Sildenafil Generic Prices in the UK

The HTA programme then commissions the research by competitive tender.

• The average in-store price of sildenafil in the UK is around £25 per packet.
• Online UK pharmacies often list sildenafil prices pre- and post-discounts.
• Buying sildenafil in combination with other medications is common in the UK.
• Prices can be lower with online UK pharmacies than traditional stores.
• UK regulation ensures sildenafil sold is genuine and safe.
• Some pharmacies offer convenient refill services for sildenafil.
• UK online platforms often provide detailed product information on sildenafil.
• The cost of sildenafil may include pharmacist consultation fees.
• In the UK, sildenafil prices are influenced by patent laws.
• Cost per dose decreases with larger bulk orders in the UK.
• UK clinics sometimes offer sildenafil packages for repeat patients.

Second, the HTA programme provides grants for clinical trials for researchers who identify research questions.

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The ICERs for one technology should not be compared to that of another technology as the model only compares each technology plus supportive care to supportive care alone. In the model epoprostenol treatment is initiated on progression to FCIV, as such the ICERs for all technologies are sensitive to the cost of epoprostenol. Due to the lack of stratified data to populate the model, and in some cases a complete absence of data, a number of assumptions had to be made, therefore bias may have been introduced by these assumptions. In addition, the data used for the model were mostly from trials of short duration containing relatively small numbers of patients. Therefore a longitudinal dataset of a sufficient number of patients would be of great benefit to future modelling in this clinical condition.

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Due to the above, the probabilistic sensitivity analysis undertaken in this report may well have underestimated the full uncertainty around each analysis. None produced results generalisable to the NHS. There was no consensus in the manufacturers' submissions on the most appropriate model structure for the technology assessment, with variability seen in the type of economic evaluation, methods used and data sources. In addition, the same comparator was not used in all submissions therefore they were not all addressing the same policy question. The strengths of this assessment report include a systematic review focusing on the most robust evidence from RCTs, comprehensive literature search, inclusion of unpublished data, comprehensive analyses highlighting the mismatch between licensed indications and available evidence, independent assessment of published economic evaluations and manufacturer submissions, a de novo model-based economic evaluation, and use of data from the systematic review to inform the model. These are assessed for importance to patients and the NHS, and scientific rigour.

Third, through its Technology Assessment Report (TAR) call-off contract, the HTA programme commissions bespoke reports, principally for NICE, but also for other policy-makers.

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Clinical and cost-effectiveness of epoprostenol, iloprost, bosentan, sitaxentan and sildenafil for pulmonary arterial hypertension within their licensed indications: a systematic review and economic evaluation. The Health Technology Assessment (HTA) programme, part of the National Institute for Health Research (NIHR), was set up in 1993. It produces high-quality research information on the effectiveness, costs and broader impact of health technologies for those who use, manage and provide care in the NHS. 'Health technologies' are broadly defined as all interventions used to promote health, prevent and treat disease, and improve rehabilitation and long-term care. The research findings from the HTA programme directly influence decision-making bodies such as the National Institute for Health and Clinical Excellence (NICE) and the National Screening Committee (NSC). TARs bring together evidence on the value of specific technologies.

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The volume of evidence and patient populations included in the trials varied between the technologies. Current evidence does not allow adequate comparisons between the technologies nor for the use of combinations of the technologies. Independent economic evaluation suggests that bosentan, sitaxentan and sildenafil may be cost-effective by standard thresholds and that iloprost and epoprostenol may not. The findings for clinical effectiveness have minimal impact on clinical practice as these technologies are already being used in NHS. The findings from the economic evaluation suggest the possibility of differential cost-effectiveness between the oral treatments.

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This requires further confirmation as current analysis was not designed for directly comparing the technologies. If confirmed, the use of the most cost-effective treatment would result in reduction in costs for the NHS. The findings from the economic evaluation suggest that epoprostenol and iloprost may not be cost-effective. Withdrawal of these technologies, however, could have substantial impact on patients who are sildenafil citrate tablet currently treated with them and could also raise ethical issues. Any changes in costs for epoprostenol and/or licensing of new treatment for FCIV patients could have impact on the cost-effectiveness of the other technologies. Some HTA research projects, including TARs, may take only months, others need several years.

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Only two RCTs have directly compared the technologies against each other. No significant difference between the technologies was observed in any outcome in both trials. However, the conclusion was limited by small sample size in one trial and differential blinding of treatments in the other trial. No independent economic analysis was undertaken for this comparison. Use of the combinations of the technologies was investigated in four RCTs.

