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The Drug Enforcement Administration...proposed a 20 percent reduction in the manufacture of certain commonly prescribed opioid painkillers as well as other controlled substances for next year...The proposal comes as U.S. regulators and lawmakers take steps to limit the supply of opioids - a class of drugs that include prescription painkillers and heroin - to combat the epidemic of abuse, overdose and addiction...The DEA's proposed production quotas for Schedule I and II substances reflect the amount needed to meet the United States' medical, scientific, industrial, export and reserve requirements...The DEA recommendation comes about two months after the Food and Drug Administration took the rare step of asking a drugmaker (Endo International) to withdraw its opioid painkiller from the market, citing the public health crisis.

Retail prices for commonly prescribed drugs are often absent from state prescription drug price websites, but when reported, can vary substantially...Objectives: To examine how often retail prices for prescription drugs are available on state public reporting websites, the variability of these reported prices, and zip code characteristics associated with greater price variation...Takeaway Points: Across state government websites reporting retail prices for medications commonly prescribed for chronic conditions, price information is often deficient. However, when retail prices for prescription medications are publicly reported, these prices vary significantly.

• This is the first study to document variation in publicly reported retail prices for prescription medications across different classes and different states.
• More consistent reporting of such prices could potentially yield substantial savings for consumers who face high out-of-pocket expenditures.
• Policy makers should work to ensure retail prices for prescription drugs are reported consistently and strive to develop new strategies to facilitate consumers’ use of this information.

An ‘unorderly’ Brexit could risk the supply of life-saving medicines to patients because the drugs are held at border checks, piled up in warehouses, or subject to ‘extensive retesting’, the British and European pharmaceutical industries have jointly warned...a disorderly Brexit could result in ‘severe disruption’ of most companies’ supply chains, as the flow of medicines from the UK to the continent and back could stall..."ongoing cooperation" between the UK and EU on medicines as "the best way of ensuring that patients across Europe and the UK are able to continue to access safe and effective medicines and to ensure that there is no adverse impact on public health"...Current European marketing authorisations that apply across the EU, and continued cooperation between national competent authorities that are facilitated by the European Medicines Agency and the European Commission will be important in maintaining effective ties...any changes to the UK–EU trading relationship should not affect the research, development, manufacture and supply of medicines across Europe, including for clinical trials.

After several years in which drug makers have been pressured to release clinical trial data, a new analysis finds many companies are still doing an incomplete or inconsistent job of being transparent...95 percent of the 42 companies reviewed – including the 25 largest drug makers, based on sales – had a publicly accessible policy...the specifics often varied wildly in terms of what is disclosed and even how to interpret some of the policies...not every drug maker committed to share results within 12 months of completing a trial...policies were found to be vague, ambiguously worded and internally contradictory...every element of best practice around transparency was committed to by at least one company, [which] strongly suggests that they are all deliverable, and that there are no practical barriers to all companies committing to meet all elements of best practice."...The findings follow years of tussling between drug makers, academics and consumer groups over the issue of transparency. A central concern is the ability for researchers to independently verify study results and, consequently, improve patient treatments that can lead to better health and lower costs...Drug makers, however, are not the only ones to have flaunted transparency...many leading medical research institutions flagrantly violated a federal law requiring public reporting of study results. The violations left gaping holes in a U.S. government database used by millions of patients and medical professionals to compare effectiveness and side effects of treatments.

The Washoe County Health District says a North Valleys resident has tested positive for West Nile Virus. It is the first human case this year in Washoe County...Although this resident had traveled outside of Washoe County and may have been exposed elsewhere, the presence of positive mosquito pools locally means that a local exposure cannot be ruled out and residents should take appropriate precautions. The announcement coincides with the identification of three positive mosquito collections in Gerlach, although the incidents are not related..."We have been expecting this to be a very active season for both mosquitoes and West Nile Virus in Washoe County due to the heavy precipitation we got this year and because of the extremely warm weather in the area," said Washoe County District Health Officer Kevin Dick. "Although we are monitoring mosquito activity, conducting monthly larvicide treatments, and fogging areas of known activity, this is a reminder that people must be vigilant and take personal measures to keep mosquitoes at bay" said Dick.

The Institute for Clinical and Economic Review is seeking public comments on its recently released outline of proposed adaptations involving the assessment of certain treatments for ultra-rare conditions, also known as orphan drugs...The proposed changes are intended to provide information for decision makers regarding the practical and ethical challenges involved in potential major advances for ultra-rare conditions. The adaptations are also intended to complement the ICER’s recent update to its value assessment framework...In order to be considered for an adapted approach, a treatment must be expected to be used in a population of less than 10,000 with a minimal chance of future indication, and must demonstrate potential to majorly improve the quality of life or the length of life for the patient...The key statements and proposed changes in the proposal include:

• ICER will continue with the same standard of evidence when rating comparative clinical effectiveness, but will offer context regarding the challenges of producing evidence for the treatments and for identifying data for long-term safety.
• ICER will continue developing cost-effective models for new treatments, but models for ultra-rare conditions will have a broader range of cost-effectiveness results—from $50,000 per quality-adjusted life year (QALY) to $500,000 per QALY—and will calculate a value-based price benchmark from the standard range. However, these reports will indicate that decision-makers often give special weighting to other benefits, causing coverage and funding decisions at higher price—resulting in higher cost-effective ratios for the treatments.
• The report sections "other benefits and disadvantages" and "contextual considerations" will include evidence and perspectives of the potential positive treatment effects on family and the community.
• ICER will conduct a collaborative process to develop a template for information in reports on research, development, and relative costs for ultra-rare condition treatments.

Laura Joszt, assistant managing editor at The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network

Nicole Crisano, PTNN. This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.

Food and Drug Administration advisers voted against approving a new opioid painkiller with a unique feature for deterring abuse: It releases a deep-blue dye if someone tries to get high by crushing, chewing or snorting pills...Panelists voted overwhelmingly against approving Intellipharmaceutics International's generic version of extended-release Oxycontin, a key drug in the U.S. opioid addiction epidemic. The FDA usually follows its advisers' advice...Doctors and scientists raised many concerns about the dye's safety for intended patients, and its effectiveness in deterring opioid abusers. Most said the company hadn't done enough studies of the drug...Some suggested blue stains around the mouth or nose from trying to abuse the drug could become popular among addicts. Others said the dye's "Scarlet Letter" shaming approach was insensitive...also...the company hadn't provided enough data to show that addicts couldn't find a way to convert the pills' active ingredient, oxycodone, into a liquid that could be injected...Advisers noted that the company hadn't studied issues such as whether the nasal irritant in the pill would prevent abusers from trying to snort it after crushing and whether the blood dye would discourage abuse attempts.

Nicole Crisano, PTNN. This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.