In the article “I.P.F., Not Aging, Could Be Causing Breathlessness” in the New York Times this week, columnist Jane Brody explains that the drug Esbriet (pirfenidone) can “slow the loss of lung function and significantly reduce deaths” from an incurable lung disease called idiopathic pulmonary fibrosis, or I.P.F.
The article notes that Esbriet was approved in the U.S. in 2014 and now 14,000 people have begun treatment, which costs $94,000 per year. The article also notes that the drug has been available for several years in other parts of the world (including Japan, India, Europe and Canada).
What the article does not mention is that this incredible drug can be purchased at just a fraction of the cost through many online pharmacies which dispense it from licensed pharmacies outside the U.S – where the cost is only about $2,000 per year, rather than $94,000 per year.
The standard dose of Esbriet is 801 mg per day – 3 capsules, each containing 267 mg of pirfenidone, according to the NIH website DailyMed. Outside the U.S., pirfenidone is sold as 200 mg capsules (so 4 capsules would provide a similar dose – 800 mg). In the U.S., the price of each 267 mg capsule (without any discount) comes out to about $85, while a 200 mg capsule from outside the U.S. costs about $1.50 (prices listed at http://www.pharmacychecker.com/generic/price-comparison/pirfenidone/200+mg/)
Why must Americans (and our government programs) pay 40 to 50 times more than to get this drug in the U.S. than from elsewhere?
Tagged with: Drug Prices, Esbriet, Idiopathic Pulmonary Fibrosis, international pharmacies, life-saving drugs, Online Pharmacies, Pirfenidone
(Read Part 1 and Part 2)
Last year we discussed the cost of hepatitis C (“Hep C”) wonder drug Sovaldi for Americans paying in cash or using their health insurance. Notably absent, in both analyses, were how our most economically challenged citizens could afford the $84,000 treatment. According to Governing, “Many of the estimated 3.2 million people living with Hep C in the United States are poor, imprisoned or elderly, which means the cost of Sovaldi falls disproportionately on Medicaid and Medicare.”
To treat every one of the 750,000 Americans with Hep C who receive state-funded treatment through Medicaid or the prison system with Sovaldi would cost $55 billion, according to Express Scripts, and budget realities mean that that simply won’t happen. Public health officials will use prior authorization guidelines in determining who will be covered, similar to the way benefits administrators with private health plans determine eligibility.
Unlike private insurers, drug manufacturers must give Medicaid a 23% discount. The lower price is helpful but does not necessarily make Sovaldi affordable. Current models of drug pricing under Medicaid are not tailored to handle Sovaldi and other specialty medications. According to a letter sent from National Association of Medicaid Directors, “Simply put, the federal Medicaid statute is not designed to allow states to respond to this new pricing approach for pharmaceuticals. Sovaldi is just the first of many such exceptionally high-cost ‘curative’ specialty drugs.”
That letter recommends several federal policies to address Sovaldi and other high priced medications, including the creation of a special federal fund for specialty meds, similar to Ryan White federal funds for AIDS; additional rebates for specialty medications that reach a certain threshold in the percent of the population affected; and, my favorite because of the ludicrousness of international price disparities where U.S. prices are twice the average of other rich countries, “Modify the ‘best price’ policies for breakthrough drugs to include the selling price in other countries.”
There are more suggestions by the NAMD, and they are good future possibilities, but we’ve got to get down to the bottom line here: if you have Medicaid, then under what circumstances will you get Sovaldi? The states are all over the place in terms of coverage policies, but usually a person has to be very sick to get Sovaldi!
The Sovaldi Squeeze, written for Medicaid Health Plans of America (MHPA) by Viohl and Associates, takes a good stab at identifying Medicaid coverage policies. Thirty-five states require prior authorization. Most, if not all, of those states require enrollees to take a liver biopsy; the results of which determine whether or not Sovaldi will be covered. Some states will only cover someone who has not used illicit drugs and alcohol for three years. Other states, including Illinois, Florida, and Louisiana will limit coverage terms to make sure the patient is complying properly with the regiment. For example, Louisiana will only cover Sovaldi for 28 days at a time.
The most extraordinary criterion I saw is referred to as the “once in a lifetime” rule in the MHPA report. As you imagined, if a patient doesn’t adhere to their covered Sovaldi treatment then it won’t be covered again.
