Barriers to receipt of novel oral oncolytics: A single-institution quality improvement investigation.

INTRODUCTION: Novel oral oncolytic agents have become the standard of care and first-line therapies for many malignancies. However, issues impacting access to these drugs are not well explored. As part of a quality improvement project in a large tertiary academic institution, we aim to identify potential barriers that delay treatment for patients who are prescribed novel oral oncolytics. METHODS: This was a retrospective review of adults who were newly prescribed a novel oral oncolytic for Food and Drug Administration-approved indications at a single tertiary care center. Patients were identified via electronic prescription data (e-Scribe). Demographics, insurance information, and prescription dates were extracted from the electronic medical record and pharmacy claims data. Statistical analyses were performed to determine whether time-to-receipt was associated with insurance category, pharmacy transfers, cost assistance, and drug prescribed. RESULTS: Of the 270 successfully filled prescriptions, the mean time-to-receipt was 7.3 ± 10.3 days (range: 0-109 days). Patients with Medicare experienced longer time-to-receipt (9.1 ± 13.1 days) compared to patients with commercial insurance (4.4 ± 3.3). Uninsured patients experienced the longest time-to-receipt (15.7 ± 7.8 days) overall. Pharmacy transfers and cost assistance programs were also significantly associated with longer time-to-receipt. Ten prescriptions remained unfilled 90 days after the study period and were considered abandoned. CONCLUSION: Insurance has a significant effect on the time-to-receipt of newly prescribed novel oral oncolytics. Pharmacy transfers and applying for cost assistance are also associated with longer wait times for patients. Our retrospective analysis identifies areas of improvement for future interventions to reduce wait times for patients receiving novel oral oncolytics.

Cost-Related Medication Nonadherence in Adults With Atherosclerotic Cardiovascular Disease in the United States, 2013 to 2017.

BACKGROUND: Medication nonadherence is associated with worse outcomes in patients with atherosclerotic cardiovascular disease (ASCVD), a group who requires long-term therapy for secondary prevention. It is important to understand to what extent drug costs, which are potentially actionable factors, contribute to medication nonadherence. METHODS: In a nationally representative survey of US adults in the National Health Interview Survey (2013-2017), we identified individuals ≥18 years with a reported history of ASCVD. Participants were considered to have experienced cost-related nonadherence (CRN) if in the preceding 12 months they reported skipping doses to save money, taking less medication to save money, or delaying filling a prescription to save money. We used survey analysis to obtain national estimates. RESULTS: Of the 14 279 surveyed individuals with ASCVD, a weighted 12.6% (or 2.2 million [95% CI, 2.1-2.4]) experienced CRN, including 8.6% or 1.5 million missing doses, 8.8% or 1.6 million taking lower than prescribed doses, and 10.5% or 1.9 million intentionally delaying a medication fill to save costs. Age <65 years, female sex, low family income, lack of health insurance, and high comorbidity burden were independently associated with CRN, with >1 in 5 reporting CRN in these subgroups. Survey respondents with CRN compared with those without CRN had 10.8-fold higher odds of requesting low-cost medications and 8.9-fold higher odds of using alternative, nonprescription, therapies. CONCLUSIONS: One in 8 patients with ASCVD reports nonadherence to medications because of cost. The removal of financial barriers to accessing medications, particularly among vulnerable patient groups, may help improve adherence to essential therapy to reduce ASCVD morbidity and mortality.

Anticancer Drug Prescription Patterns in Japan: Future Directions in Cancer Therapy.

BACKGROUND: Despite their benefits, the rapid development of new cancer treatments has been a significant driver of increasing health care expenditures in the face of limited health care budgets. In this study, we analyzed the prescribing trends for anticancer drugs from 2010 through 2016 in Japan and sought to identify unique trends that could provide a basis for future medical economic research aiming to develop more efficacious and cost-effective cancer therapies. METHODS: We used publicly available marketing data for anticancer drugs in Japan for 2010-2016. The drugs selected for this research were categorized according to the Anatomical Therapeutic Chemical Classification System. We investigated the overall anticancer drug market size, the number of anticancer drugs, the top 30 selling anticancer categories, sales and prescription volumes, and changes in sales and prescription volumes between 2010 and 2016 in the country. RESULTS: The anticancer agent market expanded each year from 2010 to 2016, with sales exceeding 1 trillion yen in 2015. The proportion of molecular targeted drugs (antineoplastic mAbs and protein kinase inhibitors) among the top 30 selling anticancer categories has continued to increase, and both the sales and prescription volumes of these drugs exceeded those of drugs in other categories, suggesting that these treatments play a dominant role in cancer pharmacotherapy. CONCLUSION: The availability and increasing use of innovative but more expensive targeted therapies were major drivers of increases in pharmaceutical expenditures for cancer treatment in Japan. Therefore, the effective use of genetic testing can mitigate these rising costs.

