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Original Article| Volume 5, ISSUE 2, e367-e374, April 2023

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Resorbable Bioinductive Collagen Implant Is Cost Effective in the Treatment of Rotator Cuff Tears

Open AccessPublished:February 11, 2023DOI:https://doi.org/10.1016/j.asmr.2023.01.002

      Purpose

      This study was conducted to investigate whether the use of resorbable bioinductive collagen implant (RBI) in addition to conventional rotator cuff repair (conventional RCR) is cost-effective when compared to conventional RCR alone, in the treatment of full-thickness rotator cuff tears (FT RCT).

      Methods

      We developed a decision analytic model to compare the expected incremental cost and clinical consequences for a cohort of patients with FT RCT. The probabilities for healing or failure to heal (retear) were estimated from the published literature. Implant and healthcare costs were estimated from a payor’s perspective in 2021 U.S. prices. An additional analysis included indirect cost estimations (e.g., productivity losses). Sensitivity analyses explored the effect of tear size, as well as the impact of risk factors.

      Results

      The base case analysis demonstrated that resorbable bioinductive collagen implant + conventional rotator cuff repair results in incremental costs of $232,468 and an additional 18 healed RCTs per 100 treated patients over 1 year. The estimated incremental cost-effectiveness ratio (ICER) is $13,061/healed RCT compared to conventional RCR alone. When return to work was included in the model, RBI + conventional RCR was found to be cost saving. Cost-effectiveness improved with tear size with the largest benefit seen in massive tears compared to large tears, as well as patients at higher risk of retearing.

      Conclusions

      This economic analysis demonstrated that RBI + conventional RCR delivered improved healing rates at a marginal increase in costs when compared to conventional RCR alone and is, therefore, cost-effective in this patient population. Considering indirect costs, RBI + conventional RCR resulted in lower costs compared to conventional RCR alone and is, therefore, deemed to be cost saving.

      Level of Evidence

      Level IV, economic analysis.

