Keytruda wins FDA Approval for Treatment of Genetically Defective Tumors

by | Last updated Dec 7, 2023 | Published on May 26, 2017 | Healthcare News

Treatment Tumors
Share this:

Medical billing and coding companies are well aware that oncologists face significant reimbursement challenges with the switch to new models of cancer care delivery such as the Oncology Care Model (OCM) and the Merit-Based Incentive Payment System (MIPS). However, the major challenge that both healthcare providers and patients face is the cost of cancer drugs. In the seventh annual Trends in Cancer Programs survey conducted by the Association of Community Cancer Centers (ACCC) in 2016, up to 83% of the respondents named the costs of cancer drugs as the top challenge, according to a Modern Medicine Network report. Keytruda (pembrolizumab) by Merck is an expensive drug that is FDA-approved to treat advanced melanoma. The FDA has now cleared Keytruda to treat tumors with a genetic defect.

In the past, cancer drugs were typically been approved and used to treat site-specific tumors like those of the brain or breast. Keytruda has become the first cancer drug to be approved by the FDA or a use not related to the site of a tumor. Studies showed the drug shrank tumors in a significant number of patients with colorectal and 14 other cancer types that had the genetic defect.

MSI-H and dMMR are genetic defects that affect cells’ internal mechanisms to repair DNA damage. Cancer takes advantage of these defects to perpetuate the growth of abnormal cells. MSI-H and dMMR are typically seen in colorectal, endometrial, and gastrointestinal cancers, and sometimes, in breast, prostate, bladder, thyroid, and several other types of cancer. Pembrolizumab works by mobilizing the patient’s immune systems to fight the disease.

The FDA’s accelerated approval for the new indication was based on five uncontrolled clinical studies of pembrolizumab involving 149 patients with MSI-H/dMMR-associated tumors. Treatment with the drug led to objective responses in 40% of the patients, and the responses persisted for 6 months or longer in 78% of cases, reports Medscape. Side effects include fatigue and diarrhea. Reports say the drug can also have immune-mediated side effects like colitis.

With the FDA’s action, Keytruda can now be used in tumors with the genetic defect that have worsened after prior treatment with other drugs, and for which there are no satisfactory alternative treatment options.

Though it is indeed a game changer, Merck’s Keytruda costs about $13,000 a month per patient. Besides drug costs, the Trends in Cancer Programs survey identified other critical issues: lack of reimbursement for supportive care services, such as patient navigation, survivorship care planning, and financial counseling, all key elements of patient-centered care.

The 2017 Hospital Outpatient Prospective Payment System (HOPPS) contains many regulations and code updates that impact cancer providers’ reimbursement. These challenges to oncology coding and billing are best resolved through outsourcing. An experienced medical billing and coding company can help physicians update their coding systems and fee schedules and other reimbursement documents to ensure compliance with the latest guidelines. Such support is crucial as physicians need to focus on patient care and not paperwork.

Rajeev Rajagopal

Rajeev Rajagopal, the President of OSI, has a wealth of experience as a healthcare business consultant in the United States. He has a keen understanding of current medical billing and coding standards.

More from This Author