Rising Prices of Targeted Oral Anticancer Medications and Associated Financial Burden on Medicare Beneficiaries.

Purpose The high cost of oncology drugs threatens the affordability of cancer care. Previous research identified drivers of price growth of targeted oral anticancer medications (TOAMs) in private insurance plans and projected the impact of closing the coverage gap in Medicare Part D in 2020. This study examined trends in TOAM prices and patient out-of-pocket (OOP) payments in Medicare Part D and estimated the actual effects on patient OOP payments of partial filling of the coverage gap by 2012. Methods Using SEER linked to Medicare Part D, 2007 to 2012, we identified patients who take TOAMs via National Drug Codes in Part D claims. We calculated total drug costs (prices) and OOP payments per patient per month and compared their rates of inflation with general health care prices. Results The study cohort included 42,111 patients who received TOAMs between 2007 and 2012. Although the general prescription drug consumer price index grew at 3% per year over 2007 to 2012, mean TOAM prices increased by nearly 12% per year, reaching $7,719 per patient per month in 2012. Prices increased over time for newly and previously launched TOAMs. Mean patient OOP payments dropped by 4% per year over the study period, with a 40% drop among patients with a high financial burden in 2011, when the coverage gap began to close. Conclusion Rising TOAM prices threaten the financial relief patients have begun to experience under closure of the coverage gap in Medicare Part D. Policymakers should explore methods of harnessing the surge of novel TOAMs to increase price competition for Medicare beneficiaries.

Sanofi vows to limit price hikes- but will it make much difference?

Sanofi's commitment to limit prices to the rise in the National Health Expenditure Data Accounts--estimated to be 5.6% annually from 2016 to 2025--is not enough, experts said.

Real-World Treatment Patterns and Costs for Patients with Renal Cell Carcinoma Initiating Treatment with Sunitinib and Pazopanib.

