Tuesday, 23 July 2019

Ceisteanna (1087)

Alan Kelly

Ceist:

1087. Deputy Alan Kelly asked the Minister for Health if health technology assessments or rapid review assessments for drug treatments have been delayed by the National Centre for Pharmacoeconomics due to insufficient organisational resources to date in 2019; if so, the assessments affected in tabular form; and if he will make a statement on the matter. [31613/19]

Amharc ar fhreagra

Freagraí scríofa (Ceist ar Health)

The National Centre for Pharmacoeconomics (NCPE) was established in 1998 and conducts the health technology assessment (HTA) of pharmaceutical products for the Health Service Executive.

The NCPE's workload has increased significantly, from less than five assessments per year in 2007 to eighty assessments per year in 2017. In addition, the complexity of individual assessments has increased greatly.

A 2017 Grant Thornton review of the NCPE indicated that it was understaffed, at 8.5 whole time equivalents, and that an additional 9 staff, including senior pharmacists, HTA assessors and statisticians, would be required to meet the additional workload.

I allocated an additional €750,000 to the NCPE in 2018 to support the recruitment of the additional staff, which has been underway since then.

The NCPE has advised that no rapid review assessments have been delayed in 2019. These assessments account for approximately 2/3 of the 70-80 assessments carried out each year.

In the first quarter of this year,11 full HTA submissions (which is the highest number ever) was received by the NCPE. The NCPE has advised that six full Health Technology Assessments (HTA) have been delayed:

1. Burosumab (Crysvita) for x-linked hypophosphataemia

2. Liposomal daunorubicin (Vyxeos) for Acute Myeloid Leukaemia (AML)

3. Lutetium Oxodotreotide (Lutathera) for Neuroendocrine tumours

4. Nivilumab + Ipilimumab for Renal Cell Carcinoma

5. Patisiran (Onpattro) for Amyloidosis

6. Pembrolizumab for adjuvant melanoma

The NCPE have confirmed that they will commence the assessment of three of these products ( items number 2, 3 and 4 above) within the next 2 weeks. By the 1st August 2019 just 3 products ( items 1, 5 and 6 above) will be waiting to start the assessment process.

The NCPE have 20.5 whole time equivalents but 4 of those positions are currently vacant. The NCPE have confirmed that they are in the process of filling these 4 positions which will address these delay to the assessment process.