-
Categories
-
Pharmaceutical Intermediates
-
Active Pharmaceutical Ingredients
-
Food Additives
- Industrial Coatings
- Agrochemicals
- Dyes and Pigments
- Surfactant
- Flavors and Fragrances
- Chemical Reagents
- Catalyst and Auxiliary
- Natural Products
- Inorganic Chemistry
-
Organic Chemistry
-
Biochemical Engineering
- Analytical Chemistry
-
Cosmetic Ingredient
- Water Treatment Chemical
-
Pharmaceutical Intermediates
Promotion
ECHEMI Mall
Wholesale
Weekly Price
Exhibition
News
-
Trade Service
The past 2022 has not been easy for everyone, especially for rare disease patients
.
However, we are still pleased to see that 14 rare disease drugs have been approved in China in 2022, and 19 rare disease drugs have been shortlisted for the preliminary formal review of medical insurance negotiations announced by the National Health Insurance Administration, and the negotiations have now been completed
.
More Huimin Insurance products increase protection against rare diseases; Charitable assistance programs continue to play a complementary role
for patients.
For the protection of rare disease drugs, at present, it mainly relies on the troika of national medical insurance, commercial health insurance and charitable assistance
.
Among them, the role of medical insurance is important and has attracted the most attention
.
There is still a distance between medical insurance negotiations and landing
There is still a distance between medical insurance negotiations and landingIn July 2022, the "2022 National Basic Medical Insurance, Work-related Injury Insurance and Maternity Insurance Drug Catalogue Adjustment Work Plan" was officially implemented, which means that the seventh round of medical insurance negotiations was officially launched, and it was clearly proposed to "encourage the research and development of rare disease treatment drugs"
.
The declaration conditions for rare disease drugs will also be further relaxed, and all six categories of drugs approved by the national drug administration for marketing between January 1, 2017 and June 30, 2022, such as new generic names, new indications or functional indications, national basic drug list, and entry into the "First Batch of Rare Disease List", can be declared
.
We can clearly see that since the confirmation of the first batch of rare disease lists in 2018, in just over four years, China's rare disease drug list has developed rapidly
.
By the end of 2021, the medical insurance negotiations were completed, and more than 80 rare disease drugs had been approved for marketing in China, of which 58 had entered the national medical insurance catalogue, involving 28 diseases
.
In the 2021 medical insurance negotiations, Biogen's spinal muscular atrophy (SMA) treatment drug nocinaxen sodium injection is one of
the most talked about rare disease drugs.
The drug entered China's "First List of Urgently Needed Overseas New Drugs for Clinical Needs" in 2018, and was approved for marketing in Chinese mainland the following year, becoming one of the rare high-value rare disease drugs
included in the national medical insurance drug list in 2021.
The price before inclusion in medical insurance was as high as 700,000 yuan per needle, and after negotiation, the price was reduced to about 33,000 yuan, and then the part reimbursed by medical insurance was reduced, and the patient's out-of-pocket expenses were only a few thousand yuan
.
A few days ago, Biogen brought the multiple sclerosis (MS) treatment dimethyl fumarate to a new round of medical insurance negotiations in World War II
.
Compared to other rare diseases, there are slightly more drugs available in the MS field
.
At present, the results of the negotiations are pending the official announcement of
the health insurance bureau.
Roche's risprand, which is also an SMA treatment, entered the Chinese market in June 2021 and also passed the prequalification for medical insurance negotiations that year, but ultimately did not enter the on-site negotiation
.
As the world's first SMA oral drug, rispram has high
administering convenience.
Before participating in the 2022 national health insurance negotiations, Roche has significantly reduced the price of rispram from the initial 63,800 yuan per bottle to 14,500 yuan
.
According to the new price, the annual fee for patients using this drug is controlled within
450,000 yuan.
This is also preparing
for negotiations to enter the new version of the medical insurance catalog.
But it is not enough to get the "admission ticket" of the medical insurance catalog, and entering the hospital and allowing patients to use drugs can be regarded as the real "landing"
.
Takeda's Fabry disease drug Repuja entered the catalogue
at the end of 2021 through national health insurance negotiations.
At the beginning of 2022, shortly after the new medical insurance catalogue came into effect, the story of patients with Fabry disease in Hebei Province running around to get drugs in hospitals was wiped
out.
Ruipjia's story is a microcosm of the difficulty of entering the hospital, compared with other drugs, Guotan drugs have innate advantages in entering the hospital, but it is still not easy
.
According to RDPAC statistics, among the national drugs, oncology drugs and self-exempt drugs are well equipped in sample hospitals, with an allocation rate of more than 45%; Medicines for chronic noncommunicable diseases followed, with an average allocation rate of about 34%; However, the allocation progress of drugs for rare diseases, bacterial fungal infections and chronic infectious diseases is low, with an average allocation rate of less than 30%.
