part d plans charge relatively high coinsurance for new hcv drugs and require rigorous utilization management, including prior authorization and quantity limits for those drugs. there is little variation in coverage between plans, leaving few options for beneficiaries to choose a plan with better benefits. This is probably because plans are concerned about adverse selection (attracting more HCV patients and sicker ones) by offering more generous coverage for HCV drugs than their competitors.
Analysis indicated that current Part D cost-sharing subsidies help mitigate financial hardship for low-income patients in need of expensive new medications; however, the total out-of-pocket expense for unsubsidized patients to complete new hcv therapy is significant, reaching $10,000. This suggests that the presence of catastrophic coverage, which was designed as a stop-loss in part d, and the recent gap discount for brand-name drugs, do not offer significant financial protection to part d enrollees who require high priced drugs.
These findings are consistent with recent reports on Part D coverage for high-priced drugs for rheumatoid arthritis and cancer.19,20 to many high-priced drugs. it is disappointing that the effectiveness or therapeutic values of drugs are not considered in benefit decisions. The new HCV drugs are very effective, but Part D plans’ coverage for them differs little from that of existing, expensive but less effective HCV drugs. It is also surprising that integrated maps charge a slightly higher cost share on average for new HCV drugs than stand-alone PDPs, although they could expect potential cost savings by reducing use of medical services by offering generous coverage for those medications.
Cost-sharing is commonly used to contain health care expenses, so plans may have naturally turned to high cost-sharing for all expensive drugs as drug spending rises. while not surprising, this raises concerns that patients’ access to necessary medications may be limited, which may worsen health outcomes. it also raises an important but difficult question of how to design benefits for high-priced drugs. One approach would be to selectively reduce cost-sharing for high-value drugs, and in particular for beneficiaries with financial hardship, to ensure patients’ access to effective drugs.
tying shared costs to value is not a new strategy. it has been adopted for drugs used to treat common chronic conditions, such as diabetes or hypertension.21,22 Applying it to new drugs can be challenging because it is difficult to define/measure the value and evidence on effectiveness in the real world or cost-saving effects is difficult. not yet established for new hcv drugs. Little is known about its impact on patient health outcomes, such as incidence or progression of liver disease, and post-therapy care utilization. a value-based approach based on clinical efficacy (using currently available information) would be limited, but could be a good starting point when implementing procedures to update information on value/effectiveness as more evidence is collected.
In addition, reducing the financial stress of beneficiaries who need expensive but effective medications can help improve patients’ access to those medications. As we showed earlier, current Part D coverage may not provide adequate financial protection for some beneficiaries because newly introduced high drug prices far exceed the initial coverage limit and exceed Part D maximum thresholds. Expanding eligibility for low-income cost-sharing subsidies for certain expensive but effective drugs could be an option to explore.
Our analysis is limited to examining HCV drug coverage without assessing its impact on drug utilization. it does not tell us how many patients would not start new drug therapies or discontinue therapies due to financial burdens. we were unable to examine prior authorization protocols and how many cases are denied. future research should address those questions as utilization data for the post-sovaldi period become available.
Despite these limitations, our review is the first to describe current Part D benefits for HCV medications and examine their financial implications for HCV patients. As baby boomers (the group most likely to have HCV) join Medicare, efforts must be made to ensure patients’ access to necessary medications.