Letairis –worth $50,000/year?

A new drug for pulmonary arterial hypertension (PAH) Letairis has been released. In PAH small arteries in the lungs narrow and the pressure of blood in the vessels increase and the right side of the heart works harder to pump the blood. The result is enlargement and then weakening of the right sided heart muscle. There is also thickening and loss of efficiency of oxygen exchange in the pulmonary blood vessels. Patients become short of breath, tired, have chest pain, dizziness and often have syncopal episodes. About 100,000 people in the United States have pulmonary arterial hypertension.

Letairis is an ERA, or endothelin receptor antagonists. The drug relaxes the vessels, lowers blood pressure and lightens the load on the heart and lungs.

Gilead the manufacturer notes:

“In two randomized, double-blind, 12-week, placebo-controlled Phase III clinical trials (ARIES-1 and ARIES-2) involving a total of 393 patients, treatment with Letairis resulted in a significant improvement in six-minute walk distance. An increase in walk distance was observed after four weeks of treatment with each dose regimen of Letairis, with a dose-response observed after 12 weeks of treatment. In ARIES-1, placebo-adjusted mean and median changes from baseline of 31 meters and 27 meters (p=0.008), respectively, were observed for the 5 mg dose. Placebo-adjusted mean and median changes from baseline of 51 meters and 39 meters (p less than 0.001), respectively, were observed for the 10 mg dose. In ARIES-2, placebo-adjusted mean and median changes from baseline of 59 meters and 45 meters (p less than 0.001), respectively, were observed for the 5 mg dose.” (Emphasis by medicynic)

“The long-term follow-up of the patients who were treated with Letairis in the two pivotal studies and the open-label extension (n=383) shows that 95 percent were still alive at one year and 94 percent were still receiving Letairis monotherapy. These uncontrolled observations do not allow comparison with a group not given Letairis and cannot be used to determine the long-term effect of Letairis.” (Emphasis by medicynic)

“Gilead is committed first and foremost to patients,” said Dr. Martin. “Our hope is that this program will ensure greater access to care for PAH patients with a variety of circumstances, including the often overlooked group of patients who have some form of prescription insurance but have prohibitively high out-of-pocket expenses.”

In the New York Times it was noted:

“Gilead said Letairis, a once-a-day pill, will cost $3,940 a month, about the same as Tracleer, which is also known as bosentan. The company said it was establishing programs to help uninsured or under-insured patients obtain the drug.”

In summary: the drug doesn’t cure the disease. Exercise improvement, depending on the dose is limited to 100 and 200 feet additional distance in a 6 minute walk. There also may be an improvement in survival but the study for this was not conclusive. The price almost $50,000/year.

It’s wonderful there is progress in this disease but the benefit is quite limited and the price exorbitant–not surprising given the Pharmaceutical Industry’s track record. The only question is when such pricing will break the bank.

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6 responses to “Letairis –worth $50,000/year?

  1. Please. The difference of 100 feet is the difference between living on your own and living in a nursing home.
    The price difference is worth it. Ask yourself, at what price would you give up your freedom?

  2. Appreciate your thoughts, but adding 100ft to the distance one walks in 6 minutes for $50,000/year? I don’t think that is a major improvement.

    In any case, my point is that drug companies gouge the sick and helpless. Pricing has little to do with the real cost of drug development–often early research is funded with tax dollars.

    We need to review our patent law and reward companies that price medications responsibly. Your might look at some of posts on patent law and drug pricing.

  3. Pulmonary Hypertension is serious, as such 50,000. for a year of extra life is worth the struggle for our family. Grandma would oppose but she will never know. The value of extra time is personal, however i hope it is available to all soon at no cost. They say there is no cure for aids, yet one would think Magic Johnson might have a magic pill. I would think the cost would be worth it to him. i am so grateful for having medications that extend life when without there would be none.

    • New drugs are marketed aggressively by drug companies (see recent Novartis behavior) for their goal is to make money for their stockholders. There are no checks and balances to the high cost. Medicare is not allowed to negotiate on price or for that matter whether it meets minimal cost/benefit requirements.

      I’m sure you are aware that the pulmonary hypertension study obfuscated whether there was a survival benefit or not. There was no conclusion that it did so. When it’s difficult to conclude whether or not a drug will increase a person’s survival it usually means there is little or no survival benefit. When drugs work well, it’s obvious. So it’s an open question whether this drug will extend life, while maybe providing some improvement in exercise tolerance, maybe.

      Regarding HIV, it’s a different type illness with numerous drugs that show survival benefit though many of those are extremely expensive as well.

  4. I am a pulmonary hypertension patient and this medication could help me discontinue an older medication with debilitating side effects. But I cannot afford it. It would cost $42,000 per year even with Medicare drug coverage. It is $96,000 if you don’t have insurance.

    Their patient assistance is a joke. If you are on Medicare and you have any reasonable income, you won’t qualify.

    • The bad joke of having a “free market” based health care system is that the market really doesn’t give a damn about health care but rather is focused on increasing it’s revenue and profit. And the market really isn’t free when the government provides patent protection that allows financial gouging. I wish I could be optimistic that there will be change but our congress is bought and paid for by the pharmaceutical industry.

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