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CLINICAL NEWS Literature Scan • PDP coverage without Medicaid (n=3,823; 34%) • OCC (n=3,607; 37%) • Medicare/Medicaid dual enrollment (n=1,405; 14%) Beneficiaries actively changed their prescription coverage status after my- eloma diagnosis; for example, 41 percent of those without coverage at diagnosis obtained either PDP or OCC by the fol- lowing January. However, PDP enrollees at diagnosis universally maintained their coverage. Baseline characteristics were similar between patients who did or did not switch coverage, except that people who obtained PDP or OCC were more likely to have no recorded comorbidities (64% vs. 54%; p=0.001) and to undergo a hemato- poietic cell transplantation (11% vs. 7%; p=0.015). The overall proportion of beneficia- ries who received active antimyeloma care increased slightly during the study period, from 88 percent in 2006 to 91 percent in 2011. The proportion who received any parenteral chemotherapy also increased, doubling from 24 to 48 percent, “mainly as a result of the ex- panding use of bortezomib,” the authors noted. “Our results highlight the increasing need to provide financial guidance and discuss economic repercussions of cancer therapy.” —ADAM J. OLSZEWSKI, MD In the group of PDP enrollees, bortezo- mib use increased from 13 to 44 percent during the study period, but the proportion of patients who received IMiDs remained “fairly steady” at 31 percent. The researchers observed that treat- ment of myeloma differed substantially by patients’ type of prescription drug cover- age ( TABLE 3 ). Compared with beneficiaries without 74 ASH Clinical News TABLE 3. Receipt of Therapy Per Drug Coverage Adjusted Relative Risk (95% CI) Prescription Drug Coverage Active Care for Myeloma Any Parenteral Chemotherapy Classic Cytotoxic Agent Bortezomib-Based Regimen None Reference Reference Reference Reference PDP 1.06 (1.05-1.07) 0.86 (0.80-0.93) 0.62 (0.51-0.76) 0.91 (0.82-1.02) OCC 1.03 (1.01-1.04) 0.95 (0.86-1.05) 0.94 (0.83-1.07) 0.98 (0.87-1.09) Medicaid/Medicare dual enrollee 1.02 (1.00-1.04) 0.78 (0.69-0.89) 0.68 (0.56-0.83) 0.79 (0.65-0.95) PDP = Part D plan; OCC = other creditable coverage TABLE 4. Survival Outcomes Per Drug Coverage Prescription Drug Coverage Median OS (95% CI), years 3-Year OS (95% CI), % None 1.7 (1.5-2.0) 39.2 (36.7- 41.7) PDP 2.6 (2.5-2.7) 45.9 (44.2-47.6) OCC 2.6 years (2.5-2.7 years) 45.5 (43.8-47.1) Medicaid/Medicare dual enrollee 1.6 years (1.5-1.8 years) 34.5% (32.0-37.1) PDP = Part D plan; OCC = other creditable coverage; OS = overall survival coverage, PDP enrollees were: • 6% more likely to receive active care for myeloma • 14% less likely to receive parenteral chemotherapy • 38% less likely to receive classic cyto- toxic agents (P values were not reported for these comparisons.) However, there were no significant dif- ferences in bortezomib use – likely because bortezomib was already covered under the drug benefits of traditional Medicare plans. OCC recipients were 3 percent more likely to receive active antimyeloma ther- apy, compared with beneficiaries without coverage, but again, the use of parenteral regimens did not differ significantly (p values not reported). After a median follow-up of 4.9 years (range not reported), 70 percent of pa- tients in the study died. Median survival was 2.3 years (range = 2.2-2.4 years) and the three-year rate of overall survival (OS) was 43.1 percent ( TABLE 4 ). While there were no differences in survival between the OCC and PDP groups, patients with OCC and PDP coverage had significantly longer survival, compared with those without coverage: • PDP: adjusted restricted mean sur- vival time (RMST) ratio = 1.16 (95% CI 1.11-1.20; p value not reported) • OCC: adjusted RMST ratio = 1.16 (95% CI 1.12-1.21; p value not reported) The researchers reported that Medicaid dual enrollees had notably worse OS, which is consistent with their burden of comorbidities and poor performance status, but, after adjustment for these unfavorable baseline characteristics, Medicaid dual enrollees actually had better OS than those without coverage (adjusted RMST ratio = 1.08; 95% CI 1.03-1.13; p value not reported). Although patients with Medicare PDP or OCC coverage appeared to have better survival outcomes, “we could not discern whether worse survival in the group without coverage was a result of not receiving therapy at all, an inability to access immunomodulatory drugs, or poor control of other medical issues,” the authors concluded. “As most patients with myeloma in the United States are covered by Medicare, our results have important implications both for the clinicians who care for these patients and for health-care policy that tackles coverage of oral and parenteral anticancer therapy.” The authors noted that this analysis was limited by its reliance on retrospective data. This introduced the potential for “unob- served clinical differences between benefi- ciaries with and without prescription drug coverage,” which may have contributed to differences in mortality outcomes. Also, the comparison of treatments was restricted to parenteral regimens, because oral IMiDs covered by PDP plans were tracked, but nonbeneficiaries who obtained oral agents through non-PDP insurance plans would not have been recorded in the Medicare database. “The inability to [comprehensively] iden- tify oral chemotherapy [use] is a major hurdle for health services research using Medicare data – a problem of increasing importance … [considering that] IMiDs are covered by more than 93 percent of Medicare prescription plans,” they added. The study exclusion criteria also means that these findings cannot be extrapolated to Medicare managed-care plan enrollees or to younger patients. “Our finding of an association be- tween prescription coverage at diagnosis and survival in myeloma will need to be evaluated in other settings where oral anticancer therapies can provide substan- tial clinical advantage,” Dr. Olszewski said. “As health-services researchers, we are looking forward to ongoing initiatives that could enrich the data in ways that will make the analyses more impactful for the clinical practice.” The study authors reported financial relationships with Spectrum Pharmaceuti- cals, Genentech, TG Therapeutics, Celgene, Kyowa Kirin, Jazz Pharmaceuticals, Tolero Pharmaceuticals, Boehringer Ingelheim, and the PhRMA Foundation. ● REFERENCE Olszewski AJ, Dusetzina SB, Trivedi AN, Davidoff AJ. Prescription drug coverage and outcomes of myeloma therapy among Medicare beneficiaries. J Clin Oncol. 2018;36:2879-86. December 2018