Monday, August 26, 2019

The Bonanza of BRCA Policy Documents: USPSTF, OP ED Collateral, and More

Update: On September 3, 2019, JAMA and USPSTF issued updated recommendations on use of medications to reduce risk of breast cancer in women with elevated risk.  For this related, but separate, topic, see an additional set of links at BOTTOM.


On Tuesday, August 20, 2019, the regular weekly edition of JAMA brought the new USPSTF positioning on BRCA testing. 

While the changes from the last USPSTF position are not large (and there were relatively few changes from a USPSTF BRCA proposal), the changes are worth noting and the penumbra of policy documents and op eds was pretty large.  I've collated the links in this blog.

Primary Documents

2019 Final USPSTF Position
  JAMA 322:625-665.  Here.

2019 Final USPSTF Evidence Report
  JAMA 322:666-685.  Here.

Prior:  2014 USPSTF Position here.
Prior:  March 2019 USPSTF BRCA Proposal here.

Associated JAMA Documents - Same Week

Patient One-Pager.  "Should I Be Tested for BRCA Mutations?"
  JAMA 322:702.  Here.

JAMA Editorial.
  "Broadening Criteria for BRCA 1/2 Evaluation: Placing the USPSTF Recommendation in Context."
   JAMA 322:619-621.  Domchek S & Robson M.  Here.

JAMA Surgery Editorial
  Editorial on USPSTF Recommendation.
  JAMA Surg (Epub).  L Newman.  Here.

JAMA Oncology Editorial
  "Hereditary Cancer Evaluation in 2019:  A Rapidly Evolving Landscape."
  JAMA Oncol (Epub).  Yung RL & Korde Larissa.  Here.

JAMA Network Open Editorial
  "USPSTF Recommendations for BRCA1 and BRCA2 Testing in the Context of a Transformative National Cnacer Control Plan."
  JAMA Open Netw (Epub).  Rajagopal PS, Nielsen S, Olopade OI.  Here.

A Selection of Other Recent Documents

The BRCA literature is massive but here are a few articles highlighted by JAMA alongside the new USPSTF documents.

"Risk-reducing mastectomy in BRCA1 and BRCA2 Mutation Carriers: A Complex Discussion."
   JAMA 321:27. (2019).  Domchek SM.  Here.

"Evaluation of Cancer-based Criteria for Use in Mainstream BRCA1 and BRCA2 Testing in Patients with Breast Cancer."
   JAMA Netw Open 2:e194428.  (2019) Kemp Z, Turnbull A, Yost, PhD, et al. Here.

"Exome Sequencing Based Screening for BRCA 1/2 Expected Pathogenic Variants Among Adult Biobank Participants."
   JAMA Netw Open 1:182140 (2018)  Manickam K et al.  Here.

Two Other Important Policy Papers: ASBS & NAS

Earlier in 2019, the American Society of Breast Surgeons recommended that all women with breast cancer should qualify for BRCA testing.   Here.

Cited by Yung and Lorissa, above, in late June 2019, National Academy of Sciences put out a 175-page eBook policy position on national cancer control priorities.   For the eBook, Guiding Cancer Control: Path to Transformation, see press release here, book here.

Trade Journals

Genomeweb here.  Myriad supports, here.  Medscape here.  MedPage here (with CME), American Academy of Family Practice here.  Backstory from May 2019, Genomeweb subscription, "USPSTF Too Reliant on Family History," here

Guardrail Around USPSTF

The USPSTF policy doesn't cover women WITH cancer, because USPSTF policies by definition are "prevention policies" either in normal people or people with a general risk factor (like obesity for diabetes prevention benefits.)    Therefore, USPSTF will not issue a guideline for people WITH cancer, any more than it would recommend dialysis to prevent death in kidney failure patients.

USPSTF does cover the issue of breast cancer patients now "free of cancer."  They are in the domain of the USPSTF guideline, whereas breast cancer patients "with cancer" would not be.

USPTF and Copay-Free Testing

Affordable Care Act generally requires payers to cover USPSTF preventive benefits one year after the release or update or new guidelines.  Several years ago, a Health & Human Services document defining nuances of these benefits, ruled that USPSTF benefit includes both screening for BRCA risk, genetic counseling, AND the genetic testing itself.  See CMS CCIIO Fact Sheet #12 here.  My web archive here.

Medicare and NCCN vs USPSTF

Medicare LCDs in every jurisdiction cover BRCA testing in women with a personal history of breast cancer AND other qualifying factors like family cancer history.   Generally, these LCDs are just about a cut-and-paste of current NCCN guidelines for BRCA testing.   NCCN provides its guidance in two columns - the left column for patients WITH cancer (e.g. a woman with breast cancer and with two sisters with breast cancer; LCDs use the LEFT column) and a right column for patients WITHOUT cancer (the patients generally covered by USPSTF guidelines.) 

LCDs follow LEFT column (w cancer), USPSTF closer to RIGHT column (no cancer)

No Laboratory Based Nuance

The USPSTF guideline doesn't cover broader ("HBOC") gene panel testing and doesn't discuss criteria for testing, bioinformatis, etc.   It simply takes a more distant view and assumes BRCA testing is a known clinical service, like mammography or PAP smears, although the reality for molecular testing is a lot more complex.   But this occurs in other ways - for example, they simply don't define "Ashkenazi" (three grandparents?  one grandparent? etc).


September 3, 2019 Update

JAMA and USPSTF released a set of documents related to medication for reducing risk of breast cancer.    The recommendations are "preventive" e.g. primary prevention, in women who do not personally HAVE breast cancer.  While the same meds can be used to reduce breast cancer recurrence after a lumpectomy, that is a medical (not preventive) use that is outside scope of USPSTF.

USPSTF Statement
JAMA 2019 322:857-67, here.

The USPSTF recommends that clinicians offer to prescribe risk-reducing medications, such as tamoxifen, raloxifene, or aromatase inhibitors, to women who are at increased risk for breast cancer and at low risk for adverse medication effects. (B recommendation) 

USPSTF Evidence Review
JAMA 2019 322:868-886, here.

Op Ed, Pace & Keating.
JAMA 2019 322:821-3, here.

JAMA Oncol Op Ed, Daley & Ross
JAMA Oncol epub, here.

Patient Page.
JAMA 2019 322:900, here.


Not related to BRCA, but MedPage also highlighted a new 8/2019 article on uses of genomic testing in breast cancer with positive nodes (Gnanajothy, here, Macias here.)