BERLIN, Feb 12 (APM) - Following months of wrangling, German umbrella payer group, GKV-Spitzenverband, and U.S. pharma Gilead have agreed a reimbursement price for hepatitis C blockbuster Sovaldi (sofosbuvir), the payer group said in a Thursday statement.
The price, valid for three years, is back-dated to January 23, and will be "published soon in the drugs pricing schedule," said the GKV, adding that a tiered pricing arrangement has been agreed which "will result in further savings over the next two years".
According to the GKV, the basis for the decision was the G-BA’s July "considerable added benefit" ruling for around 5% of chronic hepatitis C patients and minor added benefit for other patient groups. No-added benefit was given for genotypes 4, 5 and 6 or for previously-treated patients because of insufficient data. (APMHE 39147)
The GKV said it was "important in terms of the affected patients to come to an agreement that adequately reflected the G-BA’s differentiated added benefit assessment".
Gilead and the payer group had missed a January deadline to agree a price for the highly expensive but very efficacious treatment, resulting in the payer activating the mediation committee. (APMHE 41152) However, GKV said in the statement the compromise meant a decision was no longer required from the mediation committee.
The negotiations had drawn much interest and as well as criticism with Jens Spahn, the governing Christian Democrat Party's speaker for health issues, accusing the GKV of playing "poker" rather than seriously negotiating with pharmas in drug pricing talks. (APMHE 39858)
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