      Introduction

      Rotator cuff disease describes an injury or a degenerative condition that results from damage to rotator cuff enthesis and is one of the leading causes of shoulder-related disability.
      • Lee W.H.
      • Do H.K.
      • Lee J.H.
      • et al.
      Clinical outcomes of conservative treatment and arthroscopic repair of rotator cuff tears: A retrospective observational study.
      • Carr A.J.
      • Cooper C.D.
      • Campbell M.K.
      • et al.
      Clinical effectiveness and cost-effectiveness of open and arthroscopic rotator cuff repair randomised trial.
      -
      • Arshi A.
      • Kabir N.
      • Cohen J.R.
      • et al.
      Utilization and costs of postoperative physical therapy after rotator cuff repair: A comparison of privately insured and Medicare patients.
      The incidence of cuff disease varies between 5 and 40%,
      • Chen J.
      • Zheng Z.Y.
      • Ren Y.M.
      Separate double-layer repair versus en masse repair for delaminated rotator cuff tears: A systematic review and meta-analysis.
      and is age related with increasing incidence for the elderly.
      • Varshneya K.
      • Safran M.R.
      • Sherman S.L.
      • Abrams G.D.
      Costs, complications, and reoperations associated with primary arthroscopic rotator cuff repair with or without acromioplasty and/or biceps tenodesis.
      • Gumina S.
      • Passaretti D.
      • Candela V.
      Epidemiology and demographics of the rotator cuff tear.
      -
      • Minagawa H.
      • Yamamoto N.
      • Abe H.
      • et al.
      Prevalence of symptomatic and asymptomatic rotator cuff tears in the general population: From mass-screening in one village.
      Cuff tear prevalence in each decade has been reported as 0% in the 20-49, 10.7% in the 50-59, 15.2% in the 60-69, 26.5% in the 70-79, and 36.6% in over 80%.
      • Minagawa H.
      • Yamamoto N.
      • Abe H.
      • et al.
      Prevalence of symptomatic and asymptomatic rotator cuff tears in the general population: From mass-screening in one village.
      Another study found that the incidence was 9.7% for those aged less than 20 years and 82% for those aged over 80 years.
      • Teunis T.
      • Lubberts B.
      • Reilly B.T.
      • Ring D.
      A systematic review and pooled analysis of the prevalence of rotator cuff disease with increasing age.
      Cuff disease can produce considerable pain and disability with substantial direct and indirect costs associated with treatment. Direct costs are those associated with the diagnosis and treatment of cuff pathology, while indirect costs include lost income due to inability to work, lower wages, missed work days, and disability payments.
      • Mather 3rd, R.C.
      • Koenig L.
      • Acevedo D.
      • et al.
      The societal and economic value of rotator cuff repair.
      One recent U.S. study assessed the burden of illness associated with RCT and estimated that the mean all-cause direct annual surgical costs were $34,086 for patients with partial-thickness tears and $34,249 for patients with full-thickness tears. There are further indirect costs associated with productivity losses due to absenteeism and short-term disability.
      • Parikh N.
      • Martinez D.J.
      • Winer I.
      • Costa L.
      • Dua D.
      • Trueman P.
      Direct and indirect economic burden associated with rotator cuff tears and repairs in the US.
      Surgical cuff repair has been recommended for the treatment of symptomatic tendon tears with the aim of relieving the patients’ pain and restoring the function of the shoulder joint, by reproducing native anatomy.
      • McIntyre L.F.
      • McMillan S.
      • Trenhaile S.W.
      • Bishai S.K.
      • Bushnell B.D.
      Full-thickness rotator cuff tears can be safely treated with a resorbable bioinductive bovine collagen implant: One-year results of a prospective, multicenter registry.
      The ability to heal a cuff tear after surgery is impacted by age, hypertension, alcohol consumption, obesity, and other risk factors.
      • Gumina S.
      • Passaretti D.
      • Candela V.
      Epidemiology and demographics of the rotator cuff tear.
      Healing and resolution of symptoms following arthroscopic repair also depend in part on underlying physiological factors, such as tendon vascularity, tissue quality, and footprint pathology.
      • Rossi L.A.
      • Rodeo S.A.
      • Chahla J.
      • Ranalletta M.
      Current concepts in rotator cuff repair techniques: Biomechanical, functional, and structural outcomes.
      There is a substantial biologic contribution to rotator cuff disease, which has generated interest in using biological augmentation to enhance the healing environment, including the use of scaffolds, such as resorbable bioinductive collagen implants.
      • McIntyre L.F.
      • Bishai S.K.
      • Brown 3rd, P.B.
      • Bushnell B.D.
      • Trenhaile S.W.
      Patient-reported outcomes after use of a bioabsorbable collagen implant to treat partial and full thickness rotator cuff tears.
      ,
      • Barber F.A.
      • Hrnack S.A.
      • Snyder S.J.
      • Hapa O.
      Rotator cuff repair healing influenced by platelet-rich plasma construct augmentation.
      Resorbable bioinductive collagen implants have been found to be safe and effective in the surgical treatment of both partial- and full-thickness tears,
      • McIntyre L.F.
      • Bishai S.K.
      • Brown 3rd, P.B.
      • Bushnell B.D.
      • Trenhaile S.W.
      Patient-reported outcomes after use of a bioabsorbable collagen implant to treat partial and full thickness rotator cuff tears.
      ,
      • Bokor D.J.
      • Sonnabend D.
      • Deady L.
      • et al.
      Evidence of healing of partial-thickness rotator cuff tears following arthroscopic augmentation with a collagen implant: A 2-year MRI follow-up.
      ,
      • Schlegel T.F.
      • Abrams J.S.
      • Bushnell B.D.
      • Brock J.L.
      • Ho C.P.
      Radiologic and clinical evaluation of a bioabsorbable collagen implant to treat partial-thickness tears: A prospective multicenter study.
      and research is ongoing to gain further understanding of indications and optimal conditions for RBI use.
      Despite the available clinical evidence for the performance of resorbable bioinductive collagen implants; however, surgeons need information to accurately weigh the potential costs versus benefits for patients. The purpose of this study was to investigate whether the use of RBI (REGENETEN, Smith & Nephew, Andover, MA), in addition to conventional RCR is cost-effective when compared to conventional RCR alone in the treatment of full-thickness rotator cuff tears (FT RCT). Our hypothesis was that when both direct and indirect costs of care are considered, rotator cuff repair with a resorbable bioinductive collagen implant would be more cost-effective compared to conventional cuff repair in patients with FT RCT.

