National Pharmaceutical Council President Dan Leonard chatted this week with Leah Howard, Vice President of Government Relations and Advocacy, National Psoriasis Foundation (NPF), about value assessment frameworks and how her organization is engaging with framework developers like the Institute for Clinical and Economic Review (ICER). NPF is a “non-profit organization with a mission to drive efforts to cure psoriatic disease and improve the lives of those affected,” and treatments for psoriasis are the subject of an ICER assessment and public meeting on November 18.
Dan Leonard (DL): Psoriasis stepped into the spotlight a few months ago when the Institute for Clinical and Economic Review announced that it would be putting new treatments through its value assessment process. First, tell me more about psoriasis and current treatment options.
Leah Howard (LH): Psoriasis is an immune mediated inflammatory disease, affecting approximately 3 percent of the adult U.S. population.[i] Up to 30 percent of individuals with psoriasis may also develop psoriatic arthritis, an inflammatory form of arthritis that can lead to irreversible joint damage if left untreated.[ii] Beyond the physical pain and discomfort of these diseases, individuals living with psoriatic disease also face higher incidence of comorbid health conditions including cardiovascular disease,[iii] diabetes[iv], hypertension[v], and stroke[vi]. A higher prevalence of atherosclerosis[vii], Crohn’s disease[viii], cancer[ix], metabolic syndrome[x], obesity[xi] and liver disease[xii] are also found in people with psoriasis as compared to the general population.
As a heterogeneous chronic inflammatory disease, psoriatic disease requires sophisticated medical care. Without the tools to control their symptoms, people with psoriatic disease cycle through periods of intense pain; fatigue; unbearable itch; whole-body inflammation; flaking and bleeding of large swaths of the skin; and joint degradation. Recent research also suggests that the risk for comorbidities such as cardiovascular disease may increase with the severity of psoriatic disease, thereby magnifying the critical need for patient access to effective treatment options.[xiii] Additionally, treatments that work for one person may not for others, and many patients cycle through accepted treatment options.[xiv] Adding to the burden of the disease are insurance policies and practices that erect barriers for patients in urgent need of treatment, including: narrowing of provider networks, institution of step therapy policies, increasing the patient share of the treatment cost, and limited transparency of drug coverage.
DL: What was your reaction when you learned that the new treatments were going to be assessed?
The introduction of biologic products for the treatment of psoriasis and psoriatic arthritis has been the most significant advancement in care for the psoriatic disease community in recent decades. New systemic treatments, including biologics, have provided patients with an effective therapy for the first time in their lives. In fact, today many individuals may achieve a level of clearance never seen before.[xv] Biologics have also opened up a new world of combination therapies, being used alongside systemic treatments, phototherapy and/or topical treatments. Access to treatment is important to prevent much of the disability and psychosocial impacts of the disease.
When NPF saw the announcement that psoriatic disease therapies would be included in the review, we wanted to be sure that ICER was well informed about the challenges of treating psoriasis and psoriatic arthritis, and that the needs and preferences of patients were fully heard and considered as part of the review. As the patient advocacy organization for the psoriatic disease community, NPF has decades worth of information from our community, including data such as the symptoms most of concern to patients, concerns regarding treatments, etc. As ICER moves forward with this review we wanted to be sure that these data were considered as part of the assessment.
DL: How have you or your organization been engaged in the assessment process? What tips would you recommend for other organizations?
The National Psoriasis Foundation engages with all health care stakeholders with a role to play in supporting the psoriatic disease community in achieving improved health outcomes. Earlier this year, NPF held a payer roundtable to understand the challenges facing payers in designing health benefits for our community. One of the findings of this day-long roundtable was that payers are interested in more information such as new and current treatment guidelines, clinically appropriate treatment targets, and guidance on how physicians should choose among treatment options.
