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Friday, July 27, 2018

Dang. Just have to rant about some really expensive drugs: Lucemyra, Trelegy Ellipta and Andexxa.

The price of new drugs just seems to go up. I've stopped being excited about innovative pharmaceuticals that target various hard to treat diseases and conditions, simply because they cost so horribly much. Each of these new developments looks like a classic philosophical dilemma. Do I pull the lever that makes the trolley kill one person instead of 5 or do I save the one and allow the trolley to kill 5? Do I prescribe the new drug that potentially helps my patient but may destine a whole population to lousy health care by making the overall budget unsupportable?

When I was in residency in the 1980's medication that cost a dollar a pill was crazy expensive. Inflation doubles that plus a little more, so think $2.25 and pill in 2018 money. But today's expensive medication costs 10-20 dollars a pill. Or $1000 a pill for the drug to cure hepatitis C. Or, in the case of a now pretty commonly used drug for advanced cancer, $150,000 a year. This is real money. On the lower end, it costs as much as all of one's food. At the higher end, it is enough to live like a rich person. If we insist that everyone have access to some of these new drugs we admit that we will never be able to offer universal health care. It would eat up all of the money we have.

Here are the new, latest and greatest drugs announced in The Medical Letter of Drugs and Therapeutics, a publication published by a non-profit not aligned with any pharmaceutical companies.

1. Lofexidine (Lucemyra) for opioid withdrawal: this is a central alpha receptor agonist, similar to the drug clonidine, which has been available and successfully used for the physical symptoms associated with ceasing to take opioid drugs when one is addicted. It reduces the anxiety, sweating, irritability and diarrhea that characterize withdrawal. It costs $1738.00 for a week supply. It is no more effective than clonidine which costs $1 for a week, though it does cause less reduction in blood pressure. The drug of choice for this situation is buprenorphine which costs $23 for a week.

2. Trelegy Ellipta: inhalers for asthma have been prohibitively expensive for years. People with airway obstruction, classic asthma with wheezing, shortness of breath and cough, usually require inhaled medication to open up the small airways in the lungs and to reduce mucus and inflammation. Originally the only drug for this was epinephrine which eased breathing when injected, taken orally or inhaled, but also sped up the heart and caused the shakiness associated with adrenaline release. Newer drugs worked on the inflammatory response, reduced the cardiac side effects and were longer acting. Inhalers cost less than $20 for a month supply when I graduated from medical school. Now some of the common brand name inhalers, combinations of long acting bronchodilator and a corticosteroid for inflammation, cost $300-$400. Now Trelegy Ellipta has been introduced which costs $530.00 for a month's supply. It includes 3 drugs rather than 2, and if one were to buy those three types of drugs as individual inhalers they would cost more than that. People mostly use a drug like this every day forever, at a cost of $6360 per year. Many of these drugs are not available as a generic, but even generics can be costly. Some of the generic combination inhalers cost less than $100 a month, but different patients respond differently and some have no luck at all with certain drugs or combinations and will end up on branded products.

3. Andexxa (andexanet alpha) will rapidly reverse certain anticoagulants ("blood thinners"). A few years ago the most commonly used anticoagulant, warfarin (coumadin), got some competition. A new drug was approved that reduced clotting by a slightly different mechanism and did not require regular blood tests to monitor it. Now there are at least 3 such drugs commonly used for patients who have a high risk of blood clots. They are considerably more expensive but also a bit safer and quite a bit more convenient. Unlike warfarin, however, which can be reversed by vitamin K or fresh frozen plasma, the new anticoagulants did not have an effective reversal agent. So if a patient on one of these new blood thinners came in having injured themselves, with uncontrolled bleeding, it was very difficult to stop the bleeding. We did discover that prothrombin complex (Kcentra is the brand name) worked pretty well. The hitch was that it cost about $5000 for the usual injection. We still used it, but it definitely put a dent in pharmacy budgets in hospitals. Andexxa was specifically developed to reverse two of these newer anticoagulants, apixaban and rivaroxaban. It can be dosed low or high, depending on the dose of the anticoagulant. One high dose treatment costs...wait for it...think high...YES. $49,500.

Costs of this magnitude are hard to put in context. I have read that there are about 750,000 people on the newer anticoagulants. If one in a hundred of them had a bleeding episode in a year which was treated with Andexxa, that would be nearly 400 million dollars. 400 million dollars is enough money to buy a year's supply of a nice cheap generic blood pressure pill for 10 million people to help prevent the atrial fibrillation which eventually leads to prescription of the anticoagulant. Or enough money to pay for a week's vacation to Hawaii for 10,000 people, which is mostly irrelevant.

What makes me sad here is that these new drugs are being pushed out of the pharmaceutical pipeline and, although they have the potential to reduce misery if used for the conditions they can treat, they will bankrupt either real people or health care budgets or both. The folks who could benefit from them will perhaps achieve better health only to be crushed by debt or unable to afford health insurance.

Something could be done to fix this.

Pharmaceutical companies are motivated to create drugs whose high prices and popularity will result in profits. We can, however, fund drug development in a different way. If academic labs developed drugs through grants from the National Institutes of Health or other government agencies, their costs would not need to be made up by sky high drug prices. In fact, since the government pays the vast majority of health care costs in one way or another, the payoff for these grants for drug development would be through lower pharmacy costs and also improved health and productivity. This kind of payment would favor affordability and efficacy, not just expensive drugs that add very little incremental benefit for patients.

For now, new drugs come from pharmaceutical companies and are priced beyond what a conscientious health care system can pay. Still, these drugs will be advertised and prescribed and health care costs will go up and medical debt will destroy lives. It's really hard to get excited about this most recent batch of wonder drugs.

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