New Medication/Therapy Request for Consideration

Requests submitted for consideration are thoroughly vetted to include a comprehensive review of the literature for efficacy as well as a review of safety, site of care considerations, drug purchasing cost, payer coverage and clinical service considerations. 

Requirements 

In order for the Committee to review your request, the following are required:

  • Approval by the Food and Drug Administration (FDA)
  • A description of the current treatment approach including the medications and other treatments used before the current therapy came to market
  • An estimate of the number of patients who would be candidates for the new therapy (either monthly or yearly)
  • Site of care - the inpatient use of medications is not directly reimbursed (capitated system)
  • Site of care - the inpatient use of medications is not directly reimbursed (capitated system). When clinically appropriate, the outpatient infusion setting, patient self-administration or home care administration should be considered. 
Please note: Medications with Emergency Use Authorization are exempt from formulary review and may be used with careful consideration and within the EUA criteria to ensure safe use. Additionally, if off-label use of a medication is requested, please provide documentation of need and published evidence to support the off-label use.

Review & request process 

In order to keep a formulary current, the P&T Committee meets regularly to review newly released drugs and/or classes of drugs. However, given the volume and complexity of medications on the market, the review process may frequently take longer than estimated. 

Once submitted, each request will be considered in the order received (exceptions apply). A thorough evidence-based review will be initiated, the FDA-approved indication, as well as safety, effectiveness, cost, and utilization analysis. You will be contacted once the background review is complete and will be notified when the medication will be placed on the Pharmacy & Therapeutics Committee agenda for decision.  

As the requester, you will serve as the champion for the formulary addition request and will be asked to review the evidence-based review materials in advance of the P&T Committee meeting.  

You will also be expected to attend the P&T Committee meeting at UCSF where the merits of the drug will be discussed. The P&T Committee meets once monthly.