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On December 23, the National Health Insurance Administration issued the Notice on Comprehensive Investigation and Removal of Unreasonable Restrictions on Medical Insurance[1], requiring all provinces and cities to check whether there are specific restrictions on the average cost of inpatient and outpatient visits and the proportion of drugs in medical insurance, so as to prevent medical institutions from using drugs
with high clinical value and urgently needed by patients.
The problem of admission of innovative drugs has once again attracted social attention
.
The "last mile" of innovative drug admission is not a new topic
.
In recent years, China's implementation of the "dual-channel" policy, performance appraisal optimization and other reforms have provided an accelerator for innovative drug admission, but according to the third-party statistics of 193 samples of innovative drugs, 46% of drugs (89/193) are less than 300, 30% of drugs (59/193) are less than 200, covering 7.
2% of tertiary hospitals in the country according to the median, and there is still much room for improvement in the equipped rate of innovative drugs [2].
。 Innovative drugs, especially those included in the medical insurance catalogue through national negotiations and price reductions, are not ideal in the configuration of medical institutions, hinder the release of medical insurance policy dividends, are not conducive to the improvement of patient access to drugs and the sustainable development of the industry, analyze their difficulties, scientifically and reasonably smooth the admission path, need to conduct in-depth analysis
from multiple perspectives.
First, the external policy constraints of the dilemma of innovative drug admission
External policy constraints on the dilemma of admission of innovative drugsOn the whole, the difficulty of admission of innovative drugs is not the responsibility of one party, one of the main reasons is that China has not yet established a systematic linkage pharmaceutical policy, there are policy gaps or practical constraints in the admission management of innovative drugs, and the linkage of medical insurance, medical treatment and medicine needs to be further strengthened
.
1 The value selection of drugs has its own emphasis
1 The value selection of drugs has its own emphasisFor the drug regulatory authorities, ensuring the safety and effectiveness of approved products is the basic principle; Under the premise of ensuring that drugs have clinical value, the medical insurance department needs to take into account economic evaluation to maintain the relative balance of medical insurance funds; Clinical institutions pay more attention to the benefits of patients, and meeting clinical needs is the most important consideration
.
Different institutions have different value orientations and different focuses on the evaluation of
medicines.
This may lead to safe and effective and cost-effective drugs recognized by drug supervision and medical insurance being rejected by medical institutions because they are not clinically urgently needed and cannot achieve similar substitution, or there is a regret
that drugs that fill clinical gaps are "rejected" by medical insurance due to expensive prices.
2 Insufficient policy coordination may become the primary difficulty affecting the use of innovative drugs
2 Insufficient policy coordination may become the primary difficulty affecting the use of innovative drugsThere are obstacles in the supervision of innovative drugs in the "three doctors" department that need to be optimized or hindered by each other
.
Specifically, at the level of drug R&D, there is a lack of more detailed post-marketing research guidelines for drugs subject to conditional review, and medical institutions have concerns about the clinical benefits of products.
At the medical insurance level, the wave of DRG/DIP payment reform has brought new challenges to the admission of innovative drugs, and the payment standards and payment methods still need to be further planned according to the actual situation of medical institutions.
At the level of medical institutions, the policy of implementing innovative drugs and the policy of drug supervision and assessment have been "uncoordinated" for a long time[2], such as the proportion of drugs, the average cost, the number of varieties, etc.
, which are increasingly not adapted to the actual needs of the rational use of innovative drugs, and medical institutions are under the pressure of limited funds and performance evaluation externally, and face the problems of adjusting drug lists and soaring costs internally, and lack the initiative in the
allocation of innovative drugs.
