Assessing the ethics of prior authorization denials and step therapy policies in dermatology

Dear Dr Dermatoethicist: A prior authorization for dupilumab was denied for a 32-year-old female with a history of cervical cancer and severe atopic dermatitis (AD) refractory to topicals. Despite appeal, the payor advised systemic corticosteroids, cyclosporine, or phototherapy. When is it ethically permissible to prescribe less effective, more risky treatments than more expensive alternatives? Am I obliged to comply with the payor's step requirements?—Concerned Physician Dear Dr Dermatoethicist: A prior authorization for dupilumab was denied for a 32-year-old female with a history of cervical cancer and severe atopic dermatitis (AD) refractory to topicals. Despite appeal, the payor advised systemic corticosteroids, cyclosporine, or phototherapy. When is it ethically permissible to prescribe less effective, more risky treatments than more expensive alternatives? Am I obliged to comply with the payor's step requirements? —Concerned Physician Dear Concerned Physician: Payors often utilize prior authorizations and step therapies,1Nayak R.K. Pearson S.D. The ethics of 'fail first': guidelines and practical scenarios for step therapy coverage policies.Health Aff (Millwood). 2014; 33: 1779-1785https://doi.org/10.1377/hlthaff.2014.0516Crossref Scopus (25) Google Scholar whereby patients must first fail less costly treatments.1Nayak R.K. Pearson S.D. The ethics of 'fail first': guidelines and practical scenarios for step therapy coverage policies.Health Aff (Millwood). 2014; 33: 1779-1785https://doi.org/10.1377/hlthaff.2014.0516Crossref Scopus (25) Google Scholar Despite ongoing reforms,2American Medical AssociationBipartisan bill aims to reform step therapy, ensure timely care.https://www.ama-assn.org/practice-management/prior-authorization/bipartisan-bill-aims-reform-step-therapy-ensure-timely-careDate accessed: October 29, 2022Google Scholar step therapies are increasingly common in dermatology and underscore the dilemma of reducing health care expenditures while allowing effective treatment.1Nayak R.K. Pearson S.D. The ethics of 'fail first': guidelines and practical scenarios for step therapy coverage policies.Health Aff (Millwood). 2014; 33: 1779-1785https://doi.org/10.1377/hlthaff.2014.0516Crossref Scopus (25) Google Scholar Identifying ethically permissible step therapies requires close consideration of ethical principles as they apply to the clinical scenario. Any ethically appropriate step therapy should support efforts to reduce high-aggregate costs incurred from a specific therapy for which other appropriate options exist, thereby promoting sustainability of the health care system (general beneficence).1Nayak R.K. Pearson S.D. The ethics of 'fail first': guidelines and practical scenarios for step therapy coverage policies.Health Aff (Millwood). 2014; 33: 1779-1785https://doi.org/10.1377/hlthaff.2014.0516Crossref Scopus (25) Google Scholar Cost-benefit analyses should be conducted over the long term, consider medical costs that may result from disease progression or treatment discontinuity as well as direct pharmaceutical costs, and account for differing ranges of disease severity. While dupilumab is likely cost-effective for severe AD, this is questionable for moderate AD given the lower lifetime risk of complications.3Zimmermann M. Rind D. Chapman R. Kumar V. Kahn S. Carlson J. Economic evaluation of dupilumab for moderate-to-severe atopic dermatitis: a cost-utility analysis.J Drugs Dermatol. 2018; 17: 750-756PubMed Google Scholar By comparison, analyses clearly demonstrate cost-effectiveness of biologics in psoriatic arthritis due to impact on disease progression.4D'Angiolella L.S. Cortesi P.A. Lafranconi A. et al.Cost and cost effectiveness of treatments for psoriatic arthritis: a systematic literature review.Pharmacoeconomics. 2018; 36: 567-589https://doi.org/10.1007/s40273-018-0618-5Crossref PubMed Scopus (30) Google Scholar For step therapies promoting long-term cost reductions, there should be a high likelihood of clinical success (≥75%).1Nayak R.K. Pearson S.D. The ethics of 'fail first': guidelines and practical scenarios for step therapy coverage policies.Health Aff (Millwood). 2014; 33: 1779-1785https://doi.org/10.1377/hlthaff.2014.0516Crossref Scopus (25) Google Scholar Step therapies are difficult to justify against alternatives with demonstrated superiority in direct comparative studies, yet they can be warranted when only case reports or noninferiority comparisons exist.5Karas L. The ongoing step therapy debate.https://blog.petrieflom.law.harvard.edu/2021/04/19/step-therapy-pharma-biosimilars/Date accessed: October 29, 2022Google Scholar Efficacy can also be influenced by patient factors. Phototherapy is effective for AD, yet associated travel/time burden may preclude success for certain patients. Patient cost obligation (eg, copayments) can differ substantially and may influence access and adherence to effective treatments and should spur patient-provider discussions to mitigate these barriers or pursue alternative effective therapies. Step therapies promoting cost-effectiveness and demonstrating efficacy should have a comparable risk profile as alternatives and pose relatively low risk of long-term harm, including risk associated with treatment failure (nonmaleficence).1Nayak R.K. Pearson S.D. The ethics of 'fail first': guidelines and practical scenarios for step therapy coverage policies.Health Aff (Millwood). 2014; 33: 1779-1785https://doi.org/10.1377/hlthaff.2014.0516Crossref Scopus (25) Google Scholar Phototherapy has a favorable side effect profile. Cyclosporine may be acceptable but not for patients with prior malignancy or those who cannot report for lab monitoring. Potential side effects should be communicated through shared decision-making to maintain patient autonomy and because step therapies do not exonerate physicians from legal liability from treatment harm. Dermatologists should consider the following when weighing step therapies: Is the therapy likely to yield cost savings? Does it have compelling efficacy for the indication, or are there direct comparative trials supporting an alternative? Does the therapy have minimal risk of long-term harm to the specific patient? While evidence undoubtedly supports dupilumab in AD, limited head-to-head studies and conflicting cost-effectiveness assessments may justify traditional agents or phototherapy in less severe patients. In cases where step therapies cannot be justified, physicians should recognize the opportunity to construct letters of appeal or engage directly with the payor. —Dr Dermatoethicist None disclosed.