M Bullejos Molina

Resultados coste-efectividad del implante de dexametasona en edema macular

OBJECTIVE To analyze the cost-effectiveness and benefits of a dexamethasone intravitreal implant (Ozurdex®, Allergan, Irvine, CA, USA.) in its clinically relevant applications. MATERIAL AND METHODS A total of 88 eyes of 86 patients with macular edema of > 300 μm measured by optical coherence tomography (Cirrus Zeiss, Dublin, CA, USA) were included in this two-year retrospective study, with a minimum of 6 months follow-up. The patients were divide into 3 groups: group 1 with macular edema in retinal vein occlusion, group 2 with non-infectious posterior uveitis, and group 3 with diabetic macular edema. The treatment was off-label but supported by the literature. Before implantation, and on days 1, 30, 60, 90 and 180, corrected visual acuity (Snellen), central retinal thickness, intraocular pressure and biomicroscopy were evaluated. The cost-benefit analysis was tabulated by line of visual acuity gained, comparing the main therapeutic alternatives and assessment of the safety profile of the dexamethasone intravitreal implant (Ozurdex®, Allergan, Irvine, CA, USA). RESULTS The results of this study did not differ from the published studies, in terms of visual acuity improvement in 63.3% of cases, and with central macular thickness improvement in 97% of cases. There were relapses, which occurred after 120 days on average, and the need for retreatment was 40.9%. Increased intraocular pressure >23 mm Hg was among the side effects in 29.54%, and was controlled with topical treatment, except in 1.13% requiring surgical treatment. The development of cataract was 44.7%, and 10.6% required surgery. Treatment results showed less frequent use of Ozurdex® than other treatments for disease control, being a cost saving option. DISCUSSION Cost-effectiveness analyses are clinically relevant when applying treatment strategies in patients with macular edema. Dexamethasone intravitreal implant appears to be a safe and efficient therapy.

1ISG-003 Cost saving in antiretroviral therapy through breaking fixed-dose combination and switch to generic formulations

Background The commercialisation of fixed-dose combination meant an improvement in antiretroviral therapy (ART). With generics we have the opportunity to maintain the therapy at a lower cost, but we complicate the dosage regimen again. Purpose To assess the effect in costs of a two-pill, generic-based regimen compared with a branded coformulated regimen, and to project the potential annual savings in the first year of a switch to generic-based ART. We replaced Triumeq® (ABC/3TC/DTG) by a combination of Tivicay® (DTG) +generic ABC/3TC, and Atripla® (TDF/FTC/EFV) by Truvada® (TDF/FTC)+generic EFV. Material and methods We selected and analysed all patients who received Atripla® (TDF/FTC/EFV) and Triumeq® (ABC/3TC/DTG) from June 2016 to September 2017. Data were collected from the medication consumption files of the institution. We analysed the records related to the treatment. The economic savings associated with the change of treatment were quantified. Results 313 patients were analysed, 108 (34.5%) initially treated with Atripla® and 205 (65%) initially treated with Triumeq®. A total of 252 (80.5%) patients were switched to a new treatment (162 patients with Triumeq® and 90 patients whith Atripla®), four (1,27%) of whom returned to initial treatment for adverse effects. A total of 61 patients were not changed. The main reason for opposing the change was the difficulty in adherence 17 (27.8%), followed by patient refusal four (6.5%) The change to Triumeq® meant a saving of €22.380/month and the change to Atripla® a saving of €10.100/month. This represents a total saving of €389.772/year. Conclusion Generics formulations in ART is an opportunity to contain pharmaceutical costs in hospitals. Changes in therapy produced a low rate of adverse reactions (1.27%) and a cost saving of €389.772/year. It requires adherence data to be able to affirm that this strategy decreases costs without prejudice to the patient. References and/or Acknowledgements All staff of our pharmacy service No conflict of interest

