Background
More patients with ovarian cancer are being treated with poly(adenosine diphosphate-ribose) polymerase inhibitors because regulatory agencies have granted these drugs new approvals for a variety of treatment indications. However, poly(adenosine diphosphate-ribose) polymerase inhibitors are expensive. When administered as a maintenance therapy, these drugs may be administered for months or years. How much of this cost patients experience as out-of-pocket spending is unknown.
Objective
This study aimed to estimate the out-of-pocket spending that patients experience during poly(adenosine diphosphate-ribose) polymerase inhibitor treatment and to characterize which healthcare services account for that spending.
Study Design
A retrospective cohort study was performed with a sample of patients with ovarian cancer treated between 2014 and 2017 with olaparib, niraparib, or rucaparib. Patients were identified using MarketScan, a health insurance claims database. All insurance claims during poly(adenosine diphosphate-ribose) polymerase inhibitor treatment were collected. The primary outcome variable was the patients’ out-of-pocket spending (copayment, coinsurance, and deductibles) during poly(adenosine diphosphate-ribose) polymerase inhibitor treatment for the medication itself. Other outcomes of interest included out-of-pocket spending for other healthcare services, the types and frequency of other healthcare services used, health plan spending, the estimated proportion of patients’ household income used each month for healthcare, and patients’ out-of-pocket spending immediately before poly(adenosine diphosphate-ribose) polymerase inhibitor treatment.
Results
We identified 503 patients with ovarian cancer with a median age of 55 years (interquartile range, 50–62 years); 83% of those had out-of-pocket spendings during poly(adenosine diphosphate-ribose) polymerase inhibitor treatment. The median treatment duration was 124 days (interquartile range, 66–240 days). The mean out-of-pocket spending for poly(adenosine diphosphate-ribose) polymerase inhibitors was $305 (standard deviation, $2275) per month. On average, this accounted for 44.8% (standard deviation, 34.8%) of the patients’ overall monthly out-of-pocket spending. The mean out-of-pocket spending for other healthcare services was $165 (standard deviation, $769) per month. Health plans spent, on average, $12,661 (standard deviation, $15,668) per month for poly(adenosine diphosphate-ribose) polymerase inhibitors and $7108 (standard deviation, $15,254) per month for all other healthcare services. The cost sharing for office visits, laboratory tests, and imaging studies represented the majority of non–poly(adenosine diphosphate-ribose) polymerase inhibitor treatment out-of-pocket spending. The average amount patients paid for all healthcare services per month during poly(adenosine diphosphate-ribose) polymerase inhibitor treatment was $470 (standard deviation, $2407), which was estimated to be 8.7% of the patients’ monthly household income. The mean out-of-pocket spending in the 12 months before poly(adenosine diphosphate-ribose) polymerase inhibitor treatment was $3110 (standard deviation, $6987).
Conclusion
Patients can face high out-of-pocket costs for poly(adenosine diphosphate-ribose) polymerase inhibitors, although the sum of cost sharing for other healthcare services used during poly(adenosine diphosphate-ribose) polymerase inhibitor treatment is often higher. The spending on healthcare costs consumes a large proportion of these patients’ household income. Patients with ovarian cancer experience high out-of-pocket costs for healthcare, both before and during poly(adenosine diphosphate-ribose) polymerase inhibitor treatment.
Introduction
Since 2014, the poly(adenosine diphosphate-ribose) polymerase (PARP) inhibitors olaparib, rucaparib, and niraparib together have been granted 9 indications for use in patients with ovarian cancer. The clinical trials supporting these regulatory approvals show the drugs’ substantial clinical benefit, particularly among patients with a BRCA -mutated or homologous recombination (HR)-deficient tumor. However, these new therapies are expensive. A PARP inhibitor’s “sticker price” can be as high as $16,999 for a month of treatment. Previous analyses found the drugs’ cost to be an obstacle to PARP inhibitors being considered as a cost-effective treatment for ovarian cancer.
Why was this study conducted?
The clinical use of poly(adenosine diphosphate-ribose) polymerase (PARP) inhibitor therapy in the management of ovarian cancer is expanding. Like other new anticancer drugs, PARP inhibitors are costly, but how much of that cost patients experience as out-of-pocket spending is unclear.
Key findings
In this observational cohort study using insurance claims, the copayments for PARP inhibitor therapy were, on average, $305 per month. Cost sharing for these medications accounted for 45% of an average patient’s total out-of-pocket spending during each month of PARP inhibitor treatment.
What does this add to what is known?
Previous research found that the median amount that patients spend out-of-pocket is approximately $3000 during frontline treatment for ovarian cancer. This investigation found that high levels of cost sharing often persist during therapy with subsequent lines of treatment.
