medicare could have saved $3.6 billion on 77 generics buying at cash-plus prices.
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EXPLAINERMedicare's cap is statutory; the commercial version is a voluntary manufacturer promise with conditions. Before the caps, 1.3 million adults rationed insulin because of cost.
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EXPLAINERThe prices apply only to 10 drugs, only in Medicare, and only from January 2026. Here is exactly which drugs, by how much, and who actually sees the difference.
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EXPLAINERA generic must prove its absorption matches the brand within a defined statistical window. Across 2,070 FDA studies the average gap was under 5%. Generics are 90% of prescriptions and a fraction of the cost.
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EXPLAINERThe FDA's approval bar requires no clinically meaningful difference from the original, and a large switching trial found no loss of control. The savings gap is a market problem, not a safety one.
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EXPLAINERAcross all drugs, US prices are 2.78 times those in 33 other wealthy countries. The gap is not that Americans use more medicine — it is that no one sets the launch price.
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WHAT THE STUDY ACTUALLY SAYSIn the head-to-head OVERLORD-MS trial, 92.2% on rituximab and 94.8% on ocrelizumab had no new MRI lesions from months 6 to 24, meeting the prespecified bar for noninferiority.
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THE DRUG DOCKETFDA cleared oral semaglutide 25 mg on 22 December for chronic weight management and cardiovascular risk reduction. Its self-pay price, not its efficacy, is what may distinguish it.
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EXPLAINERFor the first time, Part D limits annual out-of-pocket drug spending to $2,000, with an option to pay it in monthly installments. Over a million heart patients alone were spending more.
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