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Cost and utilization of immunotherapy and targeted therapy for melanoma: Cross-sectional analysis in the Medicare population, 2013 and 2015

2019; Elsevier BV; Volume: 82; Issue: 3 Linguagem: Inglês

10.1016/j.jaad.2019.10.023

1097-6787

Kira Seiger, Chrysalyne D. Schmults, Ann W. Silk, Emily S. Ruiz,

Economic and Financial Impacts of Cancer

To the Editor: Ipilimumab, approved in 2011, was the first systemic agent to significantly prolong survival in metastatic melanoma, although it raised affordability concerns.1Fellner C. Ipilimumab (Yervoy) prolongs survival in advanced melanoma: serious side effects and a hefty price tag may limit its use.P T. 2012; 37: 503-530PubMed Google Scholar In 2013, the annualized per-patient Medicare spending for ipilimumab was more than $80,000, whereas lifetime treatment with alternative therapies was less than $50,000.2Ruiz E.S. Morgan F.C. Zigler C.M. Besaw R.J. Schmults C.D. Analysis of national skin cancer expenditures in the United States Medicare population, 2013.J Am Acad Dermatol. 2019; 80: 275-278Abstract Full Text Full Text PDF PubMed Scopus (8) Google Scholar,3Shih V. Ten Ham R.M. Bui C.T. Tran D.N. Ting J. Wilson L. Targeted therapies compared to dacarbazine for treatment of BRAF(V600E) metastatic melanoma: a cost-effectiveness analysis.J Skin Cancer. 2015; 2015: 505302Crossref PubMed Scopus (15) Google Scholar After ipilimumab was approved and through 2015, other costly immunotherapies (programmed cell death protein 1 inhibitors) and targeted therapies (BRAF and MEK inhibitors) were approved. This cross-sectional analysis evaluates Medicare spending, out-of-pocket costs (OOPC), and utilization trends for immunotherapy, targeted therapy, and other melanoma treatments in 2013 and 2015, before the standard use of dual biologic regimens.4Vennepureddy A. Thumallapally N. Motilal Nehru V. Atallah J.P. Terjanian T. Novel drugs and combination therapies for the treatment of metastatic melanoma.J Clin Med Res. 2016; 8: 63-75Crossref PubMed Google Scholar The 2013 and 2015 Medicare Limited Data Set Standard Analytic File (LDSSAF) 5% samples for Part B fee-for-service beneficiaries were queried for International Classification of Diseases, ninth and tenth revisions, Clinical Modification codes for melanoma and the Healthcare Common Procedure Coding System codes for ipilimumab and unclassified biologics, which included nivolumab and pembrolizumab in 2015. (Unique codes for nivolumab and pembrolizumab were not implemented until January 1, 2016.) Aggregate costs and number of patients treated in LDSSAF 5% samples were scaled to reflect nationwide Medicare Part B trends. Medicare Part D Prescriber Public Use Files were searched for immunotherapies and targeted therapies. Annualized total and per-patient spending (Medicare plus OOPC) were calculated for immunotherapy; targeted therapy; and hospital-based pharmaceutical, radiation, and surgical care. The 2013 costs were inflation-adjusted to December 2015 dollars. Part B and D beneficiaries cannot be linked, so per-patient spending was calculated separately. Analysis was performed with SAS, version 9.4 (SAS Institute, Cary, NC). The Partners Human Research Committee exempted this study. Among Medicare Part B fee-for-service and Part D beneficiaries from 2013 to 2015, annualized total melanoma spending increased by 21%, from $287 to $348 million (Table I). Although annualized ipilimumab spending decreased 20%, by more than $19 million, annualized spending on unclassified biologics increased 53.701%, by more than $75 million, likely due to nivolumab and pembrolizumab approval in 2014. Immunotherapy (ipilimumab and unclassified biologics) cost $153 million in 2015, comprising 44% of melanoma spending. Annualized OOPC per Part B beneficiary for ipilimumab decreased from $20,660 to $15,333 but remained costlier than unclassified biologics at $9,869 in 2015 (Table II). Annualized OOPC per patient for dabrafenib and trametinib more than doubled to $1,710 and $1,820, respectively, in 2015.Table IAnnualized melanoma spending, Part B fee-for-service beneficiaries and Part D beneficiariesType of therapyCost2013∗Dollar amounts in 2013 were adjusted for inflation using the Consumer Price Index of the Bureau of Labor Statistics at the US Department of Labor for conversion of December 2013 dollars to December 2015 dollars.2015Immunotherapy Ipilimumab (Parts B and D)Total cost$96,841,604$77,283,299Medicare payment$77,788,805$62,190,346Out-of-pocket