| Literature DB >> 30479776 |
Rena M Conti1, Kevin H Nguyen2, Meredith B Rosenthal2.
Abstract
BACKGROUND: In the United States (U.S.), large price increases for selected generic drugs have elicited public outrage. Recent legislative proposals aim to increase price transparency and identify outlier drug "price spikes." It is unknown how many and what types of products would be highlighted by such efforts.Entities:
Keywords: Costs; Generic drugs; Legislation; Prescription drugs; Price competition; Price increases
Year: 2018 PMID: 30479776 PMCID: PMC6247773 DOI: 10.1186/s40545-018-0156-8
Source DB: PubMed Journal: J Pharm Policy Pract ISSN: 2052-3211
Drug Price Increase “Hot Spots”a
| Price Change Distribution, Measured at the Drug Level | 2013-2014 | |||
|---|---|---|---|---|
| Overall | % > Medical CPI | % > 15% | % > 20% | |
| Number of Unique Molecules in Sample | 2,285 | 1,648 | 987 | 826 |
| Molecule-Seller-Formulation Combinations in Sample | 6,182 | 3,102 | 1,713 | 1,425 |
| Percentage of Molecule-Seller-Formulation Combinations Meeting Threshold | - | 50% | 28% | 13% |
| Number of Manufacturers in Sample | 378 | 319 | 213 | 197 |
| Percentage of total manufacturers producing molecules meeting threshold | - | 84% | 56% | 52% |
| Quarterly Use (millions of units) | ||||
| Mean | 7.83 | 7.03 | 7.49 | 7.94 |
| Standard Deviation | 3.48 | 3.67 | 2.62 | 2.76 |
| Quarterly Sales (millions of dollars) | ||||
| Average | 3.66 | 3.78 | 3.53 | 2.83 |
| Standard Deviation | 1.73 | 2.01 | 1.71 | 1.13 |
| Price Change | ||||
| Mean | 38% | 93% | 162% | 191% |
| Median | 2% | 17% | 41% | 52% |
| 95th Percentile | 135% | 249% | 376% | 424% |
| Standard Deviation | 1053% | 1485% | 1995% | 2187% |
| Price Level, 2013 ($) | ||||
| Average | 29.69 | 43.35 | 30.72 | 22.63 |
| Standard Deviation | 378.44 | 521.16 | 385.12 | 292.56 |
| Hot Spot Market Shareb | ||||
| Based on Total Extended Units Sold | - | 45% | 27% | 23% |
| Based on Total Inflation-Adjusted Sales | - | 25% | 12% | 8% |
aAuthors’ calculations using IQVIA Health NSP data. All analyses used STATA 14.0 (College Station, Texas)
bHot Spot market share was calculated in terms of total extended units (total extended units sold by hot spot products divided by total extend units sold of all products) and total inflation-adjusted sales (total inflation-adjusted sales of products by hot spot products divided by total inflation-adjusted sales of all products) by era
Product characteristics and average price levelsa
| Product characteristic | Percent of products ( | Mean (SD) USD Price Level in 2013 |
|---|---|---|
| Manufacturer Count per Product | ||
| 1 | 27% | 92.90 (721.02) |
| 2 | 6% | 23.47 (108.27) |
| 3 | 8% | 16.13 (71.54) |
| 4 | 6% | 8.79 (37.44) |
| ≥ 5 | 53% | 2.65 (16.94) |
| Formulation | ||
| All Others | 22% | 41.23 (526.71) |
| Injectable | 14% | 133.76 (753.03) |
| Oral | 64% | 2.63 (14.24) |
| Patent Status | ||
| Branded Generic | 21% | 112.03 (822.57) |
| Generic | 79% | 8.36 (54.11) |
| Volume in previous period | ||
| Very low volume (<1,000 units per quarter) | 10% | 142.14 (1,077.18) |
| All other drugs | 90% | 17.65 (186.61) |
| Orphan Drug Designation | ||
| No | 92% | 13.53 (78.45) |
| Yes | 8% | 214.16 (1,293.70) |
aAuthors’ calculations using IQVIA Health NSP data. All analyses used STATA 14.0 (College Station, Texas)
Odds ratios from regression analysis of factors associated with price increases above thresholds
| 2013-2014 | ||||||
|---|---|---|---|---|---|---|
| % > Medical CPI | % > 15% | % > 20% | ||||
| Odds Ratio | Odds Ratio | Odds Ratio | ||||
| Manufacturer count per product | ||||||
| 1 | 1.53 | <0.01 | 1.33 | 0.02 | 1.33 | 0.03 |
| 2 | 1.26 | 0.04 | 1.31 | 0.03 | 1.07 | 0.60 |
| 3 | 1.05 | 0.64 | 1.10 | 0.11 | 1.35 | 0.01 |
| 4 | 0.93 | 0.48 | 1.10 | 0.42 | 1.11 | 0.42 |
| ≥ 5 | Ref | - | Ref | - | Ref | - |
| Formulation | ||||||
| All Others | Ref | - | Ref | - | Ref | - |
| Injectable | 0.88 | 0.30 | 0.90 | 0.46 | 0.97 | 0.85 |
| Oral | 0.83 | 0.10 | 1.02 | 0.90 | 1.11 | 0.39 |
| Patent Status | ||||||
| Branded Generic | Ref | - | Ref | - | Ref | - |
| Generic | 0.49 | <0.01 | 0.81 | 0.09 | 0.97 | 0.84 |
| Volume in previous period | ||||||
| Volume >1,000 units | Ref | - | Ref | - | Ref | - |
| Volume <1,000 units | 1.28 | 0.02 | 1.38 | <0.01 | 1.46 | <0.01 |
| Orphan Drug Designation | ||||||
