Downgraded diagnostic criteria for hypertension, and a sudden increase of 240 million patients

For friends who have been struggling with the borderline of hypertension for a long time, today they can completely surrender.
On November 13, my country's newly released "Clinical Practice Guidelines for Hypertension in China" (hereinafter referred to as "Guidelines") lowered the diagnostic criteria for hypertension: the original diagnostic criteria for hypertension was 140/90mmHg, and the revised one was ≥130/90mmHg. 80mmHg. In other words, the "healthy" people whose blood pressure was between 130/80 mmHg and 140/90 mmHg will completely become hypertensive patients today. Perhaps, there are not a few friends who have been "successful". A study published in 2019 showed that there are as many as 243 million people in this group in China. In the field of hypertension treatment, blockbuster drugs have always been released frequently. So, what impact will the lowering of the diagnostic criteria have on the market?
1. The lonely golden track
From a commercial point of view, the business model of hypertension treatment drugs is excellent. First, the scale of hypertensive patients is large enough. According to Frost & Sullivan data, there will be 326 million hypertensive patients nationwide in 2020. Moreover, the incidence of hypertension has been soaring in recent years, and the number of patients is still increasing.
Secondly, the antihypertensive drugs take a very long cycle. Hypertension is a chronic disease that cannot be cured, but it is not immediately fatal. As long as the patient takes the medicine for a long time, the disease can be better controlled. This also means that the medication cycle for hypertensive patients is extremely long.
Judging from these two factors, high blood pressure track medicine is a proper golden track. Indeed, there is no shortage of blockbuster drugs in the field of hypertension treatment. Valsartan from Novartis. Valsartan, which was approved for marketing in 1996, had a sales peak of US$6.05 billion in 2010. In 2012, with the expiration of the valsartan patent, the "drug king" stepped down from the altar, but valsartan's ability to print money still exists. Based on valsartan, Novartis has developed a variety of valsartan compound preparations and successfully "relayed". In 2013, Novartis' valsartan amlodipine reached a sales peak of US$1.456 billion. Pfizer also once had a presence in the field of hypertension treatment. Amlodipine developed by it had an annual sales peak of nearly US$5 billion. However, the field of hypertension treatment has been somewhat lonely in recent years. Because, in the past ten years, there has not been any new research and development progress in the field of antihypertensive drugs.
So far, antihypertensive drugs mainly include calcium channel blockers, angiotensin converting enzyme inhibitors, angiotensin receptor antagonists, diuretics, β-receptor blockers, angiotensin receptor caffeine inhibitors agent for these old faces. Most of the antihypertensive drugs with these mechanisms have passed the patent period, and the market share has been carved up by generic drug companies.
2. The sudden "increase" of 240 million hypertensive patients
However, looking at it now, there may be "variables" in the domestic hypertension treatment market. As mentioned above, the release of the new "Guidelines" has significantly increased the population of hypertensive patients. Seeing this, you may be wondering, why should the diagnostic criteria for hypertension be lowered? It can be said that it is in line with international standards. At present, the United States, where innovative drugs are most developed, implements this standard for the diagnosis of hypertension. The reason is that when the blood pressure is ≥130/80 mmHg, the harm to the human body has increased significantly. According to a study in "BMJ", people with a systolic blood pressure higher than 129mmHg have a gradually increased risk of cardiovascular problems, coronary heart disease, and stroke. As we all know, for people with high blood pressure, "lower blood pressure" is the only treatment, and early detection and treatment will bring significant social benefits. In the long run, when the "hypertension" node is significantly moved forward, the probability of diseases including stroke, cardiovascular and cerebrovascular diseases will be greatly reduced, thereby reducing health expenditure. It is based on this that the "Guidelines" adjusted the diagnostic criteria for hypertension in my country, hoping to achieve early detection and early treatment of hypertension and further enhance social benefits.
The adjustment of the diagnostic criteria for hypertension may also be good for pharmaceutical companies. With the relaxation of hypertension standards, a phenomenon that will inevitably appear is that the population size of hypertensive patients will increase dramatically. According to the "Clinical Results and Economic Impact of the 2017 ACC/AHA Guidelines for Hypertension in China" published in 2019, there are about 243 million people whose blood pressure is before 130/80 mmHg and 140/90 mmHg in China. The research is jointly supported by the "12th Five-Year Plan" National Science and Technology Support Program and the National Health Science Research Public Welfare Special Fund Project, so it is also considered authoritative. It seems that the downregulation of the diagnostic criteria for hypertension will significantly increase the size of the medication population. In this regard, the capital market is also full of expectations, and the "hypertension concept sector" was born, including Huahai Pharmaceutical, Xinlitai, Hengrui Medicine and other pharmaceutical companies that have hypertension treatment drugs, have been shortlisted.
3. How big is the impact?
So, how big is the impact of the relaxation of the diagnostic criteria for hypertension? Perhaps, it is not as optimistic as the market expects. Although the "Guidelines" recommend that hypertensive patients start drug treatment earlier, not all newly enrolled patients require medication. Under the new standard, the grading of hypertensive patients is dichotomous, that is, systolic blood pressure 130-139 mmHg or/and diastolic blood pressure 80-89 mmHg is grade 1 hypertension; systolic blood pressure ≥ 140 mmHg or/and diastolic blood pressure ≥ 90 mmHg is 2 grade hypertension. Specifically, those with blood pressure ≥140/90 mmHg should start drug therapy immediately; those with blood pressure ≥130/80 mmHg with clinical comorbidities or target organ damage or ≥3 risk factors should also start drug therapy. More low-risk hypertensive patients do not need drug treatment, but only need lifestyle interventions, such as exercise, diet control, weight loss and muscle gain, quitting smoking and drinking, etc.
So, what proportion of patients need medication?
According to the "Clinical Outcomes and Economic Impact of the 2017 ACC/AHA Guidelines for Hypertension in China", 22.7% of patients with blood pressure between 130/80 mmHg and 140/90 mmHg required drug treatment. In other words, this change in diagnostic criteria may increase the need for medication for about 50 million patients. It seems that this number is not too small? However, another point to consider is that the current high blood pressure drugs are not expensive. The selection results of the seventh batch of national drug collection announced in July 2022 showed that the lower bid price of the antihypertensive drug Nifedipine Sustained-release Tablets was 2.1 yuan, which is only 4 cents per tablet based on the specification of 20mg*50 tablets/bottle. money. Obviously, it is hard to say how much performance increase this benefit can bring to many generic drug companies due to extremely low drug prices. For innovative drugs, the reduction of diagnostic criteria may bring new room for growth. But the premise is that truly innovative drugs have significant advantages in terms of efficacy or safety. After all, it is not easy to break through the market of many generic drugs.