The Real-World Impact of Step Therapy and Prior Authorization on Patients, Clinicians, and US Health Plans: Lessons to Be Learned in Europe
Author(s)
Marco A. Crisci, (PhD) Consultant1, Sophie Schmitz, Managing Partner2, Michelle Sylvanowicz, Global Advocacy3.
1Partners4Access, London, United Kingdom, 2Partners4Access, Maastricht, Netherlands, 3Bayer Consumer Care AG, Basel, Switzerland.
1Partners4Access, London, United Kingdom, 2Partners4Access, Maastricht, Netherlands, 3Bayer Consumer Care AG, Basel, Switzerland.
OBJECTIVES: Step therapy (ST), a form of Prior Authorization (PA) in US health plans, requires patients to trial older, lower cost therapies before new, innovative options. Some patients must step through off-label therapies before receiving on-label alternatives. While PA is not widely applicable in Europe, patients may still have to “trial and fail” therapies before alternatives are prescribed. Uniquely, this study captured patient, clinician and payer impacts of ST/PA in chronic conditions.
METHODS: Secondary research and social listening analyzed stakeholder mentions in rheumatoid arthritis (RA), plaque psoriasis, insomnia, migraine, and vasomotor symptoms in menopause. Using targeted search queries in PULSETM (e.g., “step therapy” + “migraine”), 17,351 mentions were identified between Oct 2021-2024; A representative subset of mentions were analyzed further (n=176). Additional secondary research on RA treatment in the UK, France, Italy and Denmark provided insights into European practices.
RESULTS: Of ST/PA mentions with identifiable sentiment (n=5,967), 82% were negative. 48% of analyzed mentions included patient and clinician concerns with delays to effective treatment or quality of life worsening; 31% reflected the administrative burden of navigating PA processes (a burden shared by all stakeholders); 17% reflected patient difficulty in affording prescriptions due to ST. Clinicians reported not appealing PA denials due to low success rates and time constraints. Contrary to payer beliefs, evidence shows earlier provision of newer treatments may reduce costs compared to ST. In the UK, France, Italy and Denmark, guidelines require patients to step through conventional antirheumatic drugs, with potentially lower efficacy and tolerability, before biologic or targeted alternatives.
CONCLUSIONS: ST hinders access to effective treatments, negatively impacting patients, clinicians, and health plans. While the administrative burden is unique to the US, European patients also face barriers to new and effective therapy access. Addressing this issue is crucial to ensure timely, cost-effective treatment access, in the interest of all stakeholders.
METHODS: Secondary research and social listening analyzed stakeholder mentions in rheumatoid arthritis (RA), plaque psoriasis, insomnia, migraine, and vasomotor symptoms in menopause. Using targeted search queries in PULSETM (e.g., “step therapy” + “migraine”), 17,351 mentions were identified between Oct 2021-2024; A representative subset of mentions were analyzed further (n=176). Additional secondary research on RA treatment in the UK, France, Italy and Denmark provided insights into European practices.
RESULTS: Of ST/PA mentions with identifiable sentiment (n=5,967), 82% were negative. 48% of analyzed mentions included patient and clinician concerns with delays to effective treatment or quality of life worsening; 31% reflected the administrative burden of navigating PA processes (a burden shared by all stakeholders); 17% reflected patient difficulty in affording prescriptions due to ST. Clinicians reported not appealing PA denials due to low success rates and time constraints. Contrary to payer beliefs, evidence shows earlier provision of newer treatments may reduce costs compared to ST. In the UK, France, Italy and Denmark, guidelines require patients to step through conventional antirheumatic drugs, with potentially lower efficacy and tolerability, before biologic or targeted alternatives.
CONCLUSIONS: ST hinders access to effective treatments, negatively impacting patients, clinicians, and health plans. While the administrative burden is unique to the US, European patients also face barriers to new and effective therapy access. Addressing this issue is crucial to ensure timely, cost-effective treatment access, in the interest of all stakeholders.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
HSD109
Topic
Health Policy & Regulatory, Health Service Delivery & Process of Care, Organizational Practices
Disease
No Additional Disease & Conditions/Specialized Treatment Areas