The Year in Review: PCSK9 inhibitors, FDA approvals and deals aplenty

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In 2015, the FDA approved numerous cardiovascular medications and devices, providing clinicians with new treatment options. Still, the prices of the treatments received scrutiny as the federal government and private insurers began paying closer attention to value and whether the benefits outweigh the costs.

As far as clinical trials, the SPRINT study presented at the American Heart Association (AHA) Scientific Sessions received the most hype and led to  debates on if the results will change practice. The  results showed that patients who had a systolic blood pressure target of less than 120 mm Hg had a 25 percent lower relative of the primary composite outcome of MI, other acute coronary syndromes, stroke, heart failure or death from cardiovascular causes compared with those who had a target of less than 140 mm Hg. Current guidelines  recommend a target of less than 140 mm Hg in healthy adults and 130 mm Hg for adults with kidney disease.

Here are other highlights from the year in cardiology:

PCSK9 Inhibitors

In the summer, the FDA approved the first two proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors:  alirocumab (Praluent, Regeneron Pharmaceuticals and Sanofi Aventis) and  evolocumab (Repatha, Amgen).

Both drugs were shown in trials to significantly lower low-density lipoprotein (LDL) cholesterol. However, some experts were  concerned that the drugs were approved before they were found to be effective at preventing or delaying major adverse cardiovascular events, including MI, ischemic stroke and death due to cardiovascular disease.

Trials are underway to determine both drugs’ effects on cardiovascular outcomes. Amgen recently noted that topline results of the FOURIER outcomes trial for evolocumab are expected to be released in the second half of 2016. Results of the alirocumab trial are expected to be released by 2017.

The costs of the PCSK9 inhibitors also were a hot topic.

The annual wholesale acquisition cost is $14,600 for alirocumab and $14,100 for evolocumab. The Institute for Clinical and Economic Review, a nonprofit healthcare research organization, released a  report that said the price should be between $3,615 and $4,811 per year based on their overall benefits.

The drug manufacturers received good news in October when Express Scripts  announced it would include both PCSK9 inhibitors on its national preferred formulary, which covers approximately 25 million people in the U.S.

Still, expect the debate on the value of PCSK9 inhibitors to continue in 2016 and beyond.

Mergers and acquisitions

The biggest deal of 2015 occurred in January, when Medtronic completed its  acquisition of Covidien for nearly $50 billion. The companies are major medical manufacturers of cardiovascular devices, including implantable cardiac therapies such as pacemakers and defibrillators, valves, catheter-based ablation systems, stents and vascular and peripheral technologies. The combined company is now headquartered in Ireland, which has a lower tax rate than the U.S.

Medtronic made a slew of smaller acquisitions throughout the year. It agreed to acquire  CardioInsight TechnologiesAptus EndosystemsRF Surgical SystemsTwelveMedina MedicalLazarus Effect and Aircraft Medical.

In October, St. Jude Medical  completed its acquisition of Thoratec for $3.3 billion, expanding its heart failure business and adding products such as the HeartMate II left ventricular assist device. That same month, Cardinal Health  completed its acquisition of Johnson and Johnson’s Cordis business for $1.944 billion.

TAVR in the spotlight

On Nov. 30, the Society of Thoracic Surgeons and the American College of Cardiology released  data from its transcatheter aortic valve replacement (TAVR) registry that showed the increasing popularity of the procedure.

Between 2012 and 2014, the  number of centers performing TAVR more than doubled from 156 to 348.

Meanwhile, marketing analytics firm GlobalData  reported in March that the compound annual growth rate for TAVR valves will increase 19.7 percent between 2013 and 2020, expanding from $881 million to more than $3 billion over the period.

In late March, the FDA  expanded the approval of the CoreValve device to include its use in valve-in-valve procedures in inoperable and high-risk patients.

In June, the FDA  approved the CoreValve Evolut R, new-generation device for treating patients with severe aortic stenosis. That same month, the FDA  approved the Sapien 3 as a treatment