BACKGROUND: Sunitinib and pazopanib are among the most prescribed targeted therapies for the systemic management of advanced renal cell carcinoma (RCC), but published cost comparisons between the 2 agents are few and limited by methodological and population differences. Also, sunitinib is administered on a 4-week on/2-week off cycle, and pazopanib is taken continuously. Thus, appropriate use and cost comparisons between the 2 drugs require methodological approaches to account for these differences. One way to accomplish this is to substitute expected for observed days supply. Recognizing the effects of nonrepresentative days supply values is important for assessing real-world treatment patterns and costs. OBJECTIVES: To (a) characterize demographic and clinical characteristics among patients with RCC newly initiating sunitinib or pazopanib, using a large administrative claims dataset; (b) characterize treatment patterns, persistence, and costs for each treatment group; and (c) assess the effect on treatment patterns and costs for sunitinib by substituting 42 days for prescriptions with 28- or 30-day supplies to account for sunitinib's 4-week on/2-week off dosing schedule. METHODS: This was a retrospective cohort study using health care claims data from the Truven MarketScan Research Databases, which include enrollment information and medical and pharmacy claims. Baseline patient demographic and clinical characteristics and treatment patterns (continuation, discontinuation, switching, or interruption; days supply; and persistence) were compared. Health care costs were calculated as mean daily index medication costs and as total, medical, and medication (all-cause and RCC-related) costs over the 12 months post-index period. Inclusion criteria were continuous health plan enrollment between 6 months pre-index and 12 months post-index; no RCC medications 6 months pre-index; ≥ 2 RCC diagnoses within ±180 days of index; and age ≥ 20 years. For demographic and clinical characteristics, treatment patterns, and costs, means (± standard deviations) for continuous data and relative frequencies for categorical data were reported. Chi-square tests or Student t-tests were used to evaluate differences other than costs. A generalized linear model with gamma distribution and log link was used for evaluating costs, controlling for patient demographic and pre-index clinical characteristics, persistence days, and index medication. All statistical tests were 2-tailed with significance set at P < 0.05 for all comparisons except for interactions with significance set at P < 0.10. The effects of substituting 42 days supply for sunitinib prescription records with 28 or 30 days supply were determined. RESULTS: In total, 609 (15.1% of the sunitinib overall sample) sunitinib patients and 183 (8.3% of the pazopanib overall sample) pazopanib patients were included. Demographic and clinical characteristics were similar for each treatment cohort. The persistence periods and number of prescriptions filled were also similar. Without substitution, significant differences were observed between treatment groups in patterns of index medication use (overall P = 0.0409), with fewer patients taking sunitinib continuing treatment than patients taking pazopanib. However, with substitution, treatment patterns differed significantly (overall P = 0.0026), but with more sunitinib patients than pazopanib patients continuing treatment. Without substitution, unadjusted daily mean index medication costs were significantly different for sunitinib ($216) versus pazopanib ($177, P < 0.0001). Substitution of sunitinib days supply eliminated the significant differences in daily index medication costs between treatment groups. The 1-year RCC-related and all-cause medication, medical, and total unadjusted costs were not significantly different between treatment groups, and substitution had no effect on these costs. After adjustment for possible confounding factors, these cost results were similar to those found with unadjusted analyses. CONCLUSIONS: In this study, patients with RCC who were initiating sunitinib and pazopanib had similar demographic and clinical characteristics and drug persistence patterns. The effect of substituting days supply values was demonstrated as an approach to considering differences in dosing cycles. Substitution significantly reduced sunitinib mean daily index medication costs and eliminated or reversed the direction of significant differences in costs between drugs during the persistence period. No significant differences were observed in unadjusted or adjusted 1-year costs. DISCLOSURES: This study was funded and conducted fully by Pfizer. All authors are employees of Pfizer. This work was presented in part as posters at the 2015 Genitourinary Cancers Symposium, of the American Society of Clinical Oncology; Rosen Shingle Creek, Orlando, FL; February 26-28, 2015, and the 20th Annual International Meeting of the International Society for Pharmacoeconomics and Outcomes Research; Philadelphia, PA; May 16-20, 2015. All authors contributed to study concept and design and to data interpretation. Mardekian was primarily responsible for data collection, along with Harnett. MacLean and Harnett worked on the manuscript, which was revised by MacLean and Mardekian.

Impact of falling reimbursement rates on physician preferences regarding drug therapy for osteoarthritis using a discrete choice experiment.

OBJECTIVES: In the European context of falling reimbursement rates for some osteoarthritis (OA) treatments, we performed a study to determine whether the cost covered by patients influenced the decisions of their physicians' prescriptions for medication. METHODS: The study involved 106 general practitioners (GPs) and 82 rheumatologists. Preferences were elicited using a discrete choice experiment. Scenarios were generated including seven treatment attributes with associated different levels: pain relief, improvement in function, retardation of joint degradation, risk of moderate side effects, risk of serious side effects, cost borne by the patient and degree of patient acceptance of the treatment. KEY FINDINGS: OA treatment choices were significantly influenced by pain relief (ß = 1.1533, P < 0.0001 for GPs and ß = 0.5043, P = 0.0024 for rheumatologists), improvement in function (ß = 1.2140 for GPs and ß = 0.7192 for rheumatologists, P < 0.0001), annual cost to the patient (ß = -0.0054 for GPs and ß = -0.0038 for rheumatologists, P < 0.0001) and serious side effects (ß = -0.5524 for GPs and ß = -0.4268 for rheumatologists, P < 0.0001). The risk of moderate side effects only had an impact on GP decision making (ß = 0.0282, P = 0.0028). All physicians were willing to make patients bear an extra annual cost of: (1) €225 among GPs and €189 among rheumatologists so that they could benefit from one unit improvement in function; and (2) €214 among GPs and €133 among rheumatologists so that they could benefit from a one unit improvement in pain relief. CONCLUSION: When making decisions about which treatment to prescribe, physicians take into account the cost to patients. Changes in reimbursement rates for some OA treatments may lead to changes in prescribing practices.

The consumer welfare implications of governmental policies and firm strategy in markets for medicines.

