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NHC Comments on Negotiation Data Elements and Drug Price Negotiation Process for Initial Price Applicability Year 2027 under Sections 11001 and 11002 of the IRA ICR Forms

Putting Patients First Blog

Overall, while the NHC appreciates CMS’ intent to streamline the data submission process and make it more accessible, we encourage ongoing dialogue and adjustments to ensure that the process remains patient-centered, efficient, and capable of capturing the full spectrum of information necessary to inform meaningful drug price negotiations.

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NHC Comments on Medicare Drug Price Negotiation Program: Draft Guidance, Implementation of Sections 1191 – 1198 of the Social Security Act for Initial Price Applicability Year 2027 and Manufacturer Effectuation of the Maximum Fair Price (MFP) in 2026 and 2027

Putting Patients First Blog

General Comments The NHC appreciates CMS’ commitment to actively engaging with stakeholders, including patients, consumer advocates, and health experts, in implementing the Medicare Drug Price Negotiation Program (DPNP).

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Year in Review: Top Regulatory Developments of 2024

Big Molecule Watch

pharmacies in 2023, and with the PBMs operating in a system from the drug private labeler all the way down to the pharmacy and health insurer. Amgens BKEMV (eculizumab-aeeb) was approved for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PHN) or atypical hemolytic uremic syndrome (aHUS).

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NHC Submits Comments to CMS RE CY 2026 Policy & Technical Changes to MA and Part D Proposed Rule

Putting Patients First Blog

3 ,4, 5 As such, the NHC supports CMS proposal to ensure that Part D sponsors cover AOMs for obesity with clinical criteria that is not more restrictive than the FDA labeling for each AOM. Comprehensive Transparency: AI applications should be fully disclosed, explainable, and accessible to patients and providers in layperson terms.

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Inflation, drug pricing and reimbursement constraints will challenge pharma sector

Pharmaceutical Technology

The survey results also indicated that drug pricing and reimbursement constraints will be the second biggest concern, hampering the industry’s growth, as indicated by 30% of the surveyed respondents. To adapt is the only way to thrive. The pharmaceutical sector will need to find new ways to offset regulatory and inflationary pressures.

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Exforge antitrust settlement caps Novartis’ year of legal disputes

Pharmaceutical Technology

The alleged actions violated the Hatch-Waxman Act, formally known as the “Drug Price Competition and Patent Term Restoration Act of 1984,” which allows generic manufacturers to market their generic versions of previously approved generic medications. These actions allegedly led to the extension of Novartis’ patents.

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US government plans proposal to push down Medicaid drug prices

Pharmaceutical Technology

The US Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS) have announced steps to push down prescription drug prices under Medicaid as part of a new proposal. It specifically seeks to improve the Medicaid Drug Rebate Program (MDRP).