Cost-based, Value-based, and Reference-based Pricing for Diagnostics

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Cost-based, Value-based, and Reference-based Pricing for Diagnostics James C. Robinson Leonard D. Schaeffer Professor of Health Economics Director, Berkeley Center for Health Technology University of California, Berkeley

Overview Static and dynamic efficiency Cost-based pricing Value-based pricing Reference pricing 2

Two Social Goals (in economic jargon) Static Efficiency Dynamic Efficiency Achieved by maximizing output, given current inputs, via effective coordination, transparent information, aligned incentives Price competition or regulation drives firms to reduce costs and improve performance Standardization and commoditization allow product comparisons and enable competition and regulation (HTA) Innovation requires investments in R&D, which are risky and require profits to ensure adequate ROI Price competition and regulation reduce revenues and profits, and undermines incentives for longterm investments Firms avoid standardization and commoditization, pursue prices and profits to finance R&D 43

The Policy Dilemma Static Efficiency Dynamic Efficiency Standardization, regulation, and price competition are good for static efficiency but bad for dynamic efficiency Easy access to the market and high prices are good for dynamic efficiency but bad for static efficiency What is to be done? What are implications for regulators, insurers, providers, and consumers? What are the implications for innovators? 54

Push Drivers (or Inhibitors) of Innovation Intellectual, Financial, and Organizational Capabilities for Translating Ideas Clinical & economic into Products and Products into Firms Scientific Research Translational research Finance Culture of entrepreneurship National Institutes for Health (NIH), state government investments, major philanthropies, Clinical research, strong IP protection, and fluid boundaries between universities and industry Angel investors, venture capital, strategic investors from Big Biopharma Experienced risk-taking individuals, incubators, magnet for young and passionate people But capabilities for innovation will only lead to new products and firms if there is a reward for innovation. Otherwise the entrepreneurs, finance, and energy will go elsewhere 5

Pull Drivers (or Inhibitors) of Innovation Market and Regulatory Factors that Reward Innovation: Access to the Clinical & economic Market, Rapid Diffusion/Adoption, and High Prices FDA Market Authorization and Post-Market Surveillance Insurers Coverage, reimbursement, and pricing Providers Physician prescription and hospital budgets Consumers Cost sharing and engagement Feedback Loop to Encourage further Investments in basic, clinical, and translational research, and then to product development 6

Cost-Based Pricing for Diagnostic Tests Many in vitro tests are very cheap, as they have been on the market a long time, have benefitted from process efficiencies, and are subject to price competition Cost-based pricing has held down expenditures for insurers and hospitals Discourages innovation if novel tests will be grouped with older tests and paid on a similar basis, or defined as the sum of several older (and cheap) tests Defines the minimum that developer can accept (averaged across all products) and stay solvent 7 7

Cost-Based Pricing Leads to Over-Payment and Under-Payment Many 7 8

Cost-Based Pricing for Clothing (by the Kilo) 9

Value-Based Pricing for Diagnostic Tests Garau, Goldman 7 10

More on Value-Based Pricing Ga 7 11

Defining Clinical Value: The Test-Treatment Pathway 1. Diagnostic test is actually delivered Appropriate timing; acceptability to patient (completion); harms inflicted by test on patient; cost of test 2. Test result are actually produced Speed of result; accuracy (sensitivity, specificity); 3. Diagnosis is made based (in part) on test Was diagnosis affected by test (definitive dx, ruling out suspected dx, confirming previous dx)? Diagnosis incorporates results of all tests. 4. Treatment is decided based (in part) on test results Did new dx affect treatment plan? Was new plan implemented? 5. Effect of new treatment plan on patient outcome is positive Appropriate timing, efficacy of treatment; patient adherence 7 12

Defining Social Value: Combining Clinical Contribution and Price High LOW VALUE: Over-Charging HIGH VALUE: Supports R&D Price Low HIGH VALUE: Promotes Affordability LOW VALUE: Cannot Sustain R&D Follow-on or incremental Innovation Meaningful Clinical Improvement 13

