A cross-European comparison of eribullin reimbursement decisions -IHS Healthcare Research Poster 2012


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Research by IHS Healthcare and Pharma for ISPOR 2012 - eribullin reimbursement decisions

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A cross-European comparison of eribullin reimbursement decisions -IHS Healthcare Research Poster 2012

  1. 1. A Cross-European Comparison ofErbulin Reimbursement DecisionsWalker S, Ando G (IHS, London, United Kingdom)Background UK: NICE published its final negative guidance on the drug in April 2012, confirming an initial negative review given in July 2011.The European Commission approved eribulin mesylate (Halaven; NICE’s Evidence Review Group concluded that the mostEisai, Japan) in March 2011 for the treatment of locally advanced optimistic ICER for the overall patient population was GBP68,600or metastatic breast cancer in patients who had progressed after per quality-adjusted life year gained, significantly exceeding theat least two chemotherapeutic regimens. Eribulin was the first normal GBP30,000 threshold applied by NICE, and did not qualifysingle-agent drug to demonstrate a significant extension in OS in for an end-of-life treatment that allows for higher QALY per ICERsmetastatic breast cancer. 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,Objectives citing an unfavourable cost-benefit ratio.The study aims to track reimbursement decisions for eribulin in The manufacturer price at launch was GBP313 per 2ML vial atfour key European markets: Italy, France, Germany, and the launch.United Kingdom (UK). Price atMethodology Market Date Decision Notes launch (per 2ML vial)Reimbursement documents related to eribulin in Italy, France, Italy Dec. 2011 Positive Reimbursement EUR 360.99Germany, and the UK were reviewed to determine whether the contingent on arespective health technology assessment agency offered a payment-by-resultspositive or negative reimbursement decision or recommendation, arrangementand to understand the reasons why they arrived at this decision.Price of the drug at launch was discerned from the reimbursement France July 2011 Positive SMR I: Important EUR 320 ASMR IV: Minordocuments or from the IHS OncoInsight Market Access Database. improvement Germany April 2012 Positive Allows for entry into EUR 396.79Results price negotiations UK NICE: SMC: Negative NICE maintained GBP 313 April Oct. negative assessment (EUR 394.3)Italy: The Italian Medicines Agency (AIFA) approved eribulin for 2012 2011 despite manufacturer’sreimbursement in December 2011. Reimbursement was appeal and offer of acontingent on a payment-by-results arrangement, by which Eisai patient accesswould pay back 100% of the costs of the medicine provided in schemethe first three months, or four cycles of treatment, if therapy wasdiscontinued due to disease progression or toxicity. ConclusionThe manufacturer price at launch was EUR360.99 per 2ML vial. Reimbursement decisions on eribulin have varied among keyFrance: France’s Transparency Commission (HAS) published European markets. Although there have been hints of a movementdetails of its recommendation to reimburse eribulin in July 2011. towards greater alignment between European reimbursementHAS determined that eribulin had a Service Médical Rendu (SMR) agencies regarding funding decisions, this has not materialisedof important (I), which entitles a drug to a 65% or 100% yet, as the Eurozone’s financial crises threaten to further stymiereimbursement rate. Eribulin was also found to bring a minor reimbursement decision harmonisation and regulators emphasisetherapeutic benefit, with an ASMR (Amélioration du Service different methodologies in their decision-making.Médical Rendu) of IV in that indication compared with alternative Endorsement of the drug in key European markets has beentherapies capecitabine, vinorelbine, and gemcitabine. tepid, with a willingness to reimburse often contingent onThe manufacturer price at launch was EUR320 per 2ML vial. restrictions. In France, the Transparency Commission’s determination that the drug only brought a minor improvementGermany: In February 2012, IQWiG published an early benefit forced the manufacturer to negotiate a lower price. In Italy, theassessment for eribulin in which it determined that the drug did payment-by-results programme is less than favourable to thenot bring any additional benefit in the third-line setting, a decision manufacturer.attributed largely to the severity of adverse events. However, theG-BA concluded in April 2012 that eribulin did indeed have addedbenefit over comparators, allowing the manufacturer to enter pricenegotiations and avoid having the drug entered into the referenceprice system, which would likely have driven down the price.The manufacturer price at launch was EUR396.79 per 2ML vial. FOR MORE INFORMATION ABOUT IHS GLOBAL INSIGHT HEALTHCARE & PHARMACEUTICAL SERVICES www.ihs.com/healthcare and www.ihs.com/healthcareblog Please email: gustav.ando@ihs.com for any questions related to this poster