Consistency Evaluation Selection Tutorial: Comprehensive analysis of drug value，Three steps before choice
Release time: 2016-09-28 & nbsp & nbsp & nbsp Source: Anonymous
Opinions on the "Work Opinions on the Evaluation of the Quality and Consistent Effects" (National Office [2016] No. 8)，State Council、CFDA、The Chinese Inspection Institute has released more than 20 related announcements，Announcement involves all aspects of consistency evaluation，From the frequency and density of the announcement of the announcement, it can be seen that this consistency evaluation work is different from the characteristics of the previous work，quite serious and very urgent。And，The work industry for the consistency evaluation of generic drugs has been included in & ldquo; 135 & rdquo;，rose to the national strategic level。Face this job，Imitation pharmaceutical company & ldquo; Every family has the hard -to -read scriptures & rdquo;，Which varieties to choose to carry out consistency evaluation are one of the key difficult problems。
Background and difficulty
1, inevitability
eliminating the low -end capacity of the industry，The consistency evaluation of generic drugs is a major measure to promote the supply -side structural reform。At present, domestic drug sales in large hospitals account for 80%，Extract of the quality of generic drugs，Improve the quality of generic drugs，Clinically realized alternative with the original research medicine，can we promote structural change in the field of drug production。It is understood，The gross profit margin of the domestic generic drug industry is less than 10%(the international average is about 40%-50%)，and over half of the variety highly repeat。
Consistency evaluation is the only way to enhance the international competitiveness of domestic generic drugs，It is also alleviating domestic medical insurance、The inevitable choice of the pressure of the new policy of drug price。
The consistency of generic drugs and the original drug is the principle of international traffic，Consistency evaluation is a way that many countries have gone。In the 1970s，The United States starts the Elimination Evolution Evaluation of Imitation Drug Bio，Start paying attention to the efficacy of generic drugs，Last 10 years，Drugs that eliminate 6,000 kinds of unprepared evaluation。Britain has conducted consistency evaluation of 36,000 medicines。Japan launched the drug quality re -evaluation project in the late 1990s。The above three countries have all upgraded the generic drug industry，Drug Quality、Industry Ecology、Industrial value is worth significantly improved。"Drug Management Law" revised by my country in 2001，Get the generic drugs into the national unified approval，Start requiring generic drugs for clinical trials; 2007 encouraged imitation of original research medicines，But it is not for compulsory requirements。"National Drug Safety & LDQUO; Twelve Five -Year Plan" was issued when it was issued，The task of evaluation of the quality consistency of generic drugs and the quality of the original drug was proposed; last year, the State Council No. 44，Put forward the requirements of quality efficacy as the original My stake betting appMy stake betting appmedicine。Consistency Evaluation，It can be said to be & ldquo; supplementary lesson & rdquo;。
2. Choose difficulty
The author combed and found out，At present, the first batch of basic drug oral preparation varieties that need to complete the consistency evaluation at the end of 2018，General name 198，involved approval number 17740，domestic production enterprises 1817，42 imported companies (see Table 1)。The variety of the approval number is extremely high，There are 16 types of a variety of more than 300 quasi -text numbers，44 species of 100 approval numbers。Only compound sulfona metamolidine，A total of 895 text number、869 companies produced。If the company will evaluate all the approval number，Obviously unrealistic，Evaluation time is also limited，Evaluation costs of each variety are about 5 million-6 million yuan。Based on the entire sales revenue in 2015, if 40%of all drug sales revenue, if it is calculated，The cost of consistency evaluation will exceed 20%of the entire annual sales revenue of basic medicines。So，The problems faced by the company also come out: Do you want to do it? What do you do?
