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Rising prices and a shift toward more expensive medications are driving the increases in prescription drug spending, according to a new report from the Department of Health and Human Services...From 2013 to 2014, drug spending rose by an estimated 12.6 percent, ending a period of slower growth that had started in 2008...Drug spending is projected to rise again to $457 billion in 2015 — up from $424 billion in 2014 — and to continue to outpace the growth in overall health care spending through 2018...Prescription drugs will account for about 16.7 percent of all US health care spending in 2015, up from a recent low of 15.3 percent in 2013...What explains this trend in drug spending? The growing number of prescriptions was one factor, but that alone was not enough to explain why spending rose so much, according to the report...The report attributed most of that growth to more prescriptions being prescribed per person, while the rest of the growth resulted from an overall population increase...higher prices were a major factor, too...The report "ignores the tremendous value medicines provide to patients, including many that offer improved treatment options for conditions that previously had few or no options..."said PhRMA...

The process of sorting out problems with the US FDA's controversial Inactive Ingredients Database is shaping up to be a huge task, particularly as the agency is working through a backlog of missing updates extending back several years...The IID is a listing of inactive ingredients found in FDA-approved drug products, and is meant to be updated in a consistent manner as new medicines and their excipients are given the go-ahead by the regulator...it emerged recently that - from around 2005 - FDA resource constraints meant that the IID was not being updated at all with new excipient listings, and was left in hiatus for around a decade...If the database is not reliable, the review times for new medicines can be extended and may lead to applications being refused, according to excipient trade body IPEC-Americas...The agency is now working hard to work through the backlog of applications...There are still major concerns about the quality of the data in the IID...the IID has become peppered with inaccurate information that has compromised its integrity, including inaccurate ingredient names and potencies and ingredients listed as a percentage with no indication of basis units...Overall, the FDA says it is aiming to transform the IID into a complete, fully-searchable database that will link into other databases on nomenclature, toxicology etc and accommodate electronic submissions, to eliminate data entry errors and potentially allow it to be updated in real time...

A prostate cancer drug developed at UCLA will provide hundreds of millions of dollars for research under a record-setting deal...Royalty Pharma...a...pharmaceutical investment company, paid $1.14 billion for royalty rights to the drug known as Xtandi (enzalutamide). It was the largest-ever technology transfer deal involving a University of California invention...UCLA pocketed $520 million of the proceeds for its 43.9% ownership stake in the drug. The funds will be placed in a portfolio that is expected to generate $60 million a year to fund campus research, scholarships for undergraduates and fellowships for graduate students. The annual haul will continue until 2027, when major patents on the drug expire.

Outraged by exorbitant prices for certain prescription drugs, lawmakers in at least 11 states have introduced legislation that would require pharmaceutical companies to justify their prices by disclosing how much they spend on research, manufacturing and marketing...The sponsors of the measures say they have a variety of goals: to educate policymakers and consumers about the reason for high prescription drug prices; to shame pharmaceutical companies into moderating their prices; and, in some states, including Massachusetts, to actually place a ceiling on prices that are determined to be unjustified...A handful of transparency bills were filed last year, but none of them passed...The industry insists that it is being unfairly targeted by the transparency measures, pointing out that prescription drugs account for only 10 percent of health care spending in the United States, $300 billion out of $3 trillion per year...Some experts in drug pricing who are sympathetic to the goals of the transparency bills are dubious that they will accomplish what their sponsors hope...

MinuteClinic Retail clinics, long seen as an antidote to more expensive doctor offices and emergency rooms, may actually boost medical spending by leading consumers to get more care...Rather than substituting for a physician office visit or trip to the hospital, 58 percent of retail clinic visits for minor conditions represented a new use of medical services, according to the study...the journal Health Affairs. Those additional visits led to a modest increase in overall health care spending of $14 per person per year...This challenges the conventional wisdom that retail clinics save the health care system money...The study doesn’t contradict earlier research that found retail clinics provide care that costs 30 to 40 percent less than similar care provided at a physician’s office and that the treatment for routine illnesses was of similar quality. But it suggests those savings are more than offset by increased use of medical services...health plans and employers should carefully consider how they cover care at retail clinics...If the goal is to lower costs...then encouraging use of retail clinics may not be a successful strategy...

Drugmakers seeking to stop "commercially confidential information" being made public in trial reports will need to demonstrate the likely economic harm publishing it would cause...The European Medicines Agency made the comments in guidelines designed to help marketing authorization holders comply with its policy on trial data dissemination...The document...details how drug firms should submit clinical reports, how they should make patient-level data anonymous and when they can ask for commercially confidential information to be redacted...Clinical trial data redaction is a controversial subject. The agency has faced both challenges from companies concerned sharing data would benefit rivals and criticism from European Ombudsman Emily O’Reilly about information it has allowed to be omitted to date...the guidance the EMA stresses that "the vast majority of the information contained in clinical reports is not considered CCI (commercially confidential information)." It also warned that drugmakers should not routinely make redaction requests every time the submit a study.

Drugs currently being used to treat psychosis or depression may be able to treat emerging viruses, according to new research led by the University of Leeds...The researchers found that some common drugs were able to prevent a particular virus from infecting cells by blocking the ion channels that regulate potassium levels...drugs that were able to inhibit the potassium ion channels were effective against the Bunyamwera virus...which is increasing in prevalence in Mediterranean countries, and is endemic in Africa, the Middle East, and some Asian countries...There are many drugs targeting ion channels that are currently in use for a wide range of conditions. Our work shows that some of these might be suitable to treat virus infections...If existing drugs are confirmed to be effective against known members of a particular virus family, this opens up the possibility of using these 'off-the-shelf' treatments in a rapid response against dangerous new related virus strains that emerge...

Doctors and cancer clinics are up in arms about a new Medicare reimbursement scheme that would cut their mark-ups on oncology drugs. But the Centers for Medicare and Medicaid Services has even bigger plans for cancer-drug payments...Pay-for-performance deals and indication-specific reimbursements are on a list of 6 programs CMS plans to try alongside the cuts targeted at physicians and hospitals. It's a rare example of Medicare plucking new ideas from the private sector, even before they've been widely adopted in the biopharma industry...CMS says it looked to private payers for "value-based purchasing tools," and wants to use strategies similar to those used by commercial health plans, pharmacy benefits managers, hospitals and other benefits managers...the agency would experiment with the sort of value-based reimbursement plans that Novartis and Amgen are using on their brand-new heart drugs Entresto and Repatha. CMS says it will be seeking "risk-sharing" deals with drugmakers to link drug payments with patient outcomes...In practice, performance-based deals can be difficult to administer, and that's one reason why U.S. payers have been reluctant to make pay-for-performance arrangements on Entresto...A U.K. government report found that the National Health Service had fallen short on clawing back rebates owed under its cost-sharing deals with drugmakers.

French regulators have raised concerns about heparin made by Chinese supplier Dongying Tiandong Pharmaceutical and called on the EMA to revoke its GMP certificate...a report filed on the European Medicines Agency’s EudraGMP database last week , ANSM inspectors who visited the firm’s facility in Dongying City in December observed 10 deviations from good manufacturing practices standards...The ANSM inspectors said Dongying had used seven batches of out of specification crude heparin to make active pharmaceutical ingredients between 2014 and 2015, which they said indicated a misunderstanding of the basic GMP principles...According to Dongying's website, the firm passed a US Food and Drug Administration inspection in 2013 and was been cleared to supply heparin sodium and enoxaparin sodium APIs by Mexican authorities in 2014.

Jon Roth, CEO of the California Pharmacists Association, discusses the status of birth control prescribing among pharmacists in California.