US Lumbar Spinal Stenosis Market Research

Part
01
of two
Part
01

Coflex and Spinal Fusion Procedures

As of 2018, there were about 1.62 million spinal fusion procedures performed in the US. Unfortunately, there is no information in the public domain specific to the number of Coflex procedures performed annually in the United States. However, using information pertinent to when Coflex was introduced, the research team estimated the average number of Coflex procedures performed yearly in the world since its inception at 13,583.

SPINAL FUSION PROCEDURES PERFORMED ANNUALLY

  • iData Research's study in 2018 revealed that around 1.62 million spinal fusion procedures performed in the US yearly.
  • Out of the annual spinal fusion procedures conducted in the United States, interbody fusions were the ones most commonly performed, with more than 352,000 performed yearly in the US, according to iData Research.
  • Cervical fixation is another significant type of spinal fusion procedure in the US. As of 2017, 85.5% of this type of spinal procedure were anterior while 14.5% of them were posterior, as per the study by iData Research.
  • However, the number of spinal fusion procedures performed in the United States jumped from 1.187 million in 2007 to over 1.391 million in 2011. Within these periods, the number of patients it was performed on went from 662,400 in 2007 to 741,700 in 2011, according to a 2014 report by Bone And Joint Burden.

FINDINGS RELEVANT TO THE NUMBER OF COFLEX PROCEDURES PERFORMED ANNUALLY

  • Globally, the Coflex procedures have been performed on over 163,000 patients in more than 60 countries since its inception, as per information on Coflex's official directory. Unfortunately, the company did not provide data showing the number of procedures performed in the United States alone; neither is such information available for any country.
  • According to the United State's National Library of Medicine, Coflex received its investigational device exemption (IDE) in 2006 before its approval by the FDA in October 2012.
  • Based on the number of Coflex procedures performed global and the date it received its investigational device exemption in 2006, we took it that the Coflex procedures began in 2006 (which is 12 years as of 2018). Thus, we estimated the average number of Coflex procedures performed annually to be 13,583 globally, as there is no data in the public domain specific to the United States.

RESEARCH STRATEGY:

We began by investigating authoritative medical research directories, including the US National Library of Medicine, Science Direct, Becker's Spine Review, and others in search of data showing the number of Coflex and spinal fusion procedures performed annually in the United States. This research produced studies by iData Research, Bone And Joint Burden, and others, which revealed the number of spinal fusion procedures performed in the US, as well as its historical data. Unfortunately, there was no study in the public domain showing the number of Coflex procedures conducted annually in the United States.

Therefore, we proceeded to investigate the official directory of Coflex, hoping to find information relevant to the number of procedures performed in the US alone. This time, we found a report by the company stating that the Coflex procedures have been performed on over 163,000 patients in more than 60 countries since its inception. However, there was no data or report by the company with insights into the number of procedures performed in the US for any of the years it received approval in the US.

Next, we switched strategies to research medical organizations in the US that perform the Coflex procedure for patients. This time we hoped to locate the total number of such institutions and the number of procedures each performed yearly. Unfortunately, this effort did not provide relevant information. Instead, we located studies conducted by several organizations such as Science Direct, Spine Research, Becker's Spine Review, the US National Library of Medicine, and others. These studies tested the clinical effectiveness of Coflex on a sample of patients in the US, but did not provide any data showing the number of procedures conducted annually in the US. However, the US National Library of Medicine's study revealed that Coflex received its investigational device exemption (IDE) in 2006 before its approval by the FDA in October 2012. Based on this information, we took it that Coflex had been in existence since 2006.

Hence, due to the lack of information specific to the United States, we estimated the number of Coflex procedures performed annually worldwide using the information available in the public domain, as a proxy for the required data.

CALCULATION

According to Coflex, over 163,000 patients in more than 60 countries have used its procedure since its inception. The company's webpage having this information had a copyright date showing 2019 in its footer, so we took it that this data was the most recent information and was for 2018 downward since 2019 is still in progress.

Next, based on the information by the US National Library of Medicine that Coflex received investigational device exemption (IDE) in 2006, we took it that the use of Coflex procedures began in 2006. Thus, from 2006 to 2018, it has been in use for 12 years (2018-2006).

