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Many health insurers now involved in German drug price talks, discounts may be revealed

by Hélène Mauduit
BERLIN, Mar 24 (APM) - Twenty-eight statutory health insurers are currently taking part in drug reimbursement price negotiations under a new procedure in Germany, and for the first time potentially revealing the extent of discount contracts from comparator drugs, sources have told APM.
Of the 124 statutory health insurers, 68 have expressed an interest and 28 are currently involved in the negotiations, a spokeswoman for the umbrella payer group GKV-Spitzenverband revealed on Monday.
Among the new data potentially being shared with the manufacturer at the negotiation table, are real-world prices of comparator drugs, including any agreed discounts, one insurer told APM. However these negotiations are strictly confidential.
Since January, under a law voted in March 2014 (APMHE 37354), one representative from a statutory health insurer among the GKV-Spitzenverband's members has to be present at the pricing negotiations. Previously, only the GKV-Spitzenverband was talking with the manufacturer.
The law has been modified in order to bring more practical experiences and assessments to the negotiations.
In Germany, new drugs are launched at a free price determined by the manufacturer and valid for 12 months. During this time, the drug is submitted to early benefit assessment (6 months), then to reimbursement price negotiations (up to 6 months). The reimbursed price comes into effect at the beginning of the 13th month.

Comparative discount prices considered

The Techniker Krankenkasse (TK), the biggest substitute health insurer, is one of the insurers participating in the new procedure and has so far taken part in several sessions for three drugs, Tim Steimle, head of drug policy department at TK, told APM.
“As an insurer, I bring my vision of care. Our role is not to represent the interests of our own company but that of all statutory health insurers, acting for the patients,” Steimle said.
“We really appreciate the participation of statutory health insurers in negotiations. With an annual rate of approximately 30 drugs, with several negotiations each, we will see a lot of negotiations annually,” he said.
“We bring our view of the current health care supply according to our data. The GKV-Spitzenverband has access to data given from some health insurers, but we have a closer knowledge of these data and they potentially play a bigger role in the negotiation.”
For example, the insurer has the opportunity to present up-to-date data on real drugs prices in the market.
“We have the opportunity to mention if the price of a drug already marketed, for example the comparative therapy for the new product, is subject to discount contracts and on what scale. Previously, this information was not mentioned, the reference price was the list price, without discount. It's quite important if the comparative drug is a generic, with a high rebate,” he said.
When the new product has no additional benefit recognised, the insurer “can give its point of view on the necessity to maintain it or not on the market, regarding the other existing products in the same indication, and on the health consequence of its possible withdrawal”.
“We can also be in a position of saying, in case of a withdrawal, that we would organise the importation of the product for our members,” he pointed out.

Attendance based on proportional coverage

GKV-Spitzenverband spokeswoman, Ann Marini, told APM in an interview on Monday, that the allocation of negotiation cases between insurers is organised through a lottery.
The number of cases per insurer depends on the number of people insured with that group (according to the official statistics). The more clients an insurer has, the more reimbursement negotiations it will take part in, she explained.
However, an insurer has the right to forgo its participation. In that case, the next insurer on the list in the drawn order attends on its behalf.
The insurer participates not only in the negotiations, but possibly afterwards, in the arbitration proceedings occurring if the price negotiation fails, the spokeswoman said. (APMHE 41862)
But its role is defined with strict boundaries, given in the written procedure adopted by the GKV Spitzenverband in its status: a common position with the insurer is defined before the negotiation and the representative of the insurer has to stick to it during the talks. At the end, the GKV Spitzenverband alone is legally responsible for the outcome of the negotiation.
Representatives must also respect strict confidentiality. They are not allowed to say which drug negotiations they taking part in and what is said during the sessions. They are allowed to give an account only to the board of the company.
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