October 20, 2017
Drug Pricing Discussion Continues
Starting in 2020, Anthem will manage own drug costs
Anthem will launch its own PBM to manage patient prescriptions and will partner with CVS for disbursement beginning in 2020. Anthem predicts the move will save $4 billion, most of which the company hopes to pass on to consumers. The decision comes after months of protracted legal battles between Anthem and their current PBM, Express Scripts, which Anthem accused of overcharging by $3 billion annually. Experts believe Anthem’s decision could force existing PBMs to lower prices and potentially lead to greater transparency in drug pricing as other insurers consider following Anthem’s example.
Ohio drug cost initiative draws opposition from physicians
An Ohio ballot initiative aimed at lowering prescription drug prices has drawn opposition from the national pharmaceuticals’ lobbying arm and major doctors’ groups in the state. If the initiative were enacted, state programs would be prohibited from paying more for any drug than the federal Department of Veteran Affairs. PhRMA and various doctors’ organizations say the bill is misguided; they point out that copays for enrollees in state programs won’t go down and dispute projected savings for taxpayers. Physician groups are also arguing the decision could cause drugmakers to hike prices on patients who are not enrolled in state programs to compensate for the loss in revenue. Proponents argue the initiative will save taxpayers money and that physicians opposing the initiative are suffering from conflicts of interest.
Cancer drug prices have jumped by double digits over past 20 years
A study published in the Journal of Clinical Oncology has found that the average price for cancer drugs rose 18 percent between 1996 and 2012, accounting for inflation. The study examined prices for 24 drugs, and found only two had dropped in price; nine drugs had price increases of 3 percent per year, almost triple the annual inflation rate of 1.1 percent. Previous studies have found that launch prices for cancer drugs have increased over time, but this is the first study to systemically track prices for existing drugs.
Second gene-altering cancer treatment clears FDA
The FDA has approved a second treatment that uses gene therapy to battle cancer. Yescarta, a treatment from Kite Pharma, modifies patients’ T cells at the genetic level, rewriting the cells to target and destroy cancer. While the treatment has yielded impressive results, side effects from the therapy can be deadly. Kite has developed a robust training program aimed at identifying and managing side-effects, and plans to roll the treatment out slowly to ensure all practitioners are properly trained.
FDA releases new guides for generics and bioequivalents
The FDA has released draft guidance for the development of generic and bioequivalent versions of 32 drugs and revised guidance for 19 treatments. The guidance provides recommendations for the design of bioequivalency studies and other techniques for acquiring quicker approval for generic or biosimilar treatments through an abbreviated new drug application.
Gottlieb pushes for alternatives to curb opioid prescriptions
The FDA is exploring different methods to encourage physicians to write shorter and lower dosage opioid prescriptions, according to Commissioner Scott Gottlieb. The agency has limited authority to regulate opioid prescribing, but is considering tightening regulations around packaging and labeling for opioid prescriptions. Potential solutions include the development of small packs for short-term opioid disbursement. The FDA is also seeking input from physicians.
The Opioid Epidemic
Administration scrambles as Trump promises emergency declaration on opioids
The Administration is trying to quickly develop a plan to address the national opioid crisis after President Trump promised to formally declare it a national emergency next week. Officials have not reached a consensus on how to implement an emergency declaration or what resources to commit, and officials are unclear which agencies are tasked with formulating key aspects of the plan. The plan is further complicated by vacancies for key positions including HHS Secretary, Homeland Security Secretary, DEA Director and head of the Office of National Drug Policy. Trump promised an emergency declaration in August, but disagreements among White House and HHS staff and opposition from then-HHS Secretary Tom Price have delayed the declaration.
Providers fight opioid addiction without federal aid
Many providers say they would welcome federal aid to combat the opioid epidemic, but have already started implementing strategies without a national emergency declaration. Even without external funding, providers are moving forward providing education for clinicians on safe prescribing; altering electronic medical records to automatically prescribe naloxone when patients’ opioid prescription exceeds a certain threshold; and allowing clinicians to look up information related to state prescription drug monitoring programs in electronic medical records. Some facilities say even if a declaration came soon, they would still take a similar approach.
Lawmakers, pharma call for repeal of 2016 law
The Ensuring Patient Access and Effective Drug Enforcement Act of 2016 has come under fire after a news report suggested the legislation hampered the DEA’s ability to prosecute drug distributers providing opioids to the market with limited oversight. The bill was seen as industry friendly and undermining efforts to stop opioids from reaching the black market. PhRMA is calling for a repeal of the law and is also asking Congress to reconsider penalties for drug distributors that fail to report suspicious purchases. Many lawmakers are also calling for action. Sen. Joe Manchin (D-WV) wants to repeal the law through an amendment to the fiscal year 2018 budget.
Monthly Vivitrol shot could provide alternative treatment for opioid addiction
Most treatments for opioid addiction involve daily dosages of methadone or Suboxone; however, an alternative drug, Vivitrol, may provide another treatment option that can be administered less frequently and is just as effective. A Norwegian study has found the treatment—which works by blocking the euphoric and sedative effects of opioids—had similar relapse rates to Suboxone, suggesting it is as effective. While the drug is a promising new front for addiction treatment, experts caution against reading too heavily into one study and are waiting on data before integrating Vivitrol into treatment options.
High cost of the opioid epidemic
Americans will be feeling the cost of the opioid epidemic for years to come, as the total cost of the crisis is expected to be about $100 billion. Contributing to the cost is an increase in Hepatitis C cases, jumping from 853 cases in 2010 to 2,436 cases in 2015. Treatment of the disease can cost tens of millions of dollars. To prevent more cases of Hepatitis C, some states have implemented syringe exchange programs, which provide clean syringes to drug users help stop the spread of the disease. However, the programs are controversial and have been shut down in many counties. If the significant number of individuals injecting are not cured, hospitals could be flooded with patients with liver disease in the future.
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