Economics is a discipline specially studied，Economics The value of the product of the allocation of resources is the value of the product，What the value of the drug is needed、How to make a reasonable selection based on the value of the medicine。
Table 1: The first batch of basic medicine oral preparation varieties that need to complete the consistency evaluation at the end of 2018
The value connotation and composition of the medicine
First look at the value of the product。In a macro sense，Commodity value includes two parts: part is the inner use value of the product，Reflected the essential attributes of the product & mdash; & mdash; what is the purpose; the other part is the market value of the product，Reflecting its social attributes，People are willing to pay for the value of use。The value of the product needs to be reflected through market value，At the same time, market value reflects the willingness and demand of consumption。
Drug value also includes the use value and market value，Use value is the function of the medicine itself，Used for treatment、Diagnosis、Diseases to prevent people，That is, the value of drugs comes from clinical; market value is consumer willingness and demand for this clinical value，That is the price that people are willing to pay for health improvement or health level。Drugs are related to human health and life safety，Therefore, it also has more public welfare and social welfare attributes，The development of the drug industry is directly related to the government's credibility，From this，Drugs also have another special value，Social value。
1. Clinical value
This is the core value of the medicine，is the basis for determining market value and social value。International，Many countries (such as German、Law, etc.) Pay attention to the clinical value of the drug，As an important basis for drug -related decisions，Price of drugs、Selection of the medical insurance directory、The formulation of clinical medication guidelines, etc.。
The "Medical Industry Reform Act" implemented by Germany in 2011 (among)，Divided the additional benefits of innovative drugs into a major、Significant、Small、Attachment of additional benefits、No additional benefits and benefits are less than 6 levels of control therapy，The first 3 levels of drugs have additional benefits，The last 3 levels do not have additional benefits，At the same time, it is stipulated that if the additional benefits of the medicine are not accepted，The drug is included in the reference price group to determine the medical insurance payment price，If you have additional benefits, pharmaceutical companies can negotiate with the Fund Committee to determine the medical insurance payment price，Often, the price determined by the reference price group is much higher than the price group。Judgment standard for additional benefits is clinical value，The judgment indicator is all due to mortality、Incidence、The quality stake online sports bettingof health -related life Stake Sports Bettingquality and adverse reactions。New drugs are required to submit dossiers when they are formulated by new drugs，Evaluate the dossier based on these 4 clinical value indicators based on these 4 clinical value indicators，Evaluation of its added value relative to the control therapy。
In France，New drugs need to pass through 3 procedures & mdash; & mdash; listing approval、Value evaluation and price consultation。If the medicine gets a listing permit，It will be evaluated by the Supreme Committee and the Transparent Committee for the treatment value，and rating the degree of increased treatment value (ASMR grading)。Based on the evaluation of the transparent committee，The negotiation price of the Health Product Economic Committee and the pharmaceutical company (including the price of retail drugs and the price of hospital drugs)。ASMR grading process is also a process of judgment of clinical value of drugs，According to the main indicators, the main indicators include: drug safety、Compliance、Quality controllability、Compliance、Innovative、Meet social needs and other social characteristics。ASMR grades directly determine the high and low factory price of the drug，Innovative drugs are ASMRI to ASMR Ⅲ，The conventional medicine is ASMRIV or ASMRV level，The price difference between each level is 30%。Drugs incorporated into the medical insurance directory need to reach ASMR IV，ASMRV drugs to be included in the directory，It is cheaper than similar medicines to。
November 2015，Start of the Chinese Pharmacist Association & ldquo; Drug value classification research & rdquo; topic，A project research by Shenyang Pharmaceutical University，Learn from morality、Method、Japan and other national experience，Three rounds of Delphi questionnaire survey，Participating more than 200 experts，Judgment indicator system for building the clinical value of Chinese drugs，These refer to the clinical value of the drug，Determine whether the medicine has clinical value，To measure the performance of the medicine on these indicators: cure rate or effectiveness、Has high security、Severely adverse reaction rate、Full due to mortality、Life quality related to patient health、Improvement of the treatment of diseases or pain、Able time、Whether it is a medicine incorporated by the guide for clinical medication、Pharmacological effects with new main indications and efficacy、Improved preparations have higher practicality in medical treatment、It has new main indications and efficacy suitable for children、Medicine compliance、convenient medication、There are new main indications and efficacy for rare diseases、Non -serious adverse reaction rate 15 indicators。
2. Market value
The market value of the drug comes from the market demand driver of the drug。
aging+disease spectrum Chinese population aging process is very fast。Data Show of the Ministry of Civil Affairs，As of the end of 2014，The 60 -year -old and above elderly population reaches 212 million，More than 15%of the total population。The bed share of the elderly is 27.2 per thousand populations，far higher than the average level of the country。It is expected to be 2050，China will have more than 1/3 of the population of more than 60 years，At that time，China will become one of the countries with the worst aging population。The medication of the elderly accounts for 70%of the entire drug market，，So，From the perspective of market value，Pharmaceuticals for elderly diseases will have a great market value。
