Incorporation Of Medicine Research Articles

Estratégias de inovação em medicamentos e vacinas no âmbito do Ceis – modelos, mecanismos e expectativas

ABSTRACT The article aimed to present relevant and original information about the innovation strategies used by Official Pharmaceutical Laboratories (LFO) to reduce the vulnerabilities of the Brazilian Unified Health System (SUS) and the productive and technological capacity of the Health Economic-Industrial Complex. The methods used included a literature review and the analysis of primary data from interviews conducted in two of the largest LFOs in the country. Their efforts and results in Research and Development (R&D) and incorporation of medicines and vaccine technologies were identified and analyzed, with emphasis on Productive Development Partnerships (PDP). Although R&D activities still need to advance, benefits were brought about by technology transfer agreements, especially by PDPs. However, the industrial and technological capacity of the Institutes is still limited and lacks investments, which hinders technological accumulation and diffusion. Thus, improvements are necessary so that the innovation strategies for the SUS present more effective results and can be reversed to the welfare of society.

Incorporation of medicines in the Unified Health System (SUS): comparison between oncology and the specialized component of pharmaceutical care.

Compliance with legal deadlines for the assessment and incorporation of technologies in Brazil's Unified Health System (SUS) is essential to ensure public access to essential medicines. The scope of this paper was to analyze the compliance with legal deadlines for incorporation and availability of medicines in the SUS, comparing Oncology and the Specialized Component of Pharmaceutical Assistance (SCPA). A comparison was made of the drugs incorporated that were submitted to Conitec in the period from January 1, 2017, to April 30, 2020. A total of 85 drugs were recommended for incorporation by Conitec, of which 15 (17.64%) were for Oncology and 70 (82.36%) were for SCPA. The time between analysis and recommendation by Conitec until the publication of the decision by the Ministry of Health was, on average, 86 days longer for oncological drugs and the availability timeframe of technologies incorporated in the oncology area was, on average, 389 days longer than for SCPA. The major progress achieved with the creation of Conitec in Brazil is acknowledged, but the results of this study point to a pressing need to improve the process of making available technologies incorporated into the SUS, especially in oncology.

Analysis of Biological Framework and Incorporating Physiological Modelling

Biological frameworks for over the past few decades have been concentrating on the incorporation of medicine and biology including computation and information technology. The present problem is the utility of medical discoveries that have been recorded for over two decades till now: Proteomics and genomics have been projected to develop targeted therapeutically approaches. These approaches are the due to the understanding of the aetiological of the sophisticate illnesses. There are various efforts that are meant to enhance the human physiome based on the evaluation of weaknesses and strengths which will be evaluated in this research. The enhancement of the human framework with validation, documentation and verification of the integrative and underlying feedback is fundamental to project the usable ecosystem. Upcoming developments of the human framework necessitate the integrative physiologists operating in the connection of other scientists. These are some of the scientists with the professionalism in the areas of human biology. These experts are to propose a usable and accurate human framework.

Analysis of Biological Framework and Incorporating Physiological Modelling

Biological frameworks for over the past few decades have been concentrating on the incorporation of medicine and biology including computation and information technology. The present problem is the utility of medical discoveries that have been recorded for over two decades till now: Proteomics and genomics have been projected to develop targeted therapeutically approaches. These approaches are the due to the understanding of the aetiological of the sophisticate illnesses. There are various efforts that are meant to enhance the human physiome based on the evaluation of weaknesses and strengths which will be evaluated in this research. The enhancement of the human framework with validation, documentation and verification of the integrative and underlying feedback is fundamental to project the usable ecosystem. Upcoming developments of the human framework necessitate the integrative physiologists operating in the connection of other scientists. These are some of the scientists with the professionalism in the areas of human biology. These experts are to propose a usable and accurate human framework.

Incorporação de medicamentos sem registro sanitário no SUS: um estudo das recomendações da Comissão Nacional de Incorporação de Tecnologias no período 2012–2016

Introduction: Drug registration is an essential tool in assessing quality, safety and efficacy.In Brazil, the current regulatory framework prohibits the incorporation of any technology into the Brazilian Public Health System (SUS) without prior registration by the Brazilian regulatory authority, the National Health Surveillance Agency (Anvisa). The National Committee for Technology Incorporation (Conitec) advises the Ministry of Health on which health technologies should be incorporated. Objective: Conitec’s recommendations to incorporate non-registered medicines and their federal procurement between January 2012 and June 2016 were studied. Method: The study was based on the information from Conitec’s website and on purchases registered in the Integrated General Services Management System database. Results: Six of the 93 drugs incorporated by SUS during the period were not registered in the Brazilian Health Regulatory Agency (Anvisa). The main reasons for incorporation of non-registered medicines were severity of disease, minor adverse events, and low budgetary impact. In 50% of the cases, medicines were already present in the SUS for the approved indications, but in presentations that made it difficult for them to be used in pediatric patients or situations of greater severity. R$ 3,159,085.96 were spent on the purchase of these drugs. Conclusions: The recommendation of incorporation of medicines not registered by Anvisa contravenes the legislation related to Conitec and the public acquisition of medicines. On the other hand, it is important to highlight the importance of drug incorporations that meet relevant therapeutic gaps.

