Thursday, 1 Dec 2016

Written Answers Nos. 208-220

Primary Medical Certificates

Questions (208)

Paul Kehoe

Question:

208. Deputy Paul Kehoe asked the Minister for Health if the Revenue Commissioners will locate a primary medical certificate for a person (details supplied); and if he will make a statement on the matter. [38244/16]

Written answers

Minister of State at the Department of Health

The Government is committed to providing services and supports for people with disabilities which will empower them to live independent lives, provide greater independence in accessing the services they choose, and enhance their ability to tailor the supports required to meet their needs and plan their lives. This commitment is outlined in the Programme for Partnership Government, which is guided by two principles: equality of opportunity and improving the quality of life for people with disabilities.

My Department has no role in relation to the work of the Office of the Revenue Commissioners. However, as applications for Primary Medical Certificates are processed by the Health Service Executive (HSE), I have arranged for the question to be referred to the HSE for investigation and direct reply.

Medicinal Products Prices

Questions (209)

John Brassil

Question:

209. Deputy John Brassil asked the Minister for Health if he will request the HSE to provide a timeframe for a decision on price negotiations with the manufacturer of Kalydeco, Ivacaftor (details supplied); and if he will make a statement on the matter. [38082/16]

Written answers

Minister for Health

As outlined in a previous reply, the HSE has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drugs schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.

In line with the 2013 Act, if a Company would like a medicine to be reimbursed by the HSE pursuant to the Community Drug Schemes or as a hospital medicine, the Company must first submit an application to the HSE to have the new medicine added to the Reimbursement List or to be priced as a hospital medicine. The Company must submit a separate application to extend a treatment to a new cohort of patients. Each application is considered separately on its merits and in line with the 2013 Act.

In reaching its decision, the HSE examines all the evidence which may be relevant in its view for the decision (including the information/dossier submitted by the Company) and will take into account such expert opinions and recommendations which may have been sought by the HSE at its sole discretion (for example, from the National Centre for Pharmacoeconomics).

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

1. the health needs of the public;

2. the cost-effectiveness of meeting health needs by supplying the item concerned rather than providing other health services;

3. the availability and suitability of items for supply or reimbursement;

4. the proposed costs, benefits and risks of the item or listed item relative to therapeutically similar items or listed items provided in other health service settings and the level of certainty in relation to the evidence of those costs, benefits and risks;

5. the potential or actual budget impact of the item or listed item;

6. the clinical need for the item or listed item;

7. the appropriate level of clinical supervision required in relation to the item to ensure patient safety;

8. the efficacy (performance in trial), effectiveness (performance in real situations) and added therapeutic benefit against existing standards of treatment (how much better it treats a condition than existing therapies); and

9. the resources available to the HSE.

I am informed that the HSE received a request and economic dossier from the manufacturer of Ivacaftor, brand name Kalydeco, for the treatment of cystic fibrosis patients aged 2 years and older weighing less than 25kg. In March of this year the HSE asked the NCPE to carry out a health technology assessment of the applicant’s economic dossier on the cost effectiveness of this treatment.

The NCPE completed its assessment and made a recommendation in October 2016. The NCPE determined that the manufacturer failed to demonstrate cost-effectiveness of the drug for its intended cohort of patients and did not recommend that it should be reimbursed for this indication at the submitted price.

A summary of the health technology assessment has been published on the NCPE website and is available at: http://www.ncpe.ie/wp-content/uploads/2015/12/Ivacaftor-2-5-years-web-summary.pdf.

As the HSE is responsible for the negotiations with manufacturers I have asked them to reply to the Deputy directly in relation to the status of negotiations with the manufacturer.

Occupational Therapy

Questions (210)

James Browne

Question:

210. Deputy James Browne asked the Minister for Health the status of the waiting list for occupational therapy services in County Wexford in view of the fact some persons are waiting over two years for essential services; and if he will make a statement on the matter. [38085/16]

Written answers

Minister for Health

As this question relates to service matters, I have arranged for the question to be referred to the Health Service Executive (HSE) for direct reply to the Deputy.

