As cancer drugs soar in price, the National Comprehensive Cancer Network is introducing cost as a measure of the overall value of a therapy, following the trail of ASCO and a doctor from Memorial Sloan Kettering Cancer Center in attempting to put a lid on drug inflation.
Robert Carlson, MD
As cancer drugs soar in price, the National Comprehensive Cancer Network (NCCN) is introducing cost as a measure of the overall value of a therapy, following the trail of ASCO and a doctor from Memorial Sloan Kettering Cancer Center in attempting to put a lid on drug inflation.
The NCCN plans to introduce price guidelines for oncologists and patients this year. “What we’ve heard from multiple payers is that they want to be able to identify therapies that have equivalent benefits and equivalent toxicities, but also lower cost, in order to do a better job of cost control and cost containment,” says Robert Carlson, MD, CEO of the NCCN.
The NCCN is building financial information into the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines), starting with the NCCN Guidelines for Chronic Myelogenous Leukemia and Multiple Myeloma. The cost component will be a part of the NCCN Evidence Blocks, slated for publication in October 2015. Cost of a particular medicine is not integral to a recommendation for a particular regimen, but it is provided along with other data to help with the choice of treatments, Carlson says.
“It’s more about providing information regarding cost, rather than necessarily restricting choice based upon cost,” he told Oncology Business Management in an interview.
NCCN Guidelines Will Soon Incorporate Cost Considerations
The NCCN Evidence Blocks, which provide a number of measures by which to evaluate a therapy choice: efficacy, safety, quality of evidence supporting the recommended therapy, consistency of evidence supporting the recommended therapy, and affordability. All of this information is presented in the form of a graphic for ease of use and understanding.
“Each of those measures is scored on a scale of 1 to 5. The block is shaded in with color to correspond to whatever the value is for that specific dimension. It allows a user to look at a number of different options and very, very efficiently scan the document to get a sense of how a specific recommendation or group of recommendations fulfills all of those different metrics,” Carlson says.
Carlson says the NCCN did it this way because they believe that using a formula to decide which drugs to use is not as helpful for patients and doctors. “Circumstances vary; how patients value different things or issues varies.” For some patients, toxicity is the primary concern, whereas for others, efficacy or cost may be the key consideration. The evidence block can serve as a starter for a productive conversation between physician and patient about which course of treatment to follow, while also empowering the patient to take a more active role, Carlson says.
“Our system is simple,” Carlson says. “It’s intuitive, it’s graphic—so we think it can be processed very quickly. It’s designed to provide information to physicians and patients so that they can figure out what their own formula is in terms of weighting the different components that people use to make decisions.”
The NCCN also plans to incorporate cost into the existing NCCN Chemotherapy Order Templates (NCCN Templates), which assist physicians in ensuring that they are administering the latest evidence-based chemotherapy regimens for their patients in a safe and consistent manner. The NCCN Templates include chemotherapy, immunotherapy, supportive care agents, monitoring parameters, and safety instructions for therapies included in the NCCN Guidelines. Now, the NCCN is planning to add the cost of chemotherapy regimens and required or recommended supportive care to those regimens, Carlson says.
Intravenous or intramuscular medications are calculated based on average sales price, whereas oral drug costs are taken from the Humana Medicare database. “That information is simply a dollar cost that will be put on that chemotherapy template document,” he says.
Anthem Responds to ASCO’s Drug Valuation Methodology
ASCO’s valuation tool introduced in June was described as a prototype and assigns a “net health benefit” score to drug regimens based on their performance in trials. A limitation of the methodology is that it can only compare therapies that have been evaluated in the same trial, though ASCO is working to develop the model so that it can be of much greater use to physicians and patients, says Richard Schilsky, MD, FASCO, chief medical officer for ASCO.
Schilsky does not anticipate the model having any influence on payer policy. It wasn’t developed for that purpose, but the hope among physicians and others who participated in its formulation is that it will spur greater thought about the true value of a potential therapy at the time a cancer treatment has to be initiated. “There are a number of limitations to the tool that I think would actually make it very difficult to use for coverage decisions,” Schilsky says.
In most cases, the multiple treatments a physician may be considering will not have not been evaluated against one another in a particular clinical trial, which means the valuation tool cannot be called into play.
Schilsky expects that the framework will become more valuable over time, as it is developed, tested, and supplemented with more trial information. “We intend to convert the published framework into a more user-friendly software application that doctors can use at the point of care. There may be statistical methods that we haven’t considered that would allow cross-trial comparisons.”
