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1. Modeling the Effects of Formulary Exclusions: How Many Patients Could Be Affected by a Specific Exclusion?

Author

Anne M. Sydor, Emily Bergin, Jonathan Kay, Erik Stone, and Robert Popovian

Subjects
Computer applications to medicine. Medical informatics, R858-859.7
Abstract

**Background:** Medication formularies, initially designed to promote the use of cost-effective generic drugs, are now designed to maximize financial benefits for the pharmacy benefit management companies that negotiate purchase prices. In the second-largest pharmacy benefit management formulary that is publicly available, 55% of mandated substitutions are not for generic or biosimilar versions of the same active ingredient and/or formulation and may not be medically or financially beneficial to patients. **Methods:** We modeled the effect of excluding novel agents for atrial fibrillation/venous thromboembolism, migraine prevention, and psoriasis, which all would require substitution with a different active ingredient. Using population data, market share of the 2 largest US formularies, and 2021 prescription data, we calculated how many people could be affected by such exclusions. Using data from the published literature, we calculated how many of those individuals are likely to discontinue treatment and/or have adverse events due to a formulary exclusion. **Results:** The number of people likely to have adverse events due to the exclusion could be as high as 1 million for atrial fibrillation/venous thromboembolism, 900 000 for migraine prevention, and 500 000 for psoriasis. The numbers likely to discontinue treatment for their condition are as high as 924 000 for atrial fibrillation/venous thromboembolism, 646 000 for migraine, and 138 000 for psoriasis. **Conclusion:** Substitution with a nonequivalent treatment is common in formularies currently in use and is not without substantial consequences for hundreds of thousands of patients. Forced medication substitution results in costly increases in morbidity and mortality and should be part of the cost-benefit analysis of any formulary exclusion.

Published
2024
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2. Helping Women with Breast Cancer Choose between Surgical Treatment Options

Author

Richard J. Barth, Christina V. Angeles, Katie E. Weichman, Courtney Goodwin, Emily Bergin, Anna N. A. Tosteson, Kari M. Rosenkranz, Elissa M. Ozanne, Catherine H. Saunders, Myrtle Mitchell, Sheldon Feldman, Amy Cyr, Marie-Anne Durand, Linda Walling, Shubhada Dhage, Caity Miller, Sherrill Jackson, Robert J. Volk, Julie Margenthaler, Camille Harris, Annemijn Aarts, Danielle Schubbe, Maria van den Muijsenbergh, Sanja Percac-Lima, Jocelyn Acosta, Renata W. Yen, Peter Scalia, Rebecca Aft, Mary C. Politi, Shuai Jiang, Rachel C Forcino, James O'Malley, Eloise Crayton, Karen Sepucha, Glyn Elwyn, Ann Bradley, and Christine M. Marx

Subjects
medicine.medical_specialty, Breast cancer, business.industry, General surgery, Medicine, business, medicine.disease, Surgical treatment
Published
2021
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3. What matters most: Randomized controlled trial of breast cancer surgery conversation aids across socioeconomic strata

Author

Glyn Elwyn, Camille Harris, Linda Walling, Danielle Schubbe, Amy E. Cyr, Eloise Crayton, Julie A. Margenthaler, Marie-Anne Durand, Renata W. Yen, Rebecca Aft, Robert J. Volk, Sherrill Jackson, Christine M. Marx, Emily Bergin, A. James O'Malley, Catherine H. Saunders, Courtney Goodwin, Caity Miller, Kari M. Rosenkranz, Mary C. Politi, Shuai Jiang, Sheldon Feldman, Anna N. A. Tosteson, Karen Sepucha, Ann Bradley, Christina V. Angeles, Sanja Percac-Lima, Shubhada Dhage, Elissa M. Ozanne, and Richard J. Barth

Subjects
Adult, Cancer Research, medicine.medical_specialty, media_common.quotation_subject, Decision quality, Health literacy, Breast Neoplasms, lower educational attainment, law.invention, Discipline, lower health literacy, lower socioeconomic status, 03 medical and health sciences, 0302 clinical medicine, Breast cancer, Quality of life (healthcare), pictorial superiority, Randomized controlled trial, law, medicine, Humans, Conversation, 030212 general & internal medicine, Socioeconomic status, conversation aids, media_common, Aged, breast cancer disparities, decision support techniques, business.industry, Communication, Regret, Original Articles, Middle Aged, medicine.disease, Surgery, Disparities Research, Oncology, Social Class, breast cancer surgery, 030220 oncology & carcinogenesis, Female, Original Article, Patient Participation, business, Decision Making, Shared
Abstract

Background Women of lower socioeconomic status (SES) with early‐stage breast cancer are more likely to report poorer physician‐patient communication, lower satisfaction with surgery, lower involvement in decision making, and higher decision regret compared to women of higher SES. The objective of this study was to understand how to support women across socioeconomic strata in making breast cancer surgery choices. Methods We conducted a 3‐arm (Option Grid, Picture Option Grid, and usual care), multisite, randomized controlled superiority trial with surgeon‐level randomization. The Option Grid (text only) and Picture Option Grid (pictures plus text) conversation aids were evidence‐based summaries of available breast cancer surgery options on paper. Decision quality (primary outcome), treatment choice, treatment intention, shared decision making (SDM), anxiety, quality of life, decision regret, and coordination of care were measured from T0 (pre‐consultation) to T5 (1‐year after surgery. Results Sixteen surgeons saw 571 of 622 consented patients. Patients in the Picture Option Grid arm (n = 248) had higher knowledge (immediately after the visit [T2] and 1 week after surgery or within 2 weeks of the first postoperative visit [T3]), an improved decision process (T2 and T3), lower decision regret (T3), and more SDM (observed and self‐reported) compared to usual care (n = 257). Patients in the Option Grid arm (n = 66) had higher decision process scores (T2 and T3), better coordination of care (12 weeks after surgery or within 2 weeks of the second postoperative visit [T4]), and more observed SDM (during the surgical visit [T1]) compared to usual care arm. Subgroup analyses suggested that the Picture Option Grid had more impact among women of lower SES and health literacy. Neither intervention affected concordance, treatment choice, or anxiety. Conclusions Paper‐based conversation aids improved key outcomes over usual care. The Picture Option Grid had more impact among disadvantaged patients. Lay Summary The objective of this study was to understand how to help women with lower incomes or less formal education to make breast cancer surgery choices.Compared with usual care, a conversation aid with pictures and text led to higher knowledge. It improved the decision process and shared decision making (SDM) and lowered decision regret. A text‐only conversation aid led to an improved decision process, more coordinated care, and higher SDM compared to usual care. The conversation aid with pictures was more helpful for women with lower income or less formal education.Conversation aids with pictures and text helped women make better breast cancer surgery choices., A paper‐based pictorial conversation aid (pictures plus text) is beneficial to all patients with early‐stage breast cancer and particularly to disadvantaged patients. Between‐surgeon variation suggests that the maximal impact of such interventions requires standardized physician training combined with these interventions.

Published
2020

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