TOPIC:

A romanian patient with hepatitis C has won in court the right to interferon-free treatment

www.ghidcabinet.ro/2016/10/un-pacient-cu...ent-fara-interferon/

“The Bucharest Court of Appeal published on October 4th the first decision for a patient with hepatitis C who do not qualify for free treatment without interferon, under the current protocol, to receive this treatment reimbursed by the National Health Insurance, according to the Association of Patients with liver disease in Romania (APAH-RO). According to the decision, the court obliged CNAS (National Health Insurance) to grant the applicant, based on prescription, the drugs Ombitasvirum Ritonavirum Paritaprevirum Dasabvirum , compensated 100% (without personal contribution) until final settlement. The decision will be implemented immediately by Presidential Ordinance.

The patient who has won this right in court is male, 43 years old and has 3 children. Suffering from hepatitis C, stage of disease F3 and has already gone through two courses of interferon, each time suffering relapses. The trial began in August 2016. It is the first trial of its kind to obtain treatment without interferon. So far, fewer than 5,000 Romanians patients (with stage F4 only) received free treatment without interferon, and the contract concluded by CNAS to provide treatment expires on 9 October 2016. Negotiations to continue the program and to sign a new contract have not started yet. According to statistics, Romania ranks first in Europe in terms of total number of cases of hepatitis C. The overall rate of hepatitis C screening is very low in Romania, and most patients is diagnosed in the context of analysis or hospitalization for other illnesses. Because many patients have no symptoms, get to a doctor when they are in advanced stages of the disease.”

This is the first romanian hep C patient who fought in court for his life. And won!
Hope others will come in the near future.

Thanks for posting Isaing4. A victory for one brave person that should have broader implications. I really hope this at least contributes to raising the profile of HepC in Romania and leads to better screening and treatment options.

Hi Isa,

this news made me think: What if 100 or 1000 patients would win such legal trials ? Would then the government (or parliament or whatever authority is in charge) decide to introduce the compulsory licensing for the generic drugs? .

I mean, Romania is in No.1 in Europe when talking about the number of patients (HCV + HBV) and is doing absolutely nothing in terms of legal changes, initiatives to start the mass treatment of the patients (like Egypt for instance did)....Our NHS could at least do what recently happened in New Zealand: start recommending people to get treated with generics if the NHS cannot afford the treatment, but at lest to encourage people to do something. To recommend this to the patients would cost the government 0 (ZERO) Euro!

Cheers,
RHF

I don't know how the law works in Romania but hopefully if this outcome sets a precedent, the legal battle for subsequent claimants will be shorter and easier.
Very happy for this person and anyone who manages to follow in his footsteps

Hi B.,

usually they work , however the context of HCV implies a lot of political will.
I believe that any European NHS would allow the treatment for a patient if the cost would be 1000 $ or less. This can be made possible only with generic drugs. And here the Rock-Paper-Scissors game between the NHS, Big Pharma and generic drugs starts.

BR
RHF

Of course rohcvfighter, the system does nothing (or almost nothing, only 5000 new therapies for patients with advanced disease F4) for a very obvious reason - money.

Generics in the Romanian NHS are not discussed yet. Only originals. For Viekira pak Romanian NHS has achieved a very good price 18,000 euros, less than interferon + ribavirin 30,000 euros. Financial interests are clear. The pharmaceutical industry is powerful and will not give up easily on the” hen with golden eggs”.

Fortunately more and more doctors in Romania are informed about the efficacy of generics and follow patients who have decided to heal now not in an uncertain future.

From the medical point of view the CNAS - Romanian NHS - they are covered. It offers interferon + ribavirin, if you're in the disease stage F0 to F3. They are not interested in the chance of cure 50% or that side effects can be significant.

It's great that there are generic for hep C. I'm happy for all those who chose this risky way in the beginning and now have succeeded or will succeed to get rid of this disease.

But I am also glad for those who choose the way to fight the system legally. Romanian legal system gave justice. I hope that the example of this patient to be followed by others.