      Methods

      Decision-Analytic Model

      We developed a decision analytic model to compare the expected incremental cost and clinical consequences for a cohort of patients with full-thickness rotator cuff tears treated with conventional RCR compared with conventional RCR plus resorbable bioinductive collagen implant (RBI). Conventional rotator cuff repair for full-thickness tears was considered to be arthroscopic or open repair with either double-row, single-row or suture bridge technique.
      • Millett P.J.
      • Warth R.J.
      • Dornan G.J.
      • Lee J.T.
      • Spiegl U.J.
      Clinical and structural outcomes after arthroscopic single-row versus double-row rotator cuff repair: a systematic review and meta-analysis of level I randomized clinical trials.
      • Sheibani-Rad S.
      • Giveans M.R.
      • Arnoczky S.P.
      • Bedi A.
      Arthroscopic single-row versus double-row rotator cuff repair: A meta-analysis of the randomized clinical trials.
      • Sobhy M.H.
      • Khater A.H.
      • Hassan M.R.
      • El Shazly O.
      Do functional outcomes and cuff integrity correlate after single- versus double-row rotator cuff repair? A systematic review and meta-analysis study.
      -
      • Xu C.
      • Zhao J.
      • Li D.
      Meta-analysis comparing single-row and double-row repair techniques in the arthroscopic treatment of rotator cuff tears.
      The base case analysis considered medium, large, and massive tears together for a cohort of patients aged 58 years and then assessed individual tear sizes in sensitivity analysis. The mean age was chosen to reflect most patients included in the studies, which contributed to the clinical data. The schematic representation of the model is shown in Fig 1.
      Figure thumbnail gr1
      Fig 1Model structure (decision analytic model) for resorbable bioinductive collagen implant plus conventional rotator cuff repair (RCR) compared to standard of care alone in full-thickness RCT.
      The treating physician has a choice of either managing the patient with conventional RCR alone or resorbable bioinductive collagen implant as an adjunct to conventional RCR. Following the treatment with either intervention, the RCT either heals or fails to heal (assumed to remain torn). Currently, there is controversy as to what constitutes healing or retearing in the literature, as it is difficult to tell whether a cuff has truly retorn, simply never healed, or some combination of both.
      • Hein J.
      • Reilly J.M.
      • Chae J.
      • Maerz T.
      • Anderson K.
      Retear rates after arthroscopic single-row, double-row, and suture bridge rotator cuff repair at a minimum of 1 year of imaging follow-up: A systematic review.
      We adopted the definition that was used in Hein et al. (2015)
      • Hein J.
      • Reilly J.M.
      • Chae J.
      • Maerz T.
      • Anderson K.
      Retear rates after arthroscopic single-row, double-row, and suture bridge rotator cuff repair at a minimum of 1 year of imaging follow-up: A systematic review.
      and Bushnell et al. (2021)
      • Bushnell B.D.
      • Connor P.M.
      • Harris H.W.
      • Ho C.P.
      • Trenhaile S.W.
      • Abrams J.S.
      Retear rates and clinical outcomes at 1 year after repair of full-thickness rotator cuff tears augmented with a bioinductive collagen implant: A prospective multicenter study.
      studies, which defined retearing as including rotator cuffs that have retorn after healing, as well as those that have not fully healed or failed to heal altogether postsurgery based on imaging studies magnetic resonance imaging, ultrasound, or arthrogram.
      • Hein J.
      • Reilly J.M.
      • Chae J.
      • Maerz T.
      • Anderson K.
      Retear rates after arthroscopic single-row, double-row, and suture bridge rotator cuff repair at a minimum of 1 year of imaging follow-up: A systematic review.
      ,
      • Bushnell B.D.
      • Connor P.M.
      • Harris H.W.
      • Ho C.P.
      • Trenhaile S.W.
      • Abrams J.S.
      Retear rates and clinical outcomes at 1 year after repair of full-thickness rotator cuff tears augmented with a bioinductive collagen implant: A prospective multicenter study.
      Patients who failed to heal could undergo revision RCR surgery, reverse total shoulder arthroplasty, or received conservative management (e.g., pain management). In the base case, we report these tears sizes combined and then considered them separately in a scenario analysis. The analysis was conducted over a 1-year time horizon in line with the clinical data that was used in the model, and no discounting was necessary, as all costs and outcomes were assumed to occur in 1 year.

