A Review of 2016 Antitumor Drug Market: Cost Growth VS Basic Medical Security

In 2016, four new antitumor drugs were approved by the FDA, and a further 12 existing antitumor agents were approved for 14 additional indications. Each one of these drugs is associated with surprising clinical benefits, but so is the average monthly cost of USD 9,000. Here, I discuss the pros and cons of the antitumor drugs approved in 2016 from the perspective of patients’ treatment cost.

Many cancer treatment methods have gradually changed over the past 15 years with the R&D and approval of more than 80 new antitumor drugs, and so have the cancer treatment costs, which have grown nearly threefold. Two important drug types among those new antitumor drugs are separately monoclonal antibodies (mAbs) and tyrosine kinase inhibitors (TKIs), of which the finding has enabled the cancer treatment to obtain great progress. There were 12 mAbs and 20 TKIs approved in total among antitumor drugs by 2014.

Fig. 1 Mechanisms of action of new antitumor drugs

There were two new mAbs, 1 DNA enzyme–inhibitor complex, and one programmed cell death protein inhibitor approved in 2016, with three marketed TKIs added the indications at the same time. Tumor patients have benefited much from those new drugs and therapies, but the expensive treatment costs have resulted in the global healthcare system to face the increasingly greater challenges, which is an acknowledged problem with few solutions.

No.1 Venetoclax

Each of the four new antitumor drugs approved by FDA in 2016 has one unique mechanism of action, as shown in Fig. 1. The small molecule oral drug Venetoclax is first introduced here. It is a kind of cell death protein inhibitor (bcl-2) and is the only drug that can treat chronic lymphocytic leukemia (CLL) induced by chromosome 17p deletion. It could obtain 80% ORR (objective response rate) and more than 12 months of median DoR (duration of response) for pretreated patients in the Phase II clinical trial, but this drug also has certain toxicological risks and shall be strictly controlled the growth of dosage. The total costs for patients to treat tumors with this drug may exceed USD 100 thousand, according to the monthly treatment cost of USD 10 thousand and at least 10-month treatment cycle.

No. 2 Atezolizumab

FDA announced the accelerated approval for the urothelial carcinoma drug atezolizumab in May 2016. As the first drug approved by FDA for urothelial carcinoma, atezolizumab is a mAb against programmed cell death 1 ligand 1 (PD-L1) and used to block the interaction between programmed cell death protein 1 (PD-1) and its ligand PD-L1. Scientists observed the patients’ ORR of 14.8% and medium DoR of up to more than 6 months in the Phase II clinical trial of atezolizumab.

The administration method of atezolizumab is one I.V. every 3 weeks, and each cycle costs overall USD 8,500. Patients cannot show obvious drug reactions under brief therapy, therefore, patients need to spend about USD 146 thousand in the long 12-month treatment. Atezolizumab has been the first drug approved for urothelium carcinoma over the years, and its unique efficacy may offer a richer basis for its price.

No.3 Olaratumab

The anti-platelet-derived growth factor receptor alpha mAb: Olaratumab was approved by FDA as first-line therapy for soft tissue sarcoma in October 2016. Patients’ can have I.V. of olaratumab on the first day and eighth day during their adriamycin chemotherapy every time. Olaratumab could increase the ORR, medium progression free survival (PFS), and medium DoR of patients receiving adriamycin chemotherapy separately from 8% to 18%, 4.4 months to 8.2 months, and 14.7 months to 26.5 months, viewed from the data of the randomized Phase I and II clinical trials. Each cycle costs about USD 9,900, and average treatment course includes 8 cycles, therefore, the total cost of such treatment is about USD 80,000.

No.4 Rucaparib

The last one among the new antitumor drugs approved by FDA in 2016 was Rucaparib, which is a kind of DNA repair enzyme inhibitor used to treat the BRCA-positive recurrent ovarian cancer. The ORR and median DoR of patients taking this drug could separately reach 54% and 9.2 months. It costs patients taking Rucaparib USD 6,870 every month and costs them USD 60 thousand in total in the long 9-month treatment.

The benefits brought by the new cancer therapies to clinical treatments are self-evident. Those newly developed drugs can provide substantial benefits to urothelium carcinoma, soft tissue sarcoma and ovarian malignant tumor, but prices of anticancer drugs have dramatic increases simultaneously, which is a great economic challenge to the global medical and health security system.

The monthly treatment costs of those new antitumor drugs approved in 2016 are about USD 6,800-10,300, without exception, with the treatment time reaching about 12 months. The economic challenge in the medical industry is in fact not only affected by those newly approved drug therapies, but also by the high-cost drug combinations and therapeutic methods selected by patients, which will result in the total treatment cost to be about USD 100 thousand. The economic challenge brought by the increase of the cancer care cost will affect all the healthcare funding models. The government, medical industry, scientists and clinical doctors have promised that the care level of cancer patients will not be reduced, but the economic constraint brought by the increase of the care cost will inevitably affect the promotion and use of those new drugs. It is an urgent need to timely solve the pressure brought economically in the long cancer research and development history of human beings.