The High Cost of Waiting for Generic Alternatives

Weeks after getting a script for what I hoped would be a cheaper alternative to Restasis (cyclosporine emulsion), I was reminded of why so many prescription medications are unaffordable.

Three pharmaceutical companies recently agreed to pay California nearly $70 million to settle allegations that they paid to delay generic versions of the narcolepsy medication Provigil (modafinil) and the pain patch Lidoderm (lidocaine topical) from entering the market.

Consumers aren’t always the hardest hit by the practice known as pay for delay. A portion of California’s settlement, like the federal settlement, is earmarked to compensate those who bought Provigil, Nuvigil, or modafinil during the timeframe. But those hurt most are people like myself, who can’t bear the cost of necessary brand prescriptions and must live without them because there are no generic alternatives.

Pay for delay

The alleged deals to keep generic versions of Provigil and Lidoderm off shelves aren’t isolated. Since 2005, generic versions of as many as 142 brand-name prescriptions have been delayed by pharmaceutical firms paying off would-be competitors, according to a report by the U.S. Public Interest Research Group (PIRG). Of 20 medications impacted by pay-for-delay deals, PIRG reported that generics were delayed an average of five years, and as long as nine years. Brand-name medications cost 10 times more on average. 

A generic version of Provigil, due to arrive in 2005, was kept off the market until 2012 after Cephalon paid more than $300 million to four generic drug manufacturers. After losing my job and health insurance coverage in 2011, my monthly price for Provigil skyrocketed from a $35 copay to $1,386 per month. My physician switched me to Nuvigil, which I was also unable to afford because a 2012 pay-for-delay deal kept its generic version from being released until 2016.  

Skirting the rules

Patents on newly developed medications typically last 20 years before cheaper generic versions can enter the market. But the monopoly on profits is largely being extended by pharmaceutical companies adding new patents and exclusivities to existing medications, according to a study published last year. Among the findings of the study, which analyzed all prescription medications on the market between 2005 and 2015: 

• Seventy-eight percent of medications associated with new patents were for existing medications.
• Nearly 40 percent of all medications on the market created additional market barriers by adding patents and exclusivities.
• Of the 100 bestselling medications, 70 percent had their protection extended at least once and 50 percent had it extended more than once. 

With a recent JAMA study showing prices have doubled since 2012 for many popular brand-name prescription medications, it’s no surprise that nearly a quarter of Americans struggle with prescription costs. 

The waiting game

Allergan still holds a lock on Restasis, which aided in the firm’s better-than-expected quarterly profits. But after much legal wrangling, generic competition is expected to arrive this year. Since the dry-eye medication Xiidra I was recently prescribed costs about the same as the roughly $500 it would cost each month to fill my Restasis prescription, I’ll be happy to see a less expensive alternative.   

***

Note: Sarcoidosis News is strictly a news and information website about the disease. It does not provide medical advice, diagnosis, or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website. The opinions expressed in this column are not those of Sarcoidosis News or its parent company, BioNews Services, and are intended to spark discussion about issues pertaining to sarcoidosis.