Policies & Legislation
CMS proposes allowing Part D plans to switch biologicals to non-interchangeable biosimilars
On 6 November 2023, the U.S. Centers for Medicare & Medicaid Services (CMS) proposed a new rule to give Medicare Part D plans more flexibility. It has been proposed that biosimilars can now be substituted for the reference biologicals, even if these have not been deemed interchangeable by the US Food and Drug Administration (FDA).
ANVISA's decision on 'Skinny labels' for generics pending
The Brazilian health regulatory agency, ANVISA (Agência Nacional de Vigilância Sanitária), is still considering whether to allow generic drug labelling to omit indications of the originator product that are still under patent.
More drugmakers sue over IRA yet one withdraws
In the United States, Boehringer and Novartis join other drugmakers [1] in suing the US government over drug price negotiations in the Inflation Reduction Act (IRA). However, Japan-based Astellas Pharma withdrew its lawsuit filed against the US government in early September 2023.
First drugs for Medicare price negotiation selected
The US Department for Health and Human Security (HSS) has selected the first drugs for Medicare price negotiation.
Updated Biosimilar Red Tape Elimination Act introduced by Senator Lee
US Republican Senator for Utah, Mike Lee, has introduced an updated ‘Biosimilar Red Tape Elimination Act.’
Inflation Reduction Act explained
The US Assistant Secretary for Planning and Evaluation’s (ASPE) ‘Medicare Part B drugs: trends in spending and utilization 2008-2021’ was published in June 2023 [1]. This outlines aspects of the Inflation Reduction Act (IRA) which is designed to address the rapid rate of increase in Part B drug spending and lower costs for Medicare enrollees.
AMLAC: regulatory agency for medicines in Latin America and the Caribbean established
AMLAC, a regional body for Latin America and the Caribbean, is being set-up to promote greater access to safe, effective medical equipment and medicines through a combination of regional regulations.
Pros and cons of tenders for generics and biosimilars
An editorial entitled ‘Tenders for Generics and Biosimilars: A Challenging Purchasing Policy’ has been published in the European Journal of Health Economics [1]. It is authored by Fernando Antoñanzas, Carmelo Juárez-Castelló, and Roberto Rodríguez-Ibeas from the University of Rioja in Spain and discusses the challenges associated with the implementation of tendering processes for generics and biosimilars in healthcare purchasing policies.
Medicare drug price negotiation: what next?
A commentary published in Value in Health by Dr Sean D Sullivan of the University of Washington School of Pharmacy offers insights into Medicare drug price negotiation [1]. The commentary discusses the implications of negotiation [2] and asks the question, ‘what next?’
Medicare drug price negotiation: implications
In 2022, The Inflation Reduction Act (IRA) was signed into law in the US. This sets out to empower the US Secretary of Health and Human Services (HHS) to develop and implement methods and a process to negotiate a limited number of prescription drug prices in the Medicare programme directly with manufacturers [1]. A commentary by Dr Sean D Sullivan of the University of Washington School of Pharmacy, published in Value in Health, offers insights into the implications of Medicare drug price negotiation [2].
