Whether or not the US Food and Drug Administration (FDA) permits automatic substitution of biosimilars, healthcare systems can still consider using formularies as a way to increase the use of more affordable biosimilars [1].
The formulary tool of therapeutic interchange can be used to exchange therapeutic alternatives according to approved written guidelines or protocols within a formulary system.
Therapeutic interchange programmes are already in place for a variety of biologicals. For example, in the case of erythropoiesis-stimulating agents (ESAs), automatic interchange programmes exist that convert orders for multiple ESA products to orders for a single ESA. This simplifies the formulary and consolidates the market share of one product in order to improve contracting and lower overall costs. Similar systems are also in place for human insulin and intravenous immune globulin.
Criteria that should be considered when setting up a therapeutic interchange programme include:
- Including products considered therapeutically equivalent in terms of safety and efficacy
- Potential savings to be made
- Developing a clear process for interchange
- Prescribers having sufficient knowledge and understanding of the products
- The ability to ‘opt out’ under certain circumstances
- The ability to assess the outcomes of therapy with the different products
In order to assure the appropriate use of biosimilars formulary management the following factors should also be considered:
- Data on efficacy and safety
- Indications
- Potential for immunogenicity
- Appropriate naming and labelling
- Pharmacovigilance plan
- The need for physician and patient education
Payers will undoubtedly provide significant incentives to use biosimilars in order to reduce costs. These may include significant co-payment or co-insurance premiums for use of an originator product when a biosimilar is available. Pharmacists will therefore need to be aware of both FDA and state laws when determining whether substitution is possible.
Conflict of interest
The authors of the research paper [1] declared that there were no conflicts of interest.
Editor’s comment
If you are interested in contributing a research paper inGaBI Journal, please send us your submission here.
If you would like to receive a PDF copy* of the Lucio article [1], please send us an email.
*For profit organizations subjected to a fee
Related articles
US state legislation on biosimilars substitution
Efficacy, extrapolation and interchangeability of biosimilars
Biosimilar substitution in the EU
Reference
1. Lucio SD, Stevenson JG, Hoffman JM. Biosimilars: implications for health-system pharmacists. Am J Health Syst Pharm. 2013;70(22):2004-17.
Source: www.gabionline.net