In addition, ASCO is moving forward with development of a supplementary tool, CancerLinQ, a database that contains information on actual patient outcomes and which can inform treatment decisions much more broadly. “This will actually allow us to compare therapies outside of the context of clinical trials. That’s a much longer term goal, because CancerLinQ is only just going to be deployed at the end of this year.”
In response to a request for comment about the ASCO valuation tool, health insurer Anthem described it as an “extremely positive step” that is in line with its own interest in seeing cost considerations play a larger role in therapy selection. Jennifer Malin, MD, staff vice president of clinical strategy for Anthem, compared ASCO’s tool with Anthem’s Cancer Care Quality Program, which she said “evaluates efficacy, toxicity, and cost for a treatment pathway and couples the pathway with enhanced reimbursement for oncologists. This is not a value framework or tool per se. Rather, it is a program to help drive quality and value as it relates to drug regimens prescribed by physicians to treat cancer.
“The ASCO metric of ‘net health benefit’ can be incorporated as a useful element to consider when evaluating the pathways,” Malin says, but she adds that from Anthem’s perspective, the framework falls short when it comes to identifying which therapies would be best in a given situation, or juggling multiple factors to make a determination of relative benefit for a particular indication.
“ASCO has decided, based on consensus, to set relative weights so that response rate to treatment is half as important as overall survival (OS), and that progression free survival (PFS) is somewhere in between,” Malin says. “The Anthem approach is not to assign specific weight to individual outcomes, such as OS, PFS, and response rate, but to consider the relative toxicity, benefit, and cost of each indication. These judgments are made by expert panels according to specific treatment scenarios.”
Malin says the ASCO tool does not have sufficient flexibility in the way that it accounts for toxicity of therapy. “The ASCO framework will only downgrade therapies due to treatment toxicity when there is a 50% increase in the number of grade 3 to 5 toxicities. As with the clinical benefits, the Anthem program accounts for toxicities according to the specific regimens and treatment scenarios.”
She says the ASCO framework does not clearly differentiate between regimens with different survival benefit. “If a therapy doubles survival from 4 weeks to 8 weeks, it gets full credit in the clinical benefit bucket in the same way as a therapy that doubled survival from 30 months to 60 months.” She says Anthem’s program emphasizes ‘absolute improvements,’ such as incremental months of life, which she says is more easily understood by oncologists and others.
DrugAbacus “Could Prompt” Higher Drug Prices
Doctors at Memorial Sloan Kettering Cancer Center this summer introduced a drug valuation tool of their own called DrugAbacus that uses building block metrics to construct what MSK doctors consider to be realistic values for drugs: efficacy, rarity, population burden of a disease, and cost of development. Each of those factors or qualities is assigned a value that goes into the total DrugAbacus fair value price estimate. Factors such as toxicity are assigned a negative dollar value, and these can knock down the end value.
The actual monthly price for Provenge (sipuleucel-t) was $77,554 at drug launch, but after being reconstructed by DrugAbacus it amounted to just $27,261.
Carlson considers the ASCO and MSK tools as fundamentally different from each other and from the cost tools the NCCN is introducing. He says he has his reservations about the DrugAbacus system, including the fear that some of the higher-than-market cost calculations it comes up with may prompt manufacturers to raise their prices; and he notes the ASCO tool has many moving parts and is not ready for bedside use. “On the other hand, the ASCO system is objective; while it’s complicated, it is transparent,” he says.
Colin White, a drug industry analyst for Datamonitor Healthcare, believes these drug valuation tools do have the potential to inform and influence payer policy, but he thinks the strongest potential for this could come—in Europe—from a drug evaluation tool from the European Society for Medical Oncology (ESMO), whose methodology stratifies drugs based on clinical benefit. “In terms of when regulatory bodies in Europe are making assessments as to the clinical benefit of drugs, they may start to look at the scoring and mention the scoring as part of their assessments in individual countries,” White predicts.
The fallout from soaring oncology drug prices is just getting started in the United States, he says, mentioning as an example the announcement in May of a plan to negotiate price concessions from drug suppliers by Express Scripts chief medical officer Steve Miller, MD.
Miller publicly stated that having to pay the same price for Tarceva (erlotinib) for use in lung and pancreatic cancer was unreasonable given that its survival benefit could be measured in months for lung cancer patients and weeks for pancreatic patients. White also recalls the now-famous plenary address at this year’s ASCO annual meeting by Leonard Saltz, MD, chief of gastrointestinal oncology at MSKCC, who expressed impatience with rising drug costs. In the United Kingdom, the pressure on manufacturers to reduce prices is growing increasingly harsh, White notes. The National Health Service announced early this year that it would trim the number of cancer drugs it covers by 30% as part of what it considers to be a necessary cost reduction program.