- Amid ‘Rebuilding Year,’ CVS Drugstore Sales Drop (forbes.com)
CVS Health, which is working to turn around the performance of certain businesses following the loss last year of some key prescription management contracts, saw profits drop thanks to lower pharmacy sales from its drugstores...CVS reported first-quarter profits that dropped 17% to $953 million, or 92 cents a share, compared to $1.1 billion, or 1.04 per share, in the year-ago quarter. Revenues rose just 3% to $44.5 billion amid slumping same-store retail pharmacy sales...CVS Health is working to overcome the loss of tens of millions of prescriptions after the Department of Defense’s Tricare plan signed a deal with Walgreens Boots Alliance and other pharmacies that excludes CVS pharmacies..."We continue to expect 2017 to be a rebuilding year," CVS Health CEO Larry Merlo said in a statement accompanying its first-quarter earnings report...
- Limits on doctor-drug rep interactions tied to prescribing changes (reuters.com)
Policies that limit or regulate interactions between doctors and pharmaceutical company representatives may affect what drugs are prescribed to patients, according to a new study...Drugs promoted by pharmaceutical representatives - known as detailed drugs - lost market share after hospitals enacted such policies, while drugs that weren't detailed gained market share...the findings suggest institutions and organizations can play a role in relationships between doctors and the drug industry..."Detailing" visits from drug representatives are one way to educate doctors about new drugs and treatments they would need to learn of elsewhere...those visits are linked to increased use of brand name and costly drugs even when less expensive generic treatments are available...The million dollar question is whether drug detailing and restrictions on detailing are affecting patient outcomes...
- This Week in Managed Care: April 28, 2017 (ajmc.com)
Laura Joszt, assistant managing editor at The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network
- Hiding Data And Other Criticisms Of Big Pharma (forbes.com)
If you have been a part of the biopharmaceutical industry, you’ve heard these criticisms hundreds of times:
- The industry hides negative data.
- Clinical studies paid for by pharma companies usually yield positive results.
- Doctors paid by pharma companies are beholden to them and will skew data in the company’s favor.
- Companies prefer "me-too" drug programs because they lack innovation.
Critics commonly use these arguments as they promote damning views of an industry that is supposed to be doing important and valued drug R&D... two recent publications in the New England Journal of Medicine show the fallacy of these claims...Despite the exciting early clinical results, Pfizer announced on November 1, 2016 that it was ending its bococizumab program... This was a devastating result...and undoubtedly cost close to a billion dollars. Unfortunately, it is not uncommon for a large clinical trial to fail...two extensive publications appeared in the NEJM comprehensively explaining the bococizumab study designs and results. So much for hiding negative data...Publishing negative studies like this was not all that common in the past, as many publications only focused on breakthrough research. As can be seen in this example, a lot can be learned from negative studies.
- Insulin makers targeted in pricing inquiries (biopharmadive.com)
Buried deep in its first quarter earnings filing with the Securities and Exchange Commission, Eli Lilly & Co. disclosed it is being investigated for insulin pricing practices by the attorneys general of New Mexico and Washington. The Washington AG is looking at Lilly's relationship with pharmacy benefit managers...Insulin competitor Novo Nordisk has also said it is under investigation by the two AGs for pricing and trade practices for its insulin products, going back as far as 2005...Things are getting complicated at the moment for the big three in insulin. As well as the investigations by the attorneys general, last month, Sanofi, Novo Nordisk and Lilly, along with the pharmacy benefit managers CVS, Express Scripts and UnitedHealth's OptumRx, were slapped with a complaint and demand for a jury trial from the Type 1 Diabetes Defense Foundation.
