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NHC Comments on Medicare Drug Price Negotiation Program: Draft Guidance, Implementation of Sections 1191 – 1198 of the Social Security Act for Initial Price Applicability Year 2027 and Manufacturer Effectuation of the Maximum Fair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

As noted in our previous communications, while the NHC would prefer a more traditional Notice and Comment rulemaking opportunity that would ensure the Agency directly responds to stakeholder feedback, we welcome this opportunity to express our reactions to CMS’ thinking on the negotiation program.

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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

We strongly urge CMS to address these issues in the IPAY 2027 portal to ensure that all participants, regardless of their familiarity with technology or survey formats, can contribute their insights without unnecessary difficulty. Additionally, CMS must ensure that this technology is accessible for people with disabilities.

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NHC Provides Input on Patient Engagement in Medicare Drug Price Negotiations

Putting Patients First Blog

Earlier this year CMS released draft guidance for Initial Payment Applicability Year (IPAY) 2027. This guidance will apply to the negotiation process for 15 drugs, which will occur next year, and the resulting prices will take effect in 2027. Conclusion To read the NHC’s full comments, click here and here.

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COPD market to reach $30.8 billion in 7MM by 2033: GlobalData

Express Pharma

Other KOLs have communicated that Dupixent is to dominate the biologics market after receiving both EMA and FDA approval, filling a gap in the COPD market. The changes made by GOLD have communicated that ICS/LABA fixed-dose combinations should not be used, which has been reflected in the COPD report, highlighting a 1.4 billion by 2033.”

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UK £62 billion behind in R&D global investment share, report reveals

European Pharmaceutical Review

The report suggested health research is a key area for R&D investment to align activity with broader social goals, communicate a clear strategic direction and improve R&D funding by crowding novel investment. . The government would need to invest an extra £1 billion in R&D by 2027. billion over a decade.

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FDA Publishes Its Draft Strategy Document on Innovative Manufacturing Technologies

FDA Law Blog: Biosimilars

This FR Notice and draft strategy document are part of FDA’s commitment under the Prescription Drug User Fee Act (PDUFA) Reauthorization Performance Goals and Procedures for Fiscal Years 2023-2027 (PDUFA VII), wherein FDA committed to advance the use and implementation of innovative manufacturing.

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Update on CDER, CBER, and CDRH Meetings with Industry

FDA Law Blog: Biosimilars

The pandemic had changed the way people live, work and communicate. Department of Health and Human Services declared the long-awaited end of the federal COVID-19 Public Health Emergency. Such changes are not limited to personal circumstances. The pandemic also deeply impacted how industry and the government conduct their operations.