Sky High: Hep C Medication Pricing and the Indian Generic Market

People are left bankrupt, families are left homeless, and many would be scratching for loose change at the end of the ordeal. Why is Hep C medication so expensive? This has been a question for many, even doctors who want to treat patients and have accessible and affordable treatments for their patients are unable to do so due to regulatory issues. 

Most importantly overcoming patent licences and regulations of different countries has been a nightmare for many trying to gain access to affordable medication. It is a known fact that Gilead the prime manufacturers of Hep C medication has signed license agreements with more than 11 Indian generic medicine manufacturers to market generic versions for low and middle income countries. However there are too many restrictions that come into play with various regulatory authorities keeping a tight scrutiny on the availability of these medications due to its associated cost.

Existing prices by Gilead for its products in the Indian generic market range anywhere from $1200-$1900 depending on the length of the treatment. Certain genericversions of the medication are said to be higher than their manufacturing cost. A study conducted by Hill et al. in 2013 indicates that the actual costs of manufacturing these drugs is relatively low, at an estimated $101 per 12 week treatment course, and with the generic competition from the Indian market the marketed prices for these drugs are said to be lower.

It is worthwhile to give patients expensive new drugs that can cure their hepatitis C much earlier than some insurers are now willing to pay for them, according to a UC San Francisco study that models the effects of treating the disease early versus late in its development.

Researchers said they were surprised by the findings, since the drugs can cost up to $100,000 for a full course of treatment. But when they factored in the long-term medical cost of delaying treatment for hepatitis C, they found the savings, in combination with improvements in the quality of patients’ lives, were enough under current standards to justify using them even at early stages of liver fibrosis. Researchers said the drugs were therefore cost effective.

Cost effectiveness is a measure of broad social benefit that health economists use to make decisions about whether medical treatments are warranted. The researchers said the balance was tipped in favor of the drugs because the hepatitisC virus can cause so much damage. Hepatitis C is one of the leading causes of liver cancer, liver transplants and liver-related death, yet the drugs can prevent much of that with an early cure. Moreover, even if costly hepatitis C treatments are delayed, they eventually will be given to many patients once the infection causes enough damage to their livers.

About 3.2 million people have hepatitis C in the United States. The vast majority were infected by blood transfusions before testing of blood donors became available in 1992. Today, most people get infected from injecting drugs.

Left unchecked, hepatitis C causes varying degrees of liver fibrosis in a majority of those infected, and causes cirrhosis in 20 to 30 percent. This damage is classified in five stages of increasing severity, from zero to four. Using sofosbuvir-ledipasvir, which is sold as Harvoni, and is one several new drugs for hepatitis C, researchers compared the costs of treating patients at all stages of fibrosis, zero through four, with the cost of waiting until stages three or four, which is when some patients are usually treated.

They found that, at current drug prices, treating half of those who are currently infected and are aware of their status but have not yet been treated would cost about $53 billion over five years, while treating these patients only at stages three and four would cost $30 billion. Since many of those patients are likely to be given the drugs at later stages of their disease, much of this cost is likely unavoidable, even if it gets delayed. But treating people early would at least avoid the costs of treating the damage from long-term infection. Researchers estimated the lifetime health care savings from treating all stages of liver fibrosis, compared to treating just three and four, at $3.3 billion.

India has been the perfect generic market for cheap and quality drugs. All the Indian manufacturing units have a license to manufacture these drugs directly from Gilead. These drugs are also said to be of very high quality and effective on patients who have already received the generic treatment. Generic versions depends upon successfully overcoming patent barriers, demonstrating equivalence to the originator compound, and obtaining regulatory approval in a timely manner in each developing country. Each Indian pharmaceutical manufacturer follow these strict guidelines and procedures ensuring quality outputs.

India is going to be a major player in the treatment for Hep C. With Gilead's license to its companies, it has a wide geographic coverage to more than 120 low income countries.

In India, for example, the same Harvoni that costs $94,500 in the US costs only about $1000. How is this possible?

Whensofosbuvir pills were registered in the US, Gilead Sciences, the company which produces them, started to spread it's market to Europe and beyond. However, India didn't acknowledge the innovation concerning the sofosbuvir molecule (because it is a little modified version of other existing antiviral molecules) and didn't grant the originator patent right - which meant that Gilead could not market it as an original medicine and priced it well above what would be considered sensible and humane.

In order not to lose profits in huge markets such as India and China, Gilead Sciences gave licences to Indian pharmaceutical companies to create generic version of Harvoni and Sovaldi and market them to Indian population. Gilead would still get their royalties but because the manufacturing process for sofosbuvir pills is not overly expensive, the average price per sofosbuvir pill in India is about $10. In the US it is $1000. And this makes all the difference to Hepatitis C patients in desperate need of sofosbuvir to get well. This is where Soul of Healing comes into its organizational endeavors. 

Every patient should be careful while buying medication from the generic market here in India which is extensively large with many individual contractors involved. Some are pure scam and the product may not be what it is advertised to be. It may be mere gimmick to make some quick bucks.

Soul of Healing alerts and advises its prospective patients against such contractors. We through our subsidiary Sunny Pharma are in touch with Gilead licensed distributors and procure medication directly from them. We assure of its authenticity and we have already helped 1000's of patients and we hope to reach out to more as time comes.

Courtesy: Med Help, UCSF Media