Get Full Government Meeting Transcripts, Videos, & Alerts Forever!
Get email alerts on the Drug Review Methodology topic
No spam. Unsubscribe anytime.
PDAB staff lay out 2026 review method for orphan-designated uses, remove small number of pediatric SKYRIZI claims
Summary
PDAB staff told the board they will use APAC claims plus a commercial data call and drug-specific filters to remove orphan-condition uses from affordability reviews; staff illustrated the approach with SKYRIZI and Keytruda and acknowledged gaps where J-code/procedure data are missing.
Chair Shelley Bailey opened the April 15 meeting of the Oregon Prescription Drug Affordability Board and turned the floor to staff for a program update and a technical briefing on the 2026 review methodology.
Sarah Young, PDAB executive director, summarized recent staff work and the calendar for the 2026 review cycle, including community forums and the carrier data call to collect 2024 claims and plan-design information. Courtney (PDAB staff) and Pei (staff analyst) then walked the board through how the team will use Oregon's APAC (all-payer-all-claims) database as the mandated gross-spend source and the complementary commercial data call to obtain net-price and plan-design details.
Pei described the specific steps staff used to identify and exclude orphan-condition uses for two drugs under methodological review. "SKYRIZI only has 1 orphan designation, which is the treatment of Crohn's disease in pediatric patients," Pei said, and explained that staff removed claims for patients born on or after Jan. 1, 2007 to isolate pediatric orphan uses. That age-based filter removed 21 APAC claims filed for 11 unique patients; staff said 9,111 non-orphan SKYRIZI claims representing 2,595 unique non-orphan patients remain for affordability analysis. For Keytruda, staff said they mapped FDA orphan-condition listings to ICD-10 codes and removed medical claims with those codes, then removed matching pharmacy claims for the same OHA unique-person IDs; that process removed about 1,281 orphan-condition claims (about 202 patients) and left roughly 10,715 non-orphan Keytruda claims for review.
Board members pressed staff on data limitations that could undercount medical administration of drugs. Dr. Dan Hartung and others raised the possibility that some medical claims lack NDCs and instead use procedure or J codes. Courtney acknowledged that APAC does not consistently provide J codes in the extracts staff routinely request and that staff can request that additional layer from APAC but must weigh the additional data volume and the time required to ingest it. John Murray described local pharmacy experience suggesting roughly one-third of electronic claims include ICD-10 codes in his sample; staff agreed to investigate further and report back on J-code availability.
Staff also described the data-pack tabs they will request from carriers: NDC-level pharmacy and medical claims, plan-design fields (formulary status, prior authorization and step-therapy), pricing with price-concession fields, and a new therapeutic-alternatives tab to compare net prices for substitute drugs. Courtney emphasized that APAC provides gross-spend and that carrier responses are the primary mechanism to capture net price concessions.
Why it matters: PDAB said the methodology is designed to protect rare-disease uses while allowing affordability analysis of broader indications, but the accuracy of exclusion filters depends on the presence of diagnostic or procedure codes in the claims. Staff committed to follow up on whether APAC can or will supply J-code data for future analyses.
The board recessed for a short break and later discussed next steps for the 2026 review schedule; staff said the first set of reviews will begin in June, with additional drug reviews and policy conversations across the summer and a final vote window in December.
The board automatically approved the minutes from its March 18 meeting during the opening business.