It can be seen from the Chinese disease spectrum，Diseases such as tumors、Cardiovascular disease and endocrine disease，It is the incidence and mortality rising rapidly，Where，Lung Cancer、Liver cancer、Gastric cancer and colorectal cancer are the most important types of disease in the field of malignant tumors。My stake betting appThe number of diabetic patients is increasing。My stake betting appAlso，Number of Alzheimer's patients continue to increase，The proportion of elderly people over 80 years old suffer from dementia higher than 40%。Another，The latest statistics of the National Health and Family Planning Commission show，More than 260 million patients with chronic diseases in China，The burden of disease caused by chronic disease accounts for nearly 70%of the burden on the total disease，Death caused by about 85%of all population deaths。These areas will also be the main field of best -selling drugs，The value of the treatment drugs in these fields is huge。
Hierarchical diagnosis and treatment+prescription outflow at the previous national health and health conference，State leaders position the first of 5 basic medical and health systems for & ldquo;，At present, pilots have been launched in 270 cities across the country，The use of drugs for primary medical institutions will be greatly improved。The National Development and Reform Commission also led the "Guiding Opinions on Promoting the Healthy Development of the Pharmaceutical Industry" this year (National Office [2016] No. 11)，Encourage medical institutions to prescribe outflow，This is also the focus of the State Council ’s medical reform in 2016，It is required that medical institutions should open a prescription in accordance with the common name of the drug，and actively provide a prescription to the patient，To ensure the right to choose the medicine for patients，Encourage patients to freely choose to buy medicine at retail pharmacies with free prescriptions。From this，Grassroots and retail terminal medication markets are expected to ferment，From the perspective of drug species of primary medical institutions，Drug use of cardiovascular system (31.27%)、Anti -infectious medication (24.69%) and digestive system and metabolic medication (22.96%) accounted for a large，The market value of these varieties is relatively high。
3. Social value
Social value comes from the attention of government and policies。First is the safety of medication。Drug safety issues have always been the focus and difficulty of national drug supervision，2015 pharmaceutical policy reform，More than 20 related systems were introduced、Specification、Management Measures，To ensure the quality and safety of the medicine。
CFDA announced in July last year that it was called & ldquo; the most stricter drug clinical trial data in history, the self -checking order & rdquo;，Clinical data checking storm never stops。According to official information，& ldquo; 722 article & rdquo; Published so far，More than 80%of the 1622 pharmaceutical registration application required by this article has already applied for withdrawal。In August this year "Announcement on the Opinions of the Related Issues of the Data Check of Drugs (Draft for Soliciting Opinions)"，Further clarify the fraud behavior of clinical data，and formulated a blacklist system。Visible，Safe medicine、Drugs with reliable quality can be a drug with social value。
Secondly, what attracted great attention from the government is the shortage of clinical drugs。Some hospitals commonly used drugs and the shortage of necessary medicines are not optimistic，Summarize the current shortage drug list listed in various places，The 289 types of base drugs evaluated in the first batch of consistency evaluations are included in the list as shown in Table 2，These varieties have high social value，It is also a variety of focus on this consistency evaluation。
Table 2: Summary of shortage drugs in various places (289 types of basis，More than 30 species)
Strategy selection
Enterprise faces choices，Analysis of three steps to complete: First of all，Comprehensively sort out the approval number variety involved in the company。Second，Analysis of their own clinical value、Market value and social value，Comparison with similar varieties My stake betting appwith other companies，Sort stake betting appthe advantages and disadvantages of all varieties，Determine its location in the first batch of varieties，If the company's variety is currently facing a high degree of repetition，The number of approvals is more，The advantages of these varieties are relatively low。
For example, the whole body in Figure 1 is anti -infective medicine，Number of approvals 7433，1500 manufacturers，digestive tract and metabolic drugs，The number of approvals 3966，Manufacturer 1299，If the company's variety is here, you must make a cautious choice; at the same time，Sort out the relevant national policies and market development needs，After the product positioning is clear，Finally choose a valuable variety that meets policy and market demand。
Figure 1: 289 Both drug varieties category distribution
We can use & ldquo; Person's product portfolio decision -making matrix & rdquo;，The horizontal coordinates are the current market performance of this variety，Including market share、Sales income, etc.，The clinical value of the vertical coordinates is the drug、Market value and social value，Value varieties are high -level varieties that focus on and retain，Especially in the & ldquo; ☆ & rdquo; Class -based companies need to spare no effort to carry out consistency evaluation as soon as possible，and ensure that it can pass。For the reason for the fact that the variety does not get a good market performance, the company must conduct carefully analysis，If the market performance is not good enough due to irregularity of the market，Perhaps after consistency evaluation，Especially the inherent value of these varieties after the industry is reshuffle can be fully reflected (shown in Figure 2)。
The variety in cash cow & rdquo; if the company has the ability to recommend it，By improving or secondary development，Dig its internal value，Promote it to become & ldquo; ☆ & rdquo; level varieties，If the company is not capable，It is recommended to abandon。Variety in the position & ldquo; thin dog & rdquo;，It should be abandoned without hesitation。
Figure 2: Variety BCG strategy selection
Summary & gt; & gt; & gt;
Consistency evaluation has entered & ldquo; The speed of life and death & rdquo;，Determine life and death，Enterprises must follow the trend，No time to hesitate，Scientific decision -making is a wise move。To choose valuable varieties, go all out，Take less detours，Strive to get the opportunity in the competition。
The common problems facing all the current companies，will be gradually resolved in the policy and system that is continuously introduced in the future，but，The problem of the company itself needs its own efforts，Actively face。No industry is always calm，Only continuous innovation，can be established in an undefeated place，Scientific issues require scientific methods to solve，Method more than the problem。(The author of this article is an associate professor at Shenyang Pharmaceutical University)
