Can pharmacogenetics (PGx) help your members and improve plan sustainability?

This article by Veronika Litinski and Ruslan Dorfman of GeneYouIn, the company behind Pillcheck, was published in Plans & Trusts (International Foundation of Employee Benefit Plans) in May/June 2017 under the title "Can Pharmacogenetics (PGx) Help Your Members and Improve Plan Sustainability?". Below is a summary of the article, followed by what has changed since it was published.

Read the full article (PDF)

What does the article cover?

Pharmacogenetics (PGx) explains how a person's inherited genetic variations affect their response to medications. With a PGx report, doctors and pharmacists can choose medications and doses that are more likely to work and less likely to cause side effects. The article explains why this matters for group benefits plans: the cost of benefits keeps rising, more members rely on prescription drugs to manage chronic conditions, and medications that don't work or cause side effects add to drug costs, absenteeism and disability claims.

How can a plan offer PGx testing?

The article describes two main ways to offer PGx as a benefit:

• A voluntary benefit paid through a health spending account (HSA). This uses an existing funding stream at no new cost to the plan and suits employers with generous HSA allocations, but it needs regular communication so that members know about it, and the financial benefit to the plan sponsor is limited.
• A voluntary benefit fully covered by the plan for members who are most likely to benefit, such as those starting certain medications or with high drug claims. This approach needs a system to identify qualifying members, support to make sure the results are applied in their care, and clear communication.

What did the community pharmacy study find?

In the Innovative Canadian Pharmacogenomic Screening Initiative in Community Pharmacy (ICANPIC) study, pharmacists in two Toronto community pharmacies offered Pillcheck testing to 100 patients, whose average age was about 57 and who took about five chronic medications. Most were tested because a medication was not working or was causing side effects. After reviewing the Pillcheck results, pharmacists found an average of 1.3 drug therapy problems per patient that were directly related to the genetic results. Their recommendations to physicians were to change the medication (60%), adjust the dose (13%), stop a medication (4%) or monitor more closely (22%).

The article also cites a US study of older adults taking several medications, in which those who had PGx testing had 39% fewer hospital admissions and 71% fewer emergency department visits than those who were not tested.

How could PGx help a plan member? Jim's story

The article describes Jim, who had a heart attack and received a stent. He was discharged with ticagrelor (Brilinta) to prevent blood clots, a statin and a blood pressure medication. Ticagrelor was expensive, and an older, less costly alternative, clopidogrel, does not work well for everyone. Jim also developed muscle aches and dizziness and could not return to work.

Jim's PGx report showed that he could safely switch to clopidogrel, saving the plan and Jim a significant amount each month. His physician also switched his statin to rosuvastatin, and his muscle aches improved. Jim returned to work.

Current guidelines support this approach. According to the 2022 CPIC guideline for clopidogrel, people who are CYP2C19 normal, rapid or ultrarapid metabolizers can take clopidogrel at the standard dose after a heart attack or stent, while intermediate and poor metabolizers should use an alternative such as ticagrelor or prasugrel, because clopidogrel is less effective for them. The 2022 CPIC guideline for statins uses the SLCO1B1, ABCG2 and CYP2C9 genes to help choose a statin and dose that lower the risk of muscle symptoms.

How is members' genetic privacy protected?

The article recommends that plan administrators make sure PGx providers protect members' personal and genetic information, in line with Canada's Personal Information Protection and Electronic Documents Act (PIPEDA). It lists these best practices, which Pillcheck follows:

• analyze only specific, well-identified genetic variations related to drug response;
• destroy any remaining DNA once testing is complete;
• share a member's report only with their consent;
• identify each sample with a unique bar code so that no personal information appears on it;
• give the health plan only aggregated information about overall use of the benefit.

A PGx test looks only at how a person processes and responds to medications. It does not assess the risk of serious diseases.

What did the economic model show?

The article presented an economic model of a personalized medication service for four conditions: depression and anxiety, pain, stroke prevention and high cholesterol. These figures are projections from a 2017 model, not results measured in a trial. For every 1,000 plan members, 183 were expected to qualify because they started treatment for one of these conditions. Over two years, the model projected:

• direct medical costs of $541,200 with the service, compared with $834,300 without it, for a service cost of $60,500;
• drug costs for the four conditions of $195,900 with the service, compared with $359,900 without it;
• 15 more members with depression or anxiety in remission;
• 2,433 fewer days lost to depression, anxiety, opioid and anticoagulant treatments.

What has changed since 2017?

Genetic information is now protected by law. The article warned that people who learn genetic information about their health could face problems with insurers. Since then, Canada passed the Genetic Non-Discrimination Act (2017), which the Supreme Court of Canada upheld in 2020. Under this law, no one can require a person to take a genetic test, or to disclose the results of a genetic test, as a condition of providing goods or services or of entering into a contract, including an insurance contract.

Almost everyone carries a relevant genetic variation. The article stated that more than 90% of North Americans carry at least one genetic variation affecting drug response. A later study of more than 7.7 million US veterans projected the figure at 99%.

Stronger evidence from trials. In a randomized clinical trial in three Canadian community pharmacies, published in 2021, people with depression or anxiety whose antidepressant treatment was guided by Pillcheck had greater improvement in depression, anxiety and disability over six months than those who received standard treatment. In the large European PREPARE trial of nearly 7,000 patients, published in 2023, prescribing guided by a 12-gene panel reduced clinically relevant side effects by about 30%.

