Evaluation of Prior Authorization Requests for Alirocumab and Evolocumab at a PPO Health Plan Blue Cross Blue Shield of Michigan OBJECTIVE: To examine baseline treatment of members requesting prior authorization (PA) of alirocumab and evolocumab and effects on LDL-C among those approved for therapy. METHODS: Retrospective review of commercially insured members with Blue Cross Blue Shield of Michigan pharmacy benefit requesting alirocumab and evolocumab from July 24, 2015 to June 30, 2016 was conducted. RESULTS: A total of 284 PA requests were received, with 272 (95.8%) being denied. Ninety-six cases were appealed, with 63 (65.6%) denied. After a denied appeal, one case was escalated for external review, and the denial was upheld. Are you kidding me – 284 patients written for a PCSK9 script, and only 33 actually got drug. WTF?
This data puts the blame on reps. However, it also shows that the eligible pool of patients per guidelines and label is just too small, so reps ask for broader patient populations because they need sales. Amgen HQ didn't do a great job marketing size. This blame should also include CFOR, Global Marketing, HECON, as well as the US CV business unit. http://www.jmcp.org/doi/pdf/10.18553/jmcp.2016.22.10-a.s1 Evaluation of Prior Authorization Requests for Alirocumab and Evolocumab at a PPO Health Plan Bigness C, Tungol Lin A. 600 E Lafayette, #512C, Detroit, MI 48226; Blue Cross Blue Shield of Michigan BACKGROUND: Alirocumab and evolocumab were FDA-approved in summer 2015 as adjunct treatment of familial hypercholesterolemia (FH) and clinical atherosclerotic cardiovascular disease (ASCVD), based on their ability to significantly reduce low density lipoprotein cholesterol (LDL-C). Studies to support cardiovascular risk reduction are in progress. Guidelines recommend statins as first line therapy in FH and ASCVD since cardiovascular risk reduction is well documented, with ezetimibe and bile acid sequestrants (BAS) as options for adjunct therapy. While statins have been the mainstay, intolerance is highly reported in the community. Alirocumab and evolocumab could significantly impact health plans financially, despite lack of cardiovascular risk reduction data. OBJECTIVE: To examine baseline treatment of members requesting prior authorization (PA) of alirocumab and evolocumab and effects on LDL-C among those approved for therapy. METHODS: Retrospective review of commercially insured members with Blue Cross Blue Shield of Michigan pharmacy benefit requesting alirocumab and evolocumab from July 24, 2015 to June 30, 2016 was conducted. Member demographics, diagnosis, current medications and intolerances, lifestyle modifications, LDL-C, and PA approval status were analyzed using pharmacy claims data and PA requests submitted by prescriber offices. Approved PAs were reviewed for repeat LDL-C after two to three months of therapy. RESULTS: A total of 284 PA requests were received, with 272 (95.8%) being denied initially. Ninety-six cases were appealed, with 63 (65.6%) denied. After a denied appeal, one case was escalated for external review, and the denial was upheld. Diagnoses included clinical ASCVD (55.6%), heterozygous FH (3.9%), and homozygous FH (0.4%). Off label use was requested among 40.1% of cases. Baseline therapy included maximal dose of high intensity statin (10.6%), ezetimibe (22.9%), and BAS (6.7%). Intolerances to statins (75.7%), ezetimibe (22.5%), and BAS (9.5%) were reported. Ninety-one members (32.0%) had documented lifestyle modifications. Forty-five members (15.8%) were initiated on therapy with samples. Average LDL-C was 160.5 mg/dL (range 38-357 mg/dL) among patients with a submitted LDL-C (n=228). A total of 25 approved cases had repeat LDL-C available (average 73.1 mg/dL, range 12-191.3 mg/dL), representing average LDL-C reduction of 60.2% (range 32.6-90.0%). CONCLUSIONS: Guideline recommendations were not consistently followed among members requesting alirocumab and evolocumab. Documented LDL-C reductions were in accordance with package labeling. SPONSORSHIP: Blue Cross Blue Shield of Michigan.
33 out of 284 patients actually got approved for the drug? I'd die for those high numbers. Michigan reps should be proud of themselves.
PCSK9 therapeutics are a sales disaster for Amgen AND Sanofi, with neither PC or specialty making the grade at EITHER company. The truth is that there are Girl Scout troops out there that move more cookies than you guys sell in drugs.
The truth is that it's up to clinicians to decide what's best for the patient. Blue Shield should be investigated for denying therapy. Payor default. Has nothing to do with companies or reps. It takes two years for new expensive biologic therapy to establish itself in a normal Payor environment. Current payor environment means no more innovation. The payors would rather their customers die.
Truth is Mgmt. will tote the company line. and put blame solely on Reps lmao Classic Shit you cant make up!
The data shows that you idiots told doctors to write Repatha off label. We have a CIA. You want us in more shit. Do your job. 40% off label is solely on you. Find more HeFH or HoFH patients. CFOR says the number of patients are there but you r*****s can't find them. NOW SELL OR DIE! Don't make me get that brown looking women VP of the CV BU to beat you down with collard greens and fried chicken.
The payors are not approving for HeFH or HoFH! Is there no one paying attention? THE PAYORS ARE DENYING APPROPRIATE PARIENTS!!! Amgen needs to 1) contract aggressively for the first time in it's existence and 2) sue the payors that are not approving appropriate patients. Biotech is powerful. Stop being afraid of your own shadow. If we spend 2 months appealing and our competitor gets the prescription because it's preferred, then that is on you Amgen. If you expect 10% of a market as if it was 1996, that is poor forecasting in the current Payor environment. Executive failure to fight politically, to be aggressive and contract broadly, and to support specialty pharmacy. Fire the HUB. GET RID OF PHARMA EXECS WHO KNOW NOTHING ABOUT BIOLOGIC INJECTABLES. STOP CONTRACTING YOUR SOUL AWAY. Stop pushing out all the professionals with launch wisdom because we are making the same mistakes over and over. Encourage criticism because mistakes are being made and fear keeps everyone quiet in this shark eat shark culture. Amgen, you are better than this.
They don't have to cover drugs. There is no law saying they have to cover it. Patients can pay out of pocket.
It is career suicide at Amgen to do this. Even if you are right and have the data to prove it. All the best people who dissented instead of suck up to management are gone. What's left is a bunch of slick talking "yes" men. This is the result of Amgen being the only company in town. The reason biotech hubs like San Francisco and Boston are superior because: 1. They attract the "A" talent that Amgen cannot 2. People there if their employer is incompetent like Amgen, they leave 3. Companies know what good talent looks like and actually has to fight to keep it because that talent has options 4. Companies don't hire smart people there to misuse them like they do at Amgen. No bait and switch where the company expects you to put your head down and be a lemming