cost$19,052,800$15,092,953 Nivolumab†Nivolumab was approved on December 22, 2014, for advanced melanoma; March 4, 2015, for lung cancer; and November 23, 2015, for metastatic renal cell carcinoma. The 2015 Part D nivolumab costs are therefore excluded from total melanoma spending because they may include patients without melanoma. (Part D)Total cost—$11,068,778Medicare payment—$10,745,422Out-of-pocket cost—$323,356 Pembrolizumab‡Pembrolizumab was approved on September 4, 2014, for advanced melanoma and October 2, 2015, for advanced non–small cell lung cancer. The 2015 Part D pembrolizumab costs are therefore excluded from total melanoma spending because they may include patients without melanoma. (Part D)Total cost—$2,246,991Medicare payment—$2,145,600Out-of-pocket cost—$101,391 Unclassified biologics§Includes Healthcare Common Procedure Coding System (HCPCS) codes J9999 (not otherwise classified antineoplastic drugs) and J3590 and J3490 (unclassified biologics). The 2015 calculations include nivolumab and pembrolizumab for the treatment of melanoma, which did not have their own HCPCS codes until January 1, 2016. The 2015 totals may include talimogene laherparepvec, which was billed with HCPCS code J9999 after its approval for metastatic melanoma on October 27, 2015, before receiving its own code in 2016. (Part B)Total cost$140,768$75,734,049Medicare payment$112,170$60,338,438Out-of-pocket cost$28,598$15,395,611Targeted therapy Cobimetinib (Part D)Total cost—$141,955Medicare payment—$134,063Out-of-pocket cost—$7,892 Dabrafenib (Part D)Total cost$3,568,412$41,377,005Medicare payment$3,407,539$39,357,221Out-of-pocket cost$160,883$2,019,784 Trametinib (Part D)Total cost$3,144,587$46,245,496Medicare payment$3,033,590$44,130,417Out-of-pocket cost$110,997$2,115,079 Vemurafenib (Part D)Total cost$39,357,711$19,023,990Medicare payment$36,947,535$17,943,782Out-of-pocket cost$2,410,176$1,080,207Other All other treatment‖All other treatment includes hospital-based pharmaceutical, radiation, and surgical care outside of ipilimumab and unclassified biologics. (Part B)Total cost$143,982,249$88,482,182Medicare payment$114,102,724$69,717,315Out-of-pocket cost$29,879,525$18,764,868 All melanoma treatment¶Does not include Part D nivolumab and pembrolizumab spending because melanoma patients could not be isolated from other cancer patients. (Parts B and D)Total cost$287,035,331$348,287,976Medicare payment$235,392,363$293,811,582Out-of-pocket cost$51,642,979$54,476,394∗ Dollar amounts in 2013 were adjusted for inflation using the Consumer Price Index of the Bureau of Labor Statistics at the US Department of Labor for conversion of December 2013 dollars to December 2015 dollars.† Nivolumab was approved on December 22, 2014, for advanced melanoma; March 4, 2015, for lung cancer; and November 23, 2015, for metastatic renal cell carcinoma. The 2015 Part D nivolumab costs are therefore excluded from total melanoma spending because they may include patients without melanoma.‡ Pembrolizumab was approved on September 4, 2014, for advanced melanoma and October 2, 2015, for advanced non–small cell lung cancer. The 2015 Part D pembrolizumab costs are therefore excluded from total melanoma spending because they may include patients without melanoma.§ Includes Healthcare Common Procedure Coding System (HCPCS) codes J9999 (not otherwise classified antineoplastic drugs) and J3590 and J3490 (unclassified biologics). The 2015 calculations include nivolumab and pembrolizumab for the treatment of melanoma, which did not have their own HCPCS codes until January 1, 2016. The 2015 totals may include talimogene laherparepvec, which was billed with HCPCS code J9999 after its approval for metastatic melanoma on October 27, 2015, before receiving its own code in 2016.‖ All other treatment includes hospital-based pharmaceutical, radiation, and surgical care outside of ipilimumab and unclassified biologics.