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Tocilizumab for severe Covid patients: Shortage continues while new stocks expected in Sept.   

21 Aug 2021

  • Shortage in pvt. hospitals, available in govt. hospitals: State Ministry 
  • Health authorities open emergency tender to import 1,000 vials 
  • MSD awaiting stock of 6,000 vials ordered by SPC in April  
  • A few available vials sold at black market prices of around Rs. 500,000 
  • Local importer says price of 400 mg/20 ml vial was Rs. 113,000 
By Maheesha Mudugamuwa  The State Ministry of Production, Supply, and Regulation of Pharmaceuticals is under heavy pressure from private hospitals in Colombo, where VIP Covid-19 patients are being treated, to issue the drug that has already been allocated for government hospitals, to private hospitals, The Sunday Morning learnt.  The pressure, however, is said to be mounting on the Ministry following a severe shortage reported, especially in the privately owned hospitals where Covid-19 patients are being treated.   As at the end of last week, the Ministry had released nearly 10 such vials to private hospitals on the request of a senior government minister, it is learnt.    Tocilizumab, sold by Roche as Actemra and RoActemra, is a type of biologic medication that has been recommended by the World Health Organisation (WHO) in June, as a treatment for patients severely ill from Covid-19.   As per the WHO, Tocilizumab can play a key role in decreasing mortality and reducing the need for invasive mechanical ventilation among severely ill patients, when delivered alongside oxygen and corticosteroids.   Also, it is reported that the drug has shown promise in clinical trials in treating Covid-19, and was approved by US health regulators in June for emergency use on hospitalised Covid-19 patients who needed oxygen, as a large trial in February showed that tocilizumab cut the risk of death among patients hospitalised with severe Covid-19, shortened recovery time, and reduced the need for mechanical ventilation.  Available in govt. hospitals Nevertheless, the drug is now said to be in short supply in Sri Lanka, especially in private hospitals, due to the drastic increase of demand during the past few weeks.  It is, however, said to be available at government hospitals.   Speaking to The Sunday Morning, State Ministry of Production, Supply, and Regulation of Pharmaceuticals Secretary Dr. R.M.S.K. Ratnayake noted that the Ministry recorded a high demand for tocilizumab from private hospitals, as several specialists engaged in Covid-19 treatment began to prescribe the medication for critically ill Covid-19 patients.   “The drug has shown a good response, but it is not specifically made for Covid-19 treatment,” he said, adding that up until the Covid-19 pandemic hit the current level, there was very little demand for tocilizumab and therefore, the quantities purchased were at a very low level.   “The demand increased suddenly, and this drug had not given 100% assurance of the recovery of severely ill Covid-19 patients but an improvement,” he stressed.  He went on to say that he had already allocated 10 vials to private hospitals while there was a certain stock available in government hospitals treating Covid-19 patients.   The Secretary, however, requested the newspaper not to reveal the number of available vials with the government hospitals, as he was worried that he might be overloaded with the requests from the private hospitals.  “We are saving the extremely costly vials for needy patients being treated at government hospitals,” he added.  Orders made According to the Ministry Secretary, they have already opened an emergency tender for 1,000 vials that would arrive in the country in early September.   In the meantime, the Ministry had given authority to purchase the available vials from the available countries after strict monitoring of the quality of the drug.   “We should be very careful when purchasing the drug from the open market, as there could be duplicates,” he added. When contacted by The Sunday Morning, the Medical Supplies Division (MSD) of the Ministry of Health noted that they were expecting an order already made by them in April through the State Pharmaceuticals Corporation (SPC) for the purchasing of 6,000 tocilizumab vials.   MSD Deputy Director General Dr. D.R.K. Herath said that stocks were not available with the MSD until the ordered vials arrived.   Tocilizumab is the second drug ever recommended by the WHO for Covid-19 treatment after it recommended dexamethasone in September 2020. Tocilizumab belongs to the class of drugs called monoclonal antibodies (mAbs) that are used in the treatment of various diseases including cancers.  In June, the US Food and Drug Administration issued an emergency use authorisation (EUA) for the drug Actemra (tocilizumab) for the treatment of hospitalised adults and paediatric patients (two years of age and older) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Actemra is not authorised for use in outpatients with Covid-19.  As per the reports, in clinical trials of hospitalised patients with Covid-19, Actemra, in addition to the routine care patients receive for treatment of Covid-19, which included corticosteroid therapy, was shown to reduce the risk of death through 28 days of follow-up and decrease the amount of time patients remained hospitalised. The risk of patients being placed on ventilators or death through 28 days of follow-up was also decreased.  Concerns over the shortage of the controversial drug were raised by Opposition Leader Sajith Premadasa in Parliament last week, when he claimed that there is a shortage of tocilizumab medication.  He told Parliament that there were many inquiries from people trying to access the medication and upon inquiry, it was revealed that there was a shortage in the market. He also urged the Government to immediately look into the issue and ensure that the medication was available for critical Covid-19 patients.  However, in his response to Premadasa in Parliament, State Minister of Production, Supply, and Regulation of Pharmaceuticals Prof. Channa Jayasumana said that there is a high demand around the world for the medicine and that only one in about 100 Covid-19 patients need it.   He assured the House that the Government has ordered more stocks of it.   Distribution Last week, the WHO and Unitaid, in a statement, warned of a global shortage of tocilizumab, and called on the company, Roche, to ensure equitable allocation of current stocks of this medicine for all countries, including low and middle-income countries and to facilitate technology transfer and knowledge and data sharing to broaden access to this important treatment.  “The ACT-A partnership Access to Covid-19 Tools (ACT) Accelerator partners are working with Roche to set up channels for distribution of tocilizumab in places where it is not yet in use, as part of their effort to support roll-out of effective new therapeutic products for Covid-19,” the WHO stated.    In addition, the WHO has issued a call for expressions of interest to its prequalification programme to expand the number of quality-assured manufacturers of the drug and thus to increase global supplies.  In the meantime, Roche has stated that the global shortage is expected to last “for at least the next several weeks”.  As per the statistics of National Medicines Regulatory Authority (NMRA), the drug had been registered in 2011 under the application no NCE 17961 under the brand name of Actremra, manufactured by Chugai Pharma Manufacturing Co. Ltd., Japan.   Meanwhile, various social media reports claimed that this drug has also been sold to certain Covid-19 patients who need it in Sri Lanka at a cost between Rs. 400,000 and Rs. 500,000.   However, when The Sunday Morning checked with A. Baur & Co. (Pvt.) Ltd., the sole importer of tocilizumab to Sri Lanka, it confirmed that the drug is now out of stock and new stocks are expected only in September.   When queried about the prices, the agent of the Baur Pharmaceutical outlet confirmed that the price of the previously imported 400 mg/20 ml vial was Rs. 113,000, but didn’t confirm the price of the stocks to arrive in September. 


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