Spend a few minutes studying your health plan’s claims data, and you’ll very likely discover your plan is spending large sums of money on men’s testosterone products.
In fact, you’ll likely discover your plan is spending several thousand dollars a 
year for each male beneficiary who is choosing to rub gel into his shoulders in the hope that the gel will enhance his sexuality. (1)
Last week, the New England Journal of Medicine provided yet another reason why your plan should take steps to alter men’s efforts to change their testosterone levels. The Journal reported that 3 large clinical trials of older men showed that testosterone gel did not improve the men’s health by increasing their energy or vitality, and only modestly improved their mood, sexual interest and sexual performance. The NEJM study can be read here.
The Journal’s report followed a torrent of other disconcerting testosterone evidence that has emerged in recent years:
- In 2003, an Institute of Medicine Committee observed there was a lack of definitive evidence that testosterone therapy conferred benefits. (2)
- In 2009, the FDA required the manufacturers of Androgel and Testim gels to add a boxed warning that children could suffer adverse effects if the children inadvertently rubbed against the gel on men’s bodies. (3)
- In 2013, a JAMA study found an almost 30% increase in rates of heart attack, death and stroke among testosterone users compared to those who didn’t take the drugs. (4)
- In 2014, another study reported a two-fold increased heart attack risk in the 90 days after men aged 65 and older filled a testosterone prescription. Among younger men with a history of heart disease, the increased risk was two-to-three fold. (5)
- In 2014, the FDA required all testosterone manufacturers to add another label warning that testosterone products increased the risks of blood clots in the veins. (6)
- In 2015, the FDA required manufacturers to add a black box warning that testosterone products can increase the risk of strokes and heart attacks. (7)
Tellingly, despite all those developments, testosterone remains a multi-billon dollar industry. And testosterone use has soared in recent years.
Moreover, men’s excessive use of testosterone products is likely to continue in the future, given manufacturers’ omnipresent “Low T” advertisements (8), and the growth of niche “Low T Lifestyle Clinics” that are sprouting up across the country. (9)
Implement An Effective Prior Authorization Program
Aware of the dangers of testosterone use, the FDA has explicitly stated: “Health care professionals should prescribe testosterone therapy only for men with low testosterone levels caused by certain medical conditions and confirmed by laboratory tests.” (10) Unfortunately, many doctors are prescribing testosterone drugs without requiring lab tests that demonstrate the existence of the specified conditions.
Accordingly, it makes sense for every Health Plan to seriously consider implementing a Prior Authorization Program that precludes testosterone coverage unless the recommended lab test evidence is provided.
To implement a successful Prior Authorization program, your Plan needs to: (i) Draft appropriate protocol standards identifying the relevant conditions; and (ii) ensure that the standards are successfully implemented (meaning your PBM is paying attention to the protocols and not simply rubber-stamping the approval of testosterone drugs).
If you’re not sure that your PBM will draft appropriate protocols, you can contact our firm and we’ll help you do so.
If you’re concerned that your PBM may simply be rubber-stamping prior authorization submissions, you should require your PBM to provide you with an approval/disapproval report, and then review the report to determine the percentage of approved submissions. Health Information Designs – an independent firm that runs PA Programs for numerous state Medicaid programs – reports that approval rates for testosterone products should be about 65% to 70%, meaning from 30% to 35% of requests should typically be denied.
Steer Usage To Low-Cost Testosterone Products
With – or without – implementing a Prior Authorization Program, every health plan should also ensure that it is steering men who do use testosterone products to the lowest cost products.
Most men who resort to testosterone products use gels, and most men using gels use Androgel. But Androgel comes in two forms – a generic at 1% strength, and a brand at 1.62% strength.
What’s the difference between the generic and the brand? The generic requires men to rub slightly more gel into their shoulders, but costs substantially less.
While the exact cost difference depends on the strength (or weakness) of your PBM contract – and how badly your PBM may be gouging your Plan – a reasonable estimate of your Plan’s costs for generic Androgel would be about $390 per 30 day prescription, whereas a reasonable estimate for your Plan’s costs for brand Androgel would be about $712 per 30 day prescription.
Notably, the AWP of brand Androgel also skyrocketed 17% last year, from $6.86 per unit in January 2015, to $7.83 per unit at the end of December 2015. Clearly, if the brand manufacturer continues to inflate its AWP, the differential between the brand and generic prices will be even greater in the future.
Men also use another brand gel – Axiron – which is also exorbitantly priced, at about $576 per 30 day prescription.
Thus, if your Plan wants to control its costs, you should eliminate coverage for both brand products: Androgel 1.62% and Axiron.
When the National Prescription Coverage Coalition analyzed claims data for our Coalition Members last year, we found that for a relatively small Plan (providing coverage to about 8,000 lives), eliminating brand coverage could save approximately $40,000 annually. When combined with an effective Prior Authorization that restricts generic use to men with demonstrated medical conditions, the savings are even greater.
Note that your Health Plan can’t simply rely on higher brand copays to steer usage, since brand manufacturers are peddling coupons to reduce plan beneficiaries’ copays — to “as little as $10 a month” (for Androgel) and to “as little as $25 a month” (for Axiron).
If you’re male and you want to check out the coupons, use the above hyperlinks to do so. But don’t forget: If you want to eliminate potential risks from these drugs, you should avoid using the coupons or the drugs!
Moreover. if you want to protect all your plan beneficiaries and reduce your Plan’s costs, you need to implement an effective Prior Authorization Program and stear those who really need the drugs to generic use.
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To read other Rx Drug Alerts, go here.
Footnotes:
- Here’s a Consumer Reports article providing certain average cost information: http://consumerhealthchoices.org/wp-content/uploads/2013/02/ChoosingWiselyTestosteroneAUA-ER.pdf
- Liverman C, Blazer D, eds. “Testosterone and aging: clinical research directions.” Washington, DC: National Academies Press, 2004.
- See http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2009/ucm149580.htm
- See http://media.jamanetwork.com/news-item/testosterone-therapy-following-coronary-angiography-associated-increased-risk-adverse-outcomes/. Note that the difference in cardiovascular events was 19.9% in the no-testosterone group, and 25.7% in the testosterone therapy group, or an absolute risk difference of 5.8%.
- See http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0085805
- See http://www.fda.gov/Drugs/DrugSafety/ucm401746.htm
- See http://www.fda.gov/Drugs/DrugSafety/ucm436259.htm
- For insight into the effect of testosterone advertising, read this article in Consumer Reports: http://www.consumerreports.org/cro/magazine/2013/07/do-you-need-to-be-treated-for-low-testosterone/index.htm
- See http://www.fiercepharmamarketing.com/story/niche-low-t-lifestyle-clinics-might-give-suffering-lilly-abbvie-meds-boost/2015-02-04
- See http://www.fda.gov/Drugs/DrugSafety/ucm436259.htm
