BlOG: Amplifying Patient Voices in Market Access: Real-World Cases
By: Henry Lee, Consultant
Published: June 2024
In the previous position piece (Amplifying Patient Voices in Market Access: Insights from DKI Health’s Patient and Caregiver Advisory Council), DKI Health received input from our Advisors regarding patients’ ongoing struggles to access their medicines, such as prior authorization, step therapy, and co-pay accumulators.
As patient voices in Market Access continue to rise, DKI Health identified several real-world cases in which patients demonstrate their influence in payers' coverage decisions in the US.
Case 1: Advocacy groups and professional societies prompt CVS Caremark to insert Eliquis back into its formulary.
Case 2: The Colorado Prescription Drug Affordability Board's review of Trikafta shows the power of patient voice in drug access and its value to drugmakers.
-Catherine Harshbarger, Colorado PDAB
Drug Affordability Review Process
Christopher McNaughton, a former college student-athlete, was diagnosed with severe ulcerative colitis (UC) in 2014. Failing to get meaningful relief from the drugs his doctors initially prescribed, he started to receive treatment from Dr. Edward Loftus Jr. at the Mayo Clinic, the best gastroenterology hospital in the US, after several referrals.
In 2018, McNaughton finally achieved remission, and his life improved drastically after Dr. Loftus prescribed him an unusual off-label use of a high-dose combination of two biological drugs: Remicade and Entyvio. At that time, his insurance had no issue to cover the combination treatment.
However, everything changed in July 2020 after McNaughton enrolled at Penn State University (PSU) and switched to the student plan provided by UnitedHealthcare (UHC). His coverage status went from “approved” to “pending” by September 2020 and from “pending” to “denial” in January 2021. Suddenly, the total outstanding bill for his treatment was $807,086.
McNaughton was fortunate enough to have his parents, who are PSU faculty members, help him appeal to PSU administrators and regain drug coverage. In March 2021, UHC agreed to pay for McNaughton’s bill until August 2021. Nevertheless, in June 2021, UHC informed him that, starting the next academic year, his drug would only be covered in significantly reduced doses, and that this decision was agreed upon by his doctor, Dr. Loftus, who had tried those drugs at a lower dose but failed, and titrated them up to help McNaughton achieve remission.
McNaughton immediately spoke to Dr. Loftus and discovered that UHC misrepresented his doctor’s approval for the coverage decision. In August 2021, McNaughton filed a lawsuit against UHC, bringing other systematic issues regarding his claim review process to light.
In the claim review process, UHC conducted an internal review with its own doctor, who has not practiced medicine since the early 1990s. In his deposition, the UHC doctor said he just copied and pasted the nurse’s recommendation and typed “agree” on his review of McNaughton’s case. Additionally, UHC sought external opinions. It was discovered during the case that UHC selectively only collected opinions in favor of coverage denial and buried opinions that disagreed. In September 2021, UHC agreed to cover McNaughton’s treatment.
In July 2023, McNaughton started a new chapter at PSU law school. He is now an advocate with the goal of becoming a health insurance attorney to represent patients who have had medical treatments denied by insurance companies.
Case 4: Co-pay accumulator policies get expanding oversight at both Federal and State levels, thanks to patient advocacy groups.
States Prohibiting Co-pay Accumulators
Arizona, Arkansas, Colorado, Connecticut, Delaware, Georgia, Illinois, Kentucky, Louisiana, Maine, New Mexico, New York, North Carolina, Oklahoma, Tennessee, Texas, Virginia, Washington, and West Virginia, as well as Puerto Rico
Conclusion
It is clear that patients’ influence on market access is growing. However, the broader patient and care partner community must still be educated, empowered, and equipped with resources to fight for access to the medications they need. Companies that want patients to stand by their side in market access should continuously invest in patient engagement, listen to patients' access challenges, and provide patients with the necessary support.
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