Biosimilar Readiness Checklist

Biosimilar Readiness Checklist

Longitudinal

Monitor HealthTrust communications (Rx Response, webinars, Member Portal) for updates on biosimilars education, approvals and contracting.

HealthTrust will:

Develop toolkits and other support documents for members to enhance approval and uptake of biosimilars
Maintain active site on the Member Portal related to the current status of biosimilars
Communicate opportunities in biosimilars market when approved and contracted

Use HealthTrust resources for education

Educate pharmacy, physicians, nursing, case managers, administration
Toolkits, webinars, print and present, FAQ documents, helpful links (i.e. ASHP, EMA, FDA)

Month One

Meet and educate administration on importance of biosimilars adoption

Month Two

Elect a physician champion to drive biosimilars implementation

Month Three

Present biosimilars/competitive biologics to different medical groupsin their scheduled meetings

Heme/Onc/BMT, GI, Rheumatologists, Hospitalists, and Intensivists should be initial targeted meetings
Introduce groups to the biosimilar/competitive biologics market
Share important slides/concepts regarding science and the manufacturing process of biologics
Understand data and evidence needed by physician groups
Answer any questions or concerns committee has regarding biosimilars/competitive biologics
Build support for biosimilar adoption in the facility with the backing of the elected physician champion
Resources on webpage: Factsheet, , FAQ, Webinars, White Papers

Month Four

Present biosimilars/competitive biologics to Pharmacy Committees, Nursing Committees and other clinical committees

Implications to practice, equivalence studies, and need for equal support systems (education, injection devices, etc.)
Resources on webpage: Factsheet, FAQ, Webinars

Month Five

Discuss the current and future landscape of biosimilars/competitive biologicsat the Pharmacy and Therapeutics Committee

Discuss what biosimilars/competitive biologics are and the science behind them, as well as financial drivers to the patent cliff and future growth of biologics and impact on hospital budget
Discuss need to develop a plan for review and approval of biosimilars upon introduction into the market
Work with the committee to determine how a formulary request will be managed by the committee and what documentation (clinical trials, etc) will be necessary for P&T approval
Develop approval requirements and pathway/policy for use of biosimilars/competitive biologics with the P&T Committee
Develop Therapeutic Interchange strategy with P&T Committee to automatically substitute branded biologic with biosimilar/competitive biologic, and necessary data to approve such a switch
Answer any questions or concerns the committee has regarding biosimilar products
Tbo-filgrastim therapeutic interchange approval
Resources on webpage: Factsheet, FAQ, P&T Print and Present, Tool kit, Webinars

Longitudinal

Meet with medical staff groups and Administration for follow-up after P&T Committee decision

Utilize HealthTrust resources and webinars to provide support documents to committee
Update groups on status of biosimilars in the USA
Inform of P&T requirements for biosimilar formulary approval
Introduce necessary requirements for additional Therapeutic Interchange status approvals
Answer any questions and concerns regarding biosimilars with committees and administration

Publish P&T Actions

Use P&T intranet site and/or newsletter to continually update staff on biosimilar approval and therapeutic interchange guidelines
Educate pharmacy, physicians, nursing, and case managers of implementation of therapeutic interchange program and date of implementation

Let Pharmacy Buyer know to adjust purchase patterns to biosimilar product