And it's already in the hot seat
over its drug price hikes, so it can't raise prices much further without risking another scandal.
With recent uproar
over drug price hikes by Valeant (vrx), Mylan (myl) and Martin Shkreli, healthcare experts have reached a consensus: The system as we know it is officially broken.
Pfizer also came under fire
over drug price increases including a record $ 107 million fine by U.K. regulators for hiking an epilepsy treatment's price by 2,600 %.
But her underlying point isn't totally invalid — the furor
over drug price hikes like Mylan's is forcing legislators and private companies alike to finally confront the issue head - on, and highlighting just how difficult the disparate and largely opaque American medical financing system makes it to address these problems in a serious way.
It aggressively ratcheted up spending to spread its influence in Washington and to have a louder say in the debates
over drug prices.
Cost - cutting by health insurers and concerns
over drug pricing have made CVS's pharma - benefits unit seem like a liability to some investors; and in the head - to - head fight, Walgreens has grabbed some market share.
Separately, state prosecutors in New York and Massachusetts are investigating Valeant
over its drug pricing and programs that provide financial assistance to help patients cover out - of - pocket expenses for their medications.
But the company was hit by regulatory and political scrutiny in the past year
over its drug pricing and its relationship to a mail - order pharmacy, and its stock took a beating.
Bayer said in a statement that it doesn't control the cost for patients at the pharmacy, because copays are determined by insurers and pharmacy - benefit managers — an argument that pharmaceuticals companies have long made when facing criticism
over drug prices.
Put simply, I believe it's frankly hard to justify holding most individual biotech stocks for especially long periods of time because of the rather limited lifespan of their products, and the political blowback
over drug prices in the United States.
Fears
over drug pricing have weighed on the company but PBMs have not been in the cross-hairs like the drug makers.
Not exact matches
The
drug at the heart of four lawsuits in New Jersey is insulin — «a century - old medicine that for most of its history cost $ 15 or less,» write Barrett and Langreth, but «whose list
price has risen more than 270 percent
over the past decade.»
Miller, chief investment officer at LMM, said he thinks the embattled drugmaker is «a completely different company» than the one that was under severe fire for jacking up
drug prices, and could see returns of 25 percent to 30 percent per year
over the next five years.
Mark Merritt, CEO of the Pharmaceutical Care Management Association (PCMA), a trade group representing the 10 largest traditional PBMs, says that while «
drug prices have gone up more than we'd like»
over the years, his members have saved employers 25 %.
Valeant has been at the center of a political firestorm
over prescription medication costs and pharmaceutical companies, which depend more on acquiring or licensing existing therapies (and then raising their
prices) rather than fueling R&D into new
drugs.
On the surface, Papa seems to have gotten an extraordinarily generous deal to turn around the beleaguered
drug company: Not only is his salary more than twice what it was when he was CEO of Perrigo (prgo), a company nearly three times as valuable as Valeant (vrx), it's also especially good considering Valeant's stock
price has fallen nearly 67 % since he took
over.
Marathon had free reign
over its
pricing thanks to the lack of available Duchenne
drug competitors.
Over in the House of Representatives, Democrats have also been hot on the tail of pharmaceutical companies that have jacked up the
prices of some of their
drugs, though they've making less headway than their Senate bipartisan counterparts.
He added that the media focuses on examples of individual
drug price hikes, it has overlooked the fact that expense of
drugs as a proportion of healthcare spending has remained «remarkably constant»
over the years.
Biogen is among companies that have been singled out for criticism in recent months; the Wall Street Journal called out the company for hiking the
price of MS
drug Avonex — 21 times, and at an annual average rate of 16 % —
over the past decade.
Lately pharma execs have been taking yet another volley of criticism
over drug -
pricing practices from Hillary Clinton and Marco Rubio — and plenty of others — without offering much in the way of a defense.
However analysts point to a bounce in Teva's shares
over the past four months and a slowing in the rate of decline of U.S. generic
drug prices as bright spots.
The debate
over high
drug prices has been a red hot topic here and inspired a lot of anger and legislative threats, especially in the midst of the 2016 election cycle.
Although the FDA can't dictate
prices or reject therapies
over pricing concerns (they can only focus on safety and efficacy), the agency can encourage more competition through moves like this (as well as speedier approval pathways) which could spur
drug makers to produce products that ultimately lower costs for patients — a goal cited by FDA Commissioner Scott Gottlieb in announcing the list.
Takeda's negotiations to acquire Valeant Pharmaceuticals International's Salix stomach -
drug business have stalled
over price disagreements, Reuters reported in November, citing people familiar with the matter.
In attacking Berkshire, Ackman was striking back after Buffett's business partner Charlie Munger last year called Valeant «deeply immoral» for its practice of raising
drug prices, sparking a sort of long - distance feud
over whose favorite stock was better.
The 32 - year - old CEO of Turing Pharmaceuticals became a target of widespread ire in September when he boosted the
price of the toxoplasmosis treatment Daraprim by
over 5,000 % after acquiring the
drug in August.