DI-067 Analysis of the use of teriflunomide in a tertiary hospital

Background Teriflunomide is an immunomodulatory agent with anti-inflammatory properties that inhibits the mitochondrial enzyme dehidroorotato-dehydrogenase (DHO-DH), which is required for the synthesis of pyrimidine, blocking the proliferation of activated B and T lymphocytes. It is believed that the therapeutic effect is related to the reduction in the number of lymphocytes. It is indicated for the treatment of adult patients with relapsing-remitting multiple sclerosis with the advantage of oral administration. Purpose To analyse the use of teriflunomide in patients diagnosed with multiple sclerosis. Material and methods A retrospective observational study from January 2013 to May 2015. We used the SAP program to evaluate the clinical history and dispensations of patients treated with teriflunomide. The following data were recorded: sex, age, EDSS, previous treatments, control of liver enzymes, kidney function, blood pressure and pregnancy test. Results 18 patients, 17 women and 1 man, were evaluated, with an average age of 41.11 years (range 23–79). Mean EDSS was 1.85 (1–5). All patients had recorded blood pressure, blood count, and kidney and liver function approximately every 2 weeks. Teriflunomide was prescribed as the firstline treatment in 5 patients (27.77%), as secondline in 3 patients (16.66%), as the third treatment in 8 patients (44.44%), and as the fourth and fifth treatments, respectively, in 1 patient (5.55%). Two patients began it before marketing. The immediately preceding treatment was glatiramer acetate in 5 patients, dimethyl fumarate in 1, interferon beta 1a 44 µg in 5 and interferon beta-1a 30 µg in 2 patients. The reasons for the change were cutaneous adverse effects on local reaction at the injection site in all cases except for dimethyl fumarate (digestive intolerance). The average duration of treatment with teriflunomide was 3.77 months (1–20), without any abandonment of treatment by that time. Conclusion While reports of teriflunomide therapeutic positioning is indicated at the forefront of relapsing-remitting multiple sclerosis, only 29.41% of our patients were prescribed this as the first choice. In the future, more patients may start teriflunomide as the firstline treatment given the comfort of the route of administration and good tolerance. Due to the short time to market, a longer term review is needed to verify the response to the drug. References and/or Acknowledgements http://www.aemps.gob.es/medicamentosUsoHumano/informesPublicos/docs/IPT-teriflunomida-aubagio.pdf No conflict of interest.

CP-080 Comparative effectiveness of ustekinumab and adalimumab in psoriasis patients previously treated with etanercept

Background Adalimumab and ustekinumab have demonstrated a high level of efficacy in the treatment of moderate-severe psoriasis in randomised controlled trials. There are, however, no data available on the comparative effectiveness of ustekinumab and adalimumab in psoriasis patients switching from etanercept. Purpose To evaluate the comparative effectiveness of adalimumab and ustekinumab in patients previously treated with etanercept. Material and methods A single centre, retrospective, observational, comparative study was carried out from 1 November 2011 to 31 March 2013, with a follow-up of 2 years. Subjects were patients with moderate-severe psoriasis that after etanercept therapy were treated with adalimumab or ustekinumab. A revision of each patient’s clinical history was carried out to asses clinical data. The primary analysis compared the percentages of patients in each treatment group who achieved ≥75% improvement from baseline PASI score (PASI 75) at week 12. Secondary endpoints included the percentages of patients with PASI 75 at week 96. Statistical analysis was performed with the SPSS 22 software. Results 28 psoriasis patients were included: 11 (39.3%) patients received adalimumab and 17 (60.7%) received ustekinumab as secondline therapy. Median age in the adalimumab and ustekinumab groups were 58 (SD 6.5) years and 49 years (SD 16.3), respectively (p = 00.08). After 12 weeks of study treatment, 76.5% of ustekinumab treated patients (13/17) achieved a PASI 75 response compared with 36.4% (4/11) in the adalimumab group (p = 0.034). At week 96, more patients had a PASI 75 in the ustekinumab group compared with the adalimumab group, but the difference was not statistically significant (70.6% vs 36.4%, p = 0.07). Conclusion Previously studies have shown that adalimumab and ustekinumab are effective after anti-TNF inhibitor therapy. However, to our knowledge, the present study is the first to evaluate the comparative effectiveness of ustekinumab and adalimumab in psoriasis patients switching from etanercept. Our study suggests that ustekinumab is associated with a higher effectiveness compared with adalimumab as secondline treatment in patients previously treated with etanercept. Prospective, randomised studies with a large number of patients are required to establish the optimal treatment in psoriasis patients who have previously received etanercept. References and/or Acknowledgements J Dermatolog Treat 2015;26:217-22 J Eur Acad Dermatol Venereol 2011;25:1037-40 No conflict of interest.

