The HSE has statutory responsibility for medicine pricing and reimbursement decisions, under the Health (Pricing and Supply of Medical Goods) Act 2013. The Act specifies criteria for decisions on the reimbursement of medicines. The Minister for Health has no role in relation to reimbursement decisions.
HSE decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds, including on the advice of the National Centre for Pharmacoeconomics (NCPE). The NCPE conducts health technology assessments (HTAs) for the HSE and makes recommendations on reimbursement to assist HSE decisions. The NCPE uses a decision framework to systematically assess a drug's clinical and cost effectiveness as a health intervention.
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 are often multi-million euro, ongoing investments. This can lead to a protracted deliberation process.
The HSE has advised that it has received two applications for pricing and reimbursement of Ocrelizumab (Ocrevus) in Multiple Sclerosis.
On 29 August 2018, the NCPE completed a health technology assessment for Ocrelizumab for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS). They recommended that Ocrelizumab not be considered for reimbursement unless cost-effectiveness can be improved relative to existing treatments.
Following a number of rounds of commercial negotiations, agreement has been reached in relation to the commercial terms which will apply to this indication when reimbursed. The HSE intends to progress Ocrelizumab for the RMS indication, which was approved for funding from October 2019, on a patient-specific basis.
On 4 October 2018 the NCPE completed their assessment for Ocrelizumab indicated for the treatment of adult patients with early primary progressive multiple sclerosis. They did not recommend that Ocrelizumab be reimbursed for this indication.
The HSE and the manufacturer have had a number of rounds of commercial negotiations in relation to this indication. Commercial discussions have concluded, the medicine has been reviewed by the HSE Drugs Group and the HSE Senior Leadership Team have received the Drugs Group recommendation. The HSE's final decision on reimbursement will take into consideration the statutory criteria contained in the 2013 Health Act.