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Accessing innovative cardiovascular drugs may soon get harder.

new publication from the Institute for Clinical and Economic Review, a drug price analysis group, assigns a C+ effectiveness grade to cholesterol-lowering drugs known as PCSK9 inhibitors.  The lukewarm valuation sets the stage for increased health plan barriers, despite the drugs’ effectiveness in reducing heart attack and stroke risk.

PCSK9 inhibitors work by preventing the PCSK9 protein from destroying a receptor on the liver that clears bad cholesterol. The receptor “lives” longer, clearing more LDL cholesterol for the patient.  For some patients who don’t sufficiently respond to traditional statin therapy, the drugs have offered unprecedented improvement.

Cost-effectiveness Analysis for PCSK9 Inhibitors

The evidence update supplements ICER’s 2015 cost-effectiveness report on PCSK9 inhibitors.  That report found the drugs to be “promising but inconclusive.”  ICER was driven to update its findings after new clinical trials data on one PCSK9 inhibitor became available earlier this year.

The effectiveness grade is the first of two parts of the evidence update.  The grade provides a premise for the second component, the organization’s “benchmark” value price.  That’s due out in August.  ICER’s benchmark prices can influence health plan coverage for advanced medicines that may exceed that price.

Drawback to ICER’s Evidence Update

But before health plans move to make access to PCSK9 inhibitors more difficult, they might consider several key drawbacks to ICER’s evidence update.

1.)  The update is premature.  Longer-term clinical testing on alirocumab, one of two PCSK9 inhibitors approved by the FDA, has not yet concluded.  ICER acknowledges that the forthcoming data from the ODYSSEY clinical trial could “shine additional light” on the value of PCSK9 inhibitors.  Yet it shows no sign of delaying its evidence update to provide a more complete picture of the drugs’ impact.

In the meantime, ICER assumes a “class effect.”  That is, rather than waiting for data specific to each PCSK9 inhibitor, the organization is prepared to simply apply its analysis of one drug to another.

2.) ICER’s update excludes a critical patient group: people with inherited high cholesterol, or familial hypercholesterolemia.  This includes young people, even children, who face staggering levels of LDL, or “bad cholesterol,” from an early age.  Some cannot lower their cholesterol enough using traditional statin therapy.  Familial hypercholesterolemia is one of the two conditions PCSK9 inhibitors are FDA-approved to treat.

3.)  ICER hinges its evaluation of PCSK9 inhibitors on the drug’s lack of mortality benefit.  Patients in clinical trials did not demonstrate that the PCSK9 inhibitor evolocumab prevented them from dying as a result of high LDL cholesterol and related events, ICER points out.   But accepting that data at face value may be shortsighted.  The duration of the trial – just two years – makes measuring mortality a challenge.  It’s also possible that the drug’s effect intensifies with time.  Risk reduction rose seven percentage points after the first year of the trial.

Existing Access Barriers

Any health plan barriers that arise from ICER’s effectiveness report – and the benchmark price that follows – would compound existing challenges.  According to a national health plan report card from the Institute for Patient Access, health plans already have rejected 43% — more than 80,000 – of patients’ prescriptions for PCSK9 inhibitors.

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