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Hepatitis C Series: New Miracle Drug Costs and Manufacturing

////Hepatitis C Series: New Miracle Drug Costs and Manufacturing

Imagine this: you have 10 pounds at hand. Would you give it to 10 hungry and weak children to buy bread that costs 1 pound each? Or would you hand it to a middle-aged beggar who needs 10 pounds to get some antibiotics to cure his nasty bacterial infection? Some might choose the former based on the utilitarian principle (i.e. achieving the greatest good for the greatest number), whereas others might choose the latter due to the seemingly more severe nature of an infection.

Unfortunately, there is no one right answer.

In healthcare, this situation is no different, except that the hospital budget would have much more than 10 pounds and that the outcome of not allocating resources to a particular group of patients would most likely be death. Medical ethics of utilitarianism or deontology would probably be contradictory (opting for the option that maximises patients’ survival vs. the one that good doctors should make as bounded by the duty to do no harm), thus rendering one helpless in the decision-making process.

Let’s take a look at drug rationing, since medicines take up a large proportion of the healthcare budget. Last year, NHS England decided to cap the numbers of hepatitis C patients receiving the new effective treatment, so that “only the sickest get the drugs immediately.” [1] This was not well-received, evident from a charity blaming them for “‘abandoning’ thousands of people to a potential death sentence by rationing drugs that can cure hepatitis C.”[1] This accusation is certainly not an exaggeration, since this blood-borne viral infection can cause liver cirrhosis (i.e. liver scarring) if untreated and could later progress to liver failure or cancer.

With about 700,000 people dying each year because of it, researchers are frantically trying to find the miracle cure. They found it recently, or so it seems, as thesenew direct-acting antiviral drugs (DAAs) can clear the virus from the blood within 12 weeks. [2] The downside, however, is its cost – a whooping £30,000 per patient. Why are they so expensive?

Whilst the suspicion that big pharma merely wanting profit cannot be refuted, one cannot ignore other factors that contribute to the high price [3], especially the cost of drug development. Drug development is not as simple as discovering the drug and conducting experiments to look at its properties and toxicity. Scientists need to further undergo 4 phases of clinical testing, which takes about 10 to 15 years to complete:

Phase 1 – verify the safety and tolerability of the drugs in 20-100 healthy volunteers (6-9 m.o)

Phase 2 – determine the effectiveness of the drug by testing on several hundred patients (up to 2 yrs)

Phase 3 – expanded testing on more patients to look at adverse reactions (1-4 yrs)

Phase 4 – usually done after the drugs is shown to work and is given a licence to distribute to investigate long-term effectiveness and side effects

(To know more, you could refer to https://www.fda.gov/ForPatients/Approvals/Drugs/ucm405622.htm and http://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/what-clinical-trials-are/phases-of-clinical-trials)

Due to the lofty sum of money that went into the development process, companies usually buy a patent that grants them the right to be the only company producing the drug and receiving the profits, thus allowing them to recover the costs. In the UK, the standard patent usually lasts for 20 years [4]. This may seem like a long period of time, but, in fact, the 20-year duration starts once the drugs are being tested in clinical trials. So what the companies get in reality is only 5 years to make money out of their drug, which explains the need to raise the price as much as they want whilst there is no competition.

With all this being said, it still begs the question: is there really the need to raise the hep C drug to £30k per patient?

Reference:

[1]https://www.theguardian.com/society/2016/jul/28/nhs-abandoning-thousands-by-rationing-hepatitis-c-drugs

[2]https://www.theguardian.com/society/2017/jun/08/miracle-hepatitis-c-drugs-costing-30k-per-patient-may-have-no-clinical-effect

[3]http://www.businessinsider.com/ap-multiple-factors-cause-high-prescription-drug-prices-in-us-2015-9

[4] http://www.nhs.uk/Conditions/Medicinesinfo/Pages/Brandnamesandgenerics.aspx

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2019-08-15T16:22:42+00:00Medicine In The News|Comments Off on Hepatitis C Series: New Miracle Drug Costs and Manufacturing

About the Author:

I'm a medical student at Cambridge University, and one of the co-founders of 6med. I created the BMAT Crash Course and Interview Crash Course, and helped code BMAT Ninja and UKCAT Ninja. If you need a hand with anything, feel free to give me a shout!