10 Policy
Pharmacy Practice News • May 2015
FDA Watch
FDA Releases Final Guidance On Abuse-Deterrent Opioids
T
he FDA released final guidance on the evaluation and labeling of abusedeterrent opioids. The guidance reflects the agency’s current thinking on how studies should be conducted and evaluated to determine if a given formulation has abusedeterrent properties, according to the FDA. The 26-page document is geared toward helping drug makers to develop opioids with potential abusedeterrent properties. It also contains recommendations for what labeling claims may be approved based on study results. “Development of abuse-deterrent products is a priority for the FDA, and we hope this guidance will lead to more approved drugs with meaningful abuse-deterrent properties,” said Janet Woodcock, MD, the director of the FDA’s Center for Drug Evaluation and Research, in a press release. “While abuse-deterrent formulations do not make an opioid impossible to abuse and cannot wholly prevent overdose and death, they are an important part of the effort to reduce opioid misuse and abuse.” The FDA said opioids could be abused and manipulated in a variety of ways to create a euphoric effect, so abuse-deterrent technology should target known or expected routes of abuse. A draft guidance on abuse-deterrent opioids was first issued by the FDA in January 2013 and broke down abuse-deterrent technology into six categories: • Physical/chemical barrier • Agonist/antagonist combinations • Aversion • Prodrug • Delivery system • Combination of two or more of the above The final guidance contains a new category, “novel approaches” that encompasses novel approaches or technology not captured in the previous categories. The FDA said it intends to take a flexible, adaptive approach to evaluating and labeling potential products because the field of abuse deterrence is relatively new, and the agency “expects that the market will foster iterative improvements in products.” “The science of abuse-deterrent medication is rapidly evolving, and the FDA is eager to engage with manufacturers to help make these medications available to patients who need them,” said Margaret A. Hamburg, MD, former FDA commissioner. “We feel this is a key part of combating opioid abuse. We have to work hard with industry to support the development of new formulations that are difficult to abuse but are effective and available when needed.” The guidance emphasized that any study designed to evaluate an opioid formulation’s abuse-deterrent properties should be “scientifically rigorous” and consider the following: appropriateness of positive controls and comparator drugs, outcome measures, data analyses to permit a meaningful statistical analysis and selection of study participants. The FDA recommended collecting data from each of the following premarket studies categories to obtain a full understanding of a product’s abuse potential: • Laboratory-based in vitro manipulation and extraction studies (category 1) • Pharmacokinetic studies (category 2) • Clinical abuse potential studies (category 3) The FDA noted that results from category 1 studies may affect the designs of the other two, and category 2 results may affect the design and need for category 3 studies. The guidance contains postmarket study recommendations for products that may be an exception to these criteria. The FDA recommended that the labeling should include information on a product’s abuse-deterrent properties—which is supported by data—to better inform health care professionals, patients and the public about a product’s abuse potential. The label should also make it clear that abuse is still possible. The agency said more research is needed at this time to develop better and safer opioids while reducing the risk for abuse and misuse. The FDA noted that this guidance does not apply to generic opioids and that this will be addressed in a future guidance. —PPN Staff
First Generic Copaxone Approved
T
he FDA approved Glatopa (Sandoz), the first generic version of Teva’s Copaxone (glatiramer acetate injection) once-daily therapy for multiple sclerosis (MS). Glatopa, a synthetic protein that stimulates myelin basic protein, is indicated for the treatment of patients with relapsing forms of MS, including those who have experienced a first clinical episode and have magnetic resonance imaging (MRI) features consistent with MS. Glatopa is dosed as a 20 mg/mL once-daily injection. Although the mechanism of action of this immunomodulator is not completely understood, it appears to block myelin damage caused by T cells. MS is a chronic, inflammatory, immune-mediated disease of the central nervous system (CNS) in which the immune system attacks the myelin, the fatty substance that surrounds and insulates nerve fibers, and sometimes the nerve fibers themselves, causing sclerosis. This damage disrupts communication between the brain and other parts of the body producing a wide variety of symptoms. MS is among the most common causes of neurologic disability in young adults and occurs more frequently in women than men. For most individuals with MS, episodes of worsening function (relapses) are initially followed by recovery periods (remissions). Over time, recovery periods may be incomplete, leading to progressive decline in function and increased disability. MS patients often
experience muscle weakness and difficulty with coordination and balance. Most people experience their first symptoms of MS between the ages of 20 and 40. For this approval, FDA scientists established a thorough scientific approach for demonstrating active ingredient sameness that considers the complexity of glatiramer acetate. In the clinical trials for Copaxone, the most common adverse reactions reported by those taking the drug were skin problems at the injection site (redness, pain, swelling and itching), vasodilation, rash, shortness of breath and chest pain. Glatopa was developed in collaboration with Momenta and will be produced entirely in the United States. —PPN Staff
CMS Finalizes 2016 Payment And Policy Updates for Medicare Health and Drug Plans
T
he Centers for Medicare & Medicaid Services (CMS) released final Medicare Advantage (MA) and Part D Prescription Drug program changes for 2016. The Rate Announcement finalizes changes in payments that will affect plans differently depending on their characteristics. On average, the expected revenue change is 1.25% without accounting for the expected growth in coding acuity that has typically added another 2%. The final revenue increase is larger than the February advance notice largely because the Medicare actuaries recently updated Medicare per-capita spending estimates for 2014 and 2015. Medicare per-capita spending in 2014, 2015 and 2016 is still expected to be below historical standards. CMS said that particular care was taken to ensure that plan sponsors have the right incentives to care for dual-eligible populations (those on Medicare and Medicaid) over the long term.
“These policies strengthen Medicare Advantage for current and future consumers by encouraging higherquality care,” said Andy Slavitt, acting CMS administrator. “As the Medicare Advantage marketplace continues to grow, consumers are getting access to better care through more choice and competition. Seniors and people with disabilities, including the dual-eligible population, will continue to have an extensive choice of plans, affordable premiums and better and more transparent information about provider networks and pharmacies.” Enrollments in and quality of the MA and the Part D Prescription Drug programs continue to grow and improve since the Affordable Care Act (ACA) became law, according to CMS. MA reached record high enrollment in 2010 with more than 16 million beneficiaries (30%) enrolled in an MA plan. (In 2010, there were 48 million total Medicare enrollees.) —PPN Staff