Estimation of cost-based prices for injectable medicines in the WHO Essential Medicines List.

OBJECTIVES: Challenges remain in ensuring universal access to affordable essential medicines. We previously estimated the expected generic prices based on cost of production for medicines in solid oral formulations (ie, capsules or tablets) on the WHO Model List of Essential Medicines (EML). The objectives of this analysis were to estimate cost-based prices for injectable medicines on the EML and to compare these to lowest current prices in England, South Africa, and India. DESIGN: Data on the cost of active pharmaceutical ingredients (APIs) exported from India were extracted from an online database of customs declarations (www.infodriveindia.com). A formula was designed to use API price data to estimate a cost-based price, by adding the costs of converting API to a finished pharmaceutical product, including the cost of formulation in vials or ampoules, transportation and an average profit margin. RESULTS: For injectable formulations on the WHO EML, medicines had prices above the estimated cost-based price in 77% of comparisons in England (median ratio 2.54), and 62% in South Africa (median ratio 1.48), while 85% of medicines in India had prices below estimated cost-based price (median ratio 0.30). 19% of injectable medicines in England, 9% in South Africa, and 5% in India had prices more than 10 times the estimated cost-based price. Medicines that appeared in the top 20 by ratio of lowest current price to estimated cost-based price for more than one country included numerous oncology medicines-irinotecan, leuprorelin, ifosfamide, daunorubicin, filgrastim and mesna-as well as valproic acid and ciclosporin. CONCLUSIONS: Estimating manufacturing costs can identify cases in which profit margins for medicines may be set significantly higher than average.

Building informed trust: developing an educational tool for injection practices and health insurance in Cambodia.

Unnecessary injections increase the risk of blood-borne infections as well as pose an avoidable financial burden on patients. Perceptions in rural Cambodia that medical drug injections provide the best quality medical care have resulted in a large proportion of the population seeking injections across medical conditions. As private providers have a higher propensity to offer injections, patients pursue more expensive care contributing to a greater financial burden. This study aimed to use an educational intervention to improve participant knowledge about injections and health insurance in order to build informed trust in safer injection practices and health insurance. Using an experimental study design, villages in rural Cambodia were randomly assigned to an intervention or control arm. Community educational workshops were implemented to improve participant knowledge about injections and health insurance. Pre-and post-intervention assessments were used to record the resulting changes in knowledge and trust in providers. Statistical analysis of survey results from the two study arms showed increases of 16.8% and 15.9% in study participant knowledge regarding injections and health insurance, respectively. Trust in health insurance increased by 12.9%. However, trust in healthcare providers proved to be resilient with small to no change. These results show that knowledge about injection safety and health insurance, as well as trust in health insurance, can be increased through information dissemination in rural Cambodia. However, health information campaigns may not easily influence people's trust in healthcare providers. Education of the general populace about safe injection practices and health insurance can contribute toward the country's efforts to reach universal health coverage.

Cost-Effective Management of Stenosing Tenosynovitis.

PURPOSE: Stenosing tenosynovitis (STS) is a common condition treated by hand surgeons. Limited evidence exists to support the nonsurgical management of STS. The purpose of this study was to prospectively evaluate a cohort of patients with STS, and to determine the strategy for treating patients with this condition that is most cost effective in terms of dollars reimbursed by payers. METHODS: Prospective data were collected on patients diagnosed with STS between March 2014 and September 2014. All patients were initially treated with a corticosteroid injection. Patients with persistent symptoms were given the option of injection or surgery. A maximum of 3 injections were offered. All patients were evaluated every 6 months through office appointments or phone calls. A cost analysis was performed in our cohort using actual reimbursement rates for injections, initial and established patient visits, and facility and physician fees for surgery, using the reimbursement rates from the 6 payers covering this patient cohort. Cost savings were calculated based on offering 1, 2, and 3 injections. RESULTS: Eighty-eight digits in 82 patients were followed for an average of 21.9 months (range, 18.7-22.7 mo) after an initial corticosteroid injection. Thirty-five digits went on to surgical release, whereas 53 digits were treated nonsurgically. Had all patients initially undergone surgery, the cost would have totaled $169,088.98 ($1,921 per digit). Offering up to 3 injections yielded a potential savings of $72,730 ($826 per digit) or 43% of the total cost. For the 33 patients who underwent more than 1 injection, offering a second injection yielded potential savings of $15,956 ($484 per digit, 22.7%), and for the 7 patients presenting a third time, a third injection saved $1,986 ($283 per digit, 14.5%). CONCLUSIONS: Based on the data from our cohort, the efficient way to treat STS in terms of health care dollars spent is to offer up to 3 injections before surgical release. The first injection had the highest component of cost savings, at $826 per digit. TYPE OF STUDY/LEVEL OF EVIDENCE: Economic/Decision Analysis III.

