PBS NewsHour- “What’s keeping less expensive biologic drugs from the U.S. market?”
A powerful new prescription painkiller consisting of pure morphine and oxycodone is currently up for FDA approval. The drug, Moxduo, is designed to quickly relieve severe pain with fewer side effects than other opioids. According to QRxPharma, the maker of the drug, Moxduo allows patients to take lower doses of morphine and oxycodone than if they took either of the drugs alone. It also reduces the risk of life-threatening respiratory complications, as well as other side effects such as nausea and dizziness.
QRxPharma made their case on Tuesday, but the FDA advisory committee voted unanimously against approving Moxduo, and expressed doubt that a morphine-oxycodone combination is more effective and safe than either drug alone. Another key concern was the potential for abuse since pure narcotic substances are easier to misuse compared with other painkillers that contain multiple ingredients in addition to a narcotic.
Last year, an FDA advisory committee voted against approving Zohydro, the first pure hydrocodone prescription drug. The FDA did not follow the panel’s recommendations and approved the drug, citing a need for strong analgesics that do not pose the risk of liver damage. Despite harsh criticism from politicians and public health advocates, the FDA has maintained its position of ensuring access to pain medications for those in need.
Citing a public health emergency of prescription drug-related deaths, Massachusetts Governor Deval Patrick banned the sale of Zohydro on March 27th. This unprecedented action is the most aggressive measure taken so far to stop the pure hydrocodone drug, which entered the market last month. Zogenix, the maker of Zohydro, sued Massachusetts and got the ban overturned yesterday. The federal judge ruled that a state could not prohibit an FDA-approved drug, and that allowing states to do so “would undermine the FDA’s ability to make drugs available to promote and protect the public health.”
Other efforts to block Zohydro include Vermont Governor Peter Shumlin’s emergency order requiring prescribers to conduct a thorough medical evaluation and risk assessment before prescribing Zohydro. Several hospitals in Vermont and New Hampshire have refused to stock the drug. Also, 28 state attorneys general signed a letter asking the FDA to revoke the drug’s approval or require the drug to be more crush-resistant.
The IMS Institute for Healthcare Informatics found that specialty drugs drove a 3.2 percent increase in total prescription drug spending in 2013, to $329.2 billion. As blockbuster drugs face generic competition, drug companies have shifted their focus to specialty drugs, which treat more complex diseases such as cancer, inflammatory conditions, and multiple sclerosis. These drugs are used by smaller patient populations, which tends to make them more expensive (Gilead’s recently released $84,000 hepatitis C treatment is a strong example).
According to the report,
“More than half of prescriptions cost patients, on average, less than $5 in out-of-pocket costs in 2013, and 86 percent of them were filled with generic medicines. Nearly a quarter of all prescriptions — 23 percent — required no out-of-pocket cost at all, an increase that the report’s authors attributed mainly to a requirement in the new health care law that contraceptive drugs be covered free.
On the other hand, those who need the costlier drugs paid disproportionately more. Only 2.3 percent of prescriptions accounted for 30 percent of all out-of-pocket costs.”
Similarly, Express Scripts reported that specialty drugs account for 27.7 percent of total drug spending, but make up less than 1 percent of all prescriptions. It also predicted that spending on specialty drugs will increase an additional 63 percent between 2014 and 2016. Faced with covering these expenses, health plans are placing specialty drugs into tiers for which beneficiaries’ are responsible for paying a percentage of the drug cost as opposed to a set co-payment.
Additional perspectives on the ICD-10 delay as healthcare providers await further guidance from CMS- read more.
Despite efforts to replace the sustainable growth rate (SGR), members of the House and Senate could not come to an agreement on how to pay for reforms and instead delayed the 24 percent cuts mandated by the SGR. If signed into law, this would be the 17th temporary fix enacted over the past 11 years to postpone SGR cuts.
The measure delaying the implementation of the ICD-10 was only one sentence of the overall bill. The transition from ICD-9 to ICD-10 has been a controversial topic; first proposed in 2005, the implementation deadline has already been delayed twice. Proponents of the change argue that the newer codes will provide a more exact and up-to-date record of diagnoses and procedures, which would improve public health and quality reporting. Also, organizations have already dedicated resources and training sessions for the ICD-10 in anticipation of the upcoming October 1, 2014 compliance deadline. Opponents of the change, mainly medical associations and smaller practices, argue that implementing the new system is overly burdensome and expensive. If this measure is passed, the new ICD-10 implementation deadline can be no earlier than October 1, 2015.
In a huge step towards transparency, CMS released data covering $77 billion in Medicare Part B payments in 2012. The information includes over 880,000 distinct health care providers and 6,000 different types of services and procedures, allowing for comparisons by physician, specialty, service/procedure, Medicare payment, and submitted charges. Only procedures that providers performed on more than 10 Medicare patients were included in the data, leaving out over $22 billion of Medicare spending on physician and provider services. This effort by CMS was made possible in 2013, when a federal judge vacated the 1979 injunction won by the American Medical Association (AMA), which prohibited the release of physician-specific Medicare data on the grounds of physician privacy.
Multiple news sources have focused on doctors who received millions in Medicare payments. The AMA has expressed concerns that the raw payments data without proper context could mislead the public. For example, doctors who treat exclusively Medicare patients, treat sicker patients, or perform expensive treatments, are likely to receive more in payments. And in some cases, multiple professionals are allowed to bill under the Medicare number of a single physician.
Nevertheless, the new data enables consumers the unprecedented ability to research and compare physicians, and helps watchdog organizations research fraud, The Wall Street Journal has launched a tool where users can search through the data by provider, name, specialty, and location.
Yesterday, the FDA approved Evzio, a hand-held device that delivers a single dose of naloxone, which reverses the effects of opioid overdose such as stopped breathing and lost consciousness. When used during the one to three hour window after someone has overdosed, naloxone can reverse the binding of the opioid drug to certain receptors in the brain that control breathing. The approval took a short 15 weeks, and the product is expected to be available this summer. Currently, naxalone treatment is available mostly in hospitals and other medical settings, and naxalone treatment outside of a medical setting can require assembly (e.g., syringes, vials, nasal spray attachments). The hand-held device is the shape of a credit card and the thickness of a cellphone, small enough to fit in one’s pocket or a medicine cabinet. It provides verbal instructions on how to administer the drug and uses a retractable needle, no assembly needed. Evzio also created a training device people can use to practice using the product.
Those in favor of the FDA’s decision believe that the new device, when widely disseminated, can help prevent the growing number of fatal opioid overdoses. The most recent data shows that in 2010, 16,651 people died from opioid overdoses in the US. Others have criticized the FDA for not focusing on the bigger issues, e.g., preventing inappropriate prescribing or the controversial approval of Zohydro, and instead approving an device that could encourage opioid abusers act irresponsibly.