CV Services Highlighted by Innovation in 2015
Cardiovascular (CV) services remain on the forefront for data-driven decision making in health care, but with CV disease still the leading cause of mortality in the US, there is much work to be done. To understand the challenges and opportunities for CV services for the year ahead, it’s helpful to take stock of the highlights from 2015.
Last year, there were more significant FDA approvals for new cardiovascular therapies, both drugs and devices, than any other year in the past decade. Many of these therapies offer incremental benefits over standard of care and others represent significant advances in care previously not available to patients, but all will require long-term outcomes tracking and thoughtful adoption to carefully assess their value. Equally as significant were studies that supported as well as challenged current clinical practice, again highlighting the utility in long-term outcomes studies and registry data.
It was impossible to go a week in 2015 without seeing a press release, article, commentary or manuscript highlighting a new therapy or study result. A brief review of the highlights and a look ahead to 2016 follow.
The Year in Review
Biggest Drug Approvals in 10 Years: PCSK9 and Entresto
The biggest CV stories of 2015 came from the most significant new cardiovascular drug approvals in the last decade. The PCSK9-inhibitor drugs for lowering low-density lipoprotein (LDL) levels (Praluent [Sanofi/Regeneron] and Repatha [Amgen]) have raised some controversy over the rising cost of drugs and their proposed value due to their high price (~$14,000 annually) and lack of long-term outcomes data (which will not be reported until 2017). As such, the number of approved prescriptions has been limited as payers are taking a cautious approach to use of these medications.
The other significant addition to CV treatment is Entresto (Novartis) for heart failure. Unlike the lack of long-term evidence supporting PCSK9 drugs, there are long-term outcomes data (up to 27 months) for Entresto showing a reduction in hospitalizations and mortality.
These new drugs could have a significant impact on patients as well as reduce acute care utilization. We will continue to carefully follow your experiences and the prescribing trends for these drugs over the year.
Structural Heart Advances: Next-Generation TAVR, Watchman
The rapid pace of innovation in structural heart procedures continued in 2015. The newest generation of devices, the Sapien 3 and CoreValve Evolut R, were FDA approved in 2015 and included a number of technological enhancements. A growth in real-world experience with TAVR has also provided valuable insight and benchmarks. A recent study of the STS/ACC TVT Registry showed that between 2013 and 2014, the number of sites implanting TAVR devices increased by 38%. In addition, data indicated that high-volume centers have better outcomes than low-volume centers, begging the question, “Have we reached a point of TAVR program saturation?” As more centers offer TAVR, monitoring outcomes to ensure this procedure is delivered optimally will be essential. With the likely expansion of TAVR to the intermediate risk patient cohort (data expected in 2016), TAVR volumes will continue to grow. However, thoughtful adoption will be necessary for procedural success.
The FDA and payers seem to be a little out of sync with these new technologies, with payers influencing adoption rates to ensure a thoughtful rollout following FDA approval. For example, the WATCHMAN device finally received FDA approval in March, but in November CMS issued a decision memo outlining 7 criteria that must be in place by a provider to be qualified to receive reimbursement for its use, potentially slowing adoption and narrowing patient indications. Expect these types of additional criteria to be the norm for novel therapies moving forward.
There will be difficult discussions regarding the use of novel therapies with vendors, providers, payers and patients moving forward, primarily regarding outcomes and financials. Ultimately, providers will be tasked with ensuring cardiovascular services remain a leader in value.
Clinical Cardiology Gains Momentum: COURAGE 15, SPRINT and Cardiac Rehab
Some of the most significant news of 2015 came from studies that re-evaluated current standard of care. The 15-year follow-up of COURAGE trial patients highlights the need for appropriateness when making decisions to revascularize. The long-term follow-up data showed there was no mortality difference between the optimal medical therapy group and the optimal medical therapy plus percutaneous coronary intervention (PCI) group. Cardiovascular providers should not minimize the significance of these results, despite some limitations with the data and the fact that newer stent technologies and improved diagnostic tools like FFR and CT-FFR are now available. While ongoing trials like ISCHEMIA will attempt to address some of these issues, optimal medical management still plays an important role.
In other news, providers may finally have an answer regarding optimal blood pressure management. The SPRINT trial suggested that more intensive blood pressure lowering (systolic blood pressures to <120 mmHg) significantly reduces the risk for cardiovascular events, including death. Three medications were needed to achieve target pressures in the intensive management group vs 2 medications in the control group, which may be significant. While this may not be the final chapter in hypertension management, it offers us a new target to manage to until further studies are completed.
Finally, data continue to support the use of cardiac rehab for patients with a variety of cardiovascular diseases. If 2014 was the year for congestive heart failure, which was granted coverage by CMS for cardiac rehab services, 2015 was the year for atrial fibrillation (AF). While CMS has not yet expanded cardiac rehab indications to cover AF, data published by Dr Prash Sanders in Australia showed that cardiac rehab (ie, weight loss, lifestyle modification, cardiopulmonary fitness) not only improved the burden and severity of atrial fibrillation, but also procedural success postablation. Watch for CMS to expand indications to include AF in the near future. In the meantime, could you create a competitive advantage by adding this service to your arrhythmia program? If you haven’t yet strengthened your cardiac rehab program, you may want to do so before this patient population is knocking on your door.
What Will 2016 Bring?
Don’t expect 2016 to be any less eventful. There is great momentum in payment reform, innovation pipelines, as well as in the realization that we must coordinate care across the entire care continuum. We feel these topics will gain even more interest over the next year.
- Payment reform will continue. There are signals that payers are pushing down the road to value, clearly evident by the CMS Comprehensive Care for Joint Replacement (CJR) Model, which caught many providers by surprise. However, we don’t think CMS is going to stop there. It is quite possible that CV services will be the next target. Start preparing for bundled payment in CV care now to ensure your financial success in the near future. Payment reform may be to the next 5 years what quality improvement efforts were to the last 5 years.
- Post-acute care (PAC) is essential. It is more important than ever to focus on what happens when a patient leaves the 4 walls of the hospital. As bundled payment takes hold (see point above) or total cost of care becomes increasingly important, you must ensure that you are partnering with the right PAC providers in the most effective ways.
- Innovation adoption will require difficult choices. Innovations will continue at a relentless pace, challenging organizations to put structure around their decision-making processes regarding what to adopt and when to offer these new therapies to their patients. You must understand who you are as an organization and how you are going to work with your physicians to ensure they have the needed tools to appropriately care for their patients. It’s important to fully assess both financial and quality aspects before adopting new therapies or approaches.
Sources: American Heart Association. New statistics show one of every three US deaths caused by cardiovascular disease. December 16, 2015; US FDA website; Holmes DR, Jr, et al. J Am Coll Cardiol. 2015;66:2813–2823; Neale T. As the number of US TAVR centers grows, patient outcomes vary. TCTMD. December 7, 2015; CMS. Proposed Decision Memo for Percutaneous Left Atrial Appendage (LAA) Closure Therapy (CAG-00445N). November 10, 2015; Ishmael H. Amgen and Regeneron face declining PCSK-9 prescription volumes. Bidness Etc. December 7, 2015; Optum, Inc. Entresto: The next blockbuster drug? July 13, 2015; Peck P. COURAGE at 15: still no edge for stenting—long-term data confirm equipoise. MedPage Today. November 11, 2015; American Heart Association. SPRINT trial: lower systolic BP target reduces CV disease risk. AHA website; Pathak RK et al. J Am Coll Cardiol. 2015;65:2159–2169; Sg2 Analysis, 2016.