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

  • 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 Webpage: Factsheet, FAQ, Webinars

Month Two

Elect a physician champion to drive biosimilars implementation

  • Hematologist or Oncologist (preferred)

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

  • Inform wholesaler of intent to move volume to biosimilar NDC