Among the sample hospitals, the equipping of nocinaxen sodium and repujia was relatively good, while the equipping rate of fampridine sustained-release tablets for the treatment of multiple sclerosis was even less than 10%.
There are several reasons for the low allocation rate of rare disease drugs in hospitals: after the zero-difference rate reform, hospital pharmacies have become cost centers, and pharmacies lack the motivation to expand; Although the Health Commission eliminated the national talk of drugs from the "proportion of drugs"
The scope of assessment, such as "total number of drugs", but there are no clear measures to motivate hospitals to equip such drugs; The storage and use of some drugs have high requirements, involving the upgrading of pharmacy software and hardware and the training
of management personnel.
In this regard, the "dual channel" and a sound prescription circulation mechanism may solve the urgent need, but in the long run, it is still necessary to pay attention to the difficulties and incentive factors
of public hospitals.
Many places have extended a helping hand to benefit the people
Many places have extended a helping hand to benefit the peopleAlthough the national basic medical insurance is strong, it is difficult to support
it alone.
To ensure the drug needs of rare disease patients, more social forces are needed to join
.
Commercial health insurance is another important "carriage"
.
As a representative of institutional innovation of commercial insurance participating in the multi-level medical insurance system, Huimin Insurance has become one of the most widely distributed inclusive commercial health insurance in all parts of
the country.
At present, there are about 200 Huimin Insurance products
in the country.
Fortunately, Huimin Insurance has also taken tentative steps in rare disease protection, and more and more products have included rare disease drugs or diseases in the scope of
coverage.
For example, Jiangsu Province stipulates that all varieties in the provincial rare disease special guarantee fund can enjoy the treatment of gradual reimbursement by Huimin insurance, and some cities will also include some rare diseases that are not included in the national catalogue and provincial special security fund into the scope of local Huimin insurance; Most of the products in Shandong Province include rare disease drugs; Shanghai
"Huhuibao" includes 5 high-value drugs for 3 rare diseases into the list of specific high-value drugs.
.
.
At present, there are about 50~60 Huimin Insurance products in the country to provide support
for rare diseases.
To a large extent, these Huimin Insurance products reflect the supplementary protection role beyond the scope of basic medical insurance, which not only helps alleviate the expenditure pressure of national medical insurance, but also tries to include more diseases or drugs within the scope of their ability, so that some rare disease patients who are not covered by medical insurance can also obtain treatment opportunities
.
Specifically, the protection of rare diseases by Huimin Insurance mainly includes several types: first, a certain proportion of reimbursement for the out-of-pocket part of drugs that have been included in the national medical insurance catalog; The second is to include some rare disease drugs in the list of special drugs for protection; The third is to guarantee drugs that need to be treated at their own expense; The fourth is to reimburse a certain amount according to the diseases included in the "First Batch of Rare Disease Catalog"
.
From the current point of view, Huimin Insurance's exploration in the field of rare diseases still has many shortcomings, many products have a narrow coverage or low reimbursement amount, and there is also the problem
of "difficult landing".
However, a number of policies in 2022 have released positive signals for rare disease protection, and in the future, it is believed that more Huimin Insurance or other health insurance products will pay attention to the field of rare diseases and bring better treatment options
to patients.
Patient assistance programs are diversified
Patient assistance programs are diversifiedA patient assistance program is when a pharmaceutical company donates drugs or funds to charitable organizations or other third-party recipient organizations, and then the recipient organization initiates the provision of drugs or funds
to patients who meet specific conditions.
For many rare disease drugs, due to the small patient population and relatively high R&D costs, pharmaceutical companies actively promote the medical insurance access of products and the layout of commercial health insurance, and often use charitable assistance projects to improve patients
' access to drugs 。 There are three main modes of implementation of China's patient charity assistance projects: first, the co-aid model, in which patients can obtain a certain number or proportion of subsequent treatment cycles for free after using a certain number of drugs or treatment cycles at their own expense; The second is the full free model, which does not require patients to purchase drugs at their own expense, and gives eligible patients a certain period of time or a certain amount of assistance drugs free of charge; The third is the financial assistance model, patients can get a certain proportion of cash back with the invoice for the purchase of drugs, and the assistance ratio is determined
according to factors such as local medical insurance policies, the proportion of patients' out-of-pocket payments, and the proportion of assistance from local charitable organizations.
At present, China's patient assistance projects have gradually formed a relatively mature operation process and diversified assistance methods, and have really improved the protection level of
rare disease patients.
In the past 2022, charitable assistance programs have played a complementary role
in addition to medical insurance and commercial insurance.
But the question to consider is, are aid projects sustainable? How can equity be better balanced for patients with different levels of economic income? Medical insurance, commercial insurance and charitable assistance are currently the troika that protects patients with rare diseases in China, and although each has certain limitations, the synergy of the three is increasing
.
With the attention and attention of the country and all sectors of society, the future of rare disease protection is worth looking forward to
.
