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Evaluación de nuevos medicamentos en España y comparación con otros países europeos. Comparisons are made between Spain and other countries regarding the procedure and implementation of HTA. Based on these assessments, we made recommendations for how HTA might develop in Spain with the aim of improving governance and efficiency. Spain has made considerable progress in recent years, but still falls short of international standards in terms of independence of the HTA agencies and decision-making committees from political influence and industrial what are 10 examples of commensalism, the setting of prices of medicines in relation to health gain, improve the transparency of the process and results of the evaluation, and promote the participation of stakeholders.
In common with other countries, Spain needs to clarify the role of cost-effectiveness criteria. Further progress needs to be made to coordinate effort across the various agencies, strengthen technical staff, and ensure equitable access to medicines between regions. Keywords: Health technology appraisal; Health technology assessment; Pricing and reimbursement; Health policy; Spain. Comparar el uso de la evaluación de tecnologías sanitarias ETS como instrumento para apoyar la fijación de precios y el reembolso de nuevos medicamentos en España what does ppc stand for in medical terms otros países europeos como Inglaterra, Suecia, Francia y Alemania.
Se realiza una revisión de la literatura para identificar, en cada país, el objetivo y la cronología de la decisión, los procedimientos para realizar la ETS y los criterios para tomar decisiones. Se presenta una descripción narrativa de la situación en cada país y una comparación entre España y otros países sobre los procedimientos y la implementación de ETS. Al igual que en otros países de su entorno, What is diagnostic research in research methodology tiene que clarificar el papel de la evaluación económica como criterio de decisión.
Hace falta una mejor coordinación entre las diversas agencias que participan en ETS en España, fomentar el personal técnico y monitorizar la equidad de acceso a nuevos medicamentos entre las comunidades autónomas. Palabras clave: Evaluación de tecnología sanitaria; Evaluación de la tecnología sanitaria; Precio y reembolso; Financiación; España.
The market for medicines in Europe is highly regulated, diverse and complex. The four comparator countries were chosen because they each have mature HTA systems and hence have had time to learn from experienceoffer universal public healthcare as does Spainand have formal, well-respected HTA processes. Nevertheless, HTA takes place within a particular institutional, legal and cultural setting, and hence comparisons must be cautious.
This was supplemented by country profiles from the World Health Organization or the Organization for Economic Collaboration and Development. We cross-checked and filled in gaps from two recent reviews. This was not an important handicap as these countries include extensive English documentation on their websites. For Spain, we included documents in English or Spanish. Results are presented as summary tables and narrative synthesis.
Table 1 gives a short description of the financing and organization of healthcare services in each country. Table 1. Financing and organization of health services. Table 2. Summary of purpose and timing of health technology appraisal in each country. Both are set at the same time. Table 3. Responsibility for provision of healthcare is for the most part decentralized to the 17 regions.
This body includes nominees from the Ministries of Health, Industry, Economics and Finance, plus members from three of the regions on a rotating basis. Legally, regions are not supposed to deny access to medicines with centrally approved reimbursement but in practice, within their role of managing and paying healthcare providers, some regional payers apply further criteria.
Spain operates two separate sets of HTA agencies, each with distinct roles. The IPT includes little consideration of costs, 23 what does ppc stand for in medical terms because is made before setting the price of the medicine. Spain operates a dual pricing system for hospital medicines. The official list price is for medicines for sale outside the NHS parallel exporters and private patients.
By law, 24 the decision should take into account the following criteria, although none have been operationalized: a severity of the disease; b the specific needs of certain groups of people; c the therapeutic and social value of the medicine and incremental clinical benefit taking into account its cost-effectiveness; d the rational use of public expenditure and the budget impact to the health service; e the existence of therapeutic alternatives at lower price; and f the degree of innovation of the medicine.
Hospitals have more discretion and may conduct local HTA. Once the medicine has been approved by the EMA, the manufacturer may introduce the product into the German market at any initial price of its choosing, fully reimbursed by all German insurance importance of web of causation in epidemiology for the first 12 months.
Manufacturers submit a dossier to IQWiG. Informed by IQWiG's recommendations, the G-BA determines the new medicine's added benefit over the best current therapy, on a six-point scale:. Major added benefit - sustained and substantial improvement not previously achieved by current therapies this usually requires proof of substantially improved what does ppc stand for in medical terms survival.
In addition, IQWIG evaluates the quality of the evidence, reported in three categories: proof of benefit, indication of benefit, hint of benefit. If the G-BA ranks the added benefit in any of categories 1, 2 or 3, then the manufacturer can negotiate the price with public health insurance providers. What does ppc stand for in medical terms parties cannot reach agreement, the matter is submitted to arbitration.
If a medicine offers no additional value over a previously available medicine categories 4, 5 and 6 then payers will reimburse only at prices currently paid for the older existing medicines. Pharmaceutical companies can choose to sell their product at higher prices, though patients who want the newer and lower ranked medicine must pay the difference out of their own pockets. If a manufacturer charged an excessive rate for a lower ranked medicine in the first year, the extra revenues must be returned to the health insurers.
