AcuPartD

Keeping you updated on the latest Medicare and Part D news


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Orphan Drugs Used to Treat Common Conditions May Lead to Higher Prices

Though some research indicates that concerns over rising orphan drug costs may be unwarranted, a study conducted by America’s Health Insurance Plans (AHIP) found that orphan drug prices were more likely to rise when the drug was primarily used to treat common conditions – in contradiction to the Orphan Drug Act of 1983 which grants drug manufacturers a period of exclusivity and financial incentives to produce drugs to treat diseases that affect fewer than 200,000 people. The study found that drugs with mostly non-orphan uses had greater price increases than drugs prescribed almost always for their rare disease indications.

Orphan drugs are vital for patients suffering from rare conditions and the Orphan Drug Act has greatly incentivized the development of new drugs. The AHIP study ultimately finds that “A proper balance has to be struck between ensuring that the incentives remain for those firms focused on developing these very important, and much needed orphan disease therapies; while not allowing the Act to be exploited purely for financial gain.” The FDA recently noted that they are continuing to receive increased numbers of applications for orphan drug designations from drug makers. As prescription drug costs, and health care costs across the board, continue to rise sharply, more scrutiny of the orphan drug program may be inevitable.

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Orphan Drug Spending Concerns May Be Unwarranted

The 1983 Orphan Drug Act provides drug manufacturers a period of exclusivity and financial incentives to produce drugs to treat diseases that affect fewer than 200,000 people. Many have speculated that an increase of FDA approved orphan drugs in recent years could be partially responsible for the rapidly increasing prescription drug spending. A recently published study conducted by IMS Health, a health care analytics firm, and drugmaker Celgene Corp. however found that orphan drug spending increased 4.8% from 2007 to 2013, compared with an 8.9% increase of total pharmaceutical spending.

Celgene has benefited handsomely from the Orphan Drug Act though and is predicted to be the number 1 orphan drug manufacturer in the world by sales in 2020. Because some orphan drugs are used to treat multiple conditions, some of which could be common, there may be incentives for drug companies to apply for orphan status even though the drug has the potential to be used by many more than 200,000 people.

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FDA Approves Abuse-Deterrent Opioid

The FDA recently approved Targiniq ER, a painkiller that contains both oxycodone, a powerful opioid, and naloxone, which is used to prevent fatal opioid overdose. When swallowed intact, the naloxone component of Targiniq ER stays dormant. However, when the pill is crushed, the naloxone component is activated and prevents the oxycodone from binding to brain receptors to provide pain relief. Though people could still become addicted or overdose when using the drug as intended, Targiniq ER limits the common abuse delivery routes such as injecting or snorting crushed pills.

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Powerful Painkiller Moxduo Up For FDA Approval

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.

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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.


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FDA Releases Draft Guidance On Use of Scientific and Medical Literature for Drug Promotion

The new FDA guidance on the use of scientific and medical literature to promote drug products enters a grey area between upholding the First Amendment right to free speech and ensuring drug safety. The FDA already regulates company-sponsored or generated studies that include information that has not been specifically approved by the FDA or fail to meet scientific standards. However, when rigorously-conducted, independent studies that are driven by scientific rather than promotional purposes recommend drug uses that are not approved by the FDA, should companies be allowed to distribute them? The FDA’s guidance outlines what qualifies as independent and scientifically sound literature, and what sort of disclosures companies should include when distributing such literature.

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OpenFDA and the Future of Drug Safety Information

The FDA has collected millions of records on adverse drug events since 1998, amounting to the world’s largest catalog of how drugs interact with the human body. The FDA publishes bulk files on a quarterly basis; however, it takes a great deal of expertise and software to understand the data. Also, the information is extremely inaccessible for anyone outside the FDA (e.g., viewing a report on a specific drug requires a Freedom of Information Act request), making it almost impossible for everyday citizens and physicians to make informed decisions about prescription drugs.

In January 2014, the FDA began the openFDA project to release datasets covering adverse drug events, recalls, and drug documentation. Beta access to the database is expected by this summer, followed by a full launch in the fall. 

Startups have tried to use the FDA’s bulk files to provide information for consumers and clients in the health care industry. For example, AdverseEvents creates reports based on the FDA’s bulk files for insurers and hospitals. DrugCite allows users to search for side effects by medications online. Founders from both organizations have expressed frustrations with the current FDA data, citing challenges such as duplicate records, misspelled drug names, and piecemeal files. Once openFDA is launched, more entrepreneurs and software developers will likely create websites and applications to satisfy the public demand for drug safety information.

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