As ICER and other value modelers conduct their work, NPF works to engage them as we do with payers and other stakeholders. To that end, following the announcement last fall that psoriatic disease therapies were on ICER’s 2016 review list, NPF reached out to introduce ourselves to ICER and to alert them to the significant challenges faced by our community. As ICER began their psoriatic disease assessment, we began an ongoing dialogue through emails and phone conversations with their staff through which we’ve presented them data on the preferences and needs of the community, introduced them to and facilitated discussions with psoriasis and psoriatic arthritis experts, and connected them directly with individuals living with psoriasis and psoriatic arthritis from whom they have gotten to hear firsthand about the multitude challenges of living with psoriatic disease. Through these discussions, we’ve presented them data on patient preferences, symptom challenges, and treatment needs. We’ve also directed them to valuable resources including the FDA’s Patient Focused Drug Development meeting held on March 17, 2016 during which the FDA heard directly from more than 200 patients about the symptoms which frustrate our community and what patients are thinking about when choosing treatments. Most recently the NPF has commented on ICER’s draft assessment report. This dialogue remains ongoing today and as future public comment opportunities arise in ICER’s psoriasis review, we intend to continue to urge the Institute to remain cognizant of heterogeneous nature of psoriatic disease, that all patients do not respond the same way to treatments or seek the same things in choosing treatments, and that ultimately physicians need to have access to all the FDA approved treatments when choosing the most appropriate course of therapy for each individual patient.
As other organizations engage with ICER, NPF would encourage them to (a) reach out early to introduce yourself and your resources to the institute before they begin their review, (b) to engage your medical experts and patient advocates in your discussions with ICER so that they might hear directly from those with an expertise on the disease studied, (c) alert them to unique challenges and concerns in the care and treatment of your community, and (d) follow up regularly and continue to urge patient perspectives to be part of the review process.
DL: How could ICER improve its patient engagement process?
- Talk to more patients—at all stages of the assessment process—living with the disease.
- Ensure patients and patient representatives have a seat at the table and are able to participate in policy dialogues.
- Share more information with patients and the public generally informing them how comments submitted during comment periods are utilized and included (or not). Additional information as to how these comments are considered would enable patient advocates to better understand the process and positively contribute to the assessment.
- Outline more clearly how information on patient preferences and desired treatment outcomes will be gathered and included in the review.
- Understand and incorporate real world treatment considerations including issues related to dosing, frequency of administration, and patient preferences regarding site of treatment into the assessment.
- Consider downstream access implications of report findings to ensure that ICER’s recommendations do not negatively impact patient health outcomes.
[i] Helmick CG, Lee-Han H, Hirsch SC, Baird TL, Bartlett CL. Prevalence of Psoriasis Among Adults in the U.S: 2003–2006 and 2009–2010 National Health and Nutrition Examination Surveys. American journal of preventive medicine. 2014;47(1):37-45. doi:10.1016/j.amepre.2014.02.012.
[ii] Gladman DD, Antoni C, Mease P, et al. Psoriatic arthritis: epidemiology, clinical features, course, and outcome. Ann Rheum Dis. 2005;64(suppl 2):ii14–ii17. - See more at: http://www.rheumatologynetwork.com/psoriatic-arthritis/classification-criteria-psoriatic-arthritis-caspar#sthash.Or6zBLgM.dpuf
[iii] Neimann AL, Shin DB, Wang X, Margolis DJ, Troxel AB, Gelfand JM. Prevalence of cardiovascular risk factors in patients with psoriasis. Journal of the American Academy of Dermatology. 2006; 55(5):829-35. And: Prodanovich S, Kirsner RS, Kravetz JD, Ma F, Martinez L, Federman DG. Association of psoriasis with coronary artery, cerebrovascular, and peripheral vascular diseases and mortality. Archives of Dermatology. 2009 Jun; 145(6):700-3.
[iv] Armstrong AW, Harskamp CT, Armstrong EJ. Psoriasis and the risk of diabetes mellitus: a systematic review and meta-analysis. JAMA Dermatology. 2013 Jan; 149(1): 84-91.And: Neimann AL, Shin DB, Wang X, Margolis DJ, Troxel AB, Gelfand JM. Prevalence of cardiovascular risk factors in patients with psoriasis. Journal of the American Academy of Dermatology. 2006; 55(5):829-35.
