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Regulator-HTA-Funder Collaborations: Generic Market Forces in USA September 9, 2015 Douglas C. Throckmorton, MD Deputy Director for Regulatory Programs Center for Drug Evaluation and Research, Food and Drug Administration, USA

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Regulator-HTA-Funder Collaborations: Generic Market Forces in USA September 9, 2015

Douglas C. Throckmorton, MD Deputy Director for Regulatory Programs Center for Drug Evaluation and Research, Food and Drug Administration, USA

Trends in Drug Pricing in US

• New launches of brand drugs with high prices: – Hepatitis C – Cancer – Multiple Sclerosis

• Increases in price for prominent generic drugs: – Naloxone, used to treat opioid drug overdose (legal and

illicit) – Doxycycline, multiple uses

CDER - Office of Planning and Analysis (OPA) 2

Most of the recent increase in US drug spending was from brand drugs

Nelson Cheung CDER - Office of Planning and Analysis (OPA) 3

Source: IMS Medicines Use Report - 2015

Interest in Drug Pricing in US

• Interest in changes in drug prices more broadly – In 2014, generic drugs accounted for 88% of

prescriptions and 28% of spending (undiscounted) • Interest in sources of price changes

Challenge: • Market forces are complex, complicating efforts to

predict the future

CDER - Office of Planning and Analysis (OPA) 4

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Naloxone Pricing Data

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Price for the 0.4 mg/mL strength increased in January 2014 • Hospira’s product increased in price by about 50% in

January 2014 • Mylan introduced its product in March 2014 and has

followed a similar pricing trend to Hospira

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Pric

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2013 2014 2015 Data By Month

Hospira Mylan

0.4 mg/mL, 1 mL vials, 10 vials Invoice Price for Naloxone Injection (2013-2015 Q1)

IMS Health IMS National Sales Perspective, Extracted: 5/19/2015

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Price for the 1 mg/mL strength increased in September 2014 • Kaleo’s auto-injector was introduced in July 2014 and was

priced at about 4 times as much as the Amphastar product • Amphastar’s price increased by about 60% in September

2014

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600

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Pric

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2013 2014 2015Data By Month

Kaleo Amphastar

IMS Health IMS National Sales Perspective, Extracted: 5/19/2015

Kaleo - 0.4 mL syringes x 2; Amphastar - 2 mL syringes x 10Invoice Price for Naloxone Injection (2013-2015 Q1)

Market Trends in US with Naloxone

CDER - Office of Planning and Analysis (OPA) 8

Naloxone Use Patterns in US • Historically, patterns of use are complicated:

– Growing interest in the US in expanding availability of naloxone to prevent opioid overdose deaths (both legal and illicit opioids)

– Used in-hospital, in ambulances, by law-enforcement officers, and by opioid users

– Injectable formulation used both on-label (IM/IV/SQ) and off-label (intra-nasal)

– Two injectable strengths: 0.4 and 1 mg/ml – Recently approval of an autoinjector form of naloxone (Evzio)

• Analysis of sales data also complicated – Direct sales from manufacturers to EMS providers or other

organizations are not captured in our sales distribution data

Nelson Cheung CDER - Office of Planning and Analysis (OPA) 9

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Each strength is sold primarily by one company

Nationally Estimated Number of Vials/Injections of Naloxone, by Strength and Manufacturer, Sold to All Settings of Care Source: IMS Health, IMS National Sales Perspective (NSP)™, April 2009-March 2015. Extracted May 2015.

Similar Complex Patterns of Use in US trends with Doxycycline

CDER - Office of Planning and Analysis (OPA) 11

Changes in Doxycycline Pricing

• During Jan-Feb 2013, price for 100 mg doxycycline rose >3000%, from 5-10 cents to as much as 3-5 dollars per pill

– Impact felt from Dermatologists to Defense….

• Price rise followed a supply disruption for one (of three main) manufacturers but persisted when supply was restored

Nelson Cheung CDER - Office of Planning and Analysis (OPA) 12

CDER - Office of Planning and Analysis (OPA) 13

These price increases are part of a recent trend in generic drugs

• 25% of generic injectable molecules in IMS data had at least one formulation with a price increase of 60% or more in 2014 (FDA analysis)

• 7% of retail drugs (mostly oral products) had a price increase of 100% or more during 2014-2015 (Drug Channels analysis)

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These price increases are part of a recent trend in generic drugs

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Summary: FDA and Generics Pricing • Changes in the price of generic drugs, like the

increases for innovator drugs, are not uncommon, including pronounced increases in price

• Variety of factors influence generic drug pricing, challenging our analysis of them: – Social patterns of use – Market forces:

• Introduction of new formulations and uses • Market concentration • Pricing flexibility • Capacity constraints

Nelson Cheung CDER - Office of Planning and Analysis (OPA) 16

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Acknowledgements

• Matthew Rosenberg – CDER/OSP/OPSA/ES • Grace Chai – CDER/OSE/OPE/DEPI II • Marta Wosinska – CDER/OSP/OPSA/ES

Thanks!

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