      Failure Rate

      The probability of healing was dependent on the tear size. The probability of a FT RCT failing to heal with conventional RCR was obtained from a systematic review of literature by Hein et al. (2015), assessing arthroscopic single-row, double-row, or suture bridge rotator cuff repair
      • Hein J.
      • Reilly J.M.
      • Chae J.
      • Maerz T.
      • Anderson K.
      Retear rates after arthroscopic single-row, double-row, and suture bridge rotator cuff repair at a minimum of 1 year of imaging follow-up: A systematic review.
      and a randomized controlled trial by Rashid et al. (2017),
      • Rashid M.S.
      • Cooper C.
      • Cook J.
      • et al.
      Increasing age and tear size reduce rotator cuff repair healing rate at 1 year data from a large randomized controlled trial.
      which used both open and arthroscopic techniques. For this analysis, we extracted data on medium, large, and massive tears treated arthroscopically to mirror the population, tear size, and surgical technique of the comparator studies. The study by Rashid et al. (2017)
      • Rashid M.S.
      • Cooper C.
      • Cook J.
      • et al.
      Increasing age and tear size reduce rotator cuff repair healing rate at 1 year data from a large randomized controlled trial.
      also reported retear rates in 256 patients by tear size in the United Kingdom. For patients treated with RBI, the probability a full-thickness tear failing to heal was obtained from a multicenter registry study using the implant
      • McIntyre L.F.
      • McMillan S.
      • Trenhaile S.W.
      • Bishai S.K.
      • Bushnell B.D.
      Full-thickness rotator cuff tears can be safely treated with a resorbable bioinductive bovine collagen implant: One-year results of a prospective, multicenter registry.
      and three prospective studies.
      • Bokor D.J.
      • Sonnabend D.
      • Deady L.
      • et al.
      Evidence of healing of partial-thickness rotator cuff tears following arthroscopic augmentation with a collagen implant: A 2-year MRI follow-up.
      ,
      • Bushnell B.D.
      • Connor P.M.
      • Harris H.W.
      • Ho C.P.
      • Trenhaile S.W.
      • Abrams J.S.
      Retear rates and clinical outcomes at 1 year after repair of full-thickness rotator cuff tears augmented with a bioinductive collagen implant: A prospective multicenter study.
      ,
      • Thon S.G.
      • O’Malley L.
      • O’Brien M.J.
      • Savoie F.H.
      Evaluation of healing rates and safety with a bioinductive collagen patch for large and massive rotator cuff tears: 2-year safety and clinical outcomes.
      The base model combined the retear rates reported in all four studies, and in all cases, 12-month data were used in the model (Table 1).
      Table 1Data Used in the Model
      Health state and Intervention costsValueLower CIUpper CIReference
      Revision cost$13,118$10,494$15,742
      • Parikh N.
      • Martinez D.J.
      • Winer I.
      • Costa L.
      • Dua D.
      • Trueman P.
      Direct and indirect economic burden associated with rotator cuff tears and repairs in the US.
      Reverse total shoulder arthroplasty$37,500$30,000$45,000
      • Parikh N.
      • Martinez D.J.
      • Winer I.
      • Costa L.
      • Dua D.
      • Trueman P.
      Direct and indirect economic burden associated with rotator cuff tears and repairs in the US.
      Societal cost workers compensation per week (median wage)$990$792$1,188
      Incremental implant cost$3,641
      Resource impact (physiotherapy sessions per patient)
       Conventional rotator cuff repair252030
      • McIntyre L.F.
      • McMillan S.
      • Trenhaile S.W.
      • Bishai S.K.
      • Bushnell B.D.
      Full-thickness rotator cuff tears can be safely treated with a resorbable bioinductive bovine collagen implant: One-year results of a prospective, multicenter registry.
      ,
      • Bushnell B.D.
      • Connor P.M.
      • Harris H.W.
      • Ho C.P.
      • Trenhaile S.W.
      • Abrams J.S.
      Retear rates and clinical outcomes at 1 year after repair of full-thickness rotator cuff tears augmented with a bioinductive collagen implant: A prospective multicenter study.
      ,
      • Dickinson R.N.
      • Kuhn J.E.
      • Bergner J.L.
      • Rizzone K.H.
      A systematic review of cost-effective treatment of postoperative rotator cuff repairs.
       Resorbable bioinductive collagen implant252030
      Return to work in weeks
       Conventional rotator cuff repair1411.216.800
      • Acevedo D.C.
      • Paxton E.S.
      • Williams G.R.
      • Abboud J.A.
      A survey of expert opinion regarding rotator cuff repair.
      ,
      • Haunschild E.D.
      • Gilat R.
      • Lavoie-Gagne O.
      • et al.
      Return to work after primary rotator cuff repair: A systematic review and meta-analysis.
       Resorbable bioinductive collagen implant6.915.5318.297
      • McIntyre L.F.
      • McMillan S.
      • Trenhaile S.W.
      • Bishai S.K.
      • Bushnell B.D.
      Full-thickness rotator cuff tears can be safely treated with a resorbable bioinductive bovine collagen implant: One-year results of a prospective, multicenter registry.
