Remove Communication Remove Documentation Remove Drug Pricing
article thumbnail

STAT+: Senator launches investigation into GSK’s asthma inhaler maneuvers

STAT

And so Hassan called on GSK to return the product to market and, meanwhile, asked for numerous documents concerning pricing, rebates and communications with regulators. This marks the second time in recent months that GSK has angered a lawmaker over the asthma inhaler switch. In March, U.S. Elizabeth Warren (D-Mass.)

article thumbnail

NHC Submits Comments on CMS Draft Guidance for IPAY 2028

Putting Patients First Blog

The NHC supports the efforts to reduce out-of-pocket costs for Medicare beneficiaries and appreciates CMS’ work to establish a process that seeks to incorporate patient perspectives into drug pricing policy. Even well-intentioned policies can create access disparities if communication and operational support are lacking.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

Navigating 340B Program Changes in 2025

Proxsys Rx

Regardless of your answer, theres no question the 340B Drug Pricing Program remains a critical resource for eligible healthcare providers, enabling them to stretch scarce federal resources to provide essential services to underserved communities. Perform self-audits to proactively identify and address your 340B program gaps.

article thumbnail

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.

article thumbnail

NHC Comments on Medicare Drug Price Negotiation Program: Draft Guidance, Implementation of Sections 1191 – 1198 of the Social Security Act for Initial Price Applicability Year 2027 and Manufacturer Effectuation of the Maximum Fair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

article thumbnail

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. Gilenya is an oral medication for multiple sclerosis.

article thumbnail

NHC Comments on IRA Guidance Response

Putting Patients First Blog

10: External Data Submission Timing The NHC understands the tight timeline for the drug selection and price negotiation processes. The NHC also requests that CMS highlight when and how the agency removed QALY-based metrics from consideration in MFP justification documentation.