Yes beaches, the important thing is that they did a legal precedent. It will be easier for those who follow.

isaing4 wrote: For Viekira pak Romanian NHS has achieved a very good price 18,000 euros,

That is a very good price. Australian Government is paying for people to get treated. Health minister was speaking very proudly of the great deal she got. Just under AUD70,000 which is a bit over USD50,000

Some people might think this is a good deal. I do not, even though I have been a beneficiary of the situation.

Hi coral,

I am happy for you that you started second treatment. Already more than a month ...
I'm sure that this time you will succeed!

I wish you all the best and good health!

Thanks so much Isa. Yes it's already a month. I have had one early blood test that looked really promising but will post when I have a more comprehensive result. I have had a few more side effects with this medication but nothing I can't cope with. Thanks again for your kind thoughts.

beaches wrote:

isaing4 wrote: For Viekira pak Romanian NHS has achieved a very good price 18,000 euros,

That is a very good price. Australian Government is paying for people to get treated. Health minister was speaking very proudly of the great deal she got. Just under AUD70,000 which is a bit over USD50,000

Some people might think this is a good deal. I do not, even though I have been a beneficiary of the situation.

The lack of price transparency on a market is quite irritating, especially when talking about people's health.
The amount of 18000 Euro indicated by Isaing is mentioned on a couple of websites, some of them are well known websites for news, while on the NHS website from Romania the price being communicated as valid from June 2016 is different (if I made the math correctly, 12 weeks of treatment would still cost ~48 000 Euro). Honestly, I hope my math is wrong and that indeed the price in RO is 18000...

For sure, the gap 18 000 - 48 000 Euro is huge, nevertheless even 18000 Euro is unrealistic for the majority of Romanian citizens.

In any case, another news is that only F3 and F4 will be treated, so those with F0-F1-F2 still need to wait or buy generics ( ).
I wonder what is now France doing?

Cheers,
RHF

The lack of price transparency on a market is quite irritating, especially when talking about people's health.

I agree. I suspect the price of just under $70,000 that beaches quotes is from the pharmacist labels on her medication which state a "Full Cost" of that amount, they will also list the price she pays which will be about $39 X 3. Other types of medicine don't seem to state a "full cost" price so I wonder what makes these ones so special? I have seen a number of different pricing models thrown around for Australia but no one from the government has confirmed any of them. I suspect we will never really know the deals that our governments are negotiating with the pharmaceutical industry. However, we do know that $1 billion has been allocated over 5 years to pay for HCV treatments so about $200m per year. The latest estimates have just been published on Australian patients treated and it is estimated that it is approx 26,300 for the period March to July 2016 so if the medication really was costing $70k per treatment Australia has spent $1.8 billion in that time and has already exceeded the five year budget by 80%! I very much doubt that and believe the real price we are paying is far lower and probably capped as many have claimed.

kirby.unsw.edu.au/sites/default/files/hi...sletter_Issue5_2.pdf

I just read a further news about this case of the Romanian patient. He is F3 and the NHS declared it does not understand the purpose of the lawsuit as F3 patients are accepted for treatment.
On the other side, I would think that the lawsuit was opened perhaps before the news from this year that NHS accepts RO F3 patients ( usually lawsuits are time consuming....).

So, if someone is not F4 nor F3, what chances exist to get treated in the near future?
And being part of the EU and expecting to have the right to health being respected implies in fact further waiting. By compare, for the generic drugs I had to wait only several days, to have it shipped to my door (and of course some couple of weeks to get documented about generics and get my prescription).
Therefore one thing someone should also consider is: which solution is more straightforward? Generics or branded?

Cheers,
RHF

A recent update: the healthcare system from Romania has just resumed ..... the negotiations for treating ~10 000 HCV patients. F3+F4 patients will be included and some of the F2 patients having certain complications. (www.agerpres.ro/sanatate/2016/12/05/cnas...-hepatita-c-15-12-16 )

10 000 patients out of >600 000, this means ~ less than 2% of the sick people will be treated in the next .... (12 months maybe?).

For sure, for those who will enter into the treatment program, this is a very good news, for the rest of ~98% which will remain outside the treatment program I would bet this is NO good news. The only good news to share is that "GENERIC HCV drugs work!".

Cheers,
RHF