Like we discovered with private health insurance and certainly for people who must pay the full price in cash, there are serious obstacles to obtaining Sovaldi even if you’re covered on Medicaid. The costs are just too prohibitive. Yes, Gilead is right that unlike maintenance medications Sovaldi (and other new Hep C meds we’ll discuss below) can cure the patient, which means lower healthcare costs overall. Nonetheless, the market is not established to handle such insane upfront costs.
You might expect that more treatments with the curative-type power of Sovaldi would add competition to bring down prices. Indeed, there are three new Hep C specialty meds on the market. Olysio, marketed by Jansen is cheaper than Sovaldi, but still sells for $840 per pill. Harvoni is actually more expensive than Sovaldi, carrying a price tag of$94,500 for three months, about ten grand more than Sovaldi. Unfortunately, like Sovaldi it is made by Gilead so the competition factor is diluted! Harvoni does have the advantage of being a stand-alone treatment, however, whereas Sovaldi is taken in conjunction with ribavirin.
Viekira Pak, marketed by Abbvie, was approved just last month. Express Scripts wisely decided to make a deal with Abbvie that it would exclude Sovaldi in exchange for lower prices on Viekira Pak! Sure enough, Gilead fought back against Abbvie by making a deal with CVS Health that Harvoni and Sovaldi would be the preferred Hep C medications for CVS’ PBM business.
And which drug is the best? We’re not going to touch on that but the online magazine, Hep Mag, has an excellent summary on all the new Hep C medications discussed above, which could prove helpful.
The market dynamics for Sovaldi and other breakthrough medications like it are highly complex but largely stacked in favor of pharmaceutical company profits against taxpayers and consumers. Neither Medicaid nor private health insurers can afford to treat the millions of people who are infected with Hep C.
To conclude, I’ll leave you with the words of Caroline, who commented on our Part 1 post about paying for Sovaldi in cash, as she sums it all up perfectly:
Tagged with: Gildead Sciences, Harvoni, Hepatitis C, medicaid, Sovaldi
“Well I’m insured but this medication is not on the formulary for either health care companies offered at my job. They are two well-known companies and according to my GI doctor, none of the insurance companies are approving this drug unless you are at least at stage 3 liver disease. So I’ll have to get a little sicker before I can get it. Thanks Gilead!”
Most people think newer is better, but according to a study published in Health Affairs that might not be the case for prescription drugs. In short, the new study shows that drugs approved by the U.S. Food and Drug Administration after enactment of the Prescription Drug User Fee Act of 1992 (PDUFA), a bill that led to more expeditious drug approvals funded by drug companies, were more likely to have safety problems than ones approved before PDUFA. These findings are not only relevant to drug safety, but also to drug savings. Older drugs are often sold as generics and, thus, will have much lower co-payments than new drugs. For those paying out-of-pocket, the cost of a generic is often 80% less than the brand.
The study analyzed 748 drug approvals between 1975 and 2009. The approvals were of new molecular entities not for generic versions of existing brand-name drugs. Before PDUFA the chances that safety issues would arise involving approved new drugs was 21.2%; after PDUFA it increased to 26.7%.
According to the lead author, “The FDA needs to make sure drugs are safe before they’re approved, not rush to judgment in order to meet artificial deadlines.” Not surprisingly, FDA and the Pharmaceutical Researchers and Manufacturers of America, take issue with the study. Their main points are that PDUFA helped speed up important drug approvals and get medications to patients faster and it improved the predictability of FDA’s system of drug approvals.
Regulations for marketing and manufacturing new drugs can save people and they can kill people. If the regulations are too rigid then patients won’t get needed medications fast enough. Or regulations can increase manufacturing costs resulting in unaffordable drug prices. If regulations are too weak then drugs will be less safe and effective. While in my opinion the study clearly has merit, PDUFA is helpful. Before its passage, drug approvals were lagging far behind other advanced economies in Europe.
Furthermore, the study does not show “causality,” meaning it does not prove that faster drug approvals after PDUFA led to less safer drugs. Nonetheless, it’s understandable that a drug with a long history of safe and effective use, accompanied by few side effects, is more trustworthy than a newly approved drug since the long term effects of the latter are unknown.
But what does this all mean for consumers and drug savings? (more…)
Tagged with: Atorvastatin, Brintellix, Crestor, Prozac, SSRI, Statin