STUDY SUMMARY: HeartFlow Continues to Deepen Market Access

Coronary Artery Disease (CAD)

Coronary artery disease (CAD) is the most common type of heart disease and affects 15.5 million Americans.^1,2 CAD is also the leading cause of death in the United States. According to mortality data from 2013, CAD was responsible for the deaths of 1 in 7 Americans and accounted for more than 370,000 deaths.² Moreover, CAD poses a tremendous economic burden on the US healthcare system and CAD-related expenditures are expected to soar in the coming decades. The American Heart Association projected that by 2035, direct medical costs of CAD will total $215 billion and morbidity and premature mortality will contribute an additional $151 billion in indirect costs to the total financial burden.¹

Guidelines for CAD

Current practice for evaluating patients with stable chest pain often requires noninvasive or invasive testing.^3,4 Coronary computed tomographic angiography (CTA) is a noninvasive anatomical test for the exclusion and detection of CAD using invasive coronary angiography (ICA) as the reference. Yet, CTA is restricted to patients at low-intermediate risk of CAD due to its relatively modest positive predictive accuracy and inability to measure functional significance.⁵

Invasive fractional flow reserve (FFR) is considered the gold standard to evaluate the physiological significance of coronary stenosis.⁵ However, executing invasive FFR is a costly and time-consuming procedure. Aside from these limitations, the FFR procedure of advancing a pressure wire across the lesion may increase the risk of rupturing a plaque or damaging the vessel wall.^6-8

An alternative diagnostic and treatment pathway for CAD is the noninvasive use of fractional flow reserve by CTA (FFR_CT), a screening test that simultaneously provides both anatomical and physiological coronary data to help clinicians more accurately assess significant CAD. Rajani and colleagues reported that when vessels interrogated by invasive FFR were compared against FFR_CT and coronary CTA stenosis alone, FFR_CT showed superior discriminatory ability with a diagnostic sensitivity of 80% and specificity of 61% in patients with a coronary stenosis severity of ≥50% (AUC 0.81 vs 0.68). Developed by HeartFlow, this diagnostic technology was granted FDA clearance in 2014 and is now available for commercial use.⁵

Based on extensive clinical data, the National Institute for Health and Care Excellence (NICE) issued recommendations for HeartFlow FFR_CT as a safe, noninvasive, and accurate diagnostic tool. Furthermore, relative to other tests, HeartFlow FFR_CT is an economical option that potentially saves £214 per patient by avoiding unnecessary tests (Table 1).⁹

Additionally, the American College of Cardiology (ACC), in collaboration with partnering organizations, has released updated appropriate use criteria for performing coronary revascularization in patients with stable ischemic heart disease. These include the use of HeartFlow FFR_CT to determine the appropriateness of revascularization in various clinical scenarios.¹⁰

PLATFORM Trial and Real-World Evidence

The PLATFORM trial and real-world evidence suggest that FFR_CT improves accuracy of coronary CTA, and is a safe and cost-effective alternative to improve to ICA in CAD.^3,11-13

PLATFORM, a multicenter, prospective, consecutive cohort study, evaluated the effectiveness of usual care testing (n = 287) compared with CTA/FFR_CT (n = 297) in 584 patients with stable chest pain. The primary end point was the percentage of patients with planned ICA in whom no significant obstructive CAD was found within 90 days.³

The results shown in Table 2^3,12,13 demonstrate that FFR_CT significantly decreases ICA in patients with suspected CAD.³

One-year follow-up data from the PLATFORM trial showed no major adverse cardiac events among the 117 patients who underwent FFR_CT in place of a scheduled ICA. Data also showed a mean cost savings of 33% with the FFR_CT-guided strategy compared with patients who received standard care ($8127 vs $12,145, respectively).¹¹

Two real-world studies presented at the ACC’s 66th Annual Scientific Session & Expo showed the benefits of an FFR_CT guided-strategy (Table 2^3,12,13).^12,13 The first study demonstrated that CTA/FFR_CT resulted in less ICA in symptomatic patients with intermediate CAD over a 12-month period, with no adverse events during follow-up, and at a lower cost versus a CTA-only guided strategy.¹³

In the second study, Kitabata and colleagues looked at the incidence and predictors of lesion specific ischemia by FFR_CT in 950 patients enrolled in the ADVANCE registry—a multicenter, prospective registry designed to evaluate the real-world utility and impact of FFR_CT on clinical outcomes and resource use following FFR_CT-guided treatment, in clinically stable symptomatic patients diagnosed with CAD by coronary CTA.^4,12 Baseline hypertension and diabetes were predictors of an abnormal FFR_CT. Additionally, severity of stenosis also increased probability of an abnormal FFR_CT, even when intermediate in grade.¹²

Policy Changes in the United States

Despite robust evidence supporting the use of invasive FFR to guide clinical decisions, FFR has been underutilized and in 2013, was estimated to be used in less than 10% of coronary revascularization procedures. The low utilization could be due to the invasive nature of the procedure, risk associated with rupturing plaques, lack of availability, and notably, the challenge of receiving reimbursements from health plans.^14,15

Therefore, it is important that large insurers and payers in the United States support the use of HeartFlow FFR_CT as part of the diagnostic and treatment pathway for CAD.

