Clinical Pathways: What Do They Mean for You and Your Product?
Ben Steele speaks to C. Lyn Fitzgerald, Vice President of U.S and Global Development at the National Comprehensive Cancer Network (NCCN) about the growing use of clinical pathways in oncology practice in the U.S, and the implications that this has for the way pharmaceutical companies do business.
Clinical pathways (subsequently referred to as ‘pathways’) are a set of evidence-based treatment protocols that attempt to standardize the care that oncology patients receive from physicians. They are being looked at by U.S. payors as a way to decrease variability in care for cancer patients while also bringing down costs. As Ms. Fitzgerald explains, “the not-for-profit organization NCCN provides the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines). These are evidence-based, and are meant to provide guidance for providers, payors, and patients on what is appropriate care. Generally, commercial pathways are a subset of guidelines also based upon evidence, but developed by private companies, who market them to payors as a way of reducing costs. The Guidelines are based on efficacy, toxicity/safety, and expert consensus, while pathways will generally factor in cost as a determinant of which drugs are included.”
“Guidelines are particularly important in cancer care because of continuous innovation. Cancer has become a chronic disease in many cases because cancer care has improved, in part, due to innovation. Whether it is new data, new therapies, or new biomarkers, the field of oncology is constantly changing. Guidelines are important because there needs to be an authoritative source, such as NCCN, that continuously reviews the evidence and then provides criteria and guidance for clinical decision-making to the cancer community: ‘here’s what’s new and appropriate’. Community oncologists will generally treat multiple forms of cancer, and it can be very difficult for someone who isn’t a subspecialist to keep on top of all the ever-evolving data when deciding how to treat a certain patient.”
“This lack of transparency puts pharma firms in a difficult position, because they don’t know what the value equation is supposed to be.”
According to the NCCN website, in a small survey conducted at NCCN’s 2012 Annual Conference, nearly 60 per cent of respondents said they had implemented or were considering implementing clinical pathways. In the future, getting on a pathway will have a big impact on the sales and market share of a new drug, and it is important for pharma to know what will qualify their product for inclusion on a pathway. The NCCN Guidelines are produced according to a transparent process, and are available to all who wish to access them. In fact, Ms. Fitzgerald says, “we also have patient versions of some of the NCCN Guidelines that are easier to read and understand. We work with patient advocacy groups to help patients understand more about these guidelines and how to use them in their conversations with physicians. However, many of the for-profit companies who have developed proprietary pathways have elected to do so without transparency and will only allow payors and physicians to access them, and only once an agreement has been signed. This lack of transparency puts pharma firms in a difficult position, because they don’t know what the value equation is supposed to be, or exactly what data they need. It is relatively clear what data they need to be approved by the FDA, but when dealing with proprietary pathways they are left in the dark.”
“Having said this, pharma should know that the pathways companies are considering cost. With or without transparency, they have to know some element of cost is going to be considered. If they are going to launch a new therapy that costs ‘x’ amount, they need to identify the incremental benefit necessary to justify the price, especially where other options already exist.”
What may be confusing to pharmaceutical companies is how exactly they demonstrate added benefit for a medication. Ms. Fitzgerald explains that “the NCCN Guidelines are based on evidence, such as randomized clinical trials, but in the case of pathways, if you are looking at costs and comparative outcomes, there may be an application for real world data. However, it’s still undetermined who is going to collect the data and how it’s going to be applicable, because of the lack of transparency.”
Identifying a patient subpopulation and developing targeted therapies may be the best way to ensure inclusion on pathways in future, as the system works by first looking at efficacy and safety, only taking cost into consideration when there are several equally beneficial treatments available: “If all things are equal, then they go to cost as a determinate for inclusion. If there is a new targeted therapy where a biomarker has been identified, and it is more expensive, but there is solid evidence that an associated subpopulation of patients would respond better, in theory that would also be on pathway because of the benefit it provided.”
“There definitely is a work-flow issue when a practice accepts multiple types of insurance who are contracting with multiple pathway companies.”
At the moment, pathways providers usually expect around 80 per cent of patients to be treated on-pathway; NCCN accepts that every patient is unique, and having a target of 80 per cent leaves room for physician and patient choice, as NCCN asserts that individual clinical situations determine the appropriateness of recommendations for the patient. Ms. Fitzgerald tells us, US Oncology published two studies validating the benefits of The US Oncology Network Level I Pathways in terms of outcomes and cost. NCCN is collaborating with McKesson Specialty Health/US Oncology on developing Value Pathways Powered by NCCN, which will be 100-percent concordant with the NCCN Guidelines and will include a level of transparency not seen in commercial development today. Moreover, these pathways, developed by physicians for physicians will be integrated in a first-of-its-kind clinical quality and regimen support system—an important step in ensuring patients receive the highest quality treatment while offering options to address costs of cancer care. Additionally, the technology will allow for analysis of the related data in concordance to Guidelines and the Value Pathways Powered by NCCN. So as to protect privacy, oncologists who use the tool will have the option to allow their practice pattern data to be reviewed in the aggregate by NCCN.
So far, physicians have been responding well to the idea of Value Pathways Powered by NCCN, and Ms. Fitzgerald predicts that their use will only grow in future due to the pressure to control costs for cancer care. She accepts that there are still technical issues that need to be resolved; “there definitely is a work-flow issue when a practice accepts multiple types of insurance who are contracting with multiple pathway companies. Managing the difference across patients creates more work for the oncologist and oncologist’s office, because they have to know when a patient comes in what kind of insurance they have, what plan they have, and therefore what pathway they are on. It is a juggling act. What is nice about utilizing the NCCN Guidelines is that they are applicable with most patients, and they are used by private and public insurers alike for coverage policy.”
The growing use of pathways is something that pharma will have to come to terms with in the next few years. This may mean more of a sense of uncertainty when it comes to the marketing of drugs, as physicians who follow pathways are less likely to be influenced by visits from sales reps. Conversely, for companies that can demonstrate added benefit, having their medications included on pathways will lead to increased sales and market share. The main point of confusion lies with the type or level of evidence needed to demonstrate benefit, and pathways companies show no signs of clarifying their criteria for selection any time soon, which means that for now pharma will have to get used to operating in the dark.
C. Lyn Fitzgerald will be joining our C-suite pathways panel at Oncology Market Access & Marketing Summit USA in Boston. Four leaders of America’s top pathways programs will reveal their formulary and explain how pathway adoption will impact your product. Find out more about this panel, as well as our other speakers, at the official website.
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