K Caekelbergh

Economic evaluation of methyl aminolaevulinate‐based photodynamic therapy in the management of actinic keratosis and basal cell carcinoma

Background  Various effective therapeutic options are currently available for the treatment of actinic keratosis (AK) and basal cell carcinoma (BCC), but none is perfect. Poor cosmesis resulting from surgical procedures and skin irritation induced by topical agents remain significant problems.

Real-life practice study of the clinical outcome and cost-effectiveness of photodynamic therapy using methyl aminolevulinate (MAL-PDT) in the management of actinic keratosis and basal cell carcinoma

Clinical trials have shown that photodynamic therapy using methyl aminolevulinate (MAL-PDT) is an effective treatment for actinic keratosis (AK), and nodular and superficial basal cell carcinoma (nBCC and sBCC) unsuitable for other available therapies. Economic evaluation models have shown that it is a cost effective intervention as well. The objectives of this prospective, observational, one arm study were (i) to verify in a real-life practice study the results obtained in previous clinical trials with MAL-PDT in the treatment of AK, nBCC and sBCC; (ii) to calculate the real-life cost of treatment and validate predictions from an economic evaluation model. Patients with AK and/or BCC were selected according to Belgian reimbursement criteria for treatment with MAL-PDT. Clinical response, cosmetic outcome and tolerability were assessed. MAL-PDT cost was calculated and compared to published model cost data. Data were collected from 247 patients (117 AK, 130 BCC). A complete clinical response was obtained for 83% of AK (85/102) and BCC (97/116) patients. A good or excellent cosmetic outcome was obtained for 95% of AK patients and 93% of BCC patients. Tolerability was good: only 2 patients withdrew for adverse events. Clinical results were similar to previous studies. Total cost of care per patient was euro 381 for AK, euro 318 for nBCC, and euro 298 for sBCC. Total cost per lesion was euro 58 for AK (identical to model prediction), euro 316 for nBCC and euro 178 for sBCC (both within 20% of model prediction). The clinical results of MAL-PDT in this real-life practice study confirm those demonstrated in previous clinical trials. Costs calculated from this study confirm predicted cost-effectiveness in the original model for MAL-PDT in the management of AK and BCC.

Resource use and cost of hepatitis C-related care.

Background Chronic hepatitis because of the hepatitis C virus (CHC) is a major health problem that can lead to decompensated cirrhosis, hepatocellular carcinoma, and eventually death, all of which are associated with significant healthcare costs. Aim To update the cost of care of CHC according to the different severity stages of the disease in a west European country (Belgium). Methods Medical records of 157 patients, who were referred to the medical specialist at different stages of disease, were reviewed to identify the medical costs over a follow-up period of 3 years or 2 years in the case of liver transplantation (LT). Six disease stages were defined on the basis of histology (Metavir classification) and/or clinical data. Results In comparison with mild disease, the cost increased 1.6 times in the case of decompensated cirrhosis, 1.9 times in the case of hepatocellular carcinoma, and 3.4 in the case of LT. The costs for medication, hospitalization, and ambulatory care were, respectively, on the one hand, 81, 8, and 11% for mild disease and, on the other, 18, 79, and 3% for LT. In the case of a sustained viral response, the cost of follow-up within 3 years decreased by 45% for patients with mild and moderate disease. Conclusion Antiviral treatment is the most important factor governing cost in mild and moderate disease, but once complications of CHC occur, hospitalization costs far exceed the cost of antiviral therapy. Already during the first 3 years of follow-up, sustained viral response decreased the cost significantly. Treatment of patients with CHC in an early stage has the potential to be cost-effective.

Cost Effectiveness of Darunavir/Ritonavir 600/100 mg bid in Protease Inhibitor-Experienced, HIV-1-Infected Adults in Belgium, Italy, Sweden and the UK

