DARRAGH O'BRIEN TD
  • HOME
  • About Darragh
  • News
  • Parliamentary Questions
    • Housing, Planning & Local Government PQ's
    • School PQs
    • Foreign Affairs PQS
    • Oral Questions
  • Newsletters
  • Videos
  • PHOTOS
  • FIANNA FAIL
  • CONTACT
  • DATA Protection Statement

News

DÁIL QUESTION addressed to the Minister of State at the Department of Health (Kathleen Lynch)  Orkambi for treatment of Cystic Fibrosis

27/4/2016

 
 To ask the Minister for Health to fast track the approval of the new drug Orkambi for the treatment of Cystic Fibrosis; and if he will make a statement on the matter.


REPLY.
I am aware that there is a lot of concern and worry among cystic fibrosis (CF) sufferers, and families of children who have CF, about the current debate on the cost and availability of this medicine.

Orkambi (lumacaftor/ivacaftor) is a combination drug for the treatment of CF in patients with two copies of a specific CF gene mutation. The drug was licensed by the U.S. Food and Drug Administration in July 2015 and by the European Medicines Agency in November 2015. To date, it has not been approved for reimbursement by any public health service in Europe. 

Each country has its own process for approval. The Irish process is laid down in law in the Health (Pricing and Supply of Medical Goods) Act 2013. Under this law, the HSE has statutory responsibility for decisions on pricing and reimbursement of medicinal products under the community drug schemes in accordance with the provisions of the law. It is appropriate that these should not be political decisions and that a scientific and evidence based approach is taken to determine the extent to which patients would benefit from treatment with expensive new drugs.

Prior to reimbursing any medicine, the HSE considers a range of statutory criteria, including clinical need, cost-effectiveness, and the resources available to the HSE. The process for approval of high-tech new drugs in Ireland involves three steps. The first step involves a Rapid Review, which has been completed. The second involves a full Health Technology Assessment by the National Centre for Pharmacoeconomics (NCPE). This expert assessment is scientific and objective and will evaluate whether the claims being made about the benefits of a new drug are valid, and to what extent, in terms of its impact on life expectancy, quality of life, reducing hospital admissions, reduced need for transplants etc. The NCPE will also consider which patient groups might benefit, how the drug compares with existing treatments and if it is cost-effective at the price being sought by the manufacturer. The Minister for Health has requested that the NCPE expedite this part of the process. The Centre hopes to be in a position to issue its recommendation to the HSE in early June, and the HSE may then engage in price negotiations with the manufacturer. 

The process being followed is the same as that for other CF drugs like Kalydeco (ivacaftor), new drugs to treat cancer and other rare diseases. Orkambi will be treated in the same way as these were, and has to be, under the law. This process is designed to secure the best value for the HSE, and the savings that accrue from this process can be used to fund other health service developments, for example isolation rooms for CF and cancer patients, better ambulance services, home supports for the elderly and safer maternity services.

I hope that it will be possible for Orkambi to be approved for patients who will benefit from it, and at a fair price, but it must go through the normal approval procedure first, like all other high-tech medicines.

Comments are closed.
    Picture

    NEWS

    Archives

    May 2025
    April 2025
    March 2025
    February 2025
    January 2025
    December 2024
    November 2024
    October 2024
    September 2024
    August 2024
    July 2024
    June 2024
    May 2024
    April 2024
    March 2024
    February 2024
    January 2024
    December 2023
    November 2023
    October 2023
    September 2023
    August 2023
    July 2023
    June 2023
    May 2023
    April 2023
    March 2023
    February 2023
    January 2023
    December 2022
    November 2022
    October 2022
    September 2022
    July 2022
    June 2022
    May 2022
    April 2022
    March 2022
    February 2022
    January 2022
    December 2021
    November 2021
    October 2021
    September 2021
    August 2021
    July 2021
    June 2021
    May 2021
    April 2021
    March 2021
    February 2021
    January 2021
    December 2020
    November 2020
    October 2020
    September 2020
    August 2020
    July 2020
    June 2020
    May 2020
    April 2020
    March 2020
    February 2020
    January 2020
    December 2019
    November 2019
    October 2019
    September 2019
    August 2019
    July 2019
    June 2019
    May 2019
    April 2019
    March 2019
    February 2019
    January 2019
    December 2018
    November 2018
    October 2018
    September 2018
    August 2018
    July 2018
    June 2018
    May 2018
    April 2018
    March 2018
    February 2018
    January 2018
    December 2017
    November 2017
    October 2017
    September 2017
    August 2017
    July 2017
    June 2017
    May 2017
    April 2017
    March 2017
    February 2017
    January 2017
    December 2016
    November 2016
    October 2016
    September 2016
    August 2016
    July 2016
    June 2016
    May 2016
    April 2016
    March 2016
    February 2016
    January 2016
    December 2015
    October 2015

Darragh O'Brien TD


Address

Darragh O'Brien TD
Leinster House
Kildare Street
Dublin 2

Telephone

T:  01-6183802

Email

For all constituency related queries please don’t hesitate to contact:
Email: [email protected]
Phone: 01-6183802
Postal Address: Dáil Éireann, Leinster House, Kildare Street, Dublin 2.

For all Department of Climate, Environment and Energy related queries please don't hesitate to contact:
Email: [email protected]
Phone: 01-6782000
Postal Address: Tom Johnson House, Haddington Road, Dublin 4, D04 K7X4.
Website: www.gov.ie/decc/

For  all Department of Transport related queries please don't hesitate to contact:
Email: [email protected]
Phone: 01-6041062
Postal Address: Department of Transport, Leeson Lane, Dublin 2, D02 TR60.
Website:
www.gov.ie/transport/
 




  • HOME
  • About Darragh
  • News
  • Parliamentary Questions
    • Housing, Planning & Local Government PQ's
    • School PQs
    • Foreign Affairs PQS
    • Oral Questions
  • Newsletters
  • Videos
  • PHOTOS
  • FIANNA FAIL
  • CONTACT
  • DATA Protection Statement