How PBMs limit access to MS therapies

The high cost of living with MS

For the estimated 1 million Americans living with MS, treatment is a lifelong necessity. A 2022 study funded by the National MS Society found that the average annual cost of living with MS is $88,487, with disease-modifying medications accounting for the largest portion of these expenses.

"MS is already an expensive disease to manage," Talente explained. "When patients cannot access affordable generics, the financial burden continues to mount. Medications like Ampyra are not optional -- they are essential for maintaining mobility and quality of life. Yet, due to PBM pricing tactics, even generics remain financially out of reach for many. 

Unlike other chronic conditions where patients may have temporary treatment plans, MS medications are often taken indefinitely, from the time of diagnosis through the rest of the patient’s life. This long-term dependency on high-cost drugs makes any form of price manipulation by PBMs particularly devastating.

The role of PBM consolidation in driving up costs

One of the most concerning findings in the FTC report is the degree of control a handful of PBMs have over the market. In 2023, just three PBMs -- Caremark, Express Scripts and OptumRx -- controlled 68% of the specialty drug dispensing revenue.

This vertical integration allows PBMs to steer prescriptions toward their own affiliated pharmacies, limiting competition and keeping prices high. The result? Reduced access, fewer choices and higher costs for patients.

"The majority of people living with MS are required to use a specialty pharmacy associated with their PBM," Talente said. "This means they can’t shop around for better service or pricing. If they have issues with their pharmacy -- such as delays in medication delivery or difficulty accessing a particular therapy -- they often have no alternative."

For MS patients, consistent access to medication is crucial. Interruptions in treatment can worsen symptoms, increase the risk of relapses and lead to irreversible disability progression. Despite this, many PBM-controlled pharmacies have been reported to delay shipments or leave medications outside, where they can be damaged by heat or cold.

"The system creates unnecessary stress and anxiety for patients who are already managing a complex disease," Talente highlighted. "These are life-saving medications, and patients shouldn’t have to worry about whether their shipment will arrive on time or in usable condition."

Spread pricing

Another controversial PBM practice identified in the FTC report is spread pricing, which allowed PBMs to generate an additional $1.4 billion in income at the expense of patients and health plan sponsors.

Spread pricing occurs when PBMs charge insurance plans and employers significantly more for a drug than what they reimburse pharmacies for it -- keeping the difference as profit. This practice has been particularly detrimental to MS patients, who already struggle with high out-of-pocket costs.

"Many MS patients are covered under employer-sponsored plans, and as drug costs increase, so do their out-of-pocket expenses," Talente noted. "From 2017 to 2021, plan sponsors saw a 21% annual increase in drug spending, while patient cost-sharing rose by 14%-15%. That means more people with MS are forced to make difficult financial choices -- like skipping doses or delaying treatment."

According to a 2019 survey conducted by the National MS Society, 40% of MS patients reported altering the use of their disease-modifying treatments due to cost, while more than 50% were concerned about affording their medications in the coming years.

As costs rise, some MS patients have turned to alternative sources, such as Mark Cuban’s Cost Plus Drug Company, which offers lower-cost generics without PBM markups. While this can provide immediate relief, Talente warned that this is not a sustainable long-term solution.

"Patients who buy from alternative pharmacies often can’t apply those costs toward their deductible or out-of-pocket maximums. This creates an unfair system where PBMs and insurers benefit, while patients bear the financial burden alone," Talente reaffirmed.

PBM-affiliated pharmacies and the impact on independent pharmacies

The FTC report also found that PBM-affiliated pharmacies generated $6.2 billion in dispensing revenue above the National Average Drug Acquisition Cost (NADAC) for the top 10 specialty generics. This raises critical questions about the role of PBMs in undermining the affordability of generics.

"These practices are deeply concerning because they negate the cost-saving benefits of generics, which were designed to offer lower-cost alternatives to brand-name drugs," Talente emphasized. "Instead, PBMs are extracting outsized profits at the expense of patients and payers." 

Another issue is that independent pharmacies are being reimbursed at lower rates than PBM-affiliated pharmacies, making it increasingly difficult for them to survive. This is especially problematic in underserved rural and urban areas, where independent pharmacies often provide critical access to specialty medications. 

"When independent pharmacies can’t compete, they shut down, reducing access for patients who rely on them," Talente cautioned. "This disproportionately impacts low-income and rural communities, where PBM-controlled specialty pharmacies may not be easily accessible."

Advocating for PBM reform

Given the overwhelming evidence of anti-competitive and profit-driven behavior in the PBM industry, the National MS Society is calling for regulatory changes to increase transparency and accountability.

Specifically, the organization supports reforms that would do the following:

• Ban spread pricing, preventing PBMs from charging insurance plans more than what they pay for drugs.
• De-link PBM compensation from drug prices, eliminating incentives for PBMs to profit from high-cost medications.
• Address step therapy requirements, which force patients to try and fail cheaper medications before getting access to prescribed treatments.
• Ensure fair formulary placement, so that specialty generics are not placed on higher-cost tiers that increase out-of-pocket expenses.

"PBMs should not be incentivized to maximize revenue at the expense of patient health," Talente argued. "Reforms are needed to ensure that cost savings from generics actually benefit patients, rather than being siphoned off as PBM profits."

With increasing scrutiny on PBMs, companies have an opportunity to take proactive steps toward a fairer drug pricing model.

Potential solutions include the following:

• Increased transparency in pricing structures to build trust with patients and healthcare providers.
• Expanding direct patient assistance programs to offset high out-of-pocket costs.
• Exploring alternative distribution models that bypass PBMs and improve affordability. 

The stakes are high for MS patients and others relying on specialty generics. Unless meaningful reforms are implemented, affordability and accessibility will continue to be a backseat to corporate profits, reinforcing a system that prioritizes financial gain over patient well-being. 

Alivia Kaylor is a scientist and the senior site editor of Pharma Life Sciences.