ACHP Media Report: Pharmacy News – August 18, 2017

Drug cost conversation continues

HHS delays 340B drug discount rule until July 2018
A rule that would set ceiling prices on the 340B drug discount program has been delayed until July 2018. The rule, which was supposed to take effect in April, authorizes HHS to fine drug manufacturers that intentionally charge hospitals more than the ceiling price for drugs. The 340B program requires drug companies to give discounts to hospitals serving low-income patients and has undergone seven years of rulemaking to tighten which hospitals receive those discounts. The American Hospital Association says it is disappointed with the continued delay.

Rising costs of drugs costing Medicaid more money
In 2016, Medicaid spending on prescription drugs rose by $3.2 billion dollars, largely due to price hikes on brand name treatments. Kaiser Health News has compiled data on hundreds of drugs that contributed to increased Medicaid cost, detailing how much more Medicaid spent in total on each specific treatment last year than in 2015. The data provides insight into what treatments are driving the bulk of Medicaid’s spending increase.

Mylan reclassifies EpiPen as brand drug
In a settlement with the Department of Justice, Mylan and CMS have struck a deal to reclassify EpiPen, saving Medicaid hundreds of millions of dollars. EpiPen was classified as a generic drug, despite marketing and pricing as a branded product. The Department of Health and Human services estimates the misclassification cost Medicaid $1.27 billion in lost rebates. EpiPen will now be classified as a brand drug, and Mylan will recalculate payments starting retroactively in April 2017.

Lawmakers press drug companies to explain MS drug prices
Two Democratic lawmakers requested documents from seven pharmaceutical manufacturers to explain rising prices of multiple sclerosis drugs. Reps. Elijah Cummings (D-MD) and Peter Welch (D-VT) requested pricing information from Bayer, Biogen, EMD Serono, Novartis, Sanofi, Teva and Roche Pharmaceuticals. Prices for some MS drugs have nearly quadrupled since 2004, according to a study in the American Academy of Neurology.

FDA Happenings

Gottlieb plans to take action on drug prices
FDA chief Scott Gottlieb has pledged to take action on rising drug costs, saying he will stop anti-competitive actions that keep prices high. Gottlieb believes drugmakers “game the system and game the rules” by preventing generic drug companies from obtaining doses of a branded product for use in drug development. Generic drugmakers often need about 5,000 doses to complete studies to develop a generic equivalent. The FDA plans to release letters generic manufacturers sent to brand companies about access to samples, and legislation is pending to improve generic companies’ access to brand medication.

Drug approval in jeopardy due to manufacturing issue
FDA regulators are currently reviewing a glaucoma drug developed by Aerie Pharmaceuticals. But before it can get approval, Aerie is stuck waiting for another manufacturer to clear up issues at the facility where the drug is being made. The manufacturing facility has had a history of FDA quality control violations. Aerie believes it’s “probable” that manufacturing issues will be cleared up in time to avoid interference with their drug’s approval.

Companies are not sufficiently reviewing drugs after approval, study finds
Pharmaceutical companies are not following guidelines laid out in the FDA’s accelerated drug approval plan. Under the program, the FDA approves therapies more quickly based on data from less stringent trials, requiring companies to complete larger, more stringent trials after approval. However, companies are often failing to meet the follow-up trial requirements. According to a study in the Journal of the American Medical Association, only 50 percent of those trials took place within three years of approval, and many trials did not meet quality standards.

Cancer drug trials struggle to secure patients for testing
There are more experimental cancer drugs than patients able to participate in clinical trials. The imbalance is partly due to companies rushing to a profitable drug opportunity, but also comes from problems securing enough specific patients the drugs can treat in a trial. Therefore, companies often must compete for patients. Some experts are concerned competition between companies may result in more studies with small sample sizes, which can negatively affect outcomes and quality.

 Opioid epidemic

Express Scripts plans to limit opioid prescriptions, concerning doctors
Express Scripts will set dosage and strength limits on opioid prescriptions for first-time users in an effort to curb overuse. The country’s largest PBM has announced it will be limiting patients to seven-day prescriptions and will only disburse short-acting opioid drugs to first-time users, regardless of a doctors’ prescription. The company will monitor and try to prevent pill shopping. The program does not apply to patients in hospice or palliative care, or to cancer patients. The decision has drawn criticism from the American Medical Association, which says doctors and their patients should decide treatment plans. In the program’s yearlong 2016 pilot program of 106,000 patients, drug-related ER visits among participants were reduced by 40 percent, suggesting the strategy may be effective in battling the epidemic. CVS Caremark has a similar program.

A growing number of states and cities are suing opioid makers
More municipalities are suing opioid makers and distributors to recoup the costs of addiction treatment stemming from the opioid crisis. The city of Cincinnati filed suit this week, alleging McKesson Corp., Cardinal Health and AmerisourceBergen Corp. pushed suspicious amounts of oxycodone and hydrocodone into the market. South Carolina sued Purdue Pharma claiming it misleads physicians and patients through deceptive marketing practices that downplayed the addictive nature of opioids. These cases join other opioid-related suits filed in Alabama, Oklahoma, Oregon, Ohio and West Virginia in the past months.