Analysts Provide Recent Drug Price Increase Details
Wells Fargo’s Equity Research Analyst, David Maris, and his team analyzed Medi-Span Price Rx data for the period from December 15 to January 3 and found the cost for many big-selling drugs grew during that time*: • Pfizer: 116 price hikes between 3% and 9.46%; • Novartis: 75 price hikes between 2.9% and 9.9%; • AstraZeneca: 18 price hikes between 1.5% and 9.9%; • Eli Lilly: 12 price hikes between 1.5% and 9.91%. • Sanofi: 11 price hikes between 1.9% and 8.53%; • Bristol-Myers Squibb: 6 price hikes between 1.5% and 7.9%; • AbbVie: 5 price hikes between 8% and 9.7%; and • GlaxoSmithKline: 4 price hikes between 3.11% and 9%. *The increases quoted are list prices that do not take into account the discounts and rebate deals that pharmaceutical companies have with payers. AbbVie’s 9.7% increase to Humira is likely to be the costliest price hike to the U.S. healthcare system. The price increase means “an added $1.2 billion to the healthcare system,” Maris wrote. Over the past five years, Humira’s price has more than doubled, he noted. AbbVie didn’t immediately respond to a request for comment. Eli Lilly increased its costs for the antidepressant Cymbalta by 9.88% and antipsychotic Zyprexa by 9.91%, according to the Wells Fargo team. Both of those drugs have generic alternatives. One drug that does not yet have a generic alternative is Eli Lilly’s Forteo, whose list price went up by 9.9%. A key patent on that drug expires at the end of this year. Pfizer raised the prices of 20 drugs by 9.44%, according to the analyst, including for Viagra, Pristiq, Lipitor, Zoloft and Chantix. All except Chantix are now available as generics and Chantix is set to lose patent protection in 2020.In response, a spokesperson Pfizer stated it “takes a measured and responsible approach to pricing,” adding that Pfizer has an assistance program for eligible patients who can’t afford its products. “It is important to note, the list price in January 2018 remains unchanged for the majority of our medicines,” the spokesperson stated. “In addition, for Pfizer’s U.S. Biopharma business, as of the third quarter of 2017, the weighted average net selling price increase year to date is 3%.” In response to criticism, many drugmakers have said discovering new, effective therapies is expensive and that millions of patients benefit every year from their products, some who have no other options.
Hospital Systems to Launch Generic Drug Company
On Thursday, Intermountain Healthcare announced a bold initiative to establish a not-for-profit generic drug company aimed at ending shortages and reducing prices. Intermountain Healthcare, a nonprofit Salt Lake City hospital group, is leading a collaboration with Ascension, SSM Health, and Trinity Health, in consultation with the U.S. Department of Veterans Affairs, to form the company. The five organizations represent more than 450 hospitals and many other health facilities across the country. More health systems could join soon and the Department of Veterans Affairs has additionally expressed interest as a purchaser. The new company intends to be an FDA approved manufacturer and will either directly manufacture generic drugs or sub-contract manufacturing to reputable contract manufacturing organizations. Executives said for now they aren’t disclosing what drugs they will make, fearing generic drug companies would respond by lowering prices now and raising them again later. They say this initiative will make essential generic medications more available and more affordable plus bring healthy competition to the market for generic drugs. “This is a shot across the bow of the bad guys,” said Dr. Marc Harrison, the chief executive of Intermountain Healthcare. “We are not going to lay down. We are going to go ahead and try and fix it.” “It’s hard to make people better if they don’t have access to the medicines they need,” Harrison further stated. “To add insult to injury, those medicines are being priced in a way that’s nonsensical.”