In June, Blue Cross Blue Shield Association’s (BCBS) Evidence Street issued a positive healthcare evidence review of Heart Flow’s technology, based on an assessment of its technical performance, diagnostic accuracy, and clinical utility in patients with stable chest pain at intermediate risk of CAD, who are being considered for ICA.¹⁶

The report concluded: “The available evidence provides support that use of CCTA with selective FFR_CT is likely to reduce the use of ICA in individuals with stable chest pain who are unlikely to benefit from revascularization by demonstrating the absence of functionally significant obstructive CAD.”¹⁶

Furthermore, it was confirmed that there is sufficient evidence “to determine that the technology results in meaningful improvements in the net health outcome.”¹⁶

In addition, Aetna recently updated its coverage policy supporting use of HeartFlow’s FFR_CT for persons with stable, recent onset chest pain of suspected cardiac origin and a clinically determined intermediate 10% to 90% risk of CAD.¹⁷

Most recently in July, New Jersey’s Horizon BCBS expanded its coverage to include the use of HeartFlow FFR_CT for certain patient populations. Coverage by Horizon BCBS was soon followed by coverage through Anthem, Blue Shield of California, as well as BCBS of Alabama, Arizona, Idaho, Kansas, Kansas City, and Nebraska. These payer’s quick adoption of HeartFlow FFR_CT suggests that other health plans may be receptive to expanding their coverage and improving FFR_CT’s accessibility.

Current Procedural Terminology (CPT) Codes

In early July, Category III Current Procedural Terminology (CPT) codes were granted and released by the American Medical Association for the regulation of HeartFlow FFR_CT (Table 3). As government payers and commercial health insurance companies use CPT codes when reviewing applications for reimbursement, this designation will simplify the compensation process for hospitals and clinics where FFR_CT is implemented.¹⁸

The application for CPT code recognition of HeartFlow FFR_CT was jointly submitted by the ACC, the Society of Cardiovascular Angiography and Interventions, and the Society for Cardiovascular Computed Tomography. This collaboration across societies indicates the clinical need for this diagnostic tool to advance current practice standards.¹⁸

Importantly, the designation of CPT codes indicates the utility of HeartFlow FFR_CT to provide much-needed clinical data to offer guidance for improved care and greater implementation in practice. Healthcare facilities with FFR_CT will be able to use these codes starting January 1, 2018.¹⁸

The designation of CPT codes for HeartFlow FFR_CT offers the advancement of this clinical tool in practice to serve a greater population of patients with suspected CAD, reducing needs for additional invasive testing. With CPT codes, clinicians can easily order this tool for actionable insights, where clinicians can develop personalized strategies of care and improve clinical outcomes.¹⁸

Conclusion and Relevance

HeartFlow FFR_CT is gaining traction in market access based on evidence from clinical and real-world studies validating its use in the diagnosis and treatment of CAD. Furthermore, NICE and ACC guidelines recommend use HeartFlow FFR_CT to guide treatment. This technology is also recognized among insurers and multiple payers across the country. Moreover, HeartFlow can be successfully implemented by physicians and hospitals for reimbursements through established CPT code designations. Given the prevalence and burden of CAD, as well as the potential for HeartFlow FFR_CT to improve clinical outcomes, streamline management of patient pathways, and reduce healthcare expenditures, FFR_CT is well-positioned to become a vital diagnostic tool in the standard of care for patients at risk for CAD.

References

1. American Heart Association. Cardiovascular disease: a costly burden for America—projections through 2035. AHA website. www.heart.org/idc/groups/heart-public/@wcm/@adv/documents/downloadable/ucm_491543.pdf. Published 2017. Accessed July 6, 2017.

2. Mozaffarian D, Benjamin EJ, Go AS, et al; American Heart Association Statistics Committee; Stroke Statistics Subcommittee. Heart disease and stroke statistics-2016 update: a report from the American Heart Association. Circulation. 2016;133(4):e38-e360. doi: 10.1161/CIR.0000000000000350.

