This article is from the public number:Everything (ID:HealthInsight), OF: Straight. FIG title from: Oriental IC
The 5-year survival rate of liver cancer is less than 20%. One of the sources of liver cancer is hepatitis C, and the cure rate is 98%.
But the new hepatitis C drug is expensive, enters the medical insurance, and increases the high expenditure; if it does not enter, the patient can’t afford it, and the result can be imagined.
Sometimes, progress brings a dilemma.
China has about 25 million hepatitis C virus (HCV) carriers, and is growing at a rate of 350,000 per year. This is the number published by Gloria Pharmaceuticals in its prospectus.
In the 20 years after HCV infection, 5-15% will be converted to cirrhosis, and about 2-4% of patients with cirrhosis will become liver cancer each year. If you take the middle number, that is to say, about 75,000 liver cancer patients will be added each year.
Most of them may die within six months of cancer, and the five-year survival rate for liver cancer is less than 20%, or even close to 10%. The singer Yu Tianyi, the actor Fu Wei, the poet Wang Guozhen, etc. all died of liver cancer.
△September 28, 2018, the artist 臧天朔 died of liver cancer
But if you trace the source, hepatitis C is already a curable disease. In 2011, the latest all-oral direct antiviral drug (DAA) program was launched in the United States, and hepatitis C treatment opened a new era. For example, the “Bingtongsha” approved for listing in China in May 2018 has a cure rate of 98%. One prediction is that by 2036, hepatitis C will become a rare disease in the United States.
However, the shortcoming of “God medicine” is expensive. Bingtongsha needs to take medicine for 12 weeks, and the cost is 69,000 yuan. Because it is not included in medical insurance, the high price has discouraged many hepatitis C patients.
There are two dilemmas:
If you are covered by health insurance, you will add a high amount of expenses. However, it can cure a large number of patients with hepatitis C, thereby reducing the number of patients with liver cancer.
If not included, a large number of patients with hepatitis C choose not to be treated due to economic constraints. Once liver cirrhosis or even liver cancer progresses from chronic hepatitis C, the cost of treatment will be greatly increased, thereby greatly increasing the burden of social diseases and causing more poverty due to illness. family.
This is almost a common problem for all high-efficiency innovative drugs.
According to the time node adjusted by the National Health Insurance Drug List in 2019, the medical insurance negotiation access list will be announced soon.
Pharmaceutical companies invest heavily in research and development of new drugs, hoping to recover costs through high drug pricing; patients hope to receive timely treatment and improve their quality of life; health insurance hopes to maintain the normal operation of the fund while taking care of fairness. Faced with the different demands of all parties, the decision to include medical insurance can be said to be one-stop.
How to balance the interests of all parties and provide evidence-based medicine to provide support for the final decision of innovative drugs that should not be included in health insurance?
The health technology assessment discussed by the participating experts at the 2019 Health Technology Assessment and Decision Support Forum held in Shanghai not long ago(HTA) It is the hope to solve this problem. In fact, in October 2018, 17 kinds of anticancer drugs were successfully incorporated into the medical insurance catalogue, and HTA has already played a role.
How health technology assessments support health care decisions
The development of medical technology is an important reason for the extension of life expectancy and the improvement of quality of life in modern people, but it is also the main driving force for the rise of modern medical expenses. Some scholars estimate that the increase in medical expenses caused by the development of medical technology accounts for 30%-50% of the increase in medical expenses.
Thus, countries that prioritize health technology assessments typically have higher health care expenditures than GDP (GDP) Countries such as the United States, the United Kingdom and Australia. They want to be able to maximize their results with the most limited resources.
Xuan Jianwei, a professor at the Institute of Pharmaceutical Economics of Sun Yat-Sen University, shared the four-quadrant model of health technology assessment at the 2019 Health Technology Assessment and Decision Support Forum held by the Shanghai Center for Health and Wellness Development, which can help us at a glance. Learn how HTA can support health care decisions.