[v] Robinson D Jr., Hackett M, Wong J, Kimball AB, Cohen R, Bala M; the IMID Study Group. Co-occurrence and comorbidities in patients with immune-mediated inflammatory disorders: an exploration using US healthcare claims data, 2001-2002. Current medical research and opinion. 2006; 22(5):989-1000. And: Armstrong AW, Harskamp CT, Armstrong EJ. The association between psoriasis and hypertension: a systematic review and meta-analysis of observational studies. Journal of Hypertension. 2012 Dec 15. [Epub ahead of print]
[vi] Gelfand JM, Dommasch ED, Shin DB, Azfar RS, Kurd SK, Wang X, Troxel AB. The Risk of Stroke in Patients with Psoriasis. Journal of Investigative Dermatology. 2009; 129, 2411–2418.
[vii] Prodanovich S, Kirsner RS, Kravetz JD, Ma F, Martinez L, Federman DG. Association of psoriasis with coronary artery, cerebrovascular, and peripheral vascular diseases and mortality. Archives of Dermatology. 2009 Jun; 145(6):700-3.
[viii] Najarian DJ, Gottlieb AB. Connections between psoriasis and Crohn’s disease. Journal of the American Academy of Dermatology 2003; 48:805-21.
[ix] Gelfand JM, Shin DB, Neimann AL, Wang X, Margolis DJ, Troxel AB. The risk of lymphoma in patients with psoriasis. Journal of Investigative Dermatology. 2006 Oct; 126(10):2194-201.
[x] Azfar RS, Gelfand JM. Psoriasis and metabolic disease: epidemiology and pathophysiology. Current Opinion in Rheumatology. 2008; 20(4)416-22. And: Armstrong AW, Harskamp CT, Armstrong EJ. Psoriasis and metabolic syndrome: A systematic review and meta-analysis of observational studies. Journal of the American Academy of Dermatology. 2013 Apr; 68(4):654-62.
[xi] Ogden CL, Fryar CD, Carroll MD, Flegal KM. Mean body weight, height and body mass index, United States 1960-2002. Advance Data 2004; 347:1-17.
[xii] Robinson D Jr., Hackett M, Wong J, Kimball AB, Cohen R, Bala M; the IMID Study Group. Co-occurrence and comorbidities in patients with immune-mediated inflammatory disorders: an exploration using US healthcare claims data, 2001-2002. Current medical research and opinion. 2006; 22(5):989-1000.
[xiii] Naik HB, Natarajan B, Stansky E, Ahlman MA, Teague H, Salahuddin T, Ng Q, Joshi AA, Krishnamoorthy P, Dave J, Rose SM, Doveikis J, Playford MP, Prussick RB, Ehrlich A, Kaplan MJ, Lockshin BN, Gelfand JM, Mehta NN. Severity of Psoriasis Associates With Aortic Vascular Inflammation Detected by FDG PET/CT and Neutrophil Activation in a Prospective Observational Study. Arterioscler Thromb Vasc Biol. 2015 Dec;35(12):2667-76. doi: 10.1161/ATVBAHA.115.306460. Epub 2015 Oct 8.
[xiv] Stern RS, Nijsten T, Feldman SR, Margolis DJ, Rolstad T. Psoriasis is common, carries a substantial burden even when not extensive, and is associated with widespread treatment dissatisfaction. Journal of Investigative Dermatology Symposium Proceedings. 2004 Mar; 9(2):136-9
[xv] Gottlieb AB, Lacour JP, Korman N, Wilhelm S, Dutronc Y, Schacht A, Erickson J, Zhang L, Mallbris L, Gerdes S. Treatment outcomes with ixekizumab in patients with moderate‐to‐severe psoriasis who have or have not received prior biological therapies: an integrated analysis of 2 Phase III randomised studies. Journal of the European Academy of Dermatology and Venereology. 2016 Oct 1.