European Cystic Fibrosis Awareness Week 2020 – Online Press Conference “Breath Unlimited & Medicine for All” HCFA-TEAM November 16, 2020

European Cystic Fibrosis Awareness Week 2020 – Online Press Conference “Breath Unlimited & Medicine for All”

Press Conference 15.11.2020

15-21 November 2020
European Cystic Fibrosis AwarenessWeek
“Medicine for all and unlimited breath”

Cystic Fibrosis,

is the most common inherited disease in the white race. In our country there are an estimated 500,000 carriers and about one child a week is born with Cystic Fibrosis. It is a multi-systemic disease that is life-threatening and affects the function of many organs, and until recently had a low life expectancy. Now more and more new drugs are becoming available increasing the life expectancy and quality of life of patients with CF, who are waiting for their definitive cure through gene therapy.

Below are the relevant statements,

from the online press conference organised by the Panhellenic Cystic Fibrosis Association in the framework of the European Cystic Fibrosis Week.

The Honorary President of the Hellenic CF Association, Mr. Dimitris Kontopidis, who is a pioneer in the effort to integrate all patients in Greece in the new treatment, but also at European level with his new role as Member of the Board of the European CF Association CF Europe, states the following:

“The new revolutionary treatments,

The new revolutionary therapies that are available and act on the causes of the disease (CFTR Modulators) have truly revolutionized the treatment of the condition with spectacular results that “freeze the disease”. There is currently a drive across Europe to have them reimbursed by insurance companies and the state, as these are high cost treatments.

In Greece there is access for eligible patients according to their mutation to the drug combinations “Kalydeco”, “Orkambi”, “Symkevi”, which are introduced and reimbursed through an individual application to the IFT with several delays. In the new triple combination (“Trikafta” in America, “Kaftrio” in Europe) we ensured the inclusion in an “early access” program of eligible critically ill patients, protecting them after a long effort at national and European level with the decisive contribution of the Minister of Health, Mr. Kikilias. But the majority of patients, who are also eligible for the new triple combination “Kaftrio”, are waiting for equal access. Individual approvals have already started to be given to other patients in an aggravated situation, in addition to those included in the early access programme, until the EOF’s negotiation procedures with the pharmaceutical company are completed.

At this point, I would like to point out that it is extremely important to reach a comprehensive portfolio agreement for all the combinations in circulation as soon as possible for 3 important reasons:

(a) it will put an end to the delays in the introduction through individual orders of the old combinations “Kalydeco”, “Orkambi”, “Symkevi” which are causing inconvenience to patients by forcing them to discontinue their treatment.

(b) all patients will have equal access to the best possible treatment that they are eligible for, including the new triple combination “Kaftrio”, which concerns the majority of patients with Cystic Fibrosis

(c) the Greek State will reimburse at the best possible price for extremely high cost treatments at a time when health systems are under suffocating pressure.”

The President of the National Organization for Medicines (EOF) and Chairman of the Pharmaceutical Price Negotiation Committee, who has taken a central role in the negotiation of these treatments, Mr.Filippou Dimitris, stated the following:

“Following the achievement of the Trikafta early access programme for around 30 patients who were in immediate need, there has been close collaboration with Vertex to accelerate the approval and marketing of the drugs in Greece. Already, the pharmaceutical formulation Orkambi has received a price in our country and Kaftrio and Kalydeco will soon receive a price. Regarding Symkevi, the company has not currently submitted a dossier for the approval of the drug in the country and we are awaiting further information. Following the completion of the pricing which is expected to be completed by mid-December for both drugs, the company is submitting a dossier to the Evaluation Committee (ECA) in order to start the evaluation and financial negotiation processes to finally be included in the positive list of reimbursed treatments. For the period of time during which the procedures and negotiations are taking place, which I must stress will be unprecedentedly short not only by our country’s standards but also by international standards, it is clear that access to these innovative treatments will be facilitated for patients who need them. Thus, in addition to the 30 patients who received the treatment under early access, another 10-15 patients have started or are expected to start based on the criteria set for access to the drug.

Cystic fibrosis patients and all citizens should know that the state and the medical community are standing by them and are making every effort to restore hope and a smile on their faces. I believe that in this case there has been excellent and smooth cooperation between everyone so that a great goal can soon be achieved. The interest of the Minister of Health, the cooperation with the medical world for the creation of the registry, the participation and role of patients in publicizing the problem and creating solutions, the cooperation of the company and the key role of the EOF were, I believe, decisive points in this effort.My position as a physician, university teacher and President of the EOF is well known and it is a life goal to help patients and to make every effort to ensure that there is immediate access to every pharmaceutical option that can be optimized. I am truly pleased to have been given the opportunity to participate in this important effort and I would like to believe that the reimbursement procedures will soon be completed in order to achieve a comprehensive settlement of treatments. Through my institutional role as Chairman of the Pharmaceutical Price Negotiation Committee, I can guarantee that these procedures will be carried out as a matter of priority and I hope that within the first half of next year every cystic fibrosis patient will be able to receive the treatment they need. Finally, I would like to express my thanks to all those who have been involved in this important effort.”

