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Still no movement on HSE approved drugs not purchased due to lack of funding - Louise O'Reilly TD

27 July, 2017 - by Louise O'Reilly TD

Sinn Féin Health Spokesperson Deputy Louise O’Reilly has again raised her concern regarding information released to her through a Parliamentary Question highlighting how nine drug treatments which the HSE has approved are in limbo because they do not have enough funds to purchase them.

Deputy O’Reilly said:

“It is quite concerning that only a number of months into the year the HSE is in a situation where they have approved nine drug treatments and want to purchase them for patients in severe need but cannot do so because they do not have enough funding.

“Information released to me through Parliamentary Question No.366 (see below for full PQ response) has shown that drugs have had to be put on hold because their 'reimbursement application could not be funded from within the HSE current budgetary envelope'.

“Instead, the HSE has had to refer each of these treatments to the Department of Health because they just do not have the available funds to purchase them.

“It is quite concerning from the perspective of patient care that drugs for heart failure, ovarian cancer, Crohns, Hodgkin’s Lymphoma, and depression which have been approved are now in limbo, and have been for some time, due to the absence of funding.

“Earlier this month when I received this information I called on the Minister Harris to come forward and make a statement on the situation, however, to date he has not adequately addressed the issue. 

“Minister Harris needs to immediately explain why 6 months into the year the HSE is struggling to purchase drugs which they believe are necessary and want to purchase in order to alleviate suffering and save lives, and he also needs to make a statement on the number of people awaiting these drugs which once purchased could potentially radically transform their lives."


DÁIL QUESTIONS addressed to the Minister for Health (Simon Harris T.D.)
by Deputies 
for WRITTEN ANSWER on 04/07/2017  
 *  366.  To ask the Minister for Health the medicines that his department has approved but are not in a position to purchase as a result of a lack of funding; the number of persons these medicines would benefit; the illness for which they are prescribed; the reason these medicines have not yet been purchased; the funding issues associated with same; and if he will make a statement on the matter.

                                                                                          - Louise O'Reilly T.D.

For WRITTEN answer on Tuesday, 4th July, 2017.

The Health Service Executive (HSE) has statutory responsibility for decisions on the pricing and reimbursement of medicines in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. The 2013 Act specifies the criteria to be applied in the making of decisions on the reimbursement of medicines. 

Part 4 of the the 2013 Act provides, inter alia, for the establishment and maintenance of a "Reimbursement List" for the purposes of section 59 of the Health Act 1970. 

Section 18 of the 2013 Act allows a supplier of an item to apply to the HSE requesting the HSE to add the item to the Reimbursement List.

In considering an application, the HSE will also have regard to Part 1 and Part 3 of Schedule 3 of the 2013 Act. 

Section 19(4) of the 2013 Act prohibits the HSE from making a relevant decision under section 18 "except in accordance with the criteria specified in Schedule 3". Schedule 3 sets out nine general criteria, of which one is the resources available to the Executive.

Under the 2016 Framework Agreement on the Supply and Pricing of Medicines, in a situation where the HSE wishes to reimburse a medicine but cannot do so from within existing resources, it may inform my Department of its decision in this respect. The Minister for Health may, as he deems appropriate, bring a Memorandum to Government in relation to the funding implications and requesting consideration of same. 

Prior to the introduction of the Framework Agreement one treatment, Ibrutinib, was referred to my Department in 2016.

In line with the Framework Agreement and since its introduction in July 2016, the HSE has referred ten treatments to my Department for consideration, one of which was Orkambi (including Kalydeco). 

Following consideration by my Department and Government of the funding implications, the HSE decided, in line with the 2013 Act to reimburse Ibrutinib and Orkambi (including Kalydeco).

The funding implications of the other nine treatments are currently under consideration by my Department. These are outlined in Table 1 below.  
  • Table 1:  Treatments referred to the Department of Health
  • Product
  • Brand
  • Indication
  • Vismodegib
  • Erivedge
  • Basal Cell Carcinoma
  • Vortioxetine
  • Brintellix
  • Depression
  • Sacubitril / Valsartan
  • Entresto
  • Heart Failure
  • Olaparib
  • Lynparza
  • Ovarian Cancer
  • Obinutuzumab
  • Gazyvaro
  • Follicular Lymphoma
  • Vedolizumab
  • Entyvio
  • Crohns & Ulcerative Colitis
  • Nivolumab
  • Opdivo
  • Renal Cell Carcinoma
  • Nivolumab
  • Opdivo
  • Hodgkins Lymphoma
  • Apremilast
  • Otezla
  • Psoriasis & Psoriatic Arthrithis
  • Each of these treatments were referred to my Department because the HSE decided to support the reimbursement application but considered that this could not be funded from within its current budgetary envelope and also taking account of the cumulative costs over a 5 year period. The HSE advise that the cumulative cost over 5 years of these treatments is approximately €120 million.

    It should be noted that the final decision in relation to the reimbursement of all medicines remains the statutory responsibility of the HSE.

    The National Centre for Pharmacoeconomics (NCPE) conducts health technological assessments on behalf of the HSE, a summary of which are available on the NCPE website These assessments include details of the estimated patient numbers and costs associated with each of these treatments. 

    As outlined in the IPHA agreement, and in line with the 2013 Act,within 180 days of receiving the application (or such longer period which may arise if further information is sought from the Company), the HSE will decide to either: 

    - add the medicine to the Reimbursement List / agree to reimburse it as a hospital medicine, 
    - will refuse to reimburse the medicine. 

    While the HSE strives to reach a decision regarding drug approval in as timely a manner as possible and within the 180 days, because of the significant monies involved, there is an onus on the HSE to ensure that the best price is achieved as these commitments often feature multi million euro investments on an ongoing basis. The achievement of more successful price negotiations also allows for further drugs to be approved within the finite budget available. 

    I have asked the HSE to refer directly to the Deputy in relation to the timelines for the individual medicines.

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