BERLIN, Jan 19 (APM) - German umbrella payer group GKV Spitzenverband has said "an agreement is still possible" in price negotiations with U.S. pharma Gilead over its hepatitis C drug Sovaldi (sofosbuvir), following the expiration of the deadline on Saturday to come to an agreement over the expensive treatment.
A mediation committee now has until mid-April to set a reimbursement price for the drug, and GKV Spitzenverband spokesman Florian Lanz said in an emailed statement on Monday it will "keep the line of communication open" with the pharma.
The GKV said it could not comment on why "confidential" pricing talks had failed so far, after Germany's highest health technology assessment (HTA) authority G-BA ruled 'considerable added benefit' for the drug in July. (APMHE 39147)
Nobody at Gilead was available for comment when asked whether it would withdraw Sovaldi from Europe's biggest pharma market if the price resulting from the mediation committee does not meet it expectations, although a number of firms have withdrawn drugs in the past following failed price negotiations or negative HTA assessments.
In June 2014, Sanofi kept its diabetes drug Lyxumia off the market (APHME 38816) as it was unhappy with the price set by the mediation committee. Novartis' diabetes drugs Galvus (vildagliptin) and Eucreas (vildagliptin+metformin) also disappeared from pharmacy shelves after the pharma failed to agree a reimbursement price with the payer. (APMHE 38784)
However, non of these drugs are as significant to patients or the companies concerned as Sovaldi.
Jens Spahn, the ruling Christian Democrat Party's (CDU) speaker for health issues, has previously accused the GKV of playing "poker" rather than seriously negotiating with pharmas in drug pricing talks, resulting in drugs being taken off the market. He added that the GKV's early statements on Sovaldi did not "bode well" for talks (APMHE 39858).
Sovaldi is also facing competition from Janssen's hepatitis C drug Olysio (simeprevir) and AbbVie's Viekirax (ombitasvir+paritaprevir+ritonavir), which the European Commission approved January 16 for genotype 1 chronic hepatitis C in combination with Exviera (dasabuvir) a month after it was approved in the U.S. (APMHE 41118).
Gilead has already faced a U.S. setback after the largest pharmacy management organisation there said it would stop covering the cost of Sovaldi and Harvoni because it had secured a cheaper price for Abbvie's Viekira Pak (ombitasvir+paritaprevir+ritonavir+dasabuvir) for the most common form of hepatitis C. (APMHE 40928)
European payers have previously criticised Sovaldi's 700 euros-a-pill price-tag (APMHE 39159), with Italy (APHME 40714) and France (APMHE 40512) negotiating a lower price for the drug. The UK's NICE is set to recommend Sovaldi, although funding for the drug has been delayed until July. (APMHE 41126)
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