- Big price hikes widespread in pharma, with dozens doubling last year: Bloomberg (fiercepharma.com)Shkreli Was Right: Everyone's Hiking Drug Prices (bloomberg.com)
Lately, the spotlight has turned on Valeant and Turing Pharmaceuticals when it comes to the drug-pricing debate. But the price-hiking strategy goes far, far beyond that pair of drugmakers...A survey of roughly 3,000 brand-name prescription treatments has found that prices more than doubled on 60 of them since December 2014...And they've more than quadrupled on 20 of the medications over that same timeframe...The data shows that price increases are an integral part of the business plan... The Wall Street Journal pointed to a slew of Big Pharma moneymakers that owed part of their success to hefty price increases...And while Valeant has pledged to nix most of its planned price increases this year, recent political pushback and public scrutiny haven't convinced some of its peers to do away with the practice...As drugmakers have argued, boosting their list prices doesn't mean necessarily boosting their bottom lines all that much. Insurers and health plans negotiate discounts, meaning pharma companies don't reap the entire increase. Still...a higher starting point for negotiations helps them end up at a higher finishing point...Even if they don't get all of that price increase, they will get some of it...
- Gilead shares pop 2% on earnings beat (video.cnbc.com)
Gilead Sciences Q4 EPS beat analysts' expectations, reports CNBC's Meg Tirrell. (video)
- On the team: Pharmacists work with athletes in professional sports (pharmacist.com)
The role of pharmacists on an athlete’s health care team is a growing component of getting athletes ready for competition...Teams have a need, and pharmacists are positioned to help...Athletes suffer from the same conditions everyone else does. They can benefit from a pharmacist’s intervention…...late 1990s, pharmacists were providing medication management software tools to track usage. Athletic teams’ medical and training staff would use the information to streamline their work, and a demand for pharmacists’ services began...steroid and doping controversies...(also) provided compelling reasons for teams and medical personnel to track and monitor drug usage…(this) tells only part of the story of what services pharmacists provide...compounding expands the tools and treatment modalities available...Nutrition is another area...Dietary supplements are a big problem...because they can contain banned substances that are not listed on the label...A pharmacist can guide athletes and direct them to supplements from trusted sources...While opportunities to work with professional athletes are few, opportunities for pharmacists to apply their knowledge and training with athletes abound...There are opportunities for involvement in sports...that would allow pharmacists to use their skills...The field is wide open…Pharmacists have to create their own opportunities by being pioneers and getting their foot in the door...Understand your field and establish your reputation and credibility so providers can call upon you as a trusted colleague and resource. Then develop your expertise in sports.
- Pharmacists take on medical cannabis dispensing role in three states (pharmacist.com)
Pharmacists in Connecticut have been dispensing medical cannabis for more than a year now. The state’s medical cannabis law requires that a board-certified pharmacist be onsite to dispense the product at a medical cannabis dispensary, of which there are currently six in Connecticut...Minnesota pharmacists began dispensing medical cannabis under the state’s 2014 cannabis legislation, and now New York’s law, also passed in 2014, includes language requiring pharmacists to dispense..."There are now three states that have a solid health care model [with a pharmacist to dispense]," said Joseph Friedman, BSPharm, founder of a medical cannabis dispensary in Illinois. Friedman is a vocal supporter of pharmacists’ role in the growing industry. No mandate under Illinois’ medical cannabis law requires pharmacists to dispense, however...Under federal law, cannabis is a Schedule I drug, but Connecticut’s law reclassifies it as a Schedule II drug. Because of this change, medical cannabis goes through the same process as other controlled substances in Connecticut, meaning it’s tracked through the Connecticut Prescription Monitoring and Reporting System, a statewide database updated weekly with patients’ prescription data...University of Minnesota College of Pharmacy is also looking into incorporating education courses about medical cannabis into the pharmacy curriculum...Including New York, 23 states and the District of Columbia currently have laws that legalize and regulate cannabis for medicinal purposes. It’s uncertain, at this point, if and how pharmacists will be part of other states’ dispensing operations...
- Alibaba health initiative takes it on the chin with CFDA move, lawsuit (fiercepharmaasia.com)
Chinese Internet giant Alibaba suffered two blows this past week: the China Food and Drug Administration announced that it will no longer work with the company on an initiative to track medicines to ensure their authenticity, and a pharmacy chain has filed a lawsuit against the company saying the initiative gave it an unfair advantage over other drug sellers...CFDA Vice Director Sun Xianze held a confab with 20 pharmacy and drug companies and wholesalers on Jan. 27 at which the decision was announced to curtail the deal with Ali Health, a subsidiary of Alibaba...The original plan with Alibaba had its detractors early on who complained about the costs involved and said the plan would do little to stop fake drugs from getting into the hands of unsuspecting patients...CFDA officials said they would continue to push for the bar code tracking system, but would instead work with a nonprofit institution and not a commercial entity...Meanwhile, Alibaba found itself in the middle of a lawsuit filed...by Yangtianhe Pharmacy...The suit says the CFDA broke the law by partnering with a commercial entity to create the system, which is called the Product Identification, Authentication and Tracking System.
