Persistent GERD Symptoms Call for Change in Care Management Coverage: A Real-World Perspective for Chronic Care Policy

December 2022 Vol 15, No 4 - Business, Review Article
F. Randy Vogenberg, PhD, FASHP, and Murray L. Harber
Dr Vogenberg is Principal, Institute for Integrated Healthcare, and Board Chair, the Employer–Provider Interface Council (EPIC), Greenville, SC; Mr Harber at the time this article was written was Executive Director, Mississippi Business Group on Health, Jackson, MS, and Fellow, EPIC.
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Abstract

BACKGROUND: In the United States, >25% of the entire population are reported to experience episodes of gastroesophageal reflux disease (GERD). Despite widespread access to effective medications for mild-to-moderate GERD, this disorder accounts for more than $24 billion per year in total health expenditures. Patients with chronic, severe GERD can experience adverse effects from GERD medications, are nonadherent, or do not respond to treatment with antacids, histamine-2 antagonists, or proton pump inhibitors. For these patients, care strategies to include surgical options have evolved since the introduction of the Nissen fundoplication in the mid-20th century.

OBJECTIVE: To assess updates to GERD guidelines with evidence-based data since 2005 on evolved surgical options in clinical practice and outline a change in insurance coverage for chronic care.

DISCUSSION: The latest iteration of transoral incisionless fundoplication (TIF), TIF 2.0, is a routine option employed today. TIF avoids laparoscopic surgery and complications associated with conventional antireflux surgical procedures. Studies of the efficacy and safety of this technique confirm that it significantly diminishes esophageal acid exposure and is associated with lower rates of serious adverse events, thereby offering economic benefits. However, recurrent use of GERD medications and the need for follow-up procedures have been reported. The health economic implications of GERD and TIF have not been fully explored for more than a decade. From the perspective of plans and plan sponsors, several key factors must be considered, including the time horizon chosen for determinations of total cost-effectiveness. Furthermore, the greatest contributor to total expenditures associated with GERD is indirect costs, such as productivity and absenteeism. In the face of limited economic information, plan sponsors (and health plans and insurers) are still deciding on coverage policy by assessing direct financial risks.

CONCLUSION: Careful trend analysis in high-prevalence, chronic disorders such as GERD can reveal potential opportunities for reducing direct and indirect economic risks through optimal coverage policies.

Key Words: chronic care management, cost of care, gastroesophageal reflux disease, GERD, health plan sponsors, innovation, medical benefits, TIF, transoral incisionless fundoplication

Am Health Drug Benefits.
2022;15(4):105-110

Manuscript received June 11, 2021
Accepted in final form November 22, 2021

Disclosures are at end of text

More than one-quarter of the US population are reported to experience episodes of gastroesophageal reflux disease (GERD).1 More than 5.5 million new GERD diagnoses were made in the United States during 2014; 326,000 diagnoses were made in the emergency department.2 Total costs in 2000 were estimated to be >$24 billion per year.3

From the perspective of the health plan sponsor (eg, corporate employer), however, the greatest factor in the economic impact of GERD is the indirect medical costs, particularly its effect on productivity.3,4 Researchers found that workers with GERD had 41% more sick leave days and 59% more short-term disability days than matched employees without GERD (P <.0001).4 On-the-job productivity was also found to be significantly lower annually (by 6.0%) in the employees with GERD.4 Productivity in workers with functional dyspepsia, a condition related to GERD, was similarly affected.5

Grossmeier established that evidence shows that employers who invest in workforce health and well-being programs are indicative of high-performing, well-managed companies.6 Employers who offer health and well-being benefits and programs and resources to support employee and family health needs can better attract and retain workforce.

Pharmaceutical Mainstays of Treatment and Coverage

In patients with mild-to-moderate GERD, antacids, histamine-2 (H2) antagonists, and proton pump inhibitors (PPIs) have been the mainstay of medical treatment. Several agents in the H2 antagonist and PPI classes have been available for sale without a prescription for many years. For example, the first H2 antagonist approved for sale without a prescription was ranitidine (Zantac) in 1995,7 and the PPI omeprazole (Prilosec, Zegerid) was made available in 2003.8

The widespread availability of over-the-counter (OTC) medications for the GERD symptoms of heartburn and reflux may have encouraged patients to self-diagnose and self-treat. In 2018, OTC antireflux drugs accounted for $60 billion in expenditures.2 Therefore, a significant number of diagnoses and expenditures are not captured in the medical claims system. In addition, such OTC treatments are typically not covered by health plans or health insurers. As a result, the cost of OTC therapy is fully borne by the patient or other entity (ie, charity) as out-of-pocket costs.

