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...Aetna...announced...it was dramatically scaling back participation in the Affordable Care Act ― thereby reducing insurer competition and forcing customers scattered across 11 states to find different sources of coverage next year...Aetna officials said the pullout was necessary because of Obamacare’s problems ― specifically, deep losses the insurer was incurring in the law’s health insurance exchanges...But the move also was directly related to a Department of Justice decision to block the insurer’s potentially lucrative merger with Humana, according to a letter from Aetna’s CEO obtained by The Huffington Post...Paired with some looming rate increases for next year’s health plans, the abrupt departure of Aetna has triggered new worries that Obamacare ― a subsidized public-private system of health insurance plans competing for beneficiaries ― is in serious trouble and may even be unsustainable...It is very likely that we would need to leave the public exchange business entirely and plan for additional business efficiencies should our deal ultimately be blocked. Aetna CEO Mark Bertolini to the Department of Justice, July 5...To Obamacare critics, Aetna’s retreat is proof the law is failing. To supporters, it shows the company was using its participation in Obama’s signature domestic policy initiative as a bargaining chip in order to secure approval of a controversial business deal...

Dozens of killers are on the state’s death row, but should any of their appeals bottom out, it would be impossible to do away with any of them...One of the two drugs needed to administer an execution by lethal injection in Nevada has expired and the drug manufacturer has refused to provide any further supplies, state officials were told Tuesday...the medication provided by the drug company Pfizer....Without the drug, the state has no way to administer an execution...The department ( Nevada Department of Corrections) is moving forward with a national request for proposals to find the drug or an equivalent...the agency would use the drugs midazolam and hydromorphone to administer a lethal injection...Both of these drugs are manufactured by Pfizer..."Pfizer makes its products to enhance and save the lives of the patients we serve," the company said in a statement issued earlier this year. "Consistent with these values, Pfizer strongly objects to the use of its products as lethal injections for capital punishment."

In the face of growing criticism over its efforts to place a value on new medicines, the Institute for Clinical and Economic Review is trying to strike back. Recently, the nonprofit took a conciliatory approach by soliciting suggestions for improving its methods, but this week it became more aggressive by trying to dispel what it calls the “myths” about its operations and motives...The controversial organization released a manifesto...that attempts to rebut its many critics, who have chastised ICER for purportedly having cozy relationships with insurers; failing to sufficiently take into account the views of patients; and not providing enough time for drug makers to respond to assessments...The move comes as ICER has played a behind-the-scenes, but increasingly significant, role in the US health care system over the past two years. In the absence of an official entity to determine the extent to which medicines are cost effective — a function that is played by government agencies in some other countries — ICER has managed to fill the void with its reports...To what extent its attempt to dispel the “myths” will be effective remains to be seen...

If you ask a life sciences chief executive to gaze into a crystal ball, he or she will tell you there is good reason to be optimistic about the future. Or so a new survey would have us believe....All 38 executives who participated in the survey reported that they are confident about what lies ahead; 79 percent are convinced their products will remain relevant for the next few years; and 97 percent are certain that they are staying on top of coming trends...What might explain such a bullish view of the world? Well, chief executives...by their very nature, tend to be optimistic people and the industry is coming to terms with its challenges...This may be a case, however, of seeing the world through the proverbial rose-colored glasses...Why? At the same time these chief executives are so upbeat, a whopping 89 percent also confessed they are concerned they will not be able to increase market share. And 74 percent expect top-line growth of between just 2 percent and 4 percent over the next three years...We wonder if their investors know how they feel about such prospects.

With the drug pricing debate raging over the last few years, the announcement of national formulary exclusions from pharmacy benefit managers is enough to send stocks spiraling. Recent announcements from Express Scripts and CVS Health have highlighted the competitive dynamic in certain markets and have stakeholders questioning why certain drugs are excluded in one place, but not another...So why the discrepancies? Is one of these drugs better than another? Safer?...Hardly – in many instances, there are only slight differences in administration or effectiveness. In most cases, the pharmacy benefit managers were just better negotiators – competition is leverage, and having leverage means you hold the power...exclusions only happen in categories with an increasing amount of competition, particularly classes that have multiple drugs that work similarly and with similar effectiveness...While many manufacturers like to believe in the benefits and differentiation of their products, very often, these benefits are highly nuanced and selective...manufacturers should really think about how they negotiate price if they're looking for the broadest patient populations...I (Susan Garfield, principal at EY's life science advisory practice) don’t foresee the fundamentals of pricing changing, but the levers that determine pricing could change. If a value paradigm is introduced and implemented in the U.S. it could create that predictability and structure...

