The HSE has statutory responsibility for medicine pricing and reimbursement under the Health (Pricing and Supply of Medical Goods) Act 2013. The Act specifies the criteria for decisions on the reimbursement of medicines. As Minister for Health, I have no role or powers in relation to such matters.
Decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds by the HSE, including advice from the National Centre for Pharmacoeconomics (NCPE).
The HSE has a robust assessment and commercial negotiation process for new medicines. This process challenges inappropriate costings from applicant companies and delivers improved value for money on new medicines, allowing more treatments to be provided within a finite budget.
The HSE strives to reach a decision in as timely a manner as possible. However, because of the significant monies involved, it must ensure that the best price is achieved, as these commitments can be ongoing multi-million euro investments.
I am advised by the HSE that it has assessed osimertinib for the following indication:
- The treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC.
In respect of this indication, the NCPE completed its Health Technology Assessment (HTA) in May 2018. Following the assessment and after a number of rounds of commercial negotiations and HSE reviews, the HSE notified the applicant in February 2019 that it was minded to not approve osimertinib for the 2nd line treatment of EGFR T790M mutation-positive non-small-cell lung cancers.
The Health (Pricing and Supply of Medical Goods) Act 2013 requires a period of representations after such notifications, before the HSE makes any formal final decision. The HSE reviewed representations received at its May 2019 meeting and they are currently under consideration.
In addition, the HSE have commissioned a HTA on osimertinib for:
- the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with activating epidermal growth factor receptor (EGFR) mutations.
I am informed that a health technology assessment is ongoing.