by Hélène Mauduit
BERLIN, July 7 (APM) - An updated framework for pricing negotiations in Germany came into force on July 1 after talks between umbrella payer group GKV-Spitzenverband and associations of pharmaceutical companies.
Three main changes to the framework (Rahmenvereinbarung nach § 130b Abs. 9 SGB V) were introduced after nine months of negotiations, according to the final report obtained by APM. The final decision was taken on June 30 by an arbitration body, since GKV-Spitzenverband and pharma lobbies (vfa, BPI, BAH and Pro Generika) had not been able to reach an agreement.
The framework, implementing the AMNOG law which has been in force since 2011, sets the procedure for price negotiations.
The update introduces new criteria for determining the reimbursed price for drugs with an added benefit rating given by health technology assessment (HTA) body G-BA.
This price is calculated by adding a "premium" to the price of the comparative therapy of the drug. In the new version, the price of the comparator therapy is no longer the only reference. Negotiations should include a "free appreciation of all specificities" of the drug and "the particularities of the therapy area".
This formulation, suggested by the pharma lobbies, should avoid the premium being calculated by use of a percentage or an algorithm that would be identical for each level of added benefit.
The weighting of European prices in the drug price referencing basket is also slightly changed, to make it more flexible.
Previously, local prices were adjusted according to differences in purchasing power between countries and sales weighted according to overall sales of the drug. With the new formulation, in some cases the size of the country's population can be used instead of sales. If this option is taken, the company has to justify its choice.
The updated framework gives companies more flexibility to "opt out" - to withdraw a drug from the market just after G-BA gives its rating.
An opt-out will be possible up to 14 days after the first negotiation meeting with GKV-Spitzenverband. Since 2011, the opt-out has been able to be activated up to four weeks after G-BA gave its rating but not after the beginning of negotiations.
With this new timing, the company will be able to take its decision slightly later, after the G-BA's rating and with the first price indication given by GKV-Spitzenverband, the arbitration body said. Pharmas had asked for this extended option.
GKV-Spitzenverband and pharma lobbies have agreed to continue go on with talks until June 30, 2017 on pricing in complex situations
hm/clg
TRY APM Market Access AND GET ACCESS TO THE FULL CONTENT
Interviews with KOLs/senior executives amongst the Regulators, Payers, Health, Medical & Pharmaceutical organisations
Events coverage with a unique focus on Market Access & sustainability of healthcare systems
6 European bureaus : Berlin, Brussels, London, Madrid, Milan & Paris
Ask for a Free trial and get access to the latest stories
Our coverage includes:
- Health Care
- Market Access
- HTA – policies & practices
- European medicine regulations
- Drug safety issues
- Pricing & Reimbursement
- International medicines agencies
If you are a Payer, Pharmaceutical or Consulting professional our premium data will keep you informed on the regulatory, pricing, market access and cost-effectiveness issues that impact all stakeholders.
REQUEST
an initial 10 day temporary access of APM Market Access.