| No | Ref | - | Ref | - | Ref | - |
| Yes | 1.15 | 0.15 | 1.04 | 0.71 | 1.12 | 0.31 |
Proposed legislation
| Title | Summary | Year Proposed |
|---|---|---|
| An Act to promote transparency and cost control of pharmaceutical drug prices (Massachusetts)a | Would require the development of a list of critical prescription drugs of substantial public interest. For each drug listed, manufacturers would report economic expenditures from research and development to marketing and advertising. This data would then be compiled into a report that would inform the public on prescription drug prices and their role in overall health care spending in the commonwealth. Report could include recommendations for actions to lower prescription drug costs and spending across the commonwealth while maintaining access to quality health care. | 2015 |
| Improving Access to Affordable Prescription Drugs Act (Franken Klobuchar Bill)b | Expands reporting requirements for drug manufacturers and establishes corresponding civil penalties for noncompliance. Adds reporting requirements for certain nonprofit patient-assistance programs. Requires the Government Accountability Office (GAO) to report to Congress on the impact of patient-assistance programs on prescription-drug pricing and expenditures. Requires the Centers for Medicare and Medicaid Services (CMS) to negotiate prices for certain prescription drugs under the Medicare program. Requires Centers for Medicare and Medicaid Innovation to test specified models for negotiating drug prices. Establishes an excise tax on prescription drugs subject to price spikes. Lessens prescription-drug cost sharing requirements under qualified health plans, group health plans, and the Medicare program. Requires drug manufacturers to provide drug rebates for drugs dispensed to certain low-income individuals under the Medicare program. | 2017 |
| Prescription Drug and Health Improvement Act of 2017 (Franken Reed Brown Gillibrand)c | Would require the Secretary of Health and Human Services to negotiate lower covered part D drug prices on behalf of Medicare beneficiaries. | 2017 |
| Fair Accountability and Innovative Research Drug Pricing Act of 2017 (McCain Baldwin Price Bill)d | Would require reporting on the justification for drug price increases and for other purposes. | 2017 |
| An act relative to prescription drugs (Vermont)e | In an attempt to increase transparency, typically the first step towards cost containment, this bill would require The Green Mountain Care Board, in collaboration with the Department of Vermont Health Access, to identify annually up to 15 prescription drugs on which the State spends significant health care dollars and for which the wholesale acquisition cost has increased by 50 percent or more over the past five years or by 15 percent or more over the past 12 months. For each drug identified, the Office of the Attorney General shall require the manufacturer to provide justification for the increase in the wholesale acquisition cost increase. | 2016 |
| Pharmaceutical Cost Transparency Act of 2016 (California)f | This bill would require each manufacturer of a prescription drug made available in California that has a wholesale acquisition costs of $10,000 or more annually or per course of treatment to file a report, no later than May 1 of each year, with the Office of Statewide Health Planning and Development on the costs of each qualifying drug. | 2015 |
| An act to require manufacturers of pharmaceutical drugs to report cost and utilization information (North Carolina)g | Would require an annual report of drug costs and use that can be used by policymakers, government agencies and others to understand pharmacy cost trend in an attempt to make information available to the public about the cost and utilization of pharmaceutical drugs made available in North Carolina. | 2015 |
a https://malegislature.gov/Bills/189/Senate/S1048
b https://www.congress.gov/115/bills/s771/BILLS-115s771is.pdf
c https://www.congress.gov/bill/115th-congress/senate-bill/348
d https://www.gpo.gov/fdsys/pkg/BILLS-115s1131is/pdf/BILLS-115s1131is.pdf
e https://legislature.vermont.gov/assets/Documents/2016/Docs/ACTS/ACT165/ACT165%20As%20Enacted.pdf
f https://leginfo.legislature.ca.gov/faces/billNavClient.xhtml?bill_id=201520160AB463
g https://webservices.ncleg.net/ViewBillDocument/2015/3341/0/DRH10298-MM-102