On Monday, Altaf Khan lay on a bed in the basement of a private hospital in Mumbai, with an intravenous drip strapped to his arm. Two days ago, the 47-year-old businessman had tested positive for Covid-19. His oxygen saturation level was stable and he had only fever, body pain and a headache – classic symptoms associated with Omicron, the new variant of the coronavirus that is driving the third wave of the pandemic in the city.

Normally, such mild symptoms resolve on their own in a few days. But Khan decided not to take any chances.

“A lot of people I know got the monoclonal antibody cocktail during the second wave,” he said, referring to an infusion of synthesised antibodies designed to mimic the immune system’s response and help the body fight off the virus. “I didn’t want to risk getting severe [infection] or hospitalised, so I decided to get the cocktail too.”

The private hospital did not dissuade Khan. On the contrary, doctors reinforced his decision by pointing out that as a diabetes patient, he fell in a high-risk group.

The hospital charged him Rs 75,000 for an infusion of casirivimab and imdevimab, sold under the brand name of Regen-Cov. It completely ignored the fact that Regeneron, the company that manufactures Regen-Cov, had conceded in a statement on December 16 that the cocktail drug had “diminished potency” against Omicron – a statement that led to a fall in the market value of its stocks.

A high profit margin

As Scroll.in had earlier reported, with a surge in Covid-19 cases, private hospitals in Mumbai are seeing a rise in admissions for the monoclonal antibody treatment, despite many patients not needing it.

Private hospitals claim they are administering the drug cocktail because patients demand it. But this underplays commercial considerations: private hospitals are making large, easy profits on the treatment, which pharmaceutical company Cipla that has marketing rights to the cocktail continues to promote despite Regeneron’s statement.

Private hospitals pay between Rs 98,000 and Rs 1.06 lakh for a 120 mg vial containing two doses of the antibody cocktail, according to distributors and pharmacists. The cost comes down further when hospitals make bulk purchases directly from the manufacturer.

A single dose costs the hospitals a maximum of Rs 53,000. But it is sold to the patient for at least Rs 60,000-Rs 65,000, information gathered by Scroll.in from six hospitals in Mumbai revealed. With the hospitals also slapping additional charges for intravenously administering the cocktail in a three-hour long procedure in outpatient departments, patients are billed at least Rs 75,000-Rs 80,000.

Major private hospitals in the city are administering the drug cocktail to 20-30 people every day. This means a hospital stands to earn a profit of over Rs 1 crore a month on the back of a therapy proven to be ineffective against Omicron, calculations by Scroll.in show.

More significantly, the profit margin per patient ranges between 15%-25%, well above the 10% limit set by the Maharashtra government on drugs used for Covid-19 patients in the 80% beds reserved at private hospitals.

“The profit margin per patient is slim, but if you look at the hundreds of people opting for the antibody cocktail, the profits are huge in absolute numbers,” explained a drug distributor in Mumbai.

The earnings increase further when patients opt for hospital admission in order to access their insurance cover. Several doctors told Scroll.in they admit such patients for 24 hours. Charges for one-day hospitalisation range from Rs 1 lakh to 1.75 lakh, depending on the bed and room opted for. This includes the cost of the drug, doctor’s consultation, disposables and nursing care. Several doctors admitted that their hospitals have fixed packages for administering the monoclonal antibody cocktail.

Outside Mumbai, the cost can even go higher. When 75-year-old Mahadev Waibase contracted Covid-19 in Ambajogai in Beed district in December, his son Anant Waibase paid Rs 1.19 lakh for a 120 mg vial of Regen-Cov. His father passed away five days after he was administered the treatment. One vial can be used for two patients. But Waibase does not know what the hospital did with the remaining content of the vial.

“It is unethical in the way it is done,” said Maharashtra additional chief secretary Dr Pradeep Vyas. The Maharashtra government plans to introduce strict criteria on the use of the cocktail for a specific group of patients, said Dr Sudhakar Shinde, who drafted the previous price cap notifications on treatment for Covid-19 in the state.

Diminished effect against Omicron

India’s Central Drugs Standards Control Organisation has approved two antibody cocktail drugs: Regeneron’s Regen-Cov, which is a combination of casirivimab and imdevimab, and Eli Lilly’s combination of bamlanivimab and etesevimab. Regen-Cov is widely available in India with Roche, Regeneron’s partner, giving Cipla the marketing authorisation to supply the drug.

There is some evidence that the drug cocktail provides protection against previous variants of the coronavirus – Delta, Gamma, Beta and Alpha. But several studies have found that most drug cocktails, barring sotrovimab and DXP-604, have a diminished effect against Omicron, which was first reported as a “variant of concern” by the World Health Organisation on November 26.