In the model, the vertical axis is the cost, the more expensive it is, the closer it is to the top; the horizontal axis is the effect/value, the closer to the right side, the better the treatment effect and the greater the value.
The cost is high and the effect is poor, that is, it falls in the upper left corner area (second quadrant), then surely, the medical insurance is rejected;
The cost is low and the effect is good, that is, it falls in the lower right corner (fourth quadrant), then it is all happy;
The cost is low and the effect is poor, that is, it falls in the lower left corner area (third quadrant), which belongs to the disputed area. In the case of limited medical insurance costs,At a relatively low cost, medical services that receive acceptable results are sometimes a last resort.
The most difficult choice is the most discussed and discussed in the academic world. It is also an effective result, but at the same time the cost is high (first quadrant)< /span> Whether the technology or drugs should be included in health insurance. Most of the innovative products are in this situation. They are also in the first quadrant. Who should choose and who to give up?
Key to see the extension of patient life and quality improvement
Continue in-depth analysis. We draw four points A, B, C, and D in the first quadrant.
If B and C are compared, C will definitely be chosen, because the same effect, C cost is lower;
If A and C are compared, choose A, because A costs better at the same cost;
The problem is that if C and D are compared, D is expensive, but the effect is better. How do you choose?
At this point, you need to introduce an incremental cost-effectiveness ratio (ICER), that is, the cost per additional unit of effect, It is indicated by a diagonal line in the first quadrant in the figure.
The point at the bottom right of the slash increases the cost to less than the upper left under the same effect. For the purposes of this figure, C should be chosen for C compared to D.
However, how to draw this slash has become a problem.
According to the current international practice, QALY(Quality Adjusted Life Year) is used as ICER (incremental cost-effectiveness ratio) is a measure of the extent to which a patient’s life can be prolonged and the quality of life improved after an intervention technique is employed.
The World Health Organization’s measure is that if a technology’s ICER < 1 times GDP per capita, it means that the increased cost is fully worthwhile; 1 times per capita GDP
It should be noted that the four points A, B, C, and D are dynamically changing. If a technology starting point is at D, but as the time to enter the market increases, or the intervention of medical insurance negotiations, its price gradually decreases, moving to point A, then the value will increase, and the possibility of being selected will increase. Big.
If you think the above is a bit complicated, then you can remember that if you spend the same amount of money, if you can extend your life for 5 years, you will have more than 4 years of high quality life or 5 years of low quality life. value.
△ Professor Xuan Jianwei, Institute of Pharmaceutical Economics, Sun Yat-sen University
Four values of defining effects
A four-quadrant model is used to analyze health care decisions, and the selection process is clear at a glance, but the mechanism behind it is not as simple as the picture shows.
The vertical axis is a good understanding, that is, the price. The core issue is the horizontal axis. How do you define the effect and value?
Health technology assessment is a multidisciplinary activity that systematically evaluates technical performance, safety, effectiveness, cost, cost effectiveness, ethics, legal and social impact. So many evaluation dimensions are difficult to cover in the actual operation process, but some dimensions are the most important and cannot be missed.
1, clinical value.
The clinical value in the health technology assessment is not exactly the same as the evaluation in drug access.
The drug admission clinical trial uses a randomized controlled trial (RCT) of the sampled clinical population, in which children, pregnant women, the elderly and Serious patients were excluded. But the person covered by the medical insurance packageGroups can’t get rid of them, in which case we need real-world research. That is, after the drug/drug approval is listed, the research on real-life population tracking will re-examine its safety, effectiveness and innovation.
2, economic value.
This is commonly referred to as pharmacoeconomic analysis.
Some innovative medicines with good clinical effects will save medical insurance expenses in the future. For example, the hepatitis C drug just mentioned is expensive, but the curative effect is remarkable. The patient with hepatitis is treated one less, the patient is cured, and the last drug is useless. This is also a value. The high cost of short-term treatment can be exchanged for long-term zero-cost and low-cost.
