Pharmacy Benefit Management, Version 2.0 PTFD 10 - Timely Consideration of New Molecular Entities


The Basics

This standard requires the P&T committee to adopt and follow a policy and procedure requiring that it consider new molecular entities for inclusion in the formulary.  The policy and procedure should include a specific timeframe after the drug's release into the market that it will take up the possibility of including it.

In addition, the P&Ps must address the use of and access to drug products before formulary review.  

Management Tips

This is another standard explicitly mentioning policies and procedures, not just compliant performance.  Be sure that the time frame you set is reasonable.  URAC suggests three to five months after the drug hits the market.  because URAC is measuring the time from introduction into the market to the time of committee consideration, it is probably a best practice to include in the discussion in the committee the date of introduction of a truck to the market.

URAC Accreditation Tips

One element of the standard is weighted 2, while the element addressing pre-review use of drugs is mandatory.

The documentation required for the desktop review phase is simply the applicable policy and procedure.

The on-site reviewer will specifically asked to be shown portions of the committee minutes in which new drugs were considered.  He/she is also likely to include this in the interview of the P&T committee member.  it therefore would be a good idea to refresh the committee member's memory as to the most recent time a new drug was considered.