Cost-effectiveness of dexamethasone and triamcinolone for the treatment of diabetic macular oedema in Finland: A Markov-model.

PURPOSE: Diabetic macular oedema (DMO), a complication of diabetes, causes vision loss and blindness. Corticosteroids are usually used as a second-line treatment. The aim of this study was to analyse the cost-effectiveness of dexamethasone implants compared to cheaper and more frequently applied triamcinolone injections. METHODS: Markov-modelling, which incorporated both eyes, was used for economic evaluation. The model consisted of five health states based on visual acuity, illustrating the progression of DMO. A cycle length of five months was chosen for dexamethasone and four months for triamcinolone. Time horizons of two and five years were applied. Transition probabilities and health state utilities were sourced from previous studies. The perspective used in this analysis was the hospital perspective. The health care costs were acquired from Kuopio University Hospital in Finland. RESULTS: In this cost-effectiveness analysis, the incremental cost-effectiveness ratio ICER with 3% discount rate was €56 591/QALY for a two-year follow-up and -€1 110 942/QALY for a five-year follow-up. In order to consider dexamethasone as cost-effective over a 2-year time horizon, the WTP needs to be around €55 000/QALY. Over the five-year follow-up, triamcinolone is clearly a dominant treatment. Sensitivity analyses support the cost-effectiveness of dexamethasone over a 2-year time horizon. CONCLUSIONS: Since the sensitivity analyses support the results, dexamethasone would be a cost-effective treatment during the first two years with WTP threshold around €55 000/QALY, and triamcinolone would be a convenient treatment after that. This recommendation is in line with the guidelines of EURETINA.

The impact of anti-vascular endothelial growth factor agents on visual impairment/blindness prevention in patients with diabetic macular edema and on associated patient and caregiver burden in Japan.

AIMS: To estimate the impact of anti-vascular endothelial growth factor (VEGF) agents on visual impairment and blindness avoided in patients with diabetic macular edema (DME) and on associated patient and caregiver productivity loss in Japan. METHODS: This study compared the impact of current care (estimated at 53.8% utilization of anti-VEGF agents using current data) with that of hypothetical care (characterized by a higher utilization of anti-VEGF agents [80.0%], as estimated by an expert panel) of DME patients. A population-based Markov model (two-eye approach) simulated visual acuity (Early Treatment Diabetic Retinopathy Study [ETDRS] letters) transitions over 5 years with DME treatments (intravitreal aflibercept, ranibizumab, and triamcinolone acetonide, and grid/focal laser) in patients with DME. Patient and caregiver productivity loss was determined using the human capital method. RESULTS: In total, 570,000 DME patients were included in the model over 5 years. Increased utilization of anti-VEGF agents resulted in 6,659 fewer cases of severe visual impairment (SVI; 26-35 ETDRS letters) or blindness (0-25 ETDRS letters) compared with the current care approach (26,023 vs 32,682 cases; 20.38% reduction) over this period. Increased utilization of anti-VEGF agents also contributed to productivity loss savings of ¥12.58 billion (US $115.64 million) (i.e., 17.01%) at the end of year 5. The total overall saving over 5 years was ¥45.83 billion (US $421.27 million) (13.45%). LIMITATIONS: Few Japanese data were available, and assumptions were made for some inputs. Vision changes dependent on the function of both eyes were not studied. Only intravitreal (not sub-Tenon's) injections of triamcinolone were considered in this model. Direct costs were not considered. CONCLUSIONS: Increased utilization of anti-VEGF agents can reduce SVI and legal blindness in patients with DME in Japan. This would also be associated with substantial savings in patient and caregiver productivity loss.

Nerve root block versus surgery (NERVES) for the treatment of radicular pain secondary to a prolapsed intervertebral disc herniation: study protocol for a multi-centre randomised controlled trial.

