Ty J. Gluckman, MD, FACC, FAHA, who is medical director of the Center for Cardiovascular Analysis, Research and Data Science at Providence St. Joseph Health in Portland, Oregon, addressed the American Society of Cardiology Congressional meeting 2022 pre-trial in Louisville, Kentucky.
With health care costs in the US already accounting for 20% of gross domestic product (GDP), every stakeholder in the system—patients, providers, the pharmaceutical industry, and payers—not only has a role in bending the cost curve, but will also face what Ty J. Gluckman, MD, FACC, FAHA, called the coming cost “tsunami” thanks to COVID-19.
Gluckman, who is medical director of the Cardiovascular Data Science, Research and Analysis Center at Providence St. Joseph Health in Portland, Oregon, addressed the 2022 American Society for Preventive Cardiology (ASPC) Congress, meeting in Louisville, Kentucky. , with a talk, “Cost of Prevention: How Much Is Too Much?”
The economic cost of atherosclerotic cardiovascular disease (ASCVD) is “staggering,” he said; it is the leading cause of death in the United States, “so it is not surprising that it has substantial direct and indirect costs.”
As of 2018, the annual direct costs of CVD are $225 billion, and the indirect costs are even higher. One approach might be to look at ways to reduce that spending, Gluckman said, or “One might have the opposite opinion, and [ask] How do we invest more so that we can bend the risk curve and thus mitigate downstream cost risk?
Unfortunately, Gluckman said, the fallout from COVID-19 may create a health care “tsunami,” according to a recent article. The post-lockdown period will be marked by increases in admissions for the indigent, rising costs to maintain healthcare workers, and an increase in the number of people with cardiovascular events.
Already, Gluckman said, the loss of workplace wellness programs and inactivity during the pandemic have led to a rise in high blood pressure and obesity. He shared charts with data on these points, adding, “The trends are pretty ominous.”
Pre-pandemic results, based on a cohort enrolled in the MESA studyshow that over a 10-year period, low-risk patients accrued less than $7,700 in direct costs, but high-risk patients could incur more than $35,800 in costs.
Thanks to the pandemic, the United States is likely to have more high-risk patients.
Novel therapies, higher OOP costs
A central balancing act facing cardiologists today is how to prescribe patients enough drugs, and the right drugs, without leaving them out of pocket (OOP).
“We have a range of pharmacotherapies that aim to move the needle on the risk factors that we treat,” he said, noting how other speakers had discussed the need for more, not less, use of sodium-glucose cotransporter 2 inhibitors. (SGLT2) or Glucagon-like peptide-1 (GLP-1) receptor agonists.
In many cases, patients would benefit from multiple medications, but the OOP would be unaffordable.
So far back like 2014the American College of Cardiology and the American Heart Association have offered guidance on how to address the cost-value equation, but a primary barrier has been a lack of data to demonstrate cost-effectiveness.
In the class of SGLT2 inhibitors, for example, cost-effectiveness studies are being redone in light of clinical trials showing that drugs first approved to treat type 2 diabetes can also treat heart failure and diabetes. chronic kidney disease. A just published study in Japan argues that given all of their indications, SGLT2 inhibitors are cost-effective when started without metformin, a long-time departure from first-line therapy.
Gluckman also noted that clinical trials are increasingly segmenting how new therapies work into specific high-risk subgroups. This was seen in FOURIER trial for the PCKS9 inhibitor evolocumab; Pharmacy benefit managers had resisted the original price, above $14,500 a year, and imposed burdensome prior authorization requirements. Prices now hover around $5,850 for these therapies, and some doctors at the ASPC meeting report that they rarely encounter a denial these days.
Although trials may report a mean effect, for the individual patient, “there is no mean treatment effect,” he said. “Rather, as many have suggested today, we should be researching our population to find out how we disproportionately use therapies, especially therapies that may be more expensive.”
Just as clinicians should advocate for approval of therapies for patients who will see the most benefit, they should stop therapy if little benefit will be seen. Such an approach will require cooperation among stakeholder groups, including industry and payers.
Gluckman ended with a call for better health plan design to ensure access not only to therapy but to all high-value health services. “I think our insurance companies, our payers, have a special responsibility for this,” he said, citing principles developed at the University of Michigan. Value Based Insurance Design Center. (A. Mark Fendrick, MD, co-editor in chief of The American Journal of Managed Care®, is director of the V-BID Center.)
Gluckman shared an excerpt from an article he co-authored on the ACC Leadership forum on this topic:
“While many insured ASCVD patients are ostensibly ‘covered’, they often face high out-of-pocket costs, in part to ensure they have ‘skin in the game.’ An unintended consequence of this cost sharing is that it indiscriminately limits the use of all clinical services, including those that are both high and low value.
“Beyond some preventive services, which are often exempt from deductibles, copays and coinsurance, current health plan designs do not provide similar access to many of the evidence-based therapies known to reduce the risk of cardiovascular events. adverse. Even for the highest-risk patients, where use is likely to have the greatest impact, these therapies paradoxically remain subject to traditional plan designs that are not value-based,” they wrote.
It’s no wonder, then, that adherence is compromised and “the promise of high-value care is lost to those who need it most.”
Both the prevalence and cost of cardiovascular disease will continue to rise, “with no end in sight,” Gluckman said. The benefits of prevention, therefore, need to be “further realized in those who are at higher or higher risk.”
With the increased availability of novel therapies, more and better data is needed to drive the value discussion so that the right patients receive the treatment. “Ultimately, insurance plans must be redesigned to ensure access to low-cost, high-quality, and easily accessible health care.”