Heart failure management to go cheaper in the country with important drugs losing their patents in January 2023. The drug combination of sacubitril plus valsartan, which is an accepted combination for heart failure, is losing patent.
In India there are estimated 10 million heart failure patients available which require standard care. The combination is to be used in place of an angiotensin-converting enzyme (ACE) inhibitor or angiotensin II receptor blocker and conjunction with other standard heart-failure treatments (beta-blocker, aldosterone antagonist). Patients must be able to tolerate ACEI or ARB before starting on sacubitril and valsartan.
The combination consists of the neprilysin inhibitor sacubitril and the angiotensin receptor blocker valsartan. The combination is sometimes described as an angiotensin receptor-neprilysin inhibitor (ARNi). It is recommended for use as a replacement for an ACE inhibitor or an angiotensin receptor blocker in people with heart failure with reduced ejection fraction.
This combination has got strong scientific data on heart failure over and above the ACE Inhibitors. It also got better mortality and morbidity rates and almost 20% reduction in hospitalization and it has brought a better quality of life and faster Improvement in symptoms. It has stronger scope to replace ACE inhibitors and ARBs in heart failure treatment.
The combination is patented by Novartis and sold under the brand name, Vymada. Novartis has also licensed certain companies like Lupin, Cipla, Mankind etc to market the combination in India. And After patent expiry, 40 more companies are expected to enter in the market, which ultimately lead to 50-75 percent price reduction.
Rightnow the pricing is 80-160 Rs per tablet and dosage is BD for duration of three to six months. It means, the total costs for complete therapy is around 2400-4800 Rs a month. But after the patent is lost, it will decline to almost 1/3. Ultimately, this medicine will be available for a bigger population. Sacubitril/Valsartan is the first superior medicine above ACE Inhibitors.
As per MAT Nov 2022 IPM Performance by AWACS, ACE inhibitors have a market of around 600 crore and Sacubitril/Valsartan market is around Rs. 435 crores. It is expected the market of Sacubitril/Valsartan will grow more.