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Tag: value-driven pharmaceuticals

What’s the Value of a Cancer Cure?

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When CMS approved Solvadi, Gilead’s $84,000 drug for hepatitis C, the stakes were raised in drug price wars.  Two opposing forces, one, a financial push toward lower costs came up against an opposing force of public sentiment. The FDA’s goal of getting 90% of patients moved from costly branded prescriptions to generics met with an an large outcry in social and traditional media for providing the best available care, rallying around the story of a patient.   The wave of sentiment seems to have won over CMS.

Granted, CMS was likely considering the reversal in its policy on Solvadi, but it was the May 12th coverage by the Kaiser Family Foundation and NPR of the patient who was denied treatment, and the amplification across social media that turned the tide toward coverage.

Solvadi had not been approved by the patient’s prescription drug carrier, so physicians lobbied CMS for coverage of Solvadi and the life of the patient. Solvadi appears to cure liver cancer in 90% of the patients who take it as recommended. CMS agreed. As a single payer, they have the incentive to balance drug costs and benefits with other costs and benefits, and new therapies often win the fight for coverage.

Getting Covered: The decision to pay for drug combinations is often quicker than FDA approval of the drug combinations

Objective health policy observers such as KFF note that in the early days of successful antiviral drug treatment for HIV, payers allowed doctors to “mix and match” medications in “off-label” or unapproved combinations as they thought best.  Medicare is often slow to approve the physician-driven cocktails, so getting CMS to adopt the strategy was a win for many very sick people in this country, as it sets a precedent for “exceptions.”

One doctor at Beth Israel Health System in Boston has a trial that has shown that combining Solvadi with another high-cost treatment, Olysio (by Janssen, cost $66,000 for a course of treatment) resulted in 90-100% cure rate.

The CMS statement in this case noted that that “the new policy will apply broadly to hepatitis C patients whose doctors prescribe the combined use of the two drugs because they meet certain criteria laid out in January by the Infectious Diseases Society of America and the American Association for the Study of Liver Diseases.” Those guidelines recommend the combined use of the two drugs in patients with advanced liver disease who have failed to be cured by earlier drug regimens – even though the FDA has not yet approved the combination—because Medicare guidelines say a patient must have access to a therapy if his or her condition warrants it.

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A New Era in Value-Driven Pharmaceuticals

flying cadeuciiAt the end of March the Amercian College of Cardiology (ACC) and the American Heart Association (AHA) issued a joint statement saying they “will begin to include value assessments when developing guidelines and performance measures (for pharmaceuticals), in recognition of accelerating health care costs and the need for care to be of value to patients.”

You may have heard of value-based medicine, but are we entering a new era of value-based medications or value-driven pharma?

Price transparency is great, but it has be combined with efficacy to get to value (price for the amount of benefit). Medical groups are catching on to how important value assessments are, because if patients can’t afford their medication, they won’t take their medication, and that obviously can turn into poor outcomes.

Twenty-seven percent of American patients didn’t fill a prescription last year according to a Kaiser Family Foundation Survey. This trend seems likely to continue as we move toward higher-deductible plans, where those with insurance can have great difficulty affording medications.

Included in the ACC/AMA statement was a quote from Paul Heidenreich, MD, FACC, writing committee co-chair and vice-chair for Quality, Clinical Affairs and Analytics in the Department of Medicine at Stanford University School of Medicine.

“There is growing recognition that a more explicit, transparent, and consistent evaluation of health care value is needed…These value assessments will provide a more complete examination of cardiovascular care, helping to generate the best possible outcomes within the context of finite resources.”

Spreading risk and payment to different members of the health care value chain is beginning to make it apparent to more people and organizations that resources are finite. Patients and their physicians are starting to ask which treatments are worth the cost and have best likelihood of adherence.

An outgrowth of the move toward digital health and accountable care is that we’re entering every patient into a potential personal clinical trial with their data followed as a longitudinal study, and we can look much more closely at efficacy and adherence and reasons why it happens and why it doesn’t.

It won’t be long before we start to see comparative effectiveness across a variety of treatments and across a variety of populations. When we can connect outcomes data, interventions and costs all in the same picture we begin to see where the value (price against results) is and where it isn’t.

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