Hence, if Coflex has been used on 163,000 patients in the world for an estimated 12 years, we calculated the average number of Coflex procedures performed annually around the globe since its introduction, as follows:
[163,000/12] = ~13,583.

Part
02
of two
Part
02

Coflex Insurance Coverage

  • Coflex® Interlaminar Stabilization® device is Paradigm Spine’s signature product which is used in over 60 countries. The company was acquired by RTI Surgical last year.
  • Coflex is covered nationally by Medicare and Paradigm Spine. The North American Spine Society (NASS) has already issued a coverage policy recommendations for Coflex procedure which will provide evidence to private insurance companies to allow their patients access to this procedure.
  • 82% of the Michigan population is covered by insurance companies for Coflex procedure; 4.1 million people were covered by Medicare, Medicaid, and ACA; while 4.5 million people were covered by Blue Cross Blue Shield.
  • 10.5 million lives throughout the states of Pennsylvania, West Virigina, and Delaware were covered for Coflex procedures; 5.5 million were covered by Medicare, Medicaid, and the Affordable Care Act; and 5 million were covered by Highmark, Inc. and affiliates.
  • Blue Cross Blue Shield also covers Coflex procedures in North Dakota. It is the largest commercial payer in North Dakota.
  • Coflex is one of the popular types of Interspinous Devices (ID) implants together with X-STOP, Wallis, and DIAM. According to the National Inpatient Sample (NIS) database, 66.7% who have undergone ID procedures was paid by Medicare while 23.1% was paid by private insurance patients last 2014.
  • Medicare national average payment for coflex is $17,253 for hospital inpatient, $14,698 for hospital outpatient, and $10,542 for Ambulatory Surgical Center (ASC).

Research Strategy:

We began by looking for precompiled data on insurance coverage for coflex procedures on the Paradigm Spine’s official website, news, and documents. While we were able to find the overall coflex coverage in states of Michigan, Pennsylvania, West Virgina, Delaware and information about coflex being covered by Blue Cross BlueShield North Dakota, we were not able to find the breakdown by insurance type for the US, as it was only mentioned that coflex is covered by Medicare nationwide. While RTI Surgical is a public company and Paradigm Spine was mentioned in its full year results last 2018, no specific details about Paradigm Spine's number of procedures covered was available in the report.

We also looked at the number of procedures or percentage of coflex procedures on both government and private healthcare companies such as Medicare, Medicaid, Blue Cross and Aetna. We even tried to look for statistics on Centers for Medicare & Medicaid Services (CMS.gov) but we were not able to find the number of coflex procedures covered by insurance. We also looked for the data on scientific journals but the only data found was the insurance coverage for Interspinous Devices (ID) implants, with no breakdown of insurance coverage among ID implants, which Coflex is a part of.

As a last resort, we tried to triangulate the data by looking at Paradigm Spine’s total revenue and the total amount paid by insurance companies such as Medicare, Medicaid, and private insurers on Coflex procedures. In that way, we would be able to determine the percentage of Coflex procedures covered by insurance in terms of the cost it incurred to insurance companies and the total revenue it generated for Paradigm Spine. Dividing the cost it incurred to insurance companies and the total revenue of Paradigm Spine would have given us an estimated percentage of the number of Coflex procedures paid by insurance companies. We were able to find the revenue of Paradigm Spine but we were not able to find the total cost it incurred to insurance companies, as the only available data pertained to Medicare's national average payment for Coflex procedures but not the total cost.


