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A look into the complex battle between pharmaceutical manufacturers and payers for balance between medication access and budget management.
The back and forth between pharmaceutical manufacturers and payers is an ongoing saga. A move by one is met with a counter by the other in a seemingly never-ending struggle to find balance between medication access and budget management. This battle has played out in the patient cost share arena for decades.
As medication costs grew, payers introduced tiered formularies and differential copays to incentivize patients and providers to choose lower cost, or “preferred,” medications. Manufacturers responded by launching copay assistance programs to help patients afford cost share. In 2017, payers’ response to copay assistance took the form of the accumulator program, which was designed to remove manufacturer assistance from the calculation of the patient’s deductible and out-of-pocket maximum progression. Payers did not stop there. Seeing that copay assistance programs often had lofty annual benefits, payers saw that accumulators had the potential to leave money at the table. Thus, the next shot in the back and forth was launched with the maximizer program. These changes have led patient cost share from being relatively basic to remarkably complex, and more change is on the horizon.
In brief, a maximizer program is designed to utilize the entire annual benefit from a pharmaceutical’s copay assistance program by altering the patient’s cost share. For example, if drug X has a copay assistance program with a maximum annual benefit of $12,000 per year, a maximizer program will set the patient cost share for that specific pharmaceutical at $1,000 per month so that over the course of the year, the entire $12,000 is utilized. This is in contrast to accumulator programs, which do not alter the patient cost share and merely prevent the manufacturer contribution from contributing to the patient’s accumulation toward their deductible and out-of-pocket maximum. Because payers cannot arbitrarily change patient’s cost share, maximizer programs require modifications to the benefit language between the pharmacy benefit manager (PBM) and the employer group. This is partly why maximizer programs have been slower to catch on than accumulators; however, now that many PBMs have made that change with their clients, maximizers are poised to be the preferred copay management program by payers.
Maximizer programs have numerous important advantages over traditional accumulator programs, beyond just using all the copay assistance. By breaking up a pharmaceutical’s annual assistance over an entire year, a maximizer program prevents patients from falling into a coverage gap when the financial assistance dries up too soon, as can be seen with accumulators. When accumulator programs were first introduced in 2017, patients with high-cost conditions, such as hemophilia, ran out of financial support early in the plan year and were then confronted with significant, often unaffordable, cost share. The result was noncompliance and worsening health.1 Maximizer programs avoid this scenario by spreading assistance throughout the year, which allows payers to save significant money and also avoid patient noncompliance and the costs/complications associated with worsening health.
Another challenge with accumulators is the administrative and operational burden. Accumulator programs may require the participating specialty pharmacy to revisit filled claims at the end of the workday, identify the amount of manufacturer copay assistance for each prescription, and then send data to the plan or PBM so the patient’s deductible/out of pocket can be adjusted accordingly. As the number of claims increases, so does the administrative workload.
Maximizers, on the other hand, are built on the front end of claim adjudication. When a prescription for a targeted medication is submitted to the PBM, the maximizer program activates and changes the patient’s cost share. Administrative work is minimized and the pharmacy is able to process the prescription and connect the patient with assistance efficiently.
Finally, the savings maximizers produce may be more predictable. Payers thrive on predictability, and trying to determine how much may be saved with accumulator programs when implemented across thousands of benefit designs is a challenge. For maximizer programs, however, a payer can estimate savings simply by taking the number of members on an impacted product, determining what proportion are subject to the maximizer, and then multiplying by the monthly patient cost as determined by the maximizer. The estimate will not always be accurate but may be more predictable than with accumulators.
Perhaps more concerning is how some PBMs are operationalizing maximizer programs. Express Scripts leverages a program called SaveonSP. The program is described in publicly available information provided to members of an employer.2 Specialty medications, more than 80 in all, are declared “nonessential benefits,” because these medications are not within the 10 essential benefits as required by the Affordable Care Act (ACA).2 Because the products are considered nonessential, patient cost share paid for these prescriptions do not count toward individual deductibles or out-of-pocket maximums2; however, benefit plan members are encouraged to enroll in SaveonSP, which will provide the medication at no cost to the patient via Express Scripts’ own Acredo specialty pharmacy.2 Furthermore, the benefit plan members are required to report whether they are using a manufacturer assistance program when they enroll in SaveonSP and provide any required information.2 Presumably, SaveonSP is able to provide drugs at no cost to the patient because the manufacturer program picks up the tab. A document online from EMI Health goes a step further by showing members what they would owe if not enrolled in SaveonSP.3 The monthly costs are significant and, undoubtedly, convince even the most hesitant members to enroll.
Perhaps most alarming in the SaveonSP example is the declaration that certain drugs used to treat a variety of diseases, including cancer, are “nonessential.” In all likelihood, this designation is to enable the key features of the program, including the high cost share and lack of progression to the out-of-pocket maximum. In addition, outside ACA mandatory classes, self-insured employers have the freedom to determine what is and isn’t covered. However, pharmaceutical manufacturers and health care providers in general should raise concerns about declaring drugs “nonessential” based not on clinical data or disease treated, but instead by the riches of that drug’s financial assistance program. Manufacturers often state that copay assistance programs can change at any time and benefits are not guaranteed. What happens to a patient if an assistance program suddenly changes, particularly in terms of amount of assistance offered? Pharmaceutical manufacturers and their advocates should continue to message employers and health plans on the risks associated with entire programs dependent on a pharmaceutical assistance program over which the PBM has no control.
The Centers for Medicare and Medicaid Services (CMS) has been active in the realm of copay management programs. On May 7, 2020, CMS finalized a rule that allows certain health plans to determine whether to apply manufacturer copay assistance to a member’s out-of-pocket maximum. The rule, which went into effect on July 13, effectively enables ACA Exchange plans and non-grandfathered plans to implement accumulator and/or maximizer programs if permitted by state law.4 As ACA Exchange plans compete to keep costs low, it is likely that accumulator or maximizer programs will grow in prevalence, further impacting manufacturers.
Perhaps more ominous for manufacturers is a proposal by CMS relating to copay support and Medicaid best price. Traditionally, copay support has not counted toward Medicaid best price because the support specifically went to the benefit of the patient; however, CMS noted that because accumulator/maximizer programs divert the assistance to the benefit of the health plan, copay support should be considered part of best price.5 The proposed rule states that the exclusion of copay support from best price should apply “only to the extent the manufacturer ensures the full value of the assistance or benefit is passed on to the consumer or patient.”5One can see that if such a rule were to be finalized, the repercussions on copay assistance programs would be significant.
The changing environment of copay management will demand an engaged and thorough approach on the part of manufacturers. While every twist and turn cannot be predicted, there are steps pharma can take:
Management of patient cost share is growing and will continue to do so as healthcare costs rise and payers struggle to keep benefits affordable. For many patients, copay assistance programs are a vital aid in affording care. Pharmaceutical manufacturers need to strike a balance between controlling program cost and providing sufficient support so patients can stay on their drugs. Manufacturer response to copay program evolution should be an integrated one, mixing advocacy, counter measures, competitive intelligence, and monitoring. Manufacturers should also expect that payers will likely evolve programs further to retain savings and maintain program effectiveness, thus continuing the back and forth with pharma.
Jeremy Schafer is senior vice president, Access Experience Team, at PRECISIONvalue.