Pfizer Ends Alzheimer’s And Parkinson’s Research
On Saturday, Pfizer announced that it is abandoning research to find new drugs aimed at treating Alzheimer’s and Parkinson’s disease. The company said it expects to eliminate 300 positions from the neuroscience discovery and early development programs in Andover and Cambridge, Massachusetts, and Groton, Connecticut, as it redistributes the money spent on research. “This was an exercise to re-allocate spend across our portfolio, to focus on those areas where our pipeline, and our scientific expertise, is strongest,” the company said in a statement.Pfizer is one of several drugmakers that is part of the Dementia Discovery Fund, a venture capital fund launched in 2015 by industry and government groups seeking to develop treatments for Alzheimer’s disease. However, despite these research efforts into potential treatments, they have faced disappointment. In 2012, Pfizer and partner Johnson & Johnson called off additional work on the drug bapineuzumab after it failed to help patients with mild to moderate Alzheimer’s in its second round of clinical trials.“It’s really alarming to see such a large pharmaceutical company deciding to abandon research into the brain and central nervous system,” James Beck, chief scientific officer at the Parkinson’s Foundation, stated. “It’s telling for how difficult it is to do research into neurodegenerative diseases.”An estimated 5.5 million Americans suffer from Alzheimer’s and approximately half a million suffer from Parkinson’s disease.Pfizer added that it will “continue to fully support” development on Tanezumab and Lyrica, two treatments targeting chronic pain, as well as programs researching rare neurological diseases.
Johnson & Johnson Loses Remicade Patent in Appeal Ruling
On Tuesday, a U.S. appeals court upheld a ruling that invalidated a crucial Johnson & Johnson patent on its blockbuster rheumatoid arthritis drug Remicade, limiting J&J’s ability to seek damages from Pfizer over its launch of Inflectra, a lower-cost version of the drug. The court said in a ruling posted on its electronic docket that the antibodies covered by this patent were already disclosed in an earlier patent and that it was “unpatentable under the doctrine of obviousness-type double patenting”. Pfizer launched its biosimilar of Remicade, Inflectra, in October 2016 after winning a set of rulings that invalidated J&J’s patent. J&J said at the time that it considered Pfizer’s maneuver to be an “at risk” launch, meaning that Pfizer would be liable for money damages to J&J if an appeals court reversed the rulings and upheld the patent. Thomas Biegi, a spokesman for Pfizer, said in a statement that it’s “a good day for patients battling chronic diseases, because the court has ruled a key patent that J&J has asserted to block access to Inflectra is invalid.” J&J said it was disappointed in the court’s ruling, which could have implications for other drugmakers because it hinged on how related applications should be handled at the patent office. “We believe that biopharmaceutical intellectual property protections, such as patents and data protection, enable us to invest in the discovery and development of tomorrow’s life-changing and life-saving new medicines,” the company said in a statement.The company said the drug has helped 2.6 million people worldwide and it’s “committed to helping ensure Remicade remains accessible and affordable to patients.”
Novartis Sandoz’ Advair Generic Rejected by FDA
On Thursday, Novartis stated that the FDA had rejected their generic copy of GlaxoSmithKline’s blockbuster asthma treatment Advair. Novartis had expected to launch its copy this year but now believes that to be “highly unlikely” after receiving a Complete Response Letter from the FDA asking for more data on the drug. Advair pairs two active ingredients, the corticosteroid fluticasone propionate with the long-acting beta2- adrenergic agonist salmeterol, in an inhaled powder delivered by a specialized device. Generic drugmakers must not only develop a copy of the drug itself, but also the device that delivers it. Sandoz’ version is the third to be turned away by the FDA. “We will be working with the agency to clarify the points raised in the CRL and will provide further information when available,” said Shawn Silvestri, head of global product development at Novartis’ Sandoz unit, in an emailed statement. “We are committed to bringing our generic Advair to patients in the U.S. as soon as possible,” he added.
Teva’s Syprine Generic Priced 14% Below Valeant Product Price
Teva Pharmaceuticals announced recently that it would begin selling a generic version of Syprine, a drug used to treat Wilson’s disease. Syprine has been available since the 1960s, but Valeant increased the price after it acquired the rights in 2015. The price increased from $652 in 2010 to $21,267 for 100 pills of the branded treatment. When Teva announced its generic alternative, the company said it would offer “a lower-cost generic alternative to patients.” In a statement earlier this month, Brendan O’Grady, head of Teva’s North America Commercial division, said the launch of the generic version of Syprine “illustrates the company’s commitment to serving patient populations in need.” Teva recently revealed the price for its generic drug: $18,275 for 100 pills, a cheaper alternative by less than $3,000. Syprine and the Teva generic work by removing high copper levels from the body. Wilson’s disease is the result of a genetic disorder of the liver that causes hepatic cells to accumulate and store excess copper. The disease impairs the liver’s ability to excrete copper into the bile and then into the gastrointestinal tract. The copper build-up is toxic to the liver, and can cause cirrhosis and death. A rare disease, Wilson’s disease affects about one in 30,000 people. It’s estimated there are between 8,000 and 10,000 Wilson’s disease patients in the United States. “Generic companies are for-profit companies, too, and so it’s not surprising to me that they price the product at what they think the market will bear,” said Dr. Aaron S. Kesselheim, an associate professor at Harvard Medical School who has studied drug prices.
