Drug Price Discussion Continues
Drugmakers cheer Amazon’s prospective entry into drug distribution
Speculation that Amazon may begin distribution of prescription drugs has many in the health industry worried, but not drugmakers. Drug companies believe Amazon’s entry could lead to huge changes in the market, creating greater efficiency and weakening pharmacists’, PBM’s and insurers’ roles in drug price negotiations. Existing health care organizations have a similar analysis, and concerns about Amazon’s entry has forced some organizations to revisit their business strategies. CVS’s talks to purchase Aetna and Anthem’s decision to launch its own PBM are two major shifts in the health care industry that experts attribute to concern over Amazon’s entry into the market.
CMS sued by hospital organizations over 340B payment cuts
Hospitals are suing CMS over the agency’s plan to cut 340B drug payments to hospitals. The American Hospital Association and the Association of American Medical Colleges believe CMS overstepped its authority by making cuts to the 340B drug payments amounting to more than $1.6 billion and setting new rules for determining whether a drug was purchased under the 340B program. Critics say the proposed rule puts safety-net hospitals at risk and hurts their ability to provide care to the most vulnerable populations. The changes go into effect on January 1.
Tax bill eliminates orphan drug incentive
The House tax bill released Thursday would eliminate a popular tax break for drug companies developing treatments for rare diseases, also known as orphan drugs. Under current law, companies can claim a tax credit for 50 percent of clinical testing costs for orphan drugs. Orphan drugs have become a big business in recent years, raising questions about abuse of incentives included in the law. The elimination of the tax break would generate $54 billion in revenue over a decade.
Legislators call on HHS to implement rule to prevent price gouging
Lawmakers are calling on the Trump Administration to implement a long-delayed rule to hold accountable drugmakers for overcharging for drugs sold as part of the 340B program. The rule—which was written during the previous administration—would assess a $5,000 fine each time a drug company deliberately overcharges a participant in the 340B program; without the new rule, HHS has limited powers to crack down on such acts. The rule has been delayed four times since it was supposed to take effect in February.
State lawsuit over price-fixing expands
A group of state attorneys general suing drugmakers over alleged price-fixing have expanded their lawsuit to include additional drug companies as plaintiffs. The suit alleges that drugmakers colluded with each other on price increases and divvied up the market, providing each drugmaker with a fixed percentage of the market. In total, 45 attorneys general are suing 18 pharmaceutical companies and two pharmaceutical executives over the allegations.
EpiPen failures linked to seven deaths
The FDA received a total of 228 reports citing EpiPen or EpiPen Jr. failures this year, with 35 hospitalizations and seven cases tied to death. EpiPen’s design has changed in recent years, which its drugmaker Mylan attributes to necessary safety upgrades. However, the changes to design also protect the device from competition by generic device makers until 2025.
FDA cracks down on supplements made with marijuana extract
The FDA has warned four companies selling marijuana-derived supplements to stop marketing their products as a cure for cancer. The companies sell a variety of oils, pills and other supplements containing cannabidiol. The supplements are different from medical marijuana and contain only trace amounts of THC, the chemical needed to cause a high. In its warnings, the FDA noted that caninabidiol has not been proven as an effective treatment for any condition.
FDA considers new packaging guidelines for opioids
FDA Commissioner Scott Gottlieb said the agency may take actions on opioids that could impact drugmakers. The FDA is looking at new packaging and distribution guidelines that would limit the number of prescription opioids distributed, such as blister packs with a defined number of doses. Gottlieb foresees some pushback from drugmakers as it will cost more to re-package drugs. The FDA is currently in discussions with drugmakers about the packaging solutions and could move quickly on implementing the new guidelines.
FDA panel recommends approval of drug to combat opioid addiction
An FDA advisory panel has recommended the approval of an experimental drug to help fight opioid addiction. The panel found that Indivior’s injectable drug, known as RBP-6000, met safety standards at a low dose. If approved, the product would be the first monthly injectable buprenorphine treatment. The FDA is expected to make a decision on approval of the drug on November 30, and typically follows the recommendations of the advisory panel.
The Opioid Epidemic
White House opioids commission releases recommendations, lacks funding
The White House opioids commission released its final report, which included 56 recommendations to curb the epidemic. Recommendations include training on safe prescribing, mandatory use of prescription drug monitoring databases and stronger penalties for fentanyl trafficking. The commission did not specify funding amounts or sources and instead asked Congress to appropriate support, which the panel recommended be sent to cities and states as block grants.
Experts say polices to address the opioid epidemic need substantial funding, and the HHS public health emergency fund has only about $57,000 left. White House press secretary Sarah Sanders suggested the Administration may ask Congress for $45 billion to address the opioid crisis, the same amount that lawmakers included in the ACA repeal bill for addiction treatment efforts.
Utah and New Jersey granted Medicaid waivers for opioid treatment
CMS has approved Medicaid waivers in Utah and New Jersey that allow the states to improve access to treatment for opioid use disorder. Utah’s waiver would expand treatment for up to 6,000 childless adults who are homeless, involved in the criminal justice system or need substance abuse treatment. New Jersey’s waiver allows the state to use Medicaid funds for residential withdrawal management treatment, medication-assisted treatment (MAT) and case management. CMS has called for additional states to apply for similar waivers to address the epidemic.