Real-world research: antihypertensive drug collection varieties can replace the hospital-end monitoring of drugs

Not long ago, the National Medical Insurance Bureau issued a notice on printing and distributing the "Reference Monitoring Scope of the First Seven Batches of Nationally Organized Drug Centralized Procurement Varieties of Alternative Drugs" (hereinafter referred to as the "Monitoring Scope") to monitor the implementation of the results of the national collection and procurement and prevent unreasonable clinical substitution use
.

Looking at the scope of monitoring, it is not difficult to find that the alternative drugs are mostly small classes of drugs of the same or adjacent treatment with overlapping indications
.
The large number of patients with cardiovascular system drugs and large clinical needs are one of the important areas of
collection.
According to the selected products, 1-5 batches of collection have been included in 97 cardiovascular system drugs
.

A large category of cardiovascular drugs is antihypertensive drugs, including calcium antagonists, diuretics, β receptor blockers, angiotensin-converting enzyme inhibitors (ACEI), angiotensin-II receptor antagonists (ARBs) 5 therapeutic sub-categories, the monitoring range of the last two therapeutic sub-categories - angiotensin-II receptor antagonists and angiotensin-converting enzyme inhibitors (ACEI) as alternatives, which will be selected for analysis
herein.

Clinical antihypertensive drugs

Mainstream varieties are included in the collection

Figure 1 shows the proportion of drug sales in the cardiovascular system of sample hospitals nationwide in 2018, and the total proportion of ACEI and ARB subcategories is 10%, which is more
clinically used.
Among them, the ARB subclass accounted for a relatively high proportion of 8%, and the ACEI subclass accounted for a relatively small proportion, at 2%.

Figure 1: Proportion of cardiovascular system drug sales in sample hospitals nationwide in 2018

According to the PDB national sample hospital market data, ARB and ACEI sub-categories have a total of 19 generic names, and the monitoring scope includes 17 mainstream generic names, which on the one hand shows the mutual fungibility of these two types of antihypertensive drugs, on the other hand, it also reflects the comprehensiveness of
monitoring.

Angiotensin II receptor antagonists are sartans, mainly including valsartan * (markers* indicating that the generic name has been included in the collection), irbesartan*, losartan*, olmesartan*, telmisartan*, candesartan*, alisartan, mesatan, and atchisartan
, all of the above 9 generic names were included in the monitoring scope, of which 6 were included.

Angiotensin-converting enzyme inhibitors (ACEI) are prelidiums, mainly including pedopril*, benazepril*, fosinopril*, ramipril, enalapril*, midazulide, captopril* and lisinopril*, all of the above 8 generic names were included in the monitoring area, of which 6 were included
.

In addition to the inclusion of more generic names in the collection, on the other hand, the generic names included in the collection are mostly clinical varieties, as shown in
Figure 2.
It can be seen that the generic names with the top sales volume have all been included in the collection, such as valsartan, irbesartan, losartan, perdopril and so on
.
In fact, in 2018, the sales of collective names accounted for 97%.

Common names that are not included in the collection tend to have a short time to market and a small market size, such as Mesatan as a new drug for Takeda, which was first listed in Chinese mainland in 2021; The original research of Azisatan was not listed in China, with Hengrui as the first imitation, and the listing time was also 2021, and no significant sales
were generated.

Figure 2: The proportion of sales of 17 monitored generic names in sample hospitals nationwide in 2018

The collective generic name is replaced by the non-collective generic name

Medical Insurance Fund "Cage for Bird"

According to PDB national sample hospital market data, the sales changes of 17 monitored generic names are shown in Figure 2, and from the "4+7" pilot in March 2019, the market size of these 17 generic names has continued to decline, from 2.
2 billion yuan in 2019 to less than 1 billion yuan in 2021, a decline of more than 50%.

Sales in the first half of 2022 were 389 million yuan, which is expected to decline further, reflecting the role of
centralized procurement and control fees.

Figure 3: Changes in the market size of 17 monitored generic names in the national sample hospitals

In terms of alternative drug monitoring, the generic name of the collection is replaced by the generic name of the non-collection of drugs
.
In 2018, the sales of the generic name of the collection accounted for 97%, but since 2019, the impact of the collection has decreased year by year, and as of the first half of 2022, the proportion is 66%, a decrease of 31 percentage points
.
On the other hand, the proportion of sales of collective names has also declined, but has remained above 90%, down 7 percentage points
from 2018 to the first half of 2022.

Figure 4: Change in the proportion of sales of collective names

Figure 5: Change in the proportion of sales of collective names

The sales volume and sales volume of the collective collection generic name have declined, reflecting that the collective name in the same treatment field has been replaced by the non-collective common name; On the other hand, the decline in sales of generic names is higher than the decline in sales, indicating that the sales substitution effect is greater than the sales substitution effect
.

Specifically, as of the first half of 2022, the market share of 17 monitored generic names has changed
significantly.
The most obvious is the non-selected generic name Alisartan, whose proportion has risen from 2% in 2018 to 32% in 2022, an increase of 30 percentage points, and the proportion of the ranking has also jumped from the original middle and lower position to the current first place, which has changed a lot
.
It can be said that under the impetus of collection, Alisartan has influenced and reshaped the market pattern
of ARB and ACEI small class antihypertensive drugs.

Figure 6: 2022 H1 national sample hospitals 17 monitoring generic names sales share

Alisartan is the first sartan-like antihypertensive drug independently developed in China on the basis of losartan, the antihypertensive effect is stable, antihypertensive can also put uric acid, in addition, unlike other sartan-like drugs, Alisartan is not metabolized by the liver, which can greatly reduce the liver burden
of hypertension patients.

Independent research and development, the first, 1.
1 class of new drugs, good efficacy, good safety, has been included in the medical insurance negotiations, perhaps the accumulation of many of the above advantages, the formation of Alisartan dimensionality reduction to combat other antihypertensive drugs capital
.
What is certain is that Alisartan has become a typical case
of collecting and prompting medical insurance funds to "change cages for birds".
Alisartan's patent protection period until 2026, whether the market pattern of ACEI and ARB antihypertensive drugs will still evolve in the direction of a dominant one, we will continue to pay attention
to.