According to the National Medical Insurance Administration's key work tasks in 2019, it is expected that a new round of national medical insurance catalog adjustment will be launched in the near future. Referring to the work progress of the 2017 catalog, is expected to be determined in March and April, then expert consultation and selection will be completed in May and June, and medical insurance access product negotiations will be held from July to September. If everything goes well, the new medical insurance catalog is expected to be released before National Day and implemented within the year.
Since the directory adjustment work time is tight and the tasks are heavy, and the time is not too long before the 2017 version of the directory, you can boldly guess: 1) The basic database may use the database when the 2017 version of the directory adjustment, and then add the new drug data to be launched after the deadline of the 2017 version of the directory database. Among them, the innovative drug part should be considered. 2) The data on supplementary and negotiations in each province should be sorted out as a reference. 3) In terms of the expert database, since each province has established its own expert database during the 2017 national catalog and provincial review, it only needs to make a small update based on the previous one to use it directly.
As for the specific review plan and whether the specific varieties can be entered into the catalog, the general principle should be the clinical demand , economic factors and market factors mentioned in the 2017 article "
Ultimate Conjecture · Analysis of varieties that are most likely to be shortlisted for the new version of the medical insurance catalog
", which will not be repeated here. There is no clear boundary between the catalog and negotiation mentioned in the previous article. With the development of two rounds of medical insurance negotiations, a general principle can be deduced: on the one hand, it should be an exclusive variety, and most of them are still in the patent period. On the other hand, it should be more expensive compared with similar or same treatment products in the catalog, and further negotiations are needed to reduce the price. In addition, this catalog review involves 11 national basic drug products that are not medically insurance. Although the basic drugs and medical insurance catalogues come from two ministries and commissions, it does not mean that 100% of basic drugs must be included in the medical insurance catalog, there should still be a certain bonus during the review.
According to the new drugs approved for market in China since 2016 and now found from the Medical Rubik's Cube
PharmaGo
, although the overall number of innovative drug products still accounts for the majority of multinational companies, domestic companies have also begun to have many innovative products on the market, which far exceeds the 2017 catalog review. This is a very gratifying progress. Although medical insurance does not have the obligation to encourage domestic innovation in theory, from actual past experience, there will be some additional bonuses.
This article mainly analyzes and predicts some popular varieties in the adjustment of the National Medical Insurance Catalog in 2019. When writing, it is a simple classification based on the "major diseases such as cancer, chronic diseases, rare diseases and children's medication" highlighted in the key tasks of the National Medical Insurance Administration. To throw bricks and attract jade, please give us more valuable suggestions.
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Diabetes drug
1. Insulin
The only major product that is still not included in the catalog is Degu insulin . Judging from the current pricing strategy of Degu insulin, it seems that it is necessary to directly enter the catalog, so it is highly likely that it will enter the catalog directly without negotiation (any example).
2. GLP-1 class
Considering that liraglutide has been negotiated to enter medical insurance in 2017, in this adjustment, exenatide, exenatide sustained release microspheres , libisinate , deglycopeptide and domestic benaglutide are expected to enter the directory. Among them, exenatide is actually the earliest GLP-1 to be launched in China, but it was not selected by experts when the catalog was adjusted in 2017. There may be problems with the transfer of domestic sales rights at that time, or it may be that from the perspective of the product itself, the drug administration twice a day and the relatively high price formed certain obstacles. Judging from the national winning bid price, exenatide will still be higher than the negotiated price of liraglutide, and sustained-release microsphere dosage forms are even more expensive, but they are better at the once-a-week compliance. Benaglutide in China is 3 times a day and is currently the most expensive. If you want to get medical insurance, you will probably have to reduce the price significantly. However, the winning bid data cannot be found at present.
Anyway, no matter which GLP-1 it is, at least liraglutide is currently used as a reference for payment standards. It is expected that the price after negotiation will not exceed 40 yuan/day. Among them, exenatide sustained release microspheres and dura glycopeptide are long-acting preparations once a week. If the negotiation can be reached, it may be slightly higher. The somaglutide and its oral preparations that I personally look forward to most are definitely not up to this directory from the review progress. Polyethylene glycol losenatide, which is also supported by major special projects, may also not be able to catch up.
The indication limitations of this category of drugs should refer to liraglutide. The more expensive the product, the more stringent the restrictions may be.
3. SGLT-2 inhibitor
Like 5 DPP-4 drugs entered into the 2017 version of the catalog, this time, dapagliflozin , enggaliflozin , calagliflozin 3 SGLT-2 inhibitors are very promising to enter the catalog, the only problem is the price. The daily cost of DPP-4 is less than 10 yuan. In contrast, the price of SGLT-2 inhibitors is still slightly higher, and some products may start negotiations. Dapagliflozin has the lowest actual daily cost and has a national basic drug bonus, so the possibility of directly entering the catalog is the greatest. The indication restrictions in this category should refer to DPP-4, which means the use of second-line drugs.
