Ireland's MMP To Review Anti-TNF Drugs in a Push to Prescribe Best-Value Biologics

Ireland’s Medicines Management Program (MMP), a body that promotes cost-effective drug prescribing, has opened a consultation related to its roadmap for prescribing best-value biologics in the Irish healthcare setting.

Under the roadmap, the MMP seeks to identify the biologics—whether reference or biosimilar—that provide the healthcare system with the best value within therapeutic classes and indications. The MMP proposes to evaluate therapeutic areas on the basis of a variety of criteria, including reimbursement price, indication, formulation considerations, available pack sizes and strengths, storage considerations, administration devices, patient factors, cost-savings potential, national clinical guidelines, supply considerations, clinical experience with the drug, and Ireland’s yet-to-be-published National Biosimilar Medicine Policy.

As part of the evaluation process, beginning in January 2019, the MMP will review the use of currently reimbursed anti—tumor necrosis factor (anti-TNF) therapies, which the roadmap notes represent the highest-expenditure category for Ireland’s reimbursement plan.

With the market entry of biosimilar adalimumab products, Ireland has the potential to reduce its annual €124 million (approximately $143 million) expenditure on adalimumab, used to treat approximately 10,400 patients, by adopting a best-value option, though it will automatically generate savings under its Framework Agreement on Supply and Pricing of Medicines, which provides for an automatic 20% drop in the price of patent-expired biologics that have commercially available biosimilars.

Once a best-value therapeutic has been identified, a prescribing and cost guidance will be published to support the prescribing of the preferred option.

Following the review of anti-TNF drugs, MMP may also review granulocyte-colony stimulating factors (such as filgrastim and pegfilgrastim), erythropoietins (such as epoetin), and fertility drugs (such as follicle-stimulating hormones, which are regulated as biologics in Europe, though they are currently regulated as drugs in the United States).

Ireland’s move to consider adopting biosimilars marks a significant step; while many European nations have seen strong uptake and cost savings from biosimilar use, a Medicines for Ireland report indicates that, as of January 2018, biosimilars had only an approximate 2% market share for biologic therapies in Ireland, despite the fact that, 38 biosimilar products were approved for use in the European Union when the report was released. Among the products with the lowest market share were biosimilar etanercept, with 1% of the market, and biosimilar insulin glargine, with just 0.2% of the market.

The MMP has opened comments only to stakeholders such as clinicians, professional organizations, and the pharmaceutical industry. It will not receive comments from the general public. The comment period will close on November 16.