Doctors must act for the benefit of the patient and at the same time economically. The high prices of new HCV drugs, approved in 2014 for the treatment of chronic hepatitis Cmake this task a balancing act. Christina Laußmann has with Dr Patrick Ingiliz from the Medical Infectiology Centre Berlin.
Dr Ingiliz, Sovaldi, Daklinza, Olysio and - brand new! - Harvoni are very effective and enormously expensive drugs that were approved for the treatment of chronic hepatitis C in 2014. A good year for HCV patients?
Definitely! Regardless of all the problems we see due to the high prices, the new drugs mean a complete reorganisation in the hepatitis C area. Both the chances of cure and tolerability have improved enormously. We can treat and cure many more people - and for the first time without interferon.
Sovaldi (sofosbuvir) has been on the market in Germany since January of this year. How many of your patients have already benefited from the new drug benefited?
Since authorisation, we have already treated around a hundred patients with sofosbuvir-containing therapies. However, we have many hundreds of hepatitis C patients in our practice, so those who have received treatment so far still make up a small proportion.
Uncertainty is everywhere.
We keep hearing that doctors don't want to prescribe the new drugs because they are afraid of recourse claims from health insurance companies. How do you experience this?
There is uncertainty everywhere. The new therapies are many times more expensive than the previous standard therapy. Depending on which variant is chosen, costs of between 60,000 and 200,000 euros are incurred. If a doctor is then subject to a performance audit, their very existence is threatened.
What do you have to bear in mind as a doctor in this situation?
As a doctor, I am required to act economically. I should select therapies whose efficacy has been proven by study data, but which remain within a reasonable economic framework. This is difficult in individual cases because I would then have to carry out a cost-effectiveness analysis for each patient. So I'm suddenly faced with the task of deciding in the consulting room whether the therapy is justified at the time or whether the patient can wait. That's why prices are having a huge impact on patient care at the moment.
What is the current situation in your practice? You said that many of your patients are not yet undergoing treatment.
We have started to prioritise patients. We try to treat the sicker ones first, i.e. patients with severe liver damage such as cirrhosis, and we prioritise those in whom the disease progresses more quickly.
Doesn't that lead to great frustration for many of your patients?
Nobody has to leave the practice angry, so far we have been able to create a good timetable for every patient. There are also good reasons to wait. The medication is still new to everyone. We have already seen drugs where side effects only appeared years later. If there is no liver damage yet, there is no need to treat immediately. Hepatitis C is a disease that can be treated.
Dr Patrick Ingiliz Is it not true that the sooner treatment is provided, the better?
This is not true insofar as there is a not inconsiderable proportion of people who do not become ill at all despite an HCV infection or in whom the disease takes a mild course. Many factors play a role in hepatitis C: Concomitant diseases, lifestyle, genetics as well as factors about the virus that cause one person to get sick and another not. I have to identify those in whom the disease but progresses, and then find out which patient needs urgent treatment.
In order to control the costs, some countries have stipulated that treatment with the new, expensive drugs is only permitted from fibrosis grade 3. What does fibrosis grade 3 mean for the patient?
From a fibrosis grade of 2, someone is at risk of developing liver damage one day. From a fibrosis grade of 4, you have cirrhosis of the liver; the patient is ill and must be treated. With a three, you are on the threshold of a four, which means that a process is taking place in the entire liver in which vital liver tissue is being remodelled into scar tissue. In other words, the liver is definitely damaged, although it can still retain its full function.
The eight-week therapy currently costs 60,000 dollars
Can you imagine such rationing being introduced in Germany and what do you think of it?
I wouldn't assume that something like this would happen. It's never happened before in Germany.
The combined pill Harvoni, consisting of the two active ingredients sofosbuvir and ledipasvir, has just been authorised in Europe. Will doctors prescribe it?
I assume that once Harvoni has been approved, the discussion about prioritisation will be somewhat relativised. With this drug, we can cure chronic hepatitis C with just one tablet a day over a period of just eight to twelve weeks, completely dispensing with interferon and usually also ribavirin. In the USA, where Harvoni has been approved since October, the eight-week therapy currently costs 60,000 dollars, which would be 40,000 euros. This is even slightly less than the classic standard therapy with telaprevir plus interferon and ribavirin. I assume that the wait is over for many people and that most colleagues will start treatment.
What would a cost comparison look like, considering that the consequences of a hepatitis C infection can also be quite expensive?
We now suddenly have extremely effective therapies at our disposal. As a result, we want to treat many more patients and many more patients want to be treated. This will inevitably lead to an extreme increase in costs. But we will also free many, many more people from the disease. Many liver transplants, which can cost several hundred thousand euros, will no longer have to be carried out. Or think of the treatment of liver cancer! So you can imagine the savings that can be made in the healthcare system thanks to the new HCV drugs.
Deterrent side effects of interferon therapy
How many of your patients have been put off by the side effects of interferon therapy?
It depends a bit on which groups you look at. We have treated over 80 per cent of HIV- and HCV-coinfected homosexual men with interferon-based therapy - but in some cases with very significant side effects. In contrast, not even 10 per cent of drug users in Germany have been treated with interferon. Either because they refuse it themselves or because the doctors refuse it. I think it's fair to say that no patient wants to undergo interferon therapy - and neither does any doctor. I don't really want to treat anyone with interferon any more.
What final advice can you give hepatitis C patients?
Even though treatment is now becoming easier and easier, liver diseases require specialised care. I would therefore go to specialised centres because they have the necessary resources and equipment to determine the degree of fibrosis, for example. Under such conditions, doctors can categorise their patients properly and make a Good strategy for treatment set.
Thank you very much for the interview!
More about Hepatitis C on I KNOW WHAT I AM DOING.