4. Compound product
. Among the five DPP-4 inhibitors that entered the 2017 edition catalog, 4 have launched metformin compound products. Engaliflozin in SGLT-2 has also launched metformin compound products. This is undoubtedly because metformin is an absolute first-line drug for diabetes treatment. Internationally, the sales of metformin compound products are pretty good, whether it is DPP4 or SGLT2. For chronic diseases such as hypertension or diabetes that require combined medication, compound products can improve patient compliance. But for domestic medical insurance catalog review, how to pay for metformin in compound products is the key.
At present, even the original metformin price is not too expensive, and the daily cost is only around 3 yuan. What's more, metformin is definitely the second batch of national volume-purchased varieties, and the daily cost will definitely be less than 1 yuan or even 0.5 yuan at that time. Therefore, for these compound products, if you adopt a pricing strategy similar to that of foreign buyers who give auxiliary drugs (note: for example, the price of engagliflozin metformin is only sold for engagliflozin), the right choice is to enter the medical insurance as early as possible. Especially for several products whose patents are about to expire, perhaps the patent cliff brought by national volume procurement can be delayed as much as possible through exclusive compound products. Judging from the current winning bid data, metformin among the sitagliptin compound is the cheapest and may be more proactive compared to other products. The empagliptin compound may be more difficult due to its short marketing time. Generally speaking, the indication limitations of compound drugs will be equivalent to the main drug.
5. Other
Currently, there are many products under development in China, GLP-1, DPP-4, and SGLT-2. Judging from the current review progress, it is estimated that it will not be able to keep up with this medical insurance catalog review. It is worth mentioning that the long-term DPP-4 inhibitor tracliptin , which was popular in the past few days. Due to some domestic patent issues, this product has been a popular domestic copy application in the past two years. But calmly analyze it, long-term DPP4 includes trigliptin and augaliptin, which is only available in Japan worldwide. Among them, Augaliptin invested 9 Phase III clinical enrollment in Europe and the United States, and eventually gave up the market. On the one hand, it was due to the safety and compliance of the product itself, and on the other hand, the important reason was price and medical insurance payment.
The ultimate goal of domestic medical insurance in the future is to implement value-oriented strategic purchases. According to this established goal, no matter what form of management is adopted in the future, the focus should be on the comprehensive consideration of real clinical value and price. Based on this, domestic companies should carefully consider their product pipelines and profit expectations, whether they are innovating or copying. The future listing of trigalliptin, medical insurance payment and market prospects will be a good example, but this article is limited, so I won’t go too far. If you have the opportunity, you may just start a single article to talk about it.
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cardiovascular drugs
1. LCZ696
Sakubalivalsartan is one of the hottest changes in this medical insurance directory. The only problem is in terms of price. The domestic pricing of this product is slightly cheaper than that of the United States, but it is still much more expensive than other heart failure drugs. If calculated based on the latest winning bid price, the daily fee is as high as 56 yuan. For reference, the daily cost of Ivabradding, a new heart failure drug newly introduced in the 2017 edition, is only 17.3 yuan. Therefore, although the probability of this product entering the catalog is very high, the probability of negotiations on price reduction is quite high. Depending on the negotiation results, this product may be subject to indication restrictions. If it is limited to second-line medication, it is okay, but if it is limited to other heart failure drugs, it will be more harmful.
2. PCSK9
This category of products is currently available in China with only eloyuzumab , but alilizumab obtained the priority review qualification of the CDE two weeks ago, and may be able to catch the last bus before the deadline. In terms of efficacy and actual clinical significance, PCSK9 is a good category. After all, the probability of clinical statin intolerance is about 15%. However, like the above-mentioned sakubalivalsartan, even under the conditions of relatively loose foreign medical insurance payments, the relatively high pricing also puts considerable payment pressure on the payer. This is actually easy to understand. Although the innovative targets have improved slightly compared to traditional and more mature treatment plans, the price is as high as more than 10 times. Any payer will carefully verify whether its pharmacoeconomics evidence is sufficient. In view of this, there are still big questions about whether this category can enter the catalogue this time. Even if it enters, it will be subject to a significant price reduction in negotiations and the indication limit is statin intolerance.