- Virginia the latest state to push drug pricing transparency bill (statnews.com)
Like a legislative game of whack-a-mole, lawmakers in yet another state are pushing a pair of bills that would force drug makers to reveal their costs. Although similar efforts have either failed or stalled in 10 other states, Virginia is now the latest venue where legislators hope a law will provide some transparency into the drug pricing process...Companion bills were introduced in the Virginia House and Senate last month to require drug makers to provide detailed information for each medicine sold with a wholesale cost of $10,000 or more for a single course of treatment. This would include costs for R&D, manufacturing and marketing, as well as price changes, profits, and financial assistance for consumers. Data would appear on a public website...In the absence of action at the federal level, however, more state officials are trying to take matters into their own hands...the pharmaceutical industry has largely succeeded in keeping such legislation at bay...
- How Would Government Negotiation of Medicare Part D Drug Prices Work? (healthaffairs.org)
Medicare Part D premiums have been flat in recent years but will increase by 13 percent from 2015 to 2016...PDPs are also increasingly placing high-cost drugs on specialty tiers within formularies, which require patients to pay as much as 33 percent of the cost of these medications...Given these rising costs, a growing number of policymakers believe the government, through the Secretary of Health and Human Services, should be allowed to negotiate drug prices in Medicare Part D...federal law currently prohibits the government from negotiating with the pharmaceutical industry to lower the cost of drugs purchased under Medicare Part D. Instead, PDPs are required to negotiate directly with pharmaceutical manufacturers to obtain rebates and other discounts on drugs.
Proponents of government negotiation argue that HHS—because of its significant purchasing power—can more effectively negotiate drug prices than individual Part D plans.
Opponents argue that allowing the government to negotiate prices for Part D would inhibit innovation and limit beneficiary access to medications.
...what it means for the government to "negotiate" drug prices.
- Potential Scope Of Negotiations
- Which Drugs Would Be Negotiated?
- What Is Being Negotiated?
- Would HHS Negotiate For All PDPs?
- The Negotiation Process
- Additional Details Needed
- Estimated Cost Savings Of HHS Price Negotiations
- Next Steps
- Aprecia completes $35M financing to support launch of the first 3-D printed medication (fiercedrugdelivery.com)
3-D printed medicine specialist Aprecia Pharmaceuticals announced that it has completed a $35 million financing round...The move should help...Aprecia commercialize the first FDA-approved 3-D printed drug, Spritam (levetiracetam), a reformulated, easy-to-swallow med for the treatment of epilepsy. The launch is expected to occur in the first half of this year...Aprecia has exclusive rights to utilize Powder-liquid 3DP, a 3-D printing technology developed by MIT in the 1980s. The technique enables the company's ZipDose delivery platform. By printing a tablet consisting of layers of powder, Aprecia drugs can achieve a high degree of dissolvability in liquid. That means dosages as high as 1,000 mg will disintegrate in liquid...The new manufacturing methodology could also facilitate decentralized drug manufacturing and customization of medications to the needs of individual patients.
- Gilead accused of manipulating HIV patents (statnews.com)
In the latest legal challenge to Gilead Sciences and its register-ringing strategy, the AIDS Healthcare Foundation has filed a lawsuit accusing the drug maker of manipulating the patent system in order to thwart competition to its HIV medicines. And the nonprofit alleged that countless HIV patients have been prevented from accessing treatment — and may have been harmed — as a result...At issue is tenofovir, or TDF, which is a cornerstone of the combination HIV treatments that Gilead sells. The patent on the TDF compound expires in December 2017 and Gilead hopes to replace it with a modified version known as TAF (Genvoya)....TAF is more potent and causes fewer side effects, notably bone damage and kidney toxicity. The foundation argued that Gilead knew of these differences thanks to animal testing dating back to 2001, but that the company delayed testing TAF in humans until 2011. In doing so, Gilead extended patent protection by a few years, the foundation charged in the lawsuit...the foundation argued that TAF is an obvious modification of TDF and, therefore, does not deserve patent protection... The nonprofit....seeks to have the TAF patents invalidated...Gilead’s refusal to make TAF available as a stand-alone drug appears to be a calculated, anticompetitive maneuver aimed at keeping competing TAF drugs off the market for years despite the weakness of Gilead’s patents covering TAF, the lawsuit claimed. The failure to make TAF available as a stand-alone drug highlights Gilead’s motive of avoiding competition at all costs...Gilead "reevaluated TAF as part of its ongoing R&D review process" and "decided to prioritize" TAF development...the company believes its patents are valid.
- Connecting the CPOE dots: Where do we go from here? (pharmacist.com)
Over the past several years, there has been a monumental push for hospitals to transition to electronic health records and computerized physician order entry, with the hope of standardizing and streamlining care, improving medication safety, and reducing errors. In fact, some studies estimate that more than 70% of prescriptions are now written electronically. Although CPOE has come a long way in a short period of time, is the technology living up to its potential?...CPOE systems are very fragmented both within hospital systems and between the hospital and the outpatient universe...CPOE in terms of safer medication prescribing is still a work in progress...We found several areas where CPOE systems fall short in terms of medication safety, and hospital pharmacists can play an important role in resolving some of these issues...
- CPOE and medication prescribing
- Interoperability
- CPOE aggravation
- The next frontier
- Room for improvement
- Hospital pharmacists’ role
When you have systems between inpatient and outpatient that don’t communicate, important information can get lost in translation…CPOE isn’t just a hospital pharmacy issue; it’s an issue for the profession at large...Pharmacy has a significant stake in the matter of CPOE, but we really are learning as we go along...that is why you see so much frustration between prescribers and the hospital systems. To solve the problem, multiple professions beyond just health care professionals, with different thought processes, will need to work together...