- Utilization management strategies such as formulary tiers and copayments serve as significant barriers to Medicare Part D drugs for many patients managing serious illness, according to a new report conducted by Avalere Health on behalf of patient advocacy group Partnership for Part D Access.
The report was commissioned in response to a newly-released rule from CMS that would create new flexibilities for the six protected classes of drugs.
The proposed rule in question would still require Medicare Part D payers to cover patient access to all six protected classes of medications. However, the rule provides some exceptions to those regulations that CMS intended to ultimately lower drug costs for patients and payers.
Part D payers could implement step therapy or prior authorization for certain protected classes. This may call into question patient access to treatment for those drugs.
Another new exception would “exclude a protected class drug from a formulary if the drug represents only a new formulation of an existing single-source drug or biological product, regardless of whether the older formulation remains on the market,” the proposal fact sheet says.
This means a Part D payer could exclude a certain drug from coverage formularies if the drug is a new formulation, whether or not the older version is still on the market.
Finally, Part D payers could exclude certain protected classes from drug formularies exceeding a certain price threshold from a specified look-back period.
But the new Avalere analysis suggested that CMS does not need to make these changes; Part D regulations are already effective at lowering costs and reducing the use of high-cost drugs when an equally effective, lower-cost alternative could work.
“This new study provides overwhelming evidence that Medicare’s protected classes policy strikes an appropriate balance between allowing plans to utilize medication management techniques and preserving a safety net for patients who absolutely need a particular medication,” Chuck Ingolglia, Senior Vice President, Public Policy and Practice Improvement at the National Council for Behavioral Health, who serves as Executive Director for the Partnership, said in a statement.
“Even with these protections in place, patients must overcome layers of restrictive barriers that plans put in place to access needed medications,” Ingolglia continued.”
Nearly 91 percent of the prescriptions filled under the protected class category were generic, despite the fact that only 35 percent of all protected class prescriptions are generics. This indicates that patients are effectively being pushed to generic options rather than higher-cost drugs.
Part D payers are also effectively using formulary tiers to ensure patients try lower-cost drugs before turning to more expensive options, the report found. For example, three-quarters of all protected class drugs are in a non-preferred tier or specialty category. Branded medications are deemed non-preferred or specialty 78 percent of the time. Generics fall into similar categories 66 percent of the time.
Overall, Part D plans cover 305 of the 455 protected class drugs on the market. Plans also require patients pay a copayment for 80 percent of branded drugs and just over a third of generic drugs.
The current use of utilization management strategies – including coinsurance, copayments, and tiered formularies – already pose limits on patient care access, the Partnership said.
“Plans are directing Part D enrollees who may not necessarily need a particular formulation of a medication to the lowest cost option available,” the Partnership wrote in a summary of the report. “For the Medicare patients who need a particular formulation of a drug, the protected classes policy ensures they are able to access the medication their physician prescribes.”
Adding more utilization management protocol, namely step therapy or prior authorization, could further hinder or delay care access.
Other industry leaders have responded to the administrations proposal, saying the proposal could threaten access to treatment for vulnerable patients. This proposal “unprotects” the protected classes, according to the Community Oncology Alliance (COA).
“Although CMS claims this proposal includes patient safeguards, navigating those hurdles while dealing with cancer is cumbersome, agonizing, and an unnecessary burden, COA president Jeff Vacirca, MD, FACP, said in a statement. “Additionally, delays in starting cancer treatment can have grave consequences and are inexcusable.”
“While COA commends and supports the Administration’s ongoing efforts to lower drug prices and costs for Medicare and its beneficiaries, weakening or dismantling protected classes is a step too far,” Vacirca continued. “Medicare patients facing cancer pay for and deserve a health care system that allows them access to the latest, evidence-based treatments that they and their oncologists decide are best for them.”
Other organizations, such as the Pharmaceutical Care Management Association (PCMA) were heartened by the Administration’s efforts to create better negotiating circumstances for payers.
“While we are reviewing the proposed rule, we are encouraged the Administration supports greater use of competitive pharmacy benefit manger (PBM) tools that strengthen Medicare Part D for beneficiaries and taxpayers,” the group wrote in a statement. “Specifically, the proposed rule increases formulary flexibility in the so-called 'protected classes' allowing for Part D plans to negotiate bigger discounts. It is also encouraging that the Administration wants to increase transparency on real-time cost sharing for beneficiaries and doctors in Part D.”
Other healthcare entities have until January 25, 2019 to submit public comment on the CMS proposal.