Audiology Services Provision

Questions (211)

Brendan Griffin

Question:

211. Deputy Brendan Griffin asked the Minister for Health if a person (details supplied) in County Kerry will be prioritised for a hearing appointment. [38086/16]

Written answers

Minister for Health

As this is a service matter it has been referred to the HSE for reply to the Deputy.

Hospital Appointments Delays

Questions (212)

James Lawless

Question:

212. Deputy James Lawless asked the Minister for Health if he will examine the case of a person (details supplied) who has been waiting indefinitely for a hospital appointment; the length of time this waiting time is expected to last; the efforts his Department has made to decrease waiting times in this specific area; and if his Department will expedite the case provided. [38093/16]

Written answers

Minister of State at the Department of Health

As this is a service issue, this question has been referred to the HSE for direct reply.

Medicinal Products Supply

Questions (213)

Mick Wallace

Question:

213. Deputy Mick Wallace asked the Minister for Health if a company (details supplied) which makes Orthotics is available as a service provider via the long-term HSE scheme or medical card scheme; if it was ever available and was removed from either scheme, when it was removed; and the reason it was removed. [38096/16]

Written answers

Minister for Health

Under the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for the administration of the primary care schemes; therefore, the matter has been referred to the HSE for attention and direct reply.

Medicinal Products Availability

Questions (214)

Martin Ferris

Question:

214. Deputy Martin Ferris asked the Minister for Health the status of children with cystic fibrosis who are waiting for treatment with the drug Kalydeco; and if he will make a statement on the matter. [38100/16]

Written answers

Minister for Health

The manufacturer submitted an application to the HSE to have Ivacaftor, brand name Kalydeco, reimbursed for the treatment of cystic fibrosis patients aged 2 years and older weighing less than 25kg. In March of this year the HSE requested that the NCPE carry out a health technology assessment of the applicant’s economic dossier on the cost effectiveness of this treatment. In the submitted economic dossier the manufacturer estimates that there are 18 patients eligible for early ivacaftor treatment.

Medicinal Products Data

Questions (215, 216, 217, 218, 220)

Bríd Smith

Question:

215. Deputy Bríd Smith asked the Minister for Health the details of any studies completed by the HSE prior to the decision to discontinue reimbursement support for eye supplements from 2017. [38102/16]

Bríd Smith

Question:

216. Deputy Bríd Smith asked the Minister for Health the number of persons nationally that have applied via the discretionary hardship arrangement for continued support and reimbursements for eye supplements. [38103/16]

Bríd Smith

Question:

217. Deputy Bríd Smith asked the Minister for Health the number of persons nationally that have successfully received reimbursements via the discretionary hardship fund for eye supplements. [38104/16]

Bríd Smith

Question:

218. Deputy Bríd Smith asked the Minister for Health the criteria used by the operators of the discretionary hardship fund in assessing persons' requests for continued reimbursement for eye supplements. [38105/16]

Bríd Smith

Question:

220. Deputy Bríd Smith asked the Minister for Health the projected savings to the HSE of the proposal to remove all eye supplements from its list of drugs qualifying for reimbursements in January 2017. [38107/16]

Written answers

Minister for Health

I propose to take Questions Nos. 215 to 218, inclusive, and 220 together.

Under the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for the administration of the community drug schemes; therefore, the matter has been referred to the HSE for attention and direct reply.

Medicinal Products Supply

Questions (219)

Bríd Smith

Question:

219. Deputy Bríd Smith asked the Minister for Health if his attention has been drawn to and his views on the current views of the clinical community of ophthalmologists on the use of eye supplements in treating and delaying the progress of diseases already contracted by persons. [38106/16]

Written answers

Minister for Health

As this is a service matter, it has been referred to the HSE for reply.

Question No. 220 answered with Question No. 215.