3. Compound products
telmisartan amlodipine, olmesartan ester amlodipine, perindopriliamlodipine, amlodipine folic acid... Don't be surprised, so many amlodipine compound preparations have been launched in China in the past two years. On the one hand, it is because amlodipine itself has good efficacy, safety and half-life. There are also many compound products for amlodipine combined with the international community. On the other hand, it should actually have some Chinese characteristics. Unlike the antihypertensive drugs used internationally, most of them are ACEI and ARB, the category with the largest market share in China is CCB, and the largest product is amlodipine. The more distinctive products among these
is perindopril amlodipine. After all, as one of the most classic cardiovascular clinical research in the past twenty years, the main drugs used are perindopril and amlodipine. From the perspective of evidence-based evidence, this product is undoubtedly the most complete. Ormesartan amlodipine may be imitated with the same indication restrictions as olmesartan hydrochlorothiazide as olmesartan hydrochlorothiazide, which will be more harmful than other ARBs. The price of amlodipine folic acid is still not found, but because it is the same manufacturer as enalapric folic acid, the price is probably not too low. As a domestic innovation, enalapric folic acid is more expensive than the original research, but it was also included in the medical insurance catalog very early. Therefore, even if amlodipine folic acid is a little more expensive, as long as the daily treatment cost is not too outrageous, it should still be included in the catalog.
Speaking of cardiovascular compound products, there are two classic products that were earlier on the market that are expected to enter the catalog this time, one is perindoprili indapamide and the other is simvastatin ezemeb. These two products have also been added to the provincial catalog in most parts of the country.
has come to this point, which coincides with the release of the government work tasks of the State Council in 2019. The article mentioned that "do a good job in preventing and treating common chronic diseases, and include outpatient medications such as hypertension and diabetes in medical insurance reimbursement." Therefore, it can be understood that in the previous article, the hypertension and diabetes products are expected to receive additional bonuses in this catalog, and the relative quota restrictions are expected to be looser, and more products will be entered.
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Central nervous system disease drugs
1. Psychiatric drugs
Bunanselin and lurasidone . The same company launched two new anti-schizophrenia drugs in one go, both of which still have certain characteristics.The pricing of Bunanselin is not too expensive. Lurasidone is not yet available, but it shouldn't be too expensive. Both of these products have great hopes to enter the catalog. Although psychiatric products seem to be relatively niche, there have always been additional bonuses from the perspective of the medical insurance catalog. There are fewer non-medical insurance products, and there are relatively few restrictions.
2. Neurology medicine
There are many new drugs on the market in the past two years. First, the second-generation MAO-B inhibitor rasagilan . The biggest problem with this product is that it is relatively expensive, more than 10 times more expensive than the first-generation silagelan in the catalog. Of course, the efficacy of rasagilan is much better. Many domestic patients are taking the Indian version before they were launched. If the price can be reduced this time, it will undoubtedly be a blessing for patients.
Another is the lortigotin patch , which has just been launched. Parkinson's patients often have poor compliance. Making drugs into topical transdermal patches can undoubtedly improve patient compliance, and it should be said that they are also very distinctive. The question that comes to the catalog is the same as that of rasagilan. If you want to use a sufficient dose, it will be similar to the daily cost of rasagilan. It is also relatively expensive. Let’s see if you can have a chance to negotiate.
Enta Capone Sedopa is a three-prepared compound drug. The single prescription is already in the catalog. The compound can improve compliance and the price is OK. In theory, there is no problem in entering the catalog, but Parkinson is a bit niche in this aspect. Whether it can enter the expert's vision is a question.
Anti-dementia field has also launched a new Liss transdermal patch . The oral dosage form of this product is called cabalatine, which is already in the catalog. It is estimated that the drug administration will unify the common name in the future. The four first-line drugs for anti-dementia are actually all in the catalog. The 2017 catalog also added Donepezil Oral Cancerous Tablets, so I feel that the chance of Liss' transparent transdermal patches are quite high, especially now, the pricing is not too expensive, and the imitation products are about to be launched.
The epilepsy field has newly launched lacosamide (lacoamide). Since it has just been launched, the pricing is still unclear. If the pricing is reasonable, the probability of entering the catalog is quite high, especially imitations are also on the market. Let me sigh here that there are so many epilepsy drugs in Alphabet. Bovacedam will be launched in the future. It should be easier to enter the catalog if there are indications for children, but this time it is too late.
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respiratory drug
Omalizumab is the world's first targeted treatment drug approved for moderate to severe asthma. The product is very good, but it is too expensive. The course cost of 100,000+ is not low. Even if you can negotiate to reduce some of the prices, you are not optimistic that the medical insurance fund can afford this product.
Indatropolium bromide, Umebol Vilanterol, tiotropium Odaterol, fluticasone furoate Vilanterol, and Odaterol. Most of the current price data are not found. Generally speaking, the price of this category is not too expensive and can be entered into the catalog. The price dimension can be referred to indaterol in the new catalogue of 2017.
bedaquiline and deramani are two new anti-tuberculosis resistance drugs. The combination of these two products can be said to be the last line of defense for multidrug-resistant tuberculosis, but it is hard to say whether medical insurance will cover these two products.
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Tumor and major disease drugs
1. PD-1
After negotiations on 17 anti-cancer drugs in 2018, the most popular product that has not yet entered the catalog is undoubtedly PD-1. Currently on the market include nivolumab (O drug), pembolizumab (K drug), teripolizumab , xindilizumab , and carrilizumab and tirelizumab may also catch the last train.