¶ Does not include Part D nivolumab and pembrolizumab spending because melanoma patients could not be isolated from other cancer patients. Open table in a new tab Table IIAnnualized per-patient melanoma spending, Part B fee-for-service beneficiaries and Part D beneficiariesType of therapyCost and utilization2013∗Dollar amounts in 2013 were adjusted for inflation using the Consumer Price Index of the Bureau of Labor Statistics at the US Department of Labor for conversion of December 2013 dollars to December 2015 dollars.2015Immunotherapy Ipilimumab (Part B)Number of patients920980Per-patient cost$102,053$77,035Medicare payment per patient$81,393$61,702Out-of-pocket cost per patient$20,660$15,333 Ipilimumab (Part D)Number of patients3118Per-patient cost$95,260$99,410Medicare payment per patient$93,794$95,696Out-of-pocket cost per patient$1466$3714 Nivolumab†Nivolumab was approved on December 22, 2014 for advanced melanoma; March 4, 2015 for lung cancer; and November 23, 2015 for metastatic renal cell carcinoma. The 2015 Part D costs may therefore include patients without melanoma. (Part D)Number of patients—315Per-patient cost—$35,139Medicare payment per patient—$34,112Out-of-pocket cost per patient—$1027 Pembrolizumab‡Pembrolizumab was approved on September 4, 2014, for advanced melanoma and October 2, 2015, for advanced non–small cell lung cancer. The 2015 Part D costs may therefore include patients without melanoma. (Part D)Number of patients—44Per-patient cost—$51,068Medicare payment per patient—$48,764Out-of-pocket cost per patient—$2304 Unclassified biologics§Includes Healthcare Common Procedure Coding System (HCPCS) codes J9999 (not otherwise classified antineoplastic drugs) and J3590 and J3490 (unclassified biologics). The 2015 calculations include nivolumab and pembrolizumab for the treatment of melanoma, which did not have their own HCPCS codes until January 1, 2016. The 2015 totals may include talimogene laherparepvec, which was billed with HCPCS code J9999 after its approval for metastatic melanoma on October 27, 2015, before receiving its own code in 2016. (Part B)Number of patients2001560Per-patient cost$704$48,547Medicare payment per patient$561$38,678Out-of-pocket cost per patient$143$9869Targeted therapy Cobimetinib (Part D)Number of patients—19Per-patient cost—$7471Medicare payment per patient—$7056Out-of-pocket cost per patient—$415 Dabrafenib (Part D)Number of patients1881181Per-patient cost$18,981$35,036Medicare payment per patient$18,125$33,325Out-of-pocket cost per patient$856$1710 Trametinib (Part D)Number of patients1441162Per-patient cost$21,837$39,798Medicare payment per patient$21,067$37,978Out-of-pocket cost per patient$771$1820 Vemurafenib (Part D)Number of patients1075472Per-patient cost$36,612$40,220Medicare payment per patient$34,370$37,936Out-of-pocket cost per patient$2242$2284∗ Dollar amounts in 2013 were adjusted for inflation using the Consumer Price Index of the Bureau of Labor Statistics at the US Department of Labor for conversion of December 2013 dollars to December 2015 dollars.† Nivolumab was approved on December 22, 2014 for advanced melanoma; March 4, 2015 for lung cancer; and November 23, 2015 for metastatic renal cell carcinoma. The 2015 Part D costs may therefore include patients without melanoma.‡ Pembrolizumab was approved on September 4, 2014, for advanced melanoma and October 2, 2015, for advanced non–small cell lung cancer. The 2015 Part D costs may therefore include patients without melanoma.§ Includes Healthcare Common Procedure Coding System (HCPCS) codes J9999 (not otherwise classified antineoplastic drugs) and J3590 and J3490 (unclassified biologics). The 2015 calculations include nivolumab and pembrolizumab for the treatment of melanoma, which did not have their own HCPCS codes until January 1, 2016. The 2015 totals may include talimogene laherparepvec, which was billed with HCPCS code J9999 after its approval for metastatic melanoma on October 27, 2015, before receiving its own code in 2016. Open table in a new tab Immunotherapy yields considerable spending for the small fraction of patients with advanced melanoma, highlighting potential savings from early detection and prevention of melanoma. High OOPC may burden elderly patients, suggesting the need for drug pricing transparency and subsequent policy to lower costs.5Narang A.K. Nicholas L.H. Out-of-pocket spending and financial burden among Medicare beneficiaries with cancer.JAMA Oncol. 2017; 3: 757-765Crossref PubMed Scopus (93) Google Scholar Market competition from new therapies may have contributed to decreased ipilimumab spending from 2013 to 2015. Study limitations are those of LDSSAF 5% samples, which include Part B fee-for-service but not Medicare Advantage beneficiaries. Total melanoma spending excluded Part D costs for nivolumab and pembrolizumab, which may include patients without melanoma. Patients could not be stratified by stage based on claims data. The influence of supplemental insurance on OOPC could not be evaluated. Future studies should assess spending on newer therapies and whether immunotherapy yields savings in other aspects of care.