BACKGROUND: Sciatica is a common condition reported to affect over 3% of the UK population at any time and is often caused by a prolapsed intervertebral disc (PID). Although the duration and severity of symptoms can vary, pain persisting beyond 6 weeks is unlikely to recover spontaneously and may require investigation and treatment. Currently, there is no specific care pathway for sciatica in the National Health Service (NHS), and no direct comparison exists between surgical microdiscectomy and transforaminal epidural steroid injection (TFESI). The NERVES (NErve Root block VErsus Surgery) trial aims to address this by comparing clinical and cost-effectiveness of surgical microdiscectomy and TFESI to treat sciatica secondary to a PID. METHODS/DESIGN: A total of 163 patients were recruited from NHS out-patient clinics across the UK and randomised to either microdiscectomy or TFESI. Adult patients (aged 16-65 years) with sciatic pain endured for between 6 weeks and 12 months are eligible if their symptoms have not been improved by at least one form of conservative (non-operative) treatment and they are willing to provide consent. Patients will be excluded if they present with neurological deficit or have had previous surgery at the same level. The primary outcome is patient-reported disability measured using the Oswestry Disability Questionnaire (ODQ) score at 18 weeks post randomisation and secondary outcomes include disability and pain scales using numerical pain ratings, modified Roland-Morris and Core Outcome Measures Index at 12-weekly intervals, and patient satisfaction at 54 weeks. Cost-effectiveness and quality of life (QOL) will be assessed using the EQ-5D-5 L and self-report cost data at 12-weekly intervals and Hospital Episode Statistics (HES) data. Adverse event data will be collected. Analysis will follow the principle of intention-to-treat. DISCUSSION: NERVES is the first trial to evaluate the comparative clinical and cost-effectiveness of microdiscectomy to local anaesthetic and steroid administered via TFESI. The results of this research may facilitate the development of an evidence-based treatment strategy for patients with sciatica. TRIAL REGISTRATION: ISRCTN, ID: ISRCTN04820368 . Registered on 5 June 2014. EudraCT EudraCT2014-002751-25. Registered on 8 October 2014.

Epidural steroids for lumbosacral radicular syndrome compared to usual care: quality of life and cost utility in general practice.

OBJECTIVE: To investigate the effect of adding segmental epidural steroid injections (SESIs) to usual care compared with usual care alone on quality of life and cost utility in lumbosacral radicular syndrome (LRS) in general practice. DESIGN: A pragmatic randomized controlled trial. Results were analyzed using mixed models. SETTING: Primary care. PARTICIPANTS: Patients (N=50) in the acute phase of LRS. INTERVENTIONS: One epidural injection containing 80mg of triamcinolone in normal saline. MAIN OUTCOME MEASURE: Back pain at 4 weeks after the start of the treatment. RESULTS: Both groups experienced a significant increase in quality of life in (especially) the physical domains of the Medical Outcomes Study 36-Item Short-Form Health Survey. The intervention group scored significantly better than the control group at certain time points in the physical domain. The differences were small. The cost-utility analysis showed that with a negligible loss of utility (3d in perfect health), societal costs (193,354 euros per quality-adjusted life year lost) would be saved because of more productivity in the intervention group. CONCLUSIONS: Although the beneficial effects of SESIs are small and the natural course of LRS is predominantly favorable, we think decision makers can consider implementing SESIs in daily practice with the purpose of saving resources. Caution must be taken, and further research should be directed at identifying patient subgroups who might benefit from SESIs, with additional focus on (costs of) complications and adverse effects.

Costs and cost-effectiveness of epidural steroids for acute lumbosacral radicular syndrome in general practice: an economic evaluation alongside a pragmatic randomized control trial.

STUDY DESIGN: A pragmatic, randomized, controlled, single-blinded trial in Dutch general practice. OBJECTIVE: Assessing the costs and cost-effectiveness of adding segmental epidural steroid injections to care as usual in radiculopathy in general practice. SUMMARY OF BACKGROUND DATA: Lumbosacral radicular syndrome (radiculopathy) is a benign, generally self-limiting but painful condition caused by a herniated lumbar intervertebral disc, which results in an inflammatory process around the nerve root. Segmental epidural steroid injections could lessen pain. Low back pain and sciatica form a large financial burden on national health care systems. Improving pain treatment could lower costs to society by diminishing loss of productivity. METHODS: Patients with acute radiculopathy were included by general practitioners. All patients received usual care. Patients in the intervention group received one segmental epidural steroid injection containing 80 mg of triamcinolone as well. Follow-up was performed using postal questionnaires at 2, 4, 6, 13, 26, and 52 weeks. Main outcomes were pain, disability and costs. Economic evaluation was performed from a societal perspective with a time horizon of 1 year. RESULTS: Sixty-three patients were included in the analysis. Mean total costs were €4414 or $5985 in the intervention group and €5121 or $6943 in the control group. This difference was mostly due to loss of productivity. The point estimate for the incremental cost-effectiveness ratio was -€730 or -$990 (1-point diminishment on the numerical rating scale back pain score in 1 patient in the course of 1 yr would save €730 or $990). Bootstrapping showed a 95% confidence interval of -€4476 to €951 or -$6068 to $1289. The cost-effectiveness acceptability curve showed that without additional investment the probability that epidural steroids are cost-effective is more than 80%. CONCLUSION: The effect on pain and disability of epidural steroids in lumbosacral radicular syndrome is small but significant, and at lower costs with no reported complications or adverse effects. Segmental epidural steroid injections could be considered by policy makers as an additional treatment option.

