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What are the types of genetic testing?
Direct-to-consumer genetic testing (DTC-GT)
Provider-mediated genetic testing (PM-GT)
Engages a healthcare professional (HCP) in a non-traditional role, i.e., HCP involvement might be limited to placing the test order or approving the order with minimal interaction/discussion with the consumer
Clinic-based genetic testing
Ordered, interpreted, and disclosed by an HCP through a traditional healthcare professional-patient relationship
Describe the types of genetic testing in terms of description, who orders it, and results?
Direct to consumer genetic testing → HCP not involved → consumer orders test → reported directly to consumer
Provider mediated genetic testing → consumer initiated with HCP involved → consumer or HCP orders test → reported directly to consumer with optional access to HCP
Clinic based genetic testing → facilitated by HCP → HCP orders test → results facilitated by HCP
In Direct to consumer testing, where are results sent to?
Sent to the consumers directly without clinician’s guidance
What are concerns in DTC Pgx testing?
Concerns of test validity and quality, misinterpretation of results, and the potential for inappropriate medical decisions
In 2013 FDA issued a warning to 23 and me to cease genetic tests for concerns about what? What happened in 2018?
2013 FDA issued a warning letter to 23andMe, Inc., to cease marketing of genetic tests for concerns about disease susceptibility testing, pharmacogenomic testing and the potential for consumers to abandon therapy or self-manage dose adjustments based on results
FDA approved 23andMe’s Personal Genome Service Pharmacogenetic Report on October 31, 2018
Analytically and clinically valid
DTC PGx test result may not be used for what?
DTC PGx test result may not be used for clinical decision making unless FDA-approved
What are ethical issues (genetic discrimination) in PGx?
Overrepresentation of European ancenstry → generalizability is an issue, self reported vs continental ancestry in study enrollment, treatment guidelines of formulary
Genetic discrimination → set copay amounts for coverage, determine premiums
What are ethical implications in PGx testing?
Confidentiality - sharing genetic information
DTC tests
Highly sensitive information impacting beyond the patient
Data use - how the genetic data will be used and shared
Children
Who should receive the results? The child, his/her legal representative, his/her doctor
How and what should be reported?
Use by Government, law-enforcement
Current laws only protects against employers and health insurers
What are legal implications in PGx testing?
Health Insurance Portability and Accountability Act (HIPAA)
Specifies how protected health information is
maintained and transmitted by covered entities
Genetic Information Nondiscrimination Act (GINA) - prohibits
discrimination by health insurers and employers
How about discrimination by life insurers, lenders or other investors?
2011 “CalGINA” (the California Genetic
Information Nondiscrimination Act)- prohibits discrimination in housing and employment
What does medical insurance cover?
Covers outpatient clinic services
Covers office delivered prescriptions
Covers most inpatient costs
Services
Drugs
May cover vaccines (some or all)
Retroactive billing
PGx testing falls under Medical
Insurance
What does pharmacy benefits cover?
Covers all outpatient drugs
May cover specific inpatient or clinic delivered medications
Do not cover inpatient drugs
Cover some vaccines
May cover MTM or other pharmacy cognitive services
Upfront adjudication
For medical benefit review of PGX, what is the focus on?
Focus is on:
Is PGX testing likely to reduce number of clinic visits?
Does PGX prevent potential serious adverse events?
Can successful treatment option be chosen without PGX?
How long will it take for the medical benefit to recoup the testing costs?
For pharmacy benefit review of PGX what is the focus on?
Focus is on:
Are the results of the test likely to result in the use of a non-preferred agent?
Will the test require that patient uses a high cost, brand-name only medication?
Do the results of the test require long-term use of a high-cost agent?
Are there alternative assessments to better evaluate appropriateness of a prescription drug?
Do all insurance companies cover PGx testing?
No
How has PGx testing historically been viewed as what?
PGx testing has historically been viewed as non-essential testing outside of oncology
You can prescribe a medication without PGx testing
If a safety or effectiveness issue arises, drugs can be switched
Many patients will receive proper medication without PGx testing
What Is a barrier in PGx testing?
Significant complexity in coverage as barrier
PGx testing is typically thought of as a lab test (medical benefit)
PGx testing primarily impact drug prescribed (prescription benefit)
For medicare and medical, how are test grouped? Which tests are covered?
Tests are grouped into Tiers
Tests which are Tier 1 are covered by Medicare and Medical (CMS)
Standard programs cover PGx testing under what?
The medical benefit
Coverage is limited to what based on evidence reviews? For example what does Aetna cover and not cover?
Coverage limited to certain drug-gene pairs based on evidence review
Aetna covers:
CYP2C19 for clopidogrel
Tumor biomarkers
Aetna Does NOT cover:
CYP2D6 for donepezil
CYP2D6 for beta blocker choice
Other P450 polymorphisms
What are barriers to PGx testing in a medical benefit?
Unless you implement, you can’t prove financial benefit. If you don’t have evidence of financial benefit, less likely to be implemented
Few utilization management strategies to encourage testing
Cost utility, cost benefit, cost effectiveness analysis
Testing is largely left to provider discretion
Medical benefits do not have strategies built to require testing before prescribing
Historically there have been few links between pharmacy and medical benefit
Makes it difficult to restrict reimbursement per drug
Require pre-authorization before running a test
Easier for insurers to restrict payment than encourage
Slows process
May result in limited use
For cost analysis of PGx testing, how are multiple budgets impacted?
Prescription drug costs impacts PBM budget
Cost of lab test impacts medical benefit budget
Theoretic savings typically impacts medical benefit budget
For cost analysis of PGx testing, return on investment requires company to what?
Be focused on total cost of care
Be able to link medical and pharmacy benefit
For implementing a PGx testing program, how it it currently managed?
Health system level
How should a system implement testing process to occur?
At diagnosis/assessment of need
Prior to a medication being prescribed
Need to ensure patient understands results of test and its implication
Ensure pharmacist is engaged in the process
What is the PA approach to implement pharmacogenomics testing?
1.) Prescription is ordered
2.) Patient tries to pick up prescription
3.) PBM denies coverage and requires PA
4.) PA informs prescriber that a pharmacogenomic test is required first
5.) Pt sent pharmacogenomic test or returns to clinic
6.) Test result come back
7.) Results are reviewed by someone (who?)
8.) Rx approved or denied based on results
The patient impact of PGx testing can result in what?
Increased lab costs (depending on if they pay for labs)
Increased out of pocket cost for medications
Plavix is available generically and comes with Tier 1 copayment /coinsurance
Effient is now available as generic prasugrel and comes with Tier 2 copayment/coinsurance
Brilinta is available brand name only, which typically require either PA or Tier 3 copayment/coinsurance
May cause patient delays in starting therapy
Places increased burden on the patient
What are barriers to implementing PGx?
Lack of sufficient knowledge of PGx
Minimal PGx training for healthcare providers other than pharmacists
Added cost of PGx testing (lack of insurance coverage)
Lack of actionable guidelines for drug selection and dosing using PGx
Lack of consistency in PGx testing and reporting
Lack of informatics infrastructure to integrate PGx data with other clinical data