The National Institute of Health in the United States updated its treatment guidelines on December 30, 2021, recommending the monoclonal antibody sotrovimab based on evidence that it is effective against Omicron. The updated guidelines do not mention casirivimab and imdevimab, or bamlanivimab and etesevimab, which are currently in use in India. The National Health Service in the United Kingdom too recommends sotrovimab. But this drug is not available in India.

Dr Sanjay Nagral, a surgeon in Mumbai, attributed the continuing use of ineffective antibody treatments in India to “a cocktail of fear, evidence that it cut short the attack in Delta and lax regulation”. He said such drugs “are used selectively in other countries with organised healthcare systems”.

Pharma push

While the drug cocktail is in high demand by patients, there is also a considerable pharmaceutical push behind publicising it.

Thirteen days after Regeneron issued the statement on the diminished effectiveness of Regen-Cov against Omicron, on December 29, Indian pharmaceutical giant Cipla organised a webinar for doctors. The webinar featured a session on the benefits of the monoclonal antibody cocktail in treating patients during the current surge in cases.

A senior doctor from a private hospital in Mumbai said that despite being aware of the reduced effectiveness of Regen-Cov, Cipla continues to push for the cocktail as a “game changer”.

Another physician said such webinars influence a large section of doctors. He gave the example of a junior doctor working with him, who took the monoclonal antibody cocktail treatment after he tested positive for Covid-19, “even though he didn’t require it”. “He said he saw the same webinar and got influenced,” the doctor said.

Scroll.in contacted Cipla to ask why a webinar advertising the antibody cocktail was held when Regeneron itself had conceded that Regen-Cov had lower potency against Omicron, and sequencing data had shown a significant presence of the new variant in India.

Dr Jaideep Gogtay, chief medical officer at Cipla, said the webinar discussed all available products for treating Covid-19. “It is important to clarify the role of all treatment options,” he said.

He added that it was difficult to identify if the Omicron variant was behind the surge in cases in India. “There is data to show that both variants, Omicron and Delta, were circulating in December. There were a lot of social events which may also be responsible for the rise in cases,” he said.

Data on sequencing, however, gives a clear indication of the growing presence of Omicron. Delhi’s latest genome sequencing data found the presence of Omicron in more than 50% of the samples. In Mumbai, Omicron was detected in 55% of samples sequenced.

Despite this, Regen-Cov’s sales continue to rise. “We have seen a more than doubling of demand in the first week of January 2022 compared to a month back,” said a spokesperson of Roche, Regeneron’s partner​​. “The demand is primarily coming from the markets where we are seeing a surge in cases, and from those set of high risk patients who stand to benefit clinically the most.”

Selective use

Among doctors in India, opinion on the use of the available antibody treatments is divided.

Pulmonologist Dr Lancelot Pinto said the government must place restrictions on the use of the cocktail. “In India, if a drug has no side effects, patients think what is the harm in using it,” he said. “If they can get it easily, they are okay paying out of their pocket for it.”

Dr NK Ganguly, former director-general of the Indian Council of Medical Research and a member of the national committee to monitor the drug stockpile, said the antibody cocktail must be used for a select group of senior citizens only. “Monoclonal antibody is partially effective against the current variant, but not in every patient,” said Ganguly, adding that a few manufacturers were working to make an antibody cocktail that would be effective against Omicron.

It is not that the antibody cocktail is completely ineffective, said Dr Avinash Supe, medical director at Khar’s Hinduja Hospital. “In a sub-group of patients, who are elderly, have co-morbidities and are at risk of progressing into severe infection, monoclonal antibody cocktail works,” he said.

“We don’t know which patient has the Omicron or the Delta variant,” he added. “Based on the clinical presentation, a doctor has to take a call.”

Supe meant that if patients show symptoms such as body ache, upper respiratory tract involvement and cough and cold, they are likely to be infected with Omicron and the drug cocktail must be avoided. “But if a patient has lung involvement and high D-Dimer value [indicating blood clots], then they may have the Delta variant and will benefit from the cocktail if they fit the age and co-morbidity criteria,” Supe said.

On the ground, several patients said no such assessment is made when they request the drug cocktail. A 40-year-old media professional, who had no symptoms, was charged Rs 1.75 lakh for a two-day stay at a private hospital in Mumbai. He said his general physician advised the cocktail and the hospital readily administered it.

A doctor at an outpatient department in another private hospital said the drug cocktail is provided to any Covid-19 patient who asks for it. “We only require an RT-PCR positive report, Aadhaar card and PAN card,” the doctor said.

According to a consulting doctor, hospitals fear refusing a particular drug because if a patient’s health deteriorates, the family will blame the hospital. “More than anything, it is the easy money and no adverse event of the drug that is encouraging rampant use by hospitals,” the senior chest doctor said.

(Courtesy: Scroll.in.)