User Not Found
| Aug 23, 2012
Fundamental changes in treatment approaches, along with payment reform, are required to meaningfully slow healthcare cost growth. Payers face various drug coverage mandates at the state and federal levels, making utilization and cost control challenging. In response, payers are implementing traditional cost controls (e.g., prior authorization (PA), quantity limitations and step edits) and cost-shifting techniques. They are simultaneously in various stages of developing novel approaches to control unnecessary spending, including tighter enforcement of biomarkers, treatment pathways and innovative payment mechanisms.
The development of treatment pathways is very relevant to clinical development and understanding the competitive landscape. Debbie Warner provides a great definition of treatment pathways in her Pharmaceutical Executive article, “Adapting to a New Era of Cancer Care.” Treatment pathways narrow and enforce guidelines, particularly for metastatic disease, where most of the new drugs are approved and where payers reimburse for a large portion of oncolytic expenditures. The higher visibility of novel and expensive oncolytics requires manufacturers to pay far more attention to demonstrating value. From a treatment choice perspective, pathways are not the NCCN guidelines or a compendium but instead provide a handful of reasonable options. The best pathway programs are developed by physicians in conjunction with payers or third-party companies. When physicians play a large role in developing pathways, reasonable and approved options are unlikely to be excluded. What might be at risk in a pathway program is any off-label utilization (category 2A, 2B, or 3 recommendations from NCCN, for example). Additionally, pathways encourage clinical trial enrollment and earlier use of non-oncolytic palliative care to limit the use of drugs that might not contribute to extending life. Translation: Later lines of therapy could be at risk along with agents that provide only marginal benefit. Agents that extend life and limit adverse events could be given preferential status.
Still, pathway programs will not be Draconian requiring 100% compliance. The largest pathway program from UPMC suggests that 75-80% compliance is a reasonable target for many cancers, though it could be lower in certain diseases such as multiple myeloma, where it can be as low as 50%.1 Generally, this allows for 20-25% of drug-related treatment decisions to be “off-pathway,” giving participating physicians a degree of flexibility.
Diseases with the largest populations are the most likely at risk, including metastatic colorectal, non-small cell lung, breast and prostate cancers. Less prevalent diseases associated with large drug expenditures also could be at risk, such as renal cell carcinoma, multiple myeloma and non-Hodgkin’s lymphoma.
Throughout my blog I have noted physicians as “participating.” This is because it is difficult to see payers mandating pathway participation in the immediate future; community practices have a choice. Since Medicare reimbursement for physician-administered drugs was lowered to ASP +6%, commercial payers have increasingly sought reimbursement cuts as well. At a minimum, participation in pathways reduces the risk of not being reimbursed. Physicians’ and practice managers’ confidence in being reimbursed for high-priced IV drugs is a large driver in prescribing regardless of pathway participation.
Given that the best pathways are physician-designed, developing solid support from physicians can increase manufacturers’ chances of being included in pathways. In most cases, the influential physicians will be local or regional KOLs from the community rather than international KOLs. Additionally, manufacturers can help their case by developing a convincing value proposition, including a large efficacy benefit on top of showing diminished requirement for drug expenditure to treat adverse events. Manufacturers also can provide clinical support for oncologists trying to justify going off pathway and work with health plans to identify compliance goals for different diseases or lines of therapy based on tumor-specific patient variability.
1 Brufsky, Adam; “Driving Evidence-Based Standardization of Care within a Framework of Personalized Medicine;” Doing It Right, and for Less: Implementing practice Changes to Manage the Growing Complexities, Inefficiencies, and Costs of Cancer Care, Education Session, ASCO 2012