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This Health Technology Assessment was commissioned by the "National system for the introduction of new health technologies within the specialist health service". The aim of this report was to assess the effect and cost-effectiveness of the disease modifying medicines used in Norway for patients with relapsing remitting multiple sclerosis (dimethyl fumarate, teriflunomide, interferon beta, peg-interferon, glatiramer acetate, natalizumab, fingolimod, and alemtuzumab). The key results are:1. We identified 37 randomised clinical trials. The quality of the available evidence ranged from very low to high.2. Alemtuzumab 12 mg had the best effect on annual relapse (for medicines we had evidence of high quality). Dimethyl fumarate 240 mg twice daily and fingolimod oral 0.5 mg were the most effective against disability progression (for medicines we had evidence of high quality).3. Our results indicated that interferon beta-1a 44 mcg and peg-interferon beta-1a were associated with more withdrawal due to adverse events than placebo. The examined treatments had no effect on mortality compared to placebo.4. Our health economic analysis, examining all multiple sclerosis treatment alternatives, indicated that alemtuzumab was more effective (in terms of quality-adjusted life-years (QALY)) and less costly than the other treatment alternatives. We did several scenario analyses and the cost-effectiveness results were robust to variations in the model assumptions.5. The results of a scenario analysis that excluded alemtuzumab (the dominant strategy), showed that three treatment alternatives (interferon beta-1b (Extavia), peg-interferon beta-1a and natalizumab) could be cost-effective depending on the willingness-to-pay (WTP) per QALY. Assuming a WTP below NOK 1,000,000, interferon beta-1b (Extavia) was 40% likely to be the most cost-effective treatment, followed by peg-interferon beta-1a (30% likely).6. The results of our model analysis showed that there is some degree of uncertainty regarding the input parameters. More research on efficacy and epidemiological data would have the greatest impact on reducing decision uncertainty.7. Our budget impact analysis based on the results of our cost-effectiveness analysis, the drugs' adverse events profile, and current clinical practice showed that there is a substantial potential for cost saving.
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This Health Technology Assessment was commissioned by the "National system for the introduction of new health technologies within the specialist health service". The aim of this report was to assess the effect and cost-effectiveness of the disease modifying medicines used in Norway for patients with relapsing remitting multiple sclerosis (dimethyl fumarate, teriflunomide, interferon beta, peg-interferon, glatiramer acetate, natalizumab, fingolimod, and alemtuzumab). The key results are:1. We identified 37 randomised clinical trials. The quality of the available evidence ranged from very low to high.2. Alemtuzumab 12 mg had the best effect on annual relapse (for medicines we had evidence of high quality). Dimethyl fumarate 240 mg twice daily and fingolimod oral 0.5 mg were the most effective against disability progression (for medicines we had evidence of high quality).3. Our results indicated that interferon beta-1a 44 mcg and peg-interferon beta-1a were associated with more withdrawal due to adverse events than placebo. The examined treatments had no effect on mortality compared to placebo.4. Our health economic analysis, examining all multiple sclerosis treatment alternatives, indicated that alemtuzumab was more effective (in terms of quality-adjusted life-years (QALY)) and less costly than the other treatment alternatives. We did several scenario analyses and the cost-effectiveness results were robust to variations in the model assumptions.5. The results of a scenario analysis that excluded alemtuzumab (the dominant strategy), showed that three treatment alternatives (interferon beta-1b (Extavia), peg-interferon beta-1a and natalizumab) could be cost-effective depending on the willingness-to-pay (WTP) per QALY. Assuming a WTP below NOK 1,000,000, interferon beta-1b (Extavia) was 40% likely to be the most cost-effective treatment, followed by peg-interferon beta-1a (30% likely).6. The results of our model analysis showed that there is some degree of uncertainty regarding the input parameters. More research on efficacy and epidemiological data would have the greatest impact on reducing decision uncertainty.7. Our budget impact analysis based on the results of our cost-effectiveness analysis, the drugs' adverse events profile, and current clinical practice showed that there is a substantial potential for cost saving.
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Drug development --- Drug Evaluation, Preclinical --- Drug Industry
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Chemistry, Pharmaceutical --- Drug Evaluation, Preclinical --- Toxicology
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Carcinogens --- Drug Evaluation --- Drug Evaluation, Preclinical
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"Provides practical guidance to solve scientific and regulatory issues in preclinical safety assessment, early clinical drug development, and post-approval impurity issues"--Provided by publisher.
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"This reference discusses in detail the broad realm of preclinical drug development. Topics range from assessment of pharmacology and toxicology through the regulatory expectations that support clinical trials. Providing chapters on pharmacokinetics, modeling and simulation, formulation and routes of administration, toxicity evaluations, the assessment of drug absorption and metabolism, and interspecies scaling, this guide is a fundamental resource for medicinal chemists, biologists, and other specialists in the drug development sciences."--Jacket.
Drug Evaluation, Preclinical --- Drug Industry --- Drug development. --- Methods. --- Methods.
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Carcinogens --- Drug Evaluation, Preclinical --- Neoplasms --- toxicity --- chemically induced
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Thalidomide. --- Thalidomide --- Abnormalities, Drug-Induced. --- Drug Evaluation, Preclinical --- Drug Evaluation, Preclinical --- Thalidomide --- Thalidomide --- Thalidomide. --- Thalidomide --- Side effects. --- History. --- Trends. --- Adverse effects. --- History. --- Side effects.
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Drug Screening. --- Drugs --- Toxicology. --- Poisoning --- Médicaments --- Toxicologie --- Empoisonnement --- Drug Evaluation, Preclinical. --- Médicaments
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