Saturday, July 19, 2014

India Just Did What Millions of Americans Wish the U.S. Government Would Do

India Just Did What Millions of Americans Wish the U.S. Government Would Do

Source:, Flickr.
India lays down the law on drugmakers
Just last week India announced in a surprise decision from the National Pharmaceutical Pricing Authority, or NPPA, that it would be capping the price of 108 different drugs ranging from diabetes treatments to HIV therapies in order to make access to these drugs more affordable for Indian citizens. This decision follows a move last year in which India initiated price controls on more than 30% of existing medicines within the country, once again in an effort to ensure that its citizens have access to these much needed drugs.

Think about what a price cap would mean in the United States. Right now there's a huge debate over the price being charged for Gilead Sciences (NASDAQ: GILD  ) revolutionary oral hepatitis C treatment, Sovaldi, which runs roughly $1,000 per day. A standard 12-week treatment is therefore going to cost the patient and insurance company a whopping $84,000.

On one hand Gilead could be viewed as justified in its superior pricing given that Sovaldi can be offered to select genotypes without the need for interferon, thus dramatically reducing the side effects associated with treatment. More importantly, Sovaldi's success rate of eliminating detectable levels of the disease after 12-weeks ranged 90% and higher in its multiple clinical studies. Yet, this is a price that's far too high for most uninsured Americans to pay and is even causing insurers to grimace in pain. Gilead has also taken substantial heat from Congress over the pricing of its drug, to the point where it's even possible that insurers could begin denying coverage to members simply because of Sovaldi's high cost. If price caps were in place within the U.S. this wouldn't even be a discussion.

The French Government Must Issue a Compulsory License for Sofosbuvir & Seek the Usage of Generics to Treat Hepatitis C

act up basel[ACT-UP Basel Press Release, Link] Act Up-Basel called the French government to learn from the current situation regarding access to new direct-acting antivirals (DAAs) molecules used in the treatment of hepatitis C (HCV), to exercise Article L613 -16 of the Code of Industrial Property on the transmission and loss of patent holder rights to issue a compulsory license [i] and make available generic versions of sofosbuvir.

Since Sofosbuvir was licensed for sell on the European market, hepatitis experts and organizations working on HCV in France are quite certain : According to their computation, access to HCV new treatments in France will only be possible through an out-of-reach spending from the national health insurance. To treat 55% of people infected with chronic HCV in France (133,000 patients, with an advanced stage of infection – stage 2-4 fibrosis or “F2″ to “F4″), the national health insurance must pay the equivalent of the annual budget of all Parisian hospitals and health centres (Assistance Public – Hôpitaux de Paris – AP-HP) for the purchase of sofosbuvir (SOF) alone [ii] or € 7 billion. To cover the cost of the triple therapy with peg-interferon (PEG-IFN) and ribavirin (RBV) for genotype 1 (Western Europe’s most common genotype) and then, in the near future, another DAA, the price of a two-or triple therapy will be even higher. With a new DAA such as datasclavir (BMS-052), it would cost between €100,000 and 150,000 per person for a 12 week treatment, while the production cost of sofosbuvir and datasclavir combined is estimated between €57 and €122. The profit reached by Gilead Sciences, the pharmaceutical corporation marketing Sovaldi (followed by Bristol Myers Squibb for datasclavir very soon) is huge. It exceeds the margins of all other industries by far, including luxury industry. For example, Sovaldi currently marketed in the United States has already helped Gilead to rake approximately $2.3 billion in a quarter [iii].

A pill that costs €2.5 to produce, sold €650: the pharmaceutical industry is the most “profitable” for all industries.


Riled by $84,000 Sovaldi, Senate panel digs into Gilead's Pharmasset buy

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