      Conventional rotator cuff repair retear rates
       Medium0.1900.1520.227
      • Hein J.
      • Reilly J.M.
      • Chae J.
      • Maerz T.
      • Anderson K.
      Retear rates after arthroscopic single-row, double-row, and suture bridge rotator cuff repair at a minimum of 1 year of imaging follow-up: A systematic review.
      ,
      • Rashid M.S.
      • Cooper C.
      • Cook J.
      • et al.
      Increasing age and tear size reduce rotator cuff repair healing rate at 1 year data from a large randomized controlled trial.
       Large0.2870.2300.345
       Massive0.5010.4010.601
       Combined0.2710.2170.325
      Resorbable bioinductive collagen implant retear rates
       Medium0.0720.0570.086
      • McIntyre L.F.
      • McMillan S.
      • Trenhaile S.W.
      • Bishai S.K.
      • Bushnell B.D.
      Full-thickness rotator cuff tears can be safely treated with a resorbable bioinductive bovine collagen implant: One-year results of a prospective, multicenter registry.
      ,
      • Bokor D.J.
      • Sonnabend D.
      • Deady L.
      • et al.
      Evidence of healing of partial-thickness rotator cuff tears following arthroscopic augmentation with a collagen implant: A 2-year MRI follow-up.
      ,
      • Bushnell B.D.
      • Connor P.M.
      • Harris H.W.
      • Ho C.P.
      • Trenhaile S.W.
      • Abrams J.S.
      Retear rates and clinical outcomes at 1 year after repair of full-thickness rotator cuff tears augmented with a bioinductive collagen implant: A prospective multicenter study.
       Large0.1190.0950.142
      • McIntyre L.F.
      • McMillan S.
      • Trenhaile S.W.
      • Bishai S.K.
      • Bushnell B.D.
      Full-thickness rotator cuff tears can be safely treated with a resorbable bioinductive bovine collagen implant: One-year results of a prospective, multicenter registry.
      ,
      • Bushnell B.D.
      • Connor P.M.
      • Harris H.W.
      • Ho C.P.
      • Trenhaile S.W.
      • Abrams J.S.
      Retear rates and clinical outcomes at 1 year after repair of full-thickness rotator cuff tears augmented with a bioinductive collagen implant: A prospective multicenter study.
      ,
      • Thon S.G.
      • O’Malley L.
      • O’Brien M.J.
      • Savoie F.H.
      Evaluation of healing rates and safety with a bioinductive collagen patch for large and massive rotator cuff tears: 2-year safety and clinical outcomes.
       Massive0.09300.0740.112
      • McIntyre L.F.
      • McMillan S.
      • Trenhaile S.W.
      • Bishai S.K.
      • Bushnell B.D.
      Full-thickness rotator cuff tears can be safely treated with a resorbable bioinductive bovine collagen implant: One-year results of a prospective, multicenter registry.
      ,
      • Bushnell B.D.
      • Connor P.M.
      • Harris H.W.
      • Ho C.P.
      • Trenhaile S.W.
      • Abrams J.S.
      Retear rates and clinical outcomes at 1 year after repair of full-thickness rotator cuff tears augmented with a bioinductive collagen implant: A prospective multicenter study.
      ,
      • Thon S.G.
      • O’Malley L.
      • O’Brien M.J.
      • Savoie F.H.
      Evaluation of healing rates and safety with a bioinductive collagen patch for large and massive rotator cuff tears: 2-year safety and clinical outcomes.
       Combined0.09280.0740.111
      Events following retear/failure
       Revision surgery0.2520.2020.303
      • Parikh N.
      • Martinez D.J.
      • Winer I.
      • Costa L.
      • Dua D.
      • Trueman P.
      Direct and indirect economic burden associated with rotator cuff tears and repairs in the US.
       Reverse total shoulder arthroplasty0.0390.0310.047
      • Parikh N.
      • Martinez D.J.
      • Winer I.
      • Costa L.
      • Dua D.
      • Trueman P.
      Direct and indirect economic burden associated with rotator cuff tears and repairs in the US.
       Conservative management0.7090.5980.897
      Risk factors for retearing
       Age >60 years2.121.443
      • Gumina S.
      • Passaretti D.
      • Candela V.
      Epidemiology and demographics of the rotator cuff tear.
       Hypertension2.051.412.98
       Alcohol consumption21.42.9
       Obesity2.41.43.76
      The probability of having a revision, reverse total shoulder arthroplasty, or conservative management following a tear recurrence was taken from the IBM Watson Health MarketScan Commercial database, which found that 25.22% and 3.9% would either have a revision surgery defined as reoperation surgery on index shoulder or reverse shoulder arthroplasty, respectively.
      • Parikh N.
      • Martinez D.J.
      • Winer I.
      • Costa L.
      • Dua D.
      • Trueman P.
      Direct and indirect economic burden associated with rotator cuff tears and repairs in the US.
      The MarketScan databases include the patient-level paid and adjudicated medical and pharmacy claims in all care settings, including physician office visits, hospital stays, and outpatient prescription pharmacy claims. We then assumed the remainder (70.9%) of the patients would be managed using conservative methods.

