Repatha RAS layoffs

I couldn’t believe hearing that all field Repatha RAS’s were laid off. What is Amgen doing? They are completely screwing the offices that count on RAS support & a virtual RAS isn’t gonna cut it. People are blaming Tuller for this awful decision.

 

This has Tuller written all over it. Offices will procrastinate the PA’s/appeals and sales will slow down dramatically. The damage is done. Now reps will be blamed for dropped sales when it was the dumb ass decision to remove the people who took the sale over the finish line.

 

Serves you fucks right. Tough shit. Now you can't fill out PA's for offices. Oh boo-hoo. Couldn't happen to a more deserving bunch.

 

Tuller making bad decisions started day 1 to force everyone to send scripts to the hub. Cost several teams dearly and all he could say is, “I am a soldier when someone tells me to do something I do it.”

Bad decisions are the norm with that guy have you seen pics of his wife!

 

We've been dancing around this doing paperwork for 4 years now. Legally we aren't allowed to pull up a desk and do PA's entirely for offices. I'm shocked we weren't busted for this before. This will hurt sales. But again we were getting away with this too long.

 

We DO NOT fill out PAs, and the RAS never did this either. This is a great job, and most would not risk their career to fill out a PA. Obviously your fishing...

 

The RAS position isn’t needed with a drug that no longer requires specialty pharmacy. The process is complicated because the office is lazy and doesn’t want to complete paperwork and because Amgen didn’t secure coverage from day one. Now that it is filled at the local pharmacy, it makes it similar to every other primary care drug on the market with the addition of the higher price tag, and the lack of insurance coverage. Amgen went for commercial plans and should have known from day one this is a Medicare part D drug.
The RAS position took pressure off the BSR and office, but is no way the same caliber as other reimbursement positions that do buy and bill. Most were previous sales reps with very little experience if any in reimbursement or even knew how to read a patient chart.Amgen “leaders” screwed everyone with their greed, arrogance, and incompetence. I wish the RAS and Repatha nurses the best in finding a reputable company with decent leadership next go around. The writing was on the wall, and us BSRs are next on the list to go. Too much overhead not enough profit.

 

What planet are you on. This was rampid company wide. Lots of pressure to get scripts and thus the RAS role did do paperwork. Stop pretending it didnt happen. You must be in HR or Legal obviously .

 

Our first RAS quit less than 90 days after launch. It was a debacle. Of course, they did PAs & denials. They were HPPA certified. Hopefully, most RASs had a heads up that this was coming. 4 years plus in a non sales job at a pharma company? And it’s contract? C’mon...

 

You have to be kidding, I can mention dozens of offices that the RAS, fill out paperwork, make copies, send in to SP. HIPPA does not give you the right to fill out paperwork , and flip through charts. Some RAS have their own office within a practice. You did the same with Prolia , the FDA is aware of what you did.

 

This wasn't true in our territory. Our RAS compliantly did her job. That being said some offices complained she didn't help them enough but that was bc she was keeping everything on the up&up and not breaking any rules. We still had good numbers regardless.

 

the fuck it wasnt true
im so glad to hear of this. now we kick ass

 

Next step, look at the reps that were working so closely with the RAS. The RAS would send this rep-usually one per territory to do the dirty work.

 

• RAS's here completely did paperwork, flipped through charts, did PA and appeal and basically were a regular employee for office. Yes they were HIPA certified but that's where it ends . It's a financial perceived value to do this and and that's against HIPA. We got away with murder doing this. The FDA knew it was going on and as usual did nothing.. There do busy trying to nail opiate companies.

 

Amgen managers have been directly managing the RAS team. They orchestrated this entire debacle.

 

Our RAS did not do anything like that. Nice try!

 

This is total and complete BS. Competitive rep trying to justify lack of success...

 

UPDATED: A new PCSK9 player draws rave reviews for inclisiran. Can a marketing war with Amgen be far behind?

The Medicines Company $MDCO waded directly into the middle of one of the most bitterly contested fields in biopharma today using a detailed set of efficacy and safety data from their Phase III study of inclisiran to build a case that their drug can whip 3 heavyweight rivals deep into the troubled PCSK9 game.
Just don’t expect the new CEO running things at the company to say much about that rivalry.
Top-lined a few days ago, the efficacy numbers posted at the European Society of Cardiology’s ESC Congress in Paris line up where the analysts had hoped, with a 54% relative reduction in LDL tied to the drug arm compared to placebo — which ranks up there with the high 50s hit by Repatha (Amgen) and Praluent (Regeneron and Sanofi). Just as importantly, the safety data on exhibit Monday look pristine, with an adverse event profile that tends to mirror the control arm along with no evidence of added toxicity — a feature that will encourage everyone in RNAi to go deeper into diseases with massive patient populations after establishing themselves in rare diseases.

The news inspired a 22% spike in the Medicines Company’s share price Tuesday morning, which starts the day with a $3.3 billion market cap.

There’s even some exploratory cardio data — which will have to be confirmed in a huge, ongoing outcomes study — to help back up their expectations for a competitive benefit on MACE and strokes that payers will want to see proved beyond a reasonable doubt.