Easy access to effective symptomatic remedies such as OTC products has helped a large proportion of the population with GERD, but a significant subset of patients experiences chronic or refractory symptoms, despite changes in lifestyle (eg, elevating the head during sleep9) and diet. Medical therapy with PPIs does not resolve symptoms in approximately 40% of patients with GERD.10-12 When these patients do seek care, they are more likely to have moderate, severe, or refractory disease, which may result in referral to gastroenterologists.13

The Reasons for Reflux

The primary anatomical cause of GERD is dysfunction in the gastroesophageal valve complex, which allows food to pass from the esophagus to the stomach. In GERD, ≥1 component of the gastroesophageal valve fails to close completely after meals, allowing a portion of the stomach’s contents, including gastric acid, to enter the esophagus, potentially reaching the pharynx and mouth. Factors include transient lower esophageal sphincter relaxation, lower esophageal sphincter pressure, failure of the angle of the gastroesophageal junction, and the presence of a hiatal hernia.14 Prolonged periods of reflux can damage the esophageal lining, causing esophagitis. If left untreated, 10% to 15% of patients with GERD will develop Barrett’s esophagus, a precursor to esophageal carcinoma.15

The common symptoms and signs of GERD include heartburn, regurgitation, persistent cough, laryngitis, and nausea. Patients who experience regurgitation on a chronic basis may also have delayed gastric emptying, which complicates medical treatment. Gastroparesis occurs in as many as 20% of patients with GERD.16 In these patients, delayed gastric emptying may be the reason for suboptimal responses to standard GERD therapies.17

Surgical treatment for management of GERD may be recommended in the following scenarios: (1) failure of medical therapies to control reflux symptoms; (2) patients are nonadherent to long-term therapy with PPIs; (3) chronic GERD has caused serious complications (eg, Barrett’s esophagus); (4) patients with adverse reactions to GERD medications; and (5) the patient experiences chronic asthma, cough, or hoarseness.18,19 Surgery seeks to address the basic anatomical issue underlying GERD—the gastroesophageal valve dysfunction. Several surgical options are available.

Surgeon Rudolph Nissen first reported on the use of fundoplication to treat reflux esophagitis in 1956 by repairing the gastroesophageal valve.20 In this procedure, the upper part of the stomach, the fundus, is stitched so that it completely surrounds the lower end of the esophagus. Originally performed as open surgery, it is generally performed as a laparoscopic procedure today. Laparoscopic Nissen fundoplication has since been the most commonly performed antireflux procedure. As opposed to medications for GERD, fundoplication surgery forms a barrier to reflux of any gastric contents, thereby protecting the esophageal lining.21

Nissen fundoplication enables a very high percentage of patients to stop taking acid-suppression medications, and it has been associated with an improvement in the quality of life of patients with GERD.22 In a study of 79 patients undergoing laparoscopic Nissen fundoplication, 92% reported that GERD symptoms were relieved completely after surgery, although approximately one-quarter were found to be taking PPIs once again at a 10-year follow-up.22 In this analysis, 15% of patients undergoing laparoscopic Nissen fundoplication required reoperation before the end of follow-up. In a separate retrospective analysis of 9462 patients undergoing laparoscopic fundoplication, reoperation was required in only 4.5% of patients based within a mean follow-up of 8.3 years.23 In comparison, Broeders and colleagues found that the need for reoperation in patients undergoing the conventional (nonlaparoscopic) procedure was >34%.22

Beyond the potential need to reoperate, Nissen fundoplication is associated with dysphagia, especially difficulty in swallowing solid foods. This has been reported in approximately 26% of patients >1 year after surgery.19 Other notable complications of this procedure are the possibility of hernia at the location of incision and excessive belching and bloating.24

Recognizing these shortcomings and that Nissen fundoplication had a long history as a useful option for patients with chronic GERD, a new surgical fundoplication technique was developed. This modification, known as transoral incisionless fundoplication (TIF), was first used in 2005. Whereas laparoscopic fundoplication requires the use of small incisions, TIF does not. Instead of using a laparoscope to visualize the surgical field, an endoscope that passes through the device enables the surgeon to see the tissue being wrapped and fastened.

TIF evolved quickly through 3 evolutionary stages: endoluminal fundoplication; TIF 1.0, which was first available in 2007; and TIF 2.0, which was introduced in 2009 (Table 1).25,26 For patients who require repair of a hiatal hernia in addition to lower esophageal sphincter modification, a combined laparoscopic and TIF 2.0 procedure has been used successfully.

Table 1

Today, virtually all transoral procedures are completed using TIF 2.0.26 In this procedure, a specialized device is passed through the oral cavity and esophagus, which then is used to engage and retract the tissue to be used in forming the plication, wrap the plicated tissue, and fasten it to maintain compression.27 The endoscope used to image the procedure is passed through the central lumen of the device, thereby avoiding the need for laparoscopic incisions.