Sources
Sources

From Part 01
Quotes
  • "For example, in the United States, our analysts looked at hundreds of CPT and ICD codes to determine that there are approximately 1.62 million instrumented spinal procedures performed annually."
Quotes
  • "Spinal fusion procedures were listed as the main hospital procedure, being performed on 380,000 patients in 2007 and 457,500 patients in 2011. "
Quotes
  • "The coflex® Interlaminar Stabilization® device is a single-piece titanium implant that goes in the back of your spine to treat moderate to severe spinal stenosis. It’s amazingly simple, very strong, and flexible enough to support your spine without having to fuse your bones together."
  • "coflex is the FIRST AND ONLY posterior lumbar motion preservation solution with Level I evidence (the highest possible level of clinical data) from two prospective randomized studies against two treatment options (decompression alone and decompression with fusion) across two countries (U.S. and Germany). It has been implanted in more than 163,000 patients in over 60 countries worldwide."
Quotes
  • "A class 3 device, the coflex device received premarket approval in October 2012. A five-year clinical trial compared coflex Interlaminar Stabilization to pedicle screw fusion surgery for treating moderate to severe LSS. The 2016 study, published in the International Journal of Spine Surgery, analyzed coflex safety, efficacy and durability. coflex patients maintained significant improvement in visual analog scale leg and back pain."
  • "This [study] not only addresses the stenosis component, but it also helps both VAS back pain and leg pain that's sustained at five years," added Dr. Mathews. "So this treatment option is clinically durable and not a transition to a bigger and more invasive fusion procedure."
Quotes
  • "It was examined under an investigational device exemption (IDE) beginning in 2006, and approved under premarket approval (PMA) in the USA in October, 2012."
From Part 02
Quotes
  • "The most commonly implanted ID includes X-STOP, Coflex, Wallis, and DIAM, with most literature surrounding the X-STOP device"
  • "The proportion of Medicare and private insurance patients undergoing interspinous device (ID) was plotted from 2008 to 2014. The percentage of patients undergoing ID placement with Medicare decreased from 79.7% to 66.7% while private insurance coverage for ID placement increased from 13.5% to 23.1%."
  • "Medicare accounted for 79.5% of payer types, and 74.2% of procedures were performed in areas designated as not low income when stratified by median income for patient zip code."
Quotes
  • "Paradigm Spine, LLC, founded in 2004, is a privately held company and remains focused on the design and development of solutions for the disease management of spinal stenosis. The Company's signature product is the coflex® Interlaminar Stabilization® device, which is currently used in over 60 countries worldwide. coflex is the only lumbar spinal device that has produced Level I evidence in two separate prospective, randomized, controlled studies against two different control groups, changing the standard of care for lumbar spinal stenosis treatment. For additional information visit www.paradigmspine.com or www.coflexsolution.com. "
  • "This is particularly significant for coflex because it provides the evidence private health insurance companies require to allow access for patients to benefit from this important, proven technology."
  • "Paradigm Spine, LLC, a leader in providing motion preservation solutions for the treatment of lumbar spinal stenosis, today announced that the North American Spine Society (NASS) has issued a coverage policy recommendation for Lumbar Interlaminar Device without Fusion and with Decompression."
Quotes
  • " Coflex® is covered nationally by Medicare and is making coverage progress toward regional and national private payor decisions. "
Quotes
  • "• Lumbar Spinal Stenosis Affects 1.6 Million U.S. Patients Annually • Coverage Issued by Health Alliance Plan of Michigan for 518,000 Lives"
Quotes
  • " 4.5 million Blue Cross Blue Shield patients in Michigan will now have access to coflex®  This is in addition to the already 4.1 million Michigan lives covered by Medicare, Medicaid & ACA  Total coverage for coflex® now at 8.6 million lives approximately 82% of Michigan state population"
Quotes
  • "Medicare national average payment for coflex is as follows: Hospital inpatient — $17,253 Hospital outpatient — $14,698 ASC — $10,542"
Quotes
  • " Medical coverage policy issued by Highmark, Inc. and affiliates operating health insurance plans for 5.0 million members in Pennsylvania (PA), West Virginia (WV), and Delaware (DE) "
  • " This Highmark policy is in addition to the already 5.5 million lives covered by Medicare, Medicaid & Affordable Care Act marketplace throughout the states of PA, WV and DE  Total coverage for coflex® now at 10.5 million lives throughout PA, WV and DE "
Quotes
  • " Broad coverage policy issued by BlueCross BlueShield of North Dakota (BCBS ND)  BCBS ND is the largest commercial payor North Dakota  Policy covers coflex® Interlaminar Stabilization®"