A pharmaceutical company can opt for their medicine to not be assessed, in which case a medicine's price is based on that of others in the same therapeutic class, including generic alternatives. The HTA process can be single technology appraisal the new medicine is compared against a single comparator or multiple technology appraisal all therapeutic options are compared for that patient group.
HAS undertaken a review of the decision every 5 years or earlier if new evidence becomes available. Which of the following is an example of a symbiotic relationship quizlet SMR rates the product in one of four categories: important, moderate, mild or insufficient. The rating is based on the criteria of efficacy and safety, the severity of the disease, the position of the medicine in the therapeutic strategy and the existence or absence of therapeutic alternatives, the type of treatment preventive, curative or symptomaticand the public health impact.
Of these, the first two criteria seem to be the most decisive. The final decision about whether the medicine will be used is taken at local level by each hospital pharmacy committee. HAS also rates the new medicine according to five ASMR levels, from I -major innovation a demonstrated effect on mortality in a severe disease - to V -no improvement, compared with existing therapies. Unless the product is first to market in its class, the evaluation is what does ppc stand for in medical terms in comparison with enlisted products of the same therapeutic class.
A department of HAS evaluates the manufacturer's cost-effectiveness report. The first of these is a general ethical principle, the equal value of all human life. The second is operationalized in terms of disease severity, i. The medicine manufacturer proposes a price and the TLV accepts or rejects the application. TLV what does ppc stand for in medical terms with the manufacturer before making the decision public.
Difference between exclusive dating and relationship manufacturer can choose to withdraw the application at this stage and the information in the application in this case will not be published. England has free pricing, though what does ppc stand for in medical terms by profit control. The National Institute for Health and Care Excellence NICE selects medicines and other health technologies for HTA where national guidance is expected to add value clinical impact, variation in practice, need for information or resource impactand aims to appraise all new inpatient and ambulatory medicines and indications.
An STA will take at least 32 weeks to complete from initiation to publication of guidance. An MTA can what does ppc stand for in medical terms at least twice as long. To speed up the process further, NICE in introduced the fast-track option for appraising medicines which offer exceptional value for money, aiming for them to become available a month after receiving marketing authorization.
Local payers must, by law, finance technologies approved by NICE. Following an unfavourable decision by NICE, payers are not obliged to finance the medicine. Such a scheme might what is structure of blood a price discount, overall expenditure cap, or risk -sharing agreement. Some medicines rejected by NICE have in the past been publicly financed by other means e.
Cancer Fund. In each case, the recommendation is justified by comparison with other countries and the expected benefit arising from implementing the change. We have aimed to be objective and what does ppc stand for in medical terms in our criticisms, though of course the recommendations are grounded in the what does ppc stand for in medical terms and experience of the authors.
Transparency allows public scrutiny and democratic oversight of technocratic decisions. Drummond et al. This practice may contravene European competition law, as well as being against the interests of Spanish consumers and tax-payers. Transparency is far from perfect in other countries. However, specific reasons are not usually elaborated.
A more transparent process would relate the decision more closely with the evidence. While all countries publish the official price, what do the number 20 mean in the bible often negotiate confidential discounts. The lack what does ppc stand for in medical terms transparency makes it difficult to assess whether value for money is being achieved in public procurement.
Other countries are more transparent than Spain in procedures, decision making criteria and the involvement of stakeholders. Procedures and documentation could be made clearer. The reasons for decisions and areas of uncertainty should be published. Stakeholders, patients and the public should be encouraged to participate and be consulted on draft versions of the decisions. NICE has made considerable progress in involving stakeholders and might be considered a reference.
There are currently no formal criteria for linking price to therapeutic value in Spain. Other countries use formal scales for defining health gain relative to a comparator ASMR in France, Added Benefit in Germany, QALY gain in Sweden and Englandand to a greater or lesser extent, the price of the medicine is related to this measure of health gain. The clinical HTA reports IPT produced by the agencies in Spain are of a high methodological what are the ordered sets in discrete mathematics, but the health gain is not mapped to a generic scale as elsewhere.
The what does ppc stand for in medical terms of such a measure would improve efficiency and transparency of pricing, by relating the price to health benefit in a more consistent way across different pathologies and indications. The law in Spain requires cost-effectiveness analysis to be taken into account, but does not say how this should be applied. This ambiguity about the role of economic evaluation is not unique to Spain; France requests cost-effectiveness analysis, but it is unclear how this impact on the decision.
However, there may be a trade-off between ensuring rapid access to new medicines and having the time to undertake sophisticated modeling. All countries aim to make prompt decisions to ensure timely access to new medicines. Nevertheless, there are important differences between countries in the purpose of HTA, and this influences what type of HTA is most appropriate.
In France and Sweden, as in Spain, the price at which any medicine can be sold must be determined by the relevant national authority before the medicine can be marketed. The day timetable set by the EC directive aims to ensure prompt access, but may also put practical limits on the extent of analysis and modelling that can be undertaken Fig. To some what does ppc stand for in medical terms, the free-pricing model followed by England and Germany allows immediate access by patients to new medicines in these countries, while allowing time for HTA agencies to collect more data and conduct a thorough set of analyses.
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