Specialty Drug Pricing and Out-of-Pocket Spending on Orally Administered Anticancer Drugs in Medicare Part D, 2010 to 2019

Abstract

This study describes point-of-sale prices for orally administered anticancer drugs offered through Medicare Part D and out-of-pocket changes in spending as a result of decreasing coinsurance and price changes between 2010 and 2019.

For Medicare beneficiaries, Part D provides access to prescribed drugs. However, access to high-priced specialty medications covered by Part D may be limited by increasing drug prices and Part D benefit designs requiring patients to pay a percentage of the drug’s price with every fill through coinsurance. To improve affordability of drugs for patients, the Affordable Care Act has gradually reduced the required coinsurance for branded drugs in the coverage gap (ie, doughnut hole) from 100% in 2010 to 25% in 2019.¹ However, price increases over that same period might have offset expected savings for patients needing specialty drugs, including anticancer drugs.^2,3,4,5 We assessed point-of-sale prices from 2010 to 2018 for orally administered anticancer drugs offered through Medicare Part D and estimated how out-of-pocket spending changed from 2010 to 2019 benefit designs as a result of decreasing coinsurance as the Part D coverage gap closed.

Methods

We used Medicare formulary and pricing files for the fourth quarter of 2010 through the fourth quarter of 2018 to describe point-of-sale prices (ie, excluding rebates and discounts) for a single fill of each anticancer medication. We compared prices in 2010 (or the first year a newer product was observed in the data) and 2018. We also calculated the percentage price increase or decrease for monthly fills over this period. We estimated price changes net of inflation, adjusting drug prices and out-of-pocket spending to 2018 US dollars using the Consumer Price Index.

Next, we calculated expected out-of-pocket spending for Medicare beneficiaries under the standard benefit design in 2010 and 2019 for the 13 drugs available during both years. This standard benefit design used coinsurance rather than copayments (98% of Part D plans required coinsurance for all drugs/years studied). We assumed beneficiaries used 12 months of therapy and no other medications for comparisons.

Results

In 2010, 13 anticancer medications were covered by Part D and 54 in 2018. The mean price per fill in 2010 was $7438 vs $13 992 in 2018. In 2018, 48 of 54 medications had monthly prices exceeding $10 000 per fill and 21 had prices exceeding $15 000 per fill (Table). Across all drugs and varying years of approval (pre-2010 through 2018), mean prices rose by 5.8% per year above inflation. Changes in mean per-fill price from the first observed fill year to 2018 was 40.4% overall, ranging from a reduction of 44% for generic imatinib ($8570 in 2016 vs $4822 in 2018) to an increase of 306% for gefitinib ($1960 in 2010 vs $7960 in 2018).

Table. Mean Point-of-Sale Prices and Price Changes for Orally Administered Anticancer Drugs Under Medicare Part D^a.

Drug Name	Brand/Generic	Approval Year	First Year Observed	Mean Price for 1-mo Fill, $		% Change
				First Year	In 2018	First vs Last Year	Mean Annual
Imatinib	Brand	2001	2010	5143	10 620	106	11.0
Gefitinib	Brand	2003	2010	1960	7960	306	16.2
Thalidomide	Brand	2003	2010	7135	8583	20	2.0
Erlotinib	Brand	2004	2010	4911	8655	76	6.8
Lenalidomide	Brand	2005	2010	11 832	21 412	81	8.4
Sorafenib	Brand	2005	2010	8508	19 118	125	10.9
Dasatinib	Brand	2006	2010	8902	13 194	48	5.7
Sunitinib	Brand	2006	2010	9595	18 706	95	8.2
Vorinostat	Brand	2006	2010	10 259	15 415	50	5.3
Lapatinib	Brand	2007	2010	4147	7659	85	8.1
Nilotinib	Brand	2007	2010	9279	10 487	13	3.0
Everolimus	Brand	2009	2010	7726	15 965	107	9.5
Pazopanib	Brand	2009	2010	6311	12 392	96	9.1
Abiraterone	Brand	2011	2011	5439	10 437	92	8.1
Crizotinib	Brand	2011	2012	11 121	16 470	48	6.5
Ruxolitinib	Brand	2011	2012	8238	12 942	57	7.1
Vemurafenib	Brand	2011	2012	11 451	11 137	−3	−0.1
Axitinib	Brand	2012	2012	9849	14 756	50	7.3
Vismodegib	Brand	2012	2012	8986	11 862	32	5.0
Bosutinib	Brand	2012	2013	9003	14 636	63	9.5
Cabozantiniba	Brand	2012	2013	11 440	16 606	45	7.5
Enzalutamide	Brand	2012	2013	8684	11 144	28	5.3
Regorafenib	Brand	2012	2013	11 613	17 284	49	7.5
Ponatinib	Brand	2012	2016	17 476	17 249	−1	−0.6
Dabrafenib	Brand	2013	2013	8360	10 179	22	3.6
Pomalidomide	Brand	2013	2013	16 410	24 406	49	8.8
Trametinib	Brand	2013	2013	9568	11 032	15	2.2
Afatinib	Brand	2013	2014	6450	8378	30	6.6
Ibrutinib	Brand	2013	2014	12 588	13 496	7	2.0
Ceritinib	Brand	2014	2014	14 515	17 115	18	4.7
Idelalisib	Brand	2014	2015	8520	10 503	23	6.2
Olaparib	Brand	2014	2016	13 568	14 374	6	2.8
Palbociclib	Brand	2015	2015	15 150	16 539	9	2.9
Panobinostat	Brand	2015	2015	14 772	16 639	13	3.5
Alectinib	Brand	2015	2016	13 024	14 887	14	6.8
Cobimetinib	Brand	2015	2016	9150	10 295	13	5.9
Imatinib	Generic	2015	2016	8570	4822	−44	−28.1
Ixazomib	Brand	2015	2016	12 704	13 627	7	3.6
Lenvatinib	Brand	2015	2016	13 676	17 651	29	13.1
Osimertinib	Brand	2015	2016	14 280	15 024	5	2.6
Sonidegib	Brand	2015	2016	10 629	11 021	4	2.1
Trifluridine	Brand	2015	2016	12 051	12 853	7	3.4
Cabozantinibb	Brand	2016	2016	15 256	17 924	17	8.1
Venetoclax	Brand	2016	2016	10 100	11 495	14	6.5
Rucaparib	Brand	2016	2017	14 285	15 300	7	6.9
Brigatinib	Brand	2017	2017	14 802	16 911	14	13.3
Midostaurin	Brand	2017	2017	16 676	17 709	6	6.0
Niraparib	Brand	2017	2017	10 212	11 867	16	15.0
Ribociclib	Brand	2017	2017	19 515	21 348	9	9.0
	Plan-Drug Observations, No.	Price per Fill in First Year, Mean	Price Per Fill in 2018, SD	Mean % Change for First vs Last Year	Mean Annual Change, SD
Drugs available since 2010 (n = 13)	150 500	7438	2651	12 883	4935	93.0	8.0
All drugs (N = 54)	31 635	11 404	4158	13 992	4341	40.4	5.8