Overall, the TIF 2.0 procedure for treatment of GERD results in improvement of reflux and regurgitation symptoms and GERD-related quality of life.25,28 It also appears to significantly diminish but not normalize esophageal acid exposure. Long-term data from a randomized clinical trial suggest that it may reduce the need for PPI use for up to 5 years.28

A meta-analysis of trials using the transoral approach revealed that the efficacy of TIF 2.0 and laparoscopic Nissen fundoplication is similar and confirmed that TIF 2.0 often avoids some of the serious side effects and complications (eg, dysphagia) of Nissen fundoplication.26

As of 2019, the rate of serious adverse events associated with TIF 2.0 was 0.43% (or 94 in 22,000 cases evaluated).25 The most common adverse events were perforation, pleural effusion, and mucosal laceration/bleeding, accounting for more than half of all events. In comparison across gastrointestinal (GI) surgeries, a 2019 pooled analysis found the rate of perforation alone in the more common screening colonoscopy to be 1.1%.29

A 2021 meta-analysis (8 studies, 418 patients) reported TIF outcomes after >3 years of follow-up (mean, 5.3 years). The authors concluded that “TIF appears to offer a long-term, safe, therapeutic option for select patients with GERD.”30

Employers’ Economic Considerations and Questions

The 3 mainstays for addressing persistent GI symptoms of regurgitation or reflux are medical treatment with an acid-controlling medication, TIF, and Nissen surgical fundoplication procedures.

For patients with mild, episodic GERD symptoms, a strategy focused on PPIs or H2 antagonists in patients is assumed to be cost-effective relative to other more invasive interventions. From the perspective of a commercial payer or plan sponsor, these medications, available as OTC or generic agents, are typically a no-cost or extremely low-cost option. Even in the larger patient population with mild-to-moderate GERD, a trial of these conventional medications would likely be undertaken before any patient seeks a fundoplication procedure (or receives prior authorization for the surgery).

For patients with chronic GERD or erosive esophagitis (with or without hiatal hernia) that is severe or refractory to antireflux medications, can an argument be made that fundoplication is cost-effective? At this time, published economic studies are lacking, especially from the plan sponsor perspective. The question implies the need to understand several factors, but intuitively, one may be most challenging from the health plan or plan sponsor’s perspective: the period over which the evaluation is performed. If the procedure is cost-effective, but only over a postsurgical time horizon that is longer than the average duration of plan enrollment or corporate employment, this may not be persuasive. On the other hand, a finding of cost-effectiveness over a time span that reflects real-world duration of employment or plan enrollment may be more meaningful to payers and plan sponsors.

Beyond this important point, the determination of cost-effectiveness involves several factors, including direct healthcare and indirect nonmedical costs. The small proportion of patients with chronic GERD for whom pharmaceutical treatment does not provide adequate long-term symptomatic relief will accrue significantly higher costs in the form of repeated office visits, higher-cost prescription medications (eg, to treat Barrett’s esophagitis), biopsy, and endoscopies. In addition, the indirect medical costs associated with chronic GERD can contribute to a significant burden on patients and employers.3,5

Over the years, claims-based reports of treatments and outcomes have provided limited information for employer plan sponsors to take action on benefit coverage. In addition, poorly captured or reported economic data, coupled with changing techniques or technology and the coronavirus pandemic, have slowed all procedures, including greater uptake and utilization of TIF 2.0.

Employers and plan sponsors that hold the financial risk for the treatment of chronic GERD may consider the impact of this condition over the course of the average duration of employment. A real-world employer checklist to perform an economic evaluation from such a perspective would include items such as:

  • A comprehensive view of the patient journey (including the potential need for reoperation or reinitiation of H2 antagonists or PPIs, usually at higher doses)
  • Claims-level data (claims paid) from both hospital and medical providers
  • Improved techniques or technology (medical or drug) in the plan
  • Outcomes-related data
  • Presurgical/postsurgical costs
  • Disability claims costs
  • Partial/full return to work
  • Absenteeism and productivity measures

It is important to note that information about OTC PPI utilization will not be available for most plans/plan sponsors because they are not covered in the typical health plan.

