Putting Patients First Blog

SEPTEMBER 3, 2024

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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Drug Pricing Insurance Coverage and Processing Labelling Communication 52

FDA Law Blog: Biosimilars

JUNE 16, 2023

Kirschenbaum — On May 24, Minnesota enacted the Commerce and Consumer Protection Omnibus Bill, Senate File 2744 ( SF 2744 ), which significantly expands the state’s existing drug pricing activities with serious implications for all drug manufacturers, and particularly generic drug manufacturers.

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Drug Pricing Biosimilars Dosage Documentation 44

Safe Biologics

DECEMBER 3, 2023

The most recen t of the webinars, hosted July 29th, examined the negative impact of the Inflation Reducation Act’s Medicare drug price setting provisions. The guidance removed the interchangeability statement from the product label/package insert of interchangeable biosimilars.

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Biosimilars Labelling Drug Pricing Packaging 130

Putting Patients First Blog

JULY 2, 2024

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). It is crucial to consider how off-label uses will be evaluated and incorporated into the negotiation process.

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Drug Pricing Insurance Coverage and Processing HIPAA Labelling 52

Big Molecule Watch

AUGUST 25, 2023

The Inflation Reduction Act’s Medicare Drug Price Negotiation Program will kick off next week. There are reports that the White House may announce the list of selected drugs even before that deadline, on Tuesday, August 29 th. Before the IRA, the government could not set prices for any drugs covered by Medicare.

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Drug Pricing Biosimilars Insurance Coverage and Processing Labelling 40

FDA Law Blog: Biosimilars

DECEMBER 3, 2023

As part of this change, the Coverage Gap Discount Program (CGDP), a program that has existed since 2011, will sunset on December 31, 2024, and be replaced by the Medicare Part D Manufacturer Discount Program (the “Discount Program”). Manufacturers must sign the agreement by March 1, 2024, to participate in the 2025 plan year.

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Labelling Drug Pricing Compounding Payment Processing 104

Express Pharma

OCTOBER 2, 2024

Speaking at the recent ASSOCHAM Annual Pharma Summit 2024, Secretary, Department of Pharmaceuticals, Dr Arunish Chawla’s review of the regulatory reforms needs to go hand in hand with the growth opportunities. Companies have also pointed out that QR codes are missing from these batches.

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Drug Pricing Documentation Labelling 94