Mylan’s triple-combo HIV treatment launches
Mylan has received regulatory approval for its third HIV drug in recent months. The Pittsburgh-based company is launching Symfi, an antiretroviral combination of 600 mg of efavirenz, 300 mg lamivudine and 300 mg of tenofovir disoproxil fumarate. The once-daily pill is indicated as a complete HIV treatment regimen in adults and children weighing at least 40 kg.
“As the largest supplier of antiretrovirals by volume in the world, Mylan has a longstanding commitment to expanding affordable access to treatments for people living with HIV,” said Mylan CEO Heather Bresch. “As we continue to grow our U.S. portfolio of ARV products, now including Symfi Lo, Symfi, and Cimduo, we are providing access to patients and empowering them to choose the lower-cost ARV treatment option that is right for them.”
The Food and Drug Administration recently approved the drug, which followed the agency’s previous approval of its Symfi Lo and and Cimduo HIV treatments. Symfi Lo was launched in early March, and expects Symfi and Cimduo to launch in the second quarter of the year.
Mylan noted that according to IQVIA, total spending on HIV medications has tripled since 2007, outpacing the roughly 60% growth in the nation’s overall drug spend. ExpressScripts data shows that HIV was the category that saw the most Medicaid spending, the third-highest health exchange spending and the fifth-highest commercial plan spending in 2017.
“Mylan has been on the forefront of bringing innovative delivery and dosage forms of ARVs to millions of patients in the developing world,” said Mylan President Rajiv Malik. “We’ve already extended our reach to people in the U.S. living with HIV with the introduction of Symfi Lo and Cimduo. Adding Symfi to our portfolio further strengthens our commitment to investing in developing and manufacturing these important products.”
Mylan said that the list price of its HIV treatments in the United States would be discounted significantly from the wholesale acquisition cost of similar medications.
Finding fraud: Tracking, technology and tips for pharmacies
Recent Congressional bills demonstrate the government’s proposed intent to crack down on the U.S. opioid epidemic. But as anyone in our industry knows, addiction is a multi-faceted problem that requires significant investments of time, money, energy, compassion and creative thinking.
When it comes to managing the dispensing of controlled substances, pharmacies are truly the last line of defense. State boards, law enforcement, and prescribers all shoulder huge responsibilities for executing prescription vigilance, but the potential for fraud is a real and ever-present problem for the retail pharmacies. Prescription fraud takes numerous forms, and the ways offenders will try to beat the system are numerous.
While the opioid crisis demands that pharmacists look once, twice, even three times at possible offenders — whether patients or prescribers — they also have a responsibility to regularly serve patients who have legitimate medication needs. Community dynamics have shifted significantly in that great distances often separate work and home lives, as well as residences of family members. It used to be that one pharmacy could serve an entire family seamlessly, and the pharmacist knew his or her customers well, using that knowledge and relationships as primary screening tools for substance abuse. Today, simple geography has changed that, making pharmacies more ubiquitous and adding complexity to the screening and distribution process.
Many patients renew scripts through an automated phone service, and simply pick up the bag without much staff interaction. Certainly, technology has made this process easier and less time-consuming for patients. Technology, in similar ways, can make it easier for pharmacy teams with the ability to analyze data about prescriptions and help set up alerts when possible fraud or compliance issues arise. When pharmacists aren’t able to secure trust based on a personal relationship, a solution that helps them understand the system’s most important data elements is the next best thing.
Furthermore, through its suspicious order monitoring program, the DEA expects retail pharmacies to carefully monitor the flow of controlled substances at their locations. There are numerous rules and regulations, but the intent is clear: retail pharmacies must have transparency and understanding about their customers, prescribers and distributors, especially in the context of its peer groups.
Prescription drug monitoring programs of the National Alliance for Model State Drug Laws provide a state-wide electronic database to collect data on certain controlled substances, but unfortunately aren’t typically part of the pharmacy’s primary daily workflow. Not only is it cumbersome to access the data, there are often lag times, which limit its application as a true contributory database. The industry requires a real-time prescription database that seamlessly integrates with workflow operations so pharmacists can help mitigate the controlled substance abuse problem rampant in our country.
Implementing a true contributory database solution is a critical step in understanding and overcoming the prescription opioid epidemic. At the same time, situational context discussed above still holds power to control fraud and abuse. While pharmacists may not have personal relationships with every customer, there are situations and circumstances surrounding the acquiring of certain medications that should be cause for concern.
The National Association of Boards of Pharmacy and the Anti-Diversion Industry Working Group, made up of pharmaceutical manufacturers and distributors, highlighted “Red Flags,” or warning signs of abuse or diversion. Be on the lookout any time a group of patients approaches the counter together: Are they all holding prescriptions for the same drug … or from the same provider? Be cautious about location of the provider: it should be in relatively close proximity to the pharmacy and patient. Ask for an explanation if the details do not add up.
It’s generally considered suspicious if a patient forgoes using insurance and requests to pay cash only for certain medication, especially controlled substances. The large majority of Americans have some form of insurance and prescription plan. Some offenders prefer late hours, hoping to sneak in under the radar of an unfamiliar pharmacist, or alternatively, come during the busiest times of day so the pharmacist will rush the request through the system. Be aware of customers who are exhibiting abnormal patterns of speaking, are afraid to make eye contact (or hiding small pupils) or seem anxious or upset. Pharmacists are customer-facing for a very important reason—they must pay attention to physical and behavioral warning signs of potential abuse.
Pharmacists should also be on the lookout for group scripts combining medications that work to intensify the drugs’ impact, such as opioids, benzodiazepines, and muscle relaxers. Also pay close attention to the provider’s credentials, specialty and condition for which the medications are being prescribed. A key question: does all this fit together and make sense as part of a treatment plan? Stay aware of local news reports about pain clinics or other prescribers under investigation for drug diversion.
Obviously, prescriptive authority must be confirmed from the outset. Fraud via stolen prescription pads is still common, as is tampering with quantities and refill amounts. Ask yourself: Does this drug make most sense in the quantity of 100, or 10? Thankfully, secure E-prescribing is becoming much more prevalent, reducing the number of altered paper prescriptions pharmacists see.
Fraud approaches the pharmacy counter every single day. Use the technology available to you to flag unusual patterns of prescribing. Use that gut instinct that tells you something is “off” with a patient or a prescriber. Pharmacists have every right and a corresponding responsibility to use professional judgement in filling prescriptions for controlled substances. Let’s all be part of the solution. Our future depends on it.
FDA approves Breckenridge’s generic Baraclude
Breckenridge Pharmaceutical has received Food and Drug Administration approval for its generic Baraclude (entecavir). The drug is indicated as a treatment for chronic hepatitis B.
Breckenridge’s generic Baraclude will be available in 0.5- and 1-mg dosage strengths. The drug will be manufactured by RA Chem Pharma, with Breckenridge as the exclusive U.S. distributor.
The generic and branded versions of Baraclude had combined U.S. sales of roughly $95.9 million for 12 months ended January 2018, according to IQVIA data.