Cost analysis of injection laryngoplasty performed under local anaesthesia versus general anaesthesia: an Australian perspective.

OBJECTIVE: To conduct a cost analysis of injection laryngoplasty performed in the operating theatre under local anaesthesia and general anaesthesia. METHODS: The retrospective study included patients who had undergone injection laryngoplasty as day cases between July 2013 and March 2016. Cost data were obtained, along with patient demographics, anaesthetic details, type of injectant, American Society of Anesthesiologists score, length of stay, total operating theatre time and surgeon procedure time. RESULTS: A total of 20 cases (general anaesthesia = 6, local anaesthesia = 14) were included in the cost analysis. The mean total cost under general anaesthesia (AU$2865.96 ± 756.29) was significantly higher than that under local anaesthesia (AU$1731.61 ± 290.29) (p < 0.001). The mean operating theatre time, surgeon procedure time and length of stay were all significantly lower under local anaesthesia compared to general anaesthesia. Time variables such as operating theatre time and length of stay were the most significant predictors of the total costs. CONCLUSION: Procedures performed under local anaesthesia in the operating theatre are associated with shorter operating theatre time and length of stay in the hospital, and provide significant cost savings. Further savings could be achieved if local anaesthesia procedures were performed in the office setting.

[The Safety of Using Long-acting Injections : From an Opposing Position-Is It Better to Administer Long-acting Injections?].

While long-acting injections (LAI) have arrived in Japan as a second-generation antipsy- chotic drug and LAI therapy for the symptom-stabilization phase is garnering attention, deaths associated with paliperidone (PAL) -LAI were sensationally reported, attracting interest regarding the safety of LAIs. In writing this report, an opportunity to oppose LAI usage was provided, so we raise the following three issues concerning the usage of the second-generation antipsychotic LAI for the symptom-stabilization phase. 1) Particularly notable adverse reactions of LAI are those acutely developed and in some cases fatal, including malignant syndrome, diabetic ketoacidosis, torsade de pointes due to pro- longed electrocardiogram QT, and leukopenia. All antipsychotic drugs come with the risk of such adverse reactions, and since the occurrence of adverse reactions cannot be predicted prior to administration, once they have developed, the offending drugs should be immediately reduced or discontinued to remove the drug from the body ; however, since this process can- not be followed with LAIs, such fatal adverse reactions may be protracted. Moreover, in the US, adverse reactions from post injection delirium/sedation syndrome (PDSS) have been reported in relation with olanzapine (OLZ) -LAI. This is a disease state in which the drug rap- idly flows into the blood following LAI intramuscular administration along with an acute increase in blood level, leading to significant sedation (lethargy in some cases) and/or serious symptoms accompanied by delirium ; therefore, in order to minimize these risks, the US FDA has made it mandatory to use a monitoring system referred to as REMS (Risk Evaluation and Mitigation Strategy)for OLZ-LAI. Whether or not the phenomenon occurs only with OLZ-LAI remains to be seen, so careful attention must be paid. 2) In Japanese psychiatric clinical sites, the current situation is that monitoring of adverse reactions for antipsychotic drugs, particularly with outpatients, is not sufficiently carried out Under such circumstances, there remain doubts when it comes to advocating -looking to replace oral drugs with LAI in the symptom-stabilization phase. 3) Replacing oral drugs with LAI in the symptom-stabilization phase significantly increases treatment costs as well as increasing the number of hospital visits. This increase in treatment cost and number of visits may have a large impact on the adherence of the patients to the drugs.

Costs for collagenase injections compared with fasciectomy in the treatment of Dupuytren's contracture: a retrospective cohort study.