- The new top 10 most expensive drugs on the planet (endpts.com)
Wholesale Acquisition Costs (List Price)
- Ravicti $793,632 – Horizon Pharma, glycerol phenylbutyrate, treatment for urea cycle disorders
- Brineura $702,000 – BioMarin, cerliponase alfa, treat of Neuronal Ceroid Lipofuscinosis Type 2 disease
- Lumizyme $626,400 – Sanofi – Genzyme, alglucosidase alfa, treat Pompe’s disease
- Carbaglu $585,408 – Recordati, carglumic acid, treats N-acetylglutamate synthase deficiency
- Actimmune $572,292 – Horizon, Interferon gamma 1-b, treats severe, malignant osteopetrosis and chronic granulomatous disease
- Soliris $542,640 – Alexion, eculizumab, treat paroxysmal nocturnal hemoglobinuria
- Alprolix $503,880 – Bioverativ, (Coagulation Factor IX [Recombinant], Fc Fusion Protein), treat hemophilia B
- Idelvion $500,000 – CSL Behring, albutrepenonacog alfa, treat hemophilia B
- Naglazyme $485,747 – Biomarin, galsulfase, treat mucopolysaccharidosis type VI
- Folotyn $450,540 – Spectrum Pharmaceuticals, pralatrexate, treat peripheral T-cell lymphoma
- Remedy for Threat to US Pharmaceutical Industry’s Profitability (forbes.com)
US pharmaceutical companies...are...very vulnerable to increasing political pressure from the Trump Administration. The good news is there are actions these companies can take…
- Pharma’s Vulnerability - Small number of US jobs vs. large US revenues...pharma companies’ largest market and largest profit pool is the US. But only a small percentage of the jobs it offers are in the US. The Trump Administration has already been vocal about returning jobs to the US...Pharmaceutical companies have taken full advantage of offshoring...The Administration can apply pricing pressure in the US, to get these companies to commit to move work back from offshore…
- What Can Pharmaceutical Companies Do In The Face Of This Pressure?...pharmaceutical firms will need to demonstrate substantial job growth in the US...this (is) possible without destroying their margins...Disruptive digital technologies and capabilities are now mature enough to allow them to migrate work from the traditional low-cost labor locations to the US into far more efficient, automated, digital processes.
- Brexit regulatory uncertainty ‘threatens UK med tech’ (reuters.com)
Regulatory uncertainty in the wake of Brexit could leave Britain's multi-billion-pound medical technology industry out in the cold, with separate regulatory systems threatening exports and jobs…That is the warning from the Institution of Mechanical Engineers…which…became the latest group to highlight the problem of regulatory uncertainty once Britain leaves the European Union…industries from aerospace to pharmaceuticals and chemicals fear Brexit may create a regulatory vacuum…the IME called on the British government to harmonize its post-Brexit rules with EU regulations on medical devices - a category covering everything from heart stents to walking aids - or risk losing billions of pounds in exports…Leaving the EU without the UK medical technology industry suffering considerable long-term damage, particularly for small businesses, will be a huge challenge…it is vital that the UK is able to maintain continuity with the EU CE certification processes, and enable UK manufacturers to export medical devices into the 100 billion euros European med tech market…
- China’s new foreign drug proposal: Pharmas excited, analysts cautious (fiercepharma.com)
China’s FDA proposed changes to its foreign drug registration regulation in mid-March, aiming at speeding up approvals. The changes have provoked anticipation for growth among Western drugmakers, particularly around two provisions having to do with drug trials…
- The CFDA would no longer require that a drug be tested through phase 1 elsewhere before being tested in humans in China, and
- ...foreign drugmakers can use data from international multicenter trials that have been conducted in China to directly file for marketing approval.
...the change would attract greater investment from drugmakers and dramatically reduce the time to introduce blockbuster treatments...the new regulation "allows the imported innovative drug to move forward more naturally in China and not be required to be tied to international[-only] processes…I think [the Chinese government] has removed some significant obstacles and at the same time wishes to retain flexibility...what is clear is China’s goal to take the lead in pharmaceutical innovation, to become a launch pad of new meds...it’s about a national pride that doesn’t want to forever be left out in a global innovation discourse..."There is less the need to protect domestic industry than to play a leading role,"…Western companies will remain an "ever-present competitive force," and gradually opening up that competition will force domestic firms to up their game, to stand on their own feet and not rely on subsidies, and gradually eliminate those who cannot keep up…
- Pharmacy Week in Review: April 28, 2017 (pharmacytimes.com)
Nicole Crisano, PTNN. This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.