OHP-037 Financial impact of simplifying antiretroviral therapy in hiv patients

Background In recent years, simplification of antiretroviral therapy is increasingly being recognised as an attractive therapeutic alternative for cost minimization. Currently, this kind of treatment is used in patients without a prior history of failure of protease inhibitors (PIs), with an undetectable viral load for the last 6 months and signs or symptoms of toxicity from nucleoside analogues. Purpose To describe the cost savings that have been achieved by changing triple therapy in antiretroviral treatment to monotherapy with a protease inhibitor (PI) boosted with ritonavir in HIV patients. Material and methods Cross-sectional study in which all patients who were on antiretroviral monotherapy on a particular date (1 March 2014) were included. The following variables obtained from the SAP application were recorded: the current and previous treatment, as well as the duration of each of the schemes. The prices of antiretroviral drugs used were those for which the Pharmacy Department had acquired them. Results A total of 953 patients were on antiretroviral treatment on 1 March 2014, 33 of whom were prescribed monotherapy boosted with ritonavir; 21 with darunavir/ritonavir and 12 with lopinavir/ritonavir. Median duration of treatment was 23 months (standard deviation (SD) = 18.69). The treatment simplification in these patients has meant savings of €263.000 (monthly average of €286 per patient (SD = €156)). The simplifications that showed higher rates of reduction of direct acquisition costs of the drugs were the switching of atazanavir/ritonavir+ tenofovir + abacavir for darunavir/ritonavir (−55% (€449/month/patient)), and atazanavir/ritonavir + tenofovir+ efavirenz for lopinavir/ritonavir (−52% (€446/month/patient)). Conclusion Simplification of antiretroviral therapy translates to an average monthly saving of 290 euros per patient, which has meant savings of €260,000 euros in comparison to the previous treatment these 33 patients had received. It is necessary to carry out more studies to corroborate that simplified antiretroviral therapy is, besides being financially attractive, a strategy as effective as traditional antiretroviral therapy. References and/or acknowledgements No conflict of interest.Background In recent years, simplification of antiretroviral therapy is increasingly being recognised as an attractive therapeutic alternative for cost minimization. Currently, this kind of treatment is used in patients without a prior history of failure of protease inhibitors (PIs), with an undetectable viral load for the last 6 months and signs or symptoms of toxicity from nucleoside analogues. Purpose To describe the cost savings that have been achieved by changing triple therapy in antiretroviral treatment to monotherapy with a protease inhibitor (PI) boosted with ritonavir in HIV patients. Material and methods Cross-sectional study in which all patients who were on antiretroviral monotherapy on a particular date (1 March 2014) were included. The following variables obtained from the SAP application were recorded: the current and previous treatment, as well as the duration of each of the schemes. The prices of antiretroviral drugs used were those for which the Pharmacy Department had acquired them. Results A total of 953 patients were on antiretroviral treatment on 1 March 2014, 33 of whom were prescribed monotherapy boosted with ritonavir; 21 with darunavir/ritonavir and 12 with lopinavir/ritonavir. Median duration of treatment was 23 months (standard deviation (SD) = 18.69). The treatment simplification in these patients has meant savings of €263.000 (monthly average of €286 per patient (SD = €156)). The simplifications that showed higher rates of reduction of direct acquisition costs of the drugs were the switching of atazanavir/ritonavir+ tenofovir + abacavir for darunavir/ritonavir (−55% (€449/month/patient)), and atazanavir/ritonavir + tenofovir+ efavirenz for lopinavir/ritonavir (−52% (€446/month/patient)). Conclusion Simplification of antiretroviral therapy translates to an average monthly saving of 290 euros per patient, which has meant savings of €260,000 euros in comparison to the previous treatment these 33 patients had received. It is necessary to carry out more studies to corroborate that simplified antiretroviral therapy is, besides being financially attractive, a strategy as effective as traditional antiretroviral therapy. References and/or acknowledgements No conflict of interest.