Cost-effectiveness of treatment of diabetic macular edema.

BACKGROUND: Macular edema is the most common cause of vision loss among patients with diabetes. OBJECTIVE: To determine the cost-effectiveness of different treatments of diabetic macular edema (DME). DESIGN: Markov model. DATA SOURCES: Published literature and expert opinion. TARGET POPULATION: Patients with clinically significant DME. TIME HORIZON: Lifetime. PERSPECTIVE: Societal. INTERVENTION: Laser treatment, intraocular injections of triamcinolone or a vascular endothelial growth factor (VEGF) inhibitor, or a combination of both. OUTCOME MEASURES: Discounted costs, gains in quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs). RESULTS OF BASE-CASE ANALYSIS: All treatments except laser monotherapy substantially reduced costs, and all treatments except triamcinolone monotherapy increased QALYs. Laser treatment plus a VEGF inhibitor achieved the greatest benefit, gaining 0.56 QALYs at a cost of $6975 for an ICER of $12 410 per QALY compared with laser treatment plus triamcinolone. Monotherapy with a VEGF inhibitor achieved similar outcomes to combination therapy with laser treatment plus a VEGF inhibitor. Laser monotherapy and triamcinolone monotherapy were less effective and more costly than combination therapy. RESULTS OF SENSITIVITY ANALYSIS: VEGF inhibitor monotherapy was sometimes preferred over laser treatment plus a VEGF inhibitor, depending on the reduction in quality of life with loss of visual acuity. When the VEGF inhibitor bevacizumab was as effective as ranibizumab, it was preferable because of its lower cost. LIMITATION: Long-term outcome data for treated and untreated diseases are limited. CONCLUSION: The most effective treatment of DME is VEGF inhibitor injections with or without laser treatment. This therapy compares favorably with cost-effective interventions for other conditions. PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality.

The outcomes and cost-effectiveness of intraarticular injection of the rheumatoid knee.

Although intraarticular injections are important to the management of rheumatoid arthritis, there are few studies regarding the cost-effectiveness of alternative injection techniques. This randomized controlled study addressed the cost-effectiveness of two different low-cost, anatomic landmark palpation-directed intraarticular injection techniques. Ninety-six symptomatic rheumatoid knees were randomized to two different low-cost, palpation-guided intraarticular injection techniques utilizing (1) a conventional syringe or (2) a mechanical syringe, the RPD (the reciprocating procedure device). Three milliliters of 1% lidocaine were used to anesthetize the synovial membrane, followed by arthrocentesis and hydrodissection, and injection of 80 mg of triamcinolone acetonide utilizing the one-needle two-syringe technique. Baseline pain, procedural pain, aspirated fluid volume, pain at outcome (2 weeks and 6 months), responders, reinjection rates, cost/patient/year, and cost/responder/year were determined. Pain was measured with the 10 cm Visual Analogue Pain Scale (VAS). Both techniques significantly reduced pain scores at outcome from baseline (P < 0.001). The mechanical syringe technique resulted in a greater volume of aspirated fluid (P < 0.01), a 38% reduction in procedural pain (P < 0.001), a 24% reduction in pain scores at outcome (P < 0.03), an increase in the responder rate (P < 0.025), 33% increase in the time to next injection (P < 0.001), 23% ($35 US) reduction in cost/patient/year for a patient treated in a physician office (P < 0.001), 24% reduction ($26 US) in cost/patient/year for a hospital outpatient (P < 0.001), and 51% ($151 US) reduction in cost/responder/year (P < 0.001). The outcomes and cost-effectiveness of intraarticular injection of the rheumatoid knee can be improved significantly with low-cost alternations in technique.

Effect of corticosteroid injection for trochanter pain syndrome: design of a randomised clinical trial in general practice.