The numbers back up a good set of odds on a near-term OK for inclisiran in 2020, provided a nasty surprise isn’t in wait along the sidelines. If so, they’ll be readying a rollout now that will take aim against two of the most touted drugs that ever fell far short of their mark.

Those lofty early expectations were bludgeoned by a high set of payer hurdles that were thrown against Repatha and Praluent with all the force insurers could muster. Already feeling the pain on hep C, they made these drugs difficult if not impossible to get at the rates set by Amgen as well as Regeneron and Sanofi, which slowly and grudgingly stepped back the wholesale price to just under $6,000 a year.

Now those same payers will likely get their shot at inclisiran, with physicians and patients likely to vastly prefer a regimen that is dramatically easier than the two established products — while no one expects payers to let down their guard on price. In the payer world, their cost trumps patient convenience if efficacy is similar.

It’s hard to get an idea, though, exactly what MedCo plans to do now, provided of course a big player like Pfizer — which had a PCSK9 drug but killed the program 3 years ago — doesn’t come along and snap it up with plans of their own.

When the biotech started out on this deal with Alnylam, then CEO — and now chief innovation officer — Clive Meanwell didn’t mince any words when it came to the prospect of royally disrupting the PCSK9 market. In his view, shared by Alnylam CEO John Maraganore, that market was ripe for the taking — and making.

Late last year, though, Meanwell was replaced at the helm as chairman Alex Denner — an activist investor with a hands-on rep — shook things up and brought in ex-Purdue CEO Mark Timney, just as Timney was being brought into a maelstrom of lawsuits for his alleged role in creating a catastrophic national opioid epidemic. Those claims against Purdue stack up into the billions of dollars, while Timney himself has reportedly been accused of telling reps to emphasize OxyContin’s abuse-deterrent properties while leaving out the fact that he knew it wouldn’t prevent abuse.

In a preview of today’s presentation, Timney — who bagged an $8.7 million set of stock options and a $50,000 bonus on his arrival — was supremely indifferent to any overhang presented by Repatha and Praluent. RNAi, he says, has a distinctly different mechanism of action, closing down on the production of bad LDL cholesterol.

“We really do not consider the monoclonal antibody to be a competitor,” the CEO told me. “The real competitor is cardiovascular disease.” Then in the next breath he notes that the multiple annual injections required to maintain efficacy for Repatha and Praluent don’t “suit” treatment of a chronic disease.

The CEO’s positioning on price, a subject that often elicits all kinds of charades ahead of a new drug approval, is boiled down to delivering on “maximizing shareholder value,” and you can interpret that any way you like.

Analysts aren’t nearly so coy.

For MedCo to carve out market share as Repatha and Praluent continue to flounder — with Sanofi and Regeneron playing the role of second fiddle to Amgen — the Wall Street crew are looking for a price in the $4,000 to $6,000 per year range. Some observers wonder if they’ll actually get in closer to ICER’s recommendation of $2,300 to $4,000 a year for the antibodies, depending on the population profile. And that could leave Praluent, which just won the latest in a long set of legal rounds with Amgen’s Repatha, a marginal and uncompetitive player that Geoff Porges believes could be relegated to the dusty back shelves.

Under their licensing deal with Alnylam, The Medicines Company gets to call the shots on marketing. But Maraganore is intensely focused on the upside here with a clear win for inclisiran. This would be the third product out of Alnylam to win an OK, and the first aimed at a broad market. Clearing the bar on safety in cardio will encourage investors to support their programs on other big targets like NASH, reducing the nagging fears of a systemic, platform safety issue that could drag on the class.

Maraganore calls inclisiran an “almost vaccine-like product, unbelievably promising and encouraging.” And he’s looking for a cut of up to 20% of the cash stream, with the high end triggered by a billion dollars in revenue. He expects that their percentage will average in the high teens, putting the company another big step toward profitability and a sustainable future.

Analysts by and large were quick to cheer the Phase III data, with growing confidence that the next two pivotal trials will read out in their favor as well.

“(W)e believe this early peek at outcomes data is encouraging for long-term trial ORION-4 and may improve physician uptake ahead of full outcomes results,” noted SVB Leerink’s optimistic Joseph Schwartz.
Biren Amin at Jefferies had this headline: “Data is as good as it gets.”

Evercore ISI’s Umer Raffat said:

Ultimately, from bigger picture perspective, the buzz from the conference is very +ve
And Yaron Werber at Cowen sees some significant headwinds buttressing a struggling Repatha and Praluent.

We view our $1.9B global sales estimate for Repatha and $625MM global sales estimate for Praluent in FY23 to be at risk due to both (1) requirement for strong market growth to achieve that estimate, and (2) competitive headwind from inclisiran.

Whatever happens to Regeneron and Sanofi, though, don’t look for Amgen to roll over and play dead. They just launched a new 13,000 patient study looking to further expand their label on Repatha. And after making huge investments and learning exactly how payers are thinking about PCSK9, it has a lead on market development that they could turn to their advantage if they choose to get competitive on pricing with the much smaller biotech rival.

The new war over PCSK9 hasn’t even started yet.