Biosimilar Readiness Checklist
Longitudinal
q 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
q 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
q Meet and educate administration on importance of biosimilars adoption
· Discuss patent cliff and growth of biosimilars/competitive biologics market
· Discuss potential cost savings opportunities
· Cover biosimilars clinical trial requirements for safety/efficacy
· Engage support and input from administration in electing a physician champion
· Resources on Web page: Factsheet, FAQ, Webinars
q Month Two
q Elect a physician champion to drive biosimilars implementation
· Hematologist or Oncologist (preferred)
q Month Three
q Present biosimilars/competitive biologics to different medical groups in 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
q Month Four
q 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
q Month Five
q Discuss the current and future landscape of biosimilars/competitive biologics at 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
q 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
q 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
Inform wholesaler of intent to move volume to biosimilar NDC