At the American Society of Clinical Oncology (ASCO) annual meeting in early June, one of the recurring themes was the patient access to cancer drugs and more specifically the problem of financial toxicity; in other words, how out-of-pocket expenses can cause financial problems for cancer patients and create barriers to access.

At ASCO, researchers highlighted patient access issue in late-breaking study of Junshi’s toripalimab, which may become the 10th anti-PD-1 checkpoint inhibitor / PD-L1 approved by the Food and Drug Administration (FDA), with potentially multiple indications, including mucosal melanoma and non-small cell lung cancer (NSCLC).

The sponsor of toripalimab in the United States, Coherus, said its mission is “to increase access to cost-effective drugs”. As a result, the company is expected to lower the prices of its competitors if the drug gets FDA approval. Finally, price competition between checkpoint inhibitors could happen in the field of cancer.

Then there is another self-declared disruptive of drug prices, EQRx, which has said it wants to “aggressively reduce” a drug it is working on. Together, EQRx and CStone are developing the monoclonal antibody, sugemalimab, which is in the late stages of clinical trials. It is important to note that during phase 3, sugemalimab met its primary endpoint of progression-free survival as a treatment for some patients with stage III NSCLC.

If toripalimab and sugemalimab get market authorization for NSCLC, they would enter an already crowded therapeutic class led by Merck’s Keytruda (pembrolizumab).

Historically, as new anti-PD-1 / PD-L1 entrants have gained approval – such as GlaxoSmithKline’s Jemperli (dostarlimab) in April of this year – price competition has not been a factor. This is strange, given how competitive and relatively crowded the various oncology indications targeted by checkpoint inhibitors have become – from melanoma and NSCLC to breast, kidney and colorectal cancer.

Price competition is simply not yet common in immuno-oncology, even in cases where patient subpopulations may be stratified by the same set of biomarkers.

With no price competition actually, how do tracking products like Regeneron and Libtayo (cemiplimab-rwic) from Sanofi differ?

In March this year, Ronny Gal, a senior research analyst covering biopharmaceuticals at Bernstein, suggested companies like Regeneron and Sanofi try discounts, in a sort of preemptive strike to push back the potential for future price controls. established by the government.

Lawmakers on both sides of the aisle have cited market failures and the lack of real competition to justify the introduction of price measures. Direct price controls are an integral part of the Lower Drug Costs Now Act (HR3), led by House Democrats, the manifesto recently released by Senator Wyden on drug price reform, but also an executive order. Trump signed last July.

Indirect price controls have also featured in proposals on ways to align price and value, especially of cancer drugs. Specifically, lawmakers seek to align price and value by commissioning health technology assessment studies to be carried out by independent entities.

Of course, drugmakers aren’t the only ones to blame for the lack of price competition. The question of why there are so few discounts in oncology relates in part to government mandates at the state and federal levels that require coverage for “all or virtually all” cancer drugs.

Oncology is one of the six protected classes of Medicare Part D. In the context of this provision, Part D plans are required to cover “all or almost all” outpatient cancer drugs. Likewise, regional Medicare Part B contractors are required to cover virtually all cancer drugs administered by physicians.

Such mandates prevent payers from being able to negotiate (or have leverage to negotiate) the price of cancer drugs. It is not known to what extent these regulations have contributed to the impoverishment of price competition.

As new anti-PD-1 / PD-L1 agents gain market authorization, market-induced price reductions could go a long way in preventing direct and indirect price control measures.