The cost sharing experienced by patients for treatment with PARP inhibitors is unknown. Whatever this amount, it is in addition to the other out-of-pocket expenses for healthcare that is incurred during cancer treatment. With more patients receiving PARP inhibitor treatment and maintenance strategies potentially lasting for years, , , the patients’ risk for experiencing financial hardship owing to the cumulative cost of treatment is high. In other cancer types, treatment-related financial burdens have been associated with diminished quality of life and coping strategies including nonadherence to medication, delayed or missed clinic visits, refusal of recommended testing, and reduced spending on non–health care necessities. , In patients with gynecologic cancers, psychological distress related to the costs of cancer care is common, as is the use of coping strategies. , Our goal with this study was to evaluate the spending that patients and their insurers incurred during treatment with PARP inhibitors.
Materials and Methods
We performed an observational, retrospective cohort study using the Truven Health MarketScan Commercial Claims and Encounters database (IBM Corporation, Armonk, NY). The MarketScan database comprises paid and adjudicated health insurance claims and includes deidentified information from a nationwide sample of commercially insured individuals (additional information about MarketScan is available in the Supplemental Appendix ). We included all individuals with ovarian cancer who had at least 1 prescription drug claim for olaparib, niraparib, or rucaparib between January 1, 2014 (the year in which the first PARP inhibitor was approved for use in ovarian cancer) and December 31, 2017 (the most recent year in which data were made available to the investigators in the MarketScan database). Using a validated approach, we identified individuals with ovarian cancer who had at least 1 inpatient or at least 2 outpatient insurance claims associated with an ovarian cancer diagnosis code (International Classification of Diseases, Ninth Revision [ICD-9], 183.0, 183.2, 183.8; ICD-10, C56) (information about the cohort selection is available in Supplemental Figure ). We used the national drug codes for olaparib, rucaparib, and niraparib to identify individuals treated with PARP inhibitors ( Supplemental Table ). To determine their out-of-pocket costs and healthcare use, we included all insurance claims that occurred during PARP inhibitor treatment, which we defined as the first day a PARP inhibitor prescription was filled until the final prescription fill date plus the number of days supplied with the final prescription.
Our primary outcome of interest was the patients’ out-of-pocket spending per month for the PARP inhibitor prescription itself. The secondary outcomes of interest included the proportion of patients who had no out-of-pocket spending during PARP inhibitor treatment, the patients’ out-of-pocket spending for all other healthcare services, the proportion of overall out-of-pocket spending accounted for by cost sharing for PARP inhibitors, total spending (ie, by the patient and insurer), the types and frequency of other healthcare services that were used during PARP inhibitor treatment, out-of-pocket spending in the year before starting the PARP inhibitor treatment, and the estimated proportion of household income used each month for healthcare-related costs. We adjusted the dollar amounts to 2018 values using the Consumer Price Index.
We calculated the out-of-pocket spending as the sum of all the cost-sharing costs incurred by the patient, including copayments, deductibles, and coinsurance. The patients’ out-of-pocket spending was divided into the following 2 categories: cost sharing for filling the PARP inhibitor prescription itself and cost sharing for any other healthcare service. To determine whether the proportion of the patients’ out-of-pocket spending that was accounted for by prescription cost sharing varied according to the total amount the patients spent each month, we categorized the patients according to their total monthly out-of-pocket spending ($0–$25, $25–$50, $50–$75, $75–$100, $100–$500, and >$500) and compared the composition of the spending among these groups. If a patient had a spending amount equal to the cutoff between 2 categories, that individual was grouped into the lower of the 2 cost categories. The total spending, for the PARP inhibitor or for other healthcare services, was the sum of the patient’s out-of-pocket spending added to the reimbursement paid by the patient’s health insurance plan. We estimated the financial burden of the treatment as a percentage of the monthly household income that was spent on healthcare by dividing a patient’s overall monthly out-of-pocket spending by their monthly household income. This estimate was averaged over the duration of the patient’s PARP inhibitor treatment course. Because the MarketScan database does not include income data, we used median estimates of household income from the United States Census Bureau for each patients’ metropolitan statistical area–a local geographic area variable included in our data source.
After observing that some patients had no out-of-pocket spending during PARP inhibitor treatment, we suspected that this could be explained by the patients reaching their health plan’s out-of-pocket maximum limit before treatment initiation. We evaluated this hypothesis by examining the patients’ out-of-pocket spending in the year preceding treatment and collected all insurance claims available for the year leading up to the index date. Patients were categorized according to whether they had out-of-pocket spending during PARP inhibitor treatment (ie, any amount of spending vs none). We compared these groups’ out-of-pocket spending before starting PARP inhibitor treatment. Using the MarketScan Benefit Plan Design supplemental MarketScan database, we also determined the proportion of the cohort that had reached their out-of-pocket maximum limit in the insurance plan period preceding the one during which they started PARP inhibitor treatment. Finally, we recalculated the outcome measures described above after excluding patients who had no out-of-pocket spending during treatment.
The cost data were analyzed descriptively. We performed group comparisons by using either a Wilcoxon rank sum test or Kruskal-Wallis test depending on the number of groups being compared and the distribution of the data. This investigation was approved by our institutional review board.
