Bearing the Brunt of IRA-Driven Formulary Pressure: Q&A with Sybil Mead

One of multiple efforts by the federal government to tackle the drug-price problem, the Medicare Part D benefit changes are an attempt to reduce the burden on beneficiaries by placing an annual out-of-pocket cap and closing coverage gaps.

While these changes are expected to improve patient affordability, critics argue that they will place more burden on providers and PBMs. As a result, these entities may start to redesign their coverage plans, likely in ways that will create more friction and potentially even reduce coverage for beneficiares.

Pharmaceutical Executive spoke with Sybil Mead, vice president of market access at Sperix Global Insights, about these changes are impacting strategies and which therapeutic areas are likely to be hit hardest. She also discussed how these efforts are impacting drug prices for drugs not included in the benefit changes plan.

Pharmaceutical Executive: How are payers shifting strategy from maximizing manufacturer rebates to a strict net price focus?
Sybil Mead: They're shifting in several ways. Within Medicare Part D, payers are effectively forced to do that for the ten negotiated drugs with the maximum fair price in place. But for non-negotiated drugs, they're achieving the same outcome through rebates. For preferred formulary positioning, they're asking manufacturers for rebates that get them to the lowest possible net price — and they're doing the same in the commercial market. Nearly 50% of payers are now benchmarking commercial rebates for non-negotiated drugs against what Medicare is setting. As Medicare goes, so goes the rest of the market, and payers are using that as leverage across their entire book of business.

PE: Which therapeutic areas are facing the steepest hurdles, and why are areas like diabetes, dermatology, and rheumatology being targeted first for the maximum fair price?
Mead: It tends to be the chronic, high-rebate categories — the ones that drive significant spending into the catastrophic coverage phase. Diabetes, dermatology, and pulmonology are showing the most formulary status changes tied to IRA redesign and related issues, and they're also facing the maximum fair price because there are so many drugs in those categories. As a result, payers are moving drugs in those areas to coinsurance and adding more prior authorizations and other utilization management tools.

PE: How are plans using the maximum fair price to squeeze discounts out of non-negotiated competitor drugs?
Mead: They're doing it in a few ways, and in some respects they're forced into it by CMS. In the therapeutic categories where maximum fair prices are in place, CMS is already reimbursing all drugs in those categories at lower rates because risk adjustments have come down as prices have fallen. So non-negotiated drugs in those same categories are getting reimbursed at lower rates too — which means payers need to either make those drugs less attractive to prescribers or get paid more by manufacturers to give them preferred access. What we're seeing is payers adding new restrictions, increasing step edits, moving drugs to non-preferred tiers, or simply demanding higher rebates in exchange for preferred placement.

PE: What does the shift toward coinsurance over flat copays mean for patient out-of-pocket predictability?
Mead: It's one of the biggest trends we're tracking right now. Payers are moving a significant portion of their benefit designs from flat copays to coinsurance, and we think that could roughly double over the next several years. What that means for patients — or really for beneficiaries — is a substantially greater and less predictable financial exposure. A flat copay is manageable and knowable. Coinsurance tied to a high-cost brand is neither. And that unpredictability puts adherence at serious risk for exactly the drugs where adherence matters most.