3 There is a lag in the uploading, issuance and implementation of policies
3 There is a lag in the uploading, issuance and implementation of policiesIn recent years, various departments in China have successively issued relevant regulations to smooth the admission channels of innovative drugs, such as the Notice on Adapting to the Normalization of National Medical Insurance Negotiations and Continuing to Do a Good Job in the Landing of Negotiated Drugs in September 2021 jointly issued by the National Health Insurance Administration and the Health Commission[3], which proposed that "the negotiated drugs for reasonable use should be listed separately, and not included in the scope of assessment indicators such as drug proportion and sub-average cost", and "for diseases that implement payment methods such as DRG, the weight of the disease should be reasonably adjusted in a timely manner according to the actual use of the negotiated drugs"
。 In March 2022, the National Health Commission issued the "National Tertiary Public Hospital Performance Evaluation Operation Manual (2022 Edition)"[4], which formulated extended indicators such as "the increase in the average cost of outpatient visits after excluding relevant items", excluding the cost
of national drugs 。 In summary, although the national level has clearly given preferential policies to innovative drugs, in actual work, the specific support measures of some provinces have not yet been released, the single-line payment process is not perfect, medical institutions are limited by diagnosis and treatment services and fail to adjust assessment indicators in a timely manner, drug allocation work lacks mandatory quantitative indicators, medical insurance and health departments lack follow-up and supervision of innovative drug admissions, and other problems are still serious, and the implementation of policies is greatly reduced
.
Second, the limiting factors of the admission dilemma of innovative drugs within medical institutions
Limiting factors within medical institutions for the admissions dilemma of innovative drugsTo accelerate the admission of innovative drugs, it is necessary to overcome the obstacles and difficulties of various stakeholders in drug supervision and use, and at the same time, we should also realize that medical institutions do not have the necessary and ability to include all innovative drugs for the time being, and scientific regulatory methods and excellent clinical advantages are powerful tools
to win market recognition.
In reality, target homogenization has become a prominent problem restricting the development of China's pharmaceutical industry, and paying attention to differentiated innovation and further improving the advantages of products in terms of safety and effectiveness will be an important "secret"
for innovative drugs to stand out.
1 The matching degree of innovative drugs with the needs of different medical institutions affects hospital admission
1 The matching degree of innovative drugs with the needs of different medical institutions affects hospital admissionInnovative drugs have their own unique therapeutic attributes, and they differ in the degree of clinical demand, indication range, dosage and marketing order
.
Medical institutions often select drugs
conditionally according to their own diagnosis and treatment characteristics and target groups.
For example, the admission rate of antineoplastic drugs in cancer specialized hospitals is significantly higher than that of general hospitals, while primary medical institutions are more motivated to admit drugs in chronic diseases such as diabetes, and the overall allocation rate of orphan drugs is significantly lower than that of other products
due to the small patient population and high management costs.
Considering the scarce human, material and financial resources of medical institutions, it is unrealistic to achieve 100% admission of innovative drugs, which is not conducive to medical institutions giving full play to their respective clinical advantages, and does not meet the adjustment standards
of changing the cage of the drug list and selecting the best among the best.
2 Meeting clinical needs is the first driving force for the admission of innovative drugs
2 Meeting clinical needs is the first driving force for the admission of innovative drugsMei Dan, chief pharmacist of Peking Union Medical College Hospital, once told the Drug Promotion Association: "As long as it is an innovative drug urgently needed in clinical practice, doctors must actively use it, if there is a situation of unwillingness to use and dare not use it, it may be that this product does not have special advantages"
.
It can be seen that meeting clinical needs is the biggest driving force for the admission of innovative drugs, and innovative drugs that fill clinical gaps or have significantly better clinical value than similar ones are often more competitive
.
3 Admission to the hospital is a gradual process that requires more scientific regulatory means
3 Admission to the hospital is a gradual process that requires more scientific regulatory meansDrugs entering medical institutions generally need to go through the steps
of clinician evaluation, preliminary selection of departments, review and discussion by the Pharmaceutical Affairs Committee, and procurement by the Pharmacy Department.
After the clinical data is gradually enriched and the clinical efficacy is further verified, its utilization rate often shows a rapid growth trend, such as the earlier batch of innovative drugs that entered the national medical insurance catalog has a better allocation rate in medical institutions, which to a certain extent reflects the effect
of improving clinical certainty and meeting clinical needs 。 According to statistics, about one-third of the new anti-tumor drugs approved for marketing in the first three quarters of 2021 are single-arm conditional approval [5], and innovative drugs that accelerate the launch often increase the difficulty of admission due to the lack of safety verification of large-scale populations, and more adequate clinical use evidence and more obvious treatment effects or alternative effects are needed in order to further exert the volume effect
of medical insurance negotiations.