3. Douglas, PS, Pontone G, Hlatky MA, et al; PLATFORM Investigators. Clinical outcomes of fractional flow reserve by computed tomographic angiography-guided diagnostic strategies vs. usual care in patients with suspected coronary artery disease: the prospective longitudinal trial of FFR(CT): outcome and resource impacts study. Eur Heart J. 2015;36(47):3359-3367. doi: 10.1093/eurheartj/ehv444.

4. Chinnaiyan KM, Akasaka T, Amano T, et al. Rationale, design and goals of the HeartFlow assessing diagnostic value of non-invasive FFRCT in Coronary Care (ADVANCE) registry. J Cardiovasc Comput Tomogr. 2017;11(1):62-67. doi: 10.1016/j.jcct.2016.12.002.

5. Rajani R, Modi B, Ntalas I, Curzen N. Non-invasive fractional flow reserve using computed tomographic angiography: where are we now and where are we going? Heart. 2017 pii: heartjnl-2016-311029. doi: 10.1136/heartjnl-2016-311029.

6. Qi X, Fan G, Zhu, D, et al; Comprehensive assessment of coronary fractional flow reserve. Arch Med Sci. 2015;11(3):483-493. doi: 10.5114/aoms.2015.52351

7. Vergallo R, Uemura S, Soeda T, et al; Prevalence and Predictors of Multiple Coronary Plaque Ruptures: In Vivo 3-Vessel Optical Coherence Tomography Imaging Study. Arterioscler Thromb Vasc Biol 2016;36:2229-38. doi: 10.1161/ATVBAHA.116.307891

8. Hakeem A, Edupuganti MM, Almomani A, et al; Long-Term Prognosis of Deferred Acute Coronary Syndrome Lesions Based on Nonischemic Fractional Flow Reserve. J Am Coll Cardiol 2016;68:1181-91. doi: 10.1016/j.jacc.2016.06.035

9. National Institute for Health and Care Excellence. HeartFlow FFRCT for estimating fractional flow reserve from coronary CT angiography. NICE website. www.nice.org.uk/guidance/mtg32. Published February 13, 2017. Accessed July 5 2017.

10. Patel MR, Calhoon JH, Dehmer GJ, et al. ACC/AATS/AHA/ASE/ASNC/SCAI/SCCT/STS 2017 Appropriate use criteria for coronary revascularization in patients with stable ischemic heart disease: a report of the American College of Cardiology Appropriate Use Criteria Task Force, American Association for Thoracic Surgery, American Heart Association, American Society of Echocardiography, American Society of Nuclear Cardiology, Society for Cardiovascular Angiography and Interventions, Society of Cardiovascular Computed Tomography, and Society of Thoracic Surgeons. J Am Coll Cardiol. 2017;69(17):2212-2241. doi: 10.1016/j.jacc.2017.02.001.

11. Douglas PS, De Bruyne B, Pontone G, et al; PLATFORM Investigators. 1-year outcomes of FFRCT-guided care in patients with suspected coronary disease: the PLATFORM study. J Am Coll Cardiol. 2016;68(5):435-445. doi: 10.1016/j.jacc.2016.05.057.

12. Kitabata H, Leipsic J, Patel M, et al. Incidence and predictors of lesion specific ischemia by FFRCT: Learnings from the international ADVANCE registry [abstract 1297-343]. J Am Coll Cardiol. 2017;69(suppl 11):297.

13. Rabbat M, Kauh B, Pontone G, Norgaard B, Lopez J, Mathew V. Fractional flow reserve derived from coronary computed tomography safely reduces invasive coronary angiography rates and cost in patients with stable coronary artery disease [abstract 1126-333]. J Am Coll Cardiol. 2017;69(suppl 11):72.

14. Zarins CK, Taylor CA, Min, JK; Computed fractional flow reserve (FFTCT) derived from coronary CT angiography. J of Cardiovasc. Trans. Res. 2013;6:708—714. doi: 10.1007/s12265-013-9498-4

15. Hannawi B, Lam WW, Wang S, et al. Current use of fractional flow reserve: a nationwide survey. Tex Heart Inst J. 2014;41(6):579-584. doi: 10.14503/THIJ-13-3917

16. BlueCross BlueShield Association. Coronary computed tomography angiography with selective noninvasive fractional flow reserve. Published June 2017. Accessed July 11, 2017.

17. Aetna. Cardiac CT, coronary CT angiography calcium scoring and CT fractional flow reserve. Aetna website. www.aetna.com/cpb/medical/data/200_299/0228.html. Updated May 12, 2017. Accessed July 5, 2017.

18. HeartFlow announces American Medical Association issues unique Category III CPT codes for HeartFlow FFRct [news release]. Redwood City, CA: Heartflow, Inc; July 5, 2017.