Weight-loss drug gets advisory committee nod: Can the benefits of weight-loss outweigh the potential costs of severe medical side-effects? An FDA Advisory Committee thinks so. On Wednesday February 22, the Endocrinologic and Metabolic Drugs Advisory Committee voted 20 to 2 to approve Vivus’s Qnexa, a weight-loss pill that combines two previously approved—and now generic—drugs, phentermine and topiramate. It’s been a long and torturous road for Vivus; the company’s backers believe the strong advisory committee meeting increases the odds of a positive nod from the agency by the drug’s April 17 PDUFA date. (And they are trying to capitalize with a February 28 public offering of 8.5 million shares of common stock.) Certainly, with one third of the population struggling with obesity, it’s a fair bet FDA will be under some pressure to approve the medicine: after all, the data show Qnexa can sheer off up to 10% of a person’s weight. Moreover, the biotech has mitigated some of the side-effect risks by proposing a REMS to monitor birth defects and a post-market cardiovascular study. Let’s assume Qnexa will be approved by mid-April. That leaves two central questions unanswered. First, how will Vivus price the drug? Second, how will payers, who typically steer patients to diet and exercise for weight-loss, cover the medicine? In reality, the answer to question two is likely linked to the first, with more payer pushback the higher Qnexa’s price tag. Certainly Vivus execs would do well to remember the tepid reception Bidil, another two generic combo with a premium price tag, received when it launched. No one is saying Qnexa is another Bidil. For starters, the product’s formulation means it would be difficult to replicate the dosing with the readily available generics. Second, the side-effect profiles of the two meds mean off-label use is unlikely. No matter what, we’re betting Vivus’s market access group has kicked its efforts into high gear, because selling an obesity drug ain’t like selling Lipitor.
- See this article from Forbes on why Qnexa won’t be the next Lipitor.
- NPR explains the FDA advisory committee meeting vote.
- You can find the relevant FDA briefing documents here and here.
Enter the cabana for comparative effectiveness: Keep your eyes peeled for new data in an ongoing cost- and comparative effectiveness study of treatments for atrial fibrillation (CABANA). The ongoing trial, begun in 2009, is designed to provide data to rate the utility of catheter ablation technology versus standard drug therapies that control heart rate and/or heart rhythm. In addition to helping doctors determine the optimal circumstances for choosing the procedure instead of less invasive drugs, CABANA will also study the comparative cost of the two treatment approaches. Equally important is the creation of the Atrial Fibrillation Registry, which collects data on AF patient treatments and outcomes and can become a stimulus for future comparative studies. It will be years before CABANA, which is sponsored by Mayo, Duke University, and St. Jude Medical among others, plays out. The trial aims to enroll 3000 patients; so far just 629 patients have participated in the effort, which is underway at more than 100 trial sites. Meantime, while most tend to think comparative effectiveness studies will judge the merits of drug A versus drug B, one of the tenets underpinning the Patient Centered Outcomes Research Institute is to devise methods that help compare the utility of devices relative to pharmacologic options. On February 27, PCORI held an open meeting to ask for public comments as it finalizes its priority draft agenda.
- See this commentary on the need for comparative studies of atrial fibrillation technologies.
- Additional information on the AF registry is here.
- You can read about the CABANA trial here.
The useful meaning of stage 2: The Centers for Medicare and Medicaid made waves at last week’s healthcare IT meeting HIMSS when it announced its proposed Stage 2 “meaningful-use” rules. The proposal emphasizes interoperable digital communication between doctors and hospitals, increased digital data collection of medical records, as well as greater patient access to those records. Advocates of Stage 2 argue these guidelines will streamline medical care across specialists, reduce errors in patient records, and better engage the patient in his or her medical evaluation and treatment. Other recommendations that aren’t full blown requirements include: making digital record systems capable of sending information to public health agencies and research registries (for example those used for cancer research); enabling the transfer of image results from X-rays, CT scans, and MRIs. Emphasis on the latter would help avoid a scenario common in today’s fragmented care environment: duplicate scans ordered by different specialists to make an evaluation. Not only can such repeat tests be costly; the radiation exposure can make them medically inadvisable. The electronic health record program was started as part of the 2009 federal stimulus package, which provided $30 billion for health care providers to develop an electronic medical record for Medicare and Medicaid patients. Stage 1, which required providers begin using EHRs to record patient diagnoses and prescriptions, was supposed to expire last year, but the current Stage 2 proposal extends the compliance deadline to 2014. Official Stage 2 rules will be published on March 7 and open for public comments until early May.
Who sets the reimbursement environment for Medicaid? Last week, the Supreme Court punted the lawsuit over Medi-Cal provider payment cuts back to the lower courts. The original case, Douglas v. Independent Living Center, began in 2008 when California lawmakers were sued by physicians and consumer groups for cutting Medicaid provider payment rates. Plaintiffs argue the extreme cuts will discourage physicisans from providing quality medical care to the economically disadvantaged. It’s not hard to understand why California lawmakers might be interested in cutting Medi-Cal costs; the state is at the brink financially and the Medicaid program, which provides healthcare coverage to 7.6 million needy Californians, is one of the state’s biggest line-items, costing more than $15 billion this year alone. Since 2008, the case has had mixed reviews from state and federal administrations. The 9th Circuit Court of Appeals in California blocked the cuts, while CMS approved some of the proposed rate changes. The contradiction between state and federal branches led the defense to bring the case to the Supreme Court using the so-called Supremacy Clause, which mandates that state rulings follow constitutionally authorized federal law. In the decision last week, however, the Supreme Court punted the case back to the 9th Court of Appeals, arguing this clause is no longer applicable, given the actions taken since the filing of Douglas v. Independent Living Center. One of the central issues: can claimants still argue Medi-Cal cuts violate federal law if CMS, a federal agency, has approved them? Even though the matter is largely out of their hands, payers and physicians navigating the Medicaid reimbursement environment are closely watching the case’s outcome.