'Frost & Sullivan' Insights
On June 13th, the official website of the National Healthcare Security Administration released the '2022 National Basic Medical Insurance, Work-related Injury Insurance, and Maternity Insurance Drug List Adjustment Work Plan' and related documents for public comment, fully reflecting attention to rare disease treatment drugs and pediatric medications. In recent years, adjustments to the medical insurance list have focused on rare disease medications, with an increase in the number of drugs included and a broader coverage of rare diseases.
After the release of the 'Work Plan', will there be more rare disease medications included in medical insurance? What are the highlights of this year's medical insurance negotiations compared to previous years, and how is the research and development of pediatric medications in China? What is the status of inclusion in medical insurance? In addition, in terms of innovative drugs, which varieties are worth paying attention to? Wang Siyi, an analyst from Frost & Sullivan's Healthcare GroupPreviously interviewed by Blue Whale Finance to discuss the outlook after the adjustment of the national medical insurance drug list.
On June 13th, the official website of the National Healthcare Security Administration released the '2022 National Basic Medical Insurance, Work-related Injury Insurance, and Maternity Insurance Drug List Adjustment Work Plan' and related documents for public comment.
According to this work plan (draft for comments), the 2022 national drug list adjustment is divided into five stages: preparation, application, expert review, negotiation, and announcement of results. The preparation stage is from May to June, the application stage is from July to August, expert review is in August, negotiation is from September to October, and results are announced in November.
Greater focus on rare disease treatment drugs and pediatric medications
Compared to 2021, the 'Work Plan' remains generally stable, while improvements have been made in terms of application scope, access rules, review procedures, etc.
This year's medical insurance drug list continues to support the treatment of COVID-19 and innovative drugs, fully reflecting attention to rare disease treatment drugs and pediatric medications. It has clearly included 'rare disease treatment drugs approved for marketing before June 30, 2022' and 'pediatric drugs approved for marketing before June 30, 2022 and included in the list of drugs encouraged for research and development applications', clearly defining the application conditions. The medication security level for relevant populations is expected to be further improved.
In fact, in recent years, adjustments to the medical insurance list have focused on rare disease medications, with an increase in the number of drugs included and a broader coverage of rare diseases. Data shows that the 2009 version of the medical insurance list included 22 rare disease medications covering 13 rare diseases; the 2017 version included 30 rare disease medications covering 15 rare diseases; the 2019 version included 39 rare disease medications covering 19 rare diseases; the 2020 version included 45 rare disease medications covering 22 rare diseases.
After last year's medical insurance adjustment, seven new rare disease medications were added, including the significantly reduced price of BeiGene's SMA treatment drug (scleromyositis) nusinersen sodium injection and Takeda's Fabre drug agalsidase α injection concentrate, which successfully entered the medical insurance list. The inclusion of these two rare disease medications is also considered by the industry as a precedent for high-value rare disease drugs entering medical insurance.
Wang Siyi, an analyst from Frost & Sullivan's Healthcare Group
Wang Siyi, an analyst from Frost & Sullivan's Greater China Healthcare Group, said that in terms of rare disease medications, seven new drugs were added to the medical insurance list last year, and for the first time, high-value drugs entered medical insurance. This year, more rare disease medications are expected to be included in medical insurance. We have also seen that existing pharmaceutical companies have taken the initiative to significantly reduce prices in advance, seeking an opportunity in the new round of medical insurance negotiations, which will also promote the accessibility of medication for patients. For example, the latest procurement platform for rituximab, used to treat SMA, has an online price of 14,500 yuan per bottle, while the retail price was 63,800 yuan per bottle before.
In terms of pediatric medications, among the 2860 drugs in the 2021 medical insurance list, there were 109 drugs clearly labeled as 'for children' or 'pediatric', accounting for less than 4%. China faces problems such as shortages of pediatric-specific drugs and a weak industry foundation.
Since 2011, the state has successively introduced multiple favorable policies to encourage the research and development and production of pediatric-specific drugs. In the 'Outline for the Development of Children in China (2021-2030)' issued by the State Council, measures such as strengthening scientific research innovation in the field of children's health, encouraging the research and development and production of pediatric medications, improving clinical medication norms for children, and clearly stating pediatric medication information in drug instructions are clearly proposed.
Competition is fierce for blockbuster products
It is worth noting that this year's list also proposed rules for non-exclusive drug access for the first time, added a public announcement link for application results, and improved the expert review process. Overall, this year's medical insurance drug list adjustment has taken another solid step towards being scientific, standardized, fair, and transparent.
According to the document requirements, the scope of this medical insurance list adjustment includes new generic drugs approved for marketing between January 1, 2017, and June 30, 2022, as well as drugs whose indications or functions have undergone significant changes.
The scope of the 2021 medical insurance negotiation adjustment required new drugs approved for marketing before June 30, 2021. In the past year, several new drugs have also been launched in China. Whether innovative drugs are included in medical insurance is also a focus.
From the perspective of recent years' medical insurance list adjustments, the proportion of innovative drugs included has been increasing year by year. The time from drug launch to inclusion in medical insurance has also been significantly shortened. The 'Blue Book on the Progress and Achievements of Medical Insurance Drug Management Reform' released by the Chinese Pharmaceutical Association and the China Medical Insurance Research Society shows that among the 34 innovative drugs launched from 2016 to 2020, 26 drugs have entered the medical insurance list, accounting for 76.5%. The time from drug launch to inclusion in medical insurance has also been greatly shortened. According to statistics, the shortest cycle from approval to inclusion in medical insurance for new drugs in 2020 was only 5 months.
