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Endo International Plc said...the U.S. health regulator has decided...not to include blood pressure treatment vasopressin in its list of drugs that can be used in compounding, in a boost to the drugmaker that makes the only FDA-approved version of the product...The company had sued the Food and Drug Administration in October 2017, alleging that the agency had improperly authorized the bulk compounding of hundreds of drugs, including “essentially a copy” of Endo’s Vasostrict...The agency’s decision renders the sale of compounded products containing vasopressin unlawful, unless manufactured using an FDA-approved product, Endo said...READ MORE

Novartis’s shift into high-tech drugs won praise for providing patients with new options but criticism over prices that may run into the millions of dollars at the Swiss drugmaker’s annual general meeting...Swiss shareholder group Actares said insurance systems are being “taken hostage” by high prices for life-saving drugs. It called out Novartis’s $475,000 cancer cell therapy Kymriah and its still-unapproved gene therapy for spinal muscular atrophy that Novartis contends is cost-effective at $4-$5 million per patient, while independent groups have concluded its value is less than that.

The Food and Drug Administration and manufacturers did not take action when evidence emerged that potentially lethal fentanyl products were being inappropriately prescribed to patients, new research...shows...even as evidence emerged that as many as half of patients were taking dangerous medications known as TIRFs that should never have been prescribed to them, the FDA and fentanyl makers did not review prescribing records of even a single physician to consider disqualifying them from the program, which would have prevented them from prescribing the products...The study focused on Transmucosal Immediate-Release Fentanyls, or TIRFs, which are more dangerous than most prescription opioids on the market due to their very high potency and rapid onset. TIRFs are designed to get into the bloodstream within seconds, and because of their risks, were approved by FDA only for adult cancer patients "who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain."

Japanese have easy access to new medicines, whose prices are decided by the government and subsidized by the country’s public health insurance system...But that may change. Japan, confronted with the ballooning cost of caring for an aging population, is introducing a cost-effectiveness test for drugs as a means of capping prices...There are no plans to deny care for patients of any age... Japan should carefully consider an impact on the industry when introducing such analysis to reduce drug prices...If Japan is going to cut prices so much, I think Japan will really run a risk of losing its current position...while drugmakers threaten to pull back from Japan, the government is prepared to call the industry’s bluff, saying Japan is too lucrative a market for companies to ignore... Unlike the United States, where insurers may deny claims, or the UK, where patients can be denied costly drugs, Japan is seen as a relatively predictable market because of its social insurance system...

The legislation, which GOP Assembly members Melissa Hardy and Glen Leavitt presented to the Assembly Commerce and Labor Committee on Monday, would bar pharmacy benefit managers, or PBMs, from stopping a pharmacist from telling patients about the availability of a less expensive, generic or more effective drug, or a less expensive manner of purchasing a drug. The proposal builds upon a pharmacy gag ban passed by the Legislature in 2017 that prevented PBMs from blocking pharmacists from sharing information about the copay or coinsurance for a prescription drug or the clinical efficacy of a less expensive alternative drug...READ MORE

Nicole Grassano, PTNN, Pharmacy Week in Review, this weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.

U.S. legislators have been introducing bills left and right proposing a variety of methods for bringing down drug prices. Now, Vermont's congressman is zeroing in on a specific class of diabetes medicines that he says have become far too expensive: insulin...Rep. Peter Welch introduced a bill on Wednesday that would make it legal for patients, wholesalers and pharmacists to import insulin from Canada, and eventually from other countries with acceptable safety standards...Welch clearly wants to make an end run around Lilly and its fellow insulin makers. If his bill were to become law, patients with valid prescriptions would be able to import low-cost insulin and have it covered by their insurance plans...

, welcome to This Week in Managed Care from the Managed Markets News Network
Jaime Rosenberg

The hearing is the latest volley in Washington's battle against soaring drug prices, which has become a top priority for the Trump administration, as well as many Democratic and some Republican lawmakers...Executives from companies including Pfizer, Johnson & Johnson and AbbVie, will appear before the Senate Finance Committee and likely face tough questions from the panel's new chairman, Republican Sen. Chuck Grassley of Iowa...

Samantha DiGrande, Welcome to This Week in Managed Care from the Managed Markets News Network