Cigna To Buy Express Scripts
On Thursday, health insurance giant Cigna said that it had agreed to buy Express Scripts, the last major standalone pharmaceutical benefit manager, for $67 billion in cash and stock, including the assumption of $15 billion in debt. “Cigna’s acquisition of Express Scripts brings together two complementary customer-centric services companies, well-positioned to drive greater quality and affordability for customers,” said David Cordani, President and CEO of Cigna. “This combination accelerates Cigna’s enterprise mission of improving the health, well-being and sense of security of those we serve, and in turn, expanding the breadth of services for our customers, partners, clients, health plans and communities. Together, we will create an expanded portfolio of health services, delivering greater consumer choice, closer alignment between the customer and health care provider, and more personalized value. This combination will create significant benefits to society and differentiated shareholder value.” “Together, our two organizations will help make the healthiest choices the easiest choices, putting health and pharmacy services within reach of everyone we serve. Adding our company’s leadership in pharmacy and medical benefit management, technology-powered clinical solutions, and specialized patient care model to Cigna’s track record of delivering value through innovation, we are positioned to transform healthcare” said Tim Wentworth, President and CEO of Express Scripts. The combined company would be named Cigna and would be based in Bloomfield, Connecticut where Cigna currently has its headquarters. Express Scripts would continue to have its headquarters in St. Louis, Missouri. The company will be led by David Cordani as President and CEO and Tim Wentworth will assume the role of President, Express Scripts. The transaction is expected to close by the end of the year and is subject to shareholder and regulatory approval.
Johnson and Johnson to sell Lifescan
Last Friday, Johnson & Johnson (J&J) stated that the private equity firm Platinum Equity extended a binding offer to purchase its LifeScan business for $2.1 billion. LifeScan, which has headquarters in Chesterbrook, Pennsylvania, and Zug, Switzerland, sells personal blood glucose meters, testing strips, and testing systems. More than 20 million people in 90 countries use its products. “Following a thorough review of all strategic options, we feel confident that the business would have a promising future with Platinum Equity,” said Ashley McEvoy, company group chair of Consumer Medical Devices at J&J. “This initiative is part of our ongoing, disciplined approach to portfolio management to focus on our most promising opportunities to help patients and drive growth.” J&J will continue to serve those impacted by diabetes in areas such as bariatric surgery and through medicines such as Invokana (canagliflozin) and Invokamet (canagliflozin/metformin HCl). The offer could be finalized by mid-June, unless it is extended, and a deal is anticipated to close by the end of 2018.
PCSK-9 Class Updates
PCSK9 inhibitors, are monoclonal antibodies. They target and inactivate a specific protein in the liver, called proprotein convertase subtilisin kexin 9, reducing the amount of harmful LDL cholesterol circulating in the bloodstream. Trial studies have recently been conducted for the drugs in this class. Praluent – On Saturday, Sanofi and Regeneron reported the results of their outcomes trial for their PCSK9 drug, Praluent. In the ODYSSEY trial, Praluent reduced the risk of a composite endpoint of heart attack, stroke, death from coronary heart disease or unstable angina requiring hospitalization by 15%, meeting its primary endpoint. The drug also cut the risk of death from any cause by 15%. For high-risk patients with LDL levels of 100 mg/dL or higher, the benefit was larger: a 24% reduction in risk of major adverse cardiovascular events (MACE) and a 29% drop in all-cause mortality. ODYSSEY tested Praluent in nearly 19,000 patients who experienced an acute coronary event the year before their enrollment. The participants were on the highest statin dose they could tolerate and received either placebo or Praluent in addition to their statin therapy. The trial followed the patients for an average of 33 months. Sanofi disclosed it will incorporate a new cost-effectiveness review by the Institute for Clinical and Economic Review (ICER) in future payer negotiations. If payers are willing to reduce barriers to access, Sanofi said it will lower the drug’s net price to within ICER’s range. The program will use a “precision medicine approach” to home in on high-risk patients.