PD-(L)1, as a representative of domestic innovative drugs, is highly competitive, and price negotiations are worth paying attention to. Currently, there are a total of 13 PD-(L)1 monoclonal antibody products on the market in China, including 9 PD-1 monoclonal antibodies and 4 PD-L1 monoclonal antibodies. Among them, 4 domestic PD-1 products have been included in medical insurance, namely Sintilimab from Innovent Biologics, Camrelizumab from Hengrui, Tislelizumab from Junshi Biologics, and Tislelizumab from BeiGene.
Wang Siyi pointed out that currently, 13 PD-(L)1 products have been approved for 52 indications in China. The 4 PD-1 products from Innovent Biologics, Hengrui, Junshi Biologics, and BeiGene have been approved for 4, 8, 5, and 9 indications respectively, and have been included in medical insurance for 4, 4, 3, and 5 indications respectively. This year, in addition to paying attention to whether new PD-(L)1 products will be included in medical insurance, we can also pay attention to whether new indications will be added to the previously included 4 products.
Last year, the million-dollar CAR-T therapy was not included in the medical insurance list. This year, there are already two domestic CAR-T products, and it is unknown whether they can enter the medical insurance list; among the ADC drugs that were launched in China last year, only Rongchang Biologics' vedotinib was successfully negotiated and included in the list but failed to negotiate. Roche's enfuramtuzumab did not pass the preliminary review list, and this year's negotiation results for ADC drugs are also of interest.
In addition, blockbuster products such as Takeda's new generation ALK tyrosine kinase inhibitor (TKI) brigatinib; AbbVie's upadacitinib, Pfizer's abemaciclib; Roche's tocilizumab injection (subcutaneous injection); and Yasheng Medicine's orlistatib (Nirvana), the first and only third-generation BCR-ABL inhibitor approved in China, are all worth paying attention to.
The results of the 2021 national medical insurance drug list adjustment showed that a total of 74 drugs were newly included in the list, and 11 drugs were removed from the list.
Zheng Jie, the leader of the expert group for calculating the medical insurance negotiation drug fund in 2021, pointed out at the press conference on medical insurance negotiation drugs: The primary working principle of the list adjustment is 'ensuring basic needs', and the fund calculation work is an important line of defense to achieve 'ensuring basic needs'. In the entire fund calculation work, the responsibility is to fully evaluate the burden levels of funds and patients, and calculate and provide affordable recommended payment standards.
At that time, Zheng Jie pointed out that according to the limited payment scope, the annual treatment costs of all drugs in the current national medical insurance list have not exceeded 300,000 yuan.
Frost & Sullivan Insights — Extended Reading
Q: Based on the newly released '2022 National Basic Medical Insurance, Work-related Injury Insurance, and Maternity Insurance Drug List Adjustment Work Plan', what do you think are the highlights of this year's medical insurance negotiations compared to previous years? How is the research and development of pediatric medications in China? What is the status of inclusion in medical insurance?
A:Compared to previous years, in addition to continuing to support innovative drugs, this year's list also clearly includes rare disease treatment drugs and pediatric medications in the application conditions, reflecting attention to special groups.
In terms of rare disease medications, seven new drugs were added to the medical insurance list last year, and for the first time, high-value drugs entered medical insurance. This year, more rare disease medications are expected to be included in medical insurance. We have also seen that existing pharmaceutical companies have taken the initiative to significantly reduce prices in advance, seeking an opportunity in the new round of medical insurance negotiations, which will also promote the accessibility of medication for patients. For example, the latest procurement platform for rituximab, used to treat SMA, has an online price of 14,500 yuan per bottle, while the retail price was 63,800 yuan per bottle before.
In terms of pediatric medications, among the 2860 drugs in the 2021 medical insurance list, there were 109 drugs clearly labeled as 'for children' or 'pediatric', accounting for less than 4%. China faces problems such as shortages of pediatric-specific drugs and a weak industry foundation. Since 2011, the state has successively introduced multiple favorable policies to encourage the research and development and production of pediatric-specific drugs. In the 'Outline for the Development of Children in China (2021-2030)' issued by the State Council, measures such as strengthening scientific research innovation in the field of children's health, encouraging the research and development and production of pediatric medications, improving clinical medication norms for children, and clearly stating pediatric medication information in drug instructions are clearly proposed. Driven by market and policy, there are already innovative pharmaceutical companies such as Yipin Haoyao Pharmaceutical that focus on the research and development of pediatric medications.
Q: In terms of innovative drugs, which varieties do you think are worth paying attention to?
A:PD-(L)1, as a representative of domestic innovative drugs, is highly competitive, and price negotiations are worth paying attention to. Currently, there are a total of 13 PD-(L)1 monoclonal antibody products on the market in China, including 9 PD-1 monoclonal antibodies and 4 PD-L1 monoclonal antibodies. Among them, 4 domestic PD-1 products have been included in medical insurance, namely Sintilimab from Innovent Biologics, Camrelizumab from Hengrui, Tislelizumab from Junshi Biologics, and Tislelizumab from BeiGene.
Currently, 13 PD-(L)1 products have been approved for 52 indications in China. The 4 PD-1 products from Innovent Biologics, Hengrui, Junshi Biologics, and BeiGene have been approved for 4, 8, 5, and 9 indications respectively, and have been included in medical insurance for 4, 4, 3, and 5 indications respectively. This year, in addition to paying attention to whether new PD-(L)1 products will be included in medical insurance, we can also pay attention to whether new indications will be added to the previously included 4 products.
*This article is reprinted from Blue Whale Finance, authored by Tu Jun, with the original title 'The National Medical Insurance List Adjustment is Approaching: Some Pharmaceutical Companies Are Reducing Prices in Advance to Seek an Opportunity, and Rare Disease and Pediatric Medications Are Under Attention'.
