October 6, 2017
PCORI would like to share a complimentary invitation to attend the 2017 Annual Meeting, Oct. 31-Nov. 2 in Arlington, Virginia. ACHP member plans are also well represented at the event – Kaiser Permanente Washington, the Permanente Medical Group and UPMC Health Plan are part of the agenda. In addition, actor Alan Alda will discuss how we talk to the public about science and health. Please use this special link to register.
Drug Price Discussion Continues
Drug providers pinched by rising costs and policy changes
Not-for-profit and public hospitals are reducing operating expenses to contend with rising drug costs and the Trump Administration’s proposed cuts to the 340B Drug Discount Program. According to a report from Moody’s Investors Service, more than 90 percent of surveyed hospitals said recent drug price increases have had a moderate to severe effect on their ability to manage patient-care costs. Providers said these factors, coupled with looming policy uncertainty, are causing them to cut back capital expenditures that would help them operate more efficiently and effectively, including spending to modernize health systems that would benefit patients. Cuts to the 340B program will have the biggest impact on safety-net hospitals that treat low-income patients.
CMS withdraws Medicare Part B payment model
CMS officially withdrew an Obama-era proposed rule that would have reduced Medicare payments for drugs administered in outpatient settings. The Part B demonstration was withdrawn after the health care industry rallied against it. The rule was unpopular with doctors as well as pharmaceutical companies who would have seen the impact on their profits. The withdrawal of the program signals that other measures to cut drug prices will be unlikely under the Trump Administration.
Lower-cost hepatitis C treatment approved
A less-expensive treatment for Hepatitis C has recently been approved, allowing insurers to expand access. Mavyret is the first drug approved by the FDA that cures all six genetic types of hepatitis C in about eight weeks for patients who have not been treated before. Other approved drugs require 12 weeks of treatment and do not cure all types of the disease. The typical sticker price for hepatitis C medication is $55,000 to $95,000 for a 12-week course of treatment, and Mavyret costs much less at $26,400 to treat the disease in about eight weeks. Many state Medicaid programs restrict access to hepatitis C drugs due to cost, and the more affordable treatment could lead to fewer restrictions and more access for patients.
States address high drug costs
Filling the void of Congressional action on rising drug prices, states are stepping up to tackle the issue. A variety of bills are making their way through state legislatures, including legislation in California, Nevada, New York and Maryland aimed at curbing the cost of drugs. Maryland became the first state to penalize drugmakers for price hikes in a law passed in May, and many experts frame this law as a test case that could help define what powers states have and what limits they face in legislation aimed at the pharmaceutical industry. Meanwhile, the California legislature passed a bill that requires drugmakers to disclose when they intend to raise prices more than 16 percent over two years.
House committee reviews right-to-try bill
The House Energy and Commerce Committee held a hearing on the Senate passed “right-to-try” bill aimed at helping terminally ill patients access investigational drugs. The bill would seek to change FDA’s oversight of the expanded access program which currently allows terminally ill patients and their doctors to request access to a drug outside of a clinical trial. The FDA has said only 30 percent of drugs patients receive through expanded access go on to win approval, and the agency has approved more than 99 percent of all expanded access requests it receives. FDA Commissioner Scott Gottlieb acknowledged that the program isn’t perfect and is seeking specific changes to the bill, including narrowing the eligibility of the bill from patients who face a “life-threatening disease or condition” to those facing “terminal illness.”
FDA approves MS drug in effort to increase generics in the market
The FDA has approved Mylan’s generic version of Teva’s multiple sclerosis drug Copaxone. Mylan is expected to start shipping the product soon and may be eligible for 180 days exclusivity. The approval of the generic was unexpected and came a day after the FDA said it would introduce new measures to speed up generic versions of complex drugs reaching the market.
The Opioid Epidemic
Senators take action on opioid epidemic
Senate Finance Committee Chairman Orrin Hatch (R-Utah), joined by 10 committee Republicans, sent a letter to HHS Acting Secretary Don Wright asking the department to increase safeguards against opioid abuse. In the letter, the lawmakers requested information about actions HHS is taking to prevent fraudulent activity and further prevent opioid abuse among Medicare Part D providers and beneficiaries.
This week, the Senate HELP committee held the first in a series of hearings to discuss the federal response to the opioid crisis. The committee heard that more research will be needed to address the crisis, including developing more options to treat opioid use disorder. At the hearing, NIH Director Francis Collins called for additional research into nondrug approaches to pain treatment that do not rely on prescription drugs, especially opioids. Some Senators voiced concerns that the Administration is not doing enough to combat the crisis. October’s hearing will focus on opioid addiction at the state and local level.
Cigna to stop covering OxyContin for some consumers
Cigna will not cover OxyContin for customers who receive health coverage through an employer in 2018 in an effort to reduce opioid addiction. At the same time, Cigna announced a contract to continue covering a competing oxycodone alternative to OxyContin, which will impose a financial penalty on that drug’s maker if too much of the drug ends up being used by the insurer’s customers. Cigna’s moves come more than a year after the insurer said it intended to cut opioid use among its customers by 25 percent by 2019. While actions by payers to curb prescription drug addiction are important, the opioid epidemic is evolving. The use of heroin, which will require a different response, is increasing, and much of the public debate has not caught up with the change.
Anti-tobacco crusader Mike Moore joins lawsuits against opioid makers
Former Mississippi Attorney General Mike Moore has taken a leadership role in the lawsuits against opioid drugmakers. Moore was responsible for filing the first lawsuit by a state against tobacco companies and is credited as a key figure in the legal battles that followed. Moore and his fellow plaintiffs argue pharmaceutical companies misled the public by downplaying the risks of opioids. Moore sees similarities between the tobacco and opioids case and plans to use similar tactics against drugmakers that he used against tobacco companies.
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