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Senators Should Look to Importation from Canada on Lomustine Price Inquiry

Earlier this week, three U.S. senators sent a letter to the CEO of Tri-Source Pharma, LLC, inquiring about the 1400% drug price spike of cancer pill Lomustine 100mg. Tri-Source owns NextSource Biotechnology, LLC, which markets the drug. Congress wants answers! How could a drug that cost $50/pill in 2013 now cost $768/pill? The answer can be found in a 2013 press release from NextSource Biotechnology: consolidating, rebranding and launching matured and orphaned drugs.

Keep in mind, we’re talking about a drug that was patented in 1976 and first approved by FDA in 1982. The drug had lost its patent protection.

Authored by Senators Susan Collins (R-ME), Claire McCaskill (D-MO) and Catherine Cortez Masto (R-NV), the letter asks for sales, expenses, profits, communications, projections, etc. related to the drug Lomustine. That’s all very interesting information and you can read the letter yourself. But I wrote about Lomustine’s price history back in December to point out, among other things, that Lomustine 100mg was (and is) available in Canada and for sale online, for a discount of 97%: $25 per pill compared to $768/pill. Check it out: Lomustine 100mg prices.

At a maximum, if knowing that patients can obtain Lomustine in Canada helps them stay alive then that’s awesome.

At a minimum, this pricing information shows how utterly stupid the price is here in America.

My earlier reporting may also help the senators uncover market manipulation by the very drug companies that are involved. The FDA-approved Lomustine, which is the generic name, that is so expensive here is branded (or better said “rebranded”) as Gleostine. The Health Canada-approved Lomustine is called CeeNu. Until 2013, the lower-cost CeeNu was available in the U.S. by Bristol-Myers Squibb for $50/pill; still twice the Canadian price, but a far cry from $768.

From that 2013 press release by NextSource Biotechnology, we learn that the company’s scheme was to have exclusive distribution of a re-branded and launched drug. When Bristol-Myers Squibb decided to stop making the drug in 2012, the FDA added it to a list of drug shortages in 2013. At the time, compounding pharmacies were making the drug. Those compounded versions are not FDA-approved but are often tolerated when there are shortages. In 2014, the compounding pharmacies were sternly warned by NextSource Biotechnology that they better cut it out because, now that there was an FDA-approved version in town, those compounded versions weren’t welcome anymore and are against FDA regulations.

But, at that time, CeeNu—the exact same product sold in the U.S. until 2013—was being marketed and sold in Canada at a much lower list price by Bristol-Myers Squibb. Unlike the compounded versions, CeeNu was approved by the FDA, meaning there couldn’t possibly be safety differences between the Canadian and U.S. drug. Moreover, both CeeNu and the re-branded Gleostine were made in the exact same plant in Italy by the same manufacturing company, Corden Pharma.

The question I’m left wondering about is whether it’s illegal or not to import CeeNu from Canada. After all, it was an FDA-approved drug and it’s made in the same plant as Gleostine. A label could be attached to meet FDA requirements. There’s no prohibition against importing FDA-approved drugs, people!

Look to Canada for Lomustine.

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Never-ending Gleevec Drug Price Increases Are Prime Example of Market Failure and Greed

Gleevec 400 mg tablets

Gleevec 400 mg tablets.  photo adapted from [CC BY-SA 3.0], Patrick Pelletier via Wikimedia Commons

An article in the Washington Post yesterday covered the steep rise in the cost of a cancer medication called Gleevec, drug company Novartis’ brand name for imatinib, which is incredibly successful in treating people with chronic myeloid leukemia (CML). Despite its concern with public perception over price at the time, Novartis charged $26,400/year when the drug hit the market in 2001. With today’s price for Gleevec now $126,000/year it seems any concerns by Novartis have gone by the wayside (or did they really exist at all?). One would think and hope that new, similar products would bring down – or at least slow increases of – the price of Gleevec. After all, competition is supposed to drive down prices.

Not in the pharmaceutical industry, at least not until a drug goes off patent. The launch of therapeutically equivalent brand medications to treat CML actually coincided with Gleevec’s steepest price increases. Bristol-Myers Squibb launched Sprycel (dasatinib) in 2006 and Novartis launched a second generation drug called Tasinga (nilotinib) in 2007, both at much higher prices than Gleevec. In 2007, the monthly prices for Gleevec, Sprycel and Tasinga were $3,757, $5,477 and $6,929, respectively. The details can be found in the Post’s article but essentially Gleevec started to play “catch up” to its competitors.

In 2007, the price of Gleevec was 46% less than Tasinga. By 2014, the discount had shrunk to 12% with Gleevec’s price at $8,156/month compared to Tasinga’s price of $9,300/month. Let’s keep in mind that the newer drugs were shown to treat people that Gleevec could not treat, which would soften the argument that these are truly competing products. But soon after their introduction, Sprycel and Tasinga were found to successfully treat people with newly diagnosed cases of CML, to more directly compete with Gleevec, yet the latter’s price soared!

Source: Graph below from the Washington Post.

Graph - increase in Gleevec Rising drug prices New drugs treating chronic myeloid leukemia were introduced at prices higher than Gleevec's. their prices have gradually risen since, and Gleevec's price has increased at a greater clip.

One source cited in the post’s article summed it up perfectly. A hematologist from the University of Chicago, Richard Larson, stated: “Ordinarily, you might think with three equally effective drugs on the market, the price should go down through competition, but it’s been a failure of the competitive pricing process.”

While the Washington Post’s article delved into the problem of out of pocket costs for Gleevec, it didn’t hammer home that the suffering in America is extreme when it comes to Gleevec’s drug price (and other medication prices as well). Gleevec is not a new topic on these blog pages, which has solicited comments from people and families crushed by drug costs. Yes, the irony is glaring: cancer medications that alleviate suffering also create suffering, too, in the form of cancer patients facing bankruptcy, feeling guilt, and causing anxiety.

It’s not just market failure – it is greed, too. I’ll let one American, Penny Kincaid, a commenter on this blog, bring it home:

“I guess I am luckier than many on Gleevec. I am paying 5% of the cost each month but the cost keeps going up. Our lives depend on this drug but still the cost is obscene. They praise themselves for creating [these] drugs for patients with [CML] but still we are forced to pay and many go broke. It is the cancer patient who has to pay up or die and they keep raising the cost. This is just wrong in so many ways and here we have the creators wanting to deny us the generic because they want that big money to keep rolling in. They should be ashamed of themselves.”

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Cancer Drug Prices Can Kill

Americans with cancer are two times as likely to go bankrupt than other Americans due to the expense of treatment, including astronomical prices for prescription drugs. As reported by ABC News the alternative to bankruptcy is sometimes death.

This blog’s focus is often on international online pharmacies as a lifeline for high drug prices in the U.S. When it comes to cancer medications, online pharmacies are not always a solution since many can only be administered in a clinical setting are not suitable for mail-order pharmacy. However, some cancer meds are suitable for mail order pharmacy, and can be found for much cheaper prices from an international online pharmacy as opposed to a U.S. pharmacy.

Bristol Myers Squibb’s product Sprycel, which treats leukemia, costs $11,000 (60 pills, 50 mg) at a CVS in New York City pharmacy. The same quantity is available from a PharmacyChecker.com approved pharmacy for $5,509, or 50% cheaper. That’s $60,000 savings a year, a discount higher than the median household income in the U.S., and for some the difference between life and death.

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