BERLIN, Jan 26 (APM) - Drugs reimbursement prices in Germany should be set retroactively to the date a drug enters the market to keep healthcare costs down - a concern as drug spend increased 10% over the past year, German umbrella payer group, GKV-Spitzenverband has said.
If the demands of the influential body were implemented, pharmas could ending up paying back the difference between the initial market entry price and the price agreed with the payer, usually 13 months after launch.
The GKV argues a retroactive pricing scheme is necessary to ensure drugs provision in Germany remains financially sustainable as “manufacturers can still demand astronomical prices for new medicines” in the first year, GKV deputy director, Johann-Magnus von Stackelberg said in a Friday statement announcing the organisation’s policy paper on drugs market reform.
According to the GKV when new, innovative drugs become available, health insurers have to pay whatever “price manufacturers demand” and that reimbursement prices agreed by the payer and pharma based on the level of added benefit “is valid only 13 months after the drugs' arrival on the market”.
The situation “offers an incentive” for pharmas to look for “excessively high prices” and can be “strategically exploited” as individual cases have shown, said the GKV in its policy paper.
The GKV told APM it would not name individual drugs for which pharmas had sought “excessively high prices” before a reimbursement price had been agreed, citing negotiation confidentiality. However, spokeswoman Ann Marini said it had “for example, observed such cases in the area of hepatitis C drugs and cancer therapeutics”.
According to the position paper, Germany’s four-year-old health technology assessment system based on identifying innovation and “rewarding added benefit” is working - with pharmas and the GKV so far agreeing on 68 reimbursement prices and health insurers registering savings of 450 million euros in 2014.
Although, pharmas withdrew a number of drugs from Germany, including Sanofi’s diabetes drug Lyxumia (APMMA 38816) and Novartis’ diabetes drugs Galvus (vildagliptin) and Eucreas (vildagliptin+metformin) after failing to agree on a reimbursement price, the number of new launches on the market showed the country “was not cut off from new drugs” and that patients were not losing out, said the GKV.
Still, the GKV said savings were “put into perspective relative to total expenditure of 33 billion euros” making it clear that “we on one hand cannot waive instruments” such as discount contracts and fixed price groups and on the other, have to make reimbursement prices retroactive to the day a drug is launched.
Drug spend increased from 22.5 billion euros in 2013 to 24.8 billion euros in 2014, according to the GKV. The rise is concomitant with a reduction in the mandatory discount given by pharmas to statutory health insurers from 16% to 7% in April 2014.
The GKV said biologics have proven to be a “positive influence” for those with serious illnesses but have led to “considerable cost increases for the health system” and suggested biosimilars could “contribute significantly to cost control”.
However, patent expiration did not necessarily lead to more competition and the GKV called for more support to develop the biosimilars market, adding that added benefit assessment is also required for patent-protected biologics - even those launched before AMNOG.
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