BURLINGTON, Mass.--()--Decision Resources, one of the world’s leading research and advisory firms for pharmaceutical and healthcare issues, finds that, when evaluating the most important attributes for emerging therapies for Crohn’s disease (CD) and ulcerative colitis (UC) to be prescribed instead of anti-TNFs agents, more gastroenterologists cite higher rates of induction and maintenance of remission than fewer restrictions from managed care organizations (MCOs) and equal or better tier position compared with the anti-TNFs. However, because many MCOs already cover Janssen Biotech’s Remicade and Abbott’s Humira on tier 2, emerging therapies will face challenges obtaining preferential coverage. To occupy the same tier as anti-TNF agents, cost levers such as positive pharmacoeconomic data, lower list price than the anti-TNFs and discounts that result in a lower net price than the anti-TNFs are the most important criteria to surveyed pharmacy directors (PDs). To win a lower tier position than the anti-TNFs, Phase III superiority trials and lower rates of hospitalization over the anti-TNFs are additional important measures to provide for both CD and UC.
“Physicians who expect to prescribe vedolizumab in place of the anti-TNFs cite preference for a new mechanism of action and the potential for lower copay as most frequent reasons”
For CD, two additional biologics and one novel oral agent are expected to launch within the next four years. Expected launches include Millennium’s CAM inhibitor vedolizumab, Janssen Biotech’s IL-12/IL-23 inhibitor Stelara and GlaxoSmithKline/ChemoCentryx’s chemokine receptor antagonist vercirnon (formerly GSK-1605786; Traficet-EN). For UC, vedolizumab is also expected to launch for this indication as well as Janssen Biotech’s TNF-alpha inhibitor Simponi and Pfizer’s novel oral Jak inhibitor tofacitinib.
The new U.S. Physician & Payer Forum report entitled How Will Reimbursement Decisions for Novel Biologics and Biosimilars Impact Prescribing in the Dynamic Markets for Crohn’s Disease and Ulcerative Colitis? finds that three-quarters of surveyed clinicians are willing to prescribe vedolizumab within its first year of availability for CD. However, most of these physicians will continue to rely on current biologics because they do not foresee replacing them with vedolizumab. Of those who would prescribe vedolizumab in place of marketed biologics, the greatest number of physicians indicated that they would prescribe vedolizumab in place of Biogen Idec’s CAM inhibitor Tysabri, followed by Remicade.
“Physicians who expect to prescribe vedolizumab in place of the anti-TNFs cite preference for a new mechanism of action and the potential for lower copay as most frequent reasons,” said Decision Resources Analyst Kathrina Quinn, Ph.D. “However, based on MCO survey data, patients are unlikely to encounter lower copays for vedolizumab as the highest percentages of pharmacy directors anticipate its placement in tier 3 or specialty tier.”
According to surveyed physicians, Simponi will have difficulty penetrating early lines of therapy for UC as the third anti-TNF to launch for UC. Negotiating with payers will be an important part of Simponi’s strategy to become a preferred anti-TNF in the UC treatment algorithm. Data suggest that MCO pharmacy directors are receptive to Simponi; approximately three-quarters of pharmacy directors that do not already include Simponi on their commercial formulary are somewhat or very likely to include it upon approval for UC, allowing it to compete more strongly against Remicade and Humira in the UC market.
The report also finds that approximately 90 percent of gastroenterologists expect to prescribe biosimilar versions of Remicade and Humira within a year of availability for either CD or UC, but most are willing to do so only if certain conditions are met. To a large extent, the conditions required for use of biosimilars in UC mirror those required for use in CD. Forty-one to 43 percent of physicians expect to prescribe biosimilars for CD and UC only if insurers demand step therapy with biosimilars prior to the brands and 42 to 48 percent of physicians are receptive to biosimilars if they carry lower out-of-pocket costs.
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