Third, accelerate the thinking and suggestions on the admission of innovative drugs
Accelerate the thinking and suggestions of innovative drug admission1 Refine policy measures and improve system linkage
1 Refine policy measures and improve system linkageThe first is to establish a clinical value-oriented linkage mechanism, strengthen the information communication between drug supervision, medical insurance and medical institutions, and achieve relative unity of values in the review and approval, medical insurance negotiation, and clinical use, so as to empower the high-quality development of the "three doctors" [6].
The second is to scientifically coordinate the rational use of various drugs in medical institutions, clarify the positioning and in-hospital allocation rate of centralized procurement, basic drugs, and national drugs, and meet the actual needs
of different levels and types of medical institutions.
The third is to strengthen policy coordination, improve the connection between national and local work, and all regions should actively respond to and implement national requirements, and continue to do a good job in supervision and support
.
2 Medical insurance and medical institutions: improve the level of comprehensive management and carry out reform pilots
2 Medical insurance and medical institutions: improve the level of comprehensive management and carry out reform pilotsAs the main choice for patients to prescribe drugs, medical institutions are also the most critical link
to accelerate the admission of innovative drugs.
In general, improvements can be made from the following aspects: First, basic mechanism optimization can be carried out, and medical institutions can promote admission by shortening the admission cycle, simplifying the admission
process of innovative drugs, and increasing the frequency of pharmaceutical meetings.
The second is to solve the bottleneck problem in local medical services and hospital management, and explore the local experience formed to promote and pilot
it nationwide.
Some regions have taken corresponding measures to support the development and use of innovative products, such as Shanghai clarifying that municipal hospitals will actively equip innovative drugs according to demand within 3 months of the release of the national medical insurance catalog, and implement a separate budget and are not included in the total medical insurance budget; Suzhou and Hangzhou do not include innovative drugs in the scope of
assessment indicators such as the proportion of drugs.
Third, it is recommended that national medical centers or research hospitals take the lead, rely on the big data platform to carry out post-marketing research of drugs, timely convert clinical results into the latest use guidelines, and promote rational drug
use.
Under the background of the national unified market, all stakeholders need to strengthen coordination and joint efforts in the future to overcome the dilemma of innovative drug admission and promote the results of innovative drugs to benefit the people
as soon as possible.
Policy Research Center, China Association for the Promotion of Pharmaceutical Innovation
Policy Research Center, China Association for the Promotion of Pharmaceutical Innovation
Author: Yang Muyao Intern yangmy@phirda.
com
com
Review proofreader: Zhang Zhijuan, Liu Fapeng
Review proofreader: Zhang Zhijuan, Liu FapengResources:
Resources:
1.
National Medical Security Administration.
Notice on Comprehensively Investigating and Canceling Unreasonable Restrictions on Medical Insurance.
National Medical Security Administration.
Notice on Comprehensively Investigating and Canceling Unreasonable Restrictions on Medical Insurance.
2.
RDPAC.
"Analysis Report on the Landing of Drugs in the National Talks" 2.
RDPAC.
"Analysis Report on the Landing of Drugs in the National Talks"
3.
National Health Commission.
"National Tertiary Public Hospital Performance Evaluation Operation Manual (2022 Edition)".
National Health Commission.
"National Tertiary Public Hospital Performance Evaluation Operation Manual (2022 Edition)".
4.
BiG Bioinnovation.
CSCO | led by Minister Yang Zhimin, 6 CDE experts report highlights! .
https://mp.
weixin.
qq.
com/s/oq16zbtUwn7BWEWxCHwsiA 4.
BiG Bioinnovation.
CSCO | led by Minister Yang Zhimin, 6 CDE experts report highlights! .
https://mp.
weixin.
qq.
com/s/oq16zbtUwn7BWEWxCHwsiA
5.
Economic Observer.
The time of the two sessions| Ding Lieming, deputy to the National People's Congress and chairman of Betta Pharmaceutical, unblock the entry of innovative drugs into medical institutions.
https://mp.
weixin.
qq.
com/s/YBPmd9ZyiZnqVRYyyteRwg
Economic Observer.
The time of the two sessions| Ding Lieming, deputy to the National People's Congress and chairman of Betta Pharmaceutical, unblock the entry of innovative drugs into medical institutions.
https://mp.
weixin.
qq.
com/s/YBPmd9ZyiZnqVRYyyteRwg