From the perspective of negotiations entering the directory, it should be said that every company has the possibility of success and failure.First of all, it is basically clear that the negotiation will be discussed according to the indication. If multiple indications have been approved during the negotiation of a product, the results of the negotiation will likely be based on only one indication. The medical insurance payment restrictions will strictly follow the one indication discussed. The indications for the subsequent approval are equivalent to non-medical insurance. In other words, although the overall market potential of PD-1 is extremely great, this medical insurance negotiation payment will only involve a small part of it. In terms of the price dimension of
reference, international prices are actually not very meaningful. O-drug and K drugs are priced lower in China than abroad, while other products are not on the market abroad and have no prices; charitable prices will be referenced; the most important thing is to consider the efficacy and price comprehensively, which includes comparisons with traditional therapies, including first-line chemotherapy and targeted drugs currently in the catalog, and horizontal comparisons between different PD-1 products will also be made. Therefore, although the final price will not be as tragic as a few hundred yuan per piece, we must make a psychological expectation of a significant price reduction compared to the existing price. For foreign companies, O-pharmaceuticals and K-pharmaceuticals, China's prices are the lowest in the world, and for domestic companies, they must also prepare for a few discounts on the existing "low prices". In terms of the results of the
negotiation, I personally prefer foreign companies. After all, whether in terms of the adequacy of clinical evidence, or in terms of negotiation preparation and personnel professionalism, foreign companies are obviously better. Judging from the two rounds of negotiations in history, there are basically two situations for products that failed in negotiations. One is that the price of foreign companies negotiated is far lower than the international price, especially for products with a long patent period, the decline is unacceptable; the other is that a few foreign companies and domestic companies are in a completely passive situation during negotiations due to the lack of clear pricing strategies and professional talents.
Especially since the development of medical insurance negotiations, the professionalism and experience of medical insurance parties have been growing, that is, "we have a stronger voice in medical insurance negotiations" (Note: This statement comes from Director Hu Jinglin). At this time, domestic companies send some amateur players to play. Although these amateur players may also be outstanding in other fields such as business or sales, assuming that the negotiation table is a football field, playing like this is basically equivalent to sending the Chinese national table tennis team to play against the French national football team.
According to the information included in the global new drug database of Pharmaceutical Rubik's Cube
NextPharma
, PD-1/PD-L1 can be said to be the hottest target in the world, with 173 related projects. Even if most products eventually die, there will be more than 10 products on the market next year and the following year. The medical insurance party can fully adopt the strategy of testing the waters this year, and then expand the scope of indications and significantly lower prices in a round of negotiations next year and the following year. At that time, Shengkuan may be comparable to last year's 4+7 volume-based procurement. Although the outcome may be cruel for enterprises, for medical insurance parties, we can achieve truly value-oriented strategic purchases, and for every insured person or ordinary people, we are all beneficiaries.
2. Her2, CDK4/6
Her2 targets The current clinically significant indications are breast cancer. Pertuzumab can be considered an upgraded product of trastuzumab. The main advantage of pyrrolitinib is that it is oral small molecule drugs and can reduce the adverse reactions of diarrhea. Both products can be used in combination with trastuzumab to further improve the survival of Her2-positive patients. piperaceli is a breakthrough improvement based on traditional aromatase inhibitors by inhibiting CDK4/6 application to HR+/Her2- breast cancer patients. From the perspective of clinical demand, these three products have sufficient reasons. As long as the price negotiation process can pass, there is no big problem in entering the catalog.
3. PARP
Olaparib is currently the only PARP inhibitor on the market in China. Other similar products cannot keep up with the progress. There is only one targeted drug for ovarian cancer at present. There is no big problem in entering the negotiation process, and the price may be reduced based on existing charities.
3. ALK
Aletinib has been approved. Ensatinib, also a second-generation ALK, has obtained the priority review qualification for the CDE, and may also be able to catch the last bus.Considering that the first-generation ALK crizotinib and the second-generation ALK celitinib have been negotiated into the catalogue during the 17 anti-cancer drugs, the prices of these two products also have reference ranges, and it is not a big problem to enter the negotiation process.
4. VEGFR
furoquintinib is a domestic targeted drug that has been launched late. The indication is colorectal cancer. The competitors with the same indication are mainly bevacizumab. The price is also referenced. It is estimated that the probability of negotiation access is very high. Afelcept intraocular reference products are ranibizumab and conbevercept. The current pricing is only a little more expensive than the reference products, and the probability of negotiation access is high. lenvatinib currently has only liver cancer indications. The reference product is probably regorafenib. The current price is slightly expensive, but there is charity. It is estimated that the directory can be accessed after negotiations are around the charity price. The most recent similarity to lenvatinib is actually the protagonist of the recent "fake drug" incident, but the original research does not seem to have a plan to go public in China, and domestic imitations will definitely not be able to catch up with this catalog review.