However, when making medical insurance decisions, it is necessary to conduct a budget analysis, that is, how much impact the new drug has on the medical insurance fund pool after the medical insurance is insured, and whether the medical insurance fund can withstand it.
3. Social value.
Treatment of diseases can also have greater social value, such as containment of infection sources, which can reduce the risk of health groups, which can also reduce medical expenses; cure diseases, patients can return to work, can Make up for the loss of social productivity caused by disease. These initiatives have great positive externalities and will also be included in health care decision-making.
4, patient value.
Treatment of diseases not only brings about social effects, but also improves the quality of life of patients, reduces adverse reactions, and improves patient outcomes.
The four links of health technology assessment applied to health care decision-making
From 2015 to 2017, the State Council has repeatedly proposed the adjustment of medical insurance catalogues in various documents, and should make full use of evaluation methods such as pharmacoeconomics.
Until 2018, the newly established National Health Insurance Board issued the Notice on the Incorporation of 17 Anticancer Drugs into the Category B of the National Basic Medical Insurance, Work Injury Insurance and Maternity Insurance Drug List(Medical Insurance [2018] No. 17), based on the evidence of drug safety, effectiveness and economics submitted by enterprises, adhere to value orientation, and scientifically and systematically evaluate the value of drugs. Comprehensive multidimensional evidence to determine the negotiated price. Health technology assessment has really moved towards the practice of medical insurance decision-making.
In general, health technology assessments are subject to the following important steps when applied to health care decisions:
Evaluation link: The pharmaceutical company/drug machinery company submits the clinical evaluation of drug/medical value and pharmacoeconomic evaluation materials.
Assessment: HTA research institutions in the medical insurance department, or third-party independent HTA research institutions (The main working capital of the institution cannot be derived from pharmaceutical companies) /span>Using HTA’s analytical method, independently complete the drug/drug evaluation report (equivalent to redo) to verify the drug company / The authenticity and accuracy of the HTA report submitted by the drug company.
Assessment: Composition of a diverse committee (health economic expert representatives, patients, health care decision makers, and even pharmaceutical companies) Discussion review report. Form conclusions including recommendations, conditional recommendations, and not recommending these levels.
Medical care decision-making link: Start the price negotiation and bidding for the recommended/conditionally recommended drugs/medicines.
Although the HTA review in China uses a simplified version of the above process, it has been included in the medical insurance reimbursement list for 17 anticancer drugs.Cheng plays an important role.
In the forum, Liu Zhengyu, secretary-general of Beijing New Sunshine Charity Foundation, revealed that the New Sunshine Charity Foundation organized experts in the process of entering the medical insurance catalogue for two children’s leukemia treatments, asparaginase and imatinib. The force completed the health technology assessment report for the two drugs and submitted it to the medical insurance bureau.
According to the calculation, about 8,000 new patients need to take asparaginase every year. After the medical insurance, the cost of treatment for each patient will be 30,000 yuan, and the total cost of treatment will be 2-3 billion yuan per year. Imatinib is a small group and enters the medical insurance catalogue, saving about 20 million yuan per year.
△Source: Vision China
Pharmaceutical companies need to be fully prepared for evaluation
As can be seen from the above analysis, the medical insurance decision is to maximize the effect with the most limited resources. There must be trade-offs in this, and there are trades in which there are interests. In order to ensure a fair and effective game, we need to evaluate and review (Appraisal) These two links do more.
Health assessment can use a variety of assessment methods. Even with the same assessment method, different clinical populations, data fields, and computational models may result in different evaluation results. Reports submitted by drug companies themselves may use data that is beneficial to them; and other interested hospitals and doctors may have another set of opinions. At this time, the participation of third-party accreditation bodies independent of stakeholder groups is particularly important to ensure the independence and impartiality of health technology assessments.