Friday, December 13, 2019

Very Brief Blog: Myriad Gets ADLT Approval for MYCHOICE / $4040 Price

CMS updated its ADLT list on December 11, adding the Myriad MYCHOICE test.   Code and descriptor are pending, but the initial PAMA price (which is the initial list price) will be $4040.

See the updated CMS ADLT info PDF here.   For more on where to find this stuff at CMS, here.

click to enlarge
The chart shows that 2 of 7 ADLT tests belong to Myriad.  Its melanoma test is an ADLT because it's a sole source LDT that is a MAAA that is covered by CMS.  The MYCHOICE test is an FDA-approved sole source test, the other class of test that qualifies for MAAA coverage. 

Myriad MYCHOICE is on the January/February AMA CPT PLA code agenda (here).

FDA.  The FDA home page for MYCHOICE (PMA P190014) is here.  The 45-page PLA review by FDA is here

Trade Press.  Genomeweb covered the FDA approval back in October, here.   Some open-access press on MYCHOICE from October is here:  
     According to Myriad, myChoice CDx is the first and only tumor test designed to determine homologous recombination deficiency status by detecting BRCA1 and BRCA2 (sequencing and large rearrangement) variants with comprehensive assessment of genomic instability using three biomarkers: loss of heterozygosity, telomeric allelic imbalance and large-scale state transitions.
     “Today’s approval marks a historic milestone for the myChoice CDx test after more than 10 years of development and demonstrates Myriad’s commitment to pioneering science and collaboration with pharmaceutical partners in order to accelerate precision therapies for people with cancer,” Myriad CSO Jerry Lanchbury, Ph.D., said in a statement.
Enhanced Pricing.  The regular off-the-rack price for BRCA 1,2 sequencing and Dup Del analysis at CMS is around $1700 for CY2020 (AMA CPT code 81162).   ADLT law provides list pricing (following by annual mark-to-market repricing) for FDA cleared or approved sole-source lab tests, so MYCHOICE as an ADLT is priced independently of legacy pricing for BRCA CPT codes.

An article by NEJM editor Longo discusses genomics and ovarian cancer discusses MYCHOICE, December 2019, here.

Coding.  ADLT codes require a product-specific code, typically either an AMA PLA code (which end in U) or a special CMS HCPCS code (which will begin with U).   With an October 23 approval, Myriad likely would have missed the October 10 PLA deadline earlier this fall.  (We know from the October/November AMA public PLA agendas that MYCHOICE wasn't in the cycle).   We don't know if they are applying for a January cycle PLA code from AMA or a CMS U-Code for 1Q2020.