^aFive branded drugs had observed data only for 2018, with mean prices for 1-month fills as follows: abemaciclib, $12 576; acalabrutinib, 14 630; enasidenib, $25 868; neratinib, $11 910; and apalutamide, $11 369.

^bDrug is available under 2 branded drug names: Cometriq (approved in 2012) and C, abometyx (approved in 2016). Prices represent the reimbursed amount at the point of sale, including both Medicare and patient contributions. First-year and last-year prices were compared against external references to ensure dosing changes were not driving the findings. In such cases, monthly prices were adjusted (n = 11) to more closely match the expected prices at launch (https://www.mskcc.org/sites/default/files/node/25097/documents/111516-drug-costs-table.pdf) and in 2018 (Medicare Part D Plan Finder [https://www.medicare.gov/find-a-plan/questions/home.aspx] and GoodRx [https://www.goodrx.com/]).

Despite efforts to close the coverage gap between 2010 and 2019, mean expected out-of-pocket spending in 2019 benefit designs increased for 12 of 13 orally administered anticancer drugs available in both years (mean 12-month out-of-pocket spending in 2010 was $8794 and in 2019 is expected to be $10 470; mean increase, $1676) (Figure). Estimated annual out-of-pocket spending in 2019 is expected to be lowest for lapatinib ($7220) and highest for lenalidomide ($15 472).

Figure. Expected Annual Patient Out-of-Pocket Spending for Anticancer Medications in 2010 and 2019 Benefit Designs.

The graph shows expected out-of-pocket spending for Medicare beneficiaries, assuming 12 months of therapy and the mean point-of-sale price for a 30-day or typical supply from the fourth quarter of 2010 and 2018, respectively. We also assumed that beneficiaries had no other medication use and used the standard benefit design (approximately 98% of plans required coinsurance for all drugs and years studied). Median prices resulted in similar spending and are not shown.

Discussion

The number of orally administered anticancer medications covered under Part D has increased since 2010, with mean monthly point-of-sale prices for anticancer drugs reaching nearly $14 000 in 2018. Anticancer drug prices have increased beyond inflation between 2010 and 2018, resulting in higher out-of-pocket spending for patients despite the Part D coverage gap closing.

Limitations of this study include use of point-of-sale prices, which do not reflect rebates or discounts. However, out-of-pocket spending for patients facing coinsurance is based on the point-of-sale price. Moreover, rebates are likely to be limited for anticancer drugs on Part D because they lack head-to-head competitors in most instances. Because anticancer drugs are part of a protected class in Part D, these findings may not generalize to other drugs.

Savings expected through closing the Part D coverage gap or through other policy changes, such as point-of-sale rebates, will be unlikely to offer financial protections to patients needing anticancer drugs. Moreover, because beneficiaries pay a percentage of the drug’s price and have no out-of-pocket spending limits on Part D, even large price decreases may not provide sufficient financial relief to patients requiring long-term anticancer drug use. Efforts to reduce drug prices and limit beneficiary out-of-pocket spending are needed to improve access to high-cost drugs.

Section Editor: Jody W. Zylke, MD, Deputy Editor.