5. Gnrh receptor antagonist
Degalik This product is similar to the goseririn implant or leuprolide microspheres that are already in the catalog. They are both long-acting drugs for the treatment of hormone-dependent prostate cancer, but have slightly improved, so there is no big problem in entering the catalog, and the price may be slightly more expensive than goseririn implants.
6. Alkalinizer
Merbal injection dosage form is a nitrogen mustard drug, and the oral dosage form is already in the catalog. Injection has improved safety. bendamustine injection is a bifunctional alkylating agent, combining the characteristics of nitrogen mustard and nitrosourea, and most of these two types of products are in the catalogue. As long as these two products are not expensive, it is not a big problem to enter the catalog, but these two companies are relatively small, so product awareness is a problem.
7. Taxane
paclitaxel liposome dosage form advantages. There are only dosage forms of amphotericin B, paclitaxel and doxorubicin in China that have liposomes, among which amphotericin B liposomes were included in the medical insurance catalog in 2017. It should be said that liposome technology can achieve attenuation and enhance efficacy, which is a future improvement direction for traditional chemotherapy drugs. There is also paclitaxel albumin, which has not been selected by experts before. It is 80% more expensive and exclusive. However, now there are two copy products in China on the market, and the possibility of entering the catalog has increased greatly. In terms of efficacy and safety, these two products have undoubtedly improved significantly compared to ordinary paclitaxel, but the price will still play a decisive role in whether it can be entered into the catalog.
8. Other
Pleshafu is used for stem cell transplantation. It is an orphan drug abroad, but the concept of orphan drug abroad is different from that of domestic rare diseases, so it is estimated that it will not participate in the review as a rare disease category. Domestic pricing is unknown, but it is because it is orphan medicine abroad that is relatively expensive, so there are some questions about whether it can be significantly reduced in price and enter the catalog.
Lucotinib is used to treat myelofibrosis and is the only product that failed in negotiations for 17 anti-cancer drugs. The reason for the failure is that the negotiation price is too much lower than the foreign price. I wonder if I can give another chance this time. Even if you can give it the opportunity, negotiation will be more difficult. The good thing is that there are no other drugs for this indication, and after all, there have been examples of the first negotiation of cetuximab but the second success, so there is still a small probability that it can be successfully discussed.
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Hepatitis C drug
According to the epidemiological data of the 2015 edition of the Hepatitis C Prevention and Treatment Guidelines in my country, HCV1b and 2a genotypes are more common in my country, with type 1b as the main one (56.8%), followed by type 2 (24.1%) and type 3 (9.1%). No genotypes 4 and 5 were found, and relatively few (6.3%) were found. Mixed genotypes are rare (about 2.1%), mostly genotype 1 mixed type 2.
So, according to the differentiation plan by company products, daratavia assurevir (type 1), obipalisdasepavir (type 1), albavir graviravir (type 1, 4), and domestic danorevir (type 1) can actually be classified into the same level, while sofosbuvir and its compound preparations can be classified into one level. Sofosbuvir (full genotype) is the most capable of taking it, not to mention that there is a basic drug bonus, which is very likely to enter the catalog.
This category is highly competitive, and the first level can actually cover more than half of the patients. Therefore, the one who can negotiate is a product that adopts a low-price strategy, and the probability of all the investment is not high. The price of sofosbuvitavita is also the key, because it will definitely be higher than the first level, so it also invisibly lowers the price of the first level.
The fierce competition in this category is also due to the fact that this negotiation is related to the first wave of medical insurance patients in China. Since the disease can be cured, foreign experience shows that whoever can obtain medical insurance payment at a suitable price can win most of the market by grabbing the first few waves of patients, and the market will eventually be almost gone. Therefore, if we cannot catch up with this negotiation, such as products such as Lavidavel, the market that can be harvested in the future will be very small. In addition, although Simerevi was approved in China, it basically means delisting, which is actually an option. After all, for multinational companies, the domestic market is large, if the output is smaller than the input, it is better to give up. For a large number of domestic products under development, it is really unknown whether the cost can be recovered in the future.
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AIDS drug
1. Integase inhibitor
dotetravir and compound preparation dotetravir (dotetravir abacavir lamivudine), ratetravir , compound preparation acoenprotetravir (avarevir cobistatritabin propofol tenofovir), I don’t know if there are any products that can achieve a breakthrough in the medical insurance catalog of integase inhibitors. Most first-line treatment plans in the world contain integase inhibitors, but due to the domestic restrictions, there is basically no hope of entering the free drug catalog in the short term. In terms of treatment costs, ratelavir is already close to emtricitabine and tenofovir in the catalog, but AIDS treatment is often combined with several types of drugs. Entering relatively expensive drugs in the catalog will cause additional burden on the fund, so it may still be difficult.