BACKGROUND: Regional pain in the hip in adults is a common cause of a general practitioner visit. A considerable part of patients suffer from (greater) trochanteric pain syndrome or trochanteric bursitis. Local corticosteroid injections is one of the treatment options. Although clear evidence is lacking, small observational studies suggest that this treatment is effective in the short-term follow-up. So far, there are no randomised controlled trials available evaluating the efficacy of injection therapy. This study will investigate the efficacy of local corticosteroid injections in the trochanter syndrome in the general practice, using a randomised controlled trial design. The cost effectiveness of the corticosteroid injection therapy will also be assessed. Secondly, the role of co-morbidity in relation to the efficacy of local corticosteroid injections will be investigated. METHODS/DESIGN: This study is a pragmatic, open label randomised trial. A total of 150 patients (age 18-80 years) visiting the general practitioner with complaints suggestive of trochanteric pain syndrome will be allocated to receive local corticosteroid injections or to receive usual care. Usual care consists of analgesics as needed. The randomisation is stratified for yes or no co-morbidity of low back pain, osteoarthritis of the hip, or both. The treatment will be evaluated by means of questionnaires at several time points within one year, with the 3 month and 1 year evaluation of pain and recovery as primary outcome. Analyses of primary and secondary outcomes will be made according to the intention-to-treat principle. Direct and indirect costs will be assessed by questionnaires. The cost effectiveness will be estimated using the following ratio: CE ratio = (cost of injection therapy minus cost of usual care)/(effect of injection therapy minus effect of usual care). DISCUSSION: This study design is appropriate to estimate effectiveness and cost-effectiveness of the injection therapy. We choose to use a pragmatic study design and are thus not able to study specific effects of the injection with corticosteroids. A distinction between placebo effect of the injection and specific effects of the corticosteroids is therefore not possible.

[Allergy to ragweed in the Rhone-Alpes and consumption of anti-allergics]. / Allergie a l'ambroisie en Rhône-Alpes et consommation des anti-allergiques.

AIMS: To measure evolution and cost consumption of anti-allergic medicines during ragweed pollen-period, geographic trend in the locations of anti-allergic consumers. Ragweed is highly spread in Rhone Alps. METHODS: We measured the ratio: number of boxes of anti-allergic medicines per one thousand patients between 6 and 64 years, refunded by twelve local health offices in the Rhone Alps area. We obtained statistical mapping for consumers of triamcinolone, we analysed in the relation to weakly ragweed pollen figures. RESULTS: Four geographic areas showed high increases of antihistaminic consumption from the middle of august to the end of september during the four years studied. A threefold increase of consumption of antihistaminic medicines, anti-allergic eye-drops and anti-allergic nasals topics was observed during ragweed pollen-period (week 33 to week 40). Antihistaminic consumption ratios increased in relation with ragweed pollen-period This study demonstrated that the anti-allergic medicines consumption reflected the image of ragweed allergy. This sanitary feature is easily obtained from the refunded databases of Medical Insurance.

Cost analysis of the use of inhaled corticosteroids in the treatment of asthma: a 1-year follow-up.

A retrospective cohort using pharmacy and medical claims was analysed to determine whether the differences in efficacy of various inhaled corticosteroids demonstrated in clinical trials lead to differences in costs of care observed in clinical practice. Subjects that had an ICD-9 (493.XX) code for asthma and a new pharmacy claim for inhaled fluticasone propionate 44 mcg (FP), beclomethasone dipropionate (BDP), triamcinolone acetonide (TAA), budesonide (BUD) or flunisolide (FLU) were identified and followed for 12 months. Annual asthma care charges (pharmacy and medical) over the 12-month observation period were significantly (P < 0.03) higher in patients treated with BDPTAA, BUD and FLU compared to FP, 24%, 27%, 34% and 45% respectively In addition, patients treated with BDPTAA, and FLU were associated with significantly (P < 0.005) higher total healthcare (asthma + non-asthma) charges compared to patients on FP, 53%, 46% and 39% respectively Asthma care and total healthcare charges remained lower for FP after including FP110 mcg and excluding patients who were extreme cost outliers (+/- 2 SD from the mean) in a univariate sensitivity analysis. This analysis supports recent randomized control trials that FP offers a superior efficacy profile at lower asthma care as well as total healthcare charges compared to other inhaled corticosteroids.