GRP-028 Assessment of Compliance and Avoided Costs After Implementation of Guidelines For Candida Infection Treatment and Invasive Fungal Infections in Non-Haematology Patients

Background The recent marketing of new high-cost antifungal agents (echinocandins and azoles) requires the design of cost-effective treatment protocols. Purpose A new treatment guide for candidaemia and other invasive fungal infections for non-haematology adult patients was approved in June 2011. The main objective was to evaluate the cost reduction by introducing this protocol in a 737-bed University Hospital serving a population of more than 400,000 inhabitants. Materials and Methods Retrospective observational study between June and December 2011. We reviewed the medical records of patients whom were prescribed antifungal treatment during that time and we assessed the adjustment to the approved treatment guidelines. To quantify the avoided costs we extracted consumption data and costs of antifungals from the pharmacy service management system (SAP®) and compared them with the same period the previous year. Results During the study 43 non-haematology patients were treated with antifungal agents. In 38 patients (88.4%) the approved treatment guidelines were followed and in 5 patients (11.6%) they were breached.The most significant breaches occurred in internal medicine (22.2%) and in critical care (3.7%). Regarding avoided costs for the six months of the study, antifungal costs were reduced by 240,616 euros. We observed a 61.9% and 48% increase in use in fluconazole and anidulafungin, and a 42.8% and 41.7% decrease in caspofungin and liposomal amphotericin B use. These results are consistent with the recommendations contained in the guide (first line use of fluconazole in non-immunosuppressed patients and in azole resistance use anidulafungin). Micafungin use was restricted to the paediatric population with consumption equal to that in the previous period. Conclusions The treatment guideline compliance was excellent at our hospital, resulting in a significant decrease in antifungal expenses. Implementation of these guidelines in the management of high-cost drugs resulted in significant cost reductions and therefore in a more rational use of healthcare budgets. No conflict of interest.

OHP-057 Measures For Palivizumab Cost Containment Analysis

Background Prescription RSV (Respiratory Syncytial Virus) immunoprophylaxis with palivizumab involves high pharmaceutical costs associated with paediatric services. It is necessary to establish protocols aimed at reducing the cost associated with these treatments, adjusted to the best cost-effectiveness criteria. Purpose To assess whether the prescriptions are consistent with indications of greater efficiency; to assess the impact of the revision of the criteria in the last vaccination campaign. Materials and Methods We analysed the cost associated with the use of palivizumab in the last six years, the criteria for indication of prophylaxis, and the impact of the restrictions introduced last season. The number of doses that can be administered has been restricted: a limitation for the higher-risk months (Nov-Jan), and more cost-effective presentations (100 mg) are to be used. We extracted from our hospital system (SAP) the dispensed prescriptions of palivizumab from September 2006 to February 2012 (5 vaccination campaigns) analysing the number of patients treated, number of doses per child, vaccination period, consumption distribution among different presentations, indication criteria and associated cost. Results An examination of the last 6 vaccination campaigns shows the impact of the measures taken. We obtained a 35% cost reduction (€98,875.25) compared to the average in recent seasons, and a 28% decrease in the number of children treated. The priority of using 100 mg vials meant a 63% reduction in the use of 50 mg vials, which are less cost-effective. The largest decrease (10%) in prescriptions was in premature infants between 29 and 35 weeks gestation. No vaccinations were done in March. Conclusions Establishing agreed more restrictive criteria used in the selection of patients to be treated, limiting the months in which the vaccine can be administered and the preferential use of 100 mg vials has brought about a 35% reduction in the cost associated with this treatment (€98,875.25) compared to previous campaigns. No conflict of interest.