Geographic differences should be considered in terms of variances in the costs of delivering healthcare, including surgical procedures, in addition to the prevalence of comorbid conditions that may exacerbate GERD symptoms. Regional differences in common healthcare procedures across the United States show variations in cost and therefore prices (Table 2).31

Table 2

In 2019 dollars, TIF costs approximately $9700, which includes both professional claims and facility costs. In comparison, laparoscopic Nissen fundoplication costs approximately $13,500. These figures are based on a national commercial claims database covering professional and facility claims for Current Procedural Terminology codes 43210 for TIF and 43280 for Nissen fundoplication. (Personal email correspondence with Thomas R. McCarty, MD, April 2, 2021)

To credibly estimate the cost-effectiveness of TIF, the question of an appropriate time horizon must be addressed. A sufficiently long period may allow for consideration of the likely need for repeat fundoplication in a proportion of patients, in addition to the use of conventional pharmaceuticals and other therapies to treat recurrent GERD symptoms. A time period of 10 years or more may be advisable, otherwise the economic evaluation will likely be biased in favor of the TIF procedure. This time frame also aligns with typical employer and plan risk-management stratification, where a small proportion of members are associated with substantially greater costs than average plan members over time.

Incorporating Clinical and Economic Aspects of TIF Related to Financial Risk

In the face of limited economic information, plan sponsors (as well as health plans and insurers) are still required to decide on coverage policy and assess their financial risks. This is known as fiduciary responsibility of health plan funds under both state-regulated or Employee Retirement Income Security Act plans. Prior authorization, step edits, and other tools provide organizations latitude in how these decisions are made and options in coverage. Underlying these decisions is an assessment of the clinical literature for optimal outcomes and professional society clinical guidelines.

In recent years, several studies have been published that further evaluate various aspects of TIF to address contemporary health insurance guidance that has lagged in plan application or updates in care coverage. In March 2020, Vaezi and colleagues reviewed the literature pertaining to endoscopic or surgical therapies for GERD.32 This was not a systematic review, but it is useful for examining emerging evidence, given the lack of clarity on the utility of these therapies. The general purpose of an analysis of this type is to identify and map the available evidence, to examine how research in this field has been conducted, and to identify knowledge gaps in this controversial area.

Although the American College of Gastroenterology has not updated its GERD treatment guidelines since 2013, the American Gastroenterological Association issued a technology coverage statement in April 2016 determining that transoral fundoplication was associated with “sustainable improvement in health outcomes, symptom relief, decrease in PPI utilization, and esophageal pH.”33 The Society of American Gastrointestinal and Endoscopic Surgeons reviewed TIF in 2017 and recommended its use in appropriately selected patients.34

In consideration of the relatively low direct medical costs of GERD, plans and their sponsors may be more interested in addressing other healthcare priorities (eg, managing the cost of specialty pharmaceuticals, controlling infection, or reining in the cost of hospital services). However, careful trend analysis in high-prevalence, chronic disorders like GERD can reveal potential opportunities for reducing direct and indirect economic risks represented by such subpopulations.

Improvements in measurable plan performance over both shorter and longer time frames are important to plan sponsors. The COVID-19 pandemic may have further raised the importance of this issue. Finding opportunities, such as that represented by refractory or severe GERD, can improve plan risks and enhance patient care. In addressing financial risks more holistically, plan sponsors can also execute their fiduciary responsibilities toward the benefit of employers and their plan members. This includes improving aspects of business operations from reduced worker disability and absence.

In addition, such an approach meets the needs of current or future employees in a highly competitive personnel marketplace. Employers can achieve such savings in GERD by knowing all their direct claims (medical and pharmacy benefit) and indirect costs associated with GERD providers in a plan year, understanding the number of plan members diagnosed or undiagnosed for GERD, and seeking to adopt improved techniques or technology (medical or drug) in their plan (see employer checklist).

Medical policies and plan coverage may need to be updated for patients with refractory or severe GERD. Even in those who undergo TIF, a proportion will require long-term PPI therapy to maintain durable improvements in disease-specific quality of life.25

Conclusion

The surgical management of GERD has evolved since the introduction of Nissen fundoplication to repair the gastroesophageal valve, first with laparoscopic procedures and then with the transoral incisionless approach. Given the sizable burden of GERD on the healthcare system, employers and plan sponsors may want to consider real-world and holistic economic factors outlined in this article to improve the efficiency of healthcare expenditures in the surgical treatment of GERD. One issue is the lack of updated clinical guidelines on GERD. Employers and plan sponsors can use this information to manage their benefit plan better fiscally until guidelines catch up to real-world practice and technologies that can avoid care in higher-cost settings.

Targeted efforts, such as those described here, in patients with refractory or severe GERD represent important opportunities around chronic conditions for plan sponsors as part of an enterprise-wide risk management approach that focuses on subpopulations of patients as members of plans associated with higher health spending.

Funding Source
Funding for this article was provided by EndoGastric Solutions.

Author Disclosure Statement
Dr Vogenberg has received honoraria from Eversana and from Employer-Provider Interface Council (EPIC) and is a Consultant to Eversana and to EndoGastric Solutions; Mr Harber is a Consultant to EndoGastric Solutions, Orexo-US, and Southern Farm Bureau Life Insurance, and owns stock in Vigilant Health.

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