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

1. A Cross-European Comparison of
Erbulin Reimbursement Decisions
Walker 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 most
Eisai, Japan) in March 2011 for the treatment of locally advanced optimistic ICER for the overall patient population was GBP68,600
or metastatic breast cancer in patients who had progressed after per quality-adjusted life year gained, significantly exceeding the
at least two chemotherapeutic regimens. Eribulin was the first normal GBP30,000 threshold applied by NICE, and did not qualify
single-agent drug to demonstrate a significant extension in OS in for an end-of-life treatment that allows for higher QALY per ICERs
metastatic 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 at
four key European markets: Italy, France, Germany, and the launch.
United Kingdom (UK).
Price at
Methodology Market Date Decision Notes launch
(per 2ML
vial)
Reimbursement documents related to eribulin in Italy, France,
Italy Dec. 2011 Positive Reimbursement EUR 360.99
Germany, and the UK were reviewed to determine whether the
contingent on a
respective health technology assessment agency offered a payment-by-results
positive or negative reimbursement decision or recommendation, arrangement
and 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: Minor
documents or from the IHS OncoInsight Market Access Database.
improvement
Germany April 2012 Positive Allows for entry into EUR 396.79
Results
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’s
reimbursement in December 2011. Reimbursement was appeal and offer of a
contingent on a payment-by-results arrangement, by which Eisai patient access
would pay back 100% of the costs of the medicine provided in scheme
the first three months, or four cycles of treatment, if therapy was
discontinued due to disease progression or toxicity.
Conclusion
The manufacturer price at launch was EUR360.99 per 2ML vial.
Reimbursement decisions on eribulin have varied among key
France: France’s Transparency Commission (HAS) published European markets. Although there have been hints of a movement
details of its recommendation to reimburse eribulin in July 2011. towards greater alignment between European reimbursement
HAS determined that eribulin had a Service Médical Rendu (SMR) agencies regarding funding decisions, this has not materialised
of important (I), which entitles a drug to a 65% or 100% yet, as the Eurozone’s financial crises threaten to further stymie
reimbursement rate. Eribulin was also found to bring a minor reimbursement decision harmonisation and regulators emphasise
therapeutic 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 been
therapies capecitabine, vinorelbine, and gemcitabine.
tepid, with a willingness to reimburse often contingent on
The manufacturer price at launch was EUR320 per 2ML vial. restrictions. In France, the Transparency Commission’s
determination that the drug only brought a minor improvement
Germany: In February 2012, IQWiG published an early benefit forced the manufacturer to negotiate a lower price. In Italy, the
assessment for eribulin in which it determined that the drug did payment-by-results programme is less than favourable to the
not bring any additional benefit in the third-line setting, a decision manufacturer.
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.
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