AbstractBackground: Two phase II trials (POWER 1 and 2) have demonstrated that darunavir co-administered with low-dose ritonavir (DRV/r) provides significant clinical benefit compared with control protease inhibitors (PIs) in highly treatment-experienced, HIV-1-infected adults, when co-administered with optimized background therapy (OBR). Objective: To determine whether DRV/r is cost effective compared with control PIs, from the perspective of Belgian, Italian, Swedish and UK reimbursement authorities, when used in treatment-experienced patients similar to those included in the POWER 1 and 2 trials. Methods: An existing Markov model containing health states defined by CD4 cell count ranges (>500, 351–500, 201–350, 101–200, 51–100 and 0–50 cells/mm3) and death was adapted for use in four European healthcare settings. Baseline demographics, CD4 cell count distribution and antiretroviral drug usage reflected those reported in the POWER 1 and 2 trials. Virological/immunological response rates and matching transition probabilities over the patients lifetime were based on results from the POWER trials and published data. After treatment failure, patients were assumed to switch to a tipranavir-containing regimen plus OBR. For each CD4 cell count range, utility values and HIV-related mortality rates were obtained from the published literature. National all-cause mortality data and published data on the increased risk of non HIV-related mortality in HIV-infected individuals were taken into account in the model. Data from observational studies conducted in each healthcare setting were used to determine resource-use patterns and costs associated with each CD4 cell count range. Unit costs were derived from official local sources; a lifetime horizon was taken and discount rates were selected based on local guidelines. Results: In the base-case analysis, quality-adjusted life-year (QALY) gains of up to 1.397 in Belgium, over 1.171 in Italy, 1.142 in Sweden and 1.091 in the UK were predicted when DRV/r-based therapy was used instead of control PI-based treatment. The base-case analyses predicted an incremental costeffectiveness ratio (ICER) of h11 438/QALY in Belgium, h12 122/QALY in Italy, h10 942/QALY in Sweden and h16 438/QALY in the UK. Assuming an acceptability threshold of h30 000/QALY, DRV/r-based therapy remained cost effective over all parameter ranges tested in extensive one-way sensitivity analyses. Probabilistic sensitivity analysis revealed a 95% (Belgium), 97% (Italy), 92% (Sweden) or 78% (UK) probability of attaining an ICER below this threshold. Conclusion: From four European payer perspectives, DRV/r-based antiretroviral therapy is predicted to be cost effective compared with currently available control PIs, when both are used with an OBR in treatment-experienced, HIV-1-infected adults who failed to respond to more than one PI-containing regimen.

A cost-utility analysis of pregabalin in the management of peripheral neuropathic pain

Abstract OBJECTIVES: To assess the cost per QALY (quality-adjusted life years) of pregabalin in the management of peripheral neuropathic pain. METHODS: We compared pregabalin on top of “usual care” with “usual care” alone. In this study, usual care was defined as a mix of drug therapies, excluding anti-epileptic drugs (AEDs), because the latter represented only 9% of current use, and clinical evidence of pregabalin was demonstrated versus usual care without anti-epileptic drugs. A Markov model was developed to simulate the evolution of a patient cohort over 1 year, and applied cycles of 4 weeks. During each cycle, patients remained in 1 out of 4 possible states: severe, moderate or mild pain, and therapy withdrawal. The health care payers perspective was taken into account. Clinical data were obtained from a trial comparing usual care plus placebo to usual care plus pregabalin, at either 150, 300, or 300/600 mg/day (the latter depending on clearance of creatinin). Resulting effects on pain were transformed into transition-probabilities between different pain levels. Cost and SF36 utility data of pain levels were obtained from a 1-month observational study in 88 patients. RESULTS: Usual care resulted in a yearly cost of € 6,200 compared to € 5,984 for an all dose pregabalin-mix, meaning a cost saving of € 216 per patient. Utility increase was 0.01 for the pregabalin-mix (QALY 0.510 usual care; 0.520 pregabalin-mix). MonteCarlo analysis showed cost savings were not significant. However, the utility gain, albeit small, was statistically significant. CONCLUSIONS: Based on this analysis, it may be concluded, that in the considered patient population, at the specialist level, pregabalin is at least cost neutral to current usual care (without AEDs) and offers a slight but significant increase in quality of life.

Impact Of A Pharmacological Cardioversion With Vernakalant On The Management Cost Of Recent Atrial Fibrillation In Belgium

For further information, please contact: LGerlier@be.imshealth.com ©2014 IMS Health Incorporated and its affiliates. All rights reserved. Trademarks are registered in the United States and in various other countries Introduction and objectives o Atrial fibrillation (AF) is the most common type of cardiac arrhythmia. It is associated with a 5-fold risk of stroke, a 3-fold incidence of congestive heart failure, a 3-fold risk of ventricular fibrillation and higher mortality1,2. o Pharmacological cardioversion or direct current cardioversion (DCC) are done to restore a normal sinus rhythm. o There is evidence that a shorter time to cardioversion significantly reduces the risk of thromboembolic complications3. o Vernakalant is an antiarrhythmic drug indicated to rapidly convert recent onset AF to sinus rhythm in adults, or in case of post-cardiac surgery AF ≤ 3 days4.

The Economic Consequences Of The Use Of Antibiotics In Belgium

Antibiotics resistance, the situation in which antibiotics lose their ability to kill or stop growth of a specific bacterium, may occur naturally as a result of mutations in a bacteria’s genes (acquired resistance). However, excessive and inapproriate use of antibiotics may accelerate the emergence and spread of antibiotic-resistant bacteria. In Belgium, several national programs have been launched since 2000 in order to increase the awareness of incorrect antibiotics use and problems of bacterial resistance. Since then, outpatient antibiotic use (based on the number of packages) decreased by 36%. Despite this reduction, outpatient use of antibiotics is still high in Belgium compared to other European countries. And, the use has not been declined since 2006-2007. Meanwhile, between 2007 and 2013, the use of antibiotics in hospitals increased by 5.6%.