| BackgroundFor a long time,the rising medical cost,the artificially high drug price,the expensive fee to see a doctor,and the common phenomenon of disappeared cheap medicine are all the problems of medical market in our country,Its reasons main include the irrational drug pricing mechanism,the imperfect medicine circulation system,imperfect supervision system and so on.But the fundamental cause lies in our country’ cost oriented pricing mechanism.Value is the basis of the price,the price is the currency performance of value,so the reasonable drug price should be able to reflect its value,but the cost oriented pricing mechanism in our country often leads to the deviation of drug price and the value.In fact,the growth of drug costs is a common problem facing in most countries of the world,most of them will realize the drug cost control through the value based pricing mechanism,and the practice proves to be effective.In our country,the value based pricing mechanism has been proposed by some scholars for a long time,but it is still mainly theoretical,and the practice effect of pharmacoeconomics evaluation is not ideal.Therefore,it is the present research emphasis for domestic scholars to learn the advanced experience of value based pricing actively from foreign countries,in order to reform the current drug pricing mechanism in our country,and make the drug price consistent with its value.Objective and significanceThis study aims to construct a set of scientific,reliable,objective and effective evaluation index system of post-marketing drugs’ value,test the reliability and validity of the index system and make empirical analysis through the way of field investigation.On this basis,we put forward to the idea of tiered pricing mechanism based on drug value and its preliminary implementation path in order to provide the reference for exploring the value based pricing mechanism in our country.The quantization of drug value through index system can comprehensively reflect the value difference between different drugs,which is beneficial for patients to choose "high quality" medicine.At the same time,making tiered price based on drug value is not only helpful to guide drug manufacturers to produce the medicine with good curative effect and high security,but also can improve its enthusiasm to development new drugs;The return of drug price to drug value can reduce the drug price in a certain extent,thus it can reduce the financial burden of patients and make the harmonious development of medical and health industry.Methods1 Documentary analysis methodOn the stage of constructing the evaluation index system of post-marketing drug value,we retrieved the Chinese database such as CNKI,NSTL and VIP Database with the key words of "drug value","clinical efficacy of drugs","drug safety"、"drug economy","value evaluation" and so on.At the same time,we retrieved ScienceDirect,Pubmed,Scopus,Google and other English database with the key words of”drug value","drug effect","drug safety","value evaluation" and so on.Then we screen the document according to its publication time and its correlation with retrieval theme,with the preference of high relevance and near publication time.Through extensive reading of related literature both at home and abroad,we organize the evaluation indexes which are related to drug value,drug clinical effect,drug safety and so on in the existing documents.And we choose the sensitive and suit indexes to build the item pool for index system with the principle of effectiveness,scientificalness,importance and the data availability.On the stage of making an empirical analysis of the index system,we retrieved the NSTL,VIP Database and CNKI with the key words of "cyclosporine","tacrolimus","immunosuppressants","lamivudine","adefovir dipivoxil","entecavir","antiviral agents for hepatitis B","salbutamol","terbutaline","cost-effectiveness analysis" and so on.At the same time,we consulted the "China Food and Drug Administration(CFDA)","National Center for ADR Monitoring,China","State Intellectual Property Office of the People’s Republic of China" and other official website,in order to know about the efficacy,safety,cost,efficient,adverse reactions,the incidence of adverse reactions,cost-effectiveness ratio and so on of the 7 kinds of drugs.2 Delphi methodDelphi method is a structured group communication method which collects the opinions of experts on a topic through questionnaire investigation.Experts anonymously publish their ratings and opinions about the indicators "back-to-backf".Then researchers make the inductive summary of experts’ opinions,and modify the indexes to the next round of consultation,until experts’ opinions tend to be consistent.The biggest advantage of this method is that it can eliminate the authority of part experts on the interference of other experts.This study were conducted 1 round pre consultation and 2 rounds of formal advisory,when each consultation finished the researchers would analyse the opinions of experts,and screen the indexes according to the experts’ opinions and the index importance.3 Field investigation methodThis study selected 3 categories,a total of 7 kinds of drugs as the research objects for the empirical analysis of the index system,and selected 52 doctors and pharmacists as investigation objects to conduct a field investigation with the"Questionnaires of the experts assessment about part post-marketing drugs’ value ".It aims to know about the doctors and pharmacists’ evaluation score about the value evaluation indexes of the selected 7 kinds of drugs such as irreplaceability,effective rate,resistance,adverse reactions,price.And the final purpose is to provide detailed data suppor for the reliability and validity test and empirical analysis of this research.Content1 The construction of evaluation index system for post-marketing drug valueCollecting the evaluation indexes through the literature research method,and screening them through 3 rounds of experts consultation and the score of index importance.Calculating the positive coefficient,authority coefficient and consistency coefficient of consulting experts,and calculating the weight of each index combined with the authority coefficient of experts and the importance score of each index,then finally formed the evaluation index system of post-marketing drug value.2 The validity and reliability of the evaluation index system for post-marketing drug value and its empirical analysisAccording to the disease mortality data of 2016 Chinese Health Statistics Yearbook,we selected 3 classes,a total of 7 kinds of drugs as the research objects,and investigate 52 experts’evaluation about the indexes of above drugs through the way of field investigation.Then,we tested the reliability and validity of the index system and made the empirical analysis according to collected data.3 Propose the assumption of drug pricing and price-adjusting mechanism based on classification of drug valueClassified the drugs according to their value scores and proposed the corresponding pricing and price-adjusting assumption,in order to provide the reference for the value based drug pricing of our country.Results1 The construction of evaluation index system for post-marketing drug valueThis study screening the item pool through Delphi method and the consultation were conducted 3 rounds including 1 round pre-consultation and 2 formal consultations.The final evaluation index system of post-marketing drug value includes 4 fist level indicators and 20 secondary level indicators,the specific indexes and corresponding weights are as follows:First level indexes:innovation(0.2423),effectiveness(0.3169),safety(0.2577)and economy(0.1831).Second level indexes:"no alternative(0.0544)","certification associated with efficacy(0.0481)","patent associated with efficacy(0.0481)","technology level of drug research and development(0.0465)",and "drug registration classification"(0.0452),the above five indexes belong to the first level index of "innovation";"Effective rate(0.0695)","treatment status(0.0570)"," etiological treatment(0.0528)","drug resistance"(0.0479),"pharmacological effect(0.0460)" and " effective time(0.0437),the above six indexes belong to the first level index of "effectiveness ";"Incidence of serious adverse reaction(0.0623)"." incidence of adverse reaction(0.0528)","severity of adverse reaction(0.0515)"," reversibility of adverse reaction(0.0484)",and "acute toxicity(0.0427)",the above five indexes belong to the first level index of "safety";"Cost-effectiveness ratio(0.0589)","reimbursement condition(0.0419)","price of the same kind drug(0.0410)" and "average daily treatment cost(0.0413)",the above four indexes belong to the first level index of "economy".The positive coefficients of 3 rounds of expert consultations were 1,0.8235 and 0.9286 respectively;The coefficients of expert authority were 0.777,0.741 and 0.749 respectively.The consistent coefficients of experts’ opinions were 0.322(P<0.001),0.263(P<0.001)and 0.476(P<0.001)respectively.2 The validity and reliability analysis of the evaluation index system for post-marketing drug value(1)Reliability analysisThe Cronbach’s alpha coefficient of the index system was 0.713>0.7,indicating that the reliability was relatively good.(2)Exploratory factor analysisThe results of the appropriate analysis showed that the KMO statistics of this study was 0.717,and the approximate chi-square of Bartlett spherical test was 714.064(P<0.001),indicating that this data meets the basic premise of exploratory factor analysis.Four factors with eigenvalue higher than 1 were extracted through principal component analysis,and the cumulative variance contribution rate is 59.363%,consistent with the theoretical ideas of the index system.Factors roted by the maximum variance,and listed the factor loadings whose absolute value are higher than 0.4.Factor 1 contains the innovation dimension,B2 and B5 items of effectiveness dimension and C2 item of safety dimension,the variance contribution rate is 21.166%;Factor 2 contains B1,B4 and B6 items of the effectiveness dimension and C3,C4 items of the safety dimension,the variance contribution rate is 14.868%.Factor 3 is the economic dimension and the variance contribution rate is 14.550%.Factor 4 is the safety dimension,and the variance contribution rate is 8.779%.