OBJECTIVES: To compare collagenase injections and surgery (fasciectomy) for Dupuytren's contracture (DC) regarding actual total direct treatment costs and short-term outcomes. DESIGN: Retrospective cohort study. SETTING: Orthopaedic department of a regional hospital in Sweden. PARTICIPANTS: Patients aged 65 years or older with previously untreated DC of 30° or greater in the metacarpophalangeal (MCP) and/or proximal interphalangeal (PIP) joints of the small, ring or middle finger. The collagenase group comprised 16 consecutive patients treated during the first 6 months following the introduction of collagenase as treatment for DC at the study centre. The controls were 16 patients randomly selected among those operated on with fasciectomy at the same centre during the preceding 3 years. INTERVENTIONS: Treatment with collagenase was given during two standard outpatient clinic visits (injection of 0.9 mg, distributed at multiple sites in a palpable cord, and next-day finger extension under local anaesthesia) followed by night-time splinting. Fasciectomy was carried out in the operating room (day surgery) under general or regional anaesthesia using standard technique, followed by therapy and splinting. PRIMARY AND SECONDARY OUTCOME MEASURES: Actual total direct costs (salaries of all medical personnel involved in care, medications, materials and other relevant costs), and total MCP and PIP extension deficit (degrees) measured by hand therapists at 6-12 weeks after the treatment. RESULTS: Collagenase injection required fewer hospital outpatient visits to a therapist and nurse than fasciectomy. Total treatment cost for collagenase injection was US$1418.04 and for fasciectomy US$2102.56. The post-treatment median (IQR) total extension deficit was 10 (0-30) for the collagenase group and 10 (0-34) for the fasciectomy group. CONCLUSIONS: Treatment of DC with one collagenase injection costs 33% less than fasciectomy with equivalent efficacy at 6 weeks regarding reduction in contracture.

Cost-effectiveness of injectable opioid treatment v. oral methadone for chronic heroin addiction.

BACKGROUND: Despite evidence of the effectiveness of injectable opioid treatment compared with oral methadone for chronic heroin addiction, the additional cost of injectable treatment is considerable, and cost-effectiveness uncertain. AIMS: To compare the cost-effectiveness of supervised injectable heroin and injectable methadone with optimised oral methadone for chronic refractory heroin addiction. METHOD: Multisite, open-label, randomised controlled trial. Outcomes were assessed in terms of quality-adjusted life-years (QALYs). Economic perspective included health, social services and criminal justice resources. RESULTS: Intervention costs over 26 weeks were significantly higher for injectable heroin (mean £8995 v. £4674 injectable methadone and £2596 oral methadone; P<0.0001). Costs overall were highest for oral methadone (mean £15 805 v. £13 410 injectable methadone and £10 945 injectable heroin; P = n.s.) due to higher costs of criminal activity. In cost-effectiveness analysis, oral methadone was dominated by injectable heroin and injectable methadone (more expensive and less effective). At willingness to pay of £30 000 per QALY, there is a higher probability of injectable methadone being more cost-effective (80%) than injectable heroin. CONCLUSIONS: Injectable opioid treatments are more cost-effective than optimised oral methadone for chronic refractory heroin addiction. The choice between supervised injectable heroin and injectable methadone is less clear. There is currently evidence to suggest superior effectiveness of injectable heroin but at a cost that policy makers may find unacceptable. Future research should consider the use of decision analytic techniques to model expected costs and benefits of the treatments over the longer term.

Tratamento da deficiência do hormônio de crescimento (GH) em crianças: comparação entre o uso de canetas versus frascos/seringas para a aplicação do GH / Growth hormone (GH) deficiency treatment in children: comparison between uses of pen versus bottles/syringes on GH administration

O objetivo deste estudo foi comparar as duas apresentações de GH recombinante humano (rGH) para tratamento da deficiência de GH (DGH). Dez crianças pré-púberes portadoras de DGH foram acompanhadas durante 6 meses. Elas receberam, por 3 meses, injeções com seringa e, a seguir, com canetas por mais 3 meses. A aceitabilidade foi avaliada através de questionário. O desperdício foi calculado através da diferença entre o número de frascos/refis utilizados e o previsto para o período. A resposta ao tratamento foi avaliada pelo ganho em desvio-padrão (DP) de altura medido a cada 3 meses. Após 6 meses, 90 por cento dos pacientes/familiares afirmaram preferir a caneta em termos de facilidade técnica e dor local, e todos consideraram a caneta melhor em termos de facilidade de transporte e armazenamento. O desperdício foi menor com a caneta, assim como o custo. Concluímos que a administração de rGH através de caneta é mais conveniente, melhor aceita pelos pacientes e resulta em menor desperdício quando comparada com o tratamento por seringa.

The aim of this study was to compare two preparations of recombinant human GH (rGH) in the treatment of GH deficient patients. Ten prepubertal GH-deficient children were followed during 6 months. They received injections with syringe for 3 months, followed by pen administration for the subsequent 3 months. Acceptability was evaluated through a questionnaire. Waste of medication was calculated by the difference between the number of used bottles or refills and the calculated amount for the period. Treatment response was evaluated by SDS gain of height measured each 3 months. After 6 months, 90 percent of patients/family members declared they preferred the pen regarding technical facility and local pain, and all patients considered the pen easier to transport and store. The waste of medication was lower with pen administration, as was the final cost. We concluded that pen-administered rGH treatment is more convenient, better accepted by the patients, and leads to less waste of medication when compared to the syringe administration.