2. Long-acting fusion inhibitor
Aiboweitai is the first original anti-AIDS drug in China and the world's first long-acting fusion inhibitor. Compared with most oral preparations, the dosing method is once a day and multiple times a day. This product can be administered once a week, which is a bit special and is expected to be negotiated. The short-acting enfuvitaminide among similar varieties is in the catalog, but it seems that it is out of stock nationwide. The winning bid price can be found and it is expensive and has no reference significance.
3. Protease inhibitor
darunavir cobistat, a newly launched enhanced type, and is also expensive. Considering that darunavir is not in the catalog, it feels very bad. The same varieties of saquinavir are in the catalog, but the original research has stopped importing and there is no valid approval document in China.
4. Nucleoside and nucleotide reverse transcriptase inhibitor
Emtricitabine propofol tenofovir This compound product can be introduced along with propofol tenofovir single agent. Tenofovir propofol is the famous TAF, namely the prodrug of tenofovir disoproxil (TDF). The theoretical indications can be hepatitis B and AIDS, but domestic unilateral prescriptions have only approved hepatitis B, and the compound of emtricitabine and integrase inhibitors are used for AIDS. The price is unknown now, and it is not cheap abroad, while the floor price of tenofovir dipyroxate in China is already a few cents at 4+7. It is difficult to enter the catalogue of propofol tenofovir series products this time unless the manufacturer can give a very preferential price.
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hematological drug
edoxaban can be roughly referred to rivaroxaban or dabigatran ester. If the price is not too expensive, it should be directly included in the catalog, and the indications will also be limited to atrial fibrillation. edasizumab is a reversal agent for dabigatran ester. The price is unknown, but it is speculated that it will be more expensive and slightly niche. There is little hope for it to enter the directory.
Bivaludin indication is PCI anticoagulation. Similar products should be enoxaparin or fundaldehyde sodium, but compared with the prices of the first two, it is really much more expensive. It is not an exclusive product, and negotiation is also difficult. Reteplase is used for acute myolysis of thrombolysis. As an emergency rescue drug, it is a new type of basic drug. Similar alteplase is already in the catalog, and there is a great hope to enter the catalog.
Altrepopa indication is primary immune thrombocytopenia (ITP). The reference drug TPO is a new product in the catalog B in 2017. There is also ITP in the medical insurance restrictions, so as long as the pricing is close to TPO, it should not be a big problem to enter the catalog. rosalatta refer to drug EPO, which is probably limited to renal anemia. As long as the price is close to EPO, it should not be a big problem to enter the catalog.
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Rare Disease Children's Drugs
1. Pulmonary hypertension
Boshentan failed in 2017, but the basic drug was introduced last year, and generic drugs are about to be launched. As long as there is no longer any mistakes in negotiations, there will be great hope for this directory. Anlishengtan took advantage of the failure of Bosentan negotiations and entered many provincial directories. The effect and price were similar to that of Bosentan, and the hope was also very high. Maxittan is an upgraded version of Bosentan, but the price is too expensive, so it is a bit difficult to negotiate.
leocigu is different from the above three endothelin receptor drugs and can also be used in combination. The daily price is probably similar to that of Bosentan and is relatively expensive, but after all, it is a relatively new product. If the negotiations are successful, the price may be higher than that of Bosentan.
未分大全 can be used in conjunction with the above two categories. The daily price is now similar to that of Maxittentan, and the possibility of successful negotiations is not very high. This category of products was originally listed as Ilo Prost, but the manufacturer plans to gradually withdraw from the Chinese market in 2015, so it is estimated that it will not participate in this catalog. In addition, PDE5 is actually a first-line drug in the international community, but there are no indications in China and cannot participate in the review.
2. Type C Niemanpike disease
Considering that Type C Niemanpike disease mostly occurs in childhood, the incidence rate is extremely low, but the survival period is not long, Macquasta may have some bonus during negotiations. The difficulty is that the daily price is a bit high now, but there is still a certain probability that the negotiation will be successful.
3. Atypical hemolytic uremia
Ekulizumab is about US$500,000/year abroad, which is too expensive. From an epidemiological point of view, these two indications are placed under the huge population base in China, and the cost will be astronomical. Therefore, unless it is less than 10% off, it will be difficult to negotiate successfully.
4. Gaucher disease and Pompei disease
Imigosidase and aracosidase α are two rare disease drugs of the same company. The price that can be found must have exceeded 1 million yuan/year. However, many local negotiations can be found nationwide, but the negotiation prices have not been made public. Some places should have fiscal and charitable subsidies. This national negotiation should be reduced based on local low prices, which is not small.
5. Tetrahydrobiopterin deficiency
saptopterin is currently priced over 300,000 yuan per year. With the above two products, many places across the country have access to negotiations. The national negotiations will further reduce the price. In addition, special medical foods for hyperphenylalanineemia are also expected to be launched. In the future, medical insurance covers some special medical foods.
