On November 13, China issued a new "Chinese Clinical Practice Guidelines on Hypertension" (hereinafter referred to as "Guidelines"), which revised down the diagnostic criteria for hypertension:
The original diagnostic standard of hypertension was 140/90mmHg, but the modified standard was ≥130/80 mmHg.
In other words, "healthy" people with blood pressure between 130/80 mmHg and 140/90 mmHg will become hypertensive today.
Perhaps, "hit" friends are not a few. A study published in 2019 put the number at 243 million.
In the field of hypertension treatment, blockbuster drugs have been frequently produced. So what impact will the lower diagnostic criteria have on the market?
From a business perspective, the business model for hypertension drugs is excellent.
First, the number of hypertensive patients is large enough. According to Frost Sullivan, 326 million people in the country will already have high blood pressure in 2020. In recent years, the incidence of hypertension has been soaring, and the number of patients is still increasing.
Secondly, the cycle of taking antihypertensive drugs is very long. High blood pressure is a chronic condition that cannot be cured, but it is not immediately fatal. As long as patients take long-term medication, the condition can be better controlled. This means that patients with high blood pressure have a very long medication cycle.
From these two factors, high blood pressure track medicine is no problem the gold track. Indeed, in the field of hypertension, there is no shortage of blockbuster drugs.
Like valsartan from Novartis. Sales of valsartan, approved for sale in 1996, peaked at $6.05 billion in 2010. In 2012, with the expiration of valsartan's patent, the "king of medicine" stepped down from the altar, but Valsartan's ability to print money remains.
Based on valsartan, Novartis has developed a variety of valsartan compound formulations and successfully "relays". In 2013, Novartis's sales of valsartan amlodipine peaked at $1.456 billion.
Pfizer also once had a foothold in hypertension. Amlodipine, which it developed, had peak annual sales of nearly $5 billion.
However, in recent years, the field of hypertension treatment has been lonely. For the last decade, there have been no new developments in the field of blood pressure drugs.
So far, the main antihypertensive drugs are calcium channel blockers, angiotensin converting enzyme inhibitors, angiotensin receptor antagonists, diuretics, beta blockers, angiotensin receptor brain cafepidase inhibitors these old faces.
Most of these drugs are out of patent, and their market share has been carved up by generic drug companies.
However, now, the domestic hypertension treatment market may be "variable".
As mentioned above, the publication of the new guidelines has significantly increased the number of patients with hypertension. Seeing this, you may wonder why the diagnostic criteria for hypertension should be lowered.
It can be said that it is in line with international standards. At present, the United States, where innovative drugs are the most developed, applies this standard to the diagnosis of hypertension. The reason is that when blood pressure is greater than 130/80 mmHg, the harm to the human body has increased significantly.
People with systolic blood pressure above 129mmHg are at increased risk for cardiovascular problems, coronary heart disease and stroke, according to a study in the journal BMJ.
As we all know, for hypertension groups, "blood pressure" is the only treatment, and early detection, early treatment will bring significant social benefits.
In the long run, when the "depressurization" node moves forward significantly, the probability of stroke, cardiovascular and cerebrovascular diseases will be greatly reduced, thus reducing health expenditure.
It is based on this, "guide" to our hypertension diagnostic standard carries on adjustment, expect to realize the hypertension early discovery, early treatment, further promote social benefit.
The adjustment of hypertension diagnostic standards, for pharmaceutical companies, may also be good. As the standard of hypertension is relaxed, the number of hypertension patients will increase.
According to the "Clinical Outcomes and Economic Impact of the 2017 ACC/AHA Guidelines on Hypertension in China" published in 2019, there are about 243 million people in China with blood pressure before 130/80 mmHg and 140/90 mmHg.
The research was jointly supported by the National Science and Technology Support Plan of the 12th Five-Year Plan and the National Public Health Research Fund, so it is considered authoritative.
It seems that lowering the diagnostic criteria for hypertension will significantly increase the size of the drug population.
In this regard, the capital market is also full of expectations, "hypertension concept plate" was born, including Huahai Pharmaceutical, Xinlitai, Hengrui Pharmaceutical and other drug companies with hypertension treatment drugs, have been shortlisted.
So how big is the impact of this relaxation of the criteria for diagnosing hypertension? Perhaps not as optimistic as the market had hoped.
Although the guidelines recommend that people with high blood pressure start medication earlier, not all newly enrolled patients need medication.
Under the new criteria, patients with hypertension were classified as grade 1 hypertension with systolic blood pressure of 130 to 139 mmHg or/and diastolic blood pressure of 80 to 89 mmHg. Grade 2 hypertension is defined as systolic blood pressure ≥140 mmHg or/and diastolic blood pressure ≥90 mmHg.
Specifically, those with blood pressure ≥140/90 mmHg were immediately initiated with medication; Patients with blood pressure ≥130/80 mmHg and clinical complications or target organ damage or ≥3 risk factors should also start drug therapy.
More patients with low-risk hypertension do not need medication, but only need lifestyle interventions, such as exercise, diet control, weight loss and muscle gain, smoking and alcohol withdrawal, etc.
So, what percentage of patients need medication?
According to "Clinical Outcomes and Economic Impact of ACC/AHA China Hypertension Guidelines 2017", 22.7% of patients with blood pressure of 130/80 mmHg and 140/90 mmHg require medication.
In other words, the change in diagnostic criteria may increase the drug demand of about 50 million patients.
Doesn't that seem like such a small number? However, it is also important to consider that the current high blood pressure drugs are not expensive.
The results of the 7th batch of national drug collection and selection published in July 2022 showed that the lowest winning price of nifedipine sustained release tablets was 2.1 yuan, which was only 4 cents per tablet according to the specifications of 20mg*50 tablets/bottle.
Obviously, it is not clear how much of a boost generics companies will get from the benefit of extremely low drug prices.
For innovative drugs, lower diagnostic standards may provide new room for growth. But only if a truly innovative drug has a significant advantage in efficacy or safety.
After all, it is not easy to break out of a market full of generic cabbages.
