Drug Cost Conversation Continues
How drugmakers extend patent protections past their end date
As prescription drug patents begin to expire, manufacturers employ a variety of techniques to protect their monopolies. Tactics vary from litigation settlements that delay the introduction of generic competitions to filing new patents for existing drugs on different components not covered by existing patents. Damian Garde of STATNews provides insight into five ways drugmakers preserve exclusive control of vital treatments.
Providers struggle to adapt to price hikes, prompting federal action
Extreme price hikes on essential, off-patent drugs are forcing providers to accept financial losses. Providers are attempting to control costs by curbing waste and overuse, but cost cutting can only go so far as some drugs have seen price increases of more than 3000 percent. Lawmakers and the FDA are attempting to spur the development of more generic drugs, in the hope it will mitigate or prevent unexpected price hikes on brand drugs. The still-pending CREATES Act would spur competition by closing loopholes that allow brand drugs to delay the development or prevent the distribution of generic competitors. Meanwhile, the FDA will accelerate its review of generics and encourage development of generics by posting a list of branded drugs not protected by patents and without a generic competitor.
Outcome-based drug pricing ineffective in addressing high prices
In response to mounting criticism of the high cost of drugs, drugmakers have begun promising rebates to insurers for treatments that prove ineffective. However, evidence suggests that outcome-based payment programs are ineffective. Insurers who have tried outcome-based programs often find that drugmakers provide few or no rebates and typically revert to volume-based pricing. Experts say these programs fail to address underlying issues in the drug cost debate, including inflated starting prices and price increases for older drugs.
California transparency bill model for other states
The California state legislature passed a drug transparency bill and sent it to Governor Jerry Brown for approval. If the bill is enacted, drugmakers would be forced to provide advance notice and justification for some price hikes and health plans would have to disclose drug costs and what percentage of premiums is attributable to drug expenses. The bill, which drew strong opposition from the pharmaceutical lobby, has been cited as a potential model for legislation in other states.
House considers user fees for over-the-counter drugs
The House has opened debate on legislation that would allow the FDA to collect user fees from over-the-counter drugmakers to help fund a speedier drug approval process. Under the bipartisan bill, drugmakers would pay a base annual fee and an additional fee for each drug they submit for review. The user fees would allow the FDA to more than triple its review staff from 30 employees to 100, significantly cutting down the time for approval.
FDA looks to close orphan drug loophole
The FDA will close a loophole around orphan drug classification that allows drugmakers to skip testing requirements when developing a common-disease drug for orphan use in kids. The designation allows companies to sidestep research that promotes new medicines for children. FDA Commissioner Scott Gottlieb acknowledged concerns about the Orphan Drug Act and drug companies receiving incentives that Congress did not intend and also signaled that more changes could be on the way.
FDA approves first biosimilar targeting cancer
The FDA has approved the first biosimilar drug designed for cancer treatment. Like generic drugs, biosimilars are near-replications of existing treatments; however, biosimilars attempt to replicate the effects of biologic drugs, which are made from living cells and difficult to duplicate. Biosimilars are seen as one route to lowering costs for high-priced biologics.
FDA practices for medical device under fire
The FDA used a streamlined review process that bypassed safety and efficacy tests on 11 of the 12 medical software devices with the highest-risk recalls between 2011 and 2015, according to a study in Milbank Quarterly. The study has raised concerns that the FDA lacks adequate review processes for medical devices with complex software, an issue exacerbated by provisions in the 21st Century Cures Act that exempts certain software devices from the agency’s jurisdiction. An FDA spokesperson acknowledges that FDA review processes need to be updated.
First app approved for substance abuse treatment
For the first time, a mobile app has been approved to help treat substance abuse disorders. The FDA approved the app, developed by a start-up called Pear Therapeutics, which is designed to be prescribed by clinician and used alongside counseling. The technology digitizes a form of talk therapy called cognitive behavioral therapy that examines the relationships between thoughts, feelings and actions. Studies have found that CBT is an effective treatment for substance use disorders, and recent research suggests that it can be administered online via a desktop or mobile app.
FDA panel warns against codeine in kids’ medicine
A federal advisory committee has warned using opioids, like codeine or hydrocodone, in children’s medicines has more risks than benefits. Codeine and hydrocodone come with serious side effects and may not be effective at treating cough in children. The FDA has already warned against prescribing cough syrup containing codeine for children under 12 and may consider expanding the age range to 18. The recommendation is part of the FDA’s ongoing effort to determine how and if opioids should be used in children’s medicine.
Data helps battle opioid crisis in Indiana
The State of Indiana has launched an online opioid data center. The effort is driven by Gov. Eric Holcomb, who has promised to address the state’s drug crisis. Police departments, hospitals, pharmacies and mental-health agencies all contribute to the database to better demonstrate the big-picture effect of the opioid epidemic. The data will be analyzed to show long-term trends and has already helped identify locations for treatment facilities. The database includes information on drug arrests, death records, pharmacy robberies, overdose-related ambulance calls and the use of naloxone. While many states have opioid-related initiatives, Indiana’s is one of the most coordinated and in-depth approaches to addressing the drug crisis.
Takoma sues drugmakers over role in opioid epidemic
The city of Takoma, Washington has filed a lawsuit that aims to hold three drugmakers accountable for economic damages related to opioid addiction. The city is alleging the drug companies made false and misleading statements about the benefits and risks of opioids. Takoma joins many cities and states in suing drug companies for their roles in opioid addiction.