Bill introduced in US to cut insulin prices

Home/Policies & Legislation | Posted 09/08/2019 post-comment0 Post your comment

Co-Chair of the Senate Diabetes Caucus, Senator Jeanne Shaheen, announced on 22 July 2019 the introduction of new legislation to combat rising insulin prices.

113 MD002138

The bipartisan bill, the Insulin Price Reduction Act, would hold pharmacy benefit managers (PBMs), big pharmaceutical companies and insurers accountable for the increasing prices by incentivizing reductions in list prices. The legislation was introduced in collaboration with Senators Collins, Carper and Cramer.

Each year, insulin and other drug manufacturers establish list prices for their products. In order to get their insulin covered by insurance, manufacturers then negotiate financial rebates to pay PBMs and insurers. The American Diabetes Association has found that as PBMs have increased rebates as a percentage of the list price, the heightened rebates have helped drive increases in list prices for insulin and resulting in higher out-of-pocket costs for patients using insulin. In Medicare alone, out-of-pocket costs for insulin have more than quadrupled since 2007. Researchers also estimate that the price of a 40-day supply of insulin rose from US$344 in 2012 to US$666 by 2016.

This bill aims to reduce the influence of middlemen, including PBMs, in causing price increases by creating a new insulin pricing model restricting the use of rebates for any insulin product that the manufacturer reduces the price to a level no higher than that in 2006. This, according to Senator Shaheen, could result in more than a 75% decrease in prices (based on estimated 2020 prices).

The rebate restrictions would apply in Medicare# Part D* and private insurance. Private insurance plans would also be required to waive the deductible for insulin products that meet the list price reduction criteria. Future price increases would be limited to no more than medical inflation.

This is not the only initiative in the US aimed at reducing the price of insulin in the country. The US Food and Drug Administration (FDA) held a public meeting on 13 May 2019 to discuss increasing access and facilitating the efficient development of biosimilar and interchangeable insulin products [1]. Part of these plans for increase access to more affordable insulin products include plans for the transition of biologicals, including insulin products, currently approved under the Food, Drug, and Cosmetic Act (FD&C Act) of the Public Health Service Act. This, according to the agency, ‘will open the pathway to market new products that are biosimilar to, or interchangeable with, these transitioned products’ [2].

#Medicare is a national social insurance program, administered by the US federal government since 1966. It provides health insurance for Americans aged 65 and older who have worked and paid into the system. It also provides health insurance to younger people with disabilities.

*Medicare Part D, also called the Medicare prescription drug benefit, is an optional US federal-government program to help Medicare beneficiaries pay for self-administered prescription drugs through prescription drug insurance premiums.

Related articles
Spotlight on the role of pharmacy benefit managers in the fight against rising drug prices

Hatch aims to promote biosimilars and generics and restrict litigation

References
1. GaBI Online - Generics and Biosimilars Initiative. FDA to hold public meeting on access to affordable insulin [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Aug 9]. Available from: www.gabionline.net/Biosimilars/General/FDA-to-hold-public-meeting-on-access-to-affordable-insulin 
2. GaBI Online - Generics and Biosimilars Initiative. Comments on FDA’s plans to transition insulin products [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Aug 9]. Available from: www.gabionline.net/Guidelines/Comments-on-FDA-s-plans-to-transition-insulin-products 

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 © 2019 Pro Pharma Communications International. All Rights Reserved.

Source: Senator Shaheen

comment icon Comments (0)
Post your comment
Related content
FDA publishes final Q&A on biosimilar development and the BPCI Act
Question-Fimea-V15E29
Home/Policies & Legislation Posted 15/10/2021
FDA voices concerns around drug patents and competition
Patent 1 V13E17
Home/Policies & Legislation Posted 08/10/2021
USA BIOSIM Act introduction
02 AA010638
Home/Policies & Legislation Posted 17/09/2021
Most viewed articles
About GaBI
Home/About GaBI Posted 05/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010