And the defiant stance actually may have boosted the
drug maker's image at a time when Americans are skeptical about the pharmaceutical industry
over high
drug prices.
Investors couldn't chalk up the selloff to the concerns
over drug -
price gouging that have depressed other pharmaceutical shares: Zoetis zts, after all, makes medications for dogs — whose health care costs have yet to inspire Senate investigations.
«The manufacturer of a
drug has no influence or control
over the
prices charged by a secondary wholesaler to a hospital or pharmacy,» reads part of a statement on the PhRMA web site, the industry's trade association group.
Big pharma has been a persistent villain in the public's consciousness
over the past year in the wake of exorbitant
drug price hikes, including on ancient medications.
The
drug, given
over four injections, costs $ 120,000 in the U.S. Bristol defends Yervoy's
price tag, saying it reflects the survival benefit and the steep cost of the
drug's development.
Ricks also addressed President Donald Trump's decision to lambast pharmaceutical companies
over the
price of prescription
drugs, in his State of the Union address Tuesday evening.
Herper homes in on a relatively new class of super-powerful (and super expensive) cholesterol - busting
drugs called PCSK9 inhibitors (which were just shown to reduce death from any cause, and particularly heart - related conditions), and how patients with staggeringly high cholesterol who would benefit from the treatments had to wrangle with insurance companies that refused to cover them
over their high
prices.
In January, Mallinckrodt raised its
price to $ 36,382 a vial, according to the data provider Truven, but that wasn't far off what it cost back in 2015 when Medicare Part D, a prescription
drug program, spent
over $ 500 million on the
drug, making it one of the top 20 expenses for the program, government data shows.
PBMs have come into the spotlight in the debate
over soaring
drug prices, with manufacturers accusing them of contributing to inflating costs.
While the
drug maker has responded to the massive backlash
over its extravagant
price increase on the device by boosting its patient assistance programs and introducing an authorized generic EpiPen version at half the cost, CVS» topline
price will still be significantly cheaper.
In order for the
drug to be cost effective, drugmakers should slash the
price of the
drug by
over two thirds — to $ 4,536, when patients would be spending about $ 100,000 to keep themselves healthy, the researchers wrote in the JAMA article.
These risks and uncertainties include: Gilead's ability to achieve its anticipated full year 2018 financial results; Gilead's ability to sustain growth in revenues for its antiviral and other programs; the risk that private and public payers may be reluctant to provide, or continue to provide, coverage or reimbursement for new products, including Vosevi, Yescarta, Epclusa, Harvoni, Genvoya, Odefsey, Descovy, Biktarvy and Vemlidy ®; austerity measures in European countries that may increase the amount of discount required on Gilead's products; an increase in discounts, chargebacks and rebates due to ongoing contracts and future negotiations with commercial and government payers; a larger than anticipated shift in payer mix to more highly discounted payer segments and geographic regions and decreases in treatment duration; availability of funding for state AIDS
Drug Assistance Programs (ADAPs); continued fluctuations in ADAP purchases driven by federal and state grant cycles which may not mirror patient demand and may cause fluctuations in Gilead's earnings; market share and price erosion caused by the introduction of generic versions of Viread and Truvada, an uncertain global macroeconomic environment; and potential amendments to the Affordable Care Act or other government action that could have the effect of lowering prices or reducing the number of insured patients; the possibility of unfavorable results from clinical trials involving investigational compounds; Gilead's ability to initiate clinical trials in its currently anticipated timeframes; the levels of inventory held by wholesalers and retailers which may cause fluctuations in Gilead's earnings; Kite's ability to develop and commercialize cell therapies utilizing the zinc finger nuclease technology platform and realize the benefits of the Sangamo partnership; Gilead's ability to submit new drug applications for new product candidates in the timelines currently anticipated; Gilead's ability to receive regulatory approvals in a timely manner or at all, for new and current products, including Biktarvy; Gilead's ability to successfully commercialize its products, including Biktarvy; the risk that physicians and patients may not see advantages of these products over other therapies and may therefore be reluctant to prescribe the products; Gilead's ability to successfully develop its hematology / oncology and inflammation / respiratory programs; safety and efficacy data from clinical studies may not warrant further development of Gilead's product candidates, including GS - 9620 and Yescarta in combination with Pfizer's utomilumab; Gilead's ability to pay dividends or complete its share repurchase program due to changes in its stock price, corporate or other market conditions; fluctuations in the foreign exchange rate of the U.S. dollar that may cause an unfavorable foreign currency exchange impact on Gilead's future revenues and pre-tax earnings; and other risks identified from time to time in Gilead's reports filed with the U.S. Securities and Exchange Commission (the S
Drug Assistance Programs (ADAPs); continued fluctuations in ADAP purchases driven by federal and state grant cycles which may not mirror patient demand and may cause fluctuations in Gilead's earnings; market share and
