Chemotherapy isn’t going away anytime soon, but the real way of the future in cancer treatment, especially solid tumors, is precision medicine that is specifically targeted to patients’ disease.
The challenge is that precision medicine requires testing, which is often expensive and not reimbursed very well by payers. That’s one of the many topics that will be discussed the MedCity Converge conference next month. Shoshannah Roth, manager of the emerging technology team at the ECRI Institute, will moderate a panel on the topic and recently discussed what her organization is doing to help with the issue. The discussion will take place on the morning of the second day of the conference and include experts from Thermo Fisher Scientific, Independence Blue Cross and Biocept.
A major effort by the group is ECRIgene, a database that helps providers, payers and government agencies navigate the hugely complex world of genetic and genomic tests, providing information on resources to compare tests, the purposes of different tests, what kinds of clinical evidence are available and so forth. ECRI aims to act as an unbiased voice and help decision makers look at evidence and context in deciding whether or not to offer a test to patients or cover it.
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A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Indeed, genetic and genomic tests, like liquid biopsy and next-generation sequencing, are expensive, but that’s not the only hurdle to getting them covered by insurers, Roth said. A particular problem comes from current procedural terminology, or CPT codes. These are the codes that physicians enter into their computers when submitting insurance claims for any tests, procedures or medications they administer. While some CPT codes are specific to certain tests, others are so general that 100 tests could fit in to them, she said. The problem for diagnostics comes from the sheer volume of tests available, with tens of thousands on the market, making it impossible to have a code for each one. Some people have come up with alternative codes, and ECRI has a system to categorize tests more finely, but there is no standardized method.
Consequently, it can be difficult to convince payers to cover tests because they may not be sure if the tests are medically necessary. And in cases in which the payers do know what kind of testing has occurred, the evidence to support it may be very sparse or nonexistent.
Liquid biopsy – using a sample of blood to look for circulating cancer cells or pieces of DNA for a tumor instead of taking a full biopsy of the tumor itself – in particular is relatively young as far as development of the technology is concerned, making it particularly challenging because there are not many studies or examples of evidence to support its use, Roth said. That in turn makes reimbursement a challenge because payers are hesitant to pay for something that doesn’t have clinical utility. Still, there are some cases in which liquid biopsy is the most suitable option, such as metastatic lung cancer, given the risk that biopsy could lead to a pulmonary embolism.
Photo: MedCity News
