by Hélène Mauduit
BERLIN, March 16 (APM) - The chair of the arbitration body in charge of reaching a reimbursement price after negotiations failed between a payer group and manufacturer in Germany, has said he is concerned about the number of pharmas deciding to withdraw products from the process.
Since the AMNOG law entered into force almost four years ago, 21 cases came to the arbitration body from 110 reviews, according to the payer group GKV-Spitzenverband. 12 cases ended positively and 9 products were withdrawn from the German market as the manufacturer opted out of negotiations.
The withdrawals were decided by the manufacturer after the ruling of the arbitration body or in some cases while the procedure was going on, noted Gerhard Schulte at the conference "drug assessment, reimbursement and innovation 2015" in Berlin on Thursday.
He assumed that the high amount of withdrawals suggested "a basic problem in the heart of the procedure," as the system was failing to reach a satisfactory compromise.
But he noted examples of when the arbitration procedure helped to find an agreement. In six cases, an agreement was founded between two meetings of the body, while the arbitration procedure was going on.
The last case occured last February with Gilead's Sovaldi (sofosbuvir) in hepatitis C (APMMA 41438). But he also cited Roche's Zelboraf (vemurafenib) in metastatic melanoma, explaining that an agreement was found in September 2014, after the body ruling. "During the arbitration, GKV-Spitzenverband presented a higher price than during the negotiation after G-BA assessment".
The arbitration body consists of an impartial chairperson, two more non-partisan members and two representatives of each contracting party (GKV-Spitzenverband and the pharma company). It has three months to establish the content of the contract. Even after the ruling, the manufacturer has always the possibility to withdraw its product from the market.
The basis of its work is the Federal Joint committee (G-BA) assessment of the product, but Schulte said the body has little room for manoeuvre beyond this.
The arbitration body has more freedom to negotiate if the drug has a recognised additional benefit, but Schulte said that overall "our latitude is very tight."
The arbitration body works with three criteria: the price of the comparative therapy chosen by G-BA; the annual cost of other therapies in the same indication excluding the comparative therapy; and the reimbursement price of the product, including rebates asked by the health insurers, in 15 European countries.
However around five or six prices are usually available and these are weighted by national sales and purchasing power.
Schulte said European prices remain difficult to find. The company has theoretically an obligation to communicate the prices in other countries but it sometimes puts forward that it has no access to data of other subsidiaries, which are legally independent companies.
The next step is to weigh every criteria and give a justification.
Gerhard Schulte indicated that in most of the cases, the body gave a weight of 50% to the additional benefit, of 25% for the other comparable therapies and 25% for the European prices. This weighting is often retained but it is not a rule, he specified. "We can decide in another case to give a weighting of 80% to the additional benefit or less than 50%."
He gave an example of product for which the company was asking 3000 euros, the average European price. The GKV-Spitzenverband was proposing an annual cost of 200 euros, the other therapies in the same indication had a cost of 1500 Euro.
The arbitration body came to a value of 800 euros according to the additional benefit recognised (four times the comparative therapy) and, with the weighing (50/25/25), the proposed price was 1525 euros.
When the medication has no additional benefit from the G-BA, the arbitration body uses the margins left in G-BA assessment on dosing, scale of population in subgroups, and defines a framework.
Schulte mentioned a case in which the arbitration body used the margins in G-BA assessment. In that case, the GKV-Spitzenverband was offering 76 cents and the firm was asking 700 euros. The arbitration body came to a ruling of 200 euros. Unfortunately, the firm decided to withdraw the product from the German market.
Unlike G-BA assessment, the arbitration body ruling can be challenged in a regional social court and then in the federal social court, but without suspensory effect.
Only two cases are on going such a procedure, said Schulte, certainly more for principles than in a hope to obtain a higher price, as the final ruling would come in a six year time (in average 3 year for each instance).
But the social court has a limited scope. "It has recognised that the arbitration body has an assessment prerogative, which means that the court can't challenge the rating made by the body. It can only judge if the body has properly used its prerogatives".
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