      Resource Utilization, Unit Costs, and Indirect Costs

      Resource use data and cost information were obtained from the published literature. Physiotherapy following shoulder repair surgery is considered a standard intervention. The average number of physiotherapy appointments after conventional RCR is 27,25 while patients who undergo RBI + conventional RCR have an average of 22 appointments.
      • McIntyre L.F.
      • McMillan S.
      • Trenhaile S.W.
      • Bishai S.K.
      • Bushnell B.D.
      Full-thickness rotator cuff tears can be safely treated with a resorbable bioinductive bovine collagen implant: One-year results of a prospective, multicenter registry.
      ,
      • Bushnell B.D.
      • Connor P.M.
      • Harris H.W.
      • Ho C.P.
      • Trenhaile S.W.
      • Abrams J.S.
      Retear rates and clinical outcomes at 1 year after repair of full-thickness rotator cuff tears augmented with a bioinductive collagen implant: A prospective multicenter study.
      In the model, we assumed there was no difference in physiotherapy appointments and, therefore, applied the average of the 3 studies, which is 24.5 appointments. The cost of physiotherapy session per hour was estimated from a published study.
      • Parikh N.
      • Martinez D.J.
      • Winer I.
      • Costa L.
      • Dua D.
      • Trueman P.
      Direct and indirect economic burden associated with rotator cuff tears and repairs in the US.
      The cost of failure to heal was based on costs relating to revision, reverse total shoulder arthroplasty, and conservative management. Revision and reverse total shoulder arthroplasty costs were based on the study by Parikh et al. (2021).
      • Parikh N.
      • Martinez D.J.
      • Winer I.
      • Costa L.
      • Dua D.
      • Trueman P.
      Direct and indirect economic burden associated with rotator cuff tears and repairs in the US.
      Conservative management costs were taken from the same study and were based on outpatient office visits, physiotherapy visits, and nonsteroidal anti-inflammatory drugs (NSAID) to manage pain.
      • Parikh N.
      • Martinez D.J.
      • Winer I.
      • Costa L.
      • Dua D.
      • Trueman P.
      Direct and indirect economic burden associated with rotator cuff tears and repairs in the US.
      One of the main concerns following rotator cuff surgery is the time it takes for patients to get back to their activities of daily living and work. In a scenario analysis, our model took into consideration costs of taking time off work due to rotator cuff injury. Data relating to the number of weeks off work for conventional RCR were calculated from Acevedo et al. (2014).
      • Acevedo D.C.
      • Paxton E.S.
      • Williams G.R.
      • Abboud J.A.
      A survey of expert opinion regarding rotator cuff repair.
      The authors found that return to work was 1 to 2 weeks for sedentary jobs and 4 to 6 months for manual labor jobs. A meta-analysis by Haunschild et al. (2021)
      • Haunschild E.D.
      • Gilat R.
      • Lavoie-Gagne O.
      • et al.
      Return to work after primary rotator cuff repair: A systematic review and meta-analysis.
      found that among workers who returned to work following RCR, 29%, 23%, and 47% performed low, moderate, and heavy work, respectively. We used these data from Haunschild et al. and Acevedo et al. to estimate the weighted number of weeks that it took people to return to work with conventional RCR to be 14 weeks. For the resorbable bioinductive collagen implant, the study by McIntyre et al. (2021)
      • McIntyre L.F.
      • McMillan S.
      • Trenhaile S.W.
      • Bishai S.K.
      • Bushnell B.D.
      Full-thickness rotator cuff tears can be safely treated with a resorbable bioinductive bovine collagen implant: One-year results of a prospective, multicenter registry.
      estimates 7 weeks, while the study by Bushnell et al. 2022
      • Bushnell B.D.
      • Connor P.M.
      • Harris H.W.
      • Ho C.P.
      • Trenhaile S.W.
      • Abrams J.S.
      Retear rates and clinical outcomes at 1 year after repair of full-thickness rotator cuff tears augmented with a bioinductive collagen implant: A prospective multicenter study.
      estimated 6.3 weeks for full-thickness tears, respectively. However, both studies did not report results by type of work (manual or sedentary) performed by study participants. The impact of return to work was subsequently converted into costs by using the average weekly pay in the United States taken from the Bureau of Labor Statistics 2021.
      Since the model assumes that RBI is used as an adjunct to conventional RCR, conventional RCR cost was assumed to be the same in both arms of the study, and only the incremental cost of the RBI surgery was considered. All costs, resource use, and clinical data used in the model are presented in Table 1.
      The base case analysis was conducted from the U.S. payer’s perspective. We also evaluated the model from a societal perspective. The societal perspective captures benefits associated with all stakeholders: patient, employee, and insurer, which results in optimal decision making, especially for regulatory and reimbursement decisions.
      • Jönsson B.
      Ten arguments for a societal perspective in the economic evaluation of medical innovations.
      ,
      • Fakhri M.A.
      • Juni M.H.
      • Faisal I.
      Societal perspective in economic evaluation.

      Cost-Effectiveness and Sensitivity Analysis

      The difference in costs (the incremental cost) was calculated as the total cost for RBI + conventional RCR, minus the total cost for conventional RCR alone and, similarly, the difference in effectiveness was calculated as the difference in healed tears at 1 year. The incremental cost-effectiveness ratio (ICER) of the RBI + conventional RCR relative to conventional RCR was calculated as the difference in costs between the interventions divided by the difference in healed tears over 1 year.
      Considering uncertainty is an important part of an economic evaluation. Sensitivity analyses helps identify which variables have the most impact on the results and, therefore, attempts to test the model under different conditions to determine the validity of the conclusions. We conducted a one-way we did not conduct probabilistic sensitivity analysis sensitivity analyses. For this one-way sensitivity analysis, we varied inputs one at a time using the data reported in the literature. Where such data were not reported, we varied each model input by ±20%, as is the case in most economic evaluations when no data are reported. Furthermore, we conducted a scenario analysis where we evaluated the impact of risk factors for rearing such as age, hypertension, obesity, and alcohol consumption on the cost effectiveness of results.