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A double-blind RCT showed no benefit for using the combination of bosentan plus epoprostenol compared to epoprostenol alone in patients of mixed FC (III and IV) with mixed types of PAH (IPAH, CTD-APAH). A double-blind RCT showed that inhaled iloprost added to ongoing bosentan and supportive treatment was more effective than ongoing bosentan and supportive treatment in patients (mainly FCIII) with mixed types of PAH. However, a further open-label RCT that included patients of FCIII with IPAH failed to demonstrate this. A double-blinded RCT showed that above licensed doses of sildenafil added to ongoing epoprostenol and supportive care was more effective than ongoing epoprostenol and supportive care in patients of mixed FC (predominantly II and III) with mixed types of PAH (IPAH and CTD-APAH). No independent economic analyses were undertaken for these comparisons. They can cost from as little as £40,000 to over £1 million, and may involve synthesising existing evidence, undertaking a trial, or other research collecting new data to answer a research problem.

• UK law restricts sildenafil sales to registered pharmacies only.
• Online UK pharmacies often offer discounts for first-time buyers.
• The price of sildenafil in the UK fluctuates with market trends.
• Generic sildenafil can cost as little as £0.30 per tablet online.
• Some UK pharmacies include free medical advice with sildenafil purchase.
• Prices in the UK are affected by import tariffs and taxes.
• Wholesale buying can reduce unit prices of sildenafil in the UK.
• Local UK laws regulate advertisement and pricing of sildenafil.
• Regular customers might receive special offers on sildenafil in the UK.
• Price transparency is improving for sildenafil in UK pharmacies.
• Availability of sildenafil in the UK has increased due to generics.

The final reports from HTA projects are peer reviewed by a number of independent expert referees before publication in the widely read journal series Health Technology Assessment.

Medical uses

HTA findings also help to improve the quality of clinical practice in the NHS indirectly in that they form a key component of the 'National Knowledge Service'. The HTA programme is needs led in that it fills gaps in the evidence needed by the NHS. There are three routes to the sildenafil pricing start of projects. Suggestions for research are actively sought from people working in the NHS, from the public and consumer groups and from professional bodies such as royal colleges and NHS trusts. These suggestions are carefully prioritised by panels of independent experts (including NHS service users). Criteria for inclusion in the HTA journal series Reports are published in the HTA journal series if (1) they have resulted from work for the HTA programme, and (2) they are of a sufficiently high scientific quality as assessed by the referees and editors.

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Long-term, double-blind RCTs of sufficient sample size that directly compare bosentan, sitaxentan and sildenafil, and evaluates outcomes including survival, quality of life, maintenance on treatment and impact on the use of resources for NHS and personal social services are needed. Possible differences in treatment effects between subcategories of PAH and between patients of different FC at baseline should be investigated within and across these trials. More RCTs that evaluate combinations of the technologies versus monotherapy, and studies investigating the feasibilities of replacing an ongoing treatment that failed to provide adequate control of the disease with a new treatment rather than adding the new treatment to the existing treatment are required. Further methodological studies that investigate the predictive value of outcome measures such as 6MWD, FC, various haemodynamic measures and other novel measures on patients' prognosis and survival are needed. The reason for substantial variation in patient's responses seen in control groups in RCTs also needs to be established. Reviews in Health Technology Assessment are termed 'systematic' when the account of the search, appraisal and synthesis

methods (to minimise biases and random errors) would, in theory, permit the replication of the review by others.

The research reported in this issue of the journal was commissioned and funded by the HTA programme on behalf of NICE as project number 05/24/01.

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The analyses included in this report were restricted by the scope of the technology appraisal, which was to include only licensed indications for the technologies currently licensed in the UK. The analyses were also limited by the short duration of RCTs and the paucity of data sildenafil oral jelly 100mg stratified by types of PAH and FC. Uncertainties mainly derive from the lack of long-term data from RCTs with regard to how long treatment effects last and whether they differ significantly for patients in different FC and to what extent. Comparisons between the technologies were not planned, and were not considered appropriate given available evidence. Most RCTs excluded patients with unstable conditions.

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The patients who are seen in clinical practice may be sicker than those included in the trials. The implication for the generalisability of the findings is uncertain. Variations in the costs of the technologies (including services) between regions/centres inevitably affect the cost-effectiveness of these technologies. Furthermore, the economic modelling suggested the cost-effectiveness of the technologies is sensitive to the costs of epoprostenol. All the five technologies, when added to supportive treatment and used at licensed dose(s), have been shown to be more effective than supportive treatment alone in RCTs that included patients of mixed FC and types of PAH.