October 5, 2009

Submission Policy for P&T Public Hearing:

The Idaho Medicaid Pharmacy and Therapeutics Committee appreciates scientific data provided by pharmaceutical companies and their scientists. Per new public testimony guidelines adopted by Idaho Medicaid in July, scientific data to be presented by pharmaceutical companies or their scientists is limited to new information not already available to P&T Committee members through Provider Synergies, OHSU’s DERP and/or other standard drug information sources. Those wishing to submit scientific data for consideration must review data already available to the Committee.

Material submitted for review needs to be limited to what will be presented. Submissions containing more than this will be returned to submitters. Product monographs and dossiers, P&T Committee briefs, extensive bibliographies, or similar inclusions will cause submissions to be rejected and returned.  

Clinical data needs to be submitted to Provider Synergies or OHSU DERP, depending upon who is providing the P&T review.

July 17, 2009 (updated January 4, 2010)

Background:
The public comment hour of the P&T meeting has historically been an important source of information for the P&T committee members. The value of this time, however, has been impaired by the limitation of time and the number of speakers who desire to give testimony during that time. Speakers often have to be cut off before they have finished giving their information. In addition, speakers often spend time giving data that is already well known to committee members. On at least one occasion, speakers were not allowed to speak because time had run out before their turn came.
Language Changes to the P&T Public Comment Guidelines:

Public comment will be limited to clinical and social comments. Testimony regarding pricing is not permitted.  

Data presented during public testimony fits generally into two categories:

·         Clinical experience, either from provider or Medicaid participant

o   Clinical experience data is available to the committee only through letters received by the committee and/or by the testimony given during the public comment period of the P&T meeting. Providers and participants will not be restricted from giving clinical experience, other than time constraints needed to accommodate speakers during the 60 minute public comment period.  

·         Scientific data provided by pharmaceutical scientists or their representatives

o   Those who wish to present scientific data should review the data already available to committee members. This is publicly available on the P&T website. Persons may present scientific data not already available to committee members. This information is most useful if reviewed in conjunction with drug class reviews committee members are already studying. Persons presenting scientific data, therefore, will be required to present their data to the Idaho Medicaid Pharmacy Unit in writing at least 30 days* prior to the meeting so it can be carefully considered by committee members prior to the meeting.

§  (*This submission period will be 15 days for the February 19, 2010 and August 20, 2010 meetings only)

o   There may be times when scientific data may become available less than one month prior to the meeting. In such cases, special requests may be made to make oral presentations at the P&T meeting.  

o   Oral presentation will be restricted to new information only. New information is considered to be: (1) new product in the drug class, (2) new indication since the last review, or (3) new studies released since the last review, excluding placebo studies only.

o   The P&T Committee chairman or his designee will review information to see if it meets the new information guidelines noted above. The Department will then advise potential speakers if they will be able to present at least 5 days prior to the meeting.

All presenters are required to disclose who they represent, including any financial relationships and conflict of interest. This is to be done on the Public Comment Sign-in Sheet as well as when addressing the P&T Committee.