DGI-063 Study of the Use and Effectiveness of Daptomycin in a Tertiary Hospital

Background Daptomycin is an antibiotic only active against Gram-positive bacteria, with rapid bactericidal activity, a concentration-dependent and post-antibiotic effect. Indicated for complicated skin or soft tissue infections in adults (cSSTI), right side endocarditis due to Staphylococcus aureus and S. aureus bacteraemia associated with right-side infective endocarditis. Abstract DGI-062 Table 1 ECOG No. metastatic sites Line number Median TT (w) 0 1 2 No data 1 2 3 Common sites 1 ≥2 SORAFENIB 3/5 2/5 2/5 3/5 40% Lung 40% Bones 4/5 1/5 5 (IQR: 2–49.5) SUNITINIB 7/13 3/13 1/13 2/13 6/13 6/13 1/13 53.85% Lung 30.77% Liver 11/13 2/13 48 (IQR: 16.5–80.5) EVEROLIMUS 1/4 3/4 2/4 1/4 1/4 50% Liver 0/4 4/4 10 (IQR: 8–12) Purpose To perform a retrospective observational study of the use and effectiveness of daptomycin in our hospital. Materials and Methods We extracted from the hospital computer system (SAP) prescribing data about daptomycin from January to December 2011. The data collected included age, sex, history number, diagnosis, causative organism, prescriber service, treatment duration and reason for suspension. Results Were treated 85 patients (69% male) with an average age of 63.3 years (range 22–86 years). The average duration of treatment was 20.5 days. Prescribers’ services were: cardiac surgery/cardiology (27%), UCI (15%), haematology (12%), internal medicine (12%), nephrology (12%) and others (22%). The diagnoses for which daptomycin was used were: 32% endocarditis, 32% cSSTI, 20% bacteraemia, 11% osteoarticular infection and 5% others. Microorganisms identified were: 11% methicillin-resistant S. aureus (MRSA), 20% coagulase-negative Staphylococcus, 5% others and 64% was empirical treatment. In 36.5% of prescriptions, daptomycin was used as second-line antibiotic treatment, either because the patient did not respond to previous antibiotic treatment (32%) or due to side effects (39% anaemia with linezolid and 29% renal damage with vancomycin). The reasons for suspending daptomycin were: 77% for improvement/patient discharge or who ended treatment or switched to oral treatment, 9% change in treatment and 14% deceased. Conclusions In 84% of cases the prescription complied with the authorised indications in datasheet. Daptomycin was prescribed first-choice in 63.5% of treatments. In 64% of case treatment was empirical without subsequent confirmation of the causative organism. It is necessary to establish a mechanism to decrease the rate of use of this antibiotic in the hospital for frontline empirical treatments. No conflict of interest.

Impact of limiting prescription of low therapeutic value drugs

Background During the last decade healthcare systems have developed different strategies for containing drug costs. Among others, in Spain the Ministry of Health together with regional Health Departments, have published guidelines for drugs considered to have low therapeutic value (LTVDs), through evidence-based studies and drug assessment data, and they encourage healthcare practitioners to avoid prescribing them. Purpose Our aim was to estimate the cost saving obtained by limiting the use of LTVDs in our hospital. Materials and methods The authors reviewed different guidelines published by Healthcare Authorities and compiled those drugs listed as LTVDs. Data was obtained from three sources: ‘Therapeutic usefulness of medical drugs reimbursed by the National Health System’ Spanish Ministry of Health 2001, ‘List of medical drugs considered as Low Therapeutic Value’ Canary Islands Health Department 2011, and ‘Medical drugs with Non-High Intrinsic Value’ Andalucia Health Department. The authors drew up a list of LTVDs and compared it with the formulary and non-formulary drugs purchased during the period August 2010–July 2011. Results A total of 110 drugs were listed as LTVDs, 59 formulary drugs and 51 non-formulary drugs. The potential cost saving obtained by restricting the use of LTVDs during the reviewed period was estimated at €88,142. By ATC classification, the most significant groups were Sensory organs (€36,118), Nervous system (€15,347), Respiratory system (€11,917) and Dermatologicals (€11,440). Conclusions Our drug formulary contains 59 LTVDs. Deleting them from the formulary as well as restricting the prescription of LTVDs through the Pharmacy and Therapeutic Committee would result in a potential saving of €88,142 per year. Furthermore, this approach encourages physicians to implement Healthcare Authorities recommendations and contributes to cost-effective and rational drug treatment.