Pricing hurdles force Bristol Myers to abandon plans for launching new cancer drug in Germany

GERMANY — Bristol Myers Squibb, following its European approval last September, has announced that it will not be launching Opdualag, an infusion of Opdivo and new antibody relatlimab, in Germany due to pricing pressures.

Opdualag was granted approval to treat advanced melanoma in adults and adolescents aged 12 years and older.

Bristol Myers spokesperson stated that Opdualag will not be marketed in Germany “for the foreseeable future” due to the country’s drug pricing law from 2010.

Under this law, the pharma giant sees no possibility to achieve a benefit rating from the Gemeinsamer Bundesausschuss (G-BA) for Opdualag.

Without this benefit rating, the price regulator does not recognize any additional benefits of Opdualag over its appropriate comparator.

As such, the drug’s yearly treatment costs cannot exceed those of its comparators, “preferably a therapy for which endpoint studies are available and which has proved beneficial in practical use,” according to the German regulator’s website.

One of the reasons for the lack of benefit rating from the G-BA is BMS’ use of progression-free survival (PFS) to measure Opdualag’s efficacy.

Although the combo drug showed statistically significant PFS over anti-PD-1 monotherapy in patients with advanced melanoma, the AMNOG law does not consider PFS a “patient-relevant endpoint.”

Briefly, the AMNOG law (Arzneimittelmarkt-Neuordnungsgesetz) is a German pharmaceutical law that requires pharmaceutical companies to prove that their new drugs have a benefit over existing treatments to get full reimbursement.

The law sets out a benefit assessment process and requires manufacturers to submit evidence of the added benefit of their drugs compared to existing therapies.

The benefit assessment is conducted by the G-BA, an independent committee made up of representatives from health insurers, physicians, and hospitals.

The committee then assigns the drug to a price group, which determines the extent to which it is reimbursed by Germany’s statutory health insurance system.

BMS disappointed by the failed launch

ristol Myers Squibb (BMS) has expressed disappointment that its newly approved drug Opdualag will not be launched in Germany due to pricing pressures.

The country’s drug pricing law makes it impossible for the pharma giant to achieve a benefit rating for Opdualag from the G-BA, and without it, the drug’s yearly treatment costs cannot be higher than what it is being compared to.

Bristol Myers noted that it remains open to reconsidering its decision should the situation change in the future.

A new law in Germany that came into effect in November 2021 could have offered an additional 20% rebate for drugs used as a combination regimen that fulfill certain criteria, which Opdualag could have potentially fulfilled.

However, the company did not pursue the process. Bristol Myers’ Germany general manager Neil Archer said that the country’s recognition of pharmaceutical innovation and investment has deteriorated significantly and that long-term planning horizons need stable framework conditions.

According to Commonwealthfund.org, in Germany, drug prices cannot be unilaterally raised after initial negotiations.

Prices only change if new clinical evidence of safety or efficacy is presented and a new price is negotiated based on that evaluation.

This differs from the U.S. system where prices are regularly increased each year without new clinical evidence.

As a result, drug prices in Germany are significantly lower than in the U.S., with U.S. net prices for the most expensive drugs up to four times higher than their German equivalents.

A recent study found that net prices for infused drugs in the U.S. were 60 percent higher than those in Germany in 2018.

In Germany, drug prices are fixed based on the ex-manufacturer price plus mark-ups from wholesalers and pharmacies, ensuring nationwide access to medicines at the same price.

The fixed-price system also prohibits discounts on prescription drugs, including those from mail-order pharmacies in other EU countries, which was challenged by the European Court of Justice in 2016 as a violation of the EU’s principle of free movement of goods.

In March 2021, the European Commission called for the German authorities to scrap the ban, leading to the development of a legal amendment by Germany’s Federal Ministry of Health called the Act on the Strengthening of Local Pharmacies.

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