This paper empirically examines the consumer welfare implications of changes in government policies related to patent protection and compulsory licensing in the Indian market for oral anti-diabetic (OAD) medicines. In contrast to previous studies on the impact of pharmaceutical patents in India, we observe, and estimate the welfare effects accruing from differential pricing and voluntary licensing strategies of patent-holding innovator firms. Three novel molecules belonging to the dipeptidyl peptidase-4 (DPP-4) inhibitor class of OADs have been launched in India by the patent holders, at lower prices than those prevailing in the developed countries. Using aggregate market transaction data, we structurally estimate demand and supply and use the parameter estimates in our model to simulate consumer welfare under various counterfactual scenarios. Our results suggest that the introduction of DPP-4 inhibitors generated a consumer surplus gain of around 7.6 cents per day for a typical DPP-4 inhibitor user under the existing differential pricing and voluntary licensing strategies. If the innovators decide to price at developed-country levels, this surplus is eliminated almost entirely. The issuance of compulsory licensing does not always improve consumer welfare because if innovators defer or delay the introduction of new drugs in response, the loss in consumer welfare could be substantial.

Canada's New Generic Pricing Policy: A Reasoned Approach to a Challenging Problem.

Alberta, quickly followed by other Canadian provinces, has introduced a new pricing model for generic drugs, in which prices are inversely related to the number of generic manufacturers of the drug. This paper examines the rationale for the new policy.

Can Walmart make us healthier? Prescription drug prices and health care utilization.

This paper analyzes how prices in the retail pharmaceutical market affect health care utilization. Specifically, I study the impact of Walmart's $4 Prescription Drug Program on utilization of antihypertensive drugs and on hospitalizations for conditions amenable to drug therapy. Identification relies on the change in the availability of cheap drugs introduced by Walmart's program, exploiting variation in the distance to the nearest Walmart across ZIP codes in a difference-in-differences framework. I find that living close to a source of cheap drugs increases utilization of antihypertensive medications by 7 percent and decreases the probability of an avoidable hospitalization by 6.2 percent.

Accuracy of annual prescription drug expenditure forecasts in AJHP.

PURPOSE: The accuracy of the forecasts of drug expenditures in nonfederal hospitals and clinics published annually in the American Journal of Health-System Pharmacy (AJHP) relative to the accuracy of forecasts produced by the Centers for Medicare and Medicaid Services (CMS) was evaluated. METHODS: AJHP-published forecasts of drug expenditure growth for nonfederal hospitals (for the years 2003 through 2013) and clinics (for the years 2004 through 2013) were compared with data on actual growth. Data on actual and projected growth published by CMS were analyzed for the years 2003 through 2012. The mean absolute error and directional accuracy of the forecasts published in AJHP for nonfederal hospitals and clinics and the CMS forecasts were determined and compared. RESULTS: Actual spending growth was within the range of the forecast published in AJHP for 2 of 11 years for nonfederal hospitals and for 3 of 10 years for clinics; the forecasts for nonfederal hospitals and clinics were directionally accurate 27.3% and 60.0% of the time, respectively. The mean absolute errors of the AJHP-published drug expenditure forecasts for the nonfederal hospital and clinic sectors were 2.0 and 4.7 percentage points, respectively. The CMS forecasts of overall drug spending were directionally accurate 70% of the time, and the mean absolute error (2.2 percentage points) was not statistically different from that of either sector forecast published in AJHP. CONCLUSION: The annual drug expenditure forecasts published in AJHP have been reasonably accurate for predicting growth in prescription expenditures when compared with other available drug expenditure forecasts.

Repairing the broken market for antibiotic innovation.

Multidrug-resistant bacterial diseases pose serious and growing threats to human health. While innovation is important to all areas of health research, it is uniquely important in antibiotics. Resistance destroys the fruit of prior research, making it necessary to constantly innovate to avoid falling back into a pre-antibiotic era. But investment is declining in antibiotics, driven by competition from older antibiotics, the cost and uncertainty of the development process, and limited reimbursement incentives. Good public health practices curb inappropriate antibiotic use, making return on investment challenging in payment systems based on sales volume. We assess the impact of recent initiatives to improve antibiotic innovation, reflecting experience with all sixty-seven new molecular entity antibiotics approved by the Food and Drug Administration since 1980. Our analysis incorporates data and insights derived from several multistakeholder initiatives under way involving governments and the private sector on both sides of the Atlantic. We propose three specific reforms that could revitalize innovations that protect public health, while promoting long-term sustainability: increased incentives for antibiotic research and development, surveillance, and stewardship; greater targeting of incentives to high-priority public health needs, including reimbursement that is delinked from volume of drug use; and enhanced global collaboration, including a global treaty.