Drug Price Discussion Continues
Drug prices focus of first Azar confirmation hearing
The Senate HELP committee held the first confirmation hearing for HHS Secretary nominee Alex Azar this week. Due to Azar’s background as a pharmaceutical executive at Eli Lily, the bulk of the hearing focused on high Rx drug prices and potential conflicts of interests. Azar testified that Rx drug prices are too high promised they would be a central focus of his tenure. He also acknowledged that government has a role in making medicine more affordable for consumers and agreed lowering drug maker list prices would have to be a part of any strategy. Azar will next testify before the Senate Finance Committee.
National Academies issues recommendations for fighting high drug prices
The National Academies of Sciences, Engineering, and Medicine has released a report on the impact of high drug prices particularly on preventing patients from acquiring treatment. The report offers several policy recommendations that include allowing the federal government to negotiate prices, stronger transparency requirements, more stringent enforcement of rules designed to promote competition, and limits on Medicare Part D out-of-pocket costs. ACHP has released a statement welcoming the report’s findings.
CVS purchase of Aetna may be finalized soon
Reports indicate CVS is close to finalizing its purchase of Aetna, with an announcement potentially coming as soon as Monday. Acquiring Aetna would allow CVS to lock in a large base of customers and provide the pharmacy with more leverage during negotiations for discounts with drug makers The move has been interpreted as an aggressive attempt by CVS to shore up its position in the health care landscape and expand its role in the health care market, as speculation mounts that Amazon may enter the prescription drug business.
Plans to cut orphan drug tax credit come under fire from patient advocates
Patients who rely on drugs developed under the Orphan Drug Act are pushing back against provisions in the tax reform bill to change corporate tax credits for manufacturers of treatments for rare conditions. Lawmakers in the House have included language to eliminate the tax credit for drug makers; the Senate bill retains the tax credit but drops it from 50 percent of preapproved clinical research costs to 27.5 percent. Patient advocates are worried cutting the credit could cause already high prices for specialty drugs to rise even higher.
PhRMA points finger at PBMs and health plans for high drug prices
PhRMA has released a report that suggests PBMs and health plans are largely to blame for high drug prices because they are responsible for setting the deductible and copay prices that determine patients’ out-of-pocket costs. The report also highlights drug rebates and discounts savings which PhRMA alleges are not passed on to consumers. The report dismisses high list prices as a minor factor and fails to address questions about why list drug prices are set so high to begin with.
Alylam pledges price increase limits for new rare disease drug
Alnylam Pharmaceuticals has announced it plans to limit future price increases to the inflation rate for a rare-disease drug in development. The drug Patisiran is designed to treat a rare disorder called ATTR amyloidosis, which affects about 50,000 people. No drug company has voluntarily promised to limit drug price increases to the inflation rate in more than two decades. Some are asking the company to work with the Institute for Clinical and Economic Review to set a fair opening cost, as the drug is currently expected to launch with a six-digit price tag.
FDA helps curb smoking
The FDA is encouraging development of nicotine-replacement therapies to help smokers kick the habit. A new Nicotine Steering Committee aims to improve over-the-counter cessation treatments, determine new effective strategies and examine how new products should be evaluated. Last summer, FDA Commissioner Scott Gottlieb announced a broad effort to steer smokers away from cigarettes, as about 480,000 people die of tobacco-related causes in the U.S. every year.
FDA aims to bring more generics to market
The FDA is looking to make it easier for generic drug makers to copy complex drugs and introduce more affordable alternatives in the market. The agency has committed to explaining how to copy complex drugs at least two years in advance of the first potential generic drug entering the market, which will help generic drug makers meet regulatory requirements. The generic drug will be approved if the drug maker can prove that its product is as safe and effective as the brand version.
Some providers concerned about FDA disclosures
Damages to the drug and medical device industries from Hurricanes Irma and Maria are calling attention to the FDA’s disclosure policies. While many drug manufacturing plants in Puerto Rico are still coping with a lack of electricity, FDA will not name specific products at risk of shortage. The policy is meant to discourage hoarding, but is causing concern for hospitals and providers who argue the policy does not give them enough time to prepare and could leave consumers with inferior, alternative products.
The FDA is also beginning to look for new sources of amino acids, following disrupted production at a Puerto Rican supplier due to Hurricane Maria. The supplier is one of the largest manufacturers of amino acids for the U.S. market, and is working with the agency to import amino acids from its facilities abroad.
The Opioid Epidemic
FDA approves monthly shot for opioid addiction treatment
The FDA has approved Sublocade, a new opioid treatment that can be delivered as a monthly shot. Delivering treatments monthly would help alleviate concerns about patients forgetting or skipping daily dosages. Treatments that allow monthly doses already exist, but Sublocade does not require a detox period before use by patients.
Opioid Commission report lacks prevention programs
Opioid misuse is much cheaper to stop before it starts. Yet, the final report from the White House Opioid Commission only included two recommendations to prevent people from seeking opioids without a medical reason. The Commission suggested an advertising campaign and a structured discussion with a health professional, tactics that are not supported by strong science to curb addiction. There are many evidence-based programs that could be helpful in combatting the opioid crisis, including workplace drug testing, prevention programs that include parents, and strengthening social connections and decision-making skills among children and teens.
New initiatives to combat the opioid crisis
Attorney General Jeff Sessions announced several new initiatives to combat the opioid crisis including expanding the Drug Enforcement Agency’s (DEA) ability to carry out policies. Sessions also announced $12 million in grants to help law enforcement combat the opioid crisis and unveiled a new DEA division overseeing the Appalachian region to help combat drug trafficking. Sessions asked state attorneys general to each designate an opioid coordinator tasked with developing a local strategy to combat the epidemic. The announcement is the most recent Justice Department action to curb opioid addiction, following a change to the way fentanyl is classified earlier this month.