All eyes are on Capitol Hill this week as the Supremes hear oral arguments in one of the most important –and politicized—cases in decades: the constitutionality of the Affordable Care Act, the signature piece of legislation passed thus far in Barack Obama’s presidency. It’s anybody’s guess how the Court will vote –questions on day 2 tied to the constitutionality of the individual mandate were pointed and seemed to fluster the administration’s lawyer Donald Verrilli.
One thing seems clear: Justice Anthony Kennedy’s view of the mandate will play a crucial role in whether that provision stands. As Scotusblog reports, if Kennedy can find a limiting principle in the federal government’s defense of the insurance mandate or think of one of his own, it could survive—and his arguments just might convince Chief Justice John Roberts to side with the four liberal justices who are already signaling they will support it. But if Kennedy, who expressed skepticism about the mandate, rules against it, the one piece of health reform that insurers really liked will go by the wayside.
Whether that scuttles payment reforms already at work by major insurers is another question. Indeed, as CIGNA CEO David Cordani told Bloomberg recently, “With or without the healthcare law, the economic forces are driving change.” In other words, even if the law gets overturned – or more likely, is held hostage by political differences that will only grow more heated in this election year—payers, providers, and product companies must evolve to find solutions that can address the basic problem that healthcare spending continues on an upward, and increasingly unaffordable, trajectory.
In short, whatever the inscrutable Justices decide come June, it won’t stop the transformation from fee-for-service and volume-based healthcare to one built on value. And, thus, product reimbursement will continue to be a heated topic.
Outside the Supreme Court case, there was plenty of healthcare news with reimbursement implications. Your top stories for this week courtesy of Halleh Balch and Ellen Licking:
Will accelerated approval lead to new patient-reported outcomes tools? That’s the question “The Pink Sheet” asks in its March 26 issue after analyzing comments made during a March 20th Oncologic Drugs Advisory Committee review of GlaxoSmithKline’s Votrient in patients with advanced soft tissue sarcoma. The regulatory body positively reviewed Votrient’s risk-benefit profile, but seems to feel more comfortable with an accelerated approval route that includes additional patient outcomes data or efficacy to confirm the drug’s clinical benefit. Inside and outside the agency there’s a desire to expand the use of accelerated approval so that innovative drugs for rare diseases can reach the market sooner. As “The Pink Sheet” points out, a by-product of these efforts could be the need for drug companies to develop validated patient-reported outcomes (PRO) instruments that clearly show how a medication improves quality-of-life. Whether such data are ultimately required for Votrient’s approval in STS, legitimate QOL measures will be an important benchmark for payers assessing the utility of the drug. Absent that information, payer pharmacy teams will have to make a coverage decision based on the median three months of progression free survival Votrient has shown thus far in clinical trials. Whether they will decide that constitutes a true benefit over currently prescribed treatments, which include generic doxorubicin, is another question.
- See this article published in “The Pink Sheet” for more detail on the take-home messages from the March 20 ODAC meeting (Subscription required).
The quest for biomarkers to predict Avastin response: Biotech giant Genentech and the personal-genomics company 23andMe are recruiting breast cancer patients to conduct a study to identify response biomarker for one Genentech’s most important revenue generators, the anti-VEGF monoclonal antibody Avastin. It’s a long overdue effort to build a case for the clinical utility of the drug in a smaller subset of patients with the metastatic breast cancer indication. Recall the FDA initially approved Avastin for metastatic breast cancer via the accelerated-approval pathway in 2008 on the basis of early-stage studies. However, last November after post-approval studies demonstrated Avastin had only a small effect on tumor growth and did not improve overall survival, regulators revoked the drug’s approval in this indication. In response to the FDA’s decision, Genentech said it would conduct a clinical trial in breast cancer patients to identify genetic predictors of Avastin response. Showing clinical utility for a biomarker –or more likely a group of biomarkers—won’t be either easy –or cheap. Neither will amassing the clinical trials data required to convince payers to cover the drug. The explosion of diagnostic tests concerns payers, who worry many have not been adequately validated via prospective clinical trials. Indeed, in a recent webinar hosted by Value & Innovation, Lee Newcomer, UnitedHealth Group’s SVP of Oncology, Genetics, and Women’s Health emphasized just how big a problem unvalidated diagnostic tests were for his company. “United pays more [annually] for [all] genetic tests than it does for chemotherapy,” he said. To justify that expense, he argued there needs to be good solid evidence that a test really makes a difference in clinical practice. “Too often those data are missing.”
- You can review the FDA’s decision on Avastin by downloading this PDF.
- The press release from 23andme and Genentech is here.
The IOM opines on -omics: Here’s another example of the need for more oversight associated with molecular tests. The Institute of Medicine released a much anticipated report finding broad problems in using genetic signatures to guide cancer treatment. The IOM report, released March 23, found that “omic” tests, which look for patterns in large sets of molecules like proteins, DNA, RNA, or metabolites, are highly prone to error, require better oversight, and are at risk of a problem called overfitting, in which too small a sample size is used to establish the correlations between biomarkers and a patient’s disease. The IOM report was triggered by a recent case involving the premature use of these diagnostics in cancer clinical trials at Duke University. The IOM made it clear the snafu could have occurred at any academic center, but that doesn’t make it any easier for Duke, which had been in major clean-up mode since the fraud committed by researcher Anil Potti came to light. Thus far, three clinical trials have been cancelled, 27 papers are expected to be partially or fully retracted, and a lawsuit against the university has been filed. While the push towards personalized medicine gains momentum, outcomes such as this are another reminder of how far the science must still progress.
- An analysis of the IOM report by Science Insider is here.
- Click here for the full IOM report.
- To read Duke’s own coverage of the IOM report, click here.
Who needs cancer pathways when you have IBM’s Watson? Memorial Sloan-Kettering Cancer Center is the latest to see potential in IBM’s supercomputer Watson for providing decision support to busy oncologists. In September 2011, IBM and the payer WellPoint announced a collaboration to develop healthcare applications using Big Blue’s Jeopardy winning machine. In late December, WellPoint further refined its ambitions, revealing it was teaming up with Cedars-Sinai to use Watson to develop cancer treatment plans. The MSKCC alliance announced last week is similar in spirit; in this instance Watson will apply its computational prowess to the university’s deep oncology database, which has outcomes and cancer histories for more than 1 million patients. A new tool will be created to allow docs to mine the patients records to determine optimal treatment paradigms based on known outcomes. It’s a spin on the concept of cancer pathways, decision support tools based on therapy guidelines recommended by major cancer societies like ASCO of NCCN. Only in this case, instead of human beings looking at the data and setting the optimal treatment regimen, Watson will sift through the volumes of unstructured data to recommend therapies based on the available evidence. Or it will—pilot programs using Watson in this manner won’t start until late 2012, with the initial focus on breast, lung, and prostate cancer. One key question for IBM and its partners: what’s the business model for this new tool? Would MMSK/Watson provide a pathway alternative that competes with the software supplied by Innovent Oncology, P4 Healthcare, Via Oncology, eviti, or others? Would the tool be sold to providers –or is the goal to sell it to payers who would then encourage providers to adopt?
- Here’s Bloomberg’s take on the news.
- A youtube video produce by IBM’s social media team explains the alliance.
Image courtesy of flickrer Jan Siefert via creative commons.