DrugAbacus: You Define the Value Source: http://www.drugabacus.org 14

Real Prices Lie Between Value and Cost 15

Reference Pricing Geez Louise I left the price tag on. 16

What Drives Price Variation? Variation in price is driven by supply factors: Manufacturers: patent protection Providers: market consolidation Variation in price is permitted by demand factors Consumers lack incentive to shop, as someone else is paying (insurer) Consumers lack information on prices and quality at the time of making choices 17

What is Reference Pricing? Sponsor (insurer, employer) establishes a maximum contribution (reference price) it will make towards paying for a particular service or product This limit is set at minimum or median of the price range charged by comparable providers Patient must pay full difference between this limit and the actual price charged by the provider (not just 20%) Patient has good coverage for low-priced options but full accountability if select a high-priced option In the US, reference pricing has been applied to: Inpatient and outpatient surgery Diagnostic radiology (e.g., CT, MRI) Drugs and laboratory tests 18

Contrast Reference Pricing in the US with Reference Pricing in Other Nations National insurance payers in many nations group drugs by therapeutic class, and then set a maximum reference price or reimbursement for the class, linked to the lowest-price drug in the class and/or the lowest price in any other nation This is not a consumer cost sharing strategy, because no one expects the consumer to pay the difference between the insurer s limit and the list price It is price negotiation strategy to obtain discounts and/or rebates from the list price 19

Reference Pricing for Laboratory Tests In 2010 Safeway implemented RP for lab tests for 500+ in vitro diagnostic tests Exclusions: oncology, mental health, dialysis, infertility, genomic tests Exclusions: tests performed in hospital, ED, surgicenter, MD office (during course of care) Reference payment set at 60% of distribution of prices for each test 7 20

Study Design: Data Claims data from Safeway on all laboratory tests used by all covered employees and dependents (N=1 million) Claims data from enrollees in Anthem (WellPoint) Blue Cross on all laboratory tests and other services (N=250 million) Claims include information on lab test, price, patient demographics, other diagnoses/procedures, type and location of laboratory Experimental group: tests subject to reference pricing Control group A: tests not subject to reference pricing Control group B: tests subject to reference pricing at Safeway but using claims from enrollees in Anthem 21

Study Design: Methods Descriptive statistics: % of patients selecting lab charging less than reference price (termed compliance ) Prices paid ($) Employer spending on lab tests per employee Charts: Five most common tests that are subject to reference pricing Five most common that are not subject to reference pricing Difference-in-difference multivariable regressions: Rate of change in compliance and prices for Safeway employees compared to rate of change for control groups Adjust for demographics, co-morbidities, geography 22

Price Trends for 5 Most Common Tests Subjected to Reference Pricing 23

Price Trends for 5 Most Common Tests NOT Subject to Reference Pricing 24

Reference Pricing Causes Shift in Consumer Choices towards Low-Priced Diagnostic Tests, 2008-2013 25

Difference-in-Difference Regression: Effect of Reference Pricing on Prices Charged for In Vitro Diagnostics, 2008-2013 (N=693,074 claims) Reference Pricing x Year RBB2013 RBB2012 RBB2011 RBB2009 RBB2008 Log price change Dollar changes -0.325*** -8.249*** (0.0288) (0.726) -0.243*** -6.180*** (0.0233) (0.591) -0.196*** -4.969*** (0.0238) (0.600) -0.0509*** -1.295*** (0.0157) (0.399) -0.0393** -0.998** (0.0193) (0.491) **Significant to.01 ***Significant to.001 26

Reference Pricing for Diagnostics: Discussion Reference pricing for laboratory tests at one major US employer reduced average price per test by 17.8% in the first year, 21.6% in the second, and 27.7% in the third year, compared to price trends for tests not subject to reference pricing These results are in line with measured effects of reference pricing on orthopedic surgery, cataract surgery, colonoscopy, arthroscopy When spending their own money, consumers make priceconscious choices If providers want to charge high prices, their test must offer high value and not merely complement existing tests 7 27

Conclusion: Social Value for Diagnostic Tests Static and dynamic efficiency require: Low prices for standardized, commodity lab tests High prices for innovative, clinically meaningful lab tests Reference-based pricing promotes the former Value-based pricing promotes the latter 28

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