      Results

      Base Case Analysis

      The base case analysis demonstrated that RBI results in improved healing/retear rates, with more patients achieving a successfully healed rotator cuff, at an increase in cost. The estimated incremental cost effectiveness ration of RBI was $13,061 per additional healed tear (see Table 2).
      Table 2Base Case Results for Resorbable Bioinductive Collagen Implant Compared to Conventional RCR, Results Expressed per 100 Treated Patients
      InterventionTotal CostTears HealedDifference in CostsDifference in Healed TearsCost per Healed Tear
      Conventional rotator cuff repair$322,12673
      Resorbable bioinductive collagen implant$554,59491$232,46818$13,061

      Scenario Analysis, Including the Impact of Interventions on Indirect Costs

      When the impact on return to work was included, RBI as an adjunct to conventional RCR was found to be cost saving compared to conventional RCR alone, saving $469,017 per 100 treated patients with FT RCT. A cost-saving strategy results in lower treatment costs overall and improved healing rates (see Table 3).
      Table 3Scenario Including Impact of Interventions on Indirect Costs, Results Expressed per 100 Treated Patients
      InterventionTotal CostTears HealedDifference in CostsDifference in Healed TearsCost per Healed Tear
      Conventional rotator cuff repair$1,708,12673
      Resorbable bioinductive collagen implant$1,239,10891-$469,01718Dominant
      Dominant means resorbable bioinductive collagen implant + conventional rotator cuff repair is cheaper overall and results in improved healing rates.
      Dominant means resorbable bioinductive collagen implant + conventional rotator cuff repair is cheaper overall and results in improved healing rates.

      Assessing the Impact of Tear Sizes on the Results

      When analyzed by tear size, the results show that the cost effectiveness of RBI improves with increasing size of tear (see Table 4).
      Table 4Assessing the Impact of Interventions on Tear Sizes, Results Expressed per 100 Treated Patients
      Impact of interventions on tear sizes on model results
      Tear SizeDifference in CostsDifference in Healed TearsCost per Healed Tear
      Base case results$232,46818$13,061
      Medium$277,08112$23,550
      Large$239,33917$14,188
      Massive$62,24241$1,525
      Impact of retear risk factors on model results
      Risk factorsDifference in CostsDifference in Healed TearsCost per Healed Tear
      Age greater than 60$85,05238$2,254
      Hypertension$94,26636$2,584
      Alcohol consumption$100,84736$2,833
      Obesity$48,19843$1,128

      Impact of Risk Factors for Retearing

      We assessed the impact of some of these factors on the model results and observed that patients with characteristics that reduce healing rates benefited from RBI. RBI improved healing rates in those conditions compared to the base case, in which risk factors were not included (see Table 4).

      One-Way Sensitivity Analysis

      The one-way sensitivity analysis results are shown in Fig 2 as a tornado diagram. The extremes of each range represent the ICER associated with ±20% variation in each of the variables. The results are portrayed in decreasing order of the variable’s impact on the ICER. The probability of failure to heal or retear rate of the standard of care had the greatest impact on the ICER, followed by the effectiveness of RBI.
      Figure thumbnail gr2
      Fig 2Tornado diagram showing impact of individual parameters on the estimated incremental cost-effectiveness ratio for resorbable bioinductive collagen implant compared to conventional rotator cuff repair, i.e., one-way sensitivity analysis varying model inputs between the reported low and uppermost values.