6. Idiopathic pulmonary fibrosis
Nidanib is a recommended drug in international guidelines, just like pirfenidone in the catalog, but the current daily price is more than twice that of pirfenidone, and you can also enter the catalog through negotiation price reduction.
7. Multiple sclerosis
terifolamine and 36 products negotiated to enter the catalog are also recommended first-line guidelines. There were recombinant human interferon β-1a and recombinant human interferon β-1b in China, but they both withdrew from the Chinese market one after another, resulting in patients who once had no medicine available and could only go abroad to buy drugs or choose second-tier drugs. With the negotiations on medical insurance for 36 products, the recombinant human interferon β-1b has returned to the domestic market, and now patients have new options. From a therapeutic perspective, the price of this product is slightly higher than that of recombinant human interferon β-1b, so it should be no problem for negotiations to enter the catalog.
8. Hemophilia
Emmysilizumab is still good, but it is too expensive. The price abroad is as high as US$400,000 per year. The domestic pricing is unknown but it is estimated that it will not be too low. Moreover, from the perspective of clinical necessity, this product may not be as strong as many rare disease drugs, so the possibility of entering the catalog is relatively low.
9. Aplastic anemia
Delarosol is an oral iron chelating agent used to prevent iron accumulation during long-term blood transfusion. Similar varieties have deferroamine in the catalog. Dilarosol is slightly more expensive by daily cost, but there are also charities at present, so it is not much expensive. The same type of deferrosterone has not been included in the catalog. Considering that most of this type of children are in the category, the price is OK based on daily costs. These two products in this category have a small price reduction and hope to enter the catalogue.
10. Children's medication
Rabulihai is used to control uric acid levels in children with leukemia and lymphoma. The price is unknown, but according to conventional speculation, it is estimated that it will not be very low, so it depends on the negotiation results.
In fact, there are some rare disease drugs on the market in China, but most of them have not yet approved the indications for rare diseases in China, such as edalavone for the treatment of amyotrophic lateral sclerosis, or tacrolimus for the treatment of myasthenia gravis. Considering that the intelligent review system of medical insurance is relatively developed now. Although these products are in the catalog, they cannot be reimbursed for use in excess indications. Unless there is a new rule explanation for rare diseases in the medical insurance catalog, you can only expect that some manufacturers can register for rare diseases.
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Conclusion
talked for a long time and was talking about transferring to the directory. In fact, this directory also involves the retrieval of some products. Many people may think of auxiliary drugs. However, after the 2017 edition of the directory and the additional indication limit, there are not many auxiliary drugs retained in the national directory. Compared with the auxiliary drug data reported by various provinces, it can be found that most auxiliary drugs are supplemented at the provincial level, or products with indication restrictions adjusted at the provincial level. Therefore, in addition to the adjustment of a few auxiliary drugs, there should be some old varieties that lack evidence based on evidence, have actually been delisted, and have not been produced and sold by manufacturers. Especially with the progress of consistency evaluation and 4+7, many better second-generation and third-generation drugs have reached the floor price, so there is naturally no need to retain so many older generation drugs in the catalog.
In addition, regarding the issue of provincial supplementary auxiliary drugs just mentioned, the National Medical Insurance Administration has recently solicited opinions on the boundaries and adjustment authority of medical insurance catalog management. In the future, the whole country may be unified into a medical insurance catalog. If this is the case, it will undoubtedly help improve the fairness of patients across the country, and will also move closer to the future dynamic adjustment and management of negative catalogs. However, at the same time, it is indeed somewhat deficient in regional epidemiological problems. In addition, some places have relatively abundant medical insurance funds and finances, and will supplement or negotiate some rare disease products in advance. This will at least play a positive role in keeping these rare disease drugs in the market. If the national catalog will be unified in the future, then for negotiations that fail, but are indeed some rare disease products that are emergency and aided, the manufacturer may choose to withdraw from the Chinese market, and the patient will eventually have no medicine available, and he will embark on the path of "drug god". Therefore, how to weigh fairness and accessibility is indeed a very difficult question. We look forward to the wisdom of managers and experts to formulate countermeasures as appropriate as possible.
looks a little longer. If the directory is managed by the state in the future, will be managed by this directory, then this adjustment of the directory may even be the last large-scale medical insurance directory adjustment. In the future, it is likely to adopt regular dynamic adjustments to manage the directory , such as regular directory adjustments and negotiations for new drugs every year. You can even learn from foreign evaluation institutions such as NICE, explore access at any time, or linkage with drug supervision approval. With the completion of the two negotiations, the negotiation materials have basically been standardized, and in the future, it is enough to further improve on the existing basis. In terms of personnel and experts, it is difficult to prepare the existing staffing of the National Health Insurance Administration and its affiliated institutions. In the future, it may be considered to imitate the CDE and establish a fixed expert advisory committee system, and adopt a recruitment system for experts participating in the medical insurance review. After establishing a complete system process, catalog review or negotiation can be initiated for new drugs at any time, and payment standards can be formulated for exclusive products. Instead of competitive categories of exclusive products, they can be left to local governments for more reference to market prices. This is also considered that after all, most of the fund coordination levels are still retained at the prefecture-level and municipal level, and handing over the local governments to set standards is more conducive to balancing fund revenue and expenditure.
