If you’ve been wondering why your company is paying so much for high-powered pain medications, here’s why.
Cephalon, manufacturer of Actiq and Fentora, has:
“agreed to plead guilty to promoting off label use of its painkiller Actiq–which was widely used for purposes outside of its original FDA approval–as well as narcolepsy pill Provigil and epilepsy treatment Gabitril. Cephalon has admitted that it had been marketing Actiq, a highly addictive narcotic lollipop produced to treat certain cancer patients, for off-label uses including migraines, sickle-cell pain crises and injuries.[emphasis added] (Fierce Healthcare)
Cephalon is the poster child for everything that is wrong with medicine in this country. They make me-too drugs; reformulate drugs to extend the patent life (fentora); aggressively market their drugs to docs who have no business prescribing them for purposes the drugs were never approved, nor are appropriate for; bribe docs to promote their drugs; and charge unbelievably high prices. Then, when the drugs do go off patent, they manipulate the price of the brand (doubling it in the case of Actiq), raising it and thereby creating a very high price for the generic. Oh, and their drugs have awful side effects – Actiq, which rots patients’ teeth is but one example.
In my work with workers comp insurers, TPAs, and self-insured employers, I see a lot of data on prescription drugs. Actiq and Fentora are almost always in the top five in terms of drug spend – (a month of Actiq easily runs $2500). Why is Actiq a big part of workers comp, you ask, because it is only FDA approved for breakthrough cancer pain, a medical condition that for all intents and purposes does not exist in workers comp? Because Cephalon has been pushing the drug to general practice docs.
In fact, only 1% of Actiq scripts were written by oncologists during the first half of 2006. So who’s dispensing the drugs?
Physical medicine and rehabilitation specialists were the second highest-dispensing specialty, accounting for 16 percent of scripts during the first six months of 2006, when oncologists and pain specialists accounted for less than 3 percent.
Cephalon will have to pay a $425 million fine, and (here’s the good part), publish the names of physicians it has paid to promote/research its drugs. The fine resulted from acase brought after a Cephalon employee refused to promote Actiq and Fentora to general practice docs, a decision that led to his termination by the company. That’s not chump change, but that shouldn’t be the end of Cephalon’s penance.
I’m hoping, really hoping, that payers will evaluate the settlement and perhaps (selectively) use the physician list to determine if they should disqualify docs from their networks, flag them in their published physician ratings, and carefully scrutinize their practice patterns.
Thanks to FierceHealthcare for the heads up on the settlement.
Oct
1
Joe,
Payors should take it a step further. They should all take Cephalon’s Amrix off their formularies. It is just a “me too” drug of flexeril, which is available generically, and very inexpensive. Amrix has a cost of over $7 a capsule. This is where payors are at fault for rising costs. Why would anyone pay for this drug? (unless Cephalon is offering huge rebates on the back end). Big Pharma claims their costs are high due to R&D. Honestly, how much R&D did Amrix take? They are using a drug that has been available for over 50 years, and a “time release” technology that has been available for years. For this they are charging over $7 a capsule? It’s just a shame.
Just so we can be clear, Cephalon does not offer any rebates at this time on any of their blockbusters.
In fact, one of their sales managers was at the Texas Formulary discussion in Austin back in July, quite worried that Amrix would get blocked, when it is just a “better” formulation of a common workers comp medication! It was painful to listen to his argument for his patent-extension on a generically available product.
Joe,
Thank you for your use of the word “appropriate” in your blog today. As you are aware, Cephalon has long been seeking approved indications for the use of Fentora outside of cancer pain. Specifically, Cephalon study C25608/3041/BP/US was examining the safety and effectiveness of Fentora for use in breakthrough pain in opioid tolerant patients with chronic neuropathic pain. Other studies have been examining its use in low back pain. If – and I hope that is a big ‘if’ – such an indication were approved, then it’s use in those cases would no longer be off-label – although any clinician can still identify this use as inappropriate.
They may have “long been seeking approved indications for the use of Fentora outside of cancer pain”, but it never stopped their reps from hitting every Workers Comp doctor in our area.
Interesting article. I forwarded to one of the physicians in our practice (PM&R Docs in Tampa) who I have heard speak out against prescribing Actiq to workers’ comp patients. After reading your article he pulled the PDR and showed me the warning (in a black box) for Actiq. It says in part “Actiq is indicated only for management of breakthrough cancer pain in patients with maligancies who are already receiving and who are tolerant of opiod therapy for their underlying persistent cancer pain”. Thanks for writing on this important issue.