The Ministry of Health said on Wednesday that “the existing framework agreement on the supply and pricing of medicines with the Irish Pharmaceutical Healthcare Association expires on 31 July this year. The agreement provides that all obligations arising from the agreement expire after that date, unless the parties continue by mutual agreement. The price and refund landscape in Ireland has changed considerably in recent years. The new legislation introduced a number of measures to reduce health spending, primarily a general substitution and reference price system. In 2016, the government also entered into a four-year framework agreement with industry on the supply and pricing of medicines to limit drug costs. The current framework agreement is expected to expire in July 2020. Cost and efficiency are the main themes of interest to the HSE. Compliance with the criteria of the 2013 Law and the 2016 Agreement is essential to successful market access in Ireland. The 2016 agreement provides a good basis for pharmaceutical companies to ensure they meet the requirements, but demonstrating good clinical efficacy remains one of the determining factors for success. It remains to be seen what impact COVID-19 will have on health spending, but any new framework agreement on prices and supply negotiated between the Irish government and industry will likely continue to focus on access to new innovative products and thus on costs and efficiency. In the absence of an extension of the current agreement on the pharmaceutical industry, rebates of around 5 million euros per month to the HSE could be jeopardized. “A new agreement should be based on the principle of joint financing, with industry and the state agreeing to cover the costs of new medicines.
This is the fairest way to ensure that patients have access to the best new treatments on time. The first step is for the government to release new funds for new drugs in the October budget,” Reid added. Despite an aging population, the budget for public spending on medicines has not increased much in recent years due to the difficult economic climate. By 2019, the supplementary budget for innovative medicines amounted to 10 million euros (or 0.4% of the annual drug budget) which the HSE had almost exhausted after eight weeks. In 2020, no specific funding has been allocated for new medicines and new indications of existing medicines. Instead, the HSE should consider funding each new drug recommended within the limited resources available. For political and political reasons, this position seems untenable, not least because the lack of access to new innovative medicines will only face strong patient opposition for budgetary reasons. For example, in 2017, the government made available additional funds for cystic fibrosis drugs Orkambi® (DCI: lumacaftor/ivacaftor) and Kalydeco® (DCI: ivacaftor) following an intense public lobbying campaign. The IPHA said on Thursday that discussions on a possible extension of the current agreement had “progressed well.” However, he stated that “for an extension to be viable, it is essential that we see the exercise in the reimbursement of new drugs that have satisfied the clinical effectiveness of HSE and value-to-money testing.” The price adjustments that will be implemented on 1 November and 1 October 2020 as part of the IPHA 2016 framework agreement are available on this link.
In response to the news, the Irish Pharmaceutical Healthcare Association (IPHA) said it was a “Game Changer” for patients in Ireland and should allow for “close collaboration” between the state and industry under a new multi-year medication agreement. If the proposed price of a drug means that the product has an ICER of more than EUR 45,000 per QALY and is therefore not considered profitable, the HSE may meet with the supplier to negotiate and attempt to agree on a price.