PD33 Incorporation Of New Medicines In Brazil: A Descriptive Analysis

Introduction:Health Technology Assessment (HTA) is important to the rational decision in healthcare systems. In Brazil, HTA is carried out by the national commission for the incorporation of technologies in the public system (Conitec), which issues reports with recommendations. This work aims to describe these recommendations and the factors influencing them.Methods:A descriptive analysis was conducted on Conitec's reports of incorporation of medicines between 2012 and 2016. The medicines were classified according to the Anatomical Therapeutic Chemical system (ATC).Results:One hundred and twenty-eight reports were assessed. Most requests were issued by the pharmaceutical industry (n=72; 47 percent), followed by the Ministry of Health (n=63; 41 percent). More reports issued by the Ministry of Health had positive recommendations compared to manufacturers (n=22 vs. n=50; χ2=30.231, df=1, p<0.001). Other antivirals were the most common class with requisitions (n=16), followed by TNF-α inhibitors (n=14) and selective immunosuppressants (n=12). Other antivirals had the most positive recommendations (n=12; 75 percent), followed by TNF-α inhibitors (n=7; 50 percent) and selective immunosuppressants (n=7; 58 percent). The difference was significant (χ2=88.65, df=63, p=0.02). TNF-α inhibitors was the class with the most negative recommendations (n=7; 50 percent), followed by monoclonal antibodies (n=6; 67 percent). Sixty-two reports contained economic assessments. Fifty-four presented incremental cost-effectiveness ratio (ICER) data and 57 presented the budget impact. Twenty-three reports showed data indicating dominance of the medicine, but only five of these were recommended for incorporation. Drugs for cancer have been recommended despite high ICER values. Decision makers accepted all the recommendations issued by Conitec.Conclusions:Data suggest that the economic evaluation is secondary to the decision of incorporation. The pharmaceutical industry is the largest applicant for the incorporation of medicines, but these requests are significantly less accepted than those made by the Ministry of Health. Conitec's recommendations are well-accepted by policy-makers. It was not possible to determine an implicit cost-effectiveness threshold.

OP158 Overview Of Technology Assessment For Multiple Sclerosis In The Brazilian Public Health System

Introduction:The National Committee for Health Technology Incorporation (CONITEC) has a structured process for the incorporation, disinvestment, or alteration of different health technologies in the Brazilian public health system and provides technical support for the decision-making process. Since its creation, CONITEC has received several submissions for the incorporation of medicines and the update of clinical practice guidelines for multiple sclerosis (MS). Nowadays, more than twelve different therapies are currently available to treat MS and the Brazilian clinical practice guideline, which was last updated in 2015, offers six medicines to treat MS that are divided into first, second, and third line treatments. The purpose of this study was to describe CONITEC's assessments of applications for incorporation, disinvestment, or alteration of medicines for MS.Methods:A case study method was used to evaluate information, retrieved from CONITEC's database, about the health technology reports developed by CONITEC's Executive Secretariat in response to applications received in the period from 2012 to 2017.Results:Ten technical reports on health technologies for MS were produced by CONITEC during the study period. This number represented four percent of the external submissions for incorporation of technologies for several clinical conditions in the public health system. Six medicines were evaluated. The highest number of submissions were for incorporation (n = 6), followed by alteration of treatment lines (n = 3), and disinvestment (n = 1); fifty percent of the submissions were not recommended. The main reasons for rejection were low or unproven efficacy, high budget impact, and inadequacy of the proposal based on the evidence presented. CONITEC's favorable recommendations caused a profound change in the current clinical practice guideline and had a significant impact on the health system.Conclusions:MS is considered a rare disease in Brazil, but there is significant pressure from society to provide better treatment options that will impact the MS scenario in the health system. The recent CONITEC assessments have led to a revolution in the treatment of MS in Brazil, which is now in the process of being updated.

Life Saving Bindi a Novel Approach to Combat Iodine Deficiency

The  thyroid  gland  produces  thyroid  hormones.  The  two  most  important  hormones  are  tetraiodothyronine  (thyroxine or T4) and tr iiodothyronine (T3).Iodine deficiency is a major health problem in India. Iodine deficiency  that  can  lead  to  disorders  like  goiter,  hypothyroidism  and  even  brain  damage.  Even  mild  iodine  deficiency  in  pregnant  women  can  result  in  children  being  born  with  c retinism  and  mental  retardation.  The  most  popular  method  of  tackling  the  problem  has  been  to  encourage  the  consumption  of  iodised  salt.  An  iodine  patch,  designed  like  a  regular  bindi,  is  expected  to  help  iodine  deficiency.  It  seems  like  a  brilliantly  simpl y  idea The  wearing of bindis form part of a cultural practice of Indian Women, which are “self - adhesive” in between their  eyebrows, have been impregnated with a solution of iodine. Production costs are minimal, wearing the iodine - infused bindi requires no behavioral change. Conclusion: Incorporation of medicine into lifestyle habits and daily  practice through novel approaches should be encouraged like Iodine Bindi in the management of other chronic  diseases.

New regulations for medicated feedingstuffs.

New legislation designed to protect the public from residues by providing better defined controls over the medicating of animal feedingstuffs begins to come into force from July 1. The 1985 Medicated Animal Feeding Stuffs Regulations have already closed a loophole whereby a POM product could be incorporated into feed and the resulting medicated feed sold without veterinary supervision. The new controls will require registration of manufacturers of medicated feedingstuffs including on farm mixers and impose conditions on the incorporation of medicines which are not licensed for in feed use (veterinary specials).