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). This includes collecting data on utilization management practices, formulary changes, and patient experiences.

Drug Pricing 52

Drug Pricing Insurance Coverage and Processing HIPAA Labelling 52

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.

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Drug Pricing Documentation Labelling 105

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.

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Biosimilars Drug Pricing Dosage Documentation 57

Safe Biologics

MAY 10, 2024

From the post: The HHS Budget in Brief document describes the policy objective simply enough: “ Permit Biosimilar Substitution without Prior FDA Determination of Interchangeability” and clarifies that this means “deem all approved biosimilars to be interchangeable with their respective reference products”.

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Biosimilars Drug Pricing Documentation Labelling 130

Pharma in Brief

NOVEMBER 12, 2023

The Board previously indicated that a second phase of consultation in 2024 would focus on the development of new Guidelines. The scoping paper states that the Board intends to finalize new Guidelines in 2024. The Board indicated that a “What We Heard” document will be released in 2024.

Drug Pricing 52

Drug Pricing Documentation 52

Ramblings of a pharmacist

FEBRUARY 16, 2022

It’s a well-thought through survey document, but I still have uncertainties about how to answer some of the questions – a part asks how many prescriptions were filled with brands and how many with generics. It’s an invaluable document, even if it isn’t perfect. How much were they?). 1) Most PBMs (not all!)

Independent Pharmacies 52

Independent Pharmacies Compounding Specialty Pharmacies Prescription Filling 52

Pharma in Brief

JANUARY 10, 2024

We also flag what to watch out for in 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.

Drug Pricing 52

Drug Pricing Documentation Biosimilars Vaccines 52

Pharmaceutical Technology

JANUARY 6, 2023

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. Fighting Entresto generics.

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Documentation Hospitals Dosage Drug Pricing 97