Aggressive Payers Block Access To PCSK9s

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Includes: AMGN, REGN, SNY
by: EP Vantage

Less than a third of US patients initially prescribed Repatha or Praluent actually received the expensive cholesterol-lowering drugs in the first year that these were on the market, thanks to a strong payer response that saw nearly eight of 10 first claims rejected.

The analysis of pharmacy transaction data revealed at ACC confirms that payers wanted to see evidence that patients had confirmed heart disease and elevated LDL in spite of optimised statin therapy. This shows the challenge that Repatha's maker, Amgen (NASDAQ:AMGN), faces as it tries to expand coverage on the basis of data showing that the injection does prevent heart attacks and strokes, but maybe not enough to justify its high price (ACC – No Repatha of glory, March 17, 2017).

Rejected

The data from Symphony Health Solutions covers transactions amounting to 90% of retail, 70% of speciality and 60% of mail order pharmacies between August 1, 2015, and July 31, 2016, roughly covering the launch year of the two PCSK9 inhibitors. It found that 79% of prescriptions were rejected in the first 24 hours. After resubmitting patient records to support the PCSK9 prescriptions, 53% were rejected.

And not all of those approved reached the patients – of the total 45,000 transactions included in the analysis, 7,400 were approved but never picked up. Meanwhile, 13,900, 31%, were approved and administered, said Anne Marie Navar, a professor at the Duke University medical school.

Dr. Navar noted that PCSK9 prescription volume had increased over that time, but the number of dispensed prescriptions did not grow at the same rate, and towards the end of the 12 months studied had gone into decline. Meanwhile, government payers like Medicare had a total rejection rate of 40%, against the 71% of commercial insurers.

“The fact that this varies so substantially by payer and is not getting better over time suggests that non-clinical factors are at play,” she said.

No heart attacks or your money back

Amgen, which supported Dr. Navar’s research along with Praluent’s sponsors, Regeneron (NASDAQ:REGN) and Sanofi (NYSE:SNY), appears to be taking those non-clinical factors seriously as it seeks to kick-start the Repatha launch.

Along with the results of the Fourier cardiovascular outcomes trial released at ACC the California-based group also announced some initiatives to persuade payers to permit greater adoption – among them, an offer to refund Repatha costs for patients who experience a myocardial infarction or stroke.

“The money-back guarantee is our confidence in our drug and what it can deliver for patients,” Scott Wasserman, Amgen’s vice-president of global development, said. “When you talk to payers, they say they want to know the budget impact, and they want some predictability. So we’re willing to take some of that risk from them.”

The cardiovascular outcomes data might also make it easier to calculate the cost and benefit of Repatha for the patients with established cardiovascular disease who have elevated LDL despite being on statin therapy. “We’re very interested in having that very open dialogue with payers around making sure the right patients get access,” he said.

With Fourier falling short of high expectations, Amgen’s commercial challenge is one of pharmacoeconomics. The group might reduce the high rejection rate documented during the first launch year and expand Repatha’s use, but this will take a combination of canny price concessions with marketing that ensures physicians are prescribing it only to the patients who are most likely to benefit.