For pharmaceutical companies, under the situation where the "winter has arrived" in the industry, this adjustment of the medical insurance catalog undoubtedly brought a spring breeze. This article only briefly sorts out the key parts of chemical drugs and biological products. Other varieties such as digestion, anesthesia, ophthalmology, etc. have access opportunities. The number of Chinese patent medicines is conventionally slightly less than that of chemical drugs. The final estimate is that the number of varieties adjusted in and out of the overall number may be slightly less than that of the 2017 edition of the catalog, but it should be considered that this is only an update after two years. It can be foreseeable that the access to this catalog will inevitably update a large number of innovative products, which is undoubtedly a practical affirmation and encouragement to innovative enterprises. In terms of the specific amount of
, although the accurate figure cannot be accurately calculated, based on the fund burden amounts of 36 and 17 drugs officially announced, the annual increase in medical insurance expenditure of new access products in this catalog will be more than 10 billion. Compared with this figure, the medical insurance funds that the industry is terrified of 4+7 volume-based procurement can save should be less than half of this figure. Of course, the more than 10 billion is based on negotiated price cuts, but "as far as enterprises are concerned, inclusion in medical insurance means broad market prospects, and the growth benefits can far offset the loss of price cuts" (Note: This statement comes from Deputy Director Chen Jinfu). Judging from the sales data of nearly two years of negotiations on 36 products, most varieties have indeed achieved a significant increase in sales after being included in medical insurance and have eaten the cake shared by medical insurance.
So, for pharmaceutical companies, how can they eat more cakes in the future? Especially in the winter of the industry, some companies may face the situation where they cannot survive the winter by taking a bite. Especially for start-ups with single products, their family background may be far less wealthy than some established companies. The success or failure of the first product medical insurance negotiations may directly lead to the survival of the company. Regarding this question, I think the answer is "The time is not as good as the place, and the place is not as good as the people." Whether it is the creation of new drugs or important imitation, companies will face increasingly professional access requirements for the medical insurance department in the future. Although some factors such as the product's own attributes and time of market are very important, it is more important to establish a professional access team as soon as possible and accurately grasp the policy situation. From corporate strategies such as product project establishment and R&D, introduction, etc. to specific details such as medical insurance negotiations and bidding bargaining, professional access talents will participate more so that the invested R&D funds or product buyout fees will not be wasted. At the same time, it is more likely to negotiate good prices during access negotiations to earn more reasonable profits for the company.
Finally, let’s talk about some personal experiences. I remember when I wrote "Ultimate Conjecture of
· Analysis of the variety of the most likely to be shortlisted for the new version of the medical insurance catalog" in 2017, I also complained at the end of the article that the access to innovative drugs seemed to be slower and slower. I didn't expect that in just two years, whether from drug supervision or medical insurance, there have been such earth-shaking changes in the access environment.At this speed, it doesn’t seem like a dream to be in line with the international community within a few years. From the patient's perspective, it is really a blessing to have more access to new drugs, especially the focus of this catalog review is also the categories that patients have long been looking forward to.
When writing this article, when searching for some varieties, you can also see posts from patients in the past, mainly focusing on two topics: one is where to buy it, and the other is when to reimburse. Many patients are sharing some channels for purchasing medicine abroad, or telling stories about poverty caused by illness. It really makes people feel sad. I hope there will be fewer and fewer such stories in the future. The Medical Insurance Catalog has been the fourth major adjustment since 2000. Each adjustment shows that the various progress of the medical insurance management department in catalog management from macro to details, especially the adjustments in the past two years have accelerated the pace of reform. is moving faster and faster towards the value-oriented medical insurance strategic purchase goal . This is the first adjustment since the establishment of the Medical Insurance Bureau, and it is bound to bear the heavy responsibility of reforming the new department and the pressure that comes with it. According to the requirements put forward at the National Medical Security Work Conference held a year ago, "respond to the society and solve the people's worries, and dare to take responsibility to promote reforms." Here, we can expect more about this adjustment and wish this adjustment a complete success.
Recommended reading:
1. How much can drug sales increase by entering medical insurance?
2. The balance of medical insurance funds is as high as 2 trillion yuan, so why should drug costs be strictly controlled?
Note: The information on new drugs approved by NMPA and FDA is continuously updated on the Medical Cube website and is available for free access.
