As health insurers adjust to a shifting regulatory landscape and changes in reimbursement, many have considered adopting restrictive formularies or new policies aimed at managing the usage of high-cost medications. While more restrictive formularies or policies for usage may temporarily cut costs, they can have serious health consequences for patients and can actually end up costing payers more in the long run.
As a member of the Medical Advisory Committee for the Immune Deficiency Foundation, I have seen firsthand in recent months the advantages payers can reap by working with medical experts and foundations before changing formularies or policies that restrict treatment options. I have also seen how failing to seek this input, especially when high-risk patient populations are involved, can have significant negative financial and health implications.
Primary immunodeficiencies represent a group of more than 200 rare disorders in which the body's immune system is either absent or hampered in its ability to function.
A majority of patients with primary immunodeficiency diseases (PI) rely upon immunoglobulin (Ig) for lifesaving, lifelong treatment – in contrast to other users who may use it on a short-term basis. Without Ig, many of these patients risk serious infections and consume more healthcare resources. Ig is a highly complex biologic derived from human plasma, and because each Ig product has a different manufacturing process, they are not interchangeable.
The Immune Deficiency Foundation has seen a growing number of insurers implement restrictive policies for Ig. These changes have forced patients who were stabilized on a specific Ig replacement product to delay treatment or switch to a policy-mandated product. Such switches can pose a very real health risk to patients with PI.
IDF patient surveys and published reports indicate that patients can experience a range of adverse events when switching Ig replacement therapies, such as fever, body aches, disabling headaches and even sudden drops in blood pressure and shock. Up to one third of reactions occur as a result of trying a new product. Restrictive product formularies expose some individuals to the risk of significant harm with no medical justification for taking that risk.
In addition to harming patient health, a switch in Ig products can actually cost insurers more. Research has shown that patients with adverse reactions use more healthcare services. We also have seen patients forego treatment altogether due to the adverse effects of switching to a new product or their inability to afford the high out-of-pocket cost of staying on their preferred treatment.
And in addition to formularies, other restrictions can harm patients' health and cost payers more. For example, insurers may require that patients stop receiving Ig if their blood serum levels are above a certain level, or that patients be retested for PI. If not using the most current medical standards, payers risk putting patients at serious risk of infection and further damage vital organs such as the lungs. Consulting with outside immunologic experts before implementing such requirements can help prevent costly problems for patients and payers.
IDF has recently partnered with some major health insurers to develop policies and strategies that keep patients with PI healthy while saving costs and we're anxious to replicate that success. Obtaining an accurate diagnosis and providing the optimal route of administration, appropriate dose and site of care for each patient requires a high level of disease-specific knowledge. We bring that knowledge to our collaborative discussions with payers. The end result is a win-win for insurers and patients.
The challenges patients with PI face mirror those of other rare disease communities. Forging proactive partnerships and fostering communication with independent medical experts and advocacy groups can provide valuable insights that will allow insurers to strategically manage costs in the long-term while maintaining high quality care for patients.
Dr. Mark Ballow is a member of the Medical Advisory Committee for the Immune Deficiency Foundation and former President of American Academy of Allergy, Asthma and Immunology.