Barriers to Biologics Access

EP: 1.Clinical Overview of Inflammatory Diseases

EP: 2.Humanistic and Economic Impact of Inflammatory Diseases

EP: 3.Cost Drivers Contributing to the Economic Impact of Inflammatory Diseases

EP: 4.Biologics Used in Inflammatory Diseases

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EP: 5.Barriers to Biologics Access

EP: 6.Savings Potential With Biosimilars

EP: 7.Opportunities Provided By Biosimilars

EP: 8.Challenges Associated With Biosimilars

EP: 9.Challenges Payers Face With Biosimilars

EP: 10.Existing FDA-Approved Biosimilars

EP: 11.Interchangeability In Biosimilars

EP: 12.Patient and Provider Education on Biosimilars

EP: 13.Cost and Time Benefits of Interchangeable Biosimilars

EP: 14.Challenges of Biosimilars With Interchangeable Designations

EP: 15.Interchangeable Biosimilar Automatic Substitution

EP: 16.Addressing the Increased Amount of Interchangeable Biosimilars in the Market

EP: 17.Future Opportunities With Interchangeable Biosimilars

Ryan Haumschild, PharmD, MS, MBA: As we know and has been pointed out, there's going to be barriers to treatment. Dr Kay, [as] someone who does a great job treating patients, and another expert in the field, I'd love to get your thoughts. With all these biologics available, it's really tempting to say we've got plenty, but we know that there are still barriers that are preventing patients from being on therapy long term. Could you discuss some of the barriers related to the access of biologics maybe from an economic and even health disparities perspective?

Jonathan Kay, MD: Certainly the economic barriers are there because these medications are quite expensive. They're not necessarily expensive to the patient because the patient pays, in most cases a copayment that's relatively negligible compared to the cost of the medication for patients who have Medicare insurance and Medicare Part D; they're paying 20% of the cost of the medication up to the doughnut hole, and then the medication is covered fully. But the real barrier based on economics is an almost artificial barrier that's placed by pharmacy benefit managers because pharmacy benefit managers are companies that contract with payers to manage their formularies and they get paid an administrative fee based upon the list price of the medication. They also get discounts and postdoc rebates from the manufacturer so that the amount that they pay for the medication is much less than the list price. They share most of that rebate and discount with the payer. But they don't necessarily disclose the complete amount so that their profit is generated both by the administrative fees that they gain from the small proportion of the list price, and also that proportion of the rebates or discounts that they keep. So the economic barriers are generated by the pharmacy benefit managers tiers the formulary, essentially the way many of us who fly airlines choose to fly a specific airline or group of airlines so that we can get status on that airline and a greater likelihood of upgrades or something like that. The pharmacy benefit managers are aligning the incentives so that they can have the most patients on the medication that will give them the largest rebate from the manufacturer. The more patients they have on a given medication, the larger the rebate usually is from the manufacturer. So the pharmacy benefit managers require prior authorization, not because they're trying to help us determine the most appropriate medication for a patient, but rather because they're trying to align the medication that's prescribed for the patient with the medication that will give them the best advantage in negotiating discounts and rebates. So the economics are complicated; medications are expensive. They're expensive to someone, certainly to society, but not necessarily directly to the patient. But the cost of the medication and the opportunities for pharmacy benefit managers to gain rebates and generate profits limits access to some biologics because the providers’ choice is not completely free and is dictated by the pharmacy benefit managers’ formulary. There are certainly health inequities where disadvantaged groups don't have the same access to health care that everybody else does. And with limited access to health care, these medications are perhaps the least accessible since they're expensive and almost impossible to obtain without some sort of coverage assistance. Medicaid provides assistance so that those disadvantaged groups that are covered by Medicaid are able to have access to these medications, but for the uninsured, whether they're uninsured because they're financially limited or whether they're uninsured because they are not working in the employment sector—they may be retired and can't afford the coverage for prescriptions—those individuals are compromised in terms of their access to these very effective medications. So their health care disparities are not necessarily aligned with social inequities but are more economic difficulties. Retired individuals oftentimes have to go to work, bagging groceries at a local grocery store to get health insurance. [I have] not seen that at Starbucks, where baristas are retirement age, but I wouldn't be surprised if we start seeing that as well.

Ryan Haumschild, PharmD, MS, MBA: I'm probably more of an economy guy myself, relating to your thing, but I definitely recognize what you're saying. It is a very tricky environment because you do have pharmacy benefit managers that are managing the benefit and also sharing some of the rebaiting. You also have health plans and employer groups that are trying to afford the increasing cost of care related to both medical and pharmacy benefit while pharmacy benefit managers may just see that pharmacy piece of it. There might be true medical cost offsets if you gave a patient therapy sooner. The more and more we aligned the benefits between pharmacy and medical, I think it's going to create better access and I think you really describe that well. And I do want to hit on health inequities because one thing that’s so important as providers and payers is that we come together to make sure that patients have an equitable chance at receiving a positive health outcome. And if they have transfer patient vulnerability and can't receive a biosimilar infusion, then how do we make sure we have something they can take in the comfort of their home? Because we know based on patient zip codes we can live 6 miles away or 300 miles away and they still have that same transportation vulnerability, and being able to attack that financial toxicity, transportation vulnerability, and make sure that we have equitable care, continues to be a challenge and something we have to work through even with extremely efficacious treatments.

Jonathan Kay, MD: Transportation vulnerability isn't limited to being unable to attend an infusion center to get an infusible biologic. Transportation vulnerability oftentimes limits access to medical appointments, and limiting access to medical appointments often delays or even prevents treatment of active disease.

Maia Kayal, MD, MS:I agree with that. I think along those lines, it's also about where patients work and whether their employer is even willing to give them time off to get the infusion, make it to that appointment, where they learn how to use an injectable. A lot of what we provide at our center is not only, of course the medical care and the medical support, [but also] the psychosocial support, because that's where, increasingly again, understanding that the psychological impact of this disease can be devastating. But if a patient doesn't have time to take off from work, to come and see you in the office, or even see their therapist that day, then it's just going to be a continuous downward spiral of the impact of the disease on their day-to-day.

Kimberly C. Chen DO, MSHLM: One thing I do want to note with all health plans, especially high-cost patients, usually they have a case manager within the health plan that can help support them in getting some of the social determinants of health issues, such as transportation, health plan, sometimes with an issue with the Medicaid sector, and sometimes with a commercial or self-funded group, it can make exceptions to pay for some of those care needs. So always keep in mind that collaboration between the health plan and providers is really a win-win to better support our patients, especially the ones with SDOH [Social Determinants of Health] needs.

Transcript edited for clarity.

This activity is supported by an educational grant from Boehringer Ingelheim.