 

The President of the Board of Directors of the Hellenic Cystic Fibrosis Association, Mrs. Anna Spinou, stated the following regarding lung transplants:

“Lung transplantation continues to be the 2nd chance for life for both patients with Cystic Fibrosis, for whom there is no treatment available, and for patients with other respiratory diseases. As Cystic Fibrosis patients, we were at the forefront in reaching an inter-country agreement with the Austrian Transplant Centre, managing to save more than 20 Cystic Fibrosis patients who were transplanted from 2014 to 2019, when our partnership as a country ended. Now the first lung transplants have started and are successfully performed at the Onassis Heart Surgery Center. It takes time to increase the number of transplants in a new centre, and the need for lung transplantation for respiratory patients is great. But transplantation without a graft does not exist, which is why we as Cystic Fibrosis patients,will take the lead and continue to support the effort to develop the National Transplant Centre and organ donation. Our ‘Unlimited Breath’ campaign will include a range of actions aimed at raising awareness and more specifically about lung transplantation.”

The Minister of Health, Mr. Kikilias Vassilis, who from the very first moment stood by the patients with Cystic Fibrosis, said the following:

“Since last November, I have been doing my duty as Minister of Health to the anguished call of Dimitris Kontopidis and Cystic Fibrosis patients.

We protected Cystic Fibrosis patients who were at great risk and burdened by activating an early access programme in our country for the revolutionary treatment then available in America.

Together with patients, we built the first National Cystic Fibrosis Registry, a valuable tool for patients, the scientific community and the National Health System to provide targeted health services where and how needed.

We are now moving ahead at an excellent pace in negotiating the reimbursement of this revolutionary treatment, with the aim that all cystic fibrosis patients in Greece will have equal access to patients in the rest of Europe.

But we are not stopping at medicine. As I had committed, we are continuing our efforts in lung transplants, with the support of the Onassis Foundation for the development of the new modern National Transplant Centre at the Onassis University Hospital.

Our goal is to give patients with respiratory diseases, such as young children with Cystic Fibrosis, the right to a second chance at life.

Finally, with the new treatments, Cystic Fibrosis patients can face the future with optimism and we will stand by them so that Greece has the best possible support regarding C.F. Units and their staffing.”

The Director of EOPYY, Mrs. Karpodini Theano, said:

“EOPYY understands the chronicity and the difficulties that Cystic Fibrosis creates in the lives of sufferers, and provides all paraclinical examinations and medication for sufferers of the disease free of charge. Also, their treating physicians can prescribe all the medications that CF sufferers need, both for the treatment of the disease and its complications. In this way, the need to visit doctors other than the treating physicians is minimized. For the consumable health material they need in order to receive their treatment, CF sufferers do not pay any contribution. The NHIF reimburses up to 10 physical therapies per month, with no co-payment, and aerotherapy once a year. With regard to the complications of the disease and the resulting need for enhanced special diets, the NHIF provides a fairly wide range of special diet formulations, which are provided to sufferers without any co-payment.

Recently, the NHIF has determined the reimbursement of the special nebuliser for CF, which is also provided without participation. The special nebuliser is necessary for taking the therapeutic formulations for CF and is a fairly large purchase expense. Until 31/12/2019, insured persons could not receive their benefit as the reimbursement price from the NHIF was too low and companies did not distribute it. This created an extra burden on patients, who had to buy it with their own money.

Following the association’s complaint to the MoH and its immediate intervention, a new price was set for the reimbursement of the special nebuliser. This corrected the distortion that had been created in previous years and from January 2020, 141 sufferers received the benefit without paying, while no nebuliser had been reimbursed for 2019.

This intervention has relieved already charged patients of a large expense, which is mandatory to maintain the quality of their health.

Finally, the EOPYY is considering meeting the request of CF sufferers to create a separate budget in the closed expenditure limits of the EOPYY regarding the reimbursement of the special nebuliser and its consumables, so that it does not fall under the rebate and claw back mechanisms.”

Follow all the actions of the Unlimited Breath campaign, which will follow throughout the European Cystic Fibrosis Week:

-on the website of the Panhellenic Cystic Fibrosis Association www.cysticfibrosis.gr
-on the facebook page here

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