(3)Confirmatory factor analysisFirstly,the initial fitting effect of first-order model and second-order model were explored respectively,and the results were compared.The results found that the fitting indexes of first-order model were CMIN/DF= 2.335,IFI= 0.767,TLI= 0.710,CFI= 0.759,and RMSEA= 0.113.The fitting effect of the second-order model is:CMIN/DF= 2.358,IFI= 0.759,TLI= 0.705,CFI= 0.750,and RMSEA= 0.114.It can be seen that although the fitting effect of the two is not ideal,the first-order model is better than the second-order model,which is better suited to the index system.Observing the first-order model’s original path diagram of the index system,we found that the corresponding factor loading was 0.14,0.24 and 0.14 respectively of items of C5,B6 and C1,which are less than 0.3.Therefore,the above 3 items should be deleted,but actually we reserved C1 for the time being because its highest weight among all the items of safety dimension.The fitting effect of the model after deleting C5 was:CMIN/DF= 2.420,IFI= 0.781,TLI= 0.722,CFI= 0.773,RMSEA= 0.117;The fitting effect of the model after deleting B6 was:CMIN/DF= 2.037,IFI= 0.849,TLI=0.805,CFI= 0.844,RMSEA= 0.100.It can be seen that the simple fitting effect and the relative fitting effect of the model had reached an acceptable range,but the absolutely fitting effect is still not ideal with the relatively large RMSEA.Thus we modified the model according to the modification index(M I.).To improve the fitting effect of the model,we established contacts between the pairs of error with high modification index according to the table of modification index,five modifications were conducted:"e2(?)e6","e2(?)e12 at 11:45","e2(?)e4","e2(?)e3","e1(?)e6",and the fitting effect after modification was:CMIN/DF=1.574,IFI= 0.922,TLI=0.892,CFI=0.919,RMSEA=0.074,which means a good fitting situation.Besides,the corresponding factor loading of C1 was 0.34>0.3,which means the the whole validity of the index system is good.3 The empirical analysis of the evaluation index system for post-marketing drug valueThe comparison results of drug value scores calculated by the index system between the data of experts evaluation and objective data showed that they had a same direction of value judgment of the three kinds of drugs.The value judgment results are tacrolimus>ciclosporin,entecavir>adefovir dipivoxil>lamivudine,salbutamol>terbutaline.Besides,the results of single sample T test showed that there was no statistical difference between the two kinds of calculating results,indicating that the expert’s judgment on the drug indexes was relatively objective,accurate and reliable.The comparison results between the drug value scores calculated by the index system with experts’ evaluation on each index and the drug value scores evaluated in a whole by experts showed that they had a same direction of value judgment of the three kinds of drugs,too.The results were also tacrolimus>ciclosporin,entecavir>adefovir dipivoxil>lamivudine,salbutamol>terbutaline.And the consistent rate of the evaluation results of all the experts was 73.91%>70%,which means the consistency is good,showed that the index system can measure the value of different drugs of the same kind correctly.That is to say,the index system is effective when applied to practice.4 Propose the grading standard based on the drug value and the corresponding drug pricing and price-adjusting strategyThis study put forward to an assumption of dividing the drugs into A,B,C,D class based on the quantitative scores of drug value.As for the post-marketing drugs,we divided it into D grade when the quantitative score is less than 30,C grade when the quantitative score between30 and 50,B grade when the quantitative score between 50 and 70,and A grade when the quantitative score is higher than 70;As for the new drugs,we divided it into D grade when the quantitative score is less than 30,C grade when the quantitative score between 30 and 60,B grade when the quantitative score between 60 and 85,and A grade when the quantitative score is higher than 85.With the principle of drug price is consistent with the value,we put forward to the price-adjusting assumption for post-marketing drugs:the price should have a reduction of 20%or more for D grade drugs,a reduction of 10%～20%for C grade drugs,a increase of 10%or above for A grade drugs,and class B drugs maintaining the existing price;At the same time,the pricing strategy for new drugs is that the price of D grade drugs should reduce 20%or more on the basis of cost plus,the price of class C drugs should reduce 10%～20%on the basis of cost plus,the price of class A drugs should rise 10%or more on the basis of cost plus,and the class B drugs should have a price on the basis of cost plus.The above assumption still needs further validation and fastidious.ConclusionThis study constructs a set of evaluation index system of post-marketing drugs value through Delphi method based on the pharmaceutical market pricing status of our country.The incentive coefficient,authority coefficient,and Kendall’ W coefficient of experts we selected are relatively good,which shows that the index system is scientific and reliable.At the same time,the analysis of the reliability and validity as well as the empirical analysis shows that the index system has good reliability and validity,and it can measure the drug value accurately and reliably,thus it can provide reference for exploring the value based drug pricing in our country.But due to the limitation of time and funds,the sample size of empirical analysis of this research is still relatively small,and there is no further verification on the assumption of drug pricing and price-adjusting mechanism.Therefore,further study should enlarge the sample size of empirical analysis,in order to verify and improve the index system and the idea of drug pricing and price-adjusting strategy. |
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