Pharmaceutical Technology

JANUARY 31, 2023

The US omnibus bill passed in late December 2022 will give the agency greater powers to regulate accelerated approval drugs, while the Inflation Reduction Act’s lowering of drug prices will create an uncertain environment for drug developers, he said. asked panel chair Ipsita Smolinski, MD of consultancy Capitol Street.

Drug Pricing

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.

Drug Pricing

Drug Channels

FEBRUARY 21, 2023

On March 14, 2023, Drug Channels Institute will release The 2023 Economic Report on U.S. drug pricing, reimbursement, and dispensing system. We are providing you with the opportunity to preorder this thoroughly updated, revised, and expanded 2023 edition at special discounted prices. The 2023 Economic Report on U.S.

Specialty Pharmacies

Big Molecule Watch

MARCH 1, 2024

Today, the district court for the District of Delaware (Judge Connolly) granted the government’s motion for summary judgment on all claims brought by AstraZeneca in its Complaint challenging the Drug Price Negotiation Program of the IRA. There are now seven remaining lawsuits challenging the Drug Price Negotiation Program of the IRA.

Biosimilars

FDA Law Blog: Biosimilars

AUGUST 14, 2024

In addition to the widely publicized drug price negotiation program, the IRA established inflation rebate programs under Medicare Part B and Part D. We have drafted a memorandum that summarizes the main provisions of this proposed rule and notes where the regulation differs from the guidances.

Pharmaceutical Manufacturing

HealthPartners

JULY 21, 2021

For example, members can compare drug prices at pharmacies or find a network provider. To protect themselves, state employers and other well-informed business organizations now insist on transparent contracts with clear fees and tight definitions. Alternative biosimilars.

Biosimilars

FDA Law Blog: Biosimilars

MARCH 5, 2024

By Faraz Siddiqui — Last Friday, the Delaware District Court rejected AstraZeneca’s lawsuit against the Medicare Drug Price Negotiation Program enacted under the Inflation Reduction Act (IRA) and CMS’s guidance implementing it. AstraZeneca argued it would very likely have products in future lists of drugs selected for negotiations.

Dosage

Putting Patients First Blog

JANUARY 27, 2025

To strengthen the proposal, the NHC recommends that CMS avoid implementing rigid definitions of overweight and obese. Instead, CMS should review Part D plan prior authorization criteria to ensure that plan definitions align with treatment guidelines and ICD-10 diagnosis codes, promoting consistency and alignment among providers and payers.

Insurance Coverage and Processing

Pharma in Brief

JANUARY 10, 2024

Expected highlights for 2024 include a final PTA regime, more details on PMPRB drug pricing guidelines and national pharmacare, and fall-out from the US mass drug importation program targeting Canadian medicines. At the same time, the definition of a “small entity” under the Patent Rules was broadened as of January 1, 2024.

Drug Pricing

FDA Law Blog: Biosimilars

DECEMBER 3, 2023

The manufacturer’s agreement must cover all its labeler codes that contain an applicable drug or a selected drug. Non-applicable drugs (e.g., The primary manufacturer of a selected drug may also request CMS to terminate its agreement if they are unwilling to participate in the Medicare Drug Price Negotiation.

Labelling

Drug Channels

FEBRUARY 22, 2022

On March 15, 2022, Drug Channels Institute will release The 2022 Economic Report on U.S. drug pricing, reimbursement, and dispensing system. We are providing you with the opportunity to preorder this thoroughly updated, revised, and expanded 2022 edition at special discounted prices. The 2022 Economic Report on U.S.

Specialty Pharmacies

FDA Law Blog: Biosimilars

JUNE 2, 2023

Kirschenbaum — Last Friday, May 26, CMS published in the Federal Register an assortment of proposals to change the regulations governing the Medicaid Drug Rebate Program. Most are new or revised definitions and administrative changes, but several proposals represent new policies that should be of concern to drug manufacturers.

Labelling