New economic evidence. A 2023 analysis in the CMAJ modelled pharmacogenetic testing for adults with moderate to severe depression in British Columbia. It projected savings of about $4,900 per patient over 20 years, mainly by preventing treatment-resistant depression, and estimated that the cost of testing would be recovered within about 2 years.

Wider coverage. Disability insurers, including Canada Life, Medavie Blue Cross and Empire Life, include Pillcheck in their disability benefits, and Bell Canada covers Pillcheck for eligible disability claimants. Canada Life, Medavie Blue Cross and Bell Canada offer their plan members access to Pillcheck at a preferred price, and selected trade unions with a long-term focus on member wellness include Pillcheck in employer-sponsored benefits. Learn more in 5 ways Pillcheck helps businesses manage benefits costs.

How can Pillcheck help your members?

Pillcheck combines a DNA test from a simple cheek swab with a medication review by pharmacists trained in pharmacogenetics. Members receive recommendations they can share with their doctors, and plan administrators receive only aggregated, anonymized reports to manage the program and measure its impact.

Pillcheck testing is performed in CAP- and COLA-accredited clinical genetic laboratories located in Canada. Pillcheck reports on 24 genes, increasing coverage with new guidelines and drug labels (see the genes tab), and covers 355 medications, which account for over 70% of dispensed prescriptions. The Pillcheck test panel ensures high accuracy for people of non-European and admixed ancestries. Your results last a lifetime, and report updates are free of charge.

To learn more about adding Pillcheck to a health benefits plan, contact us at info@pillcheck.ca.

Summary

• Pharmacogenetic testing helps plan members get medications and doses that are more likely to work, with fewer side effects.
• Plans can offer PGx through health spending accounts or as a covered benefit for members most likely to benefit.
• In community pharmacies, Pillcheck results led to medication changes or dose adjustments for most patients tested.
• Genetic information is now protected by Canada's Genetic Non-Discrimination Act.
• Newer trials and economic analyses support the value of pharmacogenetic testing for members and plans.

Frequently asked questions

Can an insurer require my genetic test results?

No. In Canada, the Genetic Non-Discrimination Act prohibits requiring a genetic test, or the disclosure of genetic test results, as a condition of a contract, including an insurance contract.

Does my employer see my Pillcheck results?

No. Results are shared only with your consent. Plan administrators receive only aggregated, anonymized information about use of the benefit.

What happens to my DNA sample?

Pillcheck analyzes only genetic variations related to drug response, and the remaining DNA is destroyed once testing is complete. Samples are identified by a bar code, not by your name.

How can a plan offer Pillcheck?

Pillcheck can be paid through a health spending account, offered at a preferred price, or covered by the plan for eligible members. Contact info@pillcheck.ca to learn more.

References

1. Litinski V, Dorfman R. Can pharmacogenetics (PGx) help your members and improve plan sustainability? Plans & Trusts. 2017;35(3):8-13.
2. Papastergiou J, Tolios P, Li W, Li J. The Innovative Canadian Pharmacogenomic Screening Initiative in Community Pharmacy (ICANPIC) study. J Am Pharm Assoc. 2017;57(5):624-629. doi:10.1016/j.japh.2017.05.006
3. Brixner D, Biltaji E, Bress A, et al. The effect of pharmacogenetic profiling with a clinical decision support tool on healthcare resource utilization and estimated costs in the elderly exposed to polypharmacy. J Med Econ. 2016;19(3):213-228. doi:10.3111/13696998.2015.1110160
4. Lee CR, Luzum JA, Sangkuhl K, et al. Clinical Pharmacogenetics Implementation Consortium guideline for CYP2C19 genotype and clopidogrel therapy: 2022 update. Clin Pharmacol Ther. 2022;112(5):959-967. doi:10.1002/cpt.2526
5. Cooper-DeHoff RM, Niemi M, Ramsey LB, et al. The Clinical Pharmacogenetics Implementation Consortium guideline for SLCO1B1, ABCG2, and CYP2C9 genotypes and statin-associated musculoskeletal symptoms. Clin Pharmacol Ther. 2022;111(5):1007-1021. doi:10.1002/cpt.2557
6. Genetic Non-Discrimination Act, S.C. 2017, c. 3. laws-lois.justice.gc.ca
7. Chanfreau-Coffinier C, Hull LE, Lynch JA, et al. Projected prevalence of actionable pharmacogenetic variants and level A drugs prescribed among US Veterans Health Administration pharmacy users. JAMA Netw Open. 2019;2(6):e195345. doi:10.1001/jamanetworkopen.2019.5345
8. Papastergiou J, Quilty LC, Li W, et al. Pharmacogenomics guided versus standard antidepressant treatment in a community pharmacy setting: a randomized controlled trial. Clin Transl Sci. 2021;14(4):1359-1368. doi:10.1111/cts.12986
9. Swen JJ, van der Wouden CH, Manson LE, et al. A 12-gene pharmacogenetic panel to prevent adverse drug reactions: an open-label, multicentre, controlled, cluster-randomised crossover implementation study. Lancet. 2023;401(10374):347-356. doi:10.1016/S0140-6736(22)01841-4
10. Ghanbarian S, Wong GWK, Bunka M, et al. Cost-effectiveness of pharmacogenomic-guided treatment for major depression. CMAJ. 2023;195(44):E1499-E1508. doi:10.1503/cmaj.221785