CMS proposes allowing Part D plans to switch biologicals to non-interchangeable biosimilars

Home/Policies & Legislation | Posted 21/11/2023 post-comment0 Post your comment

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).

Switching V19A17

At present, reference products can only be substituted at the pharmacy level with interchangeable biosimilars [1]. Current CMS guidance requires Part D plans to obtain physician-led approval prior to substituting a reference biological product with a non-interchangeable biosimilar.  This is deemed an important step in fostering confidence in substitution with biosimilars.

The new plan was outlined in the contract year 2025 Medicare Advantage and Part D policies proposed by CMS on 6 November 2023. This states that the change would apply to all plan enrollees, not only those who begin the therapy after the effective date of the change (as is the case at present). This change will facilitate fast access to cheaper medication options for all enrollees. 

The CMS proposal would permit the Part D plans to treat formulary substitutions of non-interchangeable biosimilars as ‘maintenance changes’ that do not require prior Medicare approval.

US hospital group Premier’s senior vice president of government affairs, Soumi Saha said, 'It has been known for years that biosimilars can improve patient access to medications while saving the US healthcare system billions of dollars, yet anticompetitive practices by vertically integrated payers have put their own profits ahead of lowering drug costs for patients by favouring the reference biologic[al]and lucrative rebates’.

However, Alliance for Safe Biologic Medicines’ Executive Director, Mr Michael Reilly, who served as Associate Deputy Secretary of Health and Services during the development and implementation of the Part D prescription drug benefit, highlighted, 'Substitution of biosimilars by someone other than the prescribing physician is a controversial practice banned in many countries, including nearly all of Western Europe. It is also opposed by the majority of physicians, in the US and worldwide'.

Furthermore, he added, 'Nothing has changed regarding non-interchangeable biosimilars since last year’s CMS Rule. Non-interchangeable [biosimilars] still haven’t met the FDA data requirements for interchangeability and still shouldn’t be substituted by a third party without physician approval. This ill-considered move stands in stark contrast to the opinions of the medical community, the wishes of patients, a decade of substitution policymaking across 50 states, the substitution policies of most advanced nations, and CMS’ own assurances'.

Comments are due on the CMS proposed rule by 5 January 2024.

Related articles
Biosimilars: US prescriber’s attitudes and perceptions revealed

FDA releases new information on interchangeable biologicals

45 US states have passed biosimilar substitution laws

LATIN AMERICAN FORUM
The new section of the ‘Latin American Forum’ on GaBI has been launched. The objective of this new section is to provide you with all the latest news and updates on developments of generic and biosimilar medicines in Latin America in Spanish.

View the latest headline article: Alianza entre Abbott y mAbxience para los biosimilares en los mercados emergentes

Browse the news in the Latin American Forum!

Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative.

FORO LATINOAMERICANO
Se ha lanzado la nueva sección del ‘Foro Latinoamericano’ sobre GaBI. El objetivo de esta nueva sección es brindarle las últimas noticias y actualizaciones sobre desarrollos de medicamentos genéricos y biosimilares en América Latina en español.

Ver el último artículo de cabecera: Alianza entre Abbott y mAbxience para los biosimilares en los mercados emergentes

!Explore las noticias en el Foro Latinoamericano!

Regístrese para recibir el boletín informativo GaBI Foro Latinoamericano. Informe a colegas y amigos sobre esta nueva iniciativa. 

 

Reference
1. GaBI Online - Generics and Biosimilars Initiative. FDA issues draft guidance on biosimilars and interchangeable biosimilars labelling [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Nov 21]. Available from: www.gabionline.net/guidelines/fda-issues-draft-guidance-on-biosimilars-and-interchangeable-biosimilars-labelling

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2023 Pro Pharma Communications International. All Rights Reserved.

comment icon Comments (0)
Post your comment
Related content
COFEPRIS promotes regulatory cooperation in the Americas
Latin America 1638px
Home/Policies & Legislation Posted 12/12/2023
ANVISA's decision on 'Skinny labels' for generics pending
Labelling V14I26
Home/Policies & Legislation Posted 14/11/2023
Advances in the availability of innovative medicines in Mexico
23 AA011020
Home/Policies & Legislation Posted 31/10/2023
More drugmakers sue over IRA yet one withdraws
Law V13C29
Home/Policies & Legislation Posted 10/10/2023
Most viewed articles
About GaBI
Home/About GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010