The cost of unsafe injections in pakistan and challenges for prevention program.

The burden of disease associated with unsafe therapeutic injection practices in Pakistan is very high. The number of injection per person per year has been estimated to be in the range of 8.2 to 13.6, one of the highest in developing world. Extrapolating this number to the whole country would result in 1.5 billion injections per year. Approximately 4% (75 million) of these are administered for immunization while the remainders are used for therapeutic use. Of these, 94.2% are unnecessary. Average price of an injection (not the complete prescription) is Rs. 20.6 (0.34 US dollars). Under conservative estimate, over three billion rupees or 500 million dollars out-of-pocket healthcare resources may be wasted each year. Appropriate use of injections would be highly cost effective. According to adjusted analysis, safe and appropriate use of injection in Pakistan would cost 92 million US dollars each year with a high proportion that would be injection devices paid through out-of-pocket expenses. Behaviour change for reduction in number of injections require long-term multidimentional efforts. Interventions in the form of phasing out of convention disposable injection equipment and switching to reuse prevention devices for all injections could prevent the common practice of reuse, hence reducing the transmission of infections.

The cost-effectiveness of endoscopic injection of dextranomer/hyaluronic acid copolymer for vesicoureteral reflux.

PURPOSE: Vesicoureteral reflux is a risk factor for progressive renal damage associated with urinary tract infection. Mild to moderate reflux is routinely treated with long-term antibiotic prophylaxis to prevent recurrent infections and open surgical reimplantation for breakthrough infections despite antibiotic therapy. Endoscopic subureteral injection of implant material is a therapeutic alternative to long-term prophylaxis and open surgery but its widespread use in the United States has been prevented by the lack of a stable implant material. Dextranomer/hyaluronic acid copolymer has been shown to be a safe, effective and durable implant material and was recently approved in the United States. We estimate the effect on costs and cure rates of introducing endoscopic injection with dextranomer/hyaluronic acid copolymer as a treatment alternative in the United States. MATERIALS AND METHODS: We constructed a model that mimics current clinical practice of vesicoureteral reflux treatment for 6 years, and incorporates spontaneous resolution and surgical intervention rates obtained from 2 long-term followup studies. The treatment algorithm was established using medical data from the literature, and clinical management practices from a Delphi survey of 27 pediatric urologists and nephrologists across the United States. Endoscopic injection was introduced into the model as replacement to surgery or alternative to long-term antibiotic prophylaxis. The effectiveness of dextranomer/hyaluronic acid copolymer was calculated from 140 patients (208 ureters) with grade III reflux treated in a clinical study of 221 children in Sweden. RESULTS: With current practice, the average cost per patient in 6 years was 6,640 US dollars and 23.5% of patients continued to have reflux. Replacing open surgery with endoscopic injection led to similar cure rates (22.2% failures) but costs were reduced to 5,522 US dollars. When injection was performed after 1 year of antibiotic therapy failure rates were reduced to 8.5% but costs increased to 7,644 US dollars. CONCLUSIONS: Our results show that a persistent approach to endoscopic surgery can be expected to result in overall success that equals or exceeds open surgery at a lower cost. This finding is particularly true if open reimplant is reserved for patients with high grade or persistent vesicoureteral reflux.

An economic comparison of Tubex injection systems with traditional ampuls and vials.

A time and motion study was performed at the Hospital of the University of Pennsylvania to measure and compare the direct and indirect costs of the original Tubex and Tubex Fast-Trak injection systems with comparable costs associated with single dose ampuls, vials, and multi-dose vials. Data collection involved observation of 170 injections prepared by 29 nurses on two oncology units over a 7-week period. The time and nondrug supply costs of the Tubex Fast-Trak were lower than those of all other injection systems observed, including the original Tubex. Although the drug acquisition component was higher for the Tubex systems than for conventional injection methods, an analysis of the total cost of the use of Tubex Fast-Trak demonstrated that on an annual basis, the system is nearly equal in cost to the use of single ampuls and vials. Important advantages of the prefilled cartridge system should be considered in addition to labor, supply, and drug costs when selecting cost-effective injection systems. Systems like Tubex offer advantages that may lower total cost of care, such as reduction in wastage, pilferage, contamination, dosage error, and improved cost allocation accuracy. When polled about their opinion, the majority of nurses who participated in the study indicated that Tubex Fast-Trek was their first choice over other injection methods observed.