Frequently Asked Questions

What is Trikafta?

Elexacaftor/tezacaftor/ivacaftor, sold under the brand names Trikafta and Kaftrio, is a fixed-dose combination medication used to treat cystic fibrosis. Elexacaftor/tezacaftor/ivacaftor is composed of a combination of ivacaftor, a chloride channel opener, and elexacaftor and tezacaftor, CFTR modulators. TRIKAFTA is approved for people with CF who have at least one F508del mutation in the CFTR gene. In clinical trials, TRIKAFTA showed dramatic improvements in key measures of the disease, such as lung function, sweat chloride, and quality of life-results that have had a transformative effect on people’s day to day lives. It is not a cure, but has been called a “miracle drug” by many patients. It’s the first of its kind, and many patients who are eligible to take Trikafta have avoided transplants and the progression of CF which leads to death.

What is Colorado’s PDAB?

PDAB stands for Prescription Drug Affordability Board. PDAB was initially established under SB21-175 and updated under HB23-1225. The Colorado board’s purpose is to review prescription drug costs for affordability. Each year, PDAB may select up to eighteen prescription drugs to review. The first drug that was reviewed was Trikafta. There were four other drugs reviewed within that first year: Genvoya, Enbrel, Stelara, and Cosentyx.

Trikafta and Genvoya were the only two drugs who will not have a UPL placed on them, as they were voted as “not un-affordable” by the PDAB. Enbrel, Stelara, and Cosentyx were deemed “unaffordable” and will have UPLs placed on them at a later date. The board is still determining what those UPLs will be.

What is PDAAC?

The Prescription Drug Affordability Advisory Council or PDAAC is to provide stakeholder input on prescription drug affordability. All PDAAC members meet statutory requirements for composition, geographic representation, and subject matter expertise. 

To the extent possible, the Board appointed members who have experience serving underserved communities and who reflect the state’s diversity in terms of race, immigration status, income, disability, age, gender identity, and geography.

Who is on the Colorado PDAB?

The Governor has appointed the following members to the PDAB: 

  • Sami Diab, MD of Greenwood Village, Colorado
  • Amarylis “Amy” Gutierrez, PharmD of Aurora, Colorado
  • Catherine Harshbarger of Holyoke, Colorado
  • Gail Mizner, MD, FACP, AAHIVS of Snowmass Village, Colorado and to serve as Board Chair
  • James Justin VandenBerg, PharmD, BCPS of Denver, Colorado

Who is on the Colorado PDAAC?

Council Members: 

  • Kim Bimestefer Executive Director of HCPF
  • Gail DeVore representing health care consumers
  • Sarita Parikh representing health care consumers
  • Edward A. Dauer, LL.B., M.P.H. representing statewide health care advocacy organizations
  • Kimberley Jackson, DO representing consumers with chronic diseases and PDAAC Chair 
  • Maria Fenwick representing a labor union
  • Nathan Wilkes representing employers
  • Chad Friday representing carriers
  • Marc Reece representing pharmacy benefit managers
  • Thomas Tobin, MD, MBA representing health care professionals with prescribing authority
  • R. Brett McQueen, PhD representing an organization that researches prescription drugs
  • Katelin Lucariello MPH representing manufacturers of brand name drugs
  • Neal Miller representing manufacturers of generic drugs
  • Andrew Gonzales, PharmD representing pharmacists
  • Leah Lindahl representing wholesalers

What is a UPL?

UPL stands for Upper Payment Limit which acts as a cap on what the insurance companies pay for Trikafta. The other way to look at this is the most a manufacturer can charge for a specific medication. Some people also refer to UPLs as price caps.

Sources:

The CF Foundation

Colorado PDAB