BackgroundThe European Commission approved eribulin mesylate (Halaven; Eisai, Japan) in March 2011 for the treatment of locally advanced or metastatic breast cancer in patients who had progressed after at least two chemotherapeutic regimens. Eribulin was the first single-agent drug to demonstrate a significant extension in OS in metastatic breast cancer.

ObjectivesThe study aims to track reimbursement decisions for eribulin in four key European markets: Italy, France, Germany, and the United Kingdom (UK).

MethodologyReimbursement documents related to eribulin in Italy, France, Germany, and the UK were reviewed to determine whether the respective health technology assessment agency offered a positive or negative reimbursement decision or recommendation, and to understand the reasons why they arrived at this decision. Price of the drug at launch was discerned from the reimbursement documents or from the IHS OncoInsight Market Access Database.

ResultsItaly: The Italian Medicines Agency (AIFA) approved eribulin for reimbursement in December 2011. Reimbursement was contingent on a payment-by-results arrangement, by which Eisai would pay back 100% of the costs of the medicine provided in the first three months, or four cycles of treatment, if therapy was discontinued due to disease progression or toxicity.

The manufacturer price at launch was EUR360.99 per 2ML vial.

France: France’s Transparency Commission (HAS) published details of its recommendation to reimburse eribulin in July 2011. HAS determined that eribulin had a Service Médical Rendu (SMR) of important (I), which entitles a drug to a 65% or 100% reimbursement rate. Eribulin was also found to bring a minor therapeutic benefit, with an ASMR (Amélioration du Service Médical Rendu) of IV in that indication compared with alternative therapies capecitabine, vinorelbine, and gemcitabine.

The manufacturer price at launch was EUR320 per 2ML vial.

Germany: In February 2012, IQWiG published an early benefit assessment for eribulin in which it determined that the drug did not bring any additional benefit in the third-line setting, a decision attributed largely to the severity of adverse events. However, the G-BA concluded in April 2012 that eribulin did indeed have added benefit over comparators, allowing the manufacturer to enter price negotiations and avoid having the drug entered into the reference price system, which would likely have driven down the price.

The manufacturer price at launch was EUR396.79 per 2ML vial.

UK: NICE published its final negative guidance on the drug in April 2012, confirming an initial negative review given in July 2011. NICE’s Evidence Review Group concluded that the most optimistic ICER for the overall patient population was GBP68,600 per quality-adjusted life year gained, significantly exceeding the normal GBP30,000 threshold applied by NICE, and did not qualify for an end-of-life treatment that allows for higher QALY per ICERs thresholds. This rejection came after the manufacturer both appealed the initial negative decision and offered a Patient Access Scheme. Additionally, the SMC rejected eribulin in October 2011, citing an unfavourable cost-benefit ratio.

The manufacturer price at launch was GBP313 per 2ML vial at launch.

ConclusionReimbursement decisions on eribulin have varied among key European markets. Although there have been hints of a movement towards greater alignment between European reimbursement agencies regarding funding decisions, this has not materialised yet, as the Eurozone’s financial crises threaten to further stymie reimbursement decision harmonisation and regulators emphasise different methodologies in their decision-making.

Endorsement of the drug in key European markets has been tepid, with a willingness to reimburse often contingent on restrictions. In France, the Transparency Commission’s determination that the drug only brought a minor improvement forced the manufacturer to negotiate a lower price. In Italy, the payment-by-results programme is less than favourable to the manufacturer.

Market Date Decision Notes

Price at launch (per 2ML vial)

Italy Dec. 2011 Positive Reimbursement contingent on a payment-by-results arrangement

EUR 360.99

France July 2011 Positive SMR I: Important ASMR IV: Minor improvement

EUR 320

Germany April 2012 Positive Allows for entry into price negotiations

EUR 396.79

UK NICE: April 2012

SMC: Oct. 2011

Negative NICE maintained negative assessment despite manufacturer’s appeal and offer of a patient access scheme

GBP 313 (EUR 394.3)

A Cross-European Comparison of Erbulin Reimbursement DecisionsWalker S, Ando G (IHS, London, United Kingdom)

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