PDL Guidelines 07 2014

North Carolina Medicaid and Health Choice Preferred Drug List Review Panel Guidelines and Procedures

I. Policy

The Secretary of the North Carolina Department of Health and Human Services (DHHS) established a Preferred Drug List (PDL) Review Panel to review the Medicaid and Health Choice PDL recommendations of the DHHS, the Division of Medical Assistance (DMA) and the Physicians Advisory Group (PAG) Pharmacy and Therapeutics (P&T) Committee.

II. Membership

The Review Panel shall consist of the Director of Pharmacy for the Division of Medical Assistance and the following individuals appointed by the Secretary:

  1. A representative from the Physicians Advisory Group Pharmacy & Therapeutics Committee
  2. A representative from the Old North State Medical Society
  3. A representative from the North Carolina Association of Pharmacists
  4. A representative from Community Care of North Carolina
  5. A representative from the North Carolina Psychiatric Association
  6. A representative from the North Carolina Pediatric Society
  7. A representative from the North Carolina Academy of Family Physicians
  8. A representative from the North Carolina Chapter of the American College of Physicians
  9. A representative from a research-based pharmaceutical company
  10. A representative from hospital-based pharmacy

The Director of Pharmacy for the Division of Medical Assistance shall serve as chairperson of the Review Panel. Individuals appointed to the Review Panel, except for the Division’s Director of Pharmacy, shall serve a two-year term.

III. Guidelines

  1. The activities of the PDL Review Panel will include the following:
    • Conduct an open meeting to review the recommended policies and procedures related to the Medicaid PDL.
    • Review written public comments received during the public comment period.
    • Provide opportunity for public comment during the meeting.
    • Submit policy recommendations about the proposed Medicaid PDL policy and/or procedures to DHHS.
  2. The presence of 50 percent or more of the panel members will be considered a quorum.
  3. Minutes from each Panel Review meeting will be posted for public view on the DMA website at http://www.ncdhhs.gov/dma/pharmacy/pdl.htm within 30 days of the date of the meeting at which the minutes are approved.
  4. Agendas and drug classes to be reviewed will be posted on the DMA website at http://www.ncdhhs.gov/dma/pharmacy/pdl.htm at least 10 days prior to the meetings.

IV. Public Comments Received During Meetings

  1. Time will be provided during each meeting for speakers to present comments related to the drug classes being reviewed. Public comments received from pharmaceutical representatives shall be limited to new (within the past six months) information and shall be limited to comments on the superiority of their product when compared to the recommended preferred products along with supporting evidence. Consideration will be given to the time constraints of the meeting in order to complete drug class reviews according to the agenda.
  2. Speakers are required to register in order to provide comments during the meetings.
  3. Speaker registration will be available on the DMA website until one business day prior to the meeting.
  4. Speakers should be prepared to give the following information about themselves at the beginning of their public comments:
    • Name of presenter;
    • Company/organization affiliation;
    • State if the speaker is being compensated in any way for speaking on behalf of the drug, including if the speaker receives compensation as a consultant, a member of that pharmaceutical company’s speaker’s bureau, or participates in other educational speaking assignments, or receives other funding directly or indirectly through his/her clinic from the pharmaceutical company.

V. Preferred Drug List

  1. Drug classes in which all drugs are preferred status on the proposed PDL will not be reviewed during the panel meetings.
  2. Only drug classes with proposed changes will be reviewed by the PDL Panel.
  3. The PDL shall be reviewed once a year.
  4. New-to-market drugs will be designated as non-preferred until reviewed by the P&T committee and PDL Review Panel unless there are significant financial implications to the State. The PDL will be updated with new-to-market drugs on a quarterly basis.
  5. DHHS and DMA may change the status of a drug on the PDL if there are urgent patient safety concerns, medication access issues or significant financial implications. Changes to drug status for financial reasons will be reviewed by the P&T committee for clinical appropriateness prior to the change in status. The PDL Panel will be notified by email at the time of the change and also at the next scheduled public meeting.
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