      Discussion

      Results of the economic model shows that RBI delivers improved healing rates at an incremental cost. The inclusion of indirect costs (return to work) in the analysis predicted that RBI would deliver improved healing rates at lower treatment cost than conventional surgery. Further analyses indicated that RBI becomes more cost effective in patients with larger tears and in those at risk for lack of healing or retearing.
      In today’s healthcare environment, it has become increasingly important to demonstrate that new technologies provide financial value. One way of making better informed decisions about the value of new devices is adopting cost-effectiveness analysis. Although many promising technologies deliver improved outcomes, it is also important to determine at what cost and whether the incremental cost is justifiable.
      The inclusion of indirect costs in economic evaluations is controversial. Early guidelines for economic evaluation recommended adopting a societal perspective, which considers all costs and outcomes.
      • Jönsson B.
      Ten arguments for a societal perspective in the economic evaluation of medical innovations.
      ,
      • Walker S.
      • Griffin S.
      • Asaria M.
      • et al.
      Striving for a societal perspective: A framework for economic evaluations when costs and effects fall on multiple sectors and decision makers.
      A social perspective ensures that the costs of all services associated with providing care to patients, regardless of who bears the costs, are included. Indeed, the study by Mather et al. (2013)
      • Mather 3rd, R.C.
      • Koenig L.
      • Acevedo D.
      • et al.
      The societal and economic value of rotator cuff repair.
      and Vitale et al. 2007
      • Vitale M.A.
      • Vitale M.G.
      • Zivin J.G.
      • Braman J.P.
      • Bigliani L.U.
      • Flatow E.L.
      Rotator cuff repair: An analysis of utility scores and cost-effectiveness.
      both used a societal perspective in their analysis of RCR compared to nonsurgical techniques. However, Mather et al. included productivity costs, i.e., return to work and concluded that RCR was overall cost-saving, while Vitale et al. did not include productivity costs and concluded that RCR was cost-effective compared to nonsurgical techniques. In the United States, it is estimated that about 2 million people suffer from a nonfatal work-related injury, resulting in time away from work and compensation payments of nearly $40 billion per year.
      Occupational Safety and Health Administration
      Department of Labor: Business Case for Safety.
      It would be beneficial to payors, patients, and employers to pay for interventions that can facilitate earlier return to work.
      Similarly, we adopted this more comprehensive approach and included direct costs, as well as productivity costs (return to work) associated with the treatment of RCR to better estimate the value of RBI treatment. This approach is justified since, in many cases, cuff pathology occurs in people of working age and can result in a lengthy period of inactivity and lost productivity. Such an analysis demonstrated that rotator cuff tears are associated with both a substantial treatment and broader societal cost and that the use of RBI is associated with cost savings of nearly half a million dollars in 100 treated patients. However, we acknowledge that additional evidence is needed to ascertain this finding. Payment coverage decisions now reside with third-party payors and providing them with proof of safety, efficacy, and superiority regarding cost should have the goal of improving patient access to successful treatments and new technology.
      Innovation is the hallmark of improving patient care. Introducing novel products that improve healing rates, decrease complications, and facilitate recovery are essential to improvements in treating all musculoskeletal conditions. In this analysis, RBI delivered improved healing/retear rates but at an increased direct healthcare treatment cost. In situations such as these, it is important that healthcare providers can identify those patients who may benefit the most from the new interventions to justify the incremental costs. Our analysis illustrated that those patients with larger tears and those with risk factors for adverse outcomes would experience lower cost per healed tear with use of the RBI. This is not a surprising finding, as people at increased risk of retearing have an increased baseline risk, yet we assume the impact of RBI treatment remains the same, which increases the number of healed tears, making the denominator large. A larger denominator will result in a more favorable cost-effectiveness ratio that is a smaller one or even cost-saving finding. For decision makers with responsibility for resource allocation, information such as this can help to identify how new technologies can be made available to patients in the most cost-effective manner to maximize outcomes.

      Limitations

      Our study has limitations. First, we made some simplifying assumptions, such as restricting the analysis to 12 months postsurgery. We acknowledge that in practice, retear may appear after 12 months. However, if this is the case, we believe this analysis will be conservative, as it may bias the results against RBI, which is expected to reduce the incidence of failure long term. Currently, we are awaiting long-term data to validate this hypothesis. We also assumed that risk factors that influence retear or failure rates are independent. Patients often present with multiple risk factors, such as diabetes and hypertension. Furthermore, we used data from noncomparative studies for RBI; however, we are aware of a randomized controlled study comparing RBI to conventional RCR, which has reported promising interim results showing 86% reduction in nonhealing rates in favor of RBI in 59 patients presented as a conference proceeding.
      • Comino C.V.
      • Navlet M.G.
      • Lafuente J.L.A.
      • Marco S.M.
      • Heredia J.D.
      • Ibán M.R.
      Effect of adding a bioinductive implant to a rotator cuff repair. Preliminary results of a randomized clinical trial.
      Our economic evaluation utilized noncomparative single-arm studies to estimate the impact of RBI when compared to conventional RCR, showing a 66% reduction in non-healing RCT which is less than what the interim results are showing, suggesting our analysis used conservative estimates of the potential impact of RBI. The studies for RBI, which provided evidence on return to work did not report by type of work (sedentary or manual). This information should be collected and be reported separately in future studies. We suggest updating our study once further comparative evidence becomes available. Furthermore, additional comparative evidence addressing return to work is needed segmented by occupational type, for instance, sedentary or manual.

      Conclusion

      This economic analysis demonstrated that RBI + conventional RCR delivered improved healing rates at a marginal increase in costs when compared to conventional RCR alone and is, therefore, cost-effective in this patient population. Considering indirect costs, RBI + conventional RCR resulted in lower costs compared to conventional RCR alone and is, therefore, deemed to be cost saving.

      Supplementary Data

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