With Valeant’s management assuring investors that the company is well on its way to a turnaround, the drugmaker’s problems aren’t supposed to be growing larger. But now, Valeant is facing what could be its most serious investigation yet...Federal prosecutors are probing the...drugmaker’s relationship with specialty pharmacy Philidor...while that relationship has already garnered plenty of attention from investigators...this particular set of allegations...claim Valeant defrauded insurers by hiding its close Philidor ties--is new....The new probe could also be a bigger threat. Philidor managers and Valeant itself might face criminal charges...Prosecutors are looking into whether the specialty pharmacy made false statements to insurers about its link to the drugmaker. They’re trying to figure out whether insurers thought Philidor--which helped patients snag insurance coverage for pricey Valeant meds--was neutral, rather than in Valeant’s service...

Applications for clinical trials on genetic candidates in India can be sent at the same time to the Drug Controller General of India and the Review Committee on Genetic Manipulation under the Department of Biotechnology as part of an effort to streamline the process...It was decided in the meeting that the applicant may submit parallel application to RCGM and DCGI seeking approval to conduct (a) clinical trial...The RCGM is charged under law with reviewing the safety and ethics of recombinant DNA projects and activities in India that involve genetically engineered organisms, as well as setting guidelines, and previously had the first look at any applications...the change could shorten the path to clinical trial regulatory clearances for insulin or monoclonal antibody candidates...In July, the DCGI tweaked biosimilar approval guidelines and narrowed the scope to issue waivers required to run Phase III trials and rely on clinical references to biologic drugs not marketed yet in the country as part of an effort to get a better handle on data used to support such work.

As Vietnam opens up to more foreign money, the country’s fast-growing pharmaceutical industry is emerging as one of the most attractive prizes for overseas investors...Domesco Medical Import-Export JSC, the third-biggest listed drug maker, has shot up about 150 per cent this year as it got shareholder approval to scrap the 49-per-cent foreign ownership limit on its stock. DHG Pharmaceutical JSC, the largest, has risen about 44 per cent, with Japan’s Taisho Pharmaceuticals Holdings Co. buying a 24.5-per-cent stake last month. Vietnamese health-care companies have returned 46 per cent in 2016, the best performance among 10 industry groups on the VN Index...Vietnam’s pharmaceutical market is forecast to increase to $7.2-billion (U.S.) by 2020 from $4.2-billion in 2015 and then maintain double-digit annual growth through 2025...The industry will keep growing at about 10 per cent to 15 per cent a year...

Will forcing drugmakers to disclose big price hikes and new high-cost treatments help keep medications affordable for consumers?...That’s the premise behind legislation considered this year in roughly a dozen states...some researchers and consumer advocates say these “drug price transparency” measures likely won’t bring spiraling costs down by themselves — other policy changes will be needed...California state lawmakers will review a bill that would require pharmaceutical companies to give advance notice if they plan to introduce drugs that cost $10,000 or more (per year or per course of treatment) or raise the price on existing medications by more than certain percentages...Proposals...have included requiring pharmaceutical companies to report closely held research and development costs to government agencies, creating pharmaceutical review commissions and allowing government health programs not to cover certain high-priced drugs...Most of the measures have stalled this year, except in California, New Jersey and Pennsylvania, according to the National Council of State Legislatures...If policymakers don’t push to make information available as broadly as necessary to change the drug price conversation...proposed transparency measures risk becoming no more than “PR for policymakers that want to be seen as tough on the drug companies.”

Is cancer-related, direct-to-consumer advertising beneficial?—No...In the current communications era, cancer medications, cancer-related genetic testing, and even cancer centers are often marketed directly to the public. While there is little evidence so far that it generates inappropriate treatment recommendations in oncology,  cancer-related, direct-to-consumer advertising is prone to cause harm in many other ways. These include potentially fostering patient misinterpretations of expected efficacy and toxic effects of drugs with concomitant harm to the patient-physician therapeutic relationship; encouraging patient interest in new drugs when their toxic effects are not fully appreciated; and failing to present alternative treatment approaches that may be less toxic or costly.