Whistleblower Cases: Worst Offenders
“Old” Blockbuster U.S Brand Drugs: Massive Price Increases, Declining Use
Worst Offender Profiles:
1) Vast increases in REPORTED pharma company U.S. sales for an "old" blockbuster drug since Medicare Part D began
2) ALL U.S. brand drug sales growth is driven by massive 5-to-10-fold U.S. price increases…
3) While clinical use of the U.S. brand drug by physicians and patients is SHARPLY DECLINING due to severe competition
THIS CANNOT HAPPEN IN A LEGITIMATE U.S. PHARMACEUTICAL MARKET!!!
U.S. Multiple Sclerosis (MS) Market:
- Uniform massive U.S. brand price increases in the MS category from $15,000 to $100,000 per patient/year since Medicare Part D began
- Despite severe competition and many new similar MS drugs reaching the U.S. market
- 2005: 4 similar U.S. MS drugs - each cost about $15,000/patient/year
- 2019: more than a dozen similar U.S. MS drugs - most now cost more than $100,000 patient/year
- Link to Whistleblower table of massive uniform U.S. MS drug price increases
- MASSIVE PRICE INCREASES FOR "OLD" U.S. MS BRAND DRUGS DESPITE PLUMMETING USE AND MARKET SHARE
- Severe pricing harm ONLY for Americans; competition prevented MS price increases outside the U.S.
Biogen’s Avonex (MS, on U.S. market since 1996)
- 2005 Reported U.S. Sales: $939 million
- 2017 Reported U.S. Sales: $1.9 billion
- U.S. Clinical Use/Prescriptions DOWN 60-70% since 2005
- 2017 U.S. Sales WITHOUT Price Increases: $322 million
- 2005 U.S. “List”/“Sticker” Price: $15,000/patient/year
- 2018 U.S. “List”/“Sticker” Price: $100,000/patient/year
- Cumulative harm since start of Part D: $12.5+ billion
Teva’s Copaxone (MS, on U.S. market since 1996)
- 2005 Reported U.S. Sales: $782 million
- 2017 Reported U.S. Sales: $3.0 billion
- U.S. Clinical Use/Prescriptions DOWN -40-50% since 2005
- 2017 U.S. Sales WITHOUT Price Increases: $530 million
- 2005 U.S. “List”/“Sticker” Price: $15,000/patient/year
- 2018 U.S. “List”/“Sticker” Price: $100,000/patient/year
- Cumulative harm since start of Part D: $20 billion
U.S. Insulin Market
- Uniform massive 5-10-fold U.S. insulin price increases in the decade-plus since Medicare Part D began
- Despite severe competition among numerous similar products
- Many insulins on the U.S. market for decades
- Severe U.S. patient and family harm
- Diabetes is the highest spending U.S. brand drug category
- Rising U.S. deaths from unaffordable insulin
- Diabetics traveling to abroad for cheaper black market insulin
Sanofi's Lantus (long-acting insulin, on U.S. market since 2000)
- 2005 Reported U.S. Sales: $846 million
- 2017 Reported U.S. Sales: $4.0 billion
- 2017 U.S. Sales WITHOUT Price Increases: $1.8 billion
- A top-spending drug in Medicare Part D
- Cumulative harm since start of Part D: $21.0+ billion
Eli Lilly’s Humulin (on U.S. market since 1982)
- 2005 Reported U.S. Sales: $411 million
- 2017 Reported U.S. Sales: $885 million
- U.S. Clinical Use/Prescriptions DOWN -60% since 2005
- 2017 U.S. Sales WITHOUT Price Increases: $173 million
- Cumulative harm since start of Part D: $4.1 billion
U.S. Rheumatoid Arthritis/Autoimmune Market
- Uniform massive 5-10-fold U.S. price increases in the decade-plus since Medicare Part D began
- from about $15,000 patient/year before Part D to the $75,000 patient/year range now
- Despite rising competition from numerous similar new drugs reaching the U.S market
- U.S. market still dominated by AbbVie's Humira and Amgen's Enbrel
- AbbVie's Humira is the world's top-selling drug, with 70% of its 2018 sales ($13.7 billion) in the U.S., driven by far higher U.S. prices
- Link to Whistlelblower table showing severe and lockstep Humira and Enbrel U.S. price inflation
Amgen’s Enbrel (on U.S. market since 1997)
- 2005 Reported U.S. Sales: $2.47 billion
- 2017 Reported U.S. Sales: $5.2 billion
- U.S. Clinical Use/Prescriptions DOWN -25% since 2005
- 2017 U.S. Sales WITHOUT Price Increases: $1.9 billion
- 2005 U.S. “List”/“Sticker”: $15,000/patient/year
- 2018 U.S. “List”/“Sticker”: $75,000/patient/year
- Cumulative harm since start of Part D: $19.1+ billion
Abbvie’s Humira (on U.S. market since 2003)
- 2005 Reported U.S. Sales: $560 million
- 2017 Reported U.S. Sales: $12.4 billion
- 2017 U.S. Sales WITHOUT Price Increases: $3.8 billion
- 2005 U.S. “List”/“Sticker”: $15,000/patient/year
- 2018 U.S. “List”/“Sticker”: $75,000/patient/year
- Cumulative harm since start of Part D: $32.3+ billion
U.S. Cancer Market: Novartis' Gleevec (Leukemia, on U.S market since 2001)
- Massive 5-Fold U.S. price after Part D began
- Majority of Gleevec use in Medicare Part D prior
- Early 2016 U.S. patent expiration
- 2005 Reported U.S. Sales: $524 million
- 2015 Reported U.S. Sales: $2.5 billion
- 2015 U.S. Sales WITHOUT Price Increases: $700 million
- 2005 U.S. “List”/“Sticker”: $30,000/patient/year
- 2015 U.S. “List”/“Sticker”: $150,000/patient/year
- Cumulative harm since start of Part D: $7.4+ billion
- Link to Whistleblower table showing severe Gleevec price increases
- Link to Gleevec Whistleblower cumulative harm chart
Other Major U.S. Brands
Pfizer’s Lyrica (seizures/diabetics, on U.S. market since 2004)
- 2005 Reported U.S. Sales: $717 million
- 2017 Reported U.S. Sales: $3.5 billion
- 2017 U.S. Sales WITHOUT Price Increases: $1.16 billion
- Cumulative harm since start of Part D: $10.0+ billion
Other major U.S. Pfizer brands:
- Strong U.S. sales growth driven by severe prices increases
- As clinical use sharply declined
- Premarin (hormone replacement)
- Viagra: (impotence)
- Celebrex (arthritis, pain)
- Chantix (smoking cessation)
- Link to U.S. Pfizer severe price increase and declining prescription trends