Results
From the MarketScan database, we identified 503 patients with ovarian cancer with a median age of 55 years (interquartile range [IQR], 50–62 years) who had started treatment with a PARP inhibitor during the study period ( Table 1 ). The patients’ median duration of treatment with a PARP inhibitor was 124 days (IQR, 66–240 days). A total of 3326 patient-months of PARP inhibitor treatment was observed. Consistent with its date of approval, the majority of patients (292/503; 58.1%) were treated with olaparib, and these patients contributed 75.2% of the observed patient-months of treatment. Most patients had health insurance with a preferred provider organization-type plan design (268/503; 53.3%); 91 patients (18.1%) were covered by high-deductible health plans; 106 patients (21.1%) had hospital admissions during the PARP inhibitor treatment; and 86 patients (17.1%) had no observed out-of-pocket spending during PARP inhibitor treatment.
| Characteristic | Patients |
|---|---|
| Age (y), median (IQR) | 55 (50–62) |
| Insurance type, n (%) | |
| Preferred provider organization | 268 (53.2) |
| Health maintenance organization | 51 (10.1) |
| Comprehensive plan | 46 (9.1) |
| Other a | 47 (9.3) |
| High-deductible health plan | 91 (18.1) |
| Year of first PARP prescription, n (%) | |
| 2015 | 122 (24.2) |
| 2016 | 91 (18.1) |
| 2017 | 289 (57.5) |
| Region, n (%) | |
| Northeast | 113 (22.5) |
| North central | 109 (21.7) |
| South | 188 (37.4) |
| West | 92 (18.3) |
| PARP inhibitor, b n (%) | |
| Olaparib | 292 (58.1) |
| Niraparib | 158 (31.4) |
| Rucaparib | 80 (15.9) |
| Out-of-pocket spending during PARP inhibitor treatment | 417 (82.9) |
a Other include basic or major medical, exclusive provider organization, noncapitated, capitated, or partially-capitated point-of-service, and consumer-directed type health plans
b Sum of percentages exceeds 100% because some patients were treated with >1 PARP inhibitor.
The mean and median out-of-pocket spending for PARP inhibitors was $305 (standard deviation [SD], $2275) and $39 (IQR, $0–$118) per month, respectively ( Table 2 ; Figure 1 , panel A). When excluding patients who had no out-of-pocket spending during PARP inhibitor treatment, the patients’ monthly mean and median spending for their PARP inhibitor was $368 (SD, $2494) and $55 (IQR, $17–$141), respectively. A total of 8.2% (41/503) of the patients paid, on average, more than $500 per month for their PARP inhibitor. The average amount that patients paid out-of-pocket for all healthcare services was $470 per month (SD, $2407). Compared with patients covered by a conventional health plan, monthly out-of-pocket spending for PARP inhibitors by patients covered by high-deductible health plans was not significantly different (median out-of-pocket spending, $39 and $41, respectively; P =.68).
| Type of spending | Spending for PARP Inhibitor per month | Monthly spending for other healthcare services (n=503) | Monthly overall spending (n=503) | |||
|---|---|---|---|---|---|---|
| Any PARP inhibitor (n=503) | Olaparib (n=292) | Rucaparib (n=80) | Niraparib (n=158) | |||
| Out-of-pocket costs ($), mean (SD) | ||||||
| All patients | 305 (2275) | 354 (2889) | 157 (468) | 237 (979) | 165 (769) | 470 (2407) |
| Patients with >$0 out-of-pocket spending a | 368 (2494) | 396 (3054) | 194 (513) | 322 (1132) | 199 (840) | 567 (2634) |
| Out-of-pocket costs ($), median (IQR) | ||||||
| All patients | 39 (0–118) | 45 (5–136) | 24 (0–76) | 16 (0–79) | 59 (3–140) | 125 (46–283) |
| Patients with >$0 out-of-pocket spending a | 55 (17–141) | 59 (18–150) | 38 (4–88) | 44 (13–111) | 80 (26–165) | 162 (90–328) |
| Third-party cost ($), mean (SD) | 12,661 (15,668) | 12,350 (20,151) | 11,593 (4850) | 11,611 (6184) | 7108 (15,254) | 19,769 (21,767) |
| Third-party cost ($), median (IQR) | 12,449 (9730–14,047) | 11,941 (9195–13,323) | 13,498 (8645–14,659) | 11,561 (8651–14,508) | 2321 (848–7140) | 15,040 (12,480–19,880) |
| Total cost ($), mean (SD) | 12,966 (17,734) | 12,705 (22,934) | 11,751 (4873) | 11,848 (6129) | 7274 (15,406) | 20,239 (23,354) |
| Total cost ($), median (IQR) | 12,718 (9935–14,223) | 12,144 (9368–13,381) | 13,670 (8645–14,778) | 12,165 (8814–14,603) | 2583 (926–7318) | 15,307 (12,944–20,085) |
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