The ultimate goal of is the preservation of patients’ visual function and quality of life (QoL). The disease itself as well as the medical or surgical treatment can have an enormous impact on a patient’s QoL.
Even the mere diagnosis of a chronic, irreversible, potentially blinding disorder can adversely affect the patient’s sense of well-being and QoL by eliciting significant anxiety.
Patients with rarely present with visual symptoms, at least early in the course of the disease.
A better understanding of patient-reported QoL can improve patient–physician interaction and enhance treatment adherence by customizing treatment options based on individual patient profile, thus optimizing long-term prognosis.
It is a wide-ranging concept affected in a complex way by the person’s physical health, psychological state, level of independence, social relationships, personal beliefs and their relationships to salient features of their environment.
QoL is thus the sum of a range of objectively measurable life conditions experienced by an individual. These may include physical health, personal circumstances (wealth, living conditions, etc.), social relationships, functional activities and pursuits, and wider societal and economic influences.
The subjective response to such conditions is the domain of personal satisfaction with life. The QoL of an individual or subgroup can be established by comparing their position to that of the total population.
The type of high-quality data that can be acquired in diseases that have a high prevalence, such as cardiovascular disease, is phenomenal. Ultimately the data quality is driven by the market size, because better science can be supported by larger commercial efforts.
is present in about 2% of individuals over 40 years of age. While the disease is not ubiquitous, it is certainly not rare. However, because the market for glaucoma is smaller, it is more difficult for companies, and even the government, to fund massive prospective, randomized glaucoma trials.
Prospective trials, in particular those that include a trabecular meshwork stent, must be meticulous and must follow eyes for many years with expensive technology.
Despite these challenges, two companies in the stent market, Ivantis and Glaukos, have rolled out robust research programs to validate the remarkable benefits of trabecular meshwork stents.
Over the past 20 years, Glaukos has conducted 3 major FDA pivotal trials specific to iStent (240 eyes), iStent inject (505 eyes), and iStent infinite (72 eyes). There are more than 200 peer-reviewed publications with 20,000 eyes studies, with many investigations of clinical outcomes as far out as 8 years.
For its part, Ivantis has performed 3 large level-1 randomized, controlled trials involving 800 patients for its Hydrus stent, resulting in 6 publications in Ophthalmology or the Americanl Journal of Ophthalmology and ultimately 10 original studies in more than 1,000 eyes.
The pivotal has the first 5-year data for any MIGS or other glaucoma study of its kind and size.
These data resulted in a strong treatment recommendation in 2020 from the , a designation never given to a glaucoma surgical therapy because all other surgical options in glaucoma lack similar evidence.
These studies support IOP and medication reduction after the placement of trabecular meshwork stents, and I dare say that this body of work is some of the strongest in all of glaucoma care.
With the embarrassment of riches that is the current glaucoma stent data landscape, it is fully puzzling to all glaucoma patient advocates how the could disregard the ’s recent valuation for cataract and stent codes and value the procedure at a small fraction of its recommended value.
We suppose that CMS is trying to keep a budget stable from year to year, but when important problems are solved, the budget should be adjusted. The budget certainly has been adjusted for COVID, wet macular degeneration, cancer, and myriad other diseases as solutions become available.
The call for “pay for performance” and “pay for quality” would suggest that procedures that deliver quality results should be valued and supported.
The proposed valuation by CMS does not respect the quality of accumulated data, does not appreciate the physician work involved with stent delivery, and does not support quality glaucoma patient outcomes provided by stents.
It is time for CMS and other payors to value evidence and pave a sustainable path forward for trabecular meshwork stents and other microincisional surgeries to come.