price erosion caused by the introduction of generic versions of Viread and Truvada, an uncertain global macroeconomic environment; and potential amendments to the Affordable Care Act or other government action that could have the effect of lowering
prices or reducing the number of insured patients; the possibility of unfavorable results from clinical trials involving investigational compounds; Gilead's ability to initiate clinical trials in its currently anticipated timeframes; the levels of inventory held by wholesalers and retailers which may cause fluctuations in Gilead's earnings; Kite's ability to develop and commercialize cell therapies utilizing the zinc finger nuclease technology platform and realize the benefits of the Sangamo partnership; Gilead's ability to submit new
drug applications for new product candidates in the timelines currently anticipated; Gilead's ability to receive regulatory approvals in a timely manner or at all, for new and current products, including Biktarvy; Gilead's ability to successfully commercialize its products, including Biktarvy; the risk that physicians and patients may not see advantages of these products over other therapies and may therefore be reluctant to prescribe the products; Gilead's ability to successfully develop its hematology / oncology and inflammation / respiratory programs; safety and efficacy data from clinical studies may not warrant further development of Gilead's product candidates, including GS - 9620 and Yescarta in combination with Pfizer's utomilumab; Gilead's ability to pay dividends or complete its share repurchase program due to changes in its stock price, corporate or other market conditions; fluctuations in the foreign exchange rate of the U.S. dollar that may cause an unfavorable foreign currency exchange impact on Gilead's future revenues and pre-tax earnings; and other risks identified from time to time in Gilead's reports filed with the U.S. Securities and Exchange Commission (the S
drug applications for new product candidates in the timelines currently anticipated; Gilead's ability to receive regulatory approvals in a timely manner or at all, for new and current products, including Biktarvy; Gilead's ability to successfully commercialize its products, including Biktarvy; the risk that physicians and patients may not see advantages of these products
over other therapies and may therefore be reluctant to prescribe the products; Gilead's ability to successfully develop its hematology / oncology and inflammation / respiratory programs; safety and efficacy data from clinical studies may not warrant further development of Gilead's product candidates, including GS - 9620 and Yescarta in combination with Pfizer's utomilumab; Gilead's ability to pay dividends or complete its share repurchase program due to changes in its stock
price, corporate or other market conditions; fluctuations in the foreign exchange rate of the U.S. dollar that may cause an unfavorable foreign currency exchange impact on Gilead's future revenues and pre-tax earnings; and other risks identified from time to time in Gilead's reports filed with the U.S. Securities and Exchange Commission (the SEC).
Since Marathon won an approval to treat a condition that afflicts fewer than 200,000 Americans per year and has a dearth of treatment options (rather than trying to become an also - ran in the saturated steroid therapy field), it has carte blanche
over the
drug's
pricing.
Not everyone will benefit: now that Republicans have swept the US government for the first time since 1928, it means Obamacare is
over - just a matter of time - and Affordable Care Act - vulnerable stocks such as Universal Health Services, AmSurg and Mednax will likely plunge; on the other hand pure pharma stocks like MCK and ABC will benefit as rhetoric on
drug pricing will diminish significantly, leading to more stable earnings if / when changes in
drug pricing become more stable.
The
price of insulin — a lifesaving
drug — has reached record highs as Eli Lilly, Novo Nordisk and Sanofi raised
prices more than 240 percent
over the past decade to often
over $ 300 a vial today, with
price rises frequently in lockstep, according to information technology firm Connecture.
Congress remains at an impasse
over the future of the Affordable Care Act, while employers and consumers are struggling under the weight of rising medical costs, including the soaring
price of prescription
drugs.
U.S. Food and
Drug Administration chief Scott Gottlieb on Thursday questioned whether rebates that drugmakers provide to health insurers should remain protected by federal law, sparking new concerns on Wall Street over efforts to curb drug pric
Drug Administration chief Scott Gottlieb on Thursday questioned whether rebates that drugmakers provide to health insurers should remain protected by federal law, sparking new concerns on Wall Street
over efforts to curb
drug pric
drug pricing.
The NEJM letter also analyzed the use of two
drugs that remained stable in
price over that time period, as a control group — nitroglycerin and dobutamine.
By acquiring Humana, Walmart gains preferential access to seniors through Humana Medicare advantage, and leverage
over pharmaceutical manufacturers to negotiate for lower
drug prices.
Martin Shkreli, the Turing Pharmaceuticals LLC executive who drew criticism in August
over a dramatic jump in a prescription
drug price, made headlines Thursday for a different kind of
price increase: a seven-fold surge in the shares of a microcap pharmaceutical company.
September 2015: Storm erupts
over Turing's
price increase — from $ 13.50 to $ 750 a pill — for anti-parasitic
drug Daraprim.
Congress is deadlocked
over the future of the Affordable Care Act, and employers and consumers are struggling to contain rising medical costs, particularly skyrocketing
drug prices.
He told NBC News that the decision to lower the
price was a reaction to outrage
over the increase in the
price of the
drug from $ 13.50 to $ 750 per pill.