Sovaldi-‘miracle’ hepatitis C oral drug gets official nod

Source: Dawn

November 21,2014

LAHORE: The Drug Regulatory Authority of Pakistan (DRAP) has finally fixed price of the ‘blockbuster’ oral drug – Sovaldi – after its registration in Pakistan, giving a good news to hepatitis C patients.

The decision was taken in a meeting of DRAP’s Drug Price Committee presided over by Pricing Director Mr Amanullah in Islamabad on Thursday, a senior official in the authority told Dawn.

He said the Ferozsons Laboratories is the sole company which was granted rights to sell and market this much-awaited drug in Pakistan at a price approximately Rs1,940 for each tablet. The company will make available a pack of 28 tablets for total price Rs55,000 after final approval by the federal government.

Some senior medical experts attending hepatitis C patients termed this development a major breakthrough, saying Pakistan was among a few countries where the chronic hepatitis C was alarmingly high and the patients were in dire need of this oral drug due to its surprisingly high success rate.

While highlighting the significance of the new life-saving drug, Technical Advisory Group (TAG) Member Prof Dr Ghiasun Nabi Tayab said presently approximately 10 million people in the country were living with chronic hepatitis C virus (HCV).

Of them, he said, seven million were in dire need of the new oral drug due to its above 80 per cent cure rate and almost ‘no side effects’ compared to the below 45 per cent success rate of the interferon injection therapy.

“Unfortunately, more than 280,000 new HCV patients were adding annually in Pakistan which was much disturbing for health mangers”, said Prof Tayab, who is also heading medicine department at Postgraduate Medical Institute (PGMI) in Lahore.

He said HCV infected patients were at risk of developing complications such as cirrhosis, hepatic encephalopathy, variceal bleed, hepatocellular carcinoma or liver related death.

On the other hand, unfortunately the liver transplant facility was also available only in one public sector health institute in Pakistan which was frustrating for the patients and their families.

About the Thursday’s development, the DRAP official said the American pharmaceutical company, Gilead Science, had produced this miracle drug in oral form last year for the treatment of chronic hepatitis C. The drug Sovaldi is available in the US market for $1000 for each tablet for the patients belonging to the elite class only.

It was later introduced in the international market and because of tremendously high demand of the oral drug, the company announced that the drug would be made available in the low-income countries on discounted price.

He said the DRAP, however, took one year to register and price it, ignoring the dire need the patients suffering because of the inordinate delay.

Earlier, the official said, the Gilead Science and the Ferozesons Laboratories had signed an agreement, under which the former would provide Sovaldi at a significant discount (98 % less than the US price) which was being termed a remarkable development for local patients.

The US company had recently finalised an accord with the Egypt, making available a tablet for approximately Rs8000 (in Pakistani currency) in the African country, which was much higher as compare to that for Pakistan. The hepatitis burden is enormously high in Egypt after Pakistan.

Before this development, the Sovaldi was being provided on the basis of the patient-to-patient strategy. As the doctors all over the country have started recommending the oral drug, the DRAP has been receiving requests from the patients for permission to import the same from the US.

The process of DRAP permission for the drug import to patients was taking minimum two months period. Presently, more than 3,000 patients’ applications from all over the country were pending with DRAP for permission to import the drug, the official said.

To a question, he said the new drug would be available in the local market shortly as the DRAP was going to move the case to the federal government within